Double-balloon catheter for interventional therapy of bifurcation position of blood vessel

Abstract

The invention provides a double-balloon catheter for an interventional operation at a blood vessel bifurcation position in order to solve the problem that the interventional operation at the blood vessel bifurcation position at a focus position is difficult to operate. Comprising a catheter head section, a catheter main body section, a first balloon, a second balloon, a first fluid passage and a second fluid passage, wherein the catheter head section and the catheter main body section are integrally connected; the first balloon is arranged around the catheter head section; the second balloon is arranged around the catheter main body section at the position close to the catheter head section; the catheter main body section and the catheter head section jointly form an instrument passage; the catheter head section is provided with an end opening, and a side opening is formed in the position, between the first balloon and the second balloon, of the catheter body section. Compared with the catheter main body section, the catheter head section is more easily pressed and deformed.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a double-balloon catheter used for interventional treatment at a vascular bifurcation position. Background Art

[0002] Vascular interventional surgery is often used to treat cardiovascular and cerebrovascular diseases, especially lesions such as vascular stenosis and obstruction caused by blood clots. Interventional catheters and guidewires are both commonly used vascular interventional medical devices in vascular interventional surgery.

[0003] In general vascular interventional surgical procedures, doctors establish an arterial access at the patient's femoral artery or radial artery, and with the assistance of X-ray imaging equipment, place interventional devices (catheters, guidewires, etc.) into the blood vessels and follow the human blood vessels to the lesion site, where they perform a series of treatment operations (such as balloon dilatation, arterial embolization, mechanical thrombectomy, etc.).

[0004] If the lesion is located exactly at the bifurcation of the blood vessel, it will bring certain difficulties to the interventional surgery. Especially if a branch vessel at the bifurcation of the blood vessel is blocked by a thrombus, when the interventional device reaches the bifurcation, it is easy to enter the unblocked blood vessel, but difficult to accurately enter the blocked blood vessel, making it difficult to treat the lesion segment. This situation is common in patients with thromboembolism. When a thrombus is formed and flows with the blood, it is more likely to be embedded in the bifurcation segment and compressed into one of the branch vessels under the impact of arterial blood pressure. Summary of the invention

[0005] In view of this, the purpose of the present invention is to provide a double-balloon catheter for intervention at a vascular bifurcation position, in which the first balloon is inflated to close the instrument passage of the catheter head section, and the interventional instrument passing through the instrument passage of the catheter main section can only enter the branch vessel with the disease from the side opening, so as to solve the problem that when the interventional instrument reaches the bifurcation position, it is easy to enter the unblocked blood vessel but difficult to accurately enter the blocked blood vessel position, thus making it difficult to treat the diseased segment.

[0006] In order to achieve the above object, the present invention provides the following technical solutions:

[0007] A double-balloon catheter for intervention at a vascular bifurcation position, comprising a catheter head section and a catheter main section connected in one piece, a first balloon disposed around the catheter head section, a second balloon disposed around the catheter main section at a position adjacent to the catheter head section, a first fluid passage for filling the first balloon, and a second fluid passage for filling the second balloon;

[0008] The catheter body section and the catheter head section together form an instrument passage; the catheter head section is provided with an end opening, and a side opening is provided at a position between the first balloon and the second balloon of the catheter body section;

[0009] The catheter head section is more susceptible to compression and deformation than the catheter main section. When the first balloon is inflated, the catheter head section is squeezed by the first balloon, so that the instrument passage of the catheter head section is closed; when the second balloon is inflated, although the catheter main section is squeezed by the second balloon, the instrument passage of the catheter main section remains unobstructed.

[0010] In one embodiment, a guide block connected to the proximal end of the catheter head section is provided on the inner wall of the catheter body section, and at least a portion of the guide block is located on the opposite side of the side opening. The guide block includes two sections hinged together, and after the first balloon is inflated, the guide block rotates radially and bends along the hinge to guide the interventional instrument through the side opening.

[0011] In one embodiment, the material of the catheter head section is softer than the material of the catheter body section.

[0012] In one embodiment, the catheter body section includes a metal wire mesh that prevents the catheter body section from being easily deformed, and the catheter head section does not include a metal wire mesh.

[0013] In one embodiment, the first fluid passage and the second fluid passage are respectively arranged inside the catheter main body section and extend along the radial direction of the catheter main body section.

