Vascular stenosis stent and treatment system

Abstract

The invention provides a vascular stenosis stent and a treatment system, and belongs to the field of medical instruments, the vascular stenosis stent comprises a balloon catheter, a stent catheter and a guide wire, the guide wire penetrates through the balloon catheter, the balloon catheter is sleeved with the stent catheter, the head end of the balloon catheter is provided with a guide wire penetrating opening, and the head end of the stent catheter is provided with a catheter penetrating opening; the tail end of the balloon catheter is fixedly connected with a balloon, a self-expanding stent is arranged at the tail end of the stent catheter corresponding to the outer side wall of the balloon, the balloon expands to drive the self-expanding stent to expand, the problem of blood vessel stenosis is solved after the balloon is inflated, and meanwhile the stent provides radial supporting force.

Description

Technical Field

[0001] The invention belongs to the field of medical technology, and in particular relates to a vascular stenosis stent and a treatment system. Background Art

[0002] Currently, stents used for vascular stenosis include balloon-expandable stents and self-expandable stents, but both have many disadvantages, as follows:

[0003] (1) In terms of surgical procedures, the radial support force of the balloon-expandable stent is poor after release, and the stent may collapse, increasing the risk of surgery. In order to provide support force, a self-expanding stent can be used to maintain the radial support force after release, but it requires pre-expansion and / or post-expansion of the self-expanding stent, and there are many surgical steps.

[0004] (2) In terms of support effect, for example, in bifurcated blood vessels, the diameters of the main blood vessels and the branch blood vessels are different. After the balloon and stent are stretched, they can only maintain one size. It is difficult for the balloon stent to take into account blood vessels of different diameters at the same time, and the balloon stent has poor adaptability to blood vessel size. Summary of the invention

[0005] In order to solve the above problems, the present invention adopts the following technical solutions according to some embodiments:

[0006] The present invention provides a stent for vascular stenosis, comprising a balloon catheter, a stent catheter and a guidewire, wherein the guidewire runs through the balloon catheter, the stent catheter is sheathed outside the balloon catheter, the guidewire through hole is arranged at the head end of the balloon catheter, and the catheter through hole is arranged at the head end of the stent catheter;

[0007] The end of the balloon catheter is fixedly connected to the balloon, and a self-expanding stent is arranged at the end of the stent catheter corresponding to the outer wall of the balloon, and the self-expanding stent is limited between the balloon catheter and the stent catheter;

[0008] The diameter of the balloon is less than or equal to the diameter of the blood vessel, and the diameter of the self-expanding stent is greater than or equal to the diameter of the blood vessel.

[0009] It is further configured that a flushing port is provided at the head end of the stent catheter and at one side of the catheter penetration, and an inflation port is provided at the head end of the balloon catheter and at one side of the guide wire penetration.

[0010] It is further configured that the central axis of the balloon catheter, the central axis of the stent catheter and the guide wire are coaxially arranged.

[0011] It is further configured that a conical head is provided at the end of the balloon catheter.

[0012] It is further configured that a limiting ring is arranged between the proximal end of the balloon catheter and the conical head, the limiting ring is arranged on the side wall of the balloon catheter, and the diameter of the conical head is the same as the diameter of the limiting ring.

[0013] It is further configured that a gap is provided between the balloon catheter and the stent catheter.

[0014] It is further configured that the bracket is a laser engraved open-loop bracket or a closed-loop bracket, and the bracket is made of alloy material.

[0015] It is further configured that the stent is a drug-eluting stent or a bare stent.

[0016] It is further configured that the conical head is provided with a shuttle-shaped surface.

[0017] The present invention also provides a treatment system, using the above-mentioned vascular stenosis stent, comprising the following steps:

[0018] The self-expanding stent is arranged between the limiting ring and the conical head, and then the stent catheter is sleeved on the outside of the self-expanding stent and the limiting ring. The stent catheter and the limiting ring simultaneously limit the self-expanding stent, and the balloon catheter is carried along the guide wire to the stenotic part of the blood vessel. After the stent catheter is withdrawn to release the restriction on the self-expanding stent, the self-expanding stent expands, the center of the self-expanding stent fits the plaque, and the two sides of the self-expanding stent fit the blood vessel. Subsequently, the balloon is expanded through the inflation port, driving the center of the self-expanding stent to expand the stenotic part, and the balloon catheter is withdrawn. The self-expanding stent provides radial support force.

