CN112914677B - Double-balloon injection catheter instrument for thrombolysis of blood vessel - Google Patents

Abstract

Translated fromChinese

本发明公开了一种用于血管溶栓的双球囊注射导管器械，包括注射导管、穿套在注射导管外侧的球囊以及设置在注射导管内部的腔道，注射导管包括第一导管段、第二导管段以及连接在第一导管段和第二导管段之间的注药导管段，注药导管段上设有能够通断电进行膨胀收缩的通电形变膜，还设有用于刺入栓子的注射头。本发明利用第一球囊和第二球囊将栓子所在的区域封堵成为一个封闭治疗空间，注药导管段上的注射头可以斜向角度刺入栓子中并将药物直接注射入栓子内部，同时利用注药导管段上通电形变膜能够通电膨胀断电恢复从而产生收缩的特性，在该封闭治疗空间进行扰动，从而增大栓子与溶栓药物的接触率，快速瓦解栓子。

The invention discloses a double-balloon injection catheter device for vascular thrombolysis, comprising an injection catheter, a balloon sheathed on the outside of the injection catheter, and a cavity arranged inside the injection catheter. The second catheter segment and the drug injection catheter segment connected between the first catheter segment and the second catheter segment, the drug injection catheter segment is provided with an electrified deformable membrane that can be expanded and contracted by switching on and off, and is also provided with a piercing plug sub-injection head. In the present invention, the first balloon and the second balloon are used to seal the area where the embolus is located to form a closed treatment space, and the injection head on the drug injection catheter segment can pierce into the embolism at an oblique angle and directly inject the drug into the embolus. At the same time, the energized deformable membrane on the drug injection catheter segment can be energized, expanded, and recovered from power failure, thereby generating shrinkage, and disturbance is performed in the closed treatment space, thereby increasing the contact rate between the embolus and the thrombolytic drug, and quickly disintegrating the embolus. .

Description

Double-balloon injection catheter instrument for thrombolysis of blood vessel

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a double-balloon injection catheter instrument for thrombolysis of blood vessels.

Background

Ischemic cerebral apoplexy often occurs in vascular embolism, and because the phenomenon of blood flow perfusion reduction occurs locally in brain tissues of patients, even blood flow can be completely interrupted and stopped in severe cases, and cerebral tissue hypoxia and sugar deficiency caused by blood supply can be caused, so that local brain tissues are disintegrated and damaged, cerebral thrombosis and cerebral embolism are caused, and the disability rate and the fatality rate are extremely high.

At present, the treatment methods for the diseases mainly comprise intravenous thrombolysis treatment and arterial thrombolysis treatment, wherein the intravenous thrombolysis treatment has the advantages of large dosage, strong activation effect on plasminogen in the systemic circulation, easy occurrence of side effect of systemic bleeding in the application process and certain medication risk. The arterial thrombolysis treatment is a novel treatment scheme, mainly adopts X-ray to guide, adopts a micro-catheter to insert carotid artery and femoral artery into a patient to reach the embolization part of the patient, and adopts the micro-catheter to carry out thrombolysis drug injection treatment on the patient.

Patent document CN102698354B discloses a double balloon catheter for thrombolysis, which is configured to improve the administration efficiency of a drug by forming a closed treatment space between a first balloon and a second balloon and allowing a drug solution to enter the closed treatment space through the micropores.

Patent document CN209123141U discloses a double-balloon thrombolysis catheter, which realizes fixed-point mapping of a blood vessel thrombus site and thrombolysis closure, and simultaneously establishes a temporary blood flow passage isolated from the thrombus site.

However, the above two catheters adopt a drug permeation mode for thrombolysis, the contact area between the embolus and the drug is small, so that the dissolution speed of the embolus is low, and the thrombolysis efficiency cannot be effectively improved, thereby improving the effective rate of the drug.

Disclosure of Invention

Aiming at the technical problems, the invention provides a double-balloon injection catheter device for thrombolysis of blood vessels, which can effectively increase the contact rate of emboli and thrombolysis drugs and rapidly collapse the embolus by penetrating an injection head of the embolus and disturbing the embolus by utilizing the electrification telescopic characteristic of an electrified deformable membrane.

The first technical scheme of the invention is as follows: a double-balloon injection catheter instrument for thrombolysis of blood vessels comprises an injection catheter, a balloon penetrating and sleeved outside the injection catheter and a cavity channel arranged inside the injection catheter, wherein the injection catheter comprises a first catheter section, a second catheter section and a medicine injection catheter section connected between the first catheter section and the second catheter section, the medicine injection catheter section consists of an electrified deformable membrane and is provided with an independent medicine storage cavity, and a plurality of micropores for circulation of medicine liquid are formed in the electrified deformable membrane;

the balloon includes: the first balloon and the second balloon are respectively arranged on the first catheter section and the second catheter section and are used for blocking the blood vessel through inflation so as to form a closed treatment space on two sides of the embolus;

the cavity includes: the medical liquid medicine injection device comprises a main channel for blood circulation, a first side channel for inflation, a second side channel for medicine injection and a third side channel for electrifying the electrified deformation film through a metal guide wire, and the liquid medicine is disturbed by utilizing the on-off electrical contraction of the electrified deformation film.

The second technical scheme of the invention is as follows: a double-balloon injection catheter instrument for thrombolysis of blood vessels comprises an injection catheter, a balloon sleeved outside the injection catheter and a cavity channel arranged inside the injection catheter,

the injection catheter includes a first catheter segment, a second catheter segment, and a drug-infusion catheter segment connected between the first catheter segment and the second catheter segment, the drug-infusion catheter segment including: a first connecting piece and a second connecting piece which are respectively arranged at the far end port of the first conduit section and the near end port of the second conduit section along the radial direction, and an electrified deformation film which is connected between the first connecting piece and the second connecting piece and is used for forming an independent medicine storage cavity,

at least one hoop disposed radially along an inner side of the electro-deformable membrane for providing rigid support,

the injection head is obliquely arranged on the hoop and communicated with the independent medicine storage cavity and is used for puncturing the embolus to inject medicine;

the balloon includes: the first balloon and the second balloon are respectively arranged on the first catheter section and the second catheter section and are used for blocking the blood vessel through inflation so as to form a closed treatment space on two sides of the embolus; the first balloon and the second balloon can be made of medical common polymer materials such as silicon rubber.

