CN118383834A

CN118383834A - Balloon thrombolysis catheter and method for manufacturing balloon thrombolysis catheter

Info

Publication number: CN118383834A
Application number: CN202410631205.3A
Authority: CN
Inventors: 施雯雯; 牛冬子; 翁玉麟
Original assignee: Dk Medical Technology Co ltd
Current assignee: Dk Medical Technology Co ltd
Priority date: 2024-05-21
Filing date: 2024-05-21
Publication date: 2024-07-26

Abstract

The invention discloses a balloon thrombolysis catheter and a manufacturing method thereof, wherein the balloon thrombolysis catheter comprises: the double-cavity tube comprises a first cavity and a second cavity, wherein the first cavity is a guide wire cavity and is used for penetrating a guide wire, and the second cavity is a filling cavity; the two ends of the balloon are respectively fixed on the outer side of the preset position of the double-cavity tube through binding wires in a sealing mode, the balloon is communicated with the second cavity, the second cavity can charge and release pressure of the balloon, and the balloon is an inflatable elastic balloon; the binding wire is made of developable materials. The two ends of the balloon are fixed at the preset positions of the double-cavity tube by the binding wires made of developing materials, and the positions of the binding wires can be displayed and then the positions of the balloon are determined by utilizing the developing function of the binding wires under the irradiation of X rays, so that an operator can conveniently and smoothly pull and take out thrombus.

Description

Balloon thrombolysis catheter and method for manufacturing balloon thrombolysis catheter

Technical Field

The invention relates to the technical field of medical instruments, in particular to a balloon thrombolysis catheter and a manufacturing method of the balloon thrombolysis catheter.

Background

The balloon thrombus taking catheter is one kind of interventional catheter for treating thrombus inside blood vessel. During operation, the latex balloon at the front end is pushed and passes over the part with thrombus or embolism by using the corresponding interventional instrument, the latex balloon is filled until the balloon contacts the vessel wall, and the catheter is gently withdrawn to remove the thrombus. Specifically, the balloon thrombus taking catheter positions the balloon position through an imaging technology until the balloon position is accurately inserted into a thrombus position, then the balloon is expanded through injecting liquid, and the thrombus is pulled out of a blood vessel by using the expansion force of the balloon.

In the process of removing the thrombus by adopting the balloon thrombus taking catheter, the position of the balloon needs to be accurately positioned so as to ensure that the balloon is conveyed to the accurate position and improve the thrombus removing effect.

Therefore, how to provide a balloon thrombus taking catheter with a balloon positioning function is a technical problem to be solved urgently by the skilled person.

Disclosure of Invention

In view of the above, the invention provides a balloon thrombus taking catheter with a balloon positioning function. In addition, the invention also provides a manufacturing method of the balloon thrombus taking catheter.

In order to achieve the above purpose, the present invention provides the following technical solutions:

a balloon thrombolysis catheter, comprising:

the double-cavity tube comprises a first cavity and a second cavity, wherein the first cavity is a guide wire cavity and is used for penetrating a guide wire, and the second cavity is a filling cavity;

The two ends of the balloon are respectively fixed on the outer side of the preset position of the double-cavity tube through binding wires in a sealing mode, the balloon is communicated with the second cavity, the second cavity can charge and release pressure of the balloon, and the balloon is an inflatable elastic balloon;

The binding wire is made of developable materials.

Preferably, in the balloon thrombolysis catheter, the width of the binding wire at the proximal end of the balloon is larger than the width of the binding wire at the distal end of the balloon.

Preferably, in the balloon thrombolysis catheter, the method further comprises:

the developing ring is arranged between the balloon and the joint of the double-cavity tube, and is a lantern ring capable of developing under X-rays.

Preferably, in the balloon thrombus removing catheter, the double-lumen tube is a tube capable of being developed under X-rays;

And/or the number of the groups of groups,

The double-cavity tube comprises the following component materials: polyether block amide, nylon and an auxiliary agent, wherein the auxiliary agent is barium sulfate.

