CN213100299U

CN213100299U - Folding-resistant blood vessel dilatation balloon catheter

Info

Publication number: CN213100299U
Application number: CN202020680308.6U
Authority: CN
Inventors: 翁玉麟; 牛冬子; 刘宝瑞; 石全; 李委委
Original assignee: Dingke Medical Technology Suzhou Co ltd
Current assignee: Dingke Medical Technology Suzhou Co ltd
Priority date: 2020-04-28
Filing date: 2020-04-28
Publication date: 2021-05-04
Anticipated expiration: 2030-04-28

Abstract

The utility model provides a folding endurance vasodilatation sacculus pipe, include: a balloon; the balloon wall of the balloon is of a multilayer structure; an inner lumen tube; the inner cavity tube is arranged in the balloon and penetrates through the balloon; a double lumen tube; the double-cavity tube comprises a wire guide cavity and an air cavity; the air cavity is semi-wrapped outside the wire guide cavity; the guide wire cavity is communicated with the inner cavity pipe; the air cavity is communicated with the saccule. Compared with the prior art, the utility model adopts a multi-layer balloon wall structure to ensure that the balloon has high rated burst pressure, thereby avoiding the dog bone phenomenon when the balloon is expanded to have higher hardness and is diseased; meanwhile, the double-cavity tube design is adopted, so that the outer diameter of the double-cavity tube can be reduced on the premise of ensuring the sufficient wall thickness of the wire guide cavity and the air cavity, and the trafficability and the pushing performance of the double-cavity tube are improved.

Description

Folding-resistant blood vessel dilatation balloon catheter

Technical Field

The utility model belongs to the technical field of medical instrument, especially, relate to a folding endurance vasodilatation sacculus pipe.

Background

There are two main types of surgical approaches for treating arterial stenosis or occlusion: surgical bypass surgery, minimally invasive interventional therapy. Among them, the surgical bypass or bypass surgery is mainly to replace a diseased blood vessel with an autologous vein or an artificial blood vessel by a surgical operation, thereby restoring a smooth blood flow. The minimally invasive interventional therapy is to dilate a diseased blood vessel by puncturing femoral artery, radial artery and other medical devices and instruments such as guide wires, balloon catheters, vascular stents and the like, so as to restore the smooth blood flow. The minimally invasive interventional therapy method is widely applied to clinic due to small trauma, short recovery time and no inferior treatment effect to surgical operation.

Balloon catheters originated in the 60's of the 20 th century. In 1963 Dotter inadvertently discovered that the catheter successfully performed abdominal aortic angiography by narrowing the obstructed iliac arteries while cannulating the peripheral arteries, suggesting that this method could be used to guide the catheter using a flexible guidewire to directly and gradually dilate the stenotic arteries. In 1964, Dotter et al used a coaxial catheter (coaxial catheter) for the first time to perform PTA on patients with severe arterial stenosis of the lower limbs. Followed by a metallic bare stent stage, a drug eluting stent stage, and an emerging fully degraded stent stage. Although stents have primarily replaced pure PTA balloon dilatation, a PTA balloon catheter must be used for pre-dilatation before stent implantation, and therefore, PTA balloon dilatation catheter pre-dilatation is also an essential treatment tool for stent implantation.

Peripheral arterial disease is a circulatory disorder caused by the accumulation of one or more arterial plaques, which is common in lower limb diseases, and as the disease condition becomes worse, the plaque accumulation may reduce arterial blood flow greatly, causing pain and aggravating disability, and even requiring amputation of the affected limb when the disease condition is severe, while about one-fifth of the ordinary people suffer from peripheral arterial disease. However, this disease causes limited damage and tearing to the target blood vessel and the middle layer by balloon expansion of the PTA balloon dilatation catheter, so that the tension of the blood vessel wall is reduced and the blood vessel lumen is enlarged to restore normal blood circulation.