The cavity includes: the proximal end of the main cavity channel is communicated with the outside through a plurality of inflow holes arranged on the outer side of the first catheter section, and the distal end of the main cavity channel sequentially penetrates through the medicine injection catheter section and the second catheter section and extends to the outside to form a tip part with an outflow hole for blood drainage;

the near end of the first side cavity channel is connected with an air inlet interface arranged on the outer side of the first catheter section and used for inflating the first balloon and the second balloon;

the proximal end of the second side cavity channel is connected with a medicine injection interface arranged on the outer side of the first catheter section and used for delivering medicine to the medicine storage cavity; and

the proximal end of the third side cavity is connected with a conductive interface arranged on the outer side of the first catheter section and is used for being connected with the first connecting piece through a metal guide wire to switch on and off the electrified deformation membrane so as to enable the injection head to carry out dynamic contraction type injection, the metal guide wire inputs current through an external pulse generator, the current is 0.5-1.0mA, when the input current is less than 0.5mA, effective stimulation cannot be formed on the electrified deformation membrane, and effective expansion and contraction quantity cannot be achieved, so that effective disturbance on emboli and liquid medicine in a closed treatment space cannot be achieved, the expected effect of quickly dissolving the emboli cannot be achieved, when the output current is more than 1.0mA, the stimulation effect is not changed greatly, in addition, the excessive current is unsafe for a human body, and the current is preferably 0.9mA through experiments.

Furthermore, the outer side of the injection conduit is sleeved with a guide conduit which can freely stretch out and draw back, and the guide conduit is used for protecting the injection head during pushing and withdrawing, and meanwhile, the medicine injection conduit section is provided with a flexible section, so that the medicine injection conduit section can be prevented from bending due to resistance during penetrating through an embolus through the assistance of the guide conduit, and meanwhile, the cutting rubbing of the injection head on a blood vessel can be prevented.

Furthermore, the medicine injection conduit section also comprises at least one corrugated pipe, the corrugated pipe is arranged on the first conduit section between the first balloon and the first connecting piece and/or the second conduit section between the second balloon and the second connecting piece and is used for buffering the impact force generated when the electrified deformation membrane is powered on and powered off, and the position of the balloon can be moved when the electrified deformation membrane is axially stretched after being powered on due to the fact that the buffered corrugated pipe is additionally arranged in the axial direction.

Furthermore, the hoop is also provided with a plurality of micropores which are communicated with the independent medicine storage cavity and used for permeating medicines into the closed treatment space during treatment, and after treatment is finished, waste liquid in the closed treatment space can be sucked out through the micropores and then discharged through the medicine injection interface.

Furthermore, the injection head is made of medical silica gel, so that the injection head is good in flexibility, softer and not prone to damage blood vessels, the tip of the injection head faces the second catheter section and forms an included angle of 20-30 degrees with the axial direction of the second catheter section, the length of the injection head is 0.5-1.0mm, the length of the injection head is smaller than 0.5mm, the length of the radial puncture embolus is not enough, and the length of the injection head larger than 1.0mm is prone to damage blood vessels in the stretching process, and the preferred length is 0.8 mm.

Further, the outflow hole is opened at the axial end of the tip portion or the radial outer periphery of the tip portion, and since accumulation is likely to occur at the axial end of the tip portion in general and clogging may occur when the injection catheter is passed through the stopper, it is preferable to open the outflow hole at the radial outer periphery of the tip portion in order to avoid such a situation.

Furthermore, the first connecting piece, the second connecting piece and the hoop are made of high-molecular conductive materials. The polymer conductive material is any one of polypyrrole, polythiophene and polyaniline, and preferably polypyrrole, so that the conductive material has the advantages of good conductivity, high biocompatibility and no toxicity.

Furthermore, developing points are respectively arranged at the corresponding positions of the first catheter section and the first balloon and the corresponding positions of the second catheter section and the second balloon, so that a doctor can conveniently convey the thrombolytic injection catheter to a lesion site.

Furthermore, the electrified deformation film adopts a polyacrylate film as a substrate, multi-wall carbon nanotube dispersion liquid is soaked on the upper bottom surface and the lower bottom surface of the polyacrylate film to form a polyacrylate film of a double-sided carbon nanotube film, and hydrosol consisting of nano cellulose and graphene dispersion liquid is sprayed on the upper surface of the polyacrylate film of the double-sided carbon nanotube film to serve as conductive adhesive.

The invention also provides a preparation method of the electrified deformation film, which comprises the following steps:

a1: taking a polyacrylate film, washing the polyacrylate film by using dewatering, soaking the washed polyacrylate film for 12-24h by using a mixed liquid of 1-3% by mass of hydrochloric acid solution and 10-20% by mass of water-soluble organic silicon oil, taking out the polyacrylate film, washing the polyacrylate film by using deionized water, and blowing nitrogen to dry to obtain a pretreated polyacrylate film;

a2: then ultrasonically mixing the multi-walled carbon nanotube dispersion liquid with absolute ethyl alcohol according to the ratio of 1:1 to prepare impregnation liquid, firstly uniformly spin-coating 1, 2-aminopropyl triethoxy silane (APTS) adhesion promoter for 10-30s at 500r/min by a spin coater on two surfaces of a pretreated polyacrylate film, then soaking the polyacrylate film coated with the adhesion promoter in the impregnation liquid for 5-30min, washing the surface by using a nitric acid solution with the mass fraction of 5-10% after pulling out, then washing the surface by using deionized water, and blowing nitrogen to be dry to obtain the polyacrylate film attached with the carbon nanotube film;

a3: mixing nano-cellulose, graphene dispersion liquid and deionized water according to a volume ratio of 5:1:100 to prepare conductive hydrosol, performing ultrasonic treatment for 30min, loading into a film spraying machine, and spraying on one surface of a polyacrylate film attached with a carbon nanotube film to form a viscous layer with the thickness of 10-20 microns.