[0019] Compared with the prior art, the present invention has the following beneficial effects:

[0020] (1) It combines the advantages of traditional self-expanding stents and balloon-expandable stents. During the delivery process, the expansion of the stent is limited by the stent catheter and the limit ring at the same time. When it reaches the stenotic site of the blood vessel, the balloon expands to solve the stenosis of the blood vessel. After the balloon is withdrawn, the stent is expanded by self-expansion force, and then provides radial support force, thereby ensuring the vascular support effect while reducing surgical steps, accurate positioning, and reducing coverage of normal blood vessels.

[0021] (2) The limiting ring, the fusiform surface of the conical head and the stent catheter can simultaneously limit the expansion of the stent. After the stent is expanded by the balloon, since the balloon is smaller than the blood vessel diameter and the stent is larger than the blood vessel diameter, the expansion of the blood vessel by the balloon and the supporting force of the stent can be combined to act on the inner wall of the blood vessel. The center of the self-expanding stent fits the plaque, and the two sides of the self-expanding stent fit the blood vessels. It can be widely used in various occasions such as intracranial and extracranial cerebrovascular, peripheral blood vessels, and cardiovascular.

[0022] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The accompanying drawings in the specification, which constitute a part of the present invention, are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute improper limitations on the present invention.

[0024] Figure 1This is a schematic diagram of the structure of the stent for vascular stenosis in Example 1;

[0025] Figure 2 This is a schematic diagram of the structure after the stent catheter is withdrawn at the vascular stenosis plaque in Example 1;

[0026] Figure 3 It is a schematic diagram of the structure after the balloon is expanded at the vascular stenosis plaque in Example 1.

[0027] Figure 4 It is a schematic diagram of the structure enlargement of the stent for vascular stenosis in Example 1.

[0028] Figure 5 Schematic diagram of the deployment structure of the self-expanding stent in Example 1.

[0029] Wherein: 1 balloon catheter; 11 inflation port; 12 balloon; 13 guide wire insertion port;

[0030] 2 stent catheter; 21 catheter opening; 22 self-expanding stent; 221 main support rod; 222 W-shaped connecting ring;

[0031] 23 flushing port; 24 limiting ring;

[0032] 3. Guide wire;

[0033] 4 conical head; 41 fusiform surface; 5 plaque; 6 hemostatic valve. DETAILED DESCRIPTION

[0034] The present invention will be further described below in conjunction with the accompanying drawings and embodiments.

[0035] It should be noted that the following detailed descriptions are all illustrative and intended to provide further explanation of the present invention. Unless otherwise specified, all technical and scientific terms used herein have the same meanings as those commonly understood by those skilled in the art to which the present invention belongs.

[0036] Embodiment 1:

[0037] like Figure 1 As shown, this embodiment provides a stent for vascular stenosis, including a balloon catheter 1, a stent catheter 2 and a guidewire 3, the guidewire 3 passes through the balloon catheter 1, the stent catheter 2 is sleeved outside the balloon catheter 1, the guidewire through hole 13 is arranged at the head end of the balloon catheter 1, the stent catheter 2 is arranged at the head end of the stent catheter 2, and a hemostatic valve 6 is arranged at the head end of the catheter through hole;

[0038] The end of the balloon catheter 1 is fixedly connected to the balloon 12 , and a self-expanding stent 22 is arranged at the end of the stent catheter 2 corresponding to the outer wall of the balloon 12 , and the self-expanding stent 22 is limited between the balloon catheter and the stent catheter.

[0039] A flushing port 23 is provided at the head end of the stent catheter 2 and located on the side of the guidewire penetration port 13, and an inflation port 11 is provided at the head end of the balloon catheter 1 and located on the side of the catheter penetration port. The flushing ports 23 and inflation ports 11 of the two independent catheters are not connected, and the flushing port 23 and the inflation port 11 are respectively connected to the stent catheter 2 and the balloon catheter 1, wherein the flushing port 23 is used to flush the stent, plays a lubricating role between the stent and the stent catheter, and facilitates the discharge of gas between the stent and the balloon catheter, and the inflation port 11 is used to inflate the balloon, and the balloon expands after the inflation port 11 is inflated.

