CN113729855B - Interventional combined ultrasonic thrombolysis device - Google Patents
Interventional combined ultrasonic thrombolysis device Download PDFInfo
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- CN113729855B CN113729855B CN202111005763.1A CN202111005763A CN113729855B CN 113729855 B CN113729855 B CN 113729855B CN 202111005763 A CN202111005763 A CN 202111005763A CN 113729855 B CN113729855 B CN 113729855B
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
- A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
- A61B17/2202—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being inside patient's body at the distal end of the catheter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22082—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
- A61B2017/22084—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance stone- or thrombus-dissolving
Abstract
The utility model provides an intervention formula combination supersound thrombolysis device, including outer pipe, interior pipe, forward direction ultrasonic transducer, side direction ultrasonic transducer and electric signal transmission line, interior pipe is located in the outer pipe and form the clearance with between the outer pipe, the lateral wall of outer pipe is equipped with the inhaling the key hole with clearance intercommunication, forward direction ultrasonic transducer locates the front end of outer pipe and is used for the front end transmission ultrasonic wave of outwards pipe, forward direction ultrasonic transducer is equipped with the through-hole that switches on with interior pipe, side direction ultrasonic transducer locates the lateral wall of outer pipe and is used for the side direction transmission ultrasonic wave of outwards pipe, forward direction ultrasonic transducer and side direction ultrasonic transducer all with electric signal transmission line electric connection, electric signal transmission line is used for applying the electric signal forward direction ultrasonic transducer and side direction ultrasonic transducer. The application has the advantages of high thrombolysis efficiency, thorough thrombus removal, small vascular injury, strong applicability to thrombus types and the like, and especially has better effect on thrombus with complete blockage or serious blockage and old shrinkage thrombus.
Description
Technical Field
The application relates to the technical field of medical instruments, in particular to an interventional combination ultrasonic thrombolysis device.
Background
The thrombosis often causes peripheral vascular occlusion, serious dangerous diseases such as ischemic cerebral apoplexy, myocardial infarction, pulmonary embolism and the like, and seriously endangers the life and health of human beings. The traditional methods for thrombolysis, balloon interventional angioplasty or surgical operation thrombolysis have obvious defects, the injury to patients caused by the operation thrombolysis is large, the time window of thrombolysis is short, the success rate is low, and complications such as nerve injury and internal tissue hemorrhage are often caused. The research shows that the ultrasonic-assisted thrombolysis is an effective thrombolysis method, has the characteristics of high thrombolysis efficiency and good safety, can obviously reduce the dosage of thrombolytic drugs, greatly reduces the risks of complications such as internal hemorrhage of tissues and nerve injury, and has attractive application prospect.
The interventional ultrasonic thrombolysis method combining microbubble contrast agent and thrombolytic medicine is one new thrombolysis technology, and the cavitation effect produced by ultrasonic wave and its mechanical vibration promote the thrombus to be cracked and increase the acting target of thrombolytic medicine to raise thrombolysis speed. In order to better match the use of microbubble contrast agent and thrombolytic medicine, the prior art proposes an interventional ultrasonic thrombolytic device which emits ultrasonic waves forward along the axial direction of a catheter, the device can work without the need of an ultrasonic thrombolytic probe entering into the thrombus, the thrombolytic probe is guided to a position which is 1mm away from the end of the thrombus to emit the ultrasonic waves, and the combined effect of the ultrasonic cavitation effect and the thrombolytic medicine is more beneficial to effective thrombolysis. This method has a better thrombolytic effect on fully occluded thrombus or some more occluded thrombus. However, for some old thrombi which shrink, the texture is hard and firmly adhered to the wall of the blood vessel, the ultrasonic wave which is emitted forward along the axial direction of the catheter has better thrombolysis effect on the middle part in the blood vessel, and has weaker effect on the thrombus close to the wall of the blood vessel, so the purpose of completely dissolving the thrombus cannot be achieved. At present, there is an urgent need to develop an interventional ultrasonic thrombolysis device with high thrombolysis efficiency, thorough thrombolysis and wide applicability.