The invention also provides a manufacturing method of the medicine injection catheter section, which comprises the following steps:

s1: laying the electrified deformable film with the sticky surface facing upwards on a flat plate, stringing a plurality of hoops at equal intervals by utilizing a rod body with scales, and then vertically bonding the hoops on the electrified deformable film;

s2: rolling the rod body to drive the hoop to drive the electrified deformation film to roll, finally wrapping 5-10 layers of the electrified deformation film on the periphery of the hoop, cutting, adopting a heat seal for an outer layer edge seam, and drawing out the rod body;

s3: forming a micropore or a mounting hole for mounting an injection head at a position corresponding to the hoop, and mounting the injection head in the mounting hole in a planting manner;

s4: and finally, the medicine injection conduit sections are clamped or connected between the first conduit section and the second conduit section through threads.

The invention has the beneficial effects that: the area where the embolus is located is sealed into a sealed treatment space by the first saccule and the second saccule, the injection head on the medicine injection catheter section can penetrate into the embolus at an oblique angle and directly inject the medicine into the embolus, and meanwhile, the characteristics that the electrified deformation films on the medicine injection catheter section can be electrified, expanded and disconnected to recover so as to generate shrinkage are utilized to carry out disturbance in the sealed treatment space, so that the contact rate of the embolus and the thrombolytic medicine is increased, and the embolus is quickly broken. In addition, the invention is also provided with a main channel for temporary overflowing of blood supply liquid, thereby avoiding blood complications, and is also provided with micropores for sucking waste liquid, so that the waste liquid after thrombolysis can be timely sucked away.

Drawings

Fig. 1 is a front view of a double balloon injection catheter apparatus ofembodiment 1 of the present invention;

FIG. 2 is a cross-sectional view taken along line D-D of FIG. 1;

FIG. 3 is a front view of a double balloon injection catheter apparatus according toembodiment 2 of the present invention;

FIG. 4 is a sectional view taken along line A-A of FIG. 1;

FIG. 5 is a sectional view taken along line B-B of FIG. 1;

FIG. 6 is a cross-sectional view taken along line C-C of FIG. 1;

FIG. 7 is an enlarged view at E in FIG. 2;

FIG. 8 is an enlarged view at F of FIG. 2;

FIG. 9 is an enlarged view at G of FIG. 2;

FIG. 10 is a partial schematic view of the dual balloon injection catheter device of the present invention within a guide catheter;

FIG. 11 is a schematic view of the guide catheter of FIG. 10 in a retracted configuration;

FIG. 12 is an enlarged view at H of FIG. 10;

FIG. 13 is a schematic diagram of the use of an electrically deformable membrane during thrombolysis using a dual balloon injection catheter apparatus in accordance with a preferred embodiment of the present invention during electrically powered dilation;

FIG. 14 is a schematic view of the use of the electrically deformable membrane during the de-energized contraction process of the thrombolysis process using the dual balloon injection catheter apparatus according to the preferred embodiment of the present invention;

figure 15 is a schematic representation of the use of example 7 of the present invention in therapy.

Wherein, 1-injection catheter, 11-first catheter section, 111-inflow hole, 112-air inlet interface, 113-medicine injection interface, 114-conductive interface, 115-metal guide wire, 12-second catheter section, 13-medicine injection catheter section, 131-first connecting piece, 132-second connecting piece, 133-electrified deformable membrane, 134-medicine storage cavity, 135-hoop, 136-injection head, 137-corrugated pipe, 138-micropore, 2-balloon, 21-first balloon, 22-second balloon, 3-cavity channel, 31-main cavity channel, 311-tip part, 312-outflow hole, 32-first side cavity channel, 33-second side cavity channel, 34-third side cavity channel, 4-guide catheter, 5-embolus channel, 6-vessel, 7-enclosed treatment space, 8-visualization point.

Detailed Description

The invention relates to a double-balloon injection catheter instrument for thrombolysis of blood vessels, which is mainly used for thrombolysis. Preferred embodiments of the present invention are described in detail below with reference to the accompanying drawings.

Example 1

Fig. 1 is a schematic structural diagram of a double-balloon injection catheter apparatus for vascular thrombolysis provided according to a preferred embodiment of the present invention. In the drawing, the distal end refers to the lower end, and the proximal end refers to the upper end.

As shown in figures 1, 2 and 4, the double-balloon injection catheter device for thrombolysis of blood vessels of the invention comprises aninjection catheter 1, aballoon 2 sleeved outside theinjection catheter 1 and acavity channel 3 arranged inside theinjection catheter 1,

as shown in FIG. 1,injection catheter 1 includes afirst catheter segment 11, asecond catheter segment 12, and a druginfusion catheter segment 13 connected betweenfirst catheter segment 11 andsecond catheter segment 12.