[0040] The central axis of the balloon catheter 1, the central axis of the stent catheter 2 and the guide wire 3 are coaxially arranged to prevent the guide wire 3 from bending after passing through. A conical head 4 is arranged at the end of the balloon catheter 1 and on the side wall of the balloon catheter 1. After the conical head 4 is arranged, it is convenient for guiding the balloon catheter 1 when it moves.

[0041] A limiting ring 24 is provided at the front end of the balloon catheter 1 and on the side wall of the balloon catheter 1 , and the stent body is located between the limiting ring 24 and the conical head 4 , and the conical head 4 and the limiting ring 24 play a role in limiting the stent during the advancement process.

[0042] The limiting ring 24 is used to limit the displacement of the stent body. When not in use, the limiting ring is arranged to protrude radially outward along the balloon catheter. When the stent is installed between the limiting rings 24, the limiting rings 24 are flush with the surface of the self-expanding stent 2.

[0043] A gap is set between the balloon catheter 1 and the stent catheter 2. In order to ensure the smooth withdrawal of the stent catheter 2, flushing can be performed between the stent catheter 2 and the balloon catheter 1 before the operation to ensure the moistening of the self-expanding stent 22 and the balloon catheter 1, and to facilitate the gas between the self-expanding stent 22 and the balloon catheter 1.

[0044] The stent uses a laser-engraved open-loop stent or a closed-loop stent. The stent is made of alloy material and can be a drug-eluting stent or a non-drug eluting bare stent. The drug-eluting stent is mainly composed of a stent, a drug and a drug-loaded coating on the surface of the stent. The stent plays a role in reinforcing and dilating blood vessels, and the drug reduces the risk of intravascular neovascularization through a drug release system, and the drug-loaded coating ensures the slow release of the drug.

[0045] The self-expanding stent is a net-tube-like hollow structure formed by connecting two main support rods 221 and a plurality of connecting rings 222 connecting the main support rods. The connecting rings are W-shaped and arranged non-uniformly. Both ends of the stent skeleton are sparsely arranged connecting ring portions, and the middle section of the stent skeleton is a densely arranged connecting ring portion. The stent of the present invention forms a plurality of non-uniform mesh structures, and adopts W-shaped connecting rings to connect with the main support rods to form a net-tube-like hollow structure. At the same time, after balloon expansion, the central support force of the stent is greater than that of the two sides, so it is arranged to be dense on both sides and sparse in the middle, so as to ensure that the support force of the stent after balloon expansion and the force of balloon expansion, the force applied by the stent on the blood vessel is more uniform.

[0046] The W-shaped connecting ring and the main support rod form a certain angle at the connection point to reduce the weight of the entire stent, so that both ends of the stent can ensure the radial support force of the stent while also helping to increase the flexibility of the stent. The inclined main support rod forms a spiral main support rod in the circumferential direction. The main support rod set at the same time can prevent the stent catheter from contacting with the W-shaped connecting ring when the stent catheter is withdrawn, avoid friction with the W-shaped connecting ring, thereby improving the withdrawal process.

[0047] The diameter after balloon expansion is less than or equal to the blood vessel diameter, and the diameter after self-expanding stent expansion is greater than or equal to the blood vessel diameter. Since the inflation port at the front end of the balloon is supplied with gas by an air pump, the high pressure provided by the air pump will cause deformation of the blood vessel and rupture the blood vessel. Therefore, the preset value of the diameter after balloon expansion is smaller than the blood vessel diameter. The self-expanding force of the self-expanding stent is small and it is difficult to rupture the blood vessel. Therefore, the preset value of the diameter after the stent expansion is larger than the inner diameter of the target blood vessel. For example, if the blood vessel diameter is 3mm and the diameter of the stent after expansion is 4mm, the extra 1mm is restricted by the blood vessel, so that the stent can provide support after expansion.

