A perfusion balloon catheter having a one-way valve

Abstract

The application provides a perfusion balloon catheter with a one-way valve, comprising: a balloon body part; the balloon body part comprises an inner lumen tube and a plurality of balloons arranged around the outer surface of the inner lumen tube; the distal balloon tube leg of the plurality of balloons is in contact with the tube wall of the inner lumen tube; a one-way valve is arranged between the inner lumen tube and the balloon part of the balloon. Compared with the prior art, the perfusion balloon catheter provided by the application is formed by a plurality of balloon clusters, and after expansion, a hollow cylindrical shape is formed, and a one-way valve is arranged in the cavity, which is used to simulate the leaflets in the heart valve, and the one-way valve is enabled after the balloon is opened, without the need for switching operation, and the structure is stable, and the function of the leaflets can be realized for multiple times; in addition, the design of the cluster balloon can reduce the difficulty of the balloon forming process while meeting the expected function.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of balloon catheter, in particular to a perfusion balloon catheter with a one-way valve. BACKGROUND

[0002] In vertebrates, the heart is a muscular organ with four pumping chambers: the left and right atria, and the left and right ventricles, each of which has its own independent one-way valve. Natural heart valves are defined as the aortic valve, the mitral valve (or bicuspid valve), the tricuspid valve, and the pulmonary valve. Since the aortic valve or the mitral valve is located on the left side of the heart, it bears the most pressure, so over a long period of work, the valve leaflets will lose function and need to be repaired or replaced. Traditional artificial heart valve replacement surgery involves entering the heart through a longitudinal incision in the patient's chest, such as a median sternotomy, which requires cutting through the sternum and forcing two opposing half-ribs apart to access the chest and its heart, thus placing the patient in cardiopulmonary bypass, including stopping the heart from beating to allow access to the inner chambers. However, these open-chest surgeries are particularly invasive, with a long and difficult recovery period. Minimally invasive surgical techniques are constantly evolving, in which artificial heart valves can be introduced into the patient's body using a catheter, which is introduced through a smaller incision to access, for example, the femoral artery or the heart.

[0003] However, the high cost of valve implantation surgery has deterred most patients. Currently, most medical devices on the market for heart valve repair are designed to work with artificial valve implantation surgery, and due to their relatively simple design, they have poor treatment outcomes.

[0004] Chinese patent CN201780008580.0 discloses a perfusion balloon with an internal valve for a device for performing a medical procedure in a blood vessel, in particular an aortic valve plasty, to transport a fluid flow. The device comprises a shaft, an inflatable perfusion balloon supported by the shaft and comprising an internal passage for allowing fluid to flow in the blood vessel when the perfusion balloon is in an inflated state and a valve for controlling the flow of fluid within the passage, the valve can be connected to the shaft or can comprise an elongated tube connected partially to the balloon. The balloon can comprise a plurality of cells in a single cross-section, each cell comprising a neck and the valve can be positioned in a space between the shaft and the neck for controlling the flow of fluid within the passage, a connector can also be provided for control. However, when the balloon reaches the aorta for treatment, the doctor needs to manually control the opening and closing of the internal valve multiple times, increasing the difficulty of the operation.

[0005] A perfusion balloon with an external valve for performing a medical treatment procedure in a blood vessel for transporting a fluid flow, in particular an aortic valve reshaping procedure, is disclosed in Chinese patent application No. CN201780008641.3. The device comprises an inflatable perfusion balloon comprising an internal channel for allowing fluid flow in the blood vessel when the perfusion balloon is in an inflated state, the balloon comprising a plurality of cells in a single cross-section and a cover for at least partially covering the cells. A valve is connected to the balloon and controls the fluid flow in the channel, the valve being arranged outside the channel. The valve can form a tubular extension of the cover or can be separate from the cover and can comprise a flap. A spiral cover can also form the valve. However, on the one hand, the components increase the surface of the balloon catheter, making the outer diameter of the balloon catheter larger and the hardness increased, resulting in poor passability of the balloon catheter; on the other hand, whether it is a film or a spiral cover, due to its material characteristics, it is soft and cannot withstand multiple one-way blood impacts, and the risk of treatment failure is high. Once the balloon catheter loses the one-way valve function, the important arterial trunk may be occluded at any time, causing blood supply disorders to large areas of important organs such as the heart, kidneys and brain, which is an extremely dangerous and serious vascular critical condition that seriously endangers the patient's life safety. SUMMARY

[0006] Therefore, the present application aims to provide a perfusion balloon catheter with a stable one-way valve for repairing heart valves and achieving good continuous one-way blood flow.

[0007] The present application provides a perfusion balloon catheter with a one-way valve, comprising:

[0008] a balloon body portion; the balloon body portion comprises an inner lumen tube and a plurality of balloons arranged around the outer surface of the inner lumen tube; the balloons comprise a distal balloon tube leg, a distal conical surface portion, a balloon portion, a proximal conical surface portion and a proximal balloon tube leg arranged in sequence, and the side walls of the balloon portions of adjacent balloons are in contact with each other; the distal balloon tube legs of the plurality of balloons are in contact with the tube wall of the inner lumen tube; a one-way valve is arranged between the inner lumen tube and the balloon portion of the balloon;

[0009] a double lumen tube; the double lumen tube comprises a guide wire lumen and a gas lumen; the proximal balloon tube legs of the plurality of balloons are in communication with the gas lumen; the inner lumen tube is in communication with the guide wire lumen.

[0010] Preferably, the balloon body portion further comprises a balloon protection layer; the balloon protection layer is arranged on the side of the balloon portion of the plurality of balloons away from the inner lumen tube and is integrally arranged.