Chinese patent with application number CN 201520999814.0 discloses a PTA sacculus dilating guide, including pipe seat, pipe seat reinforcement, outer tube, sacculus, elasticity reinforcing wire, the one end of outer tube is fixed in the inside of pipe seat, the other end of outer tube inserts in the sacculus, be equipped with the inner tube in the cavity of outer tube, inner tube and pipe seat fixed connection, the diameter of inner tube diminishes along the direction of pipe seat to sacculus gradually, the outer wall fixed connection of elasticity reinforcing wire and inner tube, pipe seat reinforcement and pipe seat are connected, be equipped with the mark ring in the inner tube, be equipped with length mark ring on the outer wall of outer tube. However, the catheter part is of a coaxial structure, so that the catheter part is large in size and cannot be used for treating the stenosis of the surrounding small blood vessels; and the catheter is made of a single material, so that the folding resistance and the pushing performance are poor, and the requirement of complex pathological changes cannot be met.

Chinese patent with application number CN201810252595.8 discloses a PTA sacculus dilating catheter, which comprises a tail end, wherein one end of the tail end is provided with a catheter, one end of the tail end close to the catheter and the surface of the catheter are provided with sacculus, the inside of the sacculus and the surface of the catheter are provided with symmetrically distributed marking rings, the fixed communication of one end of the catheter far away from the tail end is provided with a catheter reinforcement, and the fixed communication of one end of the catheter far away from the catheter reinforcement is provided with a catheter seat. However, the balloon burst pressure is 16ATM, when partial atherosclerosis occurs in the angiostenosis, when the balloon reaches the burst pressure, the balloon can generate a 'dog bone' phenomenon, namely the balloon at the stenosis and sclerosis part cannot be expanded, so that the internal pressure is diffused to a non-stenosis area, and the treatment effect is lost; and the protective sleeve is taken down before use, the main force of the balloon is larger through the vascular sheath hemostatic valve, and the balloon part is easy to bend.

SUMMERY OF THE UTILITY MODEL

In view of this, the technical problem to be solved by the present invention is to provide a folding-resistant vasodilatation balloon catheter, which has better passability.

The utility model provides a folding endurance vasodilatation sacculus pipe, a serial communication port, include:

a balloon; the balloon wall of the balloon is of a multilayer structure;

an inner lumen tube; the inner cavity tube is arranged in the balloon and penetrates through the balloon;

a double lumen tube; the double-cavity tube comprises a wire guide cavity and an air cavity; the air cavity is semi-wrapped outside the wire guide cavity; the guide wire cavity is communicated with the inner cavity pipe; the air cavity is communicated with the saccule.

Preferably, the guide wire cavity is a circular cavity; the cross section of the air cavity is crescent or D-shaped.

Preferably, the balloon is a non-compliant high pressure balloon.

Preferably, the balloon wall of the balloon is of a multilayer structure with polyether block polyamide layers and nylon layers alternately arranged.

Preferably, when the balloon wall of the balloon is of a double-layer structure, the thickness of the inner layer is 10% -50% of the thickness of the balloon wall, and the thickness of the outer layer is 50% -90% of the thickness of the balloon; when the wall of the balloon is a structure with more than 2 layers, the thickness of each layer is 10-30% of the thickness of the wall.

Preferably, the device further comprises a tearable protection sleeve; the tearable protection sleeve is arranged outside the balloon; the tearable protective sleeve is a hollow polytetrafluoroethylene tube.

Preferably, a tearing opening area is arranged on the pipe wall at one end of the tearable protective sleeve; the other end is a conical structure.

Drawings

Fig. 1 is a schematic structural view of a folding-resistant vasodilation balloon catheter provided by the present invention;

FIG. 2 is a schematic cross-sectional view of a dual lumen tube provided by the present invention;

fig. 3 is a schematic cross-sectional view of a multilayer balloon provided by the present invention;

fig. 4 is a schematic cross-sectional view of a double-layer balloon provided by the present invention;

fig. 5 is a schematic view of the folding and winding of the balloon provided by the present invention;

fig. 6 is a schematic view of the protection sleeve provided by the present invention.

