Subclavian artery stent

Abstract

The invention provides a subclavian artery stent. The subclavian artery stent is characterized by comprising a stent body, a pipeline balloon assembly and a supporting balloon assembly; wherein the pipeline balloon assembly comprises a pipeline balloon and a pipeline balloon catheter which are connected with each other; a balloon body of the pipeline balloon is arranged at the front end of the stent body, and a pipeline balloon catheter extends out of the rear end of the stent body; the pipeline balloon is provided with a channel through which fluid can pass; the supporting balloon assembly comprises a supporting balloon and a supporting balloon catheter which are connected with each other; a balloon body of the supporting balloon is arranged in the stent body, and a supporting balloon catheter extends out of the rear end of the stent body. In the using process of the subclavian artery stent, the bypass vertebral artery is temporarily blocked, a fluid channel is reserved, dirt blocking objects directly flow out of the channel, and the risk caused by the subclavian artery stent placement operation is greatly reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to medical devices, in particular, to a subclavian artery stent, more particularly, to a subclavian artery stent. BACKGROUND

[0002] The subclavian artery is an important branch of the aortic arch, mainly providing blood for the posterior cerebral circulation (vertebral artery blood supply) and the ipsilateral upper limb (arm, shoulder). When the artery is narrowed or occluded due to atherosclerosis, thrombosis, congenital malformation, etc., it will cause a series of ischemic symptoms. The core role of the stent is to solve these problems by "expanding the narrowed blood vessel". Therefore, the subclavian artery stent is an interventional medical device for treating subclavian artery lesions, and its core use is to restore the normal blood flow of the subclavian artery and improve the blood supply of related organs and tissues.

[0003] The ideal surgical procedure is as follows: the doctor uses a puncture needle to puncture the femoral artery, and after successful puncture, a sheath tube is placed in the blood vessel. The subsequent guide wire and stent catheter are all passed through the sheath tube into the blood vessel to avoid repeated puncture of the blood vessel; a guide wire and a contrast catheter are inserted, and after the lesion position is determined, expansion is performed; a stent matching the diameter of the blood vessel is selected, and the stent delivery catheter is slowly pushed to the subclavian artery stenosis site, and then the stent is released. However, in clinical practice, in the early stage of access, the residual plaque and other dirt in the blood vessel directly enters the vertebral artery through the bypass, and then flows into the brain, which can cause a large number of malignant complications. SUMMARY

[0004] The present application aims to overcome the above-mentioned defects, and provides a subclavian artery stent with simple structure and good effect. The subclavian artery stent temporarily blocks the vertebral artery bypass and reserves a fluid passage during use, so that the dirt directly flows out of the passage, greatly reducing the risk brought by the placement of the subclavian artery stent.

[0005] The present application provides a subclavian artery stent, characterized in that it comprises a stent body, a pipeline balloon assembly and a support balloon assembly.

[0006] The pipeline balloon assembly comprises a pipeline balloon and a pipeline balloon catheter connected to each other.

[0007] The balloon body of the pipeline balloon is arranged at the front end of the stent body, and the pipeline balloon catheter extends from the rear end of the stent body.

[0008] The pipeline balloon has a passage capable of accommodating fluid.

[0009] The support balloon assembly comprises a support balloon and a support balloon catheter connected to each other.

[0010] The balloon body of the supporting balloon is arranged in the stent body, and the supporting balloon catheter extends from the rear end of the stent body.

[0011] Further, the subclavian artery stent provided by the present application is characterized in that:

[0012] The cross section of the pipeline balloon is annular.

[0013] Further, the subclavian artery stent provided by the present application is characterized in that:

[0014] The pipeline balloon is connected to the front end of the stent body through the breakable member.

[0015] Further, the subclavian artery stent provided by the present application is characterized in that:

[0016] The pipeline balloon is provided with a first positioning mark.

[0017] Further, the subclavian artery stent provided by the present application is characterized in that:

[0018] The stent body is provided with a second positioning mark.

[0019] Further, the subclavian artery stent provided by the present application is characterized in that:

[0020] The stent body is a bare stent.

[0021] Further, the subclavian artery stent provided by the present application is characterized in that:

[0022] The stent body is unfolded under the action of the supporting balloon. BRIEF DESCRIPTION OF DRAWINGS

[0023] Figure 1 The structure schematic diagram of the subclavian artery stent provided by the present embodiment is shown in the figure.

[0024] Figure 2 The structure schematic diagram of the balloon of the subclavian artery stent provided by the present embodiment is shown in the figure.

[0025] Figure 3 The structure schematic diagram of the balloon of the subclavian artery stent provided by the present embodiment is shown in the figure.