[0011] Preferably, the outer surface of the balloon protection layer is provided with a flexible filament structure along the axial direction of the balloon; the number of the flexible filament structures is 3-10.

[0012] Preferably, the balloon protection layer is woven from filamentous material.

[0013] Preferably, the balloon protection layer is formed from a meshed elastic alloy structure.

[0014] Preferably, the meshed elastic alloy structure is a meshed nickel-titanium material structure; the balloon protection layer has two states when the balloon is not opened and when the balloon is working, respectively, and the diameter of the balloon protection layer increases simultaneously when the diameter of the balloon under pressure increases.

[0015] Preferably, the diameter of the balloon is 1 / 5 to 1 / 2 of the diameter of the balloon body portion; the number of the balloons is 2 to 10.

[0016] Preferably, the one-way valve is fixed to the outer surface of the inner lumen tube, and is umbrella-shaped or standing collar-shaped with the inner lumen tube as the axis.

[0017] Preferably, the one-way valve comprises a wire skeleton structure and a biocompatible material covering the surface of the wire skeleton structure.

[0018] Preferably, the thickness of the wire skeleton structure is 0.05 to 0.5 mm; one end of the wire skeleton structure is in contact with the inner lumen tube, and the other end is in contact with the balloon part of the plurality of balloons.

[0019] The present application provides a perfusion balloon catheter with a one-way valve, comprising: a balloon body portion; the balloon body portion comprises an inner lumen tube and a plurality of balloons arranged around the outer surface of the inner lumen tube; the balloon comprises a distal balloon tube leg, a distal conical part, a balloon part, a proximal conical part and a proximal balloon tube leg arranged in sequence, and the side walls of the balloon parts of adjacent balloons are in contact with each other; the distal balloon tube legs of the plurality of balloons are in contact with the wall of the inner lumen tube; a one-way valve is arranged between the inner lumen tube and the balloon part of the balloon; a double lumen tube; the double lumen tube comprises a guide wire lumen and a gas lumen; the proximal balloon tube legs of the plurality of balloons are in communication with the gas lumen; and the inner lumen tube is in communication with the guide wire lumen. Compared with the prior art, the balloon body portion of the perfusion balloon catheter provided by the present application is formed by a plurality of balloons, and forms a hollow cylindrical shape after expansion, and a one-way valve is arranged in the cavity, which is used to simulate the leaflets in the heart valve and perform one-way blood perfusion. After the balloon is opened, the one-way valve is already enabled, without the need for switching operation, and its structure is stable, which can realize the function of the leaflets multiple times. In addition, the design of the bundled balloon can reduce the difficulty of the balloon forming process while meeting the expected function. BRIEF DESCRIPTION OF DRAWINGS

[0020] Figure 1 The structure diagram of the perfusion balloon catheter with a one-way valve provided by the present application;

[0021] Figure 2 The structure diagram of the balloon body portion provided by the present application;

[0022] Figure 3 A cross-sectional view of the balloon body portion provided by the present application;

[0023] Figure 4-1(a) is a schematic view of a square-shaped meshed NiTi balloon protection layer according to the present application;

[0024] Figure 4-1(b) is a schematic view of a single square-shaped mesh of a meshed NiTi balloon protection layer according to the present application;

[0025] Figure 4-2(a) is a schematic view of a triangular meshed NiTi balloon protection layer according to the present application;

[0026] Figure 4-2(b) is a schematic view of a single triangular mesh of a meshed NiTi balloon protection layer according to the present application;

[0027] Figure 4-3(a) is a schematic view of a rhombus-shaped meshed NiTi balloon protection layer according to the present application;

[0028] Figure 4-3(b) is a schematic view of a single rhombus-shaped mesh of a meshed NiTi balloon protection layer according to the present application;

[0029] Figure 5 A schematic view of a one-way valve according to the present application;

[0030] Figure 6 A schematic view of another one-way valve according to the present application;

[0031] Figure 7 A cross-sectional view of a double-lumen tube according to the present application;

[0032] Figure 8 Another cross-sectional view of a double-lumen tube according to the present application. DETAILED DESCRIPTION

[0033] The technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments of the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the scope of the present application.

[0034] The present application provides a perfusion balloon catheter with a one-way valve, comprising:

[0035] The balloon body part comprises a lumen tube and a plurality of balloons arranged around the outer surface of the lumen tube; the balloon comprises a distal balloon tube leg, a distal conical surface part, a balloon part, a proximal conical surface part and a proximal balloon tube leg arranged in sequence, and the balloon part sidewalls of adjacent balloons are in contact with each other; the distal balloon tube legs of the plurality of balloons are in contact with the tube wall of the lumen tube; a one-way valve is arranged between the lumen tube and the balloon part of the balloon;

[0036] The double-lumen tube comprises a guide wire lumen and a gas lumen; the proximal balloon tube legs of the plurality of balloons are in communication with the gas lumen; the lumen tube is in communication with the guide wire lumen.

[0037] Referring to Figure 1 , Figure 1 The structure diagram of the perfusion balloon catheter with a one-way valve provided by the present application is shown in the figure, wherein 1 is a terminal tube, 2 is a balloon body part, 3 is a developing ring, 4 is a lumen tube, 5 is a one-way valve, 6 is a balloon protective layer, 7 is a double-lumen tube, 8 is a catheter reinforcing member, 9 is a seat, 10 is a guide wire lumen of the seat, and 11 is a gas lumen of the seat.