Preferably, in the balloon thrombolysis catheter, the binding wire comprises the following component materials: nylon, 10% -50% barium sulfate, bismuth chloride, gold wire or platinum iridium alloy.

Preferably, in the balloon thrombolysis catheter, the method further comprises: the operation handle is connected with the proximal end of the double-cavity tube;

the operating handle includes:

The balloon inflation and decompression interface is communicated with the second cavity and is used for inflating or sucking gas into the second cavity;

a guidewire port through which the guidewire passes from the distal end of the first lumen into the first lumen and out of the proximal end of the first lumen.

Preferably, in the balloon thrombolysis catheter, the method further comprises:

The adhesive, one end of the binding wire is fixed on the edge of the saccule through the adhesive, the other end of the binding wire is fixed on the outer side of the double-cavity tube through the adhesive, and the adhesive is waterproof adhesive.

Preferably, in the balloon thrombolysis catheter, the balloon is fixed on the outer side of the dual-lumen tube after being stretched.

Preferably, in the balloon thrombolysis catheter, the balloon is a balloon whose surface is treated by plasma technology.

A method for manufacturing a balloon thrombolysis catheter, which is applied to any one of the balloon thrombolysis catheters and comprises the following steps:

One end of the first binding wire is fixed at the far end of the double-cavity tube, the other end of the first binding wire is pulled to be wound to the edge of the far end of the balloon by the double-cavity tube, and the first binding wires are not overlapped;

coating an adhesive on the first binding wire to fix the first binding wire;

Fixing one end of the second binding wire on a double-cavity tube at the proximal end of the balloon, adding a lubricant between the balloon and the double-cavity tube, stretching the length of the balloon, and pulling the other end of the second binding wire to be wound to the edge of the proximal end of the balloon by the double-cavity tube, wherein the second binding wires are not overlapped;

and coating an adhesive on the second binding wire to fix the second binding wire.

The embodiment of the invention discloses a balloon thrombus taking catheter, wherein two ends of a balloon are fixed at preset positions of a double-cavity tube by adopting binding wires made of developing materials, and the positions of the binding wires can be displayed and further the positions of the balloon are determined by utilizing the developing function of the binding wires under X-ray irradiation, so that an operator can conveniently and smoothly pull and take out thrombus.

Drawings

In order to more clearly illustrate the embodiments of the invention or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described, it being obvious that the drawings in the following description are only some embodiments of the invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a front view of a balloon thrombolysis catheter as disclosed in an embodiment of the present invention;

FIG. 2 is a cross-sectional view taken along the direction A-A in FIG. 1;

FIG. 3 is an enlarged view of a portion of B in FIG. 1;

FIG. 4 is a cross-sectional view in the direction D-D of the balloon catheter of FIG. 3 in a first configuration;

FIG. 5 is a cross-sectional view in the direction C-C of the balloon catheter of FIG. 1 in a first configuration;

FIG. 6 is a cross-sectional view in the direction D-D of the balloon catheter of FIG. 3 in a second configuration;

FIG. 7 is a cross-sectional view in the direction C-C of the balloon catheter of FIG. 1 in a second configuration;

FIG. 8 is a front view of a balloon of the balloon catheter disclosed in an embodiment of the present invention when inflated;

FIG. 9 is a graph comparing the development effect of different balloon thrombolytic catheters disclosed in the examples of the present invention;

fig. 10 is a flowchart of a method of manufacturing a balloon catheter according to an embodiment of the present invention.

Detailed Description

The invention discloses a balloon thrombus taking catheter which has a balloon positioning function. In addition, the invention also discloses a manufacturing method of the balloon thrombus taking catheter.

The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

The terms "first" and "second" are used below for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature.