Disclosure of Invention
In order to overcome the defects and shortcomings in the prior art, the application aims to provide an interventional combined ultrasonic thrombolysis device so as to solve the problem of poor thrombolysis effect of the ultrasonic thrombolysis device in the prior art.
The aim of the application is achieved by the following technical scheme:
the application provides an interventional type combined ultrasonic thrombolysis device which comprises an outer catheter, an inner catheter, a forward ultrasonic transducer, a lateral ultrasonic transducer and an electric signal transmission line, wherein the inner catheter is arranged in the outer catheter and forms a gap with the outer catheter, the side wall of the outer catheter is provided with a thrombolytic hole communicated with the gap, the forward ultrasonic transducer is arranged at the front end of the outer catheter and is used for transmitting ultrasonic waves towards the front end of the outer catheter, the forward ultrasonic transducer is provided with a through hole communicated with the inner catheter, the lateral ultrasonic transducer is arranged at the outer side wall of the outer catheter and is used for transmitting ultrasonic waves towards the lateral direction of the outer catheter, the forward ultrasonic transducer and the lateral ultrasonic transducer are electrically connected with the electric signal transmission line, and the electric signal transmission line is used for applying electric signals to the forward ultrasonic transducer and the lateral ultrasonic transducer.
Further, the forward ultrasonic transducer comprises a plurality of piezoelectric ceramic plates stacked on each other, the polarization directions of the piezoelectric ceramic plates are parallel to the axial direction of the outer catheter, and the polarization directions of two adjacent piezoelectric ceramic plates are opposite.
Further, the thickness of each piezoelectric ceramic piece is 0.1-0.25 mm, and two adjacent piezoelectric ceramic pieces are bonded together through conductive adhesive.
Further, the edge of the forward ultrasonic transducer does not protrude beyond the outer side of the outer catheter.
Further, the front end of the forward ultrasonic transducer is provided with an acoustic matching layer, and the thickness of the acoustic matching layer is 0.5-1 mm.
Further, the lateral ultrasonic transducer comprises a plurality of piezoelectric ceramic rings which are arranged at intervals, the piezoelectric ceramic rings are arranged around the side wall of the outer catheter, and the polarization direction of the piezoelectric ceramic rings is perpendicular to the axial direction of the outer catheter.
Further, the distance between two adjacent piezoelectric ceramic rings is 1-2 mm.
Further, the lateral ultrasonic transducer is arranged on the outer side wall of the outer catheter, and the outer side face of the lateral ultrasonic transducer is flush with the outer side face of the outer catheter.
Further, the suction plug hole is arranged between the forward ultrasonic transducer and the lateral ultrasonic transducer.
Further, the number of the suction bolt holes is a plurality of the suction bolt holes and the suction bolt holes are distributed along the circumferential direction or the axial direction of the outer catheter, and the suction bolt holes are in a round or oval structure.
Further, the inner catheter passes out of the sidewall of the outer catheter at an end remote from the forward ultrasound transducer and diverges and forms a "Y" shaped double-ended tube.
Further, the electric signal transmission line is arranged in the pipe wall of the outer catheter.
Further, the interventional combination ultrasonic thrombolysis device further comprises a change-over switch and an ultrasonic signal generator, and one end of the electric signal transmission line, which is far away from the forward ultrasonic transducer and the lateral ultrasonic transducer, is electrically connected with the ultrasonic signal generator through the change-over switch.
The application has the beneficial effects that: the ultrasonic transducer transmits ultrasonic wave forward for removing thrombus at the center of the blood vessel, so that the ultrasonic thrombolysis probe can extend into the thrombus, and the ultrasonic transducer transmits ultrasonic wave to the side face for removing thrombus at the side wall of the blood vessel, so as to remove thrombus which is hard in texture and firmly adhered to the wall of the blood vessel. And thrombolytic drugs and microbubble contrast agents can be injected into the thrombus through the inner catheter, so that the thrombus can be cleaned up quickly, the thrombolytic drugs are injected out through the through holes on the forward ultrasonic transducer to be accurately aligned with the thrombus for medication, the dosage of the thrombolytic drugs can be greatly reduced, and the risks of complications such as internal hemorrhage of tissues, nerve injury and the like are greatly reduced. The thrombolysis device has the advantages of high thrombolysis efficiency, thorough thrombus removal, small vascular injury, strong applicability to thrombus types and the like, can achieve good effects on complete and partial blocking type thrombus, and has good technical advantages on complete blockage, serious blockage and old shrinkage type thrombus.
