WO2018019165A1

WO2018019165A1 - Stent delivery system

Info

Publication number: WO2018019165A1
Application number: PCT/CN2017/093493
Authority: WO
Inventors: 孙英贤
Original assignee: 孙英贤
Priority date: 2016-07-29
Filing date: 2017-07-19
Publication date: 2018-02-01
Also published as: CN107661162A

Abstract

A stent delivery system, comprising a balloon catheter and a stent (10). The present invention relates to the technical field of medical devices. Provided is a balloon catheter with a balloon (1) with two asymmetrical ends. The catheter comprises: the balloon (1), an outer tube (2), an inner tube (3), and a connector (5). The balloon (1) is sleeved around the inner tube (3). The stent (10) is pressure gripped by the balloon (1). The distal end of the stent (10) is pressed against and held by an inclined section (102) at a distal end of the balloon (1). Alternatively, the distal end of the stent (10) extends from the distal end of the balloon (1) and is pressure gripped by the inner tube (3). The distal end of the stent (10) is pressed against and held by a distal inclined section (102) with a smaller gradient, or extends from the distal end of the balloon (1) and is pressed against and held by the inner tube (3). When the balloon (1) is subject to pressure expansion, then the distal inclined section (102) with the smaller gradient lifts the distal end of the stent (10) such that a distal diameter of the stent (10) is smaller than the proximal diameter. The invention is adapted to a physiological change of a blood vessel and prevents an expansion from injuring the blood vessel.

Description

Stent delivery system

Technical field

The invention belongs to the field of medical instruments, in particular to a stent delivery system.

Background technique

Percutaneous Coronary Intervention (PCI) refers to the treatment of myocardial perfusion by transcatheter catheterization to clear the stenosis or even occlusion of the coronary lumen. The treatment method has the advantages of short treatment course, small trauma and remarkable curative effect, and has developed rapidly in recent years. According to different implementation techniques, PCI can be divided into percutaneous coronary angioplasty (PTCA), coronary stenting, coronary atherectomy, cutting balloon angioplasty, intracoronary thrombus aspiration, and the like.

During the operation, the delivery system transports the stent from the outside to the coronary artery stenosis. At the same time as the balloon is pressurized and expanded, the stent is expanded to become a cylindrical shape, supporting the vessel wall, expanding the blood vessel, achieving revascularization, and improving. The role of myocardial blood flow.

In the existing stent delivery system, both ends of the stent are located at the middle portion of the balloon (ie, the columnar portion), and the stent is expanded and cylindrical as the balloon is pressurized, and the vessels having similar diameters at both ends are The stent delivery system is a preferred option, but for a vessel having a distal diameter that is significantly smaller than the proximal vessel, the existing stent delivery system is susceptible to damage to the distal vessel of smaller diameter after the stent is distracted.

Summary of the invention

In order to avoid damage to the distal vessel having a smaller diameter after stent expansion, it is an object of the present invention to provide a stent delivery system. The stent delivery system presses the stent on the balloon such that the distal end of the stent is located at a slope of the distal end of the balloon. After the balloon is expanded, the proximal diameter of the stent is larger than the distal end to avoid distal vascular injury.

The object of the present invention is achieved by the following technical solutions:

The present invention includes a balloon catheter and a stent, the balloon catheter comprising a balloon, an outer tube, an inner tube and a joint, wherein the balloon is sleeved at a distal end of the inner tube, the holder is crimped on the balloon; The distal end is gripped on the ramp section at the distal end of the balloon, or the distal end of the stent is extended from the distal end of the balloon and is gripped on the inner tube.

Wherein: the balloon comprises an intermediate section and a slope section respectively connected to both ends of the intermediate section, and the slope section at both ends is asymmetric after the pressure expansion, that is, the slope section and the proximal end of the distal end of the balloon The slope section is radially retracted from the inside to the outside after the pressure expansion, the slope of the distal slope section is smaller than the slope of the proximal slope section, and the proximal end of the bracket is crimped on the intermediate section; A plurality of developing rings are axially disposed at a portion where the inner tube overlaps the balloon, and a distal end of the distalmost developing ring marks a boundary between the intermediate portion and a slope portion having a small distal slope or marks the distal end a slope with a small slope;

The distal end of the balloon is connected to the distal end of the inner tube, or the distal end of the balloon is connected to a connecting tube mounted at the distal end of the inner tube, the proximal end of the balloon being connected to the outer tube; The connecting tube connected to the distal end of the tube after extending the balloon is a flexible connecting portion, one end of the flexible connecting portion is connected to the inner tube, and the other end is connected with the head end, The flexible connecting portion enters the blood vessel and is bent in conformity with the shape of the blood vessel, and the distal end of the balloon is connected to the flexible connecting portion;

