WO2011093635A2

WO2011093635A2 - Balloon catheter and a blood-vessel expanding device using the same

Info

Publication number: WO2011093635A2
Application number: PCT/KR2011/000517
Authority: WO
Inventors: 장양수; 홍명기
Original assignee: 연세대학교 산학협력단; 주식회사 에이앤에이엠디
Priority date: 2010-01-29
Filing date: 2011-01-25
Publication date: 2011-08-04
Also published as: WO2011093635A3; KR20110088841A

Abstract

The present invention relates to a balloon catheter and to a blood-vessel expanding device using the same. The present invention comprises: a shaft; a first balloon which is provided on the outside of the shaft and is inserted so as to expand a main blood vessel; a second balloon which is provided on the outside of the shaft and is inserted so as to expand a branch blood vessel; and a connecting part which is formed integrally with the first balloon and the second balloon so as to connect the first balloon and the second balloon and is provided separated from the shaft. The present invention has the advantageous effect that surgery is simplified and the number of items of equipment necessary for surgery is also reduced because the first balloon and the second balloon can be expanded simultaneously by using just a single guide wire.

Description

Balloon catheter and vasodilation device using same

The present invention relates to a balloon catheter and vasodilatation apparatus using the same, and more particularly, when the lesion is caused by narrowing of the main blood vessel and the branch blood vessel, the stent can be expanded simultaneously to the lesion of the main blood vessel and the branch blood vessel. It relates to a balloon catheter and a blood vessel dilation device using the same.

In general, stents are narrowed by the various diseases issued in the human body, and the lumen in the human body is narrowed, which lowers its own function, or when the disease occurs, such as when blood vessels are narrowed and poor blood circulation occurs. Or it is a medical instrument that is performed inside the blood vessels to expand the lumen or blood vessels.

Coronary artery disease or ischemic heart disease is characterized by the deposition of fat on the walls of coronary vessels and the accompanying inflammatory response, resulting in a narrowing of the lumen of the coronary arteries. Due to the size of the lumen, the heart muscle (myocardium) does not provide sufficient blood supply.

Without enough blood supply to the myocardium, chest pain, shortness of breath and other symptoms occur depending on the extent of this. Coronary artery disease is manifested in clinical symptoms such as angina pectoris, acute myocardial infarction and sudden death.

Percutaneous coronary intervention (PCI) is a treatment method that physically expands the lumen of a narrowed coronary artery by using a balloon catheter or stent, where cholesterol is deposited on the vessel wall. However, percutaneous coronary angioplasty with balloon catheter can cause representative complications such as acute closure or vascular dissection.

Fig. 1 is a conceptual diagram showing coronary branching lesions (B), showing a case where stenosis occurs at the boundary between the proximal portion 1a, the distal portion 1b, and the branched vessel 2 of the main blood vessel 1.

For the treatment of the main vessel (1) and the branch vessel (2) showing stenosis, a balloon catheter and stent are placed in the main vessel (1) and the branch vessel (2), and then the balloon is expanded so that the stent is the main vessel (1). ) And the inner wall of the branch blood vessel (2).

When the stent is in close contact with the inner walls of the main blood vessel (1) and the branch blood vessel (2) by expanding the balloon, the size of the main blood vessel (1) and the branch blood vessel (2) because the size of the main blood vessel and the branch blood vessel are different You will use two balloon catheter of different sizes to suit your needs. This requires two balloon catheter and two guide wires for balloon catheter insertion.

In this case, as well as the stent procedure is more complicated, it may often occur that the stent fails to accurately position the operator in the main vessel (1) and branch vessels (2), respectively. In addition, the stent is not firmly attached to the main blood vessel 1 and the branch blood vessel 2, respectively, but a gap occurs between the stent and the main blood vessel 1 or the branch blood vessel 2, or more than necessary. In some cases, damage may occur in the main blood vessel (1) or branch blood vessel (2).

Accordingly, an object of the present invention is to solve the problems of the prior art as described above, and to provide a balloon catheter for simultaneously expanding the stent located in the main blood vessel and branch blood vessel using one guide wire.

Technical problems to be achieved by the present invention are not limited to the above-mentioned technical problems, and other technical problems not mentioned above will be clearly understood by those skilled in the art from the following description. Could be.