[0038] The perfusion balloon catheter with a one-way valve provided by the present application takes the balloon body part as the main body, referring to Figure 2 and Figure 3 , Figure 2 The structure diagram of the balloon body part provided by the present application is shown in the figure, Figure 3 The cross-sectional diagram of the balloon body part provided by the present application is shown in the figure; the diameter of the balloon body part is preferably 18-26 mm; in the embodiments provided by the present application, the diameter of the balloon body part is specifically 18 mm or 26 mm; the balloon body part comprises a lumen tube; the material of the lumen tube is preferably a high polymer material, and more preferably polyether block polyamide and / or nylon; the lumen tube is used for advancing a guide wire, and the inner diameter thereof is preferably matched with the used guide wire; a developing device is preferably further arranged on the lumen tube; the developing device is preferably located at the positions corresponding to the two ends of the lumen tube and the balloon part, and is used for identifying the effective length of the balloon; the developing device is preferably a developing ring; the material of the developing device is preferably platinum-iridium alloy or X-developable material; and the mounting mode of the developing device is preferably bonding, ring forging or other suitable modes, and more preferably ring forging.

[0039] The outer surface of the inner lumen tube is provided with a plurality of balloons along the length direction; the number of the balloons is preferably 2-10, more preferably 4-10, and even more preferably 6-8; the balloon includes a distal balloon tube leg, a distal conical surface, a balloon part, a proximal conical surface and a proximal balloon tube leg arranged in sequence, and the side walls of the balloon parts of adjacent balloons are in contact with each other, so that after the balloon is expanded, the plurality of balloons surround a hollow tubular structure with the inner lumen tube as the center; after the balloon is expanded, there are gaps between the distal balloon tube legs, between the distal conical surfaces, between the proximal conical surfaces and between the proximal balloon tube legs of the plurality of balloons, and blood can enter and exit the cavity formed between the plurality of balloons and the inner lumen tube through the above-mentioned gaps, thereby forming an overall exchange type balloon catheter; the plurality of balloons are preferably non-compliant balloons; the material thereof is preferably nylon or nylon inner layer and polyether block polyamide outer layer, or nylon inner layer, polyether block polyamide middle layer and polymethyl methacrylate outer layer; the diameter of the balloon part is preferably 1 / 5-1 / 2, more preferably 1 / 4-1 / 2, and even more preferably 1 / 3, of the diameter of the balloon body part; in the present application, the typical relationship between the number of balloons, the diameter of the balloons and the diameter of the balloon body part after bundling is shown in Table 1. The length of the balloon part, i.e. the effective length of the balloon body part, is preferably 30-60 mm; the distal balloon tube leg of each balloon is in contact with the tube wall of the inner lumen tube.

[0040] Table 1 Relationship between the number of balloons, the diameter of the balloons and the diameter of the balloon body part after bundling

[0041] Number of balloons 8 8 8 8 8 Nominal diameter of balloon (mm) 8 7 6 6 5 Nominal diameter of balloon body portion 2 (mm) 26 24 22 20 18

[0042] To improve the pressure resistance of the balloon, the balloon body part preferably further includes a balloon protective layer; the balloon protective layer is arranged on the side of the balloon part of the plurality of balloons away from the inner lumen tube and is integrally arranged, i.e. the balloon protective layer is located at the outermost side of the balloon body part, which can be used to protect the balloon during expansion and bundle the plurality of balloons into a circular shape, and can also increase the outer diameter of the plurality of balloons after expansion and improve the pressure resistance of the balloon; in the present application, the balloon protective layer can be formed by braiding a filamentous material; the filamentous material is preferably one or more of silk, synthetic fiber, artificial fiber, short fiber and polytetrafluoroethylene (PTFE) fiber; the thickness of the balloon protective layer is preferably 0.01-1 mm, more preferably 0.01-0.5 mm, even more preferably 0.05-0.1 mm, and most preferably 0.07-0.08 mm; the balloon protective layer and the plurality of balloons are preferably bonded by glue.

[0043] The balloon protection layer can also be formed by a net-shaped elastic alloy structure; the net-shaped elastic alloy structure is preferably a net-shaped nickel-titanium material structure; see Figure 4-1(a), which is a schematic diagram of a square net-shaped nickel-titanium material balloon protection layer; the net-shaped elastic alloy structure can be formed by laser cutting of an elastic alloy pipe or by braiding of an elastic alloy wire and welding at the connection points; in the present application, specifically, the net-shaped nickel-titanium material balloon protection layer can be formed by laser cutting of a nickel-titanium pipe or by braiding of a nickel-titanium wire and welding at the connection points; the width of the net-shaped elastic alloy structure, specifically the width of the net-shaped nickel-titanium material balloon protection layer, or the diameter of the nickel-titanium braided wire is preferably 0.05-0.3 mm, most preferably 0.1-0.2 mm; one end or both ends of the balloon protection layer formed by the net-shaped elastic alloy structure can be fixed to the surface of the outer lumen tube (double lumen tube) and the end of the balloon at one end or both ends by welding of an elastic alloy wire. The single grid shape of the balloon protection layer formed by the net-shaped elastic alloy structure can be square, triangular, or prismatic, etc. The balloon protection layer has two states when the balloon is not opened and when the balloon is working, respectively, and when the balloon inflation diameter increases, the balloon protection layer diameter also increases, and the grid of the net-shaped elastic alloy structure also increases, see Figures 4-1(b), 4-2(a), 4-2(b), 4-3(a), and 4-3(b); Figure 4-1(b) is a schematic diagram of the structure of a single square grid of a net-shaped nickel-titanium material balloon protection layer before and after balloon inflation; Figure 4-2(a) is a schematic diagram of the expansion of a triangular net-shaped nickel-titanium material balloon protection layer; Figure 4-2(b) is a schematic diagram of the structure of a single triangular grid of a net-shaped nickel-titanium material balloon protection layer before and after balloon inflation; Figure 4-3(a) is a schematic diagram of the expansion of a prismatic net-shaped nickel-titanium material balloon protection layer; and Figure 4-3(b) is a schematic diagram of the structure of a single prismatic grid of a net-shaped nickel-titanium material balloon protection layer before and after balloon inflation. When the single grid of the balloon protection layer is square (rectangular or square) after balloon inflation, the length of the single grid is preferably 2-10 mm, and the width is preferably 2-10 mm; when the single grid is triangular, the side length is preferably 2-10 mm; and when the single grid is rhombic, it is preferably a prismatic shape with an acute angle of 60°, and the side length of the prismatic shape is preferably 2-10 mm.

