Disclosure of Invention
The present invention aims to solve the disadvantages of the prior art and proposes a suction-type ultrasound recanalization catheter system.
In order to achieve the above purpose, the present invention adopts the following technical scheme: a suction-enabled ultrasonic recanalization catheter system, comprising:
the catheter body is provided with a second through hole and a metal cap, and the metal cap is positioned at the distal end of the catheter body;
a cooling medium infusion unit that cools the catheter body by cooling medium through the second port Kong Guanshu;
a suction unit operable to suck the infused cooling medium;
an ultrasonic vibration unit for transmitting vibration to the metal cap for ablating calcified plaque.
As a further description of the above technical solution, the catheter further includes a balloon unit, where the balloon unit includes at least a first balloon, and the first balloon is used for limiting the head end of the catheter body.
As a further description of the above technical solution, the balloon unit further comprises a second balloon, the first balloon being located between the metal cap and the second balloon, the second balloon being capable of being used for carrying a drug.
As a further description of the above technical solution, the balloon unit further includes a balloon-set outer tube and a connection seat connected with the balloon-set outer tube; the balloon kit outer tube is secured to the catheter body.
As a further description of the above technical solution, the cooling medium infusion unit has a cooling medium infusion rate of 18-100ml/min.
As a further description of the above technical solution, the second through hole is provided on the metal cap or on the outer tube wall of the catheter body, and the size of the second through hole ranges from 0.05 mm to 0.15mm.
As a further description of the above technical solution, the ultrasonic vibration unit comprises an ultrasonic transmission member, an amplitude transformer and an ultrasonic transducer, wherein the amplitude transformer is arranged inside a handle of the catheter system, the distal end of the ultrasonic transmission member is connected with a metal cap, and in operation, the ultrasonic transmission member transmits vibration to the metal cap and generates amplitude.
As a further description of the above technical solution, the head end of the metal cap is tapered, the taper angle of the front end of the metal cap is 10-170 °, the diameter of the metal cap is 0.8-1.2mm, and the length of the metal cap is 1.5-2.5mm.
An ultrasound recanalization catheter system, the system comprising:
a catheter body having a metal cap disposed at a distal end thereof;
an ultrasonic vibration unit for transmitting vibration to the metal cap to ablate calcified plaque;
the balloon unit is arranged on the catheter main body and at least comprises a first balloon and a second balloon, wherein the first balloon is positioned between the metal cap and the second balloon, the first balloon is used for limiting the head end of the catheter main body, and the second balloon is used for bearing medicines.
As a further description of the above technical solution, the balloon unit further includes a balloon-set outer tube and a connection seat connected with the balloon-set outer tube; the balloon kit outer tube is secured to the catheter body.
The invention has the following beneficial effects:
1. according to the invention, the cooling medium infusion unit and the suction unit are arranged, so that a large amount of cooling medium can be infused in the catheter treatment process, the catheter is cooled, the harm to a patient caused by heating of the catheter in the treatment process is reduced, the suction unit sucks and discharges broken plaques, and simultaneously provides possibility for pouring a large amount of cooling medium, thereby effectively preventing negative influence on a human body caused by pouring a large amount of cooling medium, and being beneficial to heat dissipation and strengthening cavitation effect.
2. According to the invention, by arranging the double-balloon sleeve, the far-end balloon can ensure that the far-end metal cap is positioned at the lesion center in the treatment process, so that the bias to the vascular wall is avoided, the operation efficiency is improved, the risk of damaging the vascular wall is reduced, the near-end balloon can release the surface drug coating, the drug plays a role in resisting the proliferation of the intima of the blood vessel, and the restenosis of the blood vessel is prevented.
Detailed Description
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 embodiment of the application provides a suction ultrasonic recanalization catheter system, which solves the problem that a great deal of heat can be generated in the working process of the existing ultrasonic catheter system and can cause injury to patients. The specific technical conception is as follows:
this application is through being provided with the coolant filling system in the pipe, can pour into coolant to the blood vessel in the in-process of pipe work through this system, and coolant can be for physiological saline to can cool down the pipe, reduce the heat that produces when vibration melts calcified plaque, but can wash the broken plaque tissue that melts the production to the blood vessel depths at the in-process that coolant infusion unit carries out the cooling, lead to arterial embolism, the ischemia of distal end.