Thrombosis refers to a solid substance formed in blood vessels, which can cause various diseases such as myocardial infarction, arterial and venous embolism, apoplexy, acute ischemia of limb arteries and the like.

At present, there are two main clinical methods for treating thrombus: thrombolysis and surgical thrombolysis. Among these, the limitations of drug therapy are that most thromboemboli are non-thrombotic components or have been severely organized, thrombolysis using drugs does not dissolve these emboli, and furthermore, the use of thrombolytic drugs in large amounts increases the risk of complications such as cerebral hemorrhage. For clinic, the operation of taking the thrombus is simpler, but the operation of taking the thrombus inevitably has the defects of larger wound, increased complication risk, longer recovery period and the like. In addition, the tight adhesion of thrombus and vessel wall and the secondary thrombus in the tiny branches of the vessel bring great operation difficulty to the operation of thrombus removal.

Based on the above problems, the current interventional therapy method can better complete the thrombus taking. For example: catheter thrombolysis is a simple and effective treatment method for acute limb artery and acute thrombus. Catheters for treating thrombosis include aspiration catheters and balloon thrombolysis catheters. Where the aspiration catheter uses negative pressure from the aspirator to remove the thrombus from the vessel, the aspiration difficulty will increase for some complex vessels or sites where thrombus formation is deep, and for vulnerable vessel sites, the negative pressure may cause instantaneous rupture of the vessel.

Based on this, as shown in connection with fig. 1 to 8, a balloon thrombus taking catheter is disclosed in the present application, and the position of the balloon is positioned by using a developing mode.

The balloon thrombolysis catheter as shown in fig. 1 includes: a double-cavity tube 2, a balloon 3, a binding wire assembly 4 and an operating handle 1.

The balloon 3 is sleeved at the position of the double-cavity tube 2 close to the far end through the wire binding assembly 4, and the installation position of the balloon 3 can be set according to different requirements and is within a protection range.

The balloon 3 is close to the distal end of the double-cavity tube 2, so that the double-cavity tube 2 is prevented from extending into the patient body too long when the balloon 3 extends into a thrombus position, and the length of the balloon thrombus taking catheter is prevented from being too large.

In addition, the balloon 3 is close to the distal end of the double-cavity tube 2, and an operator can control the position of the balloon 3 while controlling the distal end of the double-cavity tube 2, so that the operability of the balloon thrombus taking catheter is improved, and the position accuracy of the balloon 3 is improved.

The operation handle 1 is located at the proximal end of the dual-lumen tube 2, and it should be noted that, based on the relative position of the operator when operating the dual-lumen tube 2, the proximal end of the dual-lumen tube 2 is the end that the operator holds the dual-lumen tube 2, and the distal end of the dual-lumen tube 2 is the end far from the proximal end. The distal and proximal ends herein are distinguished by being close to the operator and far from the operator.

As shown in fig. 2, the dual lumen tube 2 includes: a catheter body 21 and a first lumen 22 and a second lumen 23 inside the catheter body, wherein the first lumen 22 is used for passing a guide wire, and the guide effect of the guide wire is used for accurately aligning the balloon 3 with thrombus. The second cavity 23 is provided with a communication hole at a preset position, and the second cavity 23 is communicated with the balloon 3 sleeved on the double-cavity tube 2 through the communication hole.

The position and shape of the communication hole of the second cavity 23 can be set according to different needs, and the communication hole is formed at a preset position of the side wall of the catheter body 21 and is a through hole communicated with the second cavity 23.

The balloon thrombus taking catheter adopts the double-cavity tube 2 to respectively form the guide wire and the gas channel, so that the structure is integrated, the volume of the balloon thrombus taking catheter is reduced, and the miniaturization development of the balloon thrombus taking catheter is realized.

In some embodiments, the first lumen 22 includes, but is not limited to, a channel having a circular longitudinal cross-section, which may facilitate guiding the threading of the guidewire and reduce friction between the guidewire and the lumen wall of the first lumen 22.