[0044] The outer surface of the balloon protective layer is preferably provided with flexible filamentous structures in the balloon axial direction for gathering force in the balloon axial direction and preventing slipping; the flexible filamentous structures are preferably bonded to the outer surface of the balloon protective layer by glue; the number of the flexible filamentous structures is preferably 3-10, more preferably 3-8, and even more preferably 3-6; when the number of the flexible filamentous structures is multiple, they are preferably uniformly distributed on the outer surface of the balloon protective layer; the flexible filamentous structures are preferably spiral metal spring wires, metal wires or high polymer material wires; the high polymer material wires are preferably nylon; the cross section of the flexible filamentous structures is preferably circular or triangular.

[0045] The outer surface of the balloon protective layer is preferably further provided with hole-like structures to enhance the surface friction.

[0046] The outer surface of the balloon protective layer is preferably further coated with a drug coating; the drug coating is preferably an anti-proliferative drug coating.

[0047] A one-way valve is arranged between the inner lumen tube and the balloon part of the balloon; the one-way valve is preferably fixed to the outer surface of the inner lumen tube to form an umbrella-like or stand-up collar-like structure with the inner lumen tube as the axis; the inclined direction of the one-way valve is the same as the blood flow direction; the fixing mode can be heat welding, laser welding or ultrasonic welding; the end of the one-way valve in contact with the balloon part is not fixed, which can be a smooth arc structure or an irregular shape; in the present application, the end of the one-way valve in contact with the balloon part is preferably an irregular shape, which can better fit the balloon part; the irregular shape is preferably petal-like; the one-way valve preferably comprises a metal wire framework structure and a biocompatible material covering the surface of the metal wire framework structure; see FIG. 4 and Figure 5 , FIG. 4 and Figure 5The unidirectional valve is preferably 0.01-0.5 mm thick; the wire skeleton structure is preferably 0.05-0.5 mm thick, more preferably 0.05-0.3 mm thick, even more preferably 0.05-0.2 mm thick, and most preferably 0.1 mm thick; the wire skeleton structure is preferably radially arranged from the inner lumen tube to the balloon portion and / or arranged around the inner lumen tube; when the wire skeleton structure is radially arranged from the inner lumen tube to the balloon portion, the number of wires is preferably 10-50; the multiple wires can be arranged at equal distances or at variable distances, without any special limitation; when the wire skeleton structure is arranged around the inner lumen tube, the number of wires is preferably 2-20, more preferably 5-15; to improve the stability of the unidirectional valve, when the wire skeleton structure is arranged around the inner lumen tube, the skeleton structure preferably further comprises wires radially arranged from the inner lumen tube to the balloon portion, and the number of wires is preferably 2-50, more preferably 3-40, even more preferably 3-20, and most preferably 3-10; the multiple wires can be arranged at equal distances or at variable distances, without any special limitation; the wires are preferably stainless steel wires or nickel-titanium wires; the biocompatible material is preferably a soft biocompatible material, and more preferably polytetrafluoroethylene and / or polyester. The inner wire-woven skeleton structure can enhance the durability of the unidirectional valve, and avoid blood reflux caused by the over-soft unidirectional valve. To improve the adhesion of the unidirectional valve to the balloon portion, the part of the unidirectional valve that is in contact with the balloon portion preferably does not contain a skeleton structure; one end of the wire skeleton structure is in contact with the inner lumen tube, and the other end is in contact with the balloon portion of the multiple balloons. The number of unidirectional valves can be one or multiple, without any special limitation; the unidirectional valve can realize unidirectional perfusion of blood by simulating the movement of a heart valve.

[0048] To improve the advancing ability of the catheter, the perfusion balloon catheter preferably further comprises a terminal tube; the distal end of the terminal tube is a closed structure and has a pointed shape; the pointed shape is designed to be more smooth, which can improve the ability of the catheter to enter a lesion site, and at the same time can reduce the damage of the catheter tip to the inner wall of the patient's blood vessel; the proximal end of the terminal tube is in communication with the distal end of the inner lumen tube, and is not in communication with the balloon; the proximal end of the terminal tube can be sleeved outside the distal balloon tube leg or located between the distal balloon tube leg and the inner lumen tube; in the present application, the distal balloon tube legs of the multiple balloons are uniformly distributed on the outer surface of the inner lumen tube in the circumferential direction of the inner lumen tube, and then connected to the proximal end of the terminal tube; the connection mode is preferably heat welding, laser welding or ultrasonic welding; the material of the terminal tube is preferably a high polymer material, and more preferably polyether block polyamide or nylon.