[0048] Embodiment 2:

[0049] The present invention also provides a treatment system, using the above-mentioned vascular stenosis stent, comprising the following steps:

[0050] The self-expanding stent is arranged between the limiting ring and the conical head, and then the stent catheter is sleeved on the outside of the self-expanding stent and the limiting ring. The stent catheter and the limiting ring simultaneously limit the self-expanding stent. The balloon catheter is carried along the guide wire to the stenotic part of the blood vessel. After the stent catheter is pulled out to release the restriction on the self-expanding stent, the plaque at the stenotic part is expanded, the center of the self-expanding stent fits the plaque, and the two sides of the self-expanding stent fit the blood vessel. Subsequently, the balloon is expanded through the inflation port to drive the center of the self-expanding stent to expand the stenotic part, and the balloon catheter is withdrawn. The self-expanding stent provides radial support force.

[0051] Although the above describes the specific implementation mode of the present invention in conjunction with the accompanying drawings, it is not intended to limit the scope of protection of the present invention. Those skilled in the art should understand that various modifications or variations that can be made by those skilled in the art on the basis of the technical solution of the present invention without creative work are still within the scope of protection of the present invention.

Claims

1. A stent for vascular stenosis, characterized in that: It comprises a balloon catheter, a stent catheter and a guide wire, wherein the guide wire runs through the balloon catheter, the stent catheter is sheathed outside the balloon catheter, the guide wire through hole is arranged at the head end of the balloon catheter, and the catheter through hole is arranged at the head end of the stent catheter; The end of the balloon catheter is fixedly connected to the balloon, and a self-expanding stent is arranged at the end of the stent catheter corresponding to the outer wall of the balloon, and the self-expanding stent is limited between the balloon catheter and the stent catheter; The diameter of the balloon is less than or equal to the inner diameter of the target blood vessel, and the diameter of the self-expanding stent is greater than or equal to the inner diameter of the target blood vessel.

2. The vascular stenosis stent according to claim 1, characterized in that: A flushing port is arranged at the head end of the stent catheter and at one side of the catheter penetration, and an inflation port is arranged at the head end of the balloon catheter and at one side of the guide wire penetration.

3. The vascular stenosis stent according to claim 1, characterized in that: The central axis of the balloon catheter, the central axis of the stent catheter and the guide wire are coaxially arranged.

4. The vascular stenosis stent according to claim 1, characterized in that: A conical head is arranged at the end of the balloon catheter.

5. The vascular stenosis stent according to claim 1, characterized in that: A limiting ring is arranged between the proximal end of the balloon catheter and the conical head. The limiting ring is arranged on the side wall of the balloon catheter. The diameter of the conical head is the same as that of the limiting ring. The limiting ring is arranged at the proximal end of the balloon catheter and protrudes radially outward along the balloon catheter.

6. The vascular stenosis stent according to claim 1, characterized in that: A gap is arranged between the balloon catheter and the stent catheter.

7. The vascular stenosis stent according to claim 1, characterized in that: The bracket is a laser engraved open-loop bracket or a closed-loop bracket, and the bracket is made of alloy material.

8. The stent for treating vascular stenosis according to claim 1, characterized in that: The stent is a drug stent or a bare stent.

9. The stent for treating vascular stenosis according to claim 4, characterized in that: The conical head is provided with a shuttle-shaped surface.

10. A vascular stenosis treatment system, characterized in that: The invention comprises a stent for vascular stenosis as claimed in any one of claims 1 to 9, wherein the self-expanding stent is arranged between a limiting ring and a conical head, and then a stent catheter is sleeved on the outside of the self-expanding stent and the limiting ring, the stent catheter and the limiting ring simultaneously limit the self-expanding stent, and a balloon catheter is carried along a guide wire to the vascular stenosis site, and after the stent catheter is withdrawn to release the restriction on the self-expanding stent, the self-expanding stent expands, the center of the self-expanding stent adheres to the plaque, and the two sides of the self-expanding stent adhere to the blood vessel, and then the balloon is expanded through the inflation port to drive the center of the self-expanding stent to expand the stenosis site, and the balloon catheter is withdrawn, and the self-expanding stent provides radial support force.

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