Detailed Description

The technical solutions in the embodiments of the present invention will be described clearly and completely below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative work belong to the protection scope of the present invention.

The utility model provides a folding endurance vasodilatation sacculus pipe, include:

a balloon; the balloon wall of the balloon is of a multilayer structure;

Referring to fig. 1, fig. 1 is a schematic structural view of the folding-resistant vasodilatation balloon catheter provided by the present invention, wherein 1 is an end tube, 2 is a balloon, 3 is a developing ring, 4 is an inner lumen tube, 5 is a dual lumen tube, 6 is a catheter reinforcement, 7 is a seat, 8 is a guide wire cavity, and 9 is an air cavity.

Referring to fig. 2, fig. 2 is a schematic cross-sectional view of a dual lumen tube provided by the present invention, 10 is a guide wire lumen, and 11 is an air lumen.

The utility model discloses the application adopts the design of double lumen pipe, can reduce the external diameter of double lumen pipe under the prerequisite of guaranteeing the sufficient wall thickness of seal wire chamber and air cavity, and then improves its trafficability characteristic and propelling movement performance, is convenient for insert in the crooked blood vessel.

The utility model provides a folding-resistant vasodilatation balloon catheter which comprises a balloon; in the present invention, the balloon is preferably a non-compliant high pressure balloon; the balloon wall of the balloon can be of a single-layer structure or a multi-layer structure, and is not particularly limited, the balloon wall of the balloon is preferably of a multi-layer structure, and more preferably of a multi-layer structure formed by alternately arranging polyether block polyamide layers and nylon layers; the polyether block polyamide layer is preferably formed from pebax7233 and/or pebax 7033; the nylon layer may be formed of nylon known to those skilled in the art, and is not particularly limited, and nylon 12 is preferred, and nylon 12L25 is more preferred; when the balloon wall of the balloon is of a double-layer structure, the thickness of the inner layer is preferably 10% -90% of the thickness of the balloon wall, more preferably 10% -50%, still more preferably 15% -45%, still more preferably 20% -45%, still more preferably 25% -40%, and most preferably 30% -35%; the thickness of the outer layer is preferably 10-90%, more preferably 50-90%, still more preferably 55-80%, still more preferably 60-70%, most preferably 65-70% of the thickness of the balloon; when the wall of the balloon is a structure with more than 2 layers, the thickness of each layer is 10-30% of the thickness of the wall. Referring to fig. 3 and 4, fig. 3 is a schematic cross-sectional view of a multilayer balloon having more than two layers, where 12 is the outermost layer, 13 is the second outer layer, 14 is the second inner layer, and 15 is the innermost layer; fig. 4 is a schematic cross-sectional view of a double-layer balloon. The balloon has high rated bursting pressure by adopting a multi-layer balloon wall structure, so that the phenomenon of dog bone can not occur when the balloon is used for dilating lesions with higher hardness. In the utility model, the balloon comprises a far-end balloon tube leg, a far-end conical surface part, a balloon part, a near-end conical surface part and a near-end balloon tube leg which are arranged in sequence; wherein the balloon portion is preferably cylindrical, which is the effective length of the balloon; the diameter of the sacculus part is preferably 1-15 mm, and more preferably 2-12 mm; the length of the balloon part, namely the effective length of the balloon is preferably 5-200 mm, and more preferably 20-150 mm; the two ends of the sacculus part are respectively provided with a conical surface and a sacculus tube leg, namely a far-end sacculus tube leg, a far-end conical surface part, a near-end conical surface part and a near-end sacculus tube leg; the inner diameter of the far balloon tube leg is preferably 0.03-0.08 inch, and more preferably 0.04-0.06 inch; the length of the far-end balloon tube leg is preferably 1-10 mm; the inner diameter of the proximal balloon tube leg is preferably 0.05-0.1 inch, and more preferably 0.06-0.08 inch; the length of the near-end balloon tube leg is preferably 1-10 mm; the balloon is preferably blow molded from a balloon tube. The saccule is preferably contracted into 3 folds, 5 folds or other proper wing numbers, so that the outer diameter of the saccule can be reduced, and the saccule part can smoothly pass through a blood vessel and abut against a lesion part in actual use; referring to fig. 5, fig. 5 is a schematic view of the folding and winding of the balloon.