The axial section of the slope section of the balloon is radially inwardly contracted from the inside of the balloon, and the axial section of the slope section is a straight section, an outwardly convex arc, an inward concave arc or a multi-segment line;

The axial section of the distal slope section of the balloon is divided into two sections, the slope of the inner side is smaller than the slope of the other section of the outer side, and the distal end of the bracket is pressed at the junction of the two sections;

The slope segments at both ends are provided with a connecting portion for connection; a portion of the inner tube overlapping the balloon is axially provided with a plurality of developing rings, and the distal end of the most distal developing ring marks the a distal end of the stent; a guide wire opening is provided on the outer tube or the joint.

The advantages and positive effects of the present invention are:

The invention clamps the distal end of the stent to the distal slope section with a small slope of the balloon or protrudes from the distal end of the balloon and presses the inner tube. When the balloon is pressurized and expanded, the distal slope of the slope is small. The segment supports the distal end of the stent, so that the distal diameter of the stent is smaller than the proximal end, which is suitable for physiological changes of the blood vessel, and avoids damage to the blood vessel after expansion.

DRAWINGS

1 is a schematic structural view of Embodiment 1 of the present invention;

Figure 2 is a partial enlarged view of a portion A in Figure 1;

3 is a schematic structural view of Embodiment 2 of the present invention;

Figure 4 is a partial enlarged view of B in Figure 3;

FIG. 5 is a schematic structural diagram of Embodiment 3 of the present invention; FIG.

6 is a schematic structural view of Embodiment 4 of the present invention;

Figure 7 is a schematic structural view of Embodiment 5 of the present invention;

Figure 8 is a schematic structural view of Embodiment 6 of the present invention;

Figure 9 is a schematic view showing the structure of a balloon of a shape according to the present invention;

Figure 10 is a schematic view showing the structure of a balloon of a second shape according to the present invention;

Figure 11 is a schematic view showing the structure of a balloon of a third shape according to the present invention;

12 is a schematic structural view of a balloon of a fourth shape according to the present invention;

Wherein: 1 is the balloon, 101 is the middle section, 102 is the slope section, 103 is the connecting part, 2 is the outer tube, 3 is the inner tube, 4 is the head end, 5 is the joint, 6 is the guide wire outlet, 7 is the developing Ring, 8 is a liquid-passing chamber, 9 is a strain relief tube, and 10 is a stent.

detailed description

The invention will be further described in detail below with reference to the accompanying drawings.

Embodiment 1

As shown in FIG. 1 and FIG. 2, the present invention includes a balloon catheter and a stent 10. The balloon catheter of the present embodiment is a rapid exchange (RX) balloon catheter, including a balloon 1, an inner tube 3, and an outer tube 2. Head end 4 and joint 5, The inner tube 3 is disposed in the outer tube 2, the inner tube 3 is internally penetrated for the guide wire to pass through, the balloon 1 is sleeved at the distal end of the inner tube 3, and the slope portion 102 at both ends of the balloon 1 is pressurized and expanded. The asymmetrical structure, that is, the slope section 102 at both ends of the balloon 1 is radially retracted from the inside to the outside after the pressure expansion, and the slope of the distal slope section is smaller than the slope of the proximal slope section. As the slope of the distal ramp section becomes smaller, the length of the inner tube 3 will be correspondingly extended. The distal end of the stent 10 is gripped on the sloped section 102 at the distal end of the balloon 1, or the distal end of the stent 10 is extended from the distal end of the balloon 1 and is gripped on the inner tube 3; after the balloon 1 is pressurized and expanded The stent 10 is propped up in a shape corresponding to the balloon 1.

As shown in FIGS. 9-12, the balloon 1 includes an intermediate section 101 and a slope section 102 respectively connected to both ends of the intermediate section 101. The intermediate section 101 is a balloon body and has a column shape, and the slope sections 102 at both ends are provided for Connected connection portion 103. The axial section of the slope section 102 of the balloon 1 is radially inwardly contracted from the inside of the balloon 1. The axial section of the slope section 102 can be a straight section (as shown in FIG. 9), an outwardly convex arc. (as shown in Figure 11), an inwardly concave arc (as shown in Figure 12) or a polyline. Alternatively, the axial section of the balloon 1 proximal ramp section 102 is radially inwardly contracted outwardly from the interior of the balloon 1, and the axial section of the ramp section 102 can be a straight section (as shown in FIG. 9), outward. a convex arc (as shown in Figure 11), an inwardly concave arc (as shown in Figure 12) or a multi-segment line; and the axial section of the distal slope section of the balloon 1 is shown in Figure 10, the distal end of the balloon 1 The axial section of the ramp section is divided into two sections, the section on the inner side (i.e., the section connected to the intermediate section 101) has a slope smaller than the slope on the outer side, and the distal end of the bracket 10 is gripped at the junction of the two sections. The axial section of the slope section 102 at both ends of the balloon 1 of the present embodiment is a straight section.