As shown in fig. 9, the drug-infusion catheter segment 13 includes: a first connectingpiece 131 and a second connectingpiece 132 which are respectively arranged at the distal port of thefirst catheter section 11 and the proximal port of thesecond catheter section 12 along the radial direction, anelectric deformation membrane 133 which is connected between the first connectingpiece 131 and the second connectingpiece 132 and is used for forming an independentdrug storage cavity 134, 12hoops 135 which are used for providing rigid support and 2 injection heads 136 which are obliquely arranged on eachhoop 135 and are communicated with the independentdrug storage cavity 134 and are used for penetrating into theembolus 5 to inject drugs are arranged along the radial direction of the inner side of theelectric deformation membrane 133, the injection heads 136 are made of medical silica gel, have good flexibility and are more flexible and are not easy to damage blood vessels, and the tips of the injection heads 136 face thesecond catheter section 12 and form an included angle of 25 degrees with the axial direction facing thesecond catheter section 12; the first connectingmember 131, the second connectingmember 132, and thehoop 135 are made of a conductive polymer material. The polymer conductive material is any one of polypyrrole, polythiophene and polyaniline, and preferably polypyrrole, so that the conductive material has the advantages of good conductivity, high biocompatibility and no toxicity. The electrifieddeformation film 133 is a polyacrylate film which uses a polyacrylate film as a substrate, the upper bottom surface and the lower bottom surface of the polyacrylate film are soaked with the multi-wall carbon nanotube dispersion liquid to form a double-sided carbon nanotube film, and hydrosol consisting of nanocellulose and graphene dispersion liquid is sprayed on the upper surface of the polyacrylate film of the double-sided carbon nanotube film to serve as conductive adhesive.

As shown in fig. 1, there are twoballoons 2, including afirst balloon 21 and asecond balloon 22 respectively disposed onfirst catheter section 11 andsecond catheter section 12, for occludingblood vessel 6 by inflation to formclosed treatment space 7 on both sides ofembolus 5, as shown in fig. 13 and 14; thefirst balloon 21 and thesecond balloon 22 may be made of a medical polymer material such as silicone rubber.

As shown in fig. 1, visualization points 8 are respectively arranged at the position of thefirst catheter section 11 corresponding to thefirst balloon 21 and the position of thesecond catheter section 12 corresponding to thesecond balloon 22, so that a doctor can conveniently deliver thethrombolytic injection catheter 1 to a lesion.

As shown in fig. 4, the channel 3 comprises a main channel 31, a first side channel 32, a second side channel 33 and a third side channel 34, wherein, as shown in fig. 2, the proximal end of the main channel 31 is communicated with the outside through a plurality of inflow holes 111 arranged on the outer side of the first catheter section 11, the distal end of the main channel 31 sequentially penetrates through the drug injection catheter section 13 and the second catheter section 12 and extends to the outside to form a tip portion 311 with an outflow hole 312 for blood drainage, and in this embodiment, the outflow hole 312 is opened at the axial end of the tip portion 311; the proximal end of the first side channel 32 is connected to an air inlet port 112 disposed on the outer side of the first catheter segment 11 for inflating the first balloon 21 and the second balloon 22; the proximal end of the second side channel 33 is connected with a medicine injection interface 113 arranged on the outer side of the first catheter section 11 and used for delivering medicine to the medicine storage cavity 134; the proximal end of the third side channel 34 is connected to the conductive interface 114 disposed on the outer side of the first catheter segment 11, and is used for connecting to the first connecting piece 131 through the metal guide wire 115 to switch on and off the electrically-conductive deformable membrane 133, so as to prompt the injection head 136 to perform dynamic contraction type injection, the metal guide wire 115 inputs current through an external pulse generator, the current is 0.5-1.0mA, when the input current is less than 0.5mA, effective stimulation cannot be formed on the electrically-conductive deformable membrane 133, and effective stretching and shrinking amount cannot be achieved, so that effective disturbance cannot be performed on the embolus 5 and the liquid medicine in the closed treatment space 7, the expected effect of quickly dissolving the embolus 5 cannot be achieved, when the output current is greater than 1.0mA, the stimulation effect does not change greatly, in addition, the excessive current is not safe for a human body, and the current is preferably 0.9mA through experiments.

In this embodiment, the method for preparing the electricallydeformed film 133 includes the following steps:

a1: taking a polyacrylate film, washing the polyacrylate film by using dewatering, soaking the cleaned polyacrylate film for 24 hours by using a mixed liquid of 2 mass percent hydrochloric acid solution and 15 mass percent water-soluble organic silicon oil, taking out the polyacrylate film, washing the polyacrylate film by using deionized water, and blowing nitrogen to dry to obtain a pretreated polyacrylate film;

a2: then ultrasonically mixing the multi-walled carbon nanotube dispersion liquid with absolute ethyl alcohol according to a ratio of 1:1 to prepare an impregnation liquid, firstly uniformly spin-coating 1, 2-aminopropyl triethoxy silane APTS adhesion promoter for 20s at 500r/min on two surfaces of a pretreated polyacrylate film by using a spin coater, then soaking the polyacrylate film coated with the adhesion promoter in the impregnation liquid for 5-30min, washing the surface by using a nitric acid solution with a mass fraction of 6% after pulling out, then washing the surface by using deionized water, and blowing nitrogen to dry to obtain the polyacrylate film attached with the carbon nanotube film;

a3: mixing nano-cellulose, graphene dispersion liquid and deionized water according to a volume ratio of 5:1:100 to prepare conductive hydrosol, performing ultrasonic treatment for 30min, loading into a film spraying machine, and spraying on one surface of a polyacrylate film attached with a carbon nanotube film to form a viscous layer with the thickness of 15 microns.

In this embodiment, the manufacturing method of the druginjection catheter section 13 comprises the following steps:

s1: laying the viscous surface of the electrifieddeformation film 133 on a flat plate, stringing thehoops 135 at equal intervals by using the rod body with scales, and vertically bonding thehoops 135 on the electrifieddeformation film 133;

s2: rolling the rod body to drive thehoop 135 to drive the electrifieddeformation film 133 to roll, finally wrapping 5-10 layers of the electrifieddeformation film 133 on the periphery of thehoop 135, cutting, adopting a heat seal for the outer layer side seam, and drawing out the rod body;

s3: amicro hole 138 or a mounting hole for mounting theinjection head 136 is formed in the position corresponding to thehoop 135, and theinjection head 136 is mounted in the mounting hole in a planting manner;

s4: and finally, thehoops 135 at the two ends are respectively heated and welded with the first connectingpiece 131 and the second connectingpiece 132 to obtain the medicineinjection conduit section 13, and finally the medicineinjection conduit section 13 is respectively clamped between thefirst conduit section 11 and thesecond conduit section 12 or is connected between the first conduit section and the second conduit section through threads.