[0026] Figure 4 The deformation structure schematic diagram of the subclavian artery stent provided by the present embodiment is shown in the figure.

[0027] Figure 5 The flow chart of the use of the subclavian artery stent provided by the present embodiment is shown in the figure. DETAILED DESCRIPTION

[0028] The present application can be implemented in various modifications and can have various embodiments, and thus specific embodiments will be illustrated in the accompanying drawings and described. However, this is not intended to limit the present application to specific embodiments, but to be understood as including all modifications, equivalents, and even alternatives falling within the spirit and technical scope of the present application.

[0029] As Figure 1 indicated, the subclavian artery stent provided by the present embodiment comprises a stent body 100, a support balloon assembly 200, and a pipeline balloon assembly 300.

[0030] The stent body 100 is a conventional bare stent that is expanded by a balloon. The stent body is coated with or fixed with a second positioning mark, which is a mark in the conventional field and can be positioned by a front-end imaging device to determine whether the stent reaches the expected target position.

[0031] The support balloon assembly 200 comprises a support balloon 210 and a support balloon catheter 220 connected to each other.

[0032] The balloon body of the support balloon 210 is arranged in the stent body 100 and covers the entire length of the stent body 100, so that when it is expanded, it can expand the entire stent body 100.

[0033] The support balloon catheter 220 extends from the rear end of the stent body 100 to the puncture inlet, so that when the puncture inlet is perfused with liquid or gas, the support balloon connected thereto can be inflated, and when the balloon does not need to be inflated, the gas or liquid can be extracted from the end.

[0034] The pipeline balloon assembly 300 comprises a pipeline balloon 310 and a pipeline balloon catheter 320 connected to each other.

[0035] The balloon body of the pipeline balloon 310 is arranged at the front end of the stent body 100 and is used to block the contralateral vertebral artery.

[0036] The pipeline balloon 310 is coated with or fixed with a first positioning mark, which is a mark in the conventional field and can be positioned by a front-end imaging device to determine whether the balloon reaches the expected target position.

[0037] It is considered that the pipeline balloon 310 is preferably located at the front side of the head end of the stent body during use, or within the controllable range of the head end of the stent body, such as Figure 4As shown, the occlusion balloon 210 is connected to the frame at the front end of the stent body 100 via a breakable component 400. This component serves two purposes: firstly, it limits the balloon's position; secondly, after use, the balloon can be easily detached by pulling the component at the distal end. Of course, this breakable component can also be other detachment / unhooking structures used in existing medical devices.

[0038] The tubular balloon catheter 320 extends from the rear end of the stent body 100 to the puncture site, thereby enabling the connected tubular balloon to inflate when liquid or gas is infused at the puncture site. When balloon inflation is not required, gas or liquid can be withdrawn from this end.

[0039] The central part of the tubular balloon 310 has a channel for fluid passage. That is, when the balloon 310 is filled with gas or liquid and inflates, its outer surface can cover the vertebral artery, thereby preventing blood (carrying plaques and other contaminants) from flowing into the vertebral artery from the side. At the same time, due to the presence of this channel, blood can continue to flow in the direction of the clavicular artery. This not only prevents contaminants from entering the vertebral artery, but also ensures that the blood flow in the subclavian artery supports the circulation of blood in the entire artery, preventing the body's functions from becoming unbalanced due to the blockage of blood flow in the vertebral artery.

[0040] Regarding this balloon with a channel, one manifestation is as follows: Figure 2 The circular balloon shown. Another form of it is as follows: Figure 3 The circular balloon shown.

[0041] Application example:

[0042] When using the aforementioned subclavian artery stent in interventional procedures to treat subclavian artery lesions, the following methods are employed:

[0043] S1: Anesthesia and Vascular Puncture: Establishing the "Surgical Access"

[0044] The patient lies supine. The doctor will disinfect the skin at the puncture site (such as the right groin) with povidone-iodine, drape it with a sterile surgical towel, and expose only the puncture area. Local anesthesia will be administered with 1% lidocaine.

[0045] The doctor punctures the femoral artery with a needle. After successful puncture, a sheath is inserted and left inside the blood vessel. Subsequent guidewires and stents are inserted into the blood vessel through the sheath, avoiding repeated punctures.

[0046] S2: Insert the guidewire and angiography catheter to determine the location of the lesion.

[0047] The doctor inserts a guidewire (approximately 0.8-1.2 mm in diameter, flexible, similar to a metal wire) through a sheath. Under the real-time imaging guidance of the DSA angiography machine, the guidewire is slowly pushed to the aortic arch and then carefully entered the subclavian artery to avoid damaging the vessel wall.