The distal end of the balloon 1 is connected to the distal end of the inner tube 3 through the connecting portion 103, or the distal end of the balloon 1 is connected to the connecting tube installed at the distal end of the inner tube 3 through the connecting portion 103, one end and the inner side of the connecting tube The distal end of the tube 3 is connected, and the other end is connected to the head end 4. The connecting tube can be a hose, a flexible connecting tube or the like. The distal end of the balloon 1 of the present embodiment is connected to the distal end of the inner tube 3 through the connecting portion 103. The proximal end of the balloon 1 is connected to the outer tube 2 via a connecting portion 103, and the distal end of the inner tube 3 is connected to the head end 4.

The balloon 1 is a liquid-passing chamber 8, and a plurality of developing rings 7 are axially disposed at a portion where the inner tube 3 overlaps the balloon 1. The position of the developing ring 7 can be displayed by a corresponding instrument, thereby helping the operator to understand the ball. The position of the capsule 1. The distal end of the distalmost developing ring 7 may mark the junction of the cylindrical intermediate section 101 of the balloon 1 with the slope section 102 of the distal slope, or the slope section 102 of the distal slope, or may be It is necessary to mark other parts of the balloon 1, and the distal end of the distalmost developing ring 7 may also mark the distal end of the stent 10. Of course, the distal end of the stent 10 may not be marked.

A guide wire outlet 6 is provided on the outer tube 2. The proximal end of the outer tube 2 is connected to the joint 5, and a strain relief tube 9 is disposed between the proximal end of the outer tube 2 and the joint 5. The strain relief tube 9 is fastened on the joint 5, and the strain relief tube 9 is used to avoid stress concentration. Improve the life of the balloon catheter.

The balloon 1 of the present embodiment is formed by pressure heating and blow molding, and the nylon pipe having an inner diameter of 0.3 to 1.5 mm, an outer diameter of 0.6 to 2.0 mm, and a length of 400 to 600 mm is at a pressure of 300 to 600 PSI and 160 to 220. Blowing under conditions of Celsius, a cylinder having a diameter of 2.0 to 5.0 mm and a length of 5.0 to 30.0 mm is obtained as a main body of the balloon 1, and a connecting portion 103 is provided at each of the slope portions 102 at both ends of the balloon 1, and the connecting portion 103 is provided. of The outer diameter is 0.60 to 1.02 mm, and the length is 1.0 to 5.0 mm. A liquid-passing chamber 8 is formed between the balloon 1 and the inner tube 3, and the balloon can be inflated after the liquid-passing chamber 8 is passed through the developing solution, thereby expanding the stent.

The outer tube 2 is made of nylon, polyethylene, polypropylene or block polyamide. The extrusion temperature is 200-280 degrees Celsius and the cooling temperature is 15-40 degrees Celsius. The extrusion length is 250-1600 mm and the outer diameter is 0.76-0.86. The outer tube 2 is obtained from a tube having a thickness of 0.04 to 0.14 mm.

The inner tube 3 is made of nylon, polyethylene, polypropylene or block polyamide, and is produced under the same conditions as the outer tube 2, and has a length of 250 to 1600 mm and an outer diameter of 0.50 to 0.61 mm.

Embodiment 2

As shown in FIG. 3 and FIG. 4, the difference between this embodiment and the first embodiment is that the distal end of the stent 10 is protruded from the distal end of the balloon 1 and is gripped on the inner tube 3. Others are the same as in the first embodiment.

Embodiment 3

As shown in FIG. 5, the difference between this embodiment and the first embodiment is that the distal end of the inner tube 3 of the present embodiment protrudes from the balloon 1 and is connected with a flexible connecting portion 11, one end of the flexible connecting portion 11 and the inner tube. 3 is connected, and the other end is connected to the head end 4. The flexible connecting portion 11 enters the blood vessel and is bent in conformity with the shape of the blood vessel. The distal end of the balloon 1 is connected to the flexible connecting portion 11 through the connecting portion 103. Others are the same as in the first embodiment.

Embodiment 4

As shown in FIG. 6, the difference between this embodiment and the first embodiment is that the balloon catheter of the present embodiment is a guide wire (OTW) type balloon catheter, and the guide wire interface 6 is disposed on the joint 5. Others are the same as in the first embodiment.