[0014] In one embodiment, when the double-balloon catheter is used, the distal ends of the catheter head section and the catheter main section are placed in the blood vessel cavity, and the proximal end of the catheter main section remains outside the body; the first fluid pathway and the second fluid pathway have a first fluid filling port and a second fluid filling port at the proximal end of the catheter main section, respectively, and the first fluid filling port and the second fluid filling port are used to fill the first balloon and the second balloon with fluid, respectively.

[0015] In one embodiment, an instrument inlet is disposed at the proximal end of the catheter body section; the instrument inlet is configured to allow an interventional instrument to enter the instrument passage and enter the blood vessel cavity through the side opening.

[0016] In one embodiment, the interventional device is a vascular interventional guidewire.

[0017] In one embodiment, the fluid used to fill the first balloon and / or the second balloon is a contrast agent liquid, so that the first balloon and / or the second balloon can be clearly imaged under an X-ray imaging device when in an inflated state.

[0018] The present invention also provides an interventional surgical instrument assembly, comprising the double-balloon catheter and an interventional instrument capable of passing through the instrument passage of the double-balloon catheter.

[0019] The embodiments of the present invention bring the following beneficial effects:

[0020] (1) The present invention reduces the difficulty of implementing interventional surgery when the lesion is located exactly at the bifurcation of the blood vessel. When a branch vessel at the bifurcation of the blood vessel is blocked by a thrombus, the double-balloon catheter provided by the present invention is used to place the first balloon and the second balloon respectively in the branch vessel without the lesion, and the side opening of the catheter is directed toward the branch vessel with the lesion. After the first balloon and the second balloon are inflated, the first balloon and the second balloon are respectively in close contact with the inner wall of the blood vessel to fix the position, and the filling of the first balloon closes the instrument passage of the catheter head section, so that the interventional instrument passing through the instrument passage of the catheter main section can only enter the branch vessel with the lesion from the side opening;

[0021] (2) The fluid filled in the present invention may be a liquid or a gas, usually a contrast agent liquid, so that the first balloon and the second balloon can be clearly imaged under an X-ray imaging device when they are filled, to assist doctors in making judgments;

[0022] (3) The present invention provides a guide block that rotates toward the middle as the first balloon is inflated, and bends itself to fit closely to the distal end of the side opening, so as to guide the interventional instrument through the side opening, thereby reducing the difficulty of the interventional instrument passing through the side opening.

[0023] Other features and advantages of the present invention will be described in the following description, and partly become apparent from the description, or understood by practicing the present invention. The purpose and other advantages of the present invention are realized and obtained by the structures particularly pointed out in the description, claims and drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without paying any creative work.

[0025] Figure 1 A schematic diagram of a use scenario of the double-balloon catheter provided by the present invention;

[0026] Figure 2 Schematic diagram of two states of the double-balloon catheter provided by the present invention;

[0027] Figure 3A schematic diagram of the application of the double-balloon catheter provided by the present invention in a usage scenario;

[0028] Figure 4 Schematic diagram of two states of the double-balloon catheter provided in Example 2 of the present invention.

[0029] Icons: 10, catheter head section; 20, catheter body section; 11, first balloon; 21, second balloon; 22, side opening; 30, interventional instrument; 40, guide block. DETAILED DESCRIPTION

[0030] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0031] Example 1

[0032] In general vascular interventional procedures, doctors create an incision in the patient's femoral artery or brachial artery, insert interventional instruments (catheters, guidewires, etc.) into the blood vessels, and follow the blood vessels to the lesion site, where they perform a series of treatment operations (such as balloon dilatation, mechanical thrombectomy, etc.). However, if the lesion site happens to be at the bifurcation of the blood vessel, it will bring certain difficulties to the interventional surgery.

[0033] like Figure 1 The figure shows a situation where a branch vessel at a bifurcation position is blocked by a thrombus. The bifurcation position has three branch vessels, A, B, and C, among which branch vessel C is blocked by a thrombus at the bifurcation position. If during the operation, it is desired to make the interventional instrument reach the branch vessel C at the distal end from the proximal branch vessel A (all "distal" and "proximal" expressions in this patent application refer to the distance based on the position of the surgical operator), due to the blockage of the thrombus, when the interventional instrument (such as the thrombus removal guide wire) reaches the bifurcation position, it is easy to enter the unblocked branch vessel B, but it is difficult to accurately reach the specific position of the blocked branch vessel C.