[0048] After the guidewire is in place, the angiography catheter is inserted along the guidewire. When the end of the angiography catheter is close to the stenosis of the subclavian artery, contrast agent is injected into the catheter using a high-pressure injector.

[0049] The DSA machine captures real-time images of blood vessels, clearly showing the location and degree of stenosis of the subclavian artery, the diameter of the vessel (e.g., "70% stenosis"), and the condition of surrounding branch vessels. The size and placement of the stent are confirmed based on the angiography results.

[0050] S3: Pre-dilation of the narrowed area (optional, depending on the condition of the blood vessels)

[0051] If the subclavian artery is severely stenotic (e.g., stenosis > 80%) or the vessel wall is rigid, it may be difficult to open it by directly placing a stent. In this case, the doctor will first perform "pre-dilation": insert a balloon dilation catheter along the guidewire and send the balloon to the stenotic site.

[0052] Fluid is injected into the balloon using a pressure pump to inflate it, opening up the narrowed blood vessel wall and widening the lumen. After expansion, the fluid in the balloon is released, the balloon catheter is withdrawn, and contrast agent is injected again to confirm the improvement in stenosis, preparing for subsequent stent implantation.

[0053] S4: Implantation of subclavian artery stent

[0054] The doctor selects a stent that matches the diameter of the blood vessel (e.g., if the blood vessel diameter is 5mm, select a stent with a diameter of 5-6mm; the length is selected according to the length of the stenosis, e.g., "if the stenosis is 2cm long, select a 3cm long stent") and compresses the stent at the end of the catheter.

[0055] The stent and its tip balloon are slowly pushed along the guidewire to the site of subclavian artery stenosis (5a). The position of the stent and balloon is confirmed by DSA imaging (note that the balloon needs to cover the entire entrance of the vertebral artery). After the position is confirmed, the doctor inflates the balloon by injecting water to close the vertebral artery (4b). Then, the support balloon inside the stent is inflated by injecting water to push the stent open and adhere to the wall (4C).

[0056] After the stent is deployed, observe whether the stent is in the correct position and fully expanded. Once confirmed, shrink the support balloon (4d) to check if the blood flow is unobstructed. If the blood flow is unobstructed, withdraw the support balloon (this withdrawal step can be omitted, i.e., just shrink the support balloon to ensure unobstructed blood flow, and then withdraw it together with the tubing balloon later).

[0057] The blood circulates for a certain period of time, thereby allowing contaminants such as plaque generated during the stent placement process and plaque within the blood vessel itself to flow out of the upper limb blood vessel (4e). Subsequently, the tubing balloon is reduced (4f) and withdrawn, leaving only the stent in the blood vessel (4g).

[0058] S5: Remove the guidewire and sheath, apply pressure to stop bleeding.

[0059] The doctor slowly withdrew the guidewire, then pulled out the sheath left in the femoral artery, and continuously pressed the femoral artery at the puncture site to stop the bleeding for about 15-20 minutes. After the bleeding was stopped, the doctor observed that there was no bleeding or hematoma at the puncture site, covered it with sterile gauze, and then applied a pressure bandage with an elastic bandage.

[0060] While the foregoing has focused on embodiments, these are merely illustrative and do not limit the invention. Those skilled in the art will understand that various modifications and applications not illustrated above can be made without departing from the essential characteristics of these embodiments. For example, the constituent elements specifically shown in the embodiments can be implemented through modifications. Furthermore, various differences related to such modifications and applications should be interpreted as being included within the scope of the invention as defined in the appended claims.

Claims

1. A subclavian artery stent, characterized in that: It includes a stent body, a tubing balloon assembly, and a support balloon assembly; The tubular balloon assembly includes a tubular balloon and a tubular balloon catheter that are connected to each other. The balloon body is located at the front end of the stent body, and the balloon catheter extends from the rear end of the stent body. The tubular balloon has a channel that allows fluid to pass through; The support balloon assembly includes a support balloon and a support balloon catheter that are connected to each other. The support balloon is housed within the stent body, and the support balloon catheter extends from the rear end of the stent body.

2. The subclavian artery stent as described in claim 1, characterized in that: The cross-section of the tubular balloon is annular.

3. The subclavian artery stent as described in claim 1, characterized in that: The tubular balloon is connected to the front end of the support body via a breakable component.

4. The subclavian artery stent as described in claim 1, characterized in that: The tubular balloon is equipped with a first positioning mark.

5. The subclavian artery stent as described in claim 1, characterized in that: The support body is provided with a second positioning mark.

6. The subclavian artery stent as described in claim 1, characterized in that: The support body is a bare support.

7. The subclavian artery stent as described in claim 1, characterized in that: The stent body deploys under the action of the support balloon.

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