CN113350670A - Perfusion balloon catheter with one-way valve - Google Patents

Abstract

Translated fromChinese

本发明提供了一种具有单向阀的灌注球囊导管，包括：球囊本体部分；所述球囊本体部分包括内腔管与围绕在内腔管外表面设置的多个球囊；所述多个球囊的远端球囊管腿与内腔管的管壁相接触；所述内腔管与球囊的球囊部之间设置有单向阀。与现有技术相比，本发明提供的灌注球囊导管球囊本体部分由多个球囊集束形成，扩张后形成中空的类圆柱状，同时空腔内设置有单向阀，用于模拟心脏瓣膜中的瓣叶，进行单向血流灌注，球囊打开后，单向阀即已启用，无需进行开关操作，且其结构稳定，能够多次实现瓣叶的功能；另外集束球囊的设计可在满足预期功能的同时，降低了对球囊成型工艺的难度。

The invention provides a perfusion balloon catheter with a one-way valve, comprising: a balloon body part; the balloon body part includes an inner lumen tube and a plurality of balloons arranged around the outer surface of the inner lumen tube; the The distal balloon tube legs of the multiple 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 part of the balloon. Compared with the prior art, the balloon body part of the perfusion balloon catheter provided by the present invention is formed by a bundle of multiple balloons, and after expansion, a hollow quasi-cylindrical shape is formed, and a one-way valve is arranged in the cavity to simulate the heart. The valve leaflets in the valve are perfused with one-way blood flow. After the balloon is opened, the one-way valve is activated without switching operation, and its structure is stable, and the function of the valve leaflets can be realized many times; in addition, the design of the cluster balloon It can meet the expected function while reducing the difficulty of the balloon forming process.

Description

Perfusion balloon catheter with one-way valve

Technical Field

The invention belongs to the technical field of balloon catheters, and particularly relates to a perfusion balloon catheter with a one-way valve.

Background

In vertebrates, the heart is a muscular organ with four compression chambers: left and right atria, and left and right ventricles, each provided with a respective independent one-way valve. Native heart valves are defined as aortic, mitral (or bicuspid), tricuspid, and pulmonary. Since the aortic or mitral valve is located on the left side of the heart and is subject to the greatest amount of pressure, loss of leaflet function occurs during long-term operation and requires repair or replacement. Conventional prosthetic heart valve replacement procedures involve accessing the heart within the chest cavity of a patient through a longitudinal chest incision, such as a median sternal incision, which entails cutting the sternum and forcing two opposing halves of the rib cage apart to access the chest cavity and the heart therein, the patient thus being in extracorporeal circulation (cardio bypass), including stopping his heart from beating to allow access to the interior chamber. However, these open chest surgeries are particularly traumatic and difficult to recover for a long period of time. Minimally invasive surgical techniques are being developed in which a prosthetic heart valve may be introduced into a patient using a catheter that is introduced through a small incision to access, for example, the femoral artery or heart.

However, most patients are prohibitive due to the high cost of the valve implantation procedure. At present, most of medical instruments which are separately used for repairing heart valves in the market are matched perfusion balloon catheters which are matched with artificial valve transplantation operations, and the treatment effect is poor due to the relatively simple design.

Chinese patent application No. CN201780008580.0 discloses an infusion balloon with an internal valve for an apparatus for performing medical procedures in blood vessels, particularly aortic valvuloplasty, to deliver fluid flow. The apparatus comprises: a shaft; an inflatable perfusion balloon supported by the shaft and including an internal passage for allowing fluid flow in the blood vessel when the perfusion balloon is in an inflated state and a valve for controlling fluid flow within the passage; the valve may be connected to the shaft or may include an elongate tube partially connected to the balloon. The balloon may comprise a plurality of cells in a single cross-section, each cell comprising a neck and a valve may be positioned in the space between the shaft and the neck for controlling the flow of fluid within the channel, and a connector may also be provided for control. However, when the balloon reaches the aorta for treatment, the physician needs to manually control the opening and closing of the internal valve for many times, which increases the difficulty of the operation.

Chinese patent application No. CN201780008641.3 discloses an infusion balloon with an external valve, a device for performing medical procedures, in particular aortic valvuloplasty, in a blood vessel for conveying fluid flow. The device includes: an inflatable perfusion balloon including an internal channel for allowing fluid flow in a blood vessel when the perfusion balloon is in an inflated state, the balloon including a plurality of cells in a single cross-section and a cover for at least partially covering the cells. A valve associated with the balloon controls fluid flow within the passage, the valve being disposed outside the passage. The valve may form a tubular extension of the cover or may be separate from the cover and may comprise a flap. The spiral cover may also form a valve. On one hand, the design adds components on the surface of the balloon catheter, so that the outer diameter of the balloon part of the balloon catheter is enlarged, the hardness is increased, and the trafficability of the balloon catheter is poor; on the other hand, no matter the film or the spiral covering piece is made of soft material, the balloon catheter cannot withstand multiple unidirectional blood impacts, the risk of treatment failure is high, once the balloon catheter loses the function of the one-way valve, important arterial trunk occlusion of a patient can happen at any time, blood supply obstacles of important organs such as large-area heart, kidney and brain are caused, and the blood vessel is extremely severe and seriously endangers the life safety of the patient.

Disclosure of Invention

In view of this, the technical problem to be solved by the present invention is to provide a perfusion balloon catheter with a stable one-way valve, which can repair heart valves and has a good continuous one-way blood flow effect.