Drawings
FIG. 1 is a schematic diagram of an interventional combination ultrasound thrombolysis device according to the present application;
FIG. 2 is a schematic cross-sectional view of an interventional combination ultrasonic thrombolysis device of the present application at the front end;
fig. 3 is a schematic cross-sectional structure of a forward ultrasonic transducer of the present application.
In the figure: the catheter comprises an outer catheter 1, a suction plug hole 2, an electric signal transmission line 3, an inner catheter 4, an ultrasonic thrombolysis probe 5, a forward ultrasonic transducer 6, a lateral ultrasonic transducer 7, a change-over switch 8, an ultrasonic signal generator 9 and a syringe 10.
Detailed Description
In order to further describe the technical means and effects adopted by the application to achieve the preset aim, the following detailed description is given of the specific implementation, structure, characteristics and effects of the interventional combination ultrasonic thrombolytic device according to the application by combining the accompanying drawings and the preferred embodiment:
as shown in fig. 1 to 3, the interventional type combined ultrasonic thrombolysis device provided by the application comprises an outer catheter 1, an inner catheter 4, a forward ultrasonic transducer 6, a lateral ultrasonic transducer 7 and an electric signal transmission line 3, wherein the inner catheter 4 is arranged in the outer catheter 1 and forms a gap with the outer catheter 1, a suction bolt hole 2 communicated with the gap is arranged on the side wall of the outer catheter 1, and dropped thrombus is sucked through the suction bolt hole 2 and flows out of the gap between the inner catheter 4 and the outer catheter 1. The forward ultrasonic transducer 6 is arranged at the front end of the outer catheter 1 and used for emitting ultrasonic waves towards the front end of the outer catheter 1, the forward ultrasonic transducer 6 is provided with a through hole communicated with the inner catheter 4, the inner diameter of the through hole is the same as the outer diameter of the inner catheter 4 and is 0.5-0.9 mm, thrombolytic drugs and microbubble contrast agents are conveyed through the inner catheter 4 or a guide wire is inserted into the through hole of the forward ultrasonic transducer 6 and is exposed out of the through hole. The lateral ultrasonic transducer 7 is provided at the outer side wall of the outer catheter 1 and serves to emit ultrasonic waves toward the lateral direction of the outer catheter 1. The forward ultrasonic transducer 6 and the lateral ultrasonic transducer 7 are electrically connected with the electric signal transmission line 3, and the electric signal transmission line 3 is used for applying electric signals to the forward ultrasonic transducer 6 and the lateral ultrasonic transducer 7, and the forward ultrasonic transducer 6 and the lateral ultrasonic transducer 7 form the ultrasonic thrombolysis probe 5. Wherein the front end is the end close to the thrombus, for example, the front end of the outer catheter 1 is the end close to the thrombus after the outer catheter 1 stretches into the blood vessel; the lateral direction is perpendicular to the axial direction of the outer catheter 1.
In this embodiment, the forward ultrasonic transducer 6 includes a plurality of piezoelectric ceramic plates stacked on each other, and the polarization direction of the piezoelectric ceramic plates is parallel to the axial direction of the outer catheter 1, so that the piezoelectric ceramic plates can emit ultrasonic waves toward the front end of the outer catheter 1. Preferably, the number of the piezoelectric ceramic plates is 6, and the thickness of each piezoelectric ceramic plate is 0.1-0.25 mm, so that the piezoelectric ultrasonic transducer can generate larger vibration displacement and the energy for transmitting ultrasonic waves is larger. Of course, the number and thickness of the piezoelectric ceramic plates can be adjusted according to practical situations. The piezoelectric ceramic piece is in a round shape or a square shape, wherein the diameter of the round section is 1-2.7 mm, the side length of the square section is 1-2 mm, and the size of the piezoelectric ceramic piece is smaller than or equal to the diameter of the outer catheter 1, so that the edge of the forward ultrasonic transducer 6 does not exceed the outer side surface of the outer catheter 1. The forward ultrasonic transducer 6 may be disposed in the outer catheter 1, and an outer side wall of the forward ultrasonic transducer 6 is connected with an inner side wall of the outer catheter 1, and of course, the size of the forward ultrasonic transducer 6 may be equal to the diameter of the outer catheter 1, and the forward ultrasonic transducer 6 is connected with a foremost end of the side wall of the outer catheter 1.
