A novel vasodilator

Abstract

This utility model discloses a novel vascular dilator, comprising an instrument rod, a balloon, an inner tube, and a stent. The stent is fitted over the balloon. One end of the inner tube passes through the instrument rod and communicates with the balloon, while the other end of the inner tube passes through the instrument rod and has a pump connection port. The side of the balloon facing away from the pump connection port is designated as the front section of the balloon. The stent is detachably fitted onto the outer wall of the front section of the balloon. The rear section of the balloon protrudes from the stent. A drug coating is applied to the outer wall of the rear section of the balloon. Opaque marking layers are provided on the outer wall of the balloon on the side of the stent facing away from the drug coating, at the connection point between the stent and the drug coating, and on the side of the drug coating facing away from the stent. The stent and the drug coating are simultaneously separated by these marking layers. This novel vascular dilator, through balloon expansion, simultaneously releases the distal stent and the proximal drug coating, simplifying the surgical procedure, shortening the surgical time, reducing radiation exposure for both patients and medical staff, and decreasing medical expenses.

Description

Technical Field

[0001] This utility model relates to a novel vasodilator, belonging to the field of medical device technology. Background Technology

[0002] True bifurcation lesions of the coronary arteries have long been a challenge in interventional treatment of coronary heart disease. Due to the complexity of the anatomical structure and the limitations of treatment devices, there is still no universally accepted optimal treatment strategy. Currently, the treatment of true bifurcation lesions of the coronary arteries mainly falls into two categories: one is the dual-stent procedure, where stents are implanted in both the main branch and the branch (such as the Crush and Culotte techniques). This ensures that the bifurcation site is adequately covered by stents, but it has drawbacks such as complex procedures, overlapping stents at the branch opening, or incomplete expansion, which can easily lead to in-stent restenosis. The other approach involves implanting a stent in the main branch and simply using a drug-eluting balloon to dilate the branch. This method simplifies the procedure, but the branch is not covered by a stent, which carries the risks of branch dissection, hematoma spread, and elastic recoil, affecting long-term outcomes. Based on this consideration, a new approach to treating bifurcation lesions (the sandwich technique) has been developed: a stent is implanted proximal to the branch, without overlapping with the main branch stent, meaning the branch opening is not covered by a stent. After stent deployment, a drug-eluting balloon is used to dilate the branch opening. While this approach addresses the issues of stent overlap at the opening and hematoma expansion at the distal branch, the procedure remains complex, time-consuming, and exposes both doctors and patients to radiation for extended periods. Furthermore, compared to the original approach, the sandwich technique requires an additional instrument (stent or drug-eluting balloon), significantly increasing medical expenses. Utility Model Content

[0003] The technical problem this invention aims to solve is how to treat branch vessels in vascular bifurcation lesions, simplify surgical procedures for bifurcation lesions, improve surgical safety, and reduce medical expenses.

[0004] To address the aforementioned technical problems, this invention provides a novel vascular dilator that simultaneously releases a stent and a drug coating through a single balloon dilation. This allows for simple and quick interventional treatment of bifurcation lesions, shortens surgical time, reduces radiation exposure for both patients and medical staff, and decreases medical expenses.

[0005] To achieve the above-mentioned technical objectives and effects, this application provides the following technical solution:

[0006] A novel vasodilator includes an instrument rod, a balloon, an inner tube, and a stent. The stent is sleeved outside the balloon. One end of the inner tube passes through one end of the instrument rod and communicates with the balloon. The other end of the inner tube passes through the other end of the instrument rod and has a pump connection port. The side of the balloon away from the pump connection port is designated as the front section of the balloon. The stent is detachably sleeved on the outer wall of the front section of the balloon. The rear section of the balloon protrudes from the stent. A drug coating is provided on the outer wall of the rear section of the balloon. Opaque marking layers are provided on the outer wall of the balloon on the side of the stent away from the drug coating, at the connection between the stent and the drug coating, and on the side of the drug coating away from the stent. The stent and the drug coating are separated by the marking layers.

[0007] Preferably, the variation range between the nominal pressure and the burst pressure of the balloon does not exceed 0.25 mm.

[0008] Preferably, the rear section of the balloon protrudes 2-4 mm from the stent.

[0009] Preferably, the diameter of the balloon after expansion is between 2 and 4 mm with a gradient of 0.25 mm.

[0010] Preferably, the length of the support is between 12 and 28 mm with a length interval of 4 mm.