The second cavity 23 includes, but is not limited to, a channel having a semicircular longitudinal section, and the second cavity 23 employs a semicircular channel, so that the longitudinal dimension of the second cavity 23 can be increased as much as possible. In some embodiments, straight sidewalls of the semicircular channels of the second chamber 23 are adjacent to the first chamber 22 to avoid over-thinning of the walls between the first chamber 22 and the second chamber 23.

Catheter body 21 includes, but is not limited to, a circular catheter. The longitudinal direction of the first lumen 22 and the second lumen 23 is a cross section along the radial direction of the double lumen tube 2.

As shown in fig. 3, the binding-wire assembly 4 in the present application includes a binding-wire 41 and an adhesive 42.

The binding wire 41 is made of a developable material, so that the binding wire 41 has a developing function, the material of the binding wire is nylon, 10% -50% of barium sulfate (BaSO ₄), bismuth chloride (BiCl ₃), gold wire or platinum iridium alloy is doped, and two ends of the balloon 3 are fixed on the outer side of the double-lumen tube 2 in a winding manner.

The developing material is visible under the X-ray equipment, so that the position of the balloon 3 can be positioned in real time in the thrombus taking operation process, the accuracy of the thrombus taking position is ensured, and an operator can conveniently and smoothly pull and take out thrombus according to the position of the balloon 3.

Both ends of the balloon 3 are fixed through the wire binding assemblies 4, so that both end positions of the balloon 3 can be displayed, an operator can accurately determine the position of the balloon 3, the problem that thrombus does not pass through is prevented, and accuracy of thrombus taking operation is improved.

The two ends of the balloon 3 are wrapped by the binding wires 41 to squeeze the balloon wall, so that the balloon wall at the two ends of the balloon 3 is thinner than the main body of the balloon 3, the diameters of the two ends of the balloon 3 are smaller, the miniaturization of the balloon thrombus taking catheter is facilitated, and the application range of the balloon thrombus taking catheter is improved.

The adhesive 42 includes, but is not limited to, glue, which is applied to the binding wire 41 by spot coating, and cured to a glue dry so that the binding wire 41 is fixed to the binding place.

Since the binding wires 41 are wound and arranged, adjacent binding wire sections are fixed through the adhesive 42, one end of the binding wire 41 is fixed on the edge of the balloon 3 through the adhesive 42, and the other end of the binding wire 41 is fixed on the outer side of the double-cavity tube 2 through the adhesive 42, so that the binding function of the binding wire 41 is realized.

In some embodiments, the adhesive is a waterproof adhesive.

According to the application, the two ends of the balloon 3 are fixed at the preset positions of the double-cavity tube 2 by adopting the binding wires 41 made of the developing material, and the positions of the binding wires 41 can be displayed and then the positions of the balloon 3 can be determined by utilizing the developing function of the binding wires 41 under the irradiation of X rays, so that an operator can conveniently pull and take out thrombus smoothly.

In some embodiments, the surface of balloon 3 is plasma treated. The surface roughness of the balloon 3 can be increased through plasma treatment, the surface roughness of the balloon 3 is larger in the process of thrombus taking in the blood vessel, the friction force of the contact between the surface of the balloon 3 and thrombus can be increased, the thrombus can be prevented from falling off, and the thrombus can be ensured to be taken out smoothly.

As shown in fig. 4 and 5, the balloon 3 of the balloon thrombus-taking catheter is sleeved outside the double-lumen tube 2, and is wound outside the balloon 3 by the binding wire 41, so that the balloon 3 is bound outside the double-lumen tube 2, and the binding wire 41 is fixed at the binding position by the adhesive 42, so that the connection stability of the binding wire 41 and the double-lumen tube 2 is enhanced.