Further, as shown in fig. 3, arrows in the figure indicate the polarization direction of the piezoelectric ceramic sheet. The polarization directions of two adjacent piezoelectric ceramic plates are opposite, and the two adjacent piezoelectric ceramic plates are bonded together through conductive adhesive. For example, two adjacent piezoelectric ceramic plates are adhered together through conductive epoxy resin, and one sides of the same electrodes of the two adjacent piezoelectric ceramic plates are arranged in opposite directions, so that an electric signal can be applied to the same electrodes of the two adjacent piezoelectric ceramic plates through one lead wire, and the number of the lead wires and the size of the thrombolytic device are reduced. The positive and negative electrodes of the piezoelectric ceramic plates are respectively connected and led out through an electric signal transmission line 3, and then are insulated and sealed.
Further, the front end of the forward ultrasonic transducer 6 is provided with an acoustic matching layer, and the thickness of the acoustic matching layer is 0.5-1 mm. The arrangement of the acoustic matching layer allows the ultrasound waves generated by the forward ultrasound transducer 6 to act effectively on the thrombus, avoiding loss of ultrasound energy. Of course, the acoustic matching layer cannot cover the through hole of the forward ultrasound transducer 6, avoiding affecting the delivery of thrombolytic drugs and microbubble contrast agent by the inner catheter 4 or the insertion of a guidewire.
Further, the lateral ultrasonic transducer 7 includes a plurality of piezoelectric ceramic rings disposed at intervals, the piezoelectric ceramic rings being disposed around the side wall of the outer catheter 1, the polarization direction of the piezoelectric ceramic rings being perpendicular to the axial direction of the outer catheter 1, so that the piezoelectric ceramic rings can emit ultrasonic waves in the lateral direction of the outer catheter 1. The energy of ultrasonic waves and the irradiation range of the ultrasonic waves can be improved by arranging a plurality of piezoelectric ceramic rings, and the more the number is, the stronger the ultrasonic energy is, and the wider the irradiation range is. Preferably, the distance between the lateral ultrasonic transducer 7 and the forward ultrasonic transducer 6 is 3-5 mm, so that the suction bolt holes 2 are conveniently formed between the lateral ultrasonic transducer 7 and the forward ultrasonic transducer 6. The number of the piezoelectric ceramic rings is 3, the interval between two adjacent piezoelectric ceramic rings is 1-2 mm, the energy of the piezoelectric ceramic rings is concentrated in the interval range, and the piezoelectric ceramic rings are easy to realize in the manufacturing process, wherein the smaller the interval of the piezoelectric ceramic rings is, the more concentrated the energy is, but the manufacturing process difficulty is increased; the positive electrodes and the negative electrodes of the piezoelectric ceramic rings are respectively connected and led out through an electric signal transmission line 3. In other embodiments, the lateral ultrasonic transducer 7 may also be composed of a plurality of piezoelectric ceramic blocks, and the plurality of piezoelectric ceramic blocks are annularly distributed on the side wall of the outer catheter 1. Of course, the side of the lateral ultrasound transducer 7 may also be provided with an acoustic matching layer, so that the ultrasound waves generated by the lateral ultrasound transducer 7 may effectively act on the thrombus on the side wall of the blood vessel, avoiding loss of ultrasound energy.