An inner cavity tube is arranged in the sacculus, penetrates through the sacculus, is used for advancing and guiding a guide wire, and is mutually independent with the inside of the sacculus and a channel for filling the sacculus; the inner diameter of the inner cavity tube is selected according to the diameter of the guide wire, the inner diameter of the inner cavity tube is preferably 0.01-0.04 inch, more preferably 0.014-0.036 inch, and more preferably 0.0145 inch, 0.0185 inch or 0.036 inch, and the inner diameter of the inner cavity tube is respectively used for matching the guide wires with the outer diameters of 0.014, 0.015 and 0.035 inch; the outer diameter of the inner cavity pipe is preferably 0.02-0.05 inch, and more preferably 0.02-0.045 inch; the length of the inner cavity pipe is preferably 30-500 mm, and more preferably 30-200 mm; in order to effectively mark the position and the effective length of the saccule, developing rings are preferably arranged at the positions of the inner cavity tube opposite to the two ends of the saccule part; the developing ring is preferably made of platinum-iridium alloy or X-ray developable material; the developer ring is preferably mounted by bonding, ring forging or other suitable means, more preferably ring forging.

In order to improve the advancing capability of the catheter, a terminal tube is preferably further included; the far end of the inner cavity pipe is preferably communicated with the tail end pipe, namely, the opening of the far end of the tail end is a tail end port, and the near end of the tail end is communicated with the inner cavity pipe; the near end of the tail end tube can be sleeved outside the far end sacculus tube leg or positioned between the far end sacculus tube leg and the inner cavity tube, and the tail end tube, the far end sacculus tube leg and the inner cavity tube are preferably connected together through welding to form the far end of the sacculus dilating catheter; the welding mode is preferably thermal welding, laser welding or ultrasonic welding; the length of the tail end pipe is preferably 1-10 mm, more preferably 2-8 mm, and most preferably 2-4 mm; the terminal tube is preferably a polyether block polyamide tube or a nylon tube, more preferably a Pebax tube; the distal end of the tail end tube is preferably of a tip structure, the tip structure is smoother, and the capability of the balloon dilatation catheter entering and passing through a lesion part can be improved; the outer diameter of the far end of the tail end pipe is preferably 0.018-0.045 inches; the distal outer diameter of the tip tube is less than 0.045 inches when the guidewire for the balloon catheter is 0.035 inches, less than 0.025 inches when the guidewire for the balloon catheter is 0.018 inches, and less than 0.018 inches when the guidewire for the balloon catheter is 0.014 inches.