Embodiment 5

As shown in FIG. 7, the difference between this embodiment and the fourth embodiment is that the distal end of the stent 10 is protruded from the distal end of the balloon 1 and is gripped on the inner tube 3. The others are the same as in the fourth embodiment.

Embodiment 6

As shown in FIG. 8 , the difference between the embodiment and the fourth embodiment is that the distal end of the inner tube 3 of the embodiment extends out of the balloon 1 and is connected with a flexible connecting portion 11 , and one end of the flexible connecting portion 11 and the inner tube 3 is connected, and the other end is connected to the head end 4. The flexible connecting portion 11 enters the blood vessel and is bent in conformity with the shape of the blood vessel. The distal end of the balloon 1 is connected to the flexible connecting portion 11 through the connecting portion 103. The others are the same as in the fourth embodiment.

The working principle of the invention is:

During the operation, the stent 10 is transported from the outside to the vascular stenosis of the affected part through the delivery system. At the same time as the balloon 1 is pressurized and expanded, the stent 10 is opened by the balloon 1 to support the blood vessel wall, thereby expanding the blood vessel, achieving revascularization, and improving. The role of myocardial blood flow. When the balloon 1 is pressurized and expanded, the distal slope section 102 with a small slope extends the stent 10 to support the distal vessel wall, because the distal end inner diameter is small, and the distal vessel wall is prevented from being broken; the columnar intermediate section 101 supports the stent support Larger, proximally affected part of the vessel wall. The delivery system is withdrawn after the stent 10 is implanted and the balloon 1 is depressurized and evacuated.

The present invention can be used for interventional procedures of the head, neck and peripheral blood vessels in addition to percutaneous coronary blood vessels.

Claims

A stent delivery system includes a balloon catheter and a stent, the balloon catheter including a balloon, an outer tube, an inner tube and a joint, wherein the balloon is sleeved at a distal end of the inner tube, and the stent is crimped on the balloon Characterized in that the distal end of the stent (10) is gripped on the slope portion (102) at the distal end of the balloon (1), or the distal end of the stent (10) is extended from the distal end of the balloon (1). Pressed on the inner tube (3).
The stent delivery system according to claim 1, wherein said balloon (1) comprises an intermediate section (101) and a slope section (102) respectively connected to both ends of the intermediate section (101), at both ends The slope section (102) is asymmetric after the pressure expansion, that is, the slope section at the distal end of the balloon (1) and the slope section at the proximal end are radially inwardly contracted from the inside to the outside after the pressure expansion. The slope of the distal ramp section is less than the slope of the proximal ramp section, and the proximal end of the bracket (10) is crimped onto the intermediate section (101).
The stent delivery system according to claim 2, wherein a portion of the inner tube (3) overlapping the balloon (1) is provided with a plurality of developing rings (7) in the axial direction, and is located at the most distal end. The distal end of the ring marks the intersection of the intermediate section (101) with the slope section (102) of the distal slope or the slope section (102) of the distal slope.
A stent delivery system according to claim 1 wherein the distal end of said balloon (1) is connected to the distal end of the inner tube (3) or the distal end of the balloon (1) is mounted to the inner tube. (3) The distal connecting tube is connected, and the proximal end of the balloon (1) is connected to the outer tube (2).
The stent delivery system according to claim 4, wherein the distal end of the inner tube (3) extends beyond the balloon (1) and the connecting tube is a flexible connecting portion (11), the flexible connecting portion ( 11) one end is connected to the inner tube (3), and the other end is connected with a head end (4). The flexible connecting portion (11) enters the blood vessel and is bent in conformity with the shape of the blood vessel, and the distal end of the balloon (1) is connected to On the flexible connecting portion (11).
A stent delivery system according to claim 1, 2 or 4, characterized in that the slope section (102) of the balloon (1) has an axial section which is radially inward from the inside of the balloon (1) Shrinking, the axial section of the ramp section (102) is a straight section, an outwardly convex arc, an inwardly concave arc or a polyline.
The stent delivery system according to claim 1, 2 or 4, characterized in that the axial section of the distal slope section (102) of the balloon (1) is divided into two sections, and the slope located on the inner side is smaller than the outer side. On the slope of the other section, the distal end of the stent (10) is crimped at the junction of the two segments.
A stent delivery system according to claim 1, 2 or 4, characterized in that the ramp sections (102) at both ends are each provided with a connection (103) for connection.
The stent delivery system according to claim 1, 2 or 4, characterized in that the inner tube (3) is provided with a plurality of developing rings (7) in the axial direction at a portion overlapping the balloon (1). The distal end of the most distal developing ring marks the distal end of the stent (10).
A stent delivery system according to claim 1, 2 or 4, characterized in that the outer tube (2) or the joint (5) is provided with a guide wire opening (6).