Further, the lateral ultrasonic transducer 7 is arranged on the outer side wall of the outer catheter 1, and the outer side surface of the lateral ultrasonic transducer 7 is flush with the outer side surface of the outer catheter 1. Preferably, the outer surface of the outer catheter 1 is provided with a mounting groove matched with the lateral ultrasonic transducer 7, the piezoelectric ceramic ring is nested or bonded on the outer surface of the outer catheter 1 and is firmly fixed, the outer diameter of the lateral ultrasonic transducer 7 is consistent with the outer diameter of the outer catheter 1, and the outer catheter 1 is ensured not to damage the inner wall of a blood vessel in the process of intervention into the blood vessel. Of course, in other embodiments, the lateral ultrasonic transducer 7 may be disposed in the wall of the outer catheter 1, that is, the lateral ultrasonic transducer 7 may be wrapped in the wall material of the outer catheter 1 when the wall of the outer catheter 1 is manufactured.
The piezoelectric materials used for the forward ultrasonic transducer 6 and the lateral ultrasonic transducer 7 are piezoelectric ceramics PZT-5A, and in practical application, suitable piezoelectric materials can be selected according to requirements, including but not limited to piezoelectric materials with high mechanical quality factors such as PZT-4, PZT-8 and the like. In this embodiment, the piezoelectric ceramic sheet is made of a piezoelectric ceramic material in a sheet-like structure, and the piezoelectric ceramic ring is made of a piezoelectric ceramic material in a ring-like structure. Piezoelectric ceramics are a class of electronic ceramic materials with piezoelectric properties. The main differences from typical piezoelectric quartz crystals that do not contain ferroelectric components are: the crystal phases constituting the main components are all grains having ferroelectricity. Since ceramics are polycrystalline aggregates with randomly oriented grains, the spontaneous polarization vectors of the individual ferroelectric grains therein are also randomly oriented. In order to make the ceramic exhibit macroscopic piezoelectric properties, it is necessary to subject the piezoelectric ceramic to polarization treatment under a strong direct current field after firing and coating the electrode on the end face so that respective polarization vectors of the original disordered orientations are preferentially oriented in the electric field direction. After the electric field is canceled, the piezoelectric ceramic subjected to polarization treatment can keep certain macroscopic residual polarization intensity, so that the ceramic has certain piezoelectric properties. For a more detailed description of piezoelectric ceramics, reference is made to the prior art, and no further description is given here.
Preferably, the forward ultrasonic transducer 6 and the lateral ultrasonic transducer 7 operate at a frequency in the range of 200 to 800kHz. In practical applications, however, the operating frequencies of the forward ultrasound transducer 6 and the lateral ultrasound transducer 7 may be adjusted as needed to achieve the best thrombolysis effect.
In this embodiment, the suction plug hole 2 is disposed between the forward ultrasonic transducer 6 and the lateral ultrasonic transducer 7, and after the thrombus is ultrasonically cracked by the forward ultrasonic transducer 6 and the lateral ultrasonic transducer 7, the thrombus can be timely extracted through the suction plug hole 2 and then transported out through the gap between the outer catheter 1 and the inner catheter 4. The number of the suction plug holes 2 is plural and the suction plug holes 2 are distributed along the circumferential direction or the axial direction of the outer catheter 1, and the suction plug holes 2 have a circular or elliptic structure. Preferably, the number of the suction plug holes 2 is two and arranged along the circumferential direction of the outer catheter 1, the suction plug holes 2 have an oval structure, and the oval has a short radius of 0.5-1 mm and a long radius of 1-2 mm, so that irregular thrombus can be sucked out more easily. Of course, in other embodiments, the suction plug hole 2 may be provided at the rear end of the lateral ultrasonic transducer 7, and the lateral ultrasonic transducer 7 is provided between the suction plug hole 2 and the forward ultrasonic transducer 6. Or the front end and the rear end of the lateral ultrasonic transducer 7 are respectively provided with a suction bolt hole 2.