The near-end sacculus tube leg is connected with the double-cavity tube, and is preferably sleeved on the tube wall at the far end of the double-cavity tube; the overlapping length of the near-end balloon tube leg and the double-cavity tube is preferably 1-10 mm; the two are preferably joined together by welding; the welding mode is preferably thermal welding, laser welding or ultrasonic welding; the double-cavity tube comprises a wire guide cavity and an air cavity; the guide wire cavity is preferably a circular cavity; the inner cavity pipe is communicated with the guide wire cavity, and is preferably inserted into the guide wire cavity of the double-cavity pipe for advancing and guiding the guide wire; the length of the overlapped part of the inner cavity pipe and the guide wire cavity is preferably 1-10 mm; the two are preferably joined together by welding; the welding is preferably by heat welding, laser welding or ultrasonic welding. The air cavity of the double-cavity tube is communicated with the balloon and is used for filling the balloon; the air cavity is semi-wrapped outside the wire guide cavity; the cross section of the air cavity is preferably crescent or D-shaped, so that the outer diameter of the double-cavity tube can be reduced on the premise of ensuring that the balloon meets the requirements of inflation and pressure relief; the ratio of the length to the width of the air cavity is preferably (1.5-3): 1) more preferably (1.5 to 2.5): 1, more preferably (1.8-2.2): 1, most preferably 2: 1; the shortest distance between the air cavity and the wire guide cavity is preferably 0.001-0.01 inch, more preferably 0.002-0.008 inch, and further preferably 0.003-0.005 inch; the shortest distance between the wall of the air cavity and the outer wall of the double-cavity pipe is preferably 0.001-0.01 inch, more preferably 0.002-0.008 inch, and still more preferably 0.003-0.005 inch; the shortest distance between the wall of the guide wire cavity and the outer wall of the double-cavity tube is preferably 0.001-0.01 inch, more preferably 0.002-0.008 inch, and even more preferably 0.003-0.005 inch. The pipe wall of the double-cavity pipe is preferably formed by polyether block polyamide, nylon and an auxiliary agent, so that the folding resistance and the trafficability of the double-cavity pipe can be increased while high pressure resistance is ensured; the auxiliary agent is selected from carbon fiber and/or barium sulfate; the diameter of the carbon fiber is preferably 1-100 mu m; the length of the carbon fiber is preferably 10-500 mu m; the particle size of the barium sulfate is preferably 1-100 mu m; the mass ratio of the polyether block polyamide to the nylon to the auxiliary agent is (50-70): (20-40): 10; in some embodiments provided by the present invention, the mass ratio of the polyether block polyamide, nylon and the auxiliary agent is 60: 30: 10; in some embodiments provided by the present invention, the mass ratio of the polyether block polyamide, nylon and the auxiliary agent is 70: 20: 10; in other embodiments provided by the present disclosure, the mass ratio of the polyether block polyamide, nylon, and the additive is 50: 40: 10; the polyether block polyamide is composed of regular linear hard polyamide chain segments embedded by soft polyether chain segments, has a plurality of excellent properties between the thermoplastic elastomer and the rubber body, and is preferably pebax7233 and/or pebax7033 in the utility model; the weight average molecular weight of the nylon is preferably 17000-23000, more preferably nylon 12, and still more preferably 12L 25.

In order to improve the marching property and the smoothness of the vascular dilatation balloon catheter in blood vessels, the surface of the double-cavity tube is preferably coated with a hydrophilic coating; the length of the hydrophilic coating is preferably 10-50 cm, namely the hydrophilic coating is preferably coated on the surface of a double-lumen tube from a proximal balloon leg to a position 10-50 cm away from the balloon; the length of the hydrophilic coating is more preferably 10-40 cm.

According to the present invention, the balloon catheter for vasodilation preferably further comprises a catheter reinforcement; the catheter reinforcing piece is sleeved at the proximal end of the double-lumen tube and is mainly used for driving out stress generated in the use process of the balloon catheter; the catheter reinforcement piece is sleeved at the near end of the double-cavity tube, and the length of the double-cavity tube exposed is preferably 5-100 mm; more preferably 10-50 mm; the catheter reinforcement is preferably connected to the double lumen tube by glue bonding; the catheter reinforcing piece is made of polyether block polyamide or nylon; the length of the catheter reinforcing piece is preferably 2-100 mm, more preferably 30-70 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 utility model, the blood vessel dilatation balloon catheter preferably further comprises a seat; the seat preferably comprises an air cavity and a guide wire cavity; wherein, the air cavity 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; in the present invention, the seat is preferably a Y-shaped structural device; the seat is preferably made of nylon or polycarbonate.