The fixation process of the binding-wire 41 is as follows:

Wire binding process of the balloon distal end: one end of the binding wire 41 is fixed at the far end position of the double-cavity tube 2 by a silicone tube, the chuck clamps the silicone tube, the other end of the binding wire 41 is pulled to wind towards the far end edge of the balloon 3, and the chuck is slowly rotated, so that the other end of the binding wire 41 winds towards the far end of the double-cavity tube 2 from the edge of the balloon 3, and the binding wires 41 cannot be overlapped. The binding wire 41 is applied with a pointed plastic rod dipped with an adhesive 42 to be cured to a dry state, and then the excess wire ends are cut off by a blade, and the wire ends are fixed and cured again by dipping with the adhesive 42.

Wire binding process of the balloon proximal end: one end of the binding wire 41 is fixed on the double-lumen tube 2 at the proximal end of the balloon 3, the balloon is stretched to 1.5 times of the original length along the axial direction, the wire binding process at the distal end of the balloon is repeated, so that the other end of the binding wire 41 is wound from the edge of the proximal end of the balloon 3 to the proximal end of the double-lumen tube 2, the binding wires 41 cannot be overlapped, and the steps are repeated to fix the binding wire 41.

It should be noted that, when the balloon 3 is fixed to the outer side of the double lumen tube 2, the ratio of the distance between the two end binding wires 41 to the initial length of the balloon 3 is about 1.5:1, a step of; the length ratio of the balloon 3 before and after the binding wire is 1:1.5, i.e. balloon 3 is fixed on double lumen tube 2, it needs to be stretched to 1.5 times the original length.

The length of the balloon 3 when secured to the dual lumen tube 2 includes, but is not limited to, 1.5 times the initial length, but may be any length between 1.3-2 times the initial length.

The balloon 3 is fixed on the outer side of the double-cavity tube 2 after being stretched, so that the thickness of the balloon 3 can be reduced, and the balloon 3 is convenient to elastically deform, namely is easier to expand.

In some embodiments, during the process of taking out the thrombus by the balloon thrombus taking catheter, the balloon 3 is sent to the front end of the thrombus, after the balloon 3 is filled, the operator pulls the double-cavity tube 2 proximally and drives the balloon 3 to move proximally, so that the balloon 3 brings the thrombus out of the blood vessel. In this process, the proximal end of the balloon 3 is in contact with thrombus, the applied force is larger, and the problem that the dual-lumen tube 2 falls off easily occurs.

In some embodiments, the dual-lumen tube 2 is near one end of the operating handle 1, and a catheter reinforcement member 5 is further disposed on the outer side of the dual-lumen tube 2 for enhancing pushing force of the proximal end of the dual-lumen tube 2 of the balloon thrombus-taking catheter.

The material of the balloon 3 comprises, but is not limited to, natural latex, and the natural latex is soft, can be well attached to the wall of a blood vessel, and has the advantages of good sealing performance, high ductility, tearing resistance and the like.

The catheter body 21 of the dual lumen tube 2 comprises a material including, but not limited to, a combination of polyether block amide (PEBAX), nylon, and an auxiliary agent, wherein the auxiliary agent is barium sulfate and the guidewire lumen is passable through a 0.018 inch or 0.035 inch gauge guidewire. The addition of barium sulfate to the material of the dual lumen tube 2 allows the dual lumen tube 2 to be a tube that can be developed under X-rays. In the process of thrombus extraction, the development range can be enlarged, and the accuracy of positioning the balloon thrombus extraction catheter is improved.

Referring to fig. 1, the operation handle 1 in some embodiments includes: a balloon inflation and decompression interface 11 and a guidewire guide port 12.

The balloon inflation and decompression interface 11 is communicated with the second cavity 23, and is used for inflating gas into the second cavity 23 or exhausting gas in the second cavity 23 through the balloon inflation and decompression interface 11.