[0049] The perfusion balloon catheter provided by the present application further comprises a double-lumen tube, as shown in Figure 6 and Figure 7 , Figure 6 andFigure 7 The cross section of the double-lumen tube is schematically shown; the double-lumen tube comprises a guide wire lumen and a gas lumen; the guide wire lumen and the gas lumen of the double-lumen tube can be coaxially arranged, at this time, the guide wire lumen is preferably located in the middle, and the gas lumen surrounds the guide wire lumen and is located on the outside; the guide wire lumen and the gas lumen can also be arranged in different axes, at this time, the cross section of the gas lumen is preferably designed in a crescent shape or a D shape, which can reduce the outer diameter of the double-lumen tube under the premise of ensuring that the balloon meets the pressure charging and discharging requirements; the gas lumen is connected with the proximal balloon tube legs of a plurality of balloons and is used for expanding the plurality of balloons; in the present application, the proximal balloon tube legs of the plurality of balloons are preferably connected with the tube wall of the gas lumen through heat welding, laser welding or ultrasonic welding; the guide wire lumen is connected with the inner lumen tube and is used for advancing a guide wire; in the present application, the tube wall of the guide wire lumen is preferably connected with the tube wall of the inner lumen tube through heat welding, laser welding or ultrasonic welding. The material of the double-lumen tube is preferably a high polymer material, and more preferably polyether block polyamide or nylon; the outer surface of the double-lumen tube is preferably provided with a hydrophilic coating, which facilitates the advancement in the blood vessel; the length of the hydrophilic coating is preferably 10-50 cm from one end of the balloon body portion to the direction away from the balloon body portion.

[0050] According to the present application, the perfusion balloon catheter preferably further comprises a catheter reinforcing member; the catheter reinforcing member is sleeved on the proximal end of the double-lumen tube and is mainly used for removing the stress generated by the balloon during use; the catheter reinforcing member is preferably sleeved on the proximal end of the double-lumen tube, so that the length of the double-lumen tube exposed outside the catheter reinforcing member is 5-100 mm, more preferably 30-50 mm, and most preferably 40 mm; the catheter reinforcing member is preferably connected with the double-lumen tube through adhesive bonding; the catheter reinforcing member is preferably a Pebax catheter reinforcing member; the length of the catheter reinforcing member is preferably 5-20 mm, and the inner diameter thereof is slightly larger than the outer diameter of the double-lumen tube.

[0051] According to the present application, the perfusion balloon catheter preferably further comprises a seat; the seat preferably comprises a gas lumen and a guide wire lumen; the seat is preferably a Y-shaped structural device; the gas lumen of the seat is connected with the gas lumen of the double-lumen tube and is used for filling the balloon; the guide wire lumen of the seat is connected with the guide wire lumen of the double-lumen tube and is used for advancing a guide wire; the seat is preferably a nylon seat or a polycarbonate seat, and more preferably a nylon seat.

[0052] The perfusion balloon catheter provided by the present application is formed by a plurality of balloon clusters, and forms a hollow cylindrical shape after expansion. A one-way valve is arranged in the cavity, which is used to simulate the leaflet in the heart valve and perform one-way blood perfusion. After the balloon is opened, the one-way valve is already enabled, without the need for switching operation. The structure is stable and can realize the function of the leaflet multiple times. In addition, the design of the cluster balloon can reduce the difficulty of the balloon forming process while meeting the expected function.

[0053] To further illustrate the present application, a perfusion balloon catheter with a one-way valve provided by the present application is described in detail below in conjunction with an embodiment.

[0054] The reagents used in the following examples are all commercially available.

[0055] Example 1

[0056] Specifically, as shown in Figure 1 , the balloon body part 2 is formed by a plurality of balloon clusters, and the number of small balloons in this embodiment is 8. The 8 small balloons are all blow molded from nylon 12 balloon tubes, and the diameter of the small balloons is about 1 / 3 of the diameter of the balloon body part 2. The diameter of the balloon body part 2 can be 18-26 mm, and the effective length of the balloon body part 2 can be 30-60 mm. In this embodiment, the diameter of the balloon body part 2 is 18 mm, and the effective length is 40 mm, i.e., the diameter of the small balloons that make up the balloon body part 2 is 5 mm, and the effective length is 40 mm. The balloon protection layer 6 is woven from artificial fibers and has a ring structure with a thickness of 0.07 mm. When the balloon 2 is opened, the balloon protection layer is bonded to the balloon 2 by glue, so that the balloon protection layer covers the effective length part of the balloon. At the same time, as shown in Figure 2 , Figure 3 , the balloon protection layer has 3 triangular nylon reinforcing filaments 21, and the cross-sectional side length of the triangular filaments is 2 mm. The effective length of the balloon 2 is the length of the middle cylindrical part of the small balloon, and each end has 8 conical parts 22 and 8 balloon tube legs 23. The inner diameter of the small balloon tube leg is 0.015-0.035 inches, and the outer diameter is 0.02-0.04 inches. The double-lumen tube 7 is made of nylon 12, and the length can be 60-160 cm. The diameter of the guide wire lumen can be 0.036-0.040 inches, and the outer diameter can be 0.070-0.100 inches. The inner lumen tube 4 is cut to a length of 80-120 mm (the length of the inner lumen tube is slightly longer than the total length of the balloon and the outer lumen tube after welding), and two development rings 3 are installed on the inner lumen tube 4 in advance. The development rings 3 are made of platinum-iridium alloy or X-ray visible material, and the installation method can be bonding, ring forging, or other suitable methods. In this embodiment, ring forging is used to identify the effective length of the balloon. In the middle region of the two development rings 3, there is a stable one-way valve 5 on the outside of the inner lumen tube 4. The one-way valve 5 is an umbrella-shaped structure with internal metal support. In this embodiment, as shown in Figure 5As shown, the internal structure is a 0.1mm nickel-titanium wire braided structure, with a circumferential spacing of 0.5mm to 2mm, or a gradually changing spacing structure. In this embodiment, the spacing is equal and 0.5mm. The number of braided wires in the diameter direction can be 2 to 20, and in this embodiment, there are 3. The outer surface of the one-way valve 5 is composed of a thin-film, soft, biocompatible polymer material. In this embodiment, the one-way valve is made of polytetrafluoroethylene (PTFE), with a thickness of 0.2mm. Its shape can be near-circular or other shapes. The inner tube 4 serves as the handle, and the one-way valve 5 is connected to the inner tube 4 with adhesive, forming an umbrella-like structure. When the balloon opens, the thin-film structure at the valve edge can adhere to the cavity formed by the bundle of 8 small balloons. The inner lumen tube is inserted into the guidewire lumen of the double-lumen tube, with an overlap length of 1–10 mm. The eight proximal balloon legs are bundled together and assembled and connected to the double-lumen tube's air chamber using laser welding. The terminal tube 1 is made of polyether block polyamide and is cut into 1–10 mm pieces (5 mm in this embodiment). It is fitted onto the distal balloon legs or the inner lumen tube outside the legs, and the distal balloon legs, inner lumen tube 4, and terminal tube 1 are welded together using thermal welding. The inner lumen tube 4 and the guidewire lumen of the double-lumen tube 7 are used to guide the guidewire. The channel formed by the air chamber of the double-lumen tube 7 connects to balloon 2 and is used to inflate the eight balloons in balloon 2. A schematic diagram of the guidewire lumen and air chamber structure is shown below. Figure 6 The proximal tubing legs of the balloon to the surface of the double-lumen tube 7 are coated with a hydrophilic coating with a length of 10-50 cm. The catheter reinforcement 8 is made of polyether block polyamide, with a length of 2-10 cm and an inner diameter slightly larger than the outer diameter of the double-lumen tube 7, with an inner diameter of 0.08-0.011 inches. It is mainly used to relieve stress generated during the use of the balloon catheter. The catheter reinforcement 8 is fitted onto the proximal end of the double-lumen tube 7, so that the exposed part of the double-lumen tube 7 is 5-10 mm long, and the two are welded together by a suitable method. In this embodiment, adhesive bonding is used. The seat 9 can be a Y-shaped structural component made of nylon, polycarbonate, or other suitable materials. In this embodiment, the material is nylon. The seat 9 is bonded to the double-lumen tube 7 and the catheter reinforcement 8 by adhesive. The guidewire lumen 10 of the seat 9 is used to guide the guidewire, and the air chamber 11 of the seat 9 is used to inflate the balloon 2.

