CN108703826A - It is a kind of to be molded endovascular stent system at once - Google Patents

Abstract

It being molded endovascular stent system, including balloon system, transport system, drug stent system at once the present invention relates to a kind of；The balloon system includes mother bulb capsule and bulbec capsule, and the bulbec capsule setting is in female balloon interior, the axis collinear of the axis of the bulbec capsule and the mother bulb capsule；The surface surrounding of the mother bulb capsule is provided with equally distributed micropore, and the micropore is one-way conduction hole；The transport system includes conduit, and the conduit includes first passage, second channel, silk guide passage；The drug stent system includes temperature sensitivity degradable liquid substance, and the temperature sensitivity degradable liquid substance forms drug stent on the outside of the mother bulb capsule.It the advantage is that, eliminating holder mesh does not have the shortcomings that medicine, and locally load concentration is low and uniform for vascular wall, and endothelialization postpones caused by can reducing part load concentration height, and it is unstable to reduce the effect of local drug concentration unevenness causes；Degradable characteristic is suitble to treat repeatedly the patient of restenosis.

Description

A kind of immediate forming intravascular stent system

technical field

The invention relates to the technical field of medical devices, in particular to an instantly forming intravascular stent system.

Background technique

Blood vessels are the tubes through which blood flows throughout the body. When blood vessels, especially arteries, are severely stenotic and occluded, local tissues may suffer from ischemia, hypoxia, necrosis, and even organ dysfunction or even failure. Angioplasty is to recanalize diseased blood vessels and restore blood supply to local tissues through various means.

Commonly used angioplasty includes balloon dilatation and stent placement, which are used to treat vascular lesions in other parts of the body except the heart and brain vessels, especially vascular lesions such as extremity blood vessels, liver blood vessels, and renal artery stenosis.

Vascular balloon dilatation is to place an expandable balloon catheter in the narrow vessel segment after percutaneous puncture of the vessel, and "open up" the vessel through physical expansion of the balloon. Stent placement is based on balloon dilation and shaping, and an internal stent is placed in the lesion to support the stenotic and occluded segment of the vessel, reduce the elastic retraction and reshaping of the vessel, and maintain the smooth blood flow in the lumen. The role of restenosis.

However, in the existing stent placement, the mesh of the stent has no therapeutic drugs, the local drug concentration of the blood vessel wall is uneven, and the endothelialization delay caused by the high local drug concentration occurs, and the curative effect is unstable; the operation is easy to cause dissection: the operation is complicated, and the operation is difficult. It is cumbersome, and the stent system needs to be replaced multiple times during multiple implants, which increases the operation time, thereby increasing the radiation exposure, and is expensive. It is not suitable for long-term vascular treatment, and cannot solve the intimal tear caused by violent balloon expansion and Dissection problem; degradable stents are prone to problems of malapposition and BVS fracture, which require OCT assistance.

Therefore, there is an urgent need for an intravascular stent that can make the drug-loaded concentration of the blood vessel wall low and uniform, easy to operate, simple to operate, low in cost, and solve the problem of poor apposition of the degradable stent.

Contents of the invention

The object of the present invention is to provide an immediate forming intravascular stent system for the deficiencies in the prior art.

For realizing above-mentioned object, the technical scheme that the present invention takes is:

An immediate forming intravascular stent system, including a balloon system, a delivery system, and a drug stent system;

The balloon system includes a mother balloon and a daughter balloon, the daughter balloon is arranged inside the mother balloon, the axis of the daughter balloon is collinear with the axis of the mother balloon, and the mother balloon The length of the sub-balloon is the same, and the diameter of the inflated sub-balloon is smaller than the diameter of the inflated mother balloon;

Evenly distributed micropores are arranged around the surface of the mother balloon, and the micropores are one-way through holes for the mother balloon to transport substances from the inside to the outside;

The delivery system includes a catheter, the catheter includes a first channel, a second channel, and a guide wire channel, the first end of the catheter passes through the mother balloon and the daughter balloon, and the first channel is connected to the daughter balloon. The child balloon is connected, and the second channel is connected with the mother balloon;

The drug stent system includes a temperature-sensitive degradable liquid substance, the temperature-sensitive degradable liquid substance enters the interior of the mother balloon from the second channel, and flows to the mother balloon through the micropores. Exudate outside, forming a drug scaffold on the outside of the mother balloon.

Preferably, the second end of the conduit is provided with a first pressure pump interface and a second pressure pump interface, the first pressure pump interface is connected to the first channel, and the second pressure pump interface is connected to the first pressure pump interface. Two-channel connection.

Preferably, the catheter further includes a third channel, which is used for blood flow in the blood vessel to pass through.

Preferably, the diameter of the first channel is smaller than the diameter of the second channel.