[0034] In order to solve this problem, the present invention provides a double-balloon catheter for intervention at a vascular bifurcation position, such as Figure 2 , Figure 3As shown, it includes a catheter head section 10 and a catheter main section 20 that are integrally connected, a first balloon 11 arranged around the catheter head section 10, a second balloon 21 arranged around the catheter main section 20 at a position adjacent to the catheter head section 10, a first fluid passage for filling the first balloon 11, and a second fluid passage for filling the second balloon 21; the catheter main section 20 and the catheter head section 10 together form an instrument passage; the catheter head section 10 is provided with an end opening, and a side opening 22 is provided at a position between the first balloon 11 and the second balloon 12 of the catheter main section 20.

[0035] Figure 2 The upper and lower figures in the figure respectively show the schematic diagram of the double balloon catheter provided by the present invention in the balloon unfilled state and the balloon filled state. Figure 2 In the schematic diagram of the balloon filling state below, the catheter head section 10 is more susceptible to compression and deformation than the catheter main section 20. Therefore, when the first balloon 11 is filled, the catheter head section 10 is squeezed by the first balloon 11, so that the instrument passage of the catheter head section 10 is closed; when the second balloon 21 is filled, although the catheter main section 20 is squeezed by the second balloon 21, the instrument passage of the catheter main section 20 remains unobstructed.

[0036] The above effect can be achieved by making the material of the catheter head section 10 softer than that of the catheter main section 20, or by making the catheter main section 20 include a metal mesh that makes the catheter main section 20 less likely to deform, while the catheter head section 10 does not include a metal mesh. Thus, the catheter head section 10 is more easily deformed under pressure than the catheter main section 20.

[0037] What is not shown in the figure is that the first fluid passage and the second fluid passage are respectively arranged inside the catheter main body section 20, extending in the radial direction of the catheter main body section 20, and their function is to fill the first balloon 11 and the second balloon 21 with fluid to make them full. The filled fluid can be liquid or gas, usually a contrast agent liquid, so that the first balloon 11 and the second balloon 21 can be clearly imaged under the X-ray imaging device when they are filled.

[0038] When the double-balloon catheter provided by the present invention is used, the distal ends of the catheter head section 10 and the catheter main section 20 are placed in the blood vessel cavity, and the proximal end of the catheter main section 20 is left outside the body to be operated by the operator. The first fluid passage and the second fluid passage have a first fluid filling port and a second fluid filling port at the proximal end of the catheter main section 20, respectively, and the first fluid filling port and the second fluid filling port are used to fill the first balloon 11 and the second balloon 21 with fluid, respectively. For example, a contrast agent is injected into the first fluid filling port and the second fluid filling port using a syringe to fill the first balloon 11 and the second balloon 21.

[0039] An instrument inlet is provided at the proximal end of the catheter body section 20 , through which the operator allows the interventional instrument 30 (such as an interventional guidewire, a thrombectomy guidewire) to enter the instrument passage of the double-balloon catheter and enter the blood vessel cavity through the side opening 22 .

[0040] like Figure 3 When a branch blood vessel C at a bifurcation position is blocked by a thrombus, the double-balloon catheter provided by the present invention is used to place the first balloon 11 and the second balloon 21 in the branch blood vessels A and B without lesions, respectively, and the side opening 22 of the catheter is directed toward the branch blood vessel C with lesions, so that after the first balloon 11 and the second balloon 21 are filled, the first balloon 11 and the second balloon 21 are respectively closely attached to the inner walls of the branch blood vessels A and B to fix their positions, and the filling of the first balloon 11 closes the instrument passage of the catheter head section 10, so that the interventional device 30 passing through the instrument passage of the catheter main section 20 can only enter the branch blood vessel C with lesions from the side opening 22.

[0041] The present invention also provides an interventional surgical instrument assembly, including a double balloon catheter and an interventional instrument 30 capable of passing through the instrument passage of the double balloon catheter. The interventional instrument 30 can be various intravascular interventional medical instruments, such as intravascular catheters, intravascular guidewires and / or sheaths, embolization instruments, etc.

[0042] Example 2

[0043] The difference from Example 1 is that Figure 4 As shown, a guide block 40 connected to the catheter head section 10 is also provided on the inner wall of the catheter main section 20, at least a part of the guide block 40 is located on the opposite side of the side opening 22, and the guide block 40 includes two sections connected by hinges. In the default state, the guide block 40 is bent 1-3° to one side of the side opening 22. After the first balloon 11 is filled, the catheter head section 10 is deformed toward the middle and proximal end, driving the guide block 40 to rotate radially and bend at the hinge, so that the hinge abuts against the distal end of the side opening 22. At this time, the interventional instrument 30 passes through the side opening 22 under the guidance of the guide block. The guide block 40 is preferably made of elastic medical silicone material, which is soft and easy to deform, and has less resistance to the filling of the first balloon 11. When the first balloon 11 is not filled, it can remain stable and close to the inner wall of the catheter main section 20. The guide block 40 is connected to the inner wall of the catheter body section 20 by bonding, and is fixedly connected to the proximal end of the first balloon 11 by melting. In order to make it easier for the guide block 40 to deform after the first balloon 11 is filled, the proximal end of the guide block 40 is partially bonded to the inner wall of the catheter body section 20, so that after the first balloon 11 is filled, the guide block 40 is partially deflected, which can better guide the interventional instrument 30 to pass through the side opening 22.