Since the second chamber 23 is communicated with the balloon 3 through the communication hole, an operator can charge gas into the balloon thrombus taking catheter through the balloon inflation and decompression interface 11, the gas enters the balloon 3 through the second chamber 23, and the balloon 3 is inflated with the gas, as shown in fig. 8. When the pressure of the balloon 3 is required to be released, the operator discharges the gas in the balloon 3 through the balloon inflation and pressure release interface 11 through the second cavity 23 by pumping until the balloon 3 is retracted.

During use of the balloon catheter, the guide wire passes through the first lumen 22 of the dual lumen tube 2, specifically, the guide wire passes through the first lumen 22 from the distal end of the first lumen 22 and out from the proximal end of the first lumen 22 through the guide wire guiding port 12, it is understood that the guide wire passes through the distal end of the first lumen 22 and out from the proximal end of the first lumen 22, and the balloon catheter is advanced to the thrombus site under the guiding action of the guide wire in the blood vessel. For the material and the size of the guide wire, the guide wire in the existing medical equipment can be seen, and the guide wire is used as a guide structure, so that the balloon 3 can be conveyed to a required position.

The working process of the balloon thrombus removing catheter comprises the following steps: the double-lumen tube 2 containing the balloon 3 in a shrunken state is gently inserted into a blood vessel through a guide wire, after the balloon 3 passes through a narrow or thrombus position, an operator fills gas into the balloon 3 through a balloon inflation and decompression interface 11, and the balloon 3 is tightly attached to the wall of the blood vessel after being filled with gas; the double lumen tube 2 is then slowly withdrawn, and the thrombus is removed by the traction of the inflated balloon 3 on the thrombus.

After the balloon 3 is filled with gas, thrombus can be taken out of the blood vessel by dragging, and the balloon can also temporarily occlude the blood vessel.

As shown in connection with fig. 1, 3, 6 and 7, in another embodiment the binding-wire assembly 4 comprises a binding-wire 41 and an adhesive 42, and further comprises a developing ring 43.

The material, connection relationship and connection manner of the binding wire 41 and the adhesive 42 can be referred to as the material, connection relationship and connection manner of the binding wire 41 and the adhesive 42 in the embodiment of fig. 4 and 5, and are not described herein.

The developing ring 43 in the embodiment of the application is fixed on the outer side of the catheter body 21 of the double-lumen tube 2 by means of ring forging and the like, and the binding wire 41 fixes the balloon 3 on the outer side of the developing ring 43, namely, at the joint of the balloon 3 and the double-lumen tube 2, the developing ring 43 is positioned between the edge of the balloon 3 and the outer wall of the double-lumen tube 2. The binding wire 41 is bonded by an adhesive 42 to form a balloon cavity sealing point.

Developing ring 43 includes, but is not limited to, a 302 stainless steel developing ring.

By adding the developing ring 43, the developing effect at the position of the binding wire assembly 4 is better, the position of the balloon 3 is more accurate, and the reliability of removing the thrombus is improved.

The balloon 3 is wound and bound by the binding wires 41 made of developing materials, so that the positioning accuracy of the balloon 3 can be improved; the double-cavity tube adopted by the invention is formed by polyether block amide (PEBAX), nylon and an auxiliary agent, the auxiliary agent is carbon fiber or barium sulfate, and compared with the polyvinyl chloride (PVC) adopted by the existing double-cavity tube, the PEBAX has better flexibility and elasticity, can better adapt to the shape and movement of a blood vessel, and can reduce the friction and the risk of thrombosis when the catheter is contacted with the blood vessel due to the smooth surface of the PEBAX and lower friction coefficient; 3. the yield is high: fixing the balloon 3 by winding the binding wire 41 is less likely to scratch the balloon 3.

In combination with the above description, the balloon catheter of the present application also has the following features compared to the existing balloon catheter:

Glue is added on the binding wire 41, so that the binding wire is fixed more firmly, the balloon 3 is not easy to fall off, and the operation is more stable.