Example 2

This embodiment is substantially the same asembodiment 1 except that:

as shown in fig. 2, the druginjection conduit section 13 further includes 2 bellows 137, thebellows 137 is disposed on thefirst conduit section 11 between thefirst balloon 21 and thefirst connector 131, and/or on thesecond conduit section 12 between thesecond balloon 22 and thesecond connector 132, and is used for buffering an impact force generated when the electrically conductivedeformable membrane 133 is powered on and powered off, and due to the addition of the buffered bellows 137 in the axial direction, the electrically conductivedeformable membrane 133 can move the position of theballoon 2 when expanding and contracting in the axial direction after being powered on.

Example 3

This embodiment is substantially the same asembodiment 2 except that:

as shown in fig. 2, theoutflow hole 312 is opened on the outer periphery in the radial direction of thetip portion 311, and since theoutflow hole 312 is generally likely to be accumulated at the axial end of thetip portion 311 when theinjection catheter 1 is passed through thestopper 5, and thus may cause clogging, it is preferable to open theoutflow hole 312 on the outer periphery in the radial direction of thetip portion 311 in order to avoid such a situation.

Example 4

This example is substantially the same as example 3, except that:

as shown in fig. 12, eachhoop 135 is further provided with 2micropores 138, and themicropores 138 are communicated with the independentdrug storage cavity 134, and are used for penetrating drugs into theclosed treatment space 7 during treatment, and after treatment, waste liquid in theclosed treatment space 7 can be sucked out through themicropores 138 and then discharged through thedrug injection port 113.

Example 5

This example is substantially the same as example 4, except that:

wherein, the length of theinjection head 136 is 0.5-1.0mm, the length is less than 0.5mm, the length of the radial insertedembolus 5 is not enough, and the length is more than 1.0mm, which is easy to cause damage to theblood vessel 6 in the expansion and contraction process, and 0.8mm is generally preferred.

Example 6

This example is substantially the same as example 5 except that:

as shown in fig. 10 and 11, the outer side of theinjection catheter 1 is sleeved with a freelytelescopic guide catheter 4 for protecting theinjection head 136 during pushing and withdrawing, and meanwhile, because the druginjection catheter section 13 has a flexible section, the bending of the druginjection catheter section 13 due to resistance in the throughembolus 5 can be reduced by the aid of theguide catheter 4, and meanwhile, theinjection head 136 can be prevented from scraping blood vessels.

The method of operation for thrombolytic therapy with the device of example 6 was:

1. taking the catheter part out of the sterile bag, and irrigating themain channel 31 and thesecond side channel 33 by using saline;

2. before the non-working state, as shown in fig. 10, theguide catheter 4 is sleeved outside theinjection catheter 1, both thefirst balloon 21 and thesecond balloon 22 are in the non-inflated state, as shown in fig. 12, theinjection head 136 is compressed inside theguide catheter 4, so that theinjection head 136 can avoid damaging the blood vessel wall in the process of pushing theinjection catheter 1 to theblood vessel 6 by using theguide catheter 4, and finally, according to the positioning display of the developingpoint 8, theinjection catheter 1 is sent to a specified position through theembolus 5 in theblood vessel 6, and as shown in fig. 11, theguide catheter 4 is withdrawn towards the proximal end;

3. after the guidingcatheter 4 is withdrawn, as shown in fig. 13, theinjection head 136 rebounds and pierces into theembolus 5, gas is introduced through thegas inlet interface 112, passes through the firstside cavity channel 32 and enters thefirst balloon 21 and thesecond balloon 22 from the opening communicated with the first side cavity channel, so that thefirst balloon 21 and thesecond balloon 22 are inflated on two sides of theembolus 5 to block theblood vessel 6, aclosed treatment space 7 is formed around theembolus 5, after the blood vessel is blocked by the two balloons, blood can flow into themain cavity channel 31 from theinflow hole 111 on the rear side of thefirst balloon 21 and finally flow out from theoutflow hole 312 on the front side of thesecond balloon 22, and blood drainage is formed;

4. the thrombolytic drug is injected through thedrug injection port 113, the thrombolytic drug is delivered to thedrug storage cavity 134 in the druginjection catheter section 13 through the secondside cavity channel 33, and seeps out to theclosed treatment space 7 from themicropores 138 and is directly injected into theembolus 5 from theinjection head 136, at this time, a pulse generator (not shown in the figure) connected with theconductive port 114 is opened, 0.9mA current is intermittently introduced, the intermittent interval is 2s, the current is transmitted to the first connectingpiece 131 of the high polymer conductive material through themetal guide wire 115 and then transmitted to the electrifieddeformable membrane 133, as shown in fig. 14, the electrifieddeformable membrane 133 expands after being electrified and expands along the axial direction of the blood vessel, thecorrugated pipes 137 at the two ends are compressed to provide buffering, and after being powered off, the electrifieddeformable membrane 133 recovers as shown in fig. 13. By utilizing the characteristic that the electrifieddeformation membrane 133 can be electrified, expanded and power-off recovered to generate contraction, theclosed treatment space 7 is disturbed, so that the contact rate of the embolus and the thrombolytic drug is increased, and theembolus 5 is quickly broken down;

5. whenembolus 5 is completely disintegrated into waste liquid, a suction needle tube is connected to themedicine injection interface 113 to suck the waste liquid out of themicropores 138 and theinjection head 136, and themicropores 138 are relatively more convenient for guiding the waste liquid clean relative to theinjection head 136 due to the plane mouth.