The present invention provides a perfusion balloon catheter with a one-way valve, comprising:

a balloon body portion; the balloon body part comprises an inner cavity pipe and a plurality of balloons arranged around the outer surface of the inner cavity pipe; the sacculus comprises a far-end sacculus tube leg, a far-end conical surface part, a sacculus part, a near-end conical surface part and a near-end sacculus tube leg which are sequentially arranged, and the side walls of the sacculus parts of the adjacent sacculus are mutually contacted; the far balloon tube legs of the balloons are in contact with the tube wall of the inner cavity tube; a one-way valve is arranged between the inner cavity tube and the balloon part of the balloon;

a double lumen tube; the double-cavity tube comprises a wire guide cavity and an air cavity; the near-end balloon tube legs of the balloons are communicated with the air cavity; the inner cavity pipe is communicated with the thread guide cavity.

Preferably, the balloon body portion further comprises a balloon protective layer; the balloon protective layer is coated on one side, away from the inner cavity tube, of the balloon parts of the balloons and integrally arranged.

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

Preferably, the balloon protection layer is formed by weaving a filamentous material.

Preferably, the balloon protective layer is formed of a reticulated elastomeric alloy structure.

Preferably, the reticular elastic alloy structure is a reticular nickel-titanium material structure; the balloon protective layer is in two states when the balloon is not opened and works, and the diameter of the balloon protective layer can be simultaneously increased along with the increase of the pressurized diameter of the balloon.

Preferably, the diameter of the balloon is 1/5-1/2 of the diameter of the balloon body part; the number of the saccules is 2-10.

Preferably, the one-way valve is fixed on the outer surface of the inner cavity tube, and the inner cavity tube is in an umbrella shape or a vertical collar shape.

Preferably, the one-way valve comprises a metal wire framework structure and a biocompatible material covered on the surface of the metal wire framework structure.

Preferably, the thickness of the metal wire framework structure is 0.05-0.5 mm; one end of the metal wire framework structure is contacted with the inner cavity pipe, and the other end of the metal wire framework structure is contacted with the balloon parts of the balloons.

The present invention provides a perfusion balloon catheter with a one-way valve, comprising: a balloon body portion; the balloon body part comprises an inner cavity pipe and a plurality of balloons arranged around the outer surface of the inner cavity pipe; the sacculus comprises a far-end sacculus tube leg, a far-end conical surface part, a sacculus part, a near-end conical surface part and a near-end sacculus tube leg which are sequentially arranged, and the side walls of the sacculus parts of the adjacent sacculus are mutually contacted; the far balloon tube legs of the balloons are in contact with the tube wall of the inner cavity tube; a one-way valve is arranged between the inner cavity tube and the balloon part of the balloon; a double lumen tube; the double-cavity tube comprises a wire guide cavity and an air cavity; the near-end balloon tube legs of the balloons are communicated with the air cavity; the inner cavity pipe is communicated with the thread guide cavity. Compared with the prior art, the balloon body part of the perfusion balloon catheter provided by the invention is formed by bundling a plurality of balloons, a hollow cylinder-like shape is formed after expansion, meanwhile, a one-way valve is arranged in the cavity and used for simulating valve leaflets in a heart valve to carry out one-way blood perfusion, and after the balloons are opened, the one-way valve is started without switching operation, and the perfusion balloon catheter is stable in structure and can realize the functions of the valve leaflets for many times; in addition, the design of the cluster balloon can meet the expected functions, and simultaneously, the difficulty of the balloon forming process is reduced.

Drawings

FIG. 1 is a schematic structural view of a perfusion balloon catheter with a one-way valve provided in accordance with the present invention;

FIG. 2 is a schematic view of a balloon body portion according to the present invention;

FIG. 3 is a schematic cross-sectional view of a balloon body portion provided by the present invention;

FIG. 4-1(a) is a schematic view of a rectangular mesh-shaped nickel-titanium balloon protective layer according to the present invention;

FIG. 4-1(b) is a schematic view of a single rectangular grid of a protective layer of a mesh-like nickel-titanium balloon in accordance with the present invention;

FIG. 4-2(a) is a schematic view of the triangular mesh shape Ni-Ti balloon protection layer according to the present invention;

fig. 4-2(b) is a schematic view of a single triangular mesh of the protective layer of the reticular nickel-titanium balloon;

FIG. 4-3(a) is a schematic view showing the protective layer of the diamond-shaped mesh nickel-titanium balloon according to the present invention;

FIG. 4-3(b) is a schematic view of a single prismatic grid of the protective layer of the reticular nickel-titanium balloon according to the present invention;

FIG. 5 is an expanded schematic view of the check valve provided by the present invention;

FIG. 6 is an expanded schematic view of another check valve provided by the present invention;

FIG. 7 is a schematic cross-sectional view of a dual lumen tube;

FIG. 8 is another cross-sectional schematic view of a dual lumen tube.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

The present invention provides a perfusion balloon catheter with a one-way valve, comprising:

a balloon body portion; the balloon body part comprises an inner cavity pipe and a plurality of balloons arranged around the outer surface of the inner cavity pipe; the sacculus comprises a far-end sacculus tube leg, a far-end conical surface part, a sacculus part, a near-end conical surface part and a near-end sacculus tube leg which are sequentially arranged, and the side walls of the sacculus parts of the adjacent sacculus are mutually contacted; the far balloon tube legs of the balloons are in contact with the tube wall of the inner cavity tube; a one-way valve is arranged between the inner cavity tube and the balloon part of the balloon;

a double lumen tube; the double-cavity tube comprises a wire guide cavity and an air cavity; the near-end balloon tube legs of the balloons are communicated with the air cavity; the inner cavity pipe is communicated with the thread guide cavity.

Referring to fig. 1, fig. 1 is a schematic structural view of a perfusion balloon catheter with a one-way valve provided by the present invention, wherein 1 is a tip tube, 2 is a balloon body portion, 3 is a developing ring, 4 is an inner lumen tube, 5 is a one-way valve, 6 is a balloon protective layer, 7 is a double lumen tube, 8 is a catheter reinforcement member, 9 is a seat, 10 is a guide wire cavity of the seat, and 11 is an air cavity of the seat.