The surface of the balloon 3 is subjected to plasma treatment, so that the roughness of the surface of the balloon 3 is increased, and the process of taking out the thrombus from the balloon 3 in the blood vessel is realized, so that the friction force of the contact between the surface of the balloon 3 and the thrombus is increased, the thrombus is prevented from falling off, and the thrombus can be taken out smoothly.

The width of the binding wire 41 at the proximal end of the balloon 3 is larger than that of the binding wire 41 at the distal end of the balloon 3, so that the stability of connection between the proximal end of the balloon 3 and the double-cavity tube can be improved, and the balloon 3 is not easy to fall off.

The balloon 3 is stretched until the length of the balloon 3 is 1.5 times of the initial length, and then is fixed by the binding wire, so that the wall of the balloon 3 is thinner, the outer diameter of the whole product is smaller, and the balloon 3 can be better centered on the double-cavity tube 2.

The double-cavity tube is arranged as a tube fitting capable of being developed under X rays, so that the accuracy of positioning the balloon thrombus taking catheter can be improved.

FIG. 9 is a graph comparing the development of different balloon thrombolytic catheters under X-rays, wherein the structure marked 100 in FIG. 9 is a balloon thrombolytic catheter with developing rings and without developing material and with prior art binding wires, and FIG. 9A is a developing ring; the structure marked 200 is a balloon thrombus-taking catheter disclosed in the embodiment of the application, specifically, the binding wire has a developing function but no developing ring, and B in FIG. 9 is the binding wire; as can be seen from fig. 9, the balloon catheter disclosed in the present application has better visualization effect under X-rays than the balloon catheter of the prior art.

In addition, the application also discloses a thrombus taking device, which comprises a balloon thrombus taking catheter, wherein the balloon thrombus taking catheter is disclosed in the embodiment, so that the thrombus taking device with the balloon thrombus taking catheter has all the technical effects and is not repeated herein.

As shown in fig. 10, the application also discloses a method for manufacturing the balloon thrombus removing catheter, which is applied to the balloon thrombus removing catheter disclosed in the embodiment, and comprises the following steps:

s1: one end of the first binding wire is fixed at the distal end position of the double-cavity tube, the other end of the first binding wire is pulled to be wound to the edge of the distal end of the balloon by the double-cavity tube, and the first binding wires are not overlapped.

Specifically, but not limited to, bonding the first binding wire to the distal end of the dual-lumen tube by using a silicone tube, clamping the silicone tube by a clamping head, pulling the other end of the first binding wire to wind towards the distal edge of the balloon, and slowly rotating the clamping head to wind the other end of the first binding wire from the edge of the balloon towards the distal end of the dual-lumen tube.

S2: and coating an adhesive on the first binding wire to fix the first binding wire.

And dipping the adhesive by using a pointed plastic rod, dispensing the adhesive on the outer side of the first binding wire, curing until the adhesive is dry, cutting off the redundant wire ends by using a blade, and dipping the adhesive again to fix the wire ends and curing.

The adhesive includes, but is not limited to, glue.

S3: one end of the second binding wire is fixed on the double-cavity tube at the proximal end of the balloon, a lubricant is added between the balloon and the double-cavity tube, the length of the balloon is stretched, the other end of the second binding wire is pulled to be wound to the edge of the proximal end of the balloon by the double-cavity tube, and the second binding wires are not overlapped.

Specifically, one end of the second binding wire is secured to the double lumen tube at the proximal end of the balloon, including but not limited to bonding the second binding wire to the distal end of the double lumen tube using a silicone tube.

A lubricant is added between the balloon and the double lumen tube, including but not limited to water, petrolatum or silicone oil, etc.

The balloon is stretched such that the length of the balloon is 1.3-2.0 times the initial length, preferably 1.5 times the initial length.

The first wire binding process of the distal end of the balloon is repeated, so that the other end of the second wire binding is wound from the edge of the proximal end of the balloon to the proximal end of the dual-lumen tube, and the wire binding cannot be overlapped.