According to the device, the suction unit is arranged, the broken plaque and particles generated by ablation can be extracted, the risks of arteriole embolism and ischemia can be effectively reduced, meanwhile, the cooling medium is infused into the cooling medium infusion system, and the suction unit can simultaneously extract the infused cooling medium when sucking the broken plaque. The catheter is cooled, and meanwhile, the problem of acute left heart failure caused by rapid and massive injection of a cooling medium such as physiological saline into blood vessels, which causes the increase of chloride ion concentration in blood plasma, and then causes hyperchlorhythmic acidosis to stimulate the chemoreceptor reflex of carotid artery and aortic body, so that the breathing is deepened and accelerated, and the left ventricular load is increased, can be avoided.
Referring to fig. 1-5, one embodiment provided by the present invention is: the utility model provides a can suction supersound is led again and is led pipe system, it includes the pipe main part, and the pipe main part includes inner tube 3 and sets up in the outside outer tube 4 of inner tube 3, is provided with metal cap 1 at the head end of pipe main part, has seted up second through-hole 102, first through-hole 101 and blind hole 103 in metal cap 1. A gap exists between the inner tube 3 and the outer tube 4 for the circulation of a cooling medium, through which the cooling medium flows and flows out from the second through holes 102, during which the catheter body can be cooled.
The blind hole 103 of the metal cap 1 is internally fixed with an ultrasonic transmission piece 2, and the ultrasonic transmission piece 2 is made of memory alloy, such as nickel-titanium alloy, and has flexibility, bending resistance, support and elasticity. The ultrasonic transmission part 2 is a part of an ultrasonic vibration unit, the ultrasonic vibration unit comprises an amplitude transformer (not shown in the figure), an ultrasonic transducer (not shown in the figure) and a host system (not shown in the figure) besides the ultrasonic transmission part 2, wherein the amplitude transformer and the ultrasonic transducer are both arranged in the handle 13, the working frequency of the ultrasonic transducer is 18-40KHZ, so that the amplitude transformer has a better vibration effect, when the ultrasonic vibration unit works, the control switch 11 on the handle 13 is pressed down, the indicator lamp 10 is on, the catheter is represented to be in a working state, at the moment, the host system provides electric energy for the ultrasonic transducer, and the ultrasonic transducer converts the electric energy into mechanical energy, and amplifies the amplitude through the action of the amplitude transformer. The amplitude transformer is mechanically coupled with the ultrasonic transmission member 2, and the vibration of the amplitude transformer is transmitted to the ultrasonic transmission member 2 and finally transmitted to the metal cap 1, so that the metal cap 1 generates larger amplitude. During the high-frequency vibration of the catheter, the infused cooling medium (such as physiological saline) is ejected from the two second through holes 102 of the metal cap 1, expands and implosions at the front end of the metal cap 1, and generates mechanical energy to ablate calcified plaque. Finally, the calcified plaque is penetrated, a guide wire channel is established so as to be convenient for placing the guide wire, and finally, the function of restoring vascular recanalization is realized. Preferably, two second through holes 102 are provided in the metal cap 1.
The application also comprises a cooling medium infusion unit which comprises a filling pipeline, one end of the filling pipeline is connected with host equipment (not shown in the figure), power is provided by the host equipment, the other end of the filling pipeline is arranged along the inside of the catheter main body and is connected with a through hole in the metal cap 1, cooling medium can be input into a blood vessel through the catheter main body by starting the host equipment such as a pump body, the filling rate of single cooling medium is 18-100ml/min, and the filling amount of single cooling medium is generally 100ml. The specific perfusion volume can be adjusted according to the state of the patient, so that the condition that the catheter main body can be cooled and high-chlorine acidosis caused by excessive physiological saline is avoided when the catheter main body is perfused once, the operation risk is reduced, and the life safety of the patient is ensured. And a needle is further arranged at one end of the perfusion pipeline 15, and when the perfusion pipeline is used, the host device is controlled to increase the infusion flow rate of the cooling medium, and a peristaltic pump is integrated on the host device and used for conveying normal saline and perfusing the far end of the catheter. Because the working principle of the ultrasonic recanalization conduit is mechanical vibration and cavitation effect, factors influencing the cavitation of the drainage basin mainly comprise: flow boundary conditions, absolute pressure, flow rate, viscosity, surface tension, content of gas core (microbubbles, solid particles, etc. in water), inflow conditions, etc., but the main factors are flow rate and pressure, according to the formula: .