The perfusion balloon catheter with the one-way valve provided by the invention takes a balloon body part as a main body, referring to fig. 2 and 3, fig. 2 is a schematic structural view of the balloon body part provided by the invention, and fig. 3 is a schematic cross-sectional view of the balloon body part provided by the invention; the diameter of the balloon body part is preferably 18-26 mm; in embodiments provided herein, the balloon body portion has a diameter of specifically 18mm or 26 mm; the balloon body portion comprises an inner lumen; the material of the inner cavity pipe is preferably a high polymer material, and more preferably polyether block polyamide and/or nylon; the inner cavity tube is used for advancing a guide wire, and the inner diameter of the inner cavity tube is preferably matched with the guide wire; the inner cavity pipe is preferably provided with a developing device; the developing device is preferably positioned at the position of the inner cavity tube corresponding to the two ends of the balloon part and is used for marking the effective length of the balloon; the developing device is preferably a developing ring; the developing device is preferably made of platinum-iridium alloy or X developable material; the developing device is preferably mounted by bonding, ring forging or other suitable means, more preferably ring forging.

A plurality of balloons are arranged on the outer surface of the inner cavity tube in a surrounding manner along the length direction; the number of the saccules is preferably 2-10, more preferably 4-10, and still more preferably 6-8; the saccule comprises a far-end saccule tube leg, a far-end conical surface part, a saccule part, a near-end conical surface part and a near-end saccule tube leg which are sequentially arranged, and the side walls of the saccule parts of adjacent saccules are mutually contacted, so that after the saccule is expanded, the plurality of saccules are surrounded to form a hollow tubular structure taking an inner cavity tube as a center; after the saccule is expanded, gaps exist among the far-end saccule tube legs, the far-end conical surface parts, the near-end conical surface parts and the near-end saccule tube legs of the plurality of saccules, and blood can enter and exit a cavity formed between the plurality of saccules and the inner cavity tube through the gaps, so that the integral exchange type saccule-obtaining catheter is formed; each of the plurality of balloons is preferably a non-compliant balloon; the material is preferably nylon, or the inner layer is nylon, the outer layer is polyether block polyamide, or the inner layer is nylon, the middle layer is polyether block polyamide, and the outer layer is polymethyl methacrylate; the diameter of the balloon part is preferably 1/5-1/2, more preferably 1/4-1/2, and still more preferably 1/3 of the diameter of the balloon body part; in the present invention, the typical relationship between the number and diameter of the balloons and the diameter of the balloon main portion after bundling is shown in table 1. The length of the balloon part, namely the effective length of the balloon body part is preferably 30-60 mm; the far end sacculus tube leg of each sacculus is contacted with the tube wall of the inner cavity tube.

TABLE 1 relationship between number and diameter of balloons and diameter of balloon body after bundling

Number ofballoons	8	8	8	8	8
						Nominal balloon diameter (mm)	8	7	6	6	5
Balloon body portion 2 nominal diameter (mm)	26	24	22	20	18

In order to improve the pressure resistance of the balloon, the balloon body part preferably further comprises a balloon protective layer; the balloon protective layer is coated on one side, away from the inner cavity tube, of the balloon parts of the balloons and integrally arranged, namely the balloon protective layer is positioned on the outermost side of the balloon body part and can be used for protecting the balloons and bundling the balloons into a circle during expansion and play a role in bundling the expanded outer diameter of the balloons to increase the balloon expansion pressure resistance; in the invention, the balloon protection layer can be formed by weaving a filamentous material; the filamentous material is preferably one or more of silk, synthetic fiber, artificial fiber, short silk and Polytetrafluoroethylene (PTFE) fiber; the thickness of the balloon protection layer is preferably 0.01-1 mm, more preferably 0.01-0.5 mm, still more preferably 0.05-0.1 mm, and most preferably 0.07-0.08 mm; the balloon protection layer and the plurality of balloons are preferably bonded by glue.

The balloon protective layer may also be formed of a reticulated elastomeric alloy structure; the reticular elastic alloy structure is preferably a reticular nickel-titanium material structure; referring to fig. 4-1(a), fig. 4-1(a) is a schematic diagram of a rectangular mesh-shaped nickel-titanium balloon protection layer; the reticular elastic alloy structure can be formed by cutting an elastic alloy pipe by laser and also can be formed by weaving elastic alloy wires and welding the elastic alloy wires at the connecting points; in the invention, specifically, the reticular nickel-titanium balloon protection layer can be formed by cutting a nickel-titanium tube by laser, or can be formed by weaving nickel-titanium wires and welding at a connecting point; the reticular elastic alloy structure, particularly the reticular width of the reticular nickel-titanium balloon protective layer or the diameter of the nickel-titanium braided wire is preferably 0.05-0.3 mm, and most preferably 0.1-0.2 mm; one end or two ends of the balloon protection layer formed by the reticular elastic alloy structure can be fixed on the surfaces of the outer cavity tube (double cavity tube) and the tail end at one end or two ends of the balloon by welding and other modes by using elastic alloy wires. The single grid shape of the balloon protection layer formed by the reticular elastic alloy structure can be square-like, and can also be of suitable structures such as triangle-like, prismatic and the like. The balloon protection layer is in two states when the balloon is not opened and works, the diameter of the balloon protection layer is simultaneously enlarged along with the enlargement of the pressurized diameter of the balloon, and the mesh of the mesh elastic alloy structure is enlarged, which is shown in fig. 4-1(b), fig. 4-2(a), fig. 4-2(b), fig. 4-3(a) and fig. 4-3 (b); wherein, fig. 4-1(b) is a schematic structural diagram before and after the pressurization of the single rectangular grid balloon of the reticular nickel-titanium balloon protective layer; fig. 4-2(a) is a schematic view showing the deployment of the protective layer of the triangular mesh nickel-titanium balloon; FIG. 4-2(b) is a schematic structural view of a single triangular mesh balloon of a protective layer of a reticular nickel-titanium balloon before and after pressurization; FIG. 4-3(a) is a schematic view showing the deployment of the protective layer of the diamond-mesh Ni-Ti balloon; fig. 4-3(b) is a schematic structural diagram of a single prismatic grid balloon with a protective layer made of a reticular nickel-titanium material before and after pressurization. When the saccule is pressurized, and a single grid of the saccule protective layer is square (rectangular or square), the length of the single grid is preferably 2-10 mm, and the width of the single grid is preferably 2-10 mm; when the single grid is a triangle, the side length of the single grid is preferably 2-10 mm; when the single grid is a rhombus, the rhombus with an acute angle of 60 degrees is preferred, and the side length of the rhombus is preferably 2-10 mm.