Preferably, at least one liquid outlet is provided at the connection between the first channel and the sub-balloon.

Preferably, at least one liquid outlet is provided at the connection between the second channel and the mother balloon.

Preferably, the temperature-sensitive degradable liquid substance is a liquid mixture, the liquid mixture is liquid when the temperature is lower than 20°C, and the liquid mixture is solid when the temperature is higher than 30°C.

Preferably, the liquid mixture includes degradable liquid metals, cell cycle inhibiting drugs, and anticoagulant drugs.

Preferably, the liquid mixture further includes nanotechnology-packaged endothelial cells.

Preferably, the catheter is a composite catheter composed of multiple catheters, the first channel, the second channel and the guidewire channel are all catheters, the first channel, the second channel and the The guide wire channel is fixedly connected.

The present invention adopts the above technical scheme, and compared with the prior art, it has the following technical effects:

The immediate forming intravascular stent system of the present invention eliminates the disadvantage that the stent mesh has no therapeutic drugs, and the local drug loading concentration on the blood vessel wall is low and uniform, which can reduce the endothelialization delay caused by the high local drug loading concentration and reduce the uneven local drug concentration The curative effect caused by it is unstable; the degradable properties are suitable for the treatment of patients with repeated restenosis, and the cell cycle drugs can be changed if necessary; flexible implantation is not afraid of dissection caused by surgical operations: due to the extrusion of the liquid, the balloon is formed on the surface of the blood vessel wall The hardened object then becomes a biological scaffold that can automatically cover the dissection; the operation is simple and the operation is simplified, and there is no need to replace the stent system multiple times during multiple implants, reducing operation time and radiation exposure; cost saving, no need for post-treatment balloons, Reduce the number of stents and reduce the cost of surgery; it is suitable for vascular treatment of long lesions, and theoretically has a good effect on bifurcation lesions and small vascular lesions, reducing the probability of restenosis; technically avoids the lack of support of drug balloons, that is, vascular The problem of elastic recoil; it better solves the problem of vascular intimal tear and dissection caused by violent expansion of the balloon; it reduces the problem of poor apposition of degradable stents, and there is no problem of BVS fracture, and OCT assistance is not required. It is limited to non-complicated coronary lesions and can be expanded to complex lesions; for CTO lesions that are extremely perforated, the system can have a good immediate occlusion of the vessel wall, reduce the risk of perforation, and be used for the treatment of high-risk lesions.

Description of drawings

Fig. 1 is a cross-sectional view of a first embodiment of a preferred embodiment of the present invention.

Fig. 2 is a cross-sectional view of a second embodiment of a preferred embodiment of the present invention.

Reference signs therein are: mother balloon 1 ; daughter balloon 2 ; catheter 3 ; first channel 4 ; second channel 5 ; guidewire channel 6 ; third channel 7 ; microhole 8 ; guidewire 9 .

Detailed ways

The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only some, not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.

It should be noted that, in the case of no conflict, the embodiments of the present invention and the features in the embodiments can be combined with each other.

The present invention will be further described below in conjunction with the accompanying drawings and specific embodiments, but not as a limitation of the present invention.

A preferred embodiment of the present invention, as shown in FIG. 1 , is an instantly forming intravascular stent system, including a balloon system, a delivery system, and a drug stent system.

The balloon system includes a mother-child balloon, the mother-child balloon includes a mother balloon 1 and a daughter balloon, the daughter balloon is arranged inside the mother balloon 1, and the axis of the daughter balloon 2 is collinear with the axis of the mother balloon 1, that is The sub-balloon 2 and the mother balloon 1 are arranged coaxially, the length of the sub-balloon 2 is the same as that of the mother balloon 1, and the diameter of the inflated daughter balloon 2 is smaller than the diameter of the mother balloon 1 after inflation.

The mother balloon 1 and the daughter balloon 2 have a channel running through the front end and the rear end of the mother balloon 1 and the daughter balloon 2 in the axial direction, so that the mother balloon 1 and the daughter balloon 2 are hollow.

Specifically, the difference between the inflated diameter of the daughter balloon 2 and the inflated diameter of the mother balloon 1 ranges from 0.01 mm to 3 mm.

The mother balloon 1 is a compliant balloon or a non-compliant balloon, and the daughter balloon 2 is a compliant balloon or a non-compliant balloon.

The surface of the female balloon 1 is provided with evenly distributed rows of micropores 8 around the surface. The micropores 8 are unidirectional through holes, which are conducted under a certain pressure so that the material inside the female balloon 1 can flow to the mother balloon 1 through the micropores 8. Balloon 1 outside.

The micropores 8 may be distributed regularly or irregularly. When the micropores 8 are distributed regularly, the micropores 8 may be distributed linearly or in a grid pattern.