Wherein P is∞ And V∞ The pressure and velocity, respectively, of a certain steady flow state point in the flow system;
ρ is the liquid density;
PV is the saturated vapor pressure;
sigma is the primary cavitation number.
Theoretically only sigmaCavitation should be generated at less than or equal to 1, stable cavitation must be generated at less than or equal to 0.5, and smaller values of sigma represent more intense cavitation effects. We increase the flow velocity V∞ In the way, the cavitation number is reduced, and the cavitation effect is more severe. In this application, therefore, by keeping the liquid flow constant, the second through hole 102 (pouring port) on the metal cap 1 is reduced in size so that the flow rate thereof is higher; wherein the second through hole 102 has a size in the range of 0.05-0.15mm.
The small holes can be kept unchanged, the liquid flow is increased, wherein the liquid flow of single filling is 18-100ml, so that the flow speed is improved, and the cavitation effect is enhanced;
the size of the small holes can be reduced and the flow rate of the liquid can be increased, so that the flow speed is faster, and the cavitation effect is enhanced.
The device also comprises a suction unit, the suction unit comprises a suction pipe 5 arranged at the distal end of the catheter main body, the suction pipe 5 is connected with a suction pipeline 14, a suction sleeve is arranged at the proximal end of the suction pipeline 14, the suction pipeline 14 is connected with a host device, suction power is provided by the host device, and the cooling medium infusion unit and the suction unit share the same host device so as to reduce the number of individuals in the instrument combination. The host device comprises a negative pressure source such as a vacuum pump, and the suction tube 5 can be arranged inside the catheter, such as the outer tube 4, or a pipeline can be arranged outside the catheter. Or as shown in fig. 4-5, the suction pipe 5 and the outer pipe 4 are concentrically arranged, and are connected through a partition board, and the suction pipes on the upper side and the lower side of the partition board can realize the suction function at the same time during suction. Meanwhile, the suction pipe 5 and the outer pipe 4 can also be two cavities in the same pipeline, in particular to a two-cavity pipeline which enables the pipeline to be in an 8 shape, wherein one cavity is used for being used as the outer pipe 4 through a guide wire and liquid passing, the other cavity is used as a suction channel, namely the suction pipe 5, refer to fig. 8-9, in this way, a part of the end part of the suction pipe 5 needs to be cut off, so that the outer pipe 4 can be adhesively mounted with the metal cap 1, and on the other hand, the end part of the suction pipe 5 is in an inclined plane due to the fact that the end part of the suction pipe 5 is cut off, the caliber and the area of the pipe orifice are larger, the single suction amount is larger during suction, and the suction efficiency can be effectively improved. In this embodiment, establish the outside at outer tube 4 with suction tube 5 cover, suction unit can be unified with ultrasonic vibration unit through control switch 11 and control, the operator can adjust the regulating switch 12 or be foot switch (another control mode) on handle 13 according to the treatment condition in the art, through the rate of adjusting increase or reduction perfusion cooling medium, with reinforcing or weakening treatment effect, via suction unit, finally with a large amount of perfusings cooling medium and particulate and broken plaque that probably exists together follow suction tube 5 suction discharge under the negative pressure effect, reduce the risk of embolism.
Further, in the application, the cooling medium infusion unit and the suction unit can form a circulation system, and the cooling medium (such as physiological saline) is infused into the blood vessel by the cooling medium infusion unit so as to realize cooling, and meanwhile, the cooling medium and ablated plaque fragments can be extracted by the suction unit so as to realize cooling of the catheter, and the cooling medium and the plaque fragments can be extracted, so that complicated steps of manually implementing cooling infusion before manually extracting the cooling medium are reduced, the steps are simplified, and the efficiency is improved.