The outer surface of the balloon protection layer is preferably provided with a flexible filamentous structure along the axial direction of the balloon, so that the force is gathered in the axial direction of the balloon, and the balloon can be prevented from slipping; the flexible filamentous structure is preferably adhered to the outer surface of the balloon protective layer through glue; the number of the flexible filamentous structures is preferably 3-10, more preferably 3-8, and further preferably 3-6; when the number of the flexible filamentous structures is multiple, the flexible filamentous structures are preferably uniformly distributed on the outer surface of the balloon protection layer; the flexible filamentous structure is preferably a spiral metal spring wire, a metal wire or a high polymer material wire; the high polymer material silk is preferably nylon; the flexible wire-like structure is preferably circular or triangular in cross-section.

The outer surface of the balloon protection layer is preferably further provided with a hole-shaped structure so as to enhance the surface friction force of the balloon protection layer.

The outer surface of the balloon protective layer is preferably further coated with a drug coating; the drug coating is preferably an antiproliferative drug coating.

A one-way valve is arranged between the inner cavity tube and the balloon part of the balloon; the one-way valve is preferably fixed on the outer surface of the inner cavity tube, and the inner cavity tube is in an umbrella shape or a vertical collar shape; the inclination direction of the one-way valve is the same as the blood flow direction; the fixing mode can be thermal welding, laser welding or ultrasonic welding; one end of the one-way valve, which is contacted with the balloon part, is not fixed, and can be in a smooth arc structure or an irregular shape; in the invention, the end of the one-way valve, which is contacted with the balloon part, is preferably in an irregular shape, and the irregular shape is attached to the surface of the balloon part at the moment and can be better attached to the balloon part; the irregular shape is preferably petal-shaped; the one-way valve preferably comprises a metal wire framework structure and a material which is covered on the surface of the metal wire framework structure and has biocompatibility; referring to fig. 4 and 5, fig. 4 and 5 are expanded schematic views of the check valve; the thickness of the one-way valve is preferably 0.01-0.5 mm; the thickness of the metal wire framework structure is preferably 0.05-0.5 mm, more preferably 0.05-0.3 mm, still more preferably 0.05-0.2 mm, and most preferably 0.1 mm; the metal wire framework structure is preferably arranged radially along the direction from the inner cavity pipe to the balloon part and/or is arranged around the inner cavity pipe; when the metal wire framework structure is radially arranged along the direction from the inner cavity tube to the balloon part, the number of the metal wires is preferably 10-50; the plurality of metal wires can be arranged at equal intervals or at variable intervals, and are not limited in particular; when the metal wire framework structure is arranged around the inner cavity pipe, the number of the metal wires is preferably 2-20, and more preferably 5-15; in order to improve the stability of the one-way valve, when the metal wire framework structure is arranged around the inner cavity pipe, the framework structure preferably further comprises metal wires radially arranged from the inner cavity pipe to the balloon part, the number of the metal wires is preferably 2-50, more preferably 3-40, further preferably 3-20, and most preferably 3-10; the plurality of metal wires can be arranged at equal intervals or at variable intervals, and are not limited in particular; the metal wire is preferably a stainless steel wire or a nickel-titanium wire; the biocompatible material is preferably a soft biocompatible material, more preferably polytetrafluoroethylene and/or dacron. The framework structure woven by the internal metal wires can enhance the durability of the one-way valve, and blood backflow caused by over-softness of the one-way valve is avoided. In order to improve the attaching performance of the one-way valve and the balloon part, the attaching part of the one-way valve and the balloon part preferably does not contain a skeleton structure; one end of the metal wire framework structure is contacted with the inner cavity pipe, and the other end of the metal wire framework structure is contacted with the balloon parts of the balloons. The number of the one-way valves can be 1 or more, and is not particularly limited; the one-way valve can realize one-way perfusion of blood flow by simulating the action of the heart valve leaflets.

In order to improve the advancing capability of the catheter, the perfusion balloon catheter preferably further comprises a terminal tube; the far end of the tail end pipe is of a closed structure and is in a tip shape; the shape of the tip is designed to be smoother, the capability of the catheter entering a lesion part can be improved, and the injury of the tail end of the catheter to the inner wall of a blood vessel of a patient can be reduced; the proximal end of the tail end tube is communicated with the distal end of the inner cavity tube and is not communicated with the saccule; the near end of the tail end tube can be sleeved outside the far end sacculus tube leg and is also positioned between the far end sacculus tube leg and the inner cavity tube; the connection is preferably by thermal, laser or ultrasonic welding; the material of the tail end pipe is preferably a high polymer material, and more preferably polyether block polyamide or nylon.