6. The gas in thefirst balloon 21 and thesecond balloon 22 is exhausted, theguide catheter 4 is pushed to wrap theinjection catheter 1 again, and the main purpose is to compress theinjection head 136 in theguide catheter 4 and facilitate the withdrawal of the blood vessel.

Example 7

As shown in fig. 15, a double-balloon injection catheter device for thrombolysis of blood vessels, the device comprises aninjection catheter 1, aballoon 2 sleeved outside theinjection catheter 1 and acavity 3 arranged inside theinjection catheter 1, and is characterized in that: theinjection catheter 1 comprises afirst catheter section 11, asecond catheter section 12 and a medicineinjection catheter section 13 connected between thefirst catheter section 11 and thesecond catheter section 12, wherein the medicineinjection catheter section 13 consists of an electrifieddeformable membrane 133 and is provided with an independentmedicine storage cavity 134, and a plurality ofmicropores 138 for the circulation of medicine liquid are formed in the electrifieddeformable membrane 133;

theballoon 2 includes: afirst balloon 21 and asecond balloon 22, respectively arranged onfirst catheter section 11 andsecond catheter section 12, for occludingblood vessel 6 by inflation to form aclosed treatment space 7 on both sides ofembolus 5;

thechannel 3 includes: themain channel 31 for blood circulation, thefirst side channel 32 for inflation, thesecond side channel 33 for medicine injection and thethird side channel 34 for electrifying the electrifieddeformation film 133 through themetal guide wire 115 disturb the medicine liquid by utilizing the on-off electrical contraction of the electrifieddeformation film 133.

Example 8

The thrombolysis test was performed using example 6 asexperimental group 1 and CN209123141U as a control group, and the test method was as follows:

1. 100 acute cerebral infarction patients collected from 8 months to 7 months in 2018 to 2019 in a hospital are selected as study subjects, the attack time of all patients is within 6h, the patients are averagely divided into two groups, namely 150 patients in an experimental group, 50 patients in a comparison group, 27 male patients in theexperimental group 1, the age of the patients is 27-65 years, the average age of the patients is 47 years, 23 female patients are 35-67 years, and the average age of the patients is 48 years; the comparison group comprises 25 male patients with the age of 24-62 years, the average age of 46 years, 25 female patients with the age of 25-60 years and the average age of 44 years, and the patients have no other systemic organic diseases, and the general data comparison difference of the two groups of patients has no statistical significance (p is more than 0.05) and has comparability.

2.Experimental group 1 interventional therapy was performed on patients ofexperimental group 1 using the catheter device of example 6, interventional therapy was performed on patients of comparative group using the catheter disclosed in CN209123141U, and the injected drugs were urokinase 50 wu;

3. the results of the therapeutic effects of theexperimental group 1 and the comparative group are shown in table 1: the curative effect judgment standard adopts a stroke scale of the national institutes of health of America to evaluate the symptoms of the patients, and a linear statistical mode is adopted to convert the result into a percent system. Scoring for 80-100 minutes to indicate recovery; 60-79 is effective; score <60 is invalid; total effective rate is the cure rate plus effective rate.

TABLE 1 therapeutic Effect ofExperimental group 1 and comparative group

	Recovery (case)	Effective (example)	Invalid (example)	Effective rate (%)
					Experimental group 1	35	15	0	100％
Comparison group
		17	28	5	90％

As can be seen from Table 1, the therapeutic effect of theexperimental group 1 is 10% higher than that of the comparative group, which indicates that the catheter device of the present invention has a significant effect on thrombolysis of blood vessels.

Example 8

The catheter device of example 6 was fabricated intoexperimental group 2 andexperimental group 3, respectively, and the working methods ofexperimental group 2 andexperimental group 3 were the same, except thatexperimental group 2 was provided with an injection head,experimental group 3 was not provided with an injection head, and bothexperimental group 2 andexperimental group 3 were tested using the test method of example 7, and the test results are shown in table 2:

table 2 test results ofexperimental group 2 andexperimental group 3

	Experimental group 2	Experimental group 3
			Whether or not there is an injection head	Is that	Whether or not
Whether or not to be electrified	Is that	Is that
			Recovery (case)	33	26
Effective (example)	16	22
			Invalid (example)	1	2
Effective rate (%)	98％	96％

As can be seen from table 2, the catheter device with the injection head is more efficient than the catheter device without the injection head.

Example 9

The catheter apparatus of example 6 was fabricated intoexperimental group 6 andexperimental group 7, respectively, and the working methods ofexperimental group 6 andexperimental group 7 were the same, except thatexperimental group 6 was powered on andexperimental group 7 was not powered on, and bothexperimental group 6 andexperimental group 7 were tested using the test method of example 7, with the test results shown in table 3:

table 3 test results ofexperimental group 4 andexperimental group 5

As can be seen from table 2, the catheter device with the injection head is more efficient than the catheter device without the injection head.

Claims (10)