According to a feature of the present invention for achieving the above object, the balloon catheter according to the present invention comprises a shaft; A first balloon provided outside the shaft and inserted into the main blood vessel and expanded; A second balloon provided at an outer side of the shaft and inserted into the branch blood vessel and expanded; And a connection part formed integrally with the first balloon and the second balloon to connect the first balloon and the second balloon and separated from the shaft.

The connecting portion is formed to have a diameter smaller than the first balloon and the second balloon.

At least one port for injecting air is formed in the shaft.

The shaft has a hollow shape and two lumens are formed therein, the guide wire penetrates into the lumen formed inside, and air is injected into the lumen formed outside.

At least one radiopaque marker is formed on the shaft.

The marker is characterized in that it is formed of one or more selected from the group consisting of stainless steel, steel, gold, platinum and lead.

At the ends of the first balloon and the second balloon is characterized in that the first shrinkage portion and the second shrinkage portion which is reduced in diameter toward the end is formed, respectively.

The marker may be formed at a boundary portion of the first balloon and the first shrinkage portion, at a boundary portion of the second balloon and the second shrinkage portion, and at a portion corresponding to the connection portion.

According to another feature of the present invention, the vasodilation device according to the present invention comprises a balloon catheter according to any one of claims 1 to 8; A first hollow stent having a plurality of cells, the first stent being expanded by the expansion of the first balloon and being in close contact with the inner wall of the main blood vessel; A hollow cylindrical second stent which is expanded by the expansion of the second balloon and is in close contact with the inner wall of the branch blood vessel and has a plurality of cells; It characterized in that it comprises at least one bridge for connecting the first stent and the second stent.

At least one of the first stent, the second stent, and the bridge is characterized in that a radiopaque marker is formed.

In the present invention, the connecting portion connecting the first balloon and the second balloon is provided without being separated on the shaft. Therefore, since the first balloon and the second balloon can be expanded at the same time with only one guide wire, the procedure is simplified and the number of equipment required for the procedure is also reduced.

1 is a conceptual diagram showing coronary branching lesion (B).

Figure 2 is a side view showing a balloon catheter according to an embodiment of the present invention.

3 is an exploded view showing a stent according to an embodiment of the present invention.

4 and 5 is a conceptual diagram schematically showing a procedure of the stent in accordance with an embodiment of the present invention.

Hereinafter, an embodiment of a balloon catheter according to the present invention and a blood vessel dilation device using the same will be described in detail with reference to the accompanying drawings.

As shown therein, the balloon catheter according to the present invention includes a shaft 10; A first balloon 20 provided outside the shaft 10 and inserted into the main blood vessel 1 and expanding; A second balloon (30) provided outside the shaft (10) and inserted into the branch blood vessel (2) and expanded; The connection part 25 which is formed integrally with the first balloon 20 and the second balloon 30 to connect the first balloon 20 and the second balloon 30 and is separated from the shaft 10 is provided. ).

The shaft 10 penetrates the first balloon 20 and the second balloon 30, and guide wires (not shown) penetrate therein. Specifically, the shaft 10 has a hollow shape and two lumens are formed therein, and guide wires penetrate through the lumens formed therein, and air is injected into the lumens formed outside.

At least one port 12 for pressurizing the first balloon 20 and the second balloon 30 penetrates the shaft 10. The ports 12 are formed at predetermined intervals on the shaft 10. In the present embodiment, two ports 12 are formed inside the relatively long second balloons 30 and the first balloons are relatively short. One is formed inside 20). The air injected through the port 12 expands the first and

second balloons

20 and 30.

In addition, at least one marker 14 is formed on the shaft 10. The marker 14 is formed of a radiopaque material, and is formed to easily determine the position of the balloon catheter. The marker 14 may be formed of a radiopaque metal or resin, and may be formed of, for example, one or more selected from the group consisting of stainless steel, gold, platinum, and lead.

In the present exemplary embodiment, the marker 14 is connected to the boundary between the first balloon 20 and the first shrinking part 22, the boundary between the second balloon 30 and the second shrinking part 32, and the connection part 25, respectively. Is formed. The position of the marker 14 in this way is to effectively determine the position of the balloon catheter.