The perfusion balloon catheter provided by the present invention further comprises a dual lumen tube, see fig. 6 and 7, fig. 6 and 7 being schematic cross-sectional views of the dual lumen tube; the double-cavity tube comprises a wire guide cavity and an air cavity; the guide wire cavity and the air cavity of the double-cavity tube can be coaxially arranged, the guide wire cavity is preferably positioned in the middle, and the air cavity surrounds the guide wire cavity and is positioned on the outer side; the wire guide cavity and the air cavity can be arranged in a non-coaxial mode, the cross section of the air cavity is preferably designed in a crescent shape or a D shape, and the outer diameter of the double-cavity tube can be reduced on the premise that the balloon meets the requirement of inflation and pressure relief; the air cavity is communicated with the near-end balloon tube legs of the balloons and is used for expanding the balloons; in the present invention, the proximal balloon legs of the plurality of balloons are preferably connected to the wall of the air cavity by heat welding, laser welding or ultrasonic welding; the guide wire cavity is communicated with the inner cavity tube and used for advancing and guiding a guide wire; in the present invention, the wall of the guide wire lumen is preferably joined to the wall of the inner lumen by thermal, laser or ultrasonic welding. The material of the double-cavity tube is preferably a high polymer material, and more preferably polyether block polyamide or nylon; the outer surface of the double-cavity tube is preferably provided with a hydrophilic coating to facilitate advancing in a blood vessel; the length of the hydrophilic coating is preferably 10-50 cm from one end of the balloon body part to the direction far away from the balloon body part.

According to the present invention, the perfusion balloon catheter preferably further comprises a catheter reinforcement; the catheter reinforcing piece is sleeved at the proximal end of the double-cavity tube and is mainly used for driving out stress generated by the balloon in the using process; the catheter reinforcement is sleeved at the near end of the double-cavity tube, preferably, the length of the double-cavity tube exposed out of the catheter reinforcement is 5-100 mm, more preferably 30-50 mm, and most preferably 40 mm; the catheter reinforcement is preferably connected to the double lumen tube by glue bonding; the catheter reinforcement is preferably a Pebax catheter reinforcement; the length of the catheter reinforcing piece is preferably 5-20 mm, and the inner diameter of the catheter reinforcing piece is slightly larger than the outer diameter of the double-cavity tube.

According to the invention, the perfusion balloon catheter preferably further comprises a seat; the seat preferably comprises an air cavity and a guide wire cavity; the seat is preferably a Y-shaped structure device; the air cavity of the seat is communicated with the air cavity of the double-cavity tube and is used for filling the saccule; the guide wire cavity of the seat is communicated with the guide wire cavity of the double-cavity tube and is used for advancing and guiding the guide wire; the seat is preferably a nylon seat or a polycarbonate seat, more preferably a nylon seat.

The balloon body part of the perfusion balloon catheter provided by the invention is formed by bundling a plurality of balloons, a hollow cylinder-like shape is formed after expansion, meanwhile, a one-way valve is arranged in a cavity and used for simulating valve leaflets in a heart valve to carry out one-way blood perfusion, and after the balloons are opened, the one-way valve is started without switching operation, has a stable structure and can realize the function of the valve leaflets for many times; in addition, the design of the cluster balloon can meet the expected functions, and simultaneously, the difficulty of the balloon forming process is reduced.

To further illustrate the present invention, a perfusion balloon catheter with a one-way valve provided by the present invention is described in detail below with reference to the examples.