[0011] Preferably, the length of the drug coating is between 2 and 4 mm with a length interval of 1 mm.

[0012] Preferably, the stent includes, but is not limited to, a metal stent or a biodegradable stent.

[0013] Preferably, the balloon has a guidewire inlet at its front end, and the instrument rod has a guidewire outlet on its outer wall that communicates with the guidewire inlet.

[0014] The novel vasodilator provided by this utility model has the following advantages:

[0015] 1. Compared with traditional balloons or stents, the novel vascular dilator of this utility model has three marking layers, located at the distal end of the stent, the proximal end of the drug coating, and the connection between the stent and the drug coating. The opaque marking layer located at the connection not only serves as a marking layer but also prevents the stent edge from scratching the drug coating.

[0016] 2. The novel vascular dilator of this utility model is equipped with both a stent and a drug-eluting balloon, which can simultaneously release the stent and drug coating through a single balloon dilation. It greatly simplifies the surgical procedure, especially in the treatment of vascular bifurcation sites, shortens the operation time, reduces the radiation exposure to patients and doctors, and saves medical expenses. Attached Figure Description

[0017] Figure 1 A schematic diagram of the structure of a novel vascular dilator provided for an embodiment of this utility model;

[0018] Figure 2 This is a schematic diagram showing the arrangement of the novel vascular dilator in human blood vessels, as provided in an embodiment of this utility model.

[0019] In the picture:

[0020] 1-Instrument rod; 11-Guidewire outlet; 2-Balloon; 21-Guidewire inlet; 3-Inner tube; 31-Pump connection port; 4-Stent; 5-Drug coating; 6-Marker layer. Detailed Implementation

[0021] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0022] Reference Figure 1 and Figure 2 A novel vascular dilator includes an instrument rod 1, a balloon 2, an inner tube 3, and a stent 4. The stent 4 is fitted over the balloon 2. One end of the inner tube 3 passes through the instrument rod 1 and communicates with the balloon 2. The other end of the inner tube 3 passes through the other end of the instrument rod 1 and is provided with a pump connection port 31. In this embodiment, the production and installation of the inner tube 3, the instrument rod 1, and the balloon 2 are all existing technologies and will not be described in detail. To avoid the balloon 2 shaking and causing the stent 4 to become unstable, the balloon 2 in this device is required to be made of a material that is not easily deformed. In order to reduce the long-term impact of the implant on the human body, in addition to the conventional metal stent 4, this device can also be equipped with a stent 4 made of biodegradable material, which can gradually degrade and disappear after being implanted into the blood vessel. The balloon 2 plays the role of filling the contrast agent and expanding the blood vessel.

[0023] Furthermore, the side of balloon 2 facing away from the pump connection port 31 is designated as the front section of balloon 2. The stent 4 is detachably fitted onto the outer wall of the front section of balloon 2. The rear section of balloon 2 protrudes beyond the stent 4. Compared to traditional stent 4 where the balloon 2 and stent 4 are matched in length, the proximal end of balloon 2 in this device requires a drug-eluting coating 5. Therefore, the proximal end of balloon 2 protrudes longer, with a protrusion distance ranging from 2 to 4 mm. During surgical procedures, the stent 4 expands and releases under the support of balloon 2. After release, the stent 4 adheres tightly to the inner wall of the blood vessel, and the friction of the blood vessel causes the stent 4 to separate from balloon 2. Typically, the resistance encountered during stent 4 expansion and release is greater, while the resistance during balloon 2 expansion is relatively smaller. To avoid uneven expansion between the drug-eluting coating 5 and the stent 4, the diameter of balloon 2 in this device is required to change little with increasing pressure, with the variation between nominal pressure and burst pressure not exceeding 0.25 mm.

[0024] Furthermore, a drug coating 5 is coated on the outer wall of the posterior segment of balloon 2. Opaque marking layers 6 are adhered to the side of balloon 2 opposite to the drug coating 5, the connection point between the stent 4 and the drug coating 5, and the outer wall of the drug coating 5 opposite to the stent 4, serving as marking aids. Simultaneously, the marking layer 6 at the connection point between the stent 4 and the drug coating 5 also acts as a separator to prevent the edge of the stent 4 from scratching the drug coating 5. When balloon 2 inflates, the drug coating 5 adheres to the inner wall of the blood vessel, thus releasing the drug. To avoid prolonged balloon 2 expansion blocking blood vessels and causing myocardial ischemia, the drug coating 5 on the proximal end of balloon 2 uses a mixture of cell proliferation inhibitors and carrier materials. After balloon 2 inflates, the drug release is completed within 30–60 seconds, and the drug adhering to the blood vessel surface reaches an effective concentration, thereby achieving simultaneous drug balloon 2 expansion and stent 4 release.