The micropores 8 may be composed of ultrafiltration membranes with a certain pore size. The ultrafiltration membrane with a certain pore size can be used to filter the substances in the mother balloon 1, so that under a certain pressure, when the substances in the mother balloon 1 flow out of the mother balloon 1, invalid substances are prevented from flowing out of the mother balloon. Balloon 1 outside.

The microhole 8 can also be a microhole 8 provided with a flap-shaped structure, that is, the microhole 8 is filled with a plate-shaped substance, and under the action of a certain pressure, the plate-shaped substance rotates to open the microhole 8, so that the mother balloon The substance in 1 flows to the outside of mother balloon 1 through micropore 8 .

The diameter of the micropores 8 is 0.01mm-1mm.

The balloon system also includes a pre-expansion balloon, and the axial direction of the pre-expansion balloon has a channel passing through the front end and the rear end of the pre-expansion balloon.

The delivery system includes a catheter 3 , the catheter 3 includes a first channel 4 , a second channel 5 , and a guide wire channel 6 , the first channel 4 is connected to the daughter balloon 2 , and the second channel 5 is connected to the mother balloon 1 .

In the present invention, the catheter 3 has various implementation forms, among which there are two preferred implementation forms.

The first embodiment is that the catheter 3 is a single catheter, and the first channel 4 , the second channel 5 and the guide wire channel 6 are all arranged inside the catheter 3 .

The second embodiment is: the catheter 3 is composed of multiple catheters, the first channel 4, the second channel 5 and the guide wire channel 6 are all catheters, and the three catheters are fixedly connected through various connection methods. If multiple fixing brackets are used for continuous fixing, the fixing brackets are circular and provided with three holes, which are respectively used for passing through the first channel 4 , the second channel 5 , and the guide wire channel 6 .

In this example, the first embodiment is preferred.

In the first embodiment, the catheter 3 runs through the mother balloon 1 and the daughter balloon 2 through the passage provided inside the mother balloon 1 and the daughter balloon 2, that is, the first end of the catheter 3 runs through the mother balloon 1 and the daughter balloon 2 and exposed.

The diameter of the catheter 3 ranges from 0.5F to 4F, that is, 0.165mm to 1.32mm.

The diameter of the first channel 4 is smaller than the diameter of the second channel 5 . In this embodiment, the ratio of the diameter of the first channel 4 to the diameter of the second channel 5 ranges from 1:1 to 1:10.

The first channel 4 is connected to the sub-balloon 2 , and at least one liquid outlet is arranged at the connection, and the liquid outlet is arranged in the middle of the sub-balloon 2 . The diameter of the liquid outlet is 0.01mm-0.05mm.

The second channel 5 is connected to the mother balloon 1 , and at least one liquid outlet is arranged at the connection, and the liquid outlet is arranged on the outside of the daughter balloon 2 . The diameter of the liquid outlet is 0.01mm-0.05mm.

Furthermore, as shown in FIG. 2 , the catheter 3 also includes a third channel 7 for allowing blood to flow through the third channel 7 when the mother balloon 1 is inflated, so as to reduce damage caused by blood flow blockage.

The second end of the conduit 3 is provided with a first pressure pump interface and a second pressure pump interface (not shown in the figure), the first pressure pump interface is connected to the first channel 4, and the second pressure pump interface is connected to the second channel 5 , the first pressure pump interface is connected to a pressure pump, and the second pressure pump interface is connected to another pressure pump.

The delivery system also includes a hypotube (not shown in the figure), and the catheter 3 is arranged inside the hypotube.

The drug stent system includes a temperature-sensitive degradable liquid substance. The temperature-sensitive degradable substance enters the inside of the mother balloon 1 from the second channel 5 and, under the action of pressure, flows from the inside of the mother balloon 1 to the mother balloon 1 through the micropore 8. The outside of the balloon 1 protrudes and forms a drug support on the outside of the mother balloon 1 .

Temperature-sensitive degradable liquid substances are mainly degradable liquid metals, which are liquid in a certain temperature range and solid in a certain temperature range.

In this embodiment, when the temperature is lower than 20°C, the temperature-sensitive degradable liquid substance is liquid; when the temperature is higher than 30°C, the temperature-sensitive degradable liquid substance is solid, and within a certain temperature with the Increase coagulation and strengthen.

In addition to degradable liquid metals, temperature-sensitive degradable liquid substances also include cell cycle inhibitory drugs and anticoagulant drugs. Drugs that inhibit the cell cycle include sirolimus, rapamycin, taxanes and other drugs, and these drugs are packaged in lipid nanometers. Anticoagulant drugs include heparin, low molecular weight heparin, etc.

Furthermore, the temperature-sensitive degradable liquid substance may also include nanotechnology-packaged endothelial cells.