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

Example 1

Specifically, as shown in fig. 1, the balloon body portion 2 is formed by bundling a plurality of balloons, the number of the small balloons in this embodiment is 8, each of the 8 balloons is formed by blowing a nylon 12 balloon tube, the diameter of the small balloon is about 1/3 of the diameter of the balloon body portion 2, the diameter of the balloon body portion 2 may be 18-26 mm, and the effective length of the balloon body portion 2 may be 30-60 mm. The diameter of the balloon body part 2 of the present embodiment is 18mm, and the effective length is 40mm, that is, the diameter of the small balloon constituting the balloon body part 2 is 5mm, and the effective length is 40 mm. The balloonprotective layer 6 is formed by weaving artificial fibers, is of an annular structure and has the thickness of 0.07 mm; when the sacculus 2 is opened, the sacculus protective layer is bonded with the sacculus 2 through glue, so that the effective length part of the sacculus is covered by the sacculus protective layer, meanwhile, as shown in figures 2 and 3, 3 triangular nylonforce gathering wires 21 are arranged on the sacculus protective layer, and the side length of the section of each triangular wire is 2 mm. The effective length of the saccule 2 is the length of the middle cylindrical part of the small saccule, the two ends of the saccule are respectively provided with 8conical surface parts 22 and 8saccule tube legs 23, the inner diameter of each saccule tube leg is 0.015-0.035 inches, and the outer diameter of each saccule tube leg is 0.02-0.04 inches. The double-cavity tube 7 is made of nylon 12, the length can be 60 cm-160 cm, the diameter of the thread guide cavity can be 0.036-0.040 inches, and the outer diameter is 0.070-0.100 inches. The inner cavity tube 4 is cut into 80 mm-120 mm (the length of the inner cavity tube is slightly larger than the total length of the welded saccule and the outer cavity tube), two developingrings 3 are installed in front of the inner cavity tube 4, the developingrings 3 are made of platinum-iridium alloy or X-ray developable materials, the installation mode can be bonding or ring forging or other suitable modes, and the ring forging is used for marking the effective length of the saccule in the embodiment. The middle area of the two developingrings 3, outside the inner cavity tube 4, has a stable one-way valve 5, and the one-way valve 5 is an umbrella structure with an internal metal support, in this embodiment, as shown in fig. 5, the inside is a 0.1mm ni-ti wire 51 braided structure, the circumferential braided wire spacing is 0.5mm to 2mm, or a spacing gradually changing structure, in this embodiment, the spacing is equal and the spacing is 0.5 mm. The number of the knitting threads in the diameter direction may be 2 to 20, specifically 3 in the present embodiment. The exterior of the check valve 5 is made of a film-shaped soft polymer material with good biocompatibility, the check valve is made of polytetrafluoroethylene, the thickness of the check valve is 0.2mm, and the periphery of the check valve can be in a similar round shape or other shapes. The inner cavity pipe 4 is an umbrella handle, the one-way valve 5 is connected with the inner cavity pipe 4 through glue, the one-way valve 5 forms an umbrella-shaped structure, and when the saccule is opened, the valve edge film structure can be pasted inside a cavity formed by bundling 8 small saccules. Inserting the inner cavity tube into the guide wire cavity of the double-cavity tube, wherein the length of the overlapped part of the inner cavity tube and the guide wire cavity can be 1-10 mm; after the 8 saccule near-end tube legs are contracted into a bundle, the bundle is assembled and communicated with the double-cavity tube air cavity, and the connection mode adopts laser welding. The material of the tail end pipe 1 is polyether block polyamide, the tail end pipe 1 is cut into 1-10 mm, the length of the tail end pipe is 5mm in the embodiment, the tail end pipe is sleeved on the far end pipe leg of the saccule or the outer inner cavity pipe of the pipe leg, and the far end pipe leg of the saccule, the inner cavity pipe 4 and the tail end pipe 1 are welded together through thermal welding. The inner cavity tube 4 and the double-cavity tube 7 are used for advancing and guiding a guide wire, a channel formed by the air cavity of the double-cavity tube 7 is connected to the balloon 2 and is used for filling 8 balloons in the balloon 2, and the structural schematic diagram of the guide wire cavity and the air cavity is shown in fig. 6. And a hydrophilic coating with the length of 10-50 cm is coated from the position of the tube leg at the near end of the saccule to the surface of the double-cavity tube 7. Thecatheter reinforcing member 8 is made of polyether block polyamide, has a length of 2-10 cm, an inner diameter slightly larger than the outer diameter of the double-cavity tube 7 and an inner diameter of 0.08-0.011 inch, and is mainly used for driving off stress generated by the balloon catheter in use. Thecatheter reinforcement member 8 is sleeved at the proximal end of the double-cavity tube 7, so that the length of the exposed part of the double-cavity tube 7 is 5-10 mm, and the two are welded together in a proper mode, wherein the embodiment adopts a glue bonding mode. The seat 9 can be made of nylon or polycarbonate or other suitable Y-shaped structural members, the seat 9, thedouble lumen tube 7 and thecatheter reinforcement member 8 are bonded together through glue, theguide wire cavity 10 of the seat 9 is used for advancing and guiding the guide wire, and the air cavity 11 of the seat 9 is used for filling the balloon 2.

Example 2

Specifically, as shown in fig. 1, the balloon body portion 2 is formed by bundling a plurality of small balloons, the number of the small balloons in this embodiment is 8, each of the 8 small balloons is formed by blowing a nylon 12 balloon tube, the diameter of the small balloon is about 1/3 of the diameter of the balloon body portion 2, the diameter of the balloon body portion 2 may be 18-26 mm, and the effective length of the balloon body portion 2 may be 30-60 mm. The diameter of the balloon body part 2 of the present embodiment is 26mm, and the effective length is 40mm, that is, the diameter of the small balloon constituting the balloon body part 2 is 8mm, and the effective length is 40 mm. The balloonprotective layer 6 is formed by weaving artificial fibers, is of a sheet structure and has a thickness of 0.07 mm; winding to form a ring structure, wherein the surface of the ring structure can be provided with a plurality of small holes with the aperture of 1 mm; increase the surface friction power behind the sacculus adherence, when sacculus body part 2 was opened, evenly scribbled 6 one sides of sacculus protective layer with glue, roll up it on sacculus body part again for sacculus protective layer cladding sacculus body part effective length part, simultaneously, 6 surfaces of sacculus protective layer can have anti proliferative medicine coating. The effective length of the balloon body part 2 is the length of the middle cylindrical part of the small balloon, two ends of the balloon body part are respectively provided with 8 conical surfaces and 8 balloon tube legs, the inner diameter of each balloon tube leg is 0.015-0.035 inches, and the outer diameter of each balloon tube leg is 0.02-0.04 inches. Theouter cavity tube 7 is made of nylon 12, the length can be 60 cm-160 cm, and the outer diameter is 0.070-0.100 inch. The inner cavity tube 4 is cut into 80-180 cm, two developingrings 3 are mounted on the inner cavity tube 4 in a front lifting mode, the developingrings 3 are made of platinum-iridium alloy or X-ray developable materials, the mounting mode can be bonding or ring forging or other suitable modes, and the ring forging is used for marking the effective length of the balloon. The middle area of the two developingrings 3 is provided with a stable one-way valve 5 on the outer side of the inner cavity tube 4, the one-way valve 5 is an umbrella-shaped structure with an internal metal support, in this embodiment, as shown in fig. 6, the internal part is a 0.1mmnickel titanium wire 61 braided structure, the number of braided wires in the diameter direction can be 10-50, the spacing can be equal or variable, and in this embodiment, the braided wires are specifically 25 braided wires with equal spacing. The exterior of the check valve 5 is made of a film-shaped soft polymer material with good biocompatibility, the check valve is made of polytetrafluoroethylene, the thickness of the check valve is 0.2mm, and the periphery of the check valve can be in a similar round shape or other shapes. The inner cavity pipe 4 is an umbrella handle, the one-way valve 5 is connected with the inner cavity pipe 4 through glue, the one-way valve 5 forms an umbrella-shaped structure, and when the balloon body part 2 is opened, the valve edge film structure can be pasted inside a cavity formed by bundling 8 small balloons. And after the 8 saccule proximal tube legs are contracted into a hollow bundle, the hollow bundle is assembled and communicated with the inner wall of theouter cavity tube 7, and the connection mode adopts laser welding. The inner lumen 4 is inserted into the balloon-attachedouter lumen 7 such that the inner lumen with thevisualization ring 3 and the one-way valve 5 is partially located in the balloon 2. The material of end pipe 1 is polyether block polyamide, cuts into 1 ~ 10mm with end pipe 1, and this embodiment is 5mm, and behind the 4 positions of adjustment inner chamber pipe, with end pipe 1,inner chamber pipe 4 and 8 sacculus distal end legs weld for distal end leg is sealed. The inner lumen 4 is used for advancing and guiding a guide wire, and the gap between the inner lumen 4 and theouter lumen 7 is used for filling the balloon 2. And a hydrophilic coating with the length of 10-50 cm is coated from the position of the near-end tube leg of the balloon to the surface of theouter cavity tube 7. Thecatheter reinforcing member 8 is made of polyether block polyamide, has a length of 2-10 cm, an inner diameter slightly larger than the outer diameter of theouter cavity tube 7 and an inner diameter of 0.08-0.011 inch, and is mainly used for driving off stress generated by the balloon catheter in use. Thecatheter reinforcement member 8 is sleeved at the proximal end of theouter cavity tube 7, so that the length of the exposed part of theouter cavity tube 7 is 5-10 mm, and the outer cavity tube are welded together in a proper mode, wherein the embodiment adopts a glue bonding mode. The seat 9 can be made of nylon or polycarbonate or other suitable Y-shaped structural members, the seat 9, theouter lumen tube 7 and thecatheter reinforcement member 8 are bonded together through glue, theguide wire cavity 10 of the seat 9 is used for advancing and guiding the guide wire, and the air cavity 11 of the seat 9 is used for filling the balloon 2.