Translated fromChinese

1.一种用于血管溶栓的双球囊注射导管器械，所述器械包括注射导管(1)、穿套在注射导管(1)外侧的球囊(2)以及设置在注射导管(1)内部的腔道(3)，其特征在于：所述注射导管(1)包括第一导管段(11)、第二导管段(12)以及连接在所述第一导管段(11)和第二导管段(12)之间的注药导管段(13)，所述注药导管段(13)是由通电形变膜(133)组成且具有独立储药空腔(134)，通电形变膜(133)上设有多个用于药液流通的微孔(138)；1. A double-balloon injection catheter device for vascular thrombolysis, the device comprising an injection catheter (1), a balloon (2) sheathed on the outside of the injection catheter (1) and arranged on the injection catheter (1) The inner lumen (3) is characterized in that: the injection catheter (1) comprises a first catheter segment (11), a second catheter segment (12), and is connected to the first catheter segment (11) and the second catheter segment (11) and the second catheter segment (12). The drug injection catheter segment (13) between the catheter segments (12), the drug injection catheter segment (13) is composed of an electrified deformable membrane (133) and has an independent medicine storage cavity (134), and the electrified deformable membrane (133) ) is provided with a plurality of micropores (138) for the circulation of medicinal liquid;所述球囊(2)包括：分别设置在第一导管段(11)、第二导管段(12)上的第一球囊(21)、第二球囊(22)，用于通过充气膨胀堵塞血管(6)以在栓子(5)的两侧形成封闭治疗空间(7)；The balloon (2) comprises: a first balloon (21) and a second balloon (22) respectively arranged on the first catheter segment (11) and the second catheter segment (12), and are used for inflation by inflation Blocking the blood vessel (6) to form a closed treatment space (7) on both sides of the embolus (5);所述腔道(3)包括：用于血液流通的主腔道(31)，用于充气的第一侧腔道(32)，用于注药的第二侧腔道(33)以及用于通过金属导丝(115)向通电形变膜(133)通电的第三侧腔道(34)，利用通电形变膜(133)通断电收缩对药液进行扰动。The lumen (3) includes: a main lumen (31) for blood circulation, a first side lumen (32) for inflation, a second side lumen (33) for injecting medicine, and a second side lumen (33) for injection. The third side channel (34) which is energized to the energized deformable membrane (133) through the metal guide wire (115), uses the energized deformable membrane (133) to perturb the medicinal liquid by on-off contraction.2.如权利要求1所述的一种用于血管溶栓的双球囊注射导管器械，其特征在于，所述注药导管段(13)包括：分别沿径向设置在所述第一导管段(11)远端口、第二导管段(12)近端口的第一连接件(131)、第二连接件(132)，以及连接在所述第一连接件(131)和第二连接件(132)之间用于形成独立储药空腔(134)的通电形变膜(133)，2. A dual-balloon injection catheter device for vascular thrombolysis according to claim 1, wherein the drug injection catheter segment (13) comprises: radially arranged on the first catheter respectively A first connector (131), a second connector (132) of the distal port of the segment (11), the proximal port of the second catheter segment (12), and the first connector (131) and the second connector connected to the first connector (131) and the second connector An electrified deformable membrane (133) between (132) for forming an independent medicine storage cavity (134),至少一个箍环(135)，所述箍环(135)沿着所述通电形变膜(133)的内侧径向设置，用于提供刚性支撑，at least one hoop (135) arranged radially along the inner side of the energized deformable membrane (133) for providing rigid support,至少一个注射头(136)，所述注射头(136)斜向设置在所述箍环(135)上并与所述独立储药空腔(134)相通，用于刺入栓子(5)中进行注药；At least one injection head (136), the injection head (136) is obliquely arranged on the hoop (135) and communicated with the independent medicine storage cavity (134), for piercing the emboli (5) injection in所述腔道(3)包括：主腔道(31)，所述主腔道(31)的近端通过设置在第一导管段(11)外侧上的多个进流孔(111)与外界相通，所述主腔道(31)的远端依次贯穿注药导管段(13)及第二导管段(12)并延伸至外界形成带有出流孔(312)的尖端部(311)，用于进行血液引流；The lumen (3) comprises: a main lumen (31), the proximal end of the main lumen (31) communicates with the outside world through a plurality of inflow holes (111) provided on the outside of the first conduit section (11). communicated, the distal end of the main lumen (31) sequentially penetrates the drug injection catheter segment (13) and the second catheter segment (12) and extends to the outside to form a tip portion (311) with an outflow hole (312), for blood drainage;第一侧腔道(32)，所述第一侧腔道(32)的近端与设置在第一导管段(11)外侧上的进气接口(112)相连，用于为第一球囊(21)、第二球囊(22)充气；A first side lumen (32), the proximal end of the first side lumen (32) is connected to an air inlet port (112) provided on the outer side of the first catheter segment (11), and is used for the first balloon (21), the second balloon (22) is inflated;第二侧腔道(33)，所述第二侧腔道(33)的近端与设置在第一导管段(11)外侧上的注药接口(113)相连，用于为所述独立储药空腔(134)送药；以及The second side lumen (33), the proximal end of the second side lumen (33) is connected with the drug injection interface (113) provided on the outer side of the first catheter section (11), and is used for the independent storage medicine cavity (134) to deliver medicine; and第三侧腔道(34)，所述第三侧腔道(34)的近端与设置在第一导管段(11)外侧上的导电接口(114)相连，用于通过金属导丝(115)连接至第一连接件(131)为通电形变膜(133)通断电，促使注射头(136)进行动态收缩式注射。A third lateral lumen (34), the proximal end of the third lateral lumen (34) is connected to a conductive interface (114) provided on the outer side of the first catheter segment (11) for passing a metal guide wire (115) ) is connected to the first connecting piece (131) to turn on and off the energized deformable membrane (133), so as to prompt the injection head (136) to perform dynamic retractable injection.3.如权利要求2所述的一种用于血管溶栓的双球囊注射导管器械，其特征在于：所述注射导管(1)的外侧穿套有能够自由伸缩的导引导管(4)，用于对所述注射头(136)在推进和撤回时进行防护。