The method of using the instant forming intravascular stent system of this embodiment is as follows: the guide wire 9 enters the vascular lesion; the pre-expansion balloon is sent into the vascular lesion along the guide wire 9, and the pre-expansion is carried out, and the pre-expansion pressure is relatively high After the pre-expansion is completed, withdraw the pre-expansion balloon, select the mother-child balloon that is slightly longer than the length of the pre-expansion balloon, and align the guide wire channel 6 of the catheter 3 with the guide wire 9, so that the mother-daughter balloon can move along the The guide wire 9 reaches the lesion; the pressure pump is used to deliver temperature-sensitive and degradable liquid substances into the mother balloon 1 through the second pressure pump interface and the second channel 5, so that the mother balloon 1 is expanded; when the mother balloon 1 is expanded When the ratio of the diameter of the blood vessel to the diameter of the blood vessel reaches 0.8-1, the pressure pump is used to deliver the mixed reagent of physiological saline and contrast agent into the sub-balloon 2 through the first pressure pump interface and the first channel 4, so that the sub-balloon 2 is expanded; The expansion of the balloon 2 causes the pressure inside the mother balloon 1 to increase rapidly. When the pressure increases to a certain level, the temperature-sensitive degradable liquid material seeps out to the outer side of the mother balloon 1 through the micropore 8 of the mother balloon 1, and evenly Distributed on the inner wall of the diseased blood vessel, and under the action of human body temperature, it will gradually solidify to form a drug stent; Withdraw the mother balloon; or repeat the above operation process several times according to the condition or operation needs.

The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the implementation and protection scope of the present invention. For those skilled in the art, they should be able to realize that all equivalents made by using the description and illustrations of the present invention The solutions obtained by replacement and obvious changes shall all be included in the protection scope of the present invention.

Claims (10)

1. An immediate forming intravascular stent system, characterized in that it comprises a balloon system, a delivery system, and a drug stent system; The balloon system includes a mother balloon (1) and a daughter balloon (2), the daughter balloon (2) is arranged inside the mother balloon (1), and the axis of the daughter balloon (2) is aligned with the The axes of the mother balloon (1) are collinear, the length of the mother balloon (1) is the same as that of the daughter balloon (2), and the diameter of the daughter balloon (2) after expansion is less than the diameter of the mother balloon (1) after expansion; Evenly distributed micropores (8) are arranged around the surface of the mother balloon (1), and the micropores (8) are unidirectional through holes for the mother balloon (1) to transport substances from inside to outside ; The delivery system includes a catheter (3), the catheter (3) includes a first channel (4), a second channel (5), and a guide wire channel (6), and the first end of the catheter (3) runs through the The mother balloon (1) and the daughter balloon (2), the first passage (4) is connected with the daughter balloon (2), the second passage (5) is connected with the mother balloon (1) connection; The drug stent system includes a temperature-sensitive degradable liquid substance, and the temperature-sensitive degradable liquid substance enters the interior of the mother balloon (1) from the second channel (5) and passes through the micropore (8) Oozing out to the outside of the mother balloon (1), forming a drug stent outside the mother balloon (1). 2. The instantly forming intravascular stent system according to claim 1, wherein the second end of the conduit (3) is provided with a first pressure pump interface and a second pressure pump interface, and the first pressure pump The interface is connected with the first channel (4), and the second pressure pump interface is connected with the second channel (5). 3. The instantly forming intravascular stent system according to claim 1, characterized in that, the catheter (3) further comprises a third channel (7), and the third channel (7) is used for blood flow in the blood vessel to pass through . 4. The instantly forming intravascular stent system according to claim 1, characterized in that, the diameter of the first channel (4) is smaller than the diameter of the second channel (5). 5. The instantly forming intravascular stent system according to claim 1, characterized in that at least one liquid outlet is provided at the connection between the first channel (4) and the sub-balloon (2). The instantly forming intravascular stent system according to claim 1, characterized in that at least one liquid outlet is provided at the connection between the second channel (5) and the mother balloon (1). 7. The instantly forming intravascular stent system according to claim 1, wherein the temperature-sensitive degradable liquid substance is a liquid mixture, and the liquid mixture is in a liquid state when the temperature is lower than 20°C, and the liquid The mixture is solid at temperatures above 30°C. 8 . The instantly forming intravascular stent system according to claim 7 , wherein the liquid mixture includes degradable liquid metal, cell cycle inhibiting drugs, and anticoagulant drugs. 9. The instantly forming intravascular stent system according to claim 8, wherein the liquid mixture further comprises endothelial cells packaged with nanotechnology. 10. the immediate forming intravascular stent system according to claim 1, is characterized in that, described catheter (3) is composite catheter, is made of many catheters, and described first channel (4), described second channel ( 5) and the guide wire channel (6) are catheters, and the first channel (4), the second channel (5) and the guide wire channel (6) are fixedly connected.