For the first through hole 101 of the metal cap 1 and the inner tube 3 can be fixed with the inner tube 3 by means of glue, hot air welding, etc. to serve as a guide wire channel, the metal cap 1 can also be fixed with the outer tube 4 by means of glue, hot air welding, etc.
The device also comprises a balloon unit, and is actually a double-balloon unit, wherein the distal balloon 6 is used for limiting the head end of the catheter, and the coaxiality and the supportability of the catheter in the blood vessel are realized by swinging the catheter fixed in the ultrasonic vibration process, so that the head end of the catheter is prevented from damaging the wall of the blood vessel in the treatment process. The proximal balloon 7 is a proximal drug balloon with antiproliferative drugs, the proximal drug balloon is fully attached to the inner wall of a blood vessel, the drug coating on the outer surface of the proximal balloon 7 is released rapidly, and the drugs can locally play a role in resisting intimal hyperplasia of the blood vessel, so that restenosis of the blood vessel after vascular intervention operation is prevented. Specifically, the distal balloon 6 is disposed between the metal cap 1 and the proximal balloon 7, the distal balloon 6 and the proximal balloon 7 are both fixed on the catheter body through the balloon sleeve outer tube 8, and the balloon sleeve outer tube 8 is connected with the connection seat 9, refer to fig. 10, specifically, a hole is formed in the front end of the connection seat 9, the inner wall of the hole presents an annular stepped structure, the first hole portion with a shallow depth and a large diameter is sleeved with the balloon sleeve outer tube 8, the second hole portion with a deep depth and a small diameter is sleeved with the catheter body, and on one hand, the balloon sleeve outer tube 8 and the connection seat 9 can be connected more stably through the connection mode, and meanwhile, an operator is also convenient to more precisely position the connection positions of the balloon sleeve outer tube 8 and the catheter body with the connection seat 9.
The outer tube 8 of the balloon kit and the catheter body can be integrated, or can be two independent units, and can be set according to specific requirements. The connecting seat 9 is a three-way connecting seat 9 and is divided into two bevel connection ends and a straight port end, and liquid can be poured into the balloon through the bevel connection ends, so that the balloon is filled.
For the metal cap 1, the head end thereof preferably exhibits a tapered shape, and the taper angle of the tapered shape is 10 to 170 °, specifically, 30 °,40 °, 50 °, etc., and the diameter of the metal cap 1 is 0.8 to 1.2mm and the length thereof is about 1.5 to 2.5mm. The metal cap with the conical head end can be inserted into the plaque more easily, so that plaque ablation can be realized more easily when the metal cap transmits vibration, and a better ablation effect is achieved. The metal cap has smaller size, so that the metal cap can easily extend into a blood vessel with narrow tortuosity, and is applicable to a wider range. The material of the metal cap 1 is one of titanium, titanium alloy or stainless steel, and the inner tube 3 connected with the first through hole 101 of the metal cap 1 has a smooth characteristic in the inner cavity so as to facilitate the passage of the guide wire, in this embodiment, the inner tube 3 is a three-layer tube, the outer layer is a polymer material, for example pebax, the middle layer is a metal, for example 304 stainless steel, and the inner layer is a polymer material, for example HDPE. It should be noted that, when the size of the metal cap is too small, only one wire guide hole is provided on the metal cap, refer to fig. 6 and 7, and the second through hole 102 is directly opened on the outer tube wall and is close to the metal cap, and the second through hole 102 on the outer tube is an inclined hole, and the direction is inclined to the metal cap, so that the liquid ejected from the small hole can still reach the front end of the metal cap 1.
Finally, it should be noted that: the foregoing description is only illustrative of the preferred embodiments of the present invention, and although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that modifications may be made to the embodiments described, or equivalents may be substituted for elements thereof, and any modifications, equivalents, improvements or changes may be made without departing from the spirit and principles of the present invention.