S4: and coating an adhesive on the second binding wire to fix the second binding wire.

And dipping the adhesive by using a pointed plastic rod, dispensing the adhesive on the outer side of the second binding wire, curing until the adhesive is dry, cutting off the redundant wire ends by using a blade, and dipping the adhesive again to fix the wire ends and curing.

According to the application, the friction force between the balloon and the double-cavity tube in the stretching process of the balloon relative to the double-cavity tube can be reduced by adding the lubricant between the balloon and the double-cavity tube.

In the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different point from other embodiments, and identical and similar parts between the embodiments are all enough to refer to each other.

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A balloon thrombectomy catheter, comprising:

A double-lumen tube, the double-lumen tube comprising a first lumen and a second lumen, the first lumen being a guidewire lumen for passing a guidewire, and the second lumen being a filling lumen;

A balloon, wherein both ends of the balloon are respectively sealed and fixed to the outside of the preset position of the double-lumen tube by binding wires, and the balloon is connected to the second cavity, and the second cavity can inflate and release the pressure of the balloon, and the balloon is an elastic balloon that can be expanded by filling with gas;

The binding wire is made of a developable material.

2 . The balloon thrombectomy catheter according to claim 1 , wherein the width of the binding wire at the proximal end of the balloon is greater than the width of the binding wire at the distal end of the balloon.

3. The balloon thrombectomy catheter according to claim 1, further comprising:

A developing ring is provided between the connection between the balloon and the double-lumen tube, and the developing ring is a sleeve ring that can be developed under X-rays.

4. The balloon thrombectomy catheter according to any one of claims 1 to 3, characterized in that the double-lumen tube is a tube that can be developed under X-rays;

and / or,

The double-lumen tube is made of materials including polyether block amide, nylon and an auxiliary agent, wherein the auxiliary agent is barium sulfate.

5. The balloon thrombectomy catheter according to any one of claims 1 to 3, characterized in that the binding wire is made of materials comprising: nylon, 10%-50% barium sulfate, bismuth chloride, gold wire or platinum-iridium alloy.

6. The balloon thrombectomy catheter according to any one of claims 1 to 3, further comprising: an operating handle connected to the proximal end of the double-lumen tube;

The operating handle comprises:

A balloon inflation and relief interface, the balloon inflation and relief interface is in communication with the second cavity and is used to inflate or extract gas into the second cavity;

A guidewire introduction port, wherein the guidewire passes into the first cavity from the distal end of the first cavity and passes out from the proximal end of the first cavity through the guidewire introduction port.

7. The balloon thrombectomy catheter according to any one of claims 1 to 3, further comprising:

Adhesive, one end of the binding wire is fixed to the edge of the balloon through the adhesive, and the other end of the binding wire is fixed to the outside of the double-lumen tube through the adhesive, and the adhesive is a waterproof adhesive.

8. The balloon thrombectomy catheter according to any one of claims 1 to 3, characterized in that the balloon is fixed to the outside of the double-lumen tube after being stretched.

9. The balloon thrombectomy catheter according to any one of claims 1 to 3, characterized in that the balloon is a balloon whose surface is treated by plasma technology.

10. A method for manufacturing a balloon thrombectomy catheter, applied to the balloon thrombectomy catheter according to any one of claims 1 to 9, characterized in that it comprises:

Fix one end of the first binding line to the distal end of the double-lumen tube, and pull the other end of the first binding line from the double-lumen tube to the edge of the distal end of the balloon, and the first binding line does not overlap;

Applying adhesive to the first binding wire to fix the first binding wire;

Fix one end of the second binding line on the double-lumen tube at the proximal end of the balloon, add lubricant between the balloon and the double-lumen tube, stretch the length of the balloon, and pull the other end of the second binding line from the double-lumen tube to the edge of the proximal end of the balloon, and the second binding line does not overlap;

Adhesive is applied to the second binding wire to fix the second binding wire.