Specifically, after the balloon catheter is inserted, the first balloon 20 is inserted into the main blood vessel 1. Therefore, the marker 14 is formed on the tip side of the first balloon 20 so that the position of the first balloon 20 can be confirmed and adjusted. Like the first balloon 20, the second balloon 30 may also have a marker 14 formed at a rear end thereof to check and adjust the position of the second balloon 20. In addition, the marker 14 is formed on the connecting portion 25 to check the boundary between the first balloon 20 and the second balloon 30 so that the first balloon 20 is completely inserted into the main blood vessel 1 side. You can check if it is.

Next, in the present invention, the first balloon 20 and the second balloon 30 are integrally formed by the connecting portion 25, and as described above, the connecting portion 25 is not sealed with the shaft 10. It is provided to be separated without. That is, the connection part 25 is formed to be spaced apart from the shaft 10. Therefore, even if only one guide wire is inserted into the shaft 10, the first balloon 20 and the second balloon 30 can be expanded together.

In other words, although the first balloon 20 and the second balloon 30 are conventionally formed to be separated from each other, in the present invention, the first balloon 20 and the second balloon 30 are connected to the connection portion 25. Since it is integrally expanded through the expansion of the first balloon 20 and the second balloon 30 even if only one guide wire is inserted. The first balloon 20 and the second balloon 30 may be expanded together by the pressure of the air injected through the port 12.

In addition, the connection portion 25 has a diameter relatively smaller than the first balloon 20 and the second balloon (30). Therefore, the first balloon 20 and the second balloon 30 can be easily bent along the direction in the blood vessel around the connecting portion 25.

On the other hand, Figure 3 is a development view showing a stent according to an embodiment of the present invention.

According to this, the stent using the balloon catheter according to the present invention corresponds to the inner wall of the main blood vessel (1), the hollow cylindrical first stent 40 having a plurality of cells 42; A hollow cylindrical second stent 50 corresponding to the inner wall of the branch blood vessel 2 and having a plurality of cells 52; A bridge 45 is formed integrally with the first stent 40 and the second stent 50 to connect the first stent 40 and the second stent 50.

The first and

second stents

40 and 50 may be formed of at least one selected from the group consisting of stainless steel, cobalt, titanium, platinum, and alloys thereof having predetermined rigidity and elasticity, and are expandable in a radial direction. A plurality of

cells

42 and 52 are formed so as to form a plurality of cells. The size and cross-sectional shape of the

cells

42 and 52 may be determined according to the degree of expansion required in consideration of the diameters of the main blood vessel 1 and the branch blood vessel 2. For example, the

cells

42 and 52 may be formed of a single open cell or a plurality of closed cells having a rhombus shape, a plurality of valleys and acids, as shown in FIG. 3. have.

In the present embodiment, the first stent 40 corresponds to the first balloon 20, and the second stent 50 corresponds to the second balloon 30. Therefore, the first stent 40 is expanded by the expansion of the first balloon 20 to be in close contact with the inner wall of the main blood vessel 1, and the second stent 50 is expanded to the expansion of the second balloon 30. It expands and adheres to the inner wall of the branch blood vessel 2. The stent shown in FIG. 3 has been described by way of example, and it is natural that a stent having another shape can be expanded by a balloon catheter.

On the other hand, the bridge 45 is preferably a plurality of linear bridge, it may be made of a metal material having a predetermined elasticity and rigidity to bend. The bridge 45 provides overall structural stabilization of the first stent 40 and the second stent 50 and contributes to the technical improvement of the delivery of the stent.

In addition, although not shown in detail in the drawing, the first and

second stents

40 and 50 and the bridge 45 may be further provided with a radiopaque marker for checking the position of the stent.

Hereinafter, the balloon catheter according to the present invention having the configuration as described above and the process of expanding the blood vessels using the blood vessel expansion device using the same will be described in detail.

According to this, the guide wire (W) is inserted into the branch blood vessel (2). At this time, the stent is inserted together in a state accommodated in the balloon catheter. Since the balloon catheter and stent inserted along the guide wire W can be easily identified by the marker 14 formed on the shaft 10, the operator can insert the balloon catheter to the desired position.

The first balloon 20 positioned at the tip of the balloon catheter inserted into the branched blood vessel 2 is partially inserted into the main blood vessel 1 as shown in FIG. 4. In addition, the first balloon 20 is bent and inserted into the main blood vessel 1 by the connecting portion 25. Since the connection portion 25 has a smaller diameter than the first balloon 20 and the second balloon 30, it is easy to bend.