[0057] Example 2

[0058] Specifically, such as Figure 1As shown, the balloon body part 2 is formed by a plurality of small balloons, in this embodiment, the number of small balloons is 8, the 8 small balloons are blow molded by nylon 12 balloon tube, the diameter of the small balloon is about 1 / 3 of the diameter of the balloon body part 2, the diameter of the balloon body part 2 can be 18-26 mm, and the effective length of the balloon body part 2 can be 30-60 mm. In this embodiment, the diameter of the balloon body part 2 is 26 mm, and the effective length is 40 mm, that is, the diameter of the small balloon constituting the balloon body part 2 is 8 mm, and the effective length is 40 mm. The balloon protective layer 6 is woven from artificial fibers and has a sheet structure with a thickness of 0.07 mm; after winding, it can form an annular structure, and its surface can have several small holes with a diameter of 1 mm; increase the surface friction of the balloon after adhesion, evenly coat glue on one side of the balloon protective layer 6 when the balloon body part 2 is opened, and then wind it on the balloon body part, so that the balloon protective layer covers the effective length part of the balloon body part, at the same time, the surface of the balloon protective layer 6 can have an anti-proliferation drug coating. The effective length of the balloon body part 2 is the length of the middle cylindrical part of the small balloon, and each end has 8 conical surfaces and 8 balloon tube legs, the inner diameter of the small balloon tube leg is 0.015-0.035 inches, and the outer diameter is 0.02-0.04 inches. The outer lumen tube 7 is made of nylon 12, and the length can be 60-160 cm, and the outer diameter is 0.070-0.100 inches. The inner lumen tube 4 is cut to 80-180 cm, and two developing rings 3 are installed on the inner lumen tube 4 in advance, the developing ring 3 is made of platinum-iridium alloy or X-ray developing material, and the installation method can be bonding or ring forging or other suitable method, in this embodiment, ring forging is used, which is used to identify the effective length of the balloon. The middle region of the two developing rings 3 has a stable one-way valve 5 outside the inner lumen tube 4, the one-way valve 5 is an umbrella-shaped structure with internal metal support, in this embodiment, as Figure 6The internal part is a 0.1 mm nickel-titanium wire 61 braid structure, and the braid wire can be 10-50 in the diameter direction, and the interval can be equal or variable, and in this embodiment, it is specifically 25 braid wires with equal interval. The external part of the one-way valve 5 is a thin film-like soft high-molecular material with good biocompatibility, and in this embodiment, the material of the one-way valve is polytetrafluoroethylene, and the thickness of the one-way valve is 0.2 mm, and the periphery can be circular or other shapes. The inner lumen tube 4 is an umbrella handle, and the one-way valve 5 and the inner lumen tube 4 are connected together by glue, and the one-way valve 5 forms an umbrella structure, and when the balloon body part 2 is opened, the valve edge film structure can be attached to the inside of the cavity formed by the 8 small balloon clusters. After the 8 balloon proximal tube legs are bundled into a hollow bundle, they are assembled and communicated with the inner wall of the outer lumen tube 7, and the connection mode adopts laser welding. Insert the inner lumen tube 4 into the above connected balloon outer lumen tube 7, and make the inner lumen tube have the developing ring 3 and the one-way valve 5 part located in the balloon 2. The end tube 1 is made of polyether block polyamide, and the end tube 1 is cut into 1-10 mm, and in this embodiment, it is 5 mm. After adjusting the position of the inner lumen tube 4, the end tube 1, the inner lumen tube 4 and the 8 balloon distal tube legs are welded to make the distal tube legs sealed. The inner lumen tube 4 is used for advancing the guide wire, and the gap between the inner lumen tube 4 and the outer lumen tube 7 is used for filling the balloon 2. The balloon proximal tube leg is coated with a hydrophilic coating with a length of 10-50 cm. The catheter reinforcing member 8 is made of polyether block polyamide, and the length can be 2-10 cm, the inner diameter is slightly larger than the outer diameter of the outer lumen tube 7, the inner diameter is 0.08-0.011 inch, and it is mainly used to remove the stress generated by the balloon catheter in use. The catheter reinforcing member 8 is sleeved on the proximal end of the outer lumen tube 7, so that the exposed part of the outer lumen tube 7 has a length of 5-10 mm, and the two are welded together by a suitable method, and in this embodiment, the glue bonding method is adopted. The seat 9 can be made of nylon or polycarbonate or other suitable material Y-shaped structure, and in this embodiment, the material is nylon. The seat 9 and the outer lumen tube 7 and the catheter reinforcing member 8 are bonded together by glue, the guide wire lumen 10 of the seat 9 is used for advancing the guide wire, and the air cavity 11 of the seat 9 is used for filling the balloon 2.