[0025] In a further embodiment, in order to accommodate blood vessels of different diameters, the diameter of balloon 2 after expansion is controlled between 2 and 4 mm with a gradient of 0.25 mm; the length of stent 4 is between 12 and 28 mm with a gradient of 4 mm; and the length of drug coating 5 is between 2 and 4 mm with a gradient of 1 mm.

[0026] Reference Figure 1 The balloon 2 has a guidewire inlet 21 at its front end, and the instrument rod 1 has a guidewire outlet 11 on its outer wall that communicates with the guidewire inlet 21. Specifically, during the operation, the balloon 2 is adhesively fitted onto the outside of the instrument rod 1, and the guidewire outlet 11 is opened on the side wall of the instrument rod 1 located outside the balloon 2 and extends to the end of the instrument rod 1 away from the pump body connection port 31 and communicates with the guidewire inlet 21. This makes it easier to insert the guidewire for guidance during the operation.

[0027] The method of using the novel vasodilator of this utility model is as follows:

[0028] In coronary artery bifurcation lesions, a stent is implanted in the main branch, while the novel vascular dilator of this invention is inserted into the branch. During balloon dilation 2, the proximal drug coating 5 is released at the opening of the branch, and the distal stent 4 is released at the proximal end of the branch. This simultaneously completes the surgical steps that previously required two separate procedures using two different instruments.

[0029] The above description is merely a preferred embodiment of this utility model and is not intended to limit this utility model in any form or substance. It should be noted that those skilled in the art can make various improvements and additions without departing from this utility model, and these improvements and additions should also be considered within the protection scope of this utility model. Any modifications, alterations, and equivalent changes made by those skilled in the art without departing from the spirit and scope of this utility model using the disclosed technical content are equivalent embodiments of this utility model. Furthermore, any modifications, alterations, and evolutions made to the above embodiments based on the essential technology of this utility model are still within the scope of the technical solution of this utility model.

Claims

1. A novel vasodilator, comprising an instrument rod (1), a balloon (2), an inner tube (3), and a stent (4), wherein the stent (4) is sleeved outside the balloon (2), one end of the inner tube (3) passes through the instrument rod (1) and communicates with the balloon (2), and the other end of the inner tube (3) passes through the other end of the instrument rod (1) and is provided with a pump connection port (31), characterized in that, The side of the balloon (2) away from the pump body connection port (31) is designated as the front section of the balloon (2). The support (4) is detachably sleeved on the outer wall of the front section of the balloon (2). The rear section of the balloon (2) protrudes from the support (4). A drug coating (5) is provided on the outer wall of the rear section of the balloon (2). An opaque marking layer (6) is provided on the side of the balloon (2) away from the support (4) away from the drug coating (5), at the connection between the support (4) and the drug coating (5), and on the outer wall of the drug coating (5) away from the support (4). The support (4) and the drug coating (5) are separated by the marking layer (6).

2. The novel vasodilator as described in claim 1, characterized in that, The variation range of the balloon (2) between the nominal pressure and the burst pressure does not exceed 0.25 mm.

3. The novel vasodilator as described in claim 1, characterized in that, The rear section of the balloon (2) protrudes 2-4 mm from the stent (4).

4. The novel vasodilator as described in claim 1, characterized in that, The diameter of the balloon (2) after expansion is between 2 and 4 mm with a gradient of 0.25 mm.

5. The novel vasodilator as described in claim 1, characterized in that, The length of the bracket (4) is between 12 and 28 mm with a length gradient of 4 mm.

6. The novel vasodilator as described in claim 1, characterized in that, The length of the drug coating (5) is between 2 and 4 mm with a length gradient of 1 mm.

7. The novel vasodilator as described in claim 1, characterized in that, The stent (4) includes, but is not limited to, a metal stent (4) or a biodegradable stent (4).

8. The novel vasodilator as described in claim 1, characterized in that, The balloon (2) has a guidewire inlet (21) at its front end, and the instrument rod (1) has a guidewire outlet (11) on its outer wall that communicates with the guidewire inlet (21).

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