According to the utility model, the blood vessel dilatation balloon catheter preferably further comprises a tearable protective sleeve; a tearing opening area is arranged on the pipe wall at one end of the tearable protective sleeve to realize a tearable structure; for convenient taking, the tearable protective sleeve is preferably provided with a hand-held area; in order to improve the marching property of the tearable protective sleeve, the other end of the tearable protective sleeve, i.e. the end without the opening area, is of a conical structure, also called a distal-end cone; as shown in fig. 6; fig. 6 is a schematic view of a tearable protective sleeve, wherein 18 is the distal taper of the protective sleeve, 19 is the grip area, 20 is the protective sleeve tearable opening, and 21 is the protective sleeve tear notch; the tearable protection sleeve is arranged outside the balloon; the tearable protective sleeve is a hollow polytetrafluoroethylene tube; to improve the strength of the tear-off protective sleeve, the distal end of the tear-off protective sleeve may be reinforced with metal. When the blood vessel dilatation sacculus pipe is actually used, the tearable protective sleeve is preferably inserted into the silica gel pad of the blood vessel sheath firstly, then the sacculus pipe is pushed into the blood vessel sheath, and after the sacculus completely carries out the blood vessel sheath, the tearable protective sleeve can be withdrawn (or the protective sleeve is torn, as shown in figure 6), so that the blood flow backtracking of the blood vessel sheath opening can not occur, and the sacculus can not be damaged due to the fact that the silica gel pad is too tight when the sacculus is inserted.

In order to further explain the present invention, the following detailed description is made of a folding-resistant vasodilating balloon catheter according to the present invention with reference to the embodiments.

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

Example 1

The balloon catheter of the embodiment is of an integral exchange type, and the outer diameter of the matched guide wire is 0.035'.

As shown in figure 1, the integral exchange type sacculus catheter for dilating the narrow blood vessel mainly comprises a 1 end tube, a 2 sacculus, a 3 developing ring, a 4 inner cavity tube, a 5 double cavity tube, a 6 catheter reinforcing part, a 7 seat, an 8 guide wire cavity and a 9 air cavity.

The balloon catheter provided in embodiment 1 includes a dual lumen tube 5 having a proximal end and a distal end opposite to each other, the dual lumen tube 5 is designed as a circular lumen and a crescent-shaped lumen, the material of the wall of the dual lumen tube is shown in table 1, the material used in this embodiment is 60% pebax + 30% nylon + 10% carbon fiber, the circular lumen is used for advancing a guide wire, and the crescent-shaped lumen is used for inflating or deflating the balloon. The air chamber adopts a crescent design, so that the outer diameter of the double-cavity tube can be reduced as much as possible, the pressure charging and releasing time is not greatly different from that of other products on the market, and the comparison results of the pressure charging and releasing time are shown in tables 2 and 3. An expandable balloon 2 at the distal end of the dual lumen tube 5 and a catheter stiffener 6 and seat 7 at the proximal end of the dual lumen tube 5. The near end of the balloon 2 is connected and sealed with the far end of the double-lumen tube 5, the inner lumen tube 4 axially penetrates through the balloon 2, the far end of the inner lumen tube 4 is connected and sealed with the far end of the balloon 2, and the near end is connected and sealed with the guide wire cavity of the double-lumen tube 5.

As shown in fig. 3 and 4, the balloon 2 is formed by hot blow molding a double-layer balloon tube with an inner layer of pebax7233 and an outer layer of nylon on a balloon forming machine with a convex mold, and has high rated burst pressure. The balloon burst pressure test and the comparison with the common balloon burst pressure shown in table 4 show that the balloon burst pressure test and the comparison with the common balloon burst pressure test have higher burst pressure and better capability of dilating the stenosed blood vessel compared with the common balloons in the market. The balloon 2 has a contracted state and an expanded state, when the inside of the balloon 2 is subjected to the pressure of a liquid medium or a gas medium, the expandable balloon 2 is gradually changed from the contracted state to the expanded state, and the diameter of the balloon 2 is increased to reach the nominal diameter along with the increase of the internal pressure.