[0044] Finally, it should be noted that the above embodiments are only specific implementations of the present invention, which are used to illustrate the technical solutions of the present invention, rather than to limit them. The protection scope of the present invention is not limited thereto. Although the present invention is described in detail with reference to the above embodiments, those skilled in the art should understand that any person skilled in the art can still modify the technical solutions recorded in the above embodiments within the technical scope disclosed by the present invention, or can easily think of changes, or make equivalent replacements for some of the technical features therein; and these modifications, changes or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present invention, and should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be based on the protection scope of the claims.

Claims

1. A double-balloon catheter for intervention at a vascular bifurcation, characterized in that: The catheter comprises an integrally connected catheter head section and a catheter main section, a first balloon disposed around the catheter head section, a second balloon disposed around the catheter main section adjacent to the catheter head section, a first fluid passage for filling the first balloon, and a second fluid passage for filling the second balloon; The catheter body section and the catheter head section together form an instrument passage; the catheter head section is provided with an end opening, and a side opening is provided at a position between the first balloon and the second balloon of the catheter body section; The catheter head section is more susceptible to compression and deformation than the catheter main section. When the first balloon is inflated, the catheter head section is squeezed by the first balloon, so that the instrument passage of the catheter head section is closed; when the second balloon is inflated, although the catheter main section is squeezed by the second balloon, the instrument passage of the catheter main section remains unobstructed.

2. The double-balloon catheter for intervention at a vascular bifurcation position according to claim 1, characterized in that: A guide block connected to the proximal end of the catheter head section is arranged on the inner wall of the catheter main section, and at least a part of the guide block is located on the opposite side of the side opening. The guide block includes two sections hinged together, and after the first balloon is inflated, it rotates radially and bends along the hinge to guide the interventional instrument through the side opening.

3. The double-balloon catheter for intervention at a vascular bifurcation position according to claim 1, characterized in that: The material of the catheter head section is softer than the material of the catheter body section.

4. The double-balloon catheter for intervention at a vascular bifurcation position according to claim 1, characterized in that: The catheter body section includes a metal wire mesh that makes the catheter body section less likely to deform, and the catheter head section does not include the metal wire mesh.

5. The double-balloon catheter for intervention at a vascular bifurcation position according to claim 4, characterized in that: The first fluid passage and the second fluid passage are respectively arranged inside the catheter main body section and extend along the radial direction of the catheter main body section.

6. The double-balloon catheter for intervention at a vascular bifurcation position according to claim 5, characterized in that: When the double-balloon catheter is in use, the distal ends of the catheter head section and the catheter main section are placed in the blood vessel cavity, and the proximal end of the catheter main section remains outside the body; the first fluid pathway and the second fluid pathway have a first fluid filling port and a second fluid filling port at the proximal end of the catheter main section, respectively, and the first fluid filling port and the second fluid filling port are used to fill the first balloon and the second balloon with fluid, respectively.

7. The double-balloon catheter for intervention at a vascular bifurcation position according to claim 6, characterized in that: An instrument inlet is disposed at the proximal end of the catheter body section; the instrument inlet is configured to allow interventional instruments to enter the instrument passage and enter the blood vessel cavity through the side opening.

8. The double-balloon catheter for intervention at a vascular bifurcation position according to claim 1, characterized in that: The interventional device is a vascular intervention guidewire.

9. The double-balloon catheter for intervention at a vascular bifurcation position according to claim 1, characterized in that: The fluid used to fill the first balloon and / or the second balloon is a contrast agent liquid, so that the first balloon and / or the second balloon can be clearly imaged under an X-ray imaging device when in an inflated state.

10. An interventional surgical instrument assembly, characterized in that: The invention comprises a double-balloon catheter for intervention at a vascular bifurcation position as claimed in any one of claims 1 to 9, and an interventional instrument capable of passing through an instrument passage of the double-balloon catheter.

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