Example 3

Specifically, as shown in fig. 1, the balloon body portion 2 is formed by bundling a plurality of small balloons, the number of the small balloons in this embodiment is 8, each of the 8 small balloons is formed by blowing a nylon 12 balloon tube, the diameter of the small balloon is about 1/3 of the diameter of the balloon body portion 2, the diameter of the balloon body portion 2 may be 18-26 mm, and the effective length of the balloon body portion 2 may be 30-60 mm. The diameter of the balloon body part 2 of the present embodiment is 26mm, and the effective length is 40mm, that is, the diameter of the small balloon constituting the balloon body part 2 is 8mm, and the effective length is 40 mm. Sacculusprotective layer 6 is netted nickel titanium material, netted nickel titanium material sacculus protective layer is formed by external diameter 3.5 ~ 5.5mm internal diameter 3.3 ~ 5.3mm nickel titanium pipe laser cutting, netted nickel titanium material sacculus protective layer both ends utilize nickel titanium wire to be fixed in the outer chamber pipe and the end at sacculus body part 2 both ends respectively through modes such as welding, sacculus body part 2 effective length region does not have the physics with netted nickel titanium material sacculus protective layer and fixes, when sacculus body part 2 pressurizes, netted nickel titanium material sacculus protective layer can launch along with sacculus body part 2 simultaneously, when sacculus body part 2 diameters reach 32mm, netted nickel titanium material sacculus protective layer diameter no longer increases. As shown in FIGS. 4-1(a) and 4-1(b), when the protective layer of the reticular nickel-titanium balloon is completely opened, the single grid can be square, the length of the square hole is preferably 2-10 mm, and the width is preferably 2-10 mm. The single grid can also be triangular, as shown in the expanded figures of the reticular nickel-titanium balloon protective layer in fig. 4-2(a) and 4-2(b), the triangular grid is preferably an equilateral triangle, and the side length is preferably 2-10 mm. The single grid can also be prismatic, as shown in the expanded figures of the reticular nickel-titanium balloon protective layers in the figures 4-3(a) and 4-3(b), the prismatic grid is preferably prismatic with an acute angle of 60 degrees, and the side length of the prismatic grid is preferably 2-10 mm. In this embodiment, when the protective layer of the reticular nickel-titanium balloon is completely opened, the single grid is prismatic, and the side length is 5 mm; the effective length of the sacculus 2 is the length of the middle cylindrical part of the small sacculus, the two ends of the sacculus are respectively provided with 8 conical surfaces and 8 sacculus tube legs, the inner diameter of each sacculus tube leg is 0.015-0.035 inches, and the outer diameter of each sacculus tube leg is 0.02-0.04 inches. Theouter cavity tube 7 is made of nylon 12, the length can be 60 cm-160 cm, and the outer diameter is 0.070-0.100 inch. The inner cavity tube 4 is cut into 80-180 cm, two developingrings 3 are mounted on the inner cavity tube 4 in a front lifting mode, the developingrings 3 are made of platinum-iridium alloy or X-ray developable materials, the mounting mode can be bonding or ring forging or other suitable modes, and the ring forging is used for marking the effective length of the balloon. The middle area of the two developingrings 3 is provided with a stable one-way valve 5 on the outer side of the inner cavity tube 4, the one-way valve 5 is an umbrella-shaped structure with an internal metal support, in this embodiment, as shown in fig. 6, the internal part is a 0.1mm nickel-titanium wire 61 braided structure, the number of braided wires in the diameter direction can be 10-50, the spacing can be equal or variable, and in this embodiment, the number of braided wires is specifically 25 at equal intervals. The exterior of the check valve 5 is made of a film-shaped soft polymer material with good biocompatibility, the check valve is made of polytetrafluoroethylene, the thickness of the check valve is 0.2mm, and the periphery of the check valve can be in a similar round shape or other shapes. The inner cavity pipe 4 is an umbrella handle, the one-way valve 5 is connected with the inner cavity pipe 4 through glue, the one-way valve 5 forms an umbrella-shaped structure, and when the balloon body part 2 is opened, the valve edge film structure can be pasted inside a cavity formed by bundling 8 small balloons. And after the 8 saccule proximal tube legs are contracted into a hollow bundle, the hollow bundle is assembled and communicated with the inner wall of theouter cavity tube 7, and the connection mode adopts laser welding. The inner lumen 4 is inserted into the balloon-attachedouter lumen 7 such that the inner lumen with thevisualization ring 3 and the one-way valve 5 is partially located in the balloon 2. The material of end pipe 1 is polyether block polyamide, cuts into 1 ~ 10mm with end pipe 1, and this embodiment is 5mm, and behind the 4 positions of adjustment inner chamber pipe, with end pipe 1,inner chamber pipe 4 and 8 sacculus distal end legs weld for distal end leg is sealed. The inner lumen 4 is used for advancing and guiding a guide wire, and the gap between the inner lumen 4 and theouter lumen 7 is used for filling the balloon 2. And a hydrophilic coating with the length of 10-50 cm is coated from the position of the near-end tube leg of the balloon to the surface of theouter cavity tube 7. Thecatheter reinforcing member 8 is made of polyether block polyamide, has a length of 2-10 cm, an inner diameter slightly larger than the outer diameter of theouter cavity tube 7 and an inner diameter of 0.08-0.011 inch, and is mainly used for driving off stress generated by the balloon catheter in use. Thecatheter reinforcement member 8 is sleeved at the proximal end of theouter cavity tube 7, so that the length of the exposed part of theouter cavity tube 7 is 5-10 mm, and the outer cavity tube are welded together in a proper mode, wherein the embodiment adopts a glue bonding mode. The seat 9 can be made of nylon or polycarbonate or other suitable Y-shaped structural members, the seat 9, theouter lumen tube 7 and thecatheter reinforcement member 8 are bonded together through glue, theguide wire cavity 10 of the seat 9 is used for advancing and guiding the guide wire, and the air cavity 11 of the seat 9 is used for filling the balloon 2.