Specifically, as shown in fig. 3 and 4, the balloon 2 is formed by blow molding a balloon tube made of 35% inner-layer pebax7233 and 65% outer-layer nylon 12L 25; the diameter of the sacculus 2 can be 1-15 mm, the effective length of the sacculus 2 can be 5-200 mm, the diameter of the sacculus 2 is 7mm, the effective length is 60mm, and the thickness of the sacculus wall is 0.003 inch. The effective length of the saccule 2 is the length of the middle cylindrical part of the saccule 2, two ends of the saccule are respectively provided with a conical surface and a saccule tube leg, and the inner diameters of the saccule tube legs at the two ends are respectively 0.074 inch (near end) and 0.053 inch (far end). The proximal leg of the balloon is cut into 6mm and the distal leg is cut into 6mm for later use. The double-cavity tube 5 is made of 60% pebax, 30% nylon and 10% carbon fiber, the length can be 500 mm-1600 mm, the diameter of the internal guide wire cavity can be 0.038 inch or other suitable sizes, in the embodiment, the inner diameter of the double-cavity tube guide wire cavity is 0.036 inch, the air cavity is crescent-shaped, the length is 0.04 inch, the width is 0.02 inch, the shortest distance between the wall of the guide wire cavity and the wall of the double-cavity tube is 0.003 inch, the shortest distance between the wall of the air cavity and the wall of the double-cavity tube is 0.003 inch, the shortest distance between the guide wire cavity and the air cavity is 0.003 inch, and the outer diameter of the double-cavity tube is 0.071. The lumen tubing 4 is made of nylon 12 with an inner diameter of 0.036 inches and an outer diameter of 0.045 inches. The inner lumen tube 4 is cut into 30-200 mm (the length of the inner lumen tube is slightly longer than the total length of the balloon), the inner lumen tube 4 is inserted into the distal guide wire lumen of the double lumen tube 5, the length of the overlapped part can be 1-10 mm, in this embodiment, 6 mm. And then the near-end tube leg of the saccule is sleeved on the far-end outer wall of the double-cavity tube 5, the length of the overlapping part of the near-end tube leg of the saccule and the double-cavity tube 5 can be 1-10 mm, in this embodiment, 6mm, and then the overlapping part of the near-end tube leg of the saccule, the inner cavity tube 4 and the double-cavity tube 5 is welded together by heat welding. The distal end of the inner lumen 4 may be flush with the balloon distal leg. Two developing rings 3 are installed in the inner cavity tube 4 in a front lifting mode, the developing rings 3 are made of platinum-iridium alloy, the inner diameter of the developing rings is 0.046 inch, the outer diameter of the developing rings is 0.05 inch, 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 balloon 2. The material of the tail end pipe 1 is pebax, the tail end pipe 1 is cut into 1-10 mm, the length of the tail end pipe is 3mm, the tail end pipe is sleeved on the far end pipe leg of the sacculus or the inner cavity pipe 4 outside the pipe leg, and the far end pipe leg of the sacculus, the inner cavity pipe 4 and the tail end pipe 1 are welded together through hot welding to form the far end of the sacculus dilating catheter. And then molding the tail end by using a tip molding device. The inner cavity tube 4 and the double-cavity tube 5 are used for advancing and guiding the guide wire, and a channel formed by the air cavity of the double-cavity tube 5 is connected to the inside of the balloon 2 and used for filling the balloon 2. And a hydrophilic coating with the length of 10-40 mm is coated from the position of the near-end tube leg of the balloon to the surface of the double-cavity tube 5. The catheter reinforcing part 6 is made of pebax, can be 2-10 mm in length, has an inner diameter slightly larger than the outer diameter of the double-cavity tube 5 and an outer diameter of 0.09 inch, and is mainly used for expelling stress generated by the balloon catheter in use. The catheter reinforcement member 6 is sleeved at the proximal end of the double-cavity tube, so that the length of the part, exposed out of the catheter reinforcement member, of the double-cavity tube 5 is 5-100 mm, the catheter reinforcement member and the double-cavity tube are welded together in a proper mode, and the embodiment adopts a glue bonding mode. The seat 7 material can be nylon or the Y type structure of polycarbonate or other suitable materials, and the material is nylon in this embodiment, bonds seat 7 and double lumen pipe 5 and pipe reinforcement 6 together through glue, and the guide wire chamber 8 of seat 7 is used for advancing the guide wire, and the air cavity 9 of seat 7 is used for filling sacculus 2.