[0059] Example 3

[0060] Specifically, as Figure 1As shown, the balloon body part 2 is formed by a plurality of small balloons, and in this embodiment, the number of small balloons is 8. The 8 small balloons are blow molded from nylon 12 balloon tubes. The diameter of the small balloons is about 1 / 3 of the diameter of the balloon body part 2. The diameter of the balloon body part 2 can be 18-26 mm, and the effective length of the balloon body part 2 can be 30-60 mm. In this embodiment, the diameter of the balloon body part 2 is 26 mm, and the effective length is 40 mm. That is, the diameter of the small balloons that form the balloon body part 2 is 8 mm, and the effective length is 40 mm. The balloon protective layer 6 is a meshed nickel-titanium material. The meshed nickel-titanium material balloon protective layer is laser cut from a nickel-titanium tube with an outer diameter of 3.5-5.5 mm and an inner diameter of 3.3-5.3 mm. The two ends of the meshed nickel-titanium material balloon protective layer are fixed to the outer lumen tube and the end of the balloon body part 2 by welding or other suitable methods using a nickel-titanium wire. The effective length region of the balloon body part 2 is not physically fixed to the meshed nickel-titanium material balloon protective layer. When the balloon body part 2 is inflated, the meshed nickel-titanium material balloon protective layer can be deployed simultaneously with the balloon body part 2. When the diameter of the balloon body part 2 reaches 32 mm, the diameter of the meshed nickel-titanium material balloon protective layer no longer increases. Figure 4-1(a) and 4-1(b) As shown, the single mesh of the meshed nickel-titanium material balloon protective layer when fully opened can be square. The length of the square hole is preferably 2-10 mm, and the width is preferably 2-10 mm. Figure 4-2(a) and 4-2(b) As shown in the expanded view of the meshed nickel-titanium material balloon protective layer, the triangular mesh is preferably an equilateral triangle, and the side length is preferably 2-10 mm. Figure 4-3(a) and 4-3(b) As shown in the expanded view of the meshed nickel-titanium material balloon protective layer, the prismatic mesh is preferably a prismatic shape with an acute angle of 60°, and the prismatic side length is preferably 2-10 mm. In this embodiment, the single mesh of the meshed nickel-titanium material balloon protective layer when fully opened is prismatic with a side length of 5 mm. The effective length of the balloon 2 is the length of the middle cylindrical part of the small balloon, and each end has 8 conical surfaces and 8 balloon tube legs. The inner diameter of the small balloon tube leg is 0.015-0.035 inches, and the outer diameter is 0.02-0.04 inches. The outer lumen tube 7 is made of nylon 12, and the length can be 60-160 cm, and the outer diameter is 0.070-0.100 inches. The inner lumen tube 4 is cut to a length of 80-180 cm, and two development rings 3 are installed on the inner lumen tube 4 in advance. The development rings 3 are made of platinum-iridium alloy or X-ray visible material, and the installation method can be bonding, ring forging, or other suitable methods. In this embodiment, ring forging is used to identify the effective length of the balloon. The middle region of the two development rings 3 has a stable one-way valve 5 on the outside of the inner lumen tube 4. The one-way valve 5 is an umbrella-shaped structure with internal metal support. In this embodiment, as shown in Figure 6The internal part is a 0.1mm nickel-titanium wire 61 woven structure, and the woven wire in the diameter direction can be 10-50, and the interval can be equal or variable, and in this embodiment, it is specifically equal to 25 woven wires. The one-way valve 5 is composed of a thin film-like soft high-molecular material with good biocompatibility, and in this embodiment, the material of the one-way valve is polytetrafluoroethylene, and the thickness of the one-way valve is 0.2mm, and the periphery can be circular or other shapes. The inner cavity tube 4 is the umbrella handle, and the one-way valve 5 and the inner cavity tube 4 are connected together by glue, and the one-way valve 5 forms an umbrella structure, and when the balloon body part 2 is opened, the valve edge film structure can be attached to the inside of the cavity formed by the 8 small balloon clusters. After the 8 balloon proximal tube legs are bundled into a hollow bundle, they are assembled and communicated with the inner wall of the outer cavity tube 7, and the connection method adopts laser welding. Insert the inner cavity tube 4 into the above connected balloon outer cavity tube 7, and make the inner cavity tube have the development ring 3 and the one-way valve 5 part located in the balloon 2. The end tube 1 is made of polyether block polyamide, and the end tube 1 is cut into 1-10mm, and in this embodiment, it is 5mm, after adjusting the position of the inner cavity tube 4, the end tube 1, the inner cavity tube 4 and the 8 balloon distal tube legs are welded, so that the distal tube legs are sealed. The inner cavity tube 4 is used for advancing the guide wire, and the gap between the inner cavity tube 4 and the outer cavity tube 7 is used for filling the balloon 2. The balloon proximal tube leg is coated with a hydrophilic coating with a length of 10-50cm. The catheter reinforcing member 8 is made of polyether block polyamide, and the length can be 2-10cm, the inner diameter is slightly larger than the outer diameter of the outer cavity tube 7, the inner diameter is 0.08-0.011 inch, and it is mainly used to remove the stress generated by the balloon catheter in use. The catheter reinforcing member 8 is sleeved on the proximal end of the outer cavity tube 7, so that the exposed part of the outer cavity tube 7 has a length of 5-10mm, and the two are welded together by a suitable method, and in this embodiment, the glue bonding method is adopted. The seat 9 can be a Y-shaped structure made of nylon, polycarbonate or other suitable materials, and in this embodiment, the material is nylon. The seat 9 and the outer cavity tube 7 and the catheter reinforcing member 8 are bonded together by glue, the guide wire lumen 10 of the seat 9 is used for advancing the guide wire, and the air lumen 11 of the seat 9 is used for filling the balloon 2.