3. A double-balloon injection catheter device for vascular thrombolysis as claimed in claim 2, characterized in that: the outer side of the injection catheter (1) is sheathed with a freely retractable guiding catheter (4) , used to protect the injection head (136) when advancing and retracting.4.如权利要求2所述的一种用于血管溶栓的双球囊注射导管器械，其特征在于：所述注药导管段(13)还包括至少一个波纹管(137)，所述波纹管(137)设置在所述第一球囊(21)和所述第一连接件(131)之间的所述第一导管段(11)上，和/或所述第二球囊(22)与所述第二连接件(132)之间的所述第二导管段(12)上，用于缓冲通电形变膜(133)在通断电时产生的冲击力。4. A double-balloon injection catheter device for vascular thrombolysis according to claim 2, characterized in that: said drug injection catheter segment (13) further comprises at least one corrugated pipe (137), said corrugated pipe A tube (137) is arranged on the first catheter segment (11) between the first balloon (21) and the first connector (131), and/or the second balloon (22) ) and the second conduit section (12) between the second connecting piece (132), for buffering the impact force generated by the energized deformable film (133) when the energized deformation film (133) is turned on and off.5.如权利要求2所述的一种用于血管溶栓的双球囊注射导管器械，其特征在于：所述箍环(135)上还设置有多个微孔(138)，所述微孔(138)与所述独立储药空腔(134)相通，在治疗时用于向所述封闭治疗空间(7)内渗透药物，在治疗结束后，在封闭治疗空间(7)内的废液可通过所述微孔(138)被吸出，进而通过所述注药接口(113)排出。5. A double-balloon injection catheter device for vascular thrombolysis according to claim 2, characterized in that: the hoop (135) is further provided with a plurality of micro-holes (138), The hole (138) communicates with the independent medicine storage cavity (134), and is used for infiltrating the medicine into the closed treatment space (7) during treatment. The liquid can be sucked out through the micro holes (138), and then discharged through the drug injection interface (113).6.如权利要求2所述的一种用于血管溶栓的双球囊注射导管器械，其特征在于：所述注射头(136)的材质为医用硅胶，注射头(136)的尖端朝向所述第二导管段(12)，且与朝向第二导管段(12)的轴向呈20-30度夹角。6. A double-balloon injection catheter device for vascular thrombolysis according to claim 2, characterized in that: the material of the injection head (136) is medical silica gel, and the tip of the injection head (136) is directed toward the The second conduit section (12) is at an included angle of 20-30 degrees with the axial direction toward the second conduit section (12).7.如权利要求2所述的一种用于血管溶栓的双球囊注射导管器械，其特征在于：所述第一连接件(131)、第二连接件(132)、箍环(135)均采用高分子导电材料。7. A double-balloon injection catheter device for vascular thrombolysis according to claim 2, characterized in that: the first connector (131), the second connector (132), the hoop (135) ) are made of polymer conductive materials.8.如权利要求2所述的一种用于血管溶栓的双球囊注射导管器械，其特征在于：所述第一导管段(11)与所述第一球囊(21)对应处，以及所述第二导管段(12)与所述第二球囊(22)对应处上各设有显影点(8)。8. A double-balloon injection catheter device for vascular thrombolysis according to claim 2, characterized in that: the first catheter segment (11) corresponds to the first balloon (21), And the corresponding parts of the second catheter section (12) and the second balloon (22) are respectively provided with developing points (8).9.如权利要求2所述的一种用于血管溶栓的双球囊注射导管器械，其特征在于：所述通电形变膜(133)是采用聚丙烯酸酯薄膜作为基底，并在所述聚丙烯酸酯薄膜的上下底面浸渍多壁碳纳米管分散液形成双面碳纳米管薄膜的聚丙烯酸酯薄膜，在所述双面碳纳米管薄膜的聚丙烯酸酯薄膜的上表面喷涂由纳米纤维素和石墨烯分散液组成的水溶胶作为导电胶。9. The double-balloon injection catheter device for vascular thrombolysis according to claim 2, characterized in that: the energized deformable membrane (133) is made of polyacrylate film as a base, and is formed in the polyacrylate The upper and lower surfaces of the acrylic film are dipped in the multi-walled carbon nanotube dispersion to form a polyacrylate film of double-sided carbon nanotube film, and the upper surface of the polyacrylate film of the double-sided carbon nanotube film is sprayed with nanocellulose and The hydrosol composed of graphene dispersion is used as the conductive glue.10.如权利要求2所述的一种用于血管溶栓的双球囊注射导管器械，其特征在于：所述注药导管段(13)的制作方法包括以下步骤：10. A double-balloon injection catheter device for vascular thrombolysis as claimed in claim 2, characterized in that: the manufacturing method of the drug injection catheter segment (13) comprises the following steps:S1：将通电形变膜(133)带有粘性的一面朝上铺设在平板上，利用带有刻度的杆体将多个所述箍环(135)等距串起，然后将多个箍环(135)垂直粘接在通电形变膜(133)上；S1: Lay the energized deformable film (133) with the sticky side facing up on the flat plate, use a scaled rod body to string together a plurality of the hoop rings (135) at equal distances, and then connect the plurality of hoop rings (135). 135) vertically bonded on the energized deformation film (133);S2：滚动杆体将箍环(135)带动通电形变膜(133)收卷滚动，最终至通电形变膜(133)在箍环(135)外周包裹5-10层，裁剪，外层边缝采用热封口，并抽出杆体；S2: The rolling rod body drives the hoop (135) to roll up and roll the energized deformation film (133), and finally the energized deformation film (133) wraps 5-10 layers on the outer circumference of the hoop (135). Seal and pull out the rod body;S3：在箍环(135)对应的位置开设微孔(138)或者用于安装注射头(136)的安装孔，将注射头(136)采用种植的方式安装在安装孔内；S3: opening a micro-hole (138) or a mounting hole for mounting the injection head (136) at the position corresponding to the hoop (135), and installing the injection head (136) in the mounting hole by planting;S4：将两端的箍环(135)分别与第一连接件(131)、第二连接件(132)进行加热熔接，得到注药导管段(13)，最后将注药导管段(13)分别卡接或者通过螺纹连接在第一导管段(11)和第二导管段(12)之间。S4: heat and weld the hoops (135) at both ends with the first connector (131) and the second connector (132) respectively to obtain the drug injection conduit section (13), and finally separate the drug injection conduit section (13) It is snap-fit or screwed between the first conduit section (11) and the second conduit section (12).

Images