Table 2 shows the results of in vitro simulated hemodynamic bench tests performed on the perfusion balloon catheters with one-way valves obtained in examples 1 to 3, and it should be noted that the bench test results may not completely represent the actual clinical performance of the present invention, and different results may be generated under different conditions.

TABLE 2 in vitro simulated hemodynamic bench test of the invention

Bench test conditions in table 2:

environmental medium: in vitro simulated blood;

temperature: 34-42 ℃;

cardiac output: simulating the heart function by a pulse pump, wherein the pressure is 80-160 mmHg;

blood: adding glycerol into the purified water to achieve the viscosity similar to that of real blood;

and (3) blood vessel model: formed from a mixture of silica gel and the developing material silver iodide. The inner wall is coated with a lubricating material to adjust the friction coefficient of the inner wall of the blood vessel and ensure that the friction coefficient of the blood vessel wall is close to the physiological state of the blood vessel of a human body.

Claims (10)

1. A perfusion balloon catheter with a one-way valve, comprising:

a balloon body portion; the balloon body part comprises an inner cavity pipe and a plurality of balloons arranged around the outer surface of the inner cavity pipe; the sacculus comprises a far-end sacculus tube leg, a far-end conical surface part, a sacculus part, a near-end conical surface part and a near-end sacculus tube leg which are sequentially arranged, and the side walls of the sacculus parts of the adjacent sacculus are mutually contacted; the far balloon tube legs of the balloons are in contact with the tube wall of the inner cavity tube; a one-way valve is arranged between the inner cavity tube and the balloon part of the balloon;

a double lumen tube; the double-cavity tube comprises a wire guide cavity and an air cavity; the near-end balloon tube legs of the balloons are communicated with the air cavity; the inner cavity pipe is communicated with the thread guide cavity.

2. The perfusion balloon catheter of claim 1, wherein the balloon body portion further comprises a balloon protective layer; the balloon protective layer is coated on one side, away from the inner cavity tube, of the balloon parts of the balloons and integrally arranged.

3. The perfusion balloon catheter of claim 2, wherein the outer surface of the balloon protective layer is provided with a flexible filamentous structure along the balloon axial direction; the number of the flexible filamentous structures is 3-10.

4. The perfusion balloon catheter of claim 2, wherein the balloon protective layer is formed from a braided filamentous material.

5. The perfusion balloon catheter of claim 2, wherein the balloon protective layer is formed of a reticulated elastomeric alloy structure.

6. The perfusion balloon catheter of claim 5, wherein the reticulated elastomeric alloy structure is a reticulated nitinol structure; the balloon protective layer is in two states when the balloon is not opened and works, and the diameter of the balloon protective layer can be simultaneously increased along with the increase of the pressurized diameter of the balloon.

7. The perfusion balloon catheter of claim 1, wherein the balloon has a diameter 1/5-1/2 of a diameter of a balloon body portion; the number of the saccules is 2-10.

8. The perfusion balloon catheter of claim 1, wherein the one-way valve is secured to an outer surface of the inner lumen tube, the inner lumen tube being an umbrella or a standing collar.

9. The perfusion balloon catheter of claim 1, wherein the one-way valve comprises a wire framework structure and a biocompatible material covering a surface of the wire framework structure.

10. The perfusion balloon catheter of claim 7, wherein the thickness of the wire skeleton structure is 0.05-0.5 mm; one end of the metal wire framework structure is contacted with the inner cavity pipe, and the other end of the metal wire framework structure is contacted with the balloon parts of the balloons.

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