The operator inflates the first balloon 20 and the second balloon 30 by injecting air through the port 12 when the first balloon 20 and the second balloon 30 are inserted as desired. . The first balloon 20 and the second balloon 30 are connected by the connecting portion 25, the connecting portion 25 is not sealed to the shaft 10, so the first balloon 20 and the second balloon 30 can be expanded together. Therefore, in this embodiment, there is an advantage that the insertion of the balloon catheter and stent with only one guide wire (W).

The first balloon 20 and the second balloon 30 are expanded to extend the first stent 40 and the second stent 50, respectively. The first stent 40 is in close contact with the inner wall of the main blood vessel 1, and the second stent 50 is in close contact with the inner wall of the branch blood vessel 2, respectively. In this case, the main blood vessel 1 and the branch blood vessel 2 can be expanded to treat branched lesions.

The scope of the present invention is not limited to the embodiments described above, but is defined by the claims, and various changes and modifications can be made by those skilled in the art within the scope of the claims. It is self evident.

Claims

A shaft;

A first balloon provided outside the shaft and inserted into the main blood vessel and expanded;

A second balloon provided at an outer side of the shaft and inserted into the branch blood vessel and expanded;

Balloon catheter characterized in that it is formed integrally with the first balloon and the second balloon to connect the first balloon and the second balloon, and is provided separated from the shaft.
The method of claim 1,

The connecting part is a balloon catheter, characterized in that formed to have a smaller diameter than the first balloon and the second balloon.
The method of claim 1,

Balloon catheter, characterized in that at least one port for injecting air is formed in the shaft.
The method of claim 3, wherein

The shaft has a hollow shape and two lumens are formed therein, the guide wire penetrates into the lumen formed inside, and air is injected into the lumen formed outside.
The method of claim 1,

Balloon catheter, characterized in that at least one or more radiopaque markers are formed on the shaft.
The method of claim 5,

And the marker is formed of at least one selected from the group consisting of stainless steel, steel, gold, platinum and lead.
The method of claim 5,

Balloon catheter, characterized in that the first shrinkage portion and the second shrinkage portion is formed at the end of the first balloon and the second balloon is reduced in diameter toward the end.
The method of claim 7, wherein

The marker is a balloon catheter, characterized in that formed on the boundary portion of the first balloon and the first contraction portion, the boundary portion of the second balloon and the second contraction portion, and the portion corresponding to the connecting portion.
A shaft, a first balloon provided outside the shaft and inserted into the main blood vessel and expanding, a second balloon provided outside the shaft and inserted into the branched blood vessel and expanded, the first balloon and a second balloon; A balloon catheter integrally formed with a connecting portion connecting the first balloon and the second balloon and separated from the shaft;

A first hollow stent having a plurality of cells, the first stent being expanded by the expansion of the first balloon and being in close contact with the inner wall of the main blood vessel;

A hollow cylindrical second stent which is expanded by the expansion of the second balloon and is in close contact with the inner wall of the branch blood vessel and has a plurality of cells;

Vasodilation apparatus comprising at least one bridge connecting the first stent and the second stent.
The method of claim 9,

The connecting portion is a blood vessel expansion device, characterized in that formed to have a smaller diameter than the first balloon and the second balloon.
The method of claim 9,

And at least one port for injecting air is formed in the shaft.
The method of claim 11,

The shaft has a hollow shape and two lumens are formed therein, the vessel extending device, characterized in that the guide wire is penetrated by the lumen formed inside and air is injected into the lumen formed outside.
The method of claim 9,

At least one of the first stent, the second stent and the bridge is a blood vessel dilation device, characterized in that the radiopaque marker is formed.
The method of claim 13,

The marker is formed of at least one selected from the group consisting of stainless steel, steel, gold, platinum and lead.
The method of claim 13,

Vasodilation apparatus, characterized in that the first and second contraction portion is formed at the ends of the first balloon and the second balloon is reduced in diameter toward the end.
The method of claim 15,

And the marker is formed at a boundary between the first balloon and the first contraction portion, at a boundary between the second balloon and the second contraction portion, and at a portion corresponding to the connection portion.