[0061] The in vitro simulated blood flow dynamics bench test results of the perfusion balloon catheter with one-way valve obtained in embodiments 1-3 are shown in table 2, it should be noted that the bench test results may not completely represent the actual clinical performance of the present application, and different results may be produced under different conditions.

[0062] Table 2: In vitro simulated blood flow dynamics bench test of the present application

[0063]

[0064]

[0065] Table 2: Bench test conditions:

[0066] Environment: In vitro simulation of blood;

[0067] Temperature: 34-42℃;

[0068] Cardiac output: The function of heart is simulated by a pulsating pump, and the pressure is simulated to be 80-160mmHg;

[0069] Blood: Purified water plus glycerin is used to reach a similar viscosity as real blood;

[0070] Vessel model: Formed by a mixture of silicone and developing material iodized silver. The inner wall is coated with lubricating material to adjust the friction coefficient of the inner wall of the vessel, to ensure that the friction coefficient of the vessel wall is close to the physiological state of human blood vessels.

Claims

1. A perfusion balloon catheter having a one-way valve, characterized in that, The balloon body part comprises a lumen tube and a plurality of balloons arranged around the outer surface of the lumen tube; the balloons comprise a distal balloon tube leg, a distal conical surface part, a balloon part, a proximal conical surface part and a proximal balloon tube leg arranged in sequence, and the side walls of the balloon parts of adjacent balloons are in contact with each other; the distal balloon tube legs of the plurality of balloons are in contact with the tube wall of the lumen tube; a one-way valve is arranged between the lumen tube and the balloon part of the balloon; the diameter of the balloon part is 1 / 5-1 / 2 of the diameter of the balloon body part; the number of the balloons is 2-10; The double-lumen tube comprises a guide wire lumen and a gas lumen; the proximal balloon tube legs of the plurality of balloons are in communication with the gas lumen; the lumen tube is in communication with the guide wire lumen; The balloon body part further comprises a balloon protection layer; the balloon protection layer is arranged on the side of the balloon part of the plurality of balloons away from the lumen tube and is integrally arranged; the balloon protection layer is formed of a net-shaped elastic alloy structure; the shape of the balloon protection layer formed by the net-shaped elastic alloy structure is square-like, triangle-like or prismatic; the balloon protection layer has two states when the balloon is not opened and when the balloon is working, respectively; when the diameter of the balloon increases due to inflation, the diameter of the balloon protection layer also increases, and the mesh of the net-shaped elastic alloy structure also increases accordingly; The outer surface of the balloon protection layer is provided with flexible filamentous structures along the axial direction of the balloon; the number of the flexible filamentous structures is 3-10; the flexible filamentous structures are spiral metal spring wires, metal wires or high polymer material wires; the cross section of the flexible filamentous structures is circular or triangular; The outer surface of the balloon protection layer is provided with hole-like structures; The one-way valve is fixed to the outer surface of the lumen tube and is umbrella-shaped or standing collar-shaped with the lumen tube as the axis; the inclined direction of the one-way valve is the same as the blood flow direction; the end of the one-way valve in contact with the balloon part is irregular in shape; the irregular shape is petal-shaped; The one-way valve comprises a metal wire framework structure and a biocompatible material covering the surface of the metal wire framework structure; The metal wire framework structure is radially arranged along the direction from the lumen tube to the balloon part and / or is arranged around the lumen tube; When the metal wire framework structure is arranged around the lumen tube, the metal wire framework structure further comprises metal wires radially arranged along the direction from the lumen tube to the balloon part; The part of the one-way valve in contact with the balloon part does not contain a framework structure; One end of the metal wire framework structure is in contact with the lumen tube, and the other end is in contact with the balloon part of the plurality of balloons. The balloon protection layer is formed by weaving filamentous materials.

2. The perfusion balloon catheter of claim 1, wherein, The balloon protection layer is formed by a net-shaped elastic alloy structure.

3. The perfusion balloon catheter of claim 1, wherein, The net-shaped elastic alloy structure is a net-shaped nickel-titanium material structure; the balloon protection layer has two states when the balloon is not opened and when the balloon is working, respectively; when the diameter of the balloon increases due to inflation, the diameter of the balloon protection layer also increases.

4. The perfusion balloon catheter of claim 3, wherein, The thickness of the metal wire framework structure is 0.05-0.5 mm; one end of the metal wire framework structure is in contact with the lumen tube, and the other end is in contact with the balloon part of the plurality of balloons.

5. The perfusion balloon catheter of claim 1, wherein, ​

Images