The embodiment of the using method of the utility model is as follows:

s1) carrying out preoperative radiography to evaluate the condition of the lesion blood vessel, and selecting a balloon catheter and a catheter sheath with proper sizes.

S2) selecting a proper position to puncture the blood vessel, and placing the first guide wire into the blood vessel pathological change position through the catheter sheath.

S3) passing the free end of the first guide wire through the tip tube 1, the inner lumen tube 4, the guide wire lumen 8 in sequence.

S4) inserting the protective sleeve into the silicone pad at the opening of the catheter sheath, and then pushing the balloon forward along the first guide wire to the vascular lesion (after the balloon portion passes through the opening of the vascular sheath, the protective sleeve is torn from the tearable opening and removed from the balloon catheter).

S5) the pump is started to inflate the balloon to the nominal pressure.

S6), after reaching the expansion time, starting a pump to vacuumize the balloon to enable the balloon to be completely contracted, and then withdrawing the balloon catheter and the first guide wire.

In practical applications, if necessary, the method further includes withdrawing the first guide wire from the balloon dilatation catheter and injecting a contrast medium to the lesion site through a conduit through which the first guide wire passes so as to observe the lesion site between the steps S3 and S4 (whole-body exchange type).

TABLE 1 composition and content of the material of the wall of the double-chamber tube

TABLE 2 pressurization time comparison table

The control group in table 2 is cuker and medton force. As can be seen from table 2, the balloon catheter provided in example 1 has a standard inflation time, and meets the use requirements.

TABLE 3 decompression time comparison table

The control group in table 3 is cuker and medton force. As can be seen from table 3, the pressure relief time of the balloon catheter provided in example 1 is within the standard range, and meets the use requirements.

TABLE 4 burst pressure comparison table

The control group in table 4 is cuker and medton force.

In tables 2 to 4, the representatives of the respective numbers are: PTA in PTA XX-XXX XXX is serial number, the first two XX represent the last two compatible guide wire diameter, the last three XXX represents the first two or three balloon diameter, the middle XXX represents the first two or three balloon length, and the last X represents the effective catheter length; wherein, take PAT35-12080C as an example, wherein PAT represents serial number; 35 represents the last two compatible guide wire diameters; 120 represents the first two or three digits of the balloon diameter; 80 represents the first two or three data of the balloon length; c represents the effective length of the catheter.

Effective length of balloon catheter: the effective length of the PTAXX-XXXXXA balloon catheter is (50 +/-10) cm; the effective length of the PTAXX-XXXXXB balloon catheter is (90 +/-10) cm; the effective length of the PTAXX-XXXXXC balloon catheter is (130 +/-10) cm.

Claims

1. A fold-resistant vasodilating balloon catheter, comprising:

a balloon; the balloon wall of the balloon is of a multilayer structure;

2. The fold-resistant vasodilation balloon catheter of claim 1, wherein the guidewire lumen is a circular lumen; the cross section of the air cavity is crescent or D-shaped.

3. The flex-resistant vasodilation balloon catheter of claim 1, wherein the balloon is a non-compliant high pressure balloon.

4. The folding-resistant vasodilation balloon catheter according to claim 3, wherein the balloon wall of the balloon is a multi-layer structure of polyether block polyamide layers and nylon layers which are alternately arranged.

5. The folding-resistant vasodilation balloon catheter according to claim 4, wherein when the balloon wall of the balloon is of a double-layer structure, the thickness of the inner layer is 10% -50% of the thickness of the balloon wall, and the thickness of the outer layer is 50% -90% of the thickness of the balloon; when the wall of the balloon is a structure with more than 2 layers, the thickness of each layer is 10-30% of the thickness of the wall.

6. The collapsible vasodilation balloon catheter of claim 1, further comprising a tear-off protective sleeve; the tearable protection sleeve is arranged outside the balloon; the tearable protective sleeve is a hollow polytetrafluoroethylene tube.

7. The folding-resistant vasodilation balloon catheter according to claim 6, wherein one end wall of the tearable protective sleeve is provided with a tear opening area; the other end is a conical structure.