Further, as shown in fig. 1, the inner catheter 4 is penetrated out from the side wall of the outer catheter 1 at an end remote from the forward ultrasonic transducer 6, and diverges and forms a "Y" shaped double-way tube. I.e. the front end of the inner catheter 4 is sleeved on the through hole of the forward ultrasonic transducer 6, the tail end of the inner catheter 4 is positioned outside the body and is provided with a Y-shaped double-way catheter, and the two separated catheters are connected with the injector 10 and are respectively used for injecting thrombolytic drugs and microbubble contrast agents. Of course, the catheters (outer catheter 1, inner catheter 4) may also be used for inserting a guide wire during insertion into a blood vessel, thereby guiding the sonothrombolysis probe to the thrombus site.
In this embodiment, the electrical signal transmission line 3 is disposed in the wall of the outer catheter 1, that is, when the wall of the outer catheter 1 is manufactured, the electrical signal transmission line 3 is wrapped in the wall material of the outer catheter 1. Of course, the electric signal transmission line 3 may be provided on the inner side wall of the outer catheter 1, but may affect the discharge of thrombus.
Further, the external catheter 1 is connected at one end (tip) located outside the body to a suction pump for extraction of micro plaque after thrombolysis. Preferably, the outer catheter 1 has a length of 90-110 mm to facilitate better handling of the outer catheter 1 extending into the blood vessel.
Further, the interventional type combined ultrasonic thrombolysis device further comprises a change-over switch 8 and an ultrasonic signal generator 9, and one end of the electric signal transmission line 3, which is far away from the forward ultrasonic transducer 6 and the lateral ultrasonic transducer 7, is electrically connected with the ultrasonic signal generator 9 through the change-over switch 8. The forward ultrasonic transducer 6 and the lateral ultrasonic transducer 7 are connected to the same ultrasonic signal generator 9 through a change-over switch 8, and the ultrasonic transducers required to be used are controlled to work independently through the change-over switch 8. In practical application, two ultrasonic transducers can be respectively connected with two ultrasonic signal generators 9 according to the selection of the size, the type and the like of thrombus, so that the two ultrasonic transducers can be simultaneously operated according to the selection, and the optimal thrombolysis effect is achieved. The ultrasonic signal generator 9 comprises a signal generator, a signal amplifier, a switch and an ultrasonic transducer connector, wherein the ultrasonic signal generator 9 is started to generate a driving signal through the switch, and the driving signal is amplified through the signal amplifier, so that the ultrasonic transducer is driven to emit ultrasonic waves.
In this embodiment, the fully blocked thrombus is taken as an example of thrombolysis object, and the main steps of intravascular thrombolysis by adopting the interventional combined ultrasonic thrombolysis device provided by the application are as follows:
step one: introducing a guide wire through a blood vessel to enable the guide wire to reach a thrombus position; the method comprises the steps of guiding and inserting a catheter and an ultrasonic thrombolysis probe 5 through a guide wire, injecting a microbubble contrast agent through an inner catheter 4, and determining the thrombus position; then, the forward ultrasonic transducer 6 is inserted into the end part of the thrombus, and the guide wire is pulled out; thereafter, thrombolytic drugs are injected through the inner catheter 4.
Step two: the ultrasonic signal generator 9 is started, the forward ultrasonic transducer 6 is driven to emit ultrasonic waves, the ultrasonic waves in the forward direction along the axis of the catheter are applied to the end part of the thrombus, cavitation effect is generated to promote the thrombus to be cracked, thrombolytic drugs are promoted to further permeate into the thrombus, thrombolytic drug action targets are increased, and thrombolysis is promoted.
Step three: after the second step is completed, the middle part of the thrombus is effectively and primarily dissolved. At this time, the catheter and the ultrasonic thrombolysis probe 5 are further introduced into the thrombus; then, the ultrasonic signal generator 9 is started, the lateral ultrasonic transducer 7 is driven to emit ultrasonic waves, the ultrasonic waves along the radial direction (lateral direction) of the catheter are applied to the inside of the thrombus, the whole thrombus is effectively dissolved under the combined action of the ultrasonic waves, the microbubble contrast agent and the thrombolytic drug, and particularly, the thrombus adhered to the wall of the blood vessel is thoroughly dissolved.
Step four: repeating the second and third steps if necessary. If necessary, the forward ultrasonic transducer 6 and the lateral ultrasonic transducer 7 can be simultaneously started, so that the forward ultrasonic transducer 6 and the lateral ultrasonic transducer 7 simultaneously emit ultrasonic waves for thrombolysis treatment, thereby realizing high-efficiency and thorough dissolution of the whole thrombus.
Step five: after the step four is completed, the whole thrombus is effectively dissolved, and the dissolved thrombus is a micron-sized thrombus plaque which can be absorbed along with blood circulation. In order to prevent the possibility of further embolism caused by some larger micro-thrombus plaques along with the blood circulation flowing to the distal end, a suction pump is started, dissolved thrombus is extracted out of the body through a suction plug hole 2 on the outer catheter 1, so that the thrombus is thoroughly removed, and the distal embolism is avoided.
Through the steps one to five, the interventional combined ultrasonic thrombolysis device provided by the embodiment of the application is utilized to carry out ultrasonic thrombolysis operation, so that various types of thrombus can be subjected to high-efficiency and thorough thrombolysis treatment. The device has the advantages of high thrombolysis efficiency, thorough thrombolysis, small vascular injury and strong applicability to thrombus types, and in addition, the device can greatly reduce the dosage of thrombolytic drugs and greatly reduce the risks of complications such as internal hemorrhage of tissues, nerve injury and the like.
In practical application, the interventional combination ultrasonic thrombolysis device provided by the application is suitable for various types of thrombus, and has good technical advantages especially for old thrombus which is seriously and even completely blocked or contracted. The forward ultrasonic transducer 6 and the lateral ultrasonic transducer 7 in the device can realize ultrasonic treatment of thrombus, and for the thrombus with serious blockage, the forward ultrasonic transducer 6 mainly primarily dissolves the thrombus in the early stage, so that an ultrasonic thrombolysis probe can enter the thrombus; then, the lateral ultrasonic transducer 7 is utilized to effectively dissolve the whole thrombus, and the synergistic effect of the two transducers shortens the treatment time and improves the clearance rate of the thrombus. Two transducers are required to operate simultaneously when necessary to achieve optimal thrombolytic therapy.
The application adopts a forward ultrasonic transducer 6 and a lateral ultrasonic transducer 7, thereby optimizing the design of the ultrasonic thrombolysis probe 5. The ultrasonic transducer 6 emits ultrasonic wave forward for removing thrombus at the center of the blood vessel, so that the ultrasonic thrombolysis probe 5 can extend into the thrombus, and the ultrasonic transducer 7 emits ultrasonic wave to the side surface for removing thrombus at the side wall of the blood vessel, so as to remove thrombus which is hard in texture and firmly adhered to the wall of the blood vessel. And the thrombolytic medicine can be injected into the thrombus through the inner catheter 4, so that the thrombus can be cleaned up quickly, the thrombolytic medicine is ejected out through the through hole on the forward ultrasonic transducer 6 to be accurately aligned with the thrombus for medication, the dosage of the thrombolytic medicine can be greatly reduced, and the risks of complications such as internal hemorrhage of tissues, nerve injury and the like are greatly reduced. The thrombolysis device of the application has the advantages of high thrombolysis efficiency, thorough thrombus removal, small vascular injury, strong applicability to thrombus types and the like, can obtain good effects on complete and partial blocking type thrombus, and has good technical advantages especially on complete blocking type thrombus and old shrinkage type thrombus
In this document, terms such as up, down, left, right, front, rear, etc. are defined by the positions of the structures in the drawings and the positions of the structures with respect to each other, for the sake of clarity and convenience in expressing the technical solution. It should be understood that the use of such orientation terms should not limit the scope of the claimed application. It should also be understood that the terms "first" and "second," etc., as used herein, are used merely for distinguishing between names and not for limiting the number and order.
The present application is not limited to the preferred embodiments, but is capable of modification and variation in all aspects, including the following description, but not limited to, as long as the modifications and variations are possible in light of the above-described aspects, and the present application is not limited to the above-described embodiments.
Claims (11)
1. An interventional type combined ultrasonic thrombolysis device is characterized by comprising an outer catheter (1), an inner catheter (4), a forward ultrasonic transducer (6), a lateral ultrasonic transducer (7) and an electric signal transmission line (3), wherein the inner catheter (4) is arranged in the outer catheter (1) and forms a gap with the outer catheter (1), a bolt absorbing hole (2) communicated with the gap is formed in the side wall of the outer catheter (1), the forward ultrasonic transducer (6) is arranged at the front end of the outer catheter (1) and is used for transmitting ultrasonic waves towards the front end of the outer catheter (1), the forward ultrasonic transducer (6) is provided with a through hole communicated with the inner catheter (4), the lateral ultrasonic transducer (7) is arranged on the outer side wall of the outer catheter (1) and is used for transmitting ultrasonic waves towards the lateral side of the outer catheter (1), the forward ultrasonic transducer (6) and the lateral ultrasonic transducer (7) are electrically connected with the electric signal transmission line (3), the electric signal transmission line (3) is used for transmitting ultrasonic waves towards the front ultrasonic transducer (6) and the lateral ultrasonic transducer (8) and the combined ultrasonic thrombolysis device (9), one end of the electric signal transmission line (3) far away from the forward ultrasonic transducer (6) and the lateral ultrasonic transducer (7) is electrically connected with the ultrasonic signal generator (9) through the change-over switch (8), and the forward ultrasonic transducer (6) and the lateral ultrasonic transducer (7) form an ultrasonic thrombolysis probe (5);
the main steps of the device for intravascular thrombolysis are as follows:
step one: introducing a guide wire through a blood vessel, leading the guide wire to reach a thrombus position, guiding and introducing a catheter and the ultrasonic thrombolysis probe (5) through the guide wire, injecting a microbubble contrast agent through the inner catheter (4), determining the thrombus position, leading the forward ultrasonic transducer (6) to be inserted into the end part of the thrombus, extracting the guide wire, and injecting thrombolysis medicine through the inner catheter (4);
step two: starting the ultrasonic signal generator (9), driving the forward ultrasonic transducer (6) to emit ultrasonic waves, applying the ultrasonic waves in the forward direction along the axis of the catheter to the end part of the thrombus, generating cavitation effect to promote the thrombus to be cracked, promoting the thrombolytic medicine to further permeate into the thrombus, increasing the action target point of the thrombolytic medicine, and promoting the thrombolysis;
step three: after the second step is completed, the middle part of the thrombus is effectively and primarily dissolved, and at the moment, the catheter and the ultrasonic thrombolysis probe (5) further enter the thrombus; then, the ultrasonic signal generator (9) is started, the lateral ultrasonic transducer (7) is driven to emit ultrasonic waves, the ultrasonic waves along the radial direction of the catheter are applied to the inside of the thrombus, and the whole thrombus is effectively dissolved under the combined action of the ultrasonic waves, the microbubble contrast agent and the thrombolytic drug;
step four: repeating the second step and the third step, and simultaneously starting the forward ultrasonic transducer (6) and the lateral ultrasonic transducer (7), so that the forward ultrasonic transducer (6) and the lateral ultrasonic transducer (7) simultaneously emit ultrasonic waves for thrombolysis treatment, thereby realizing high-efficiency and thorough dissolution of the whole thrombus;
step five: the thrombus is dissolved into micron-level thrombus plaque, and can be absorbed along with blood circulation, meanwhile, a suction pump is started, the dissolved thrombus is extracted out of the body through the suction plug hole (2) on the outer catheter (1), so that the thrombus is thoroughly removed, and the occurrence of distal embolism is avoided.
2. An interventional combination ultrasound thrombolytic device according to claim 1, characterized in that the forward ultrasound transducer (6) comprises a plurality of mutually stacked piezoceramic plates, the polarization direction of which is parallel to the axis direction of the outer catheter (1), the polarization directions of adjacent two piezoceramic plates being opposite.
3. The interventional type combined ultrasonic thrombolytic device according to claim 2, wherein the thickness of a single piezoelectric ceramic plate is 0.1-0.25 mm, and two adjacent piezoelectric ceramic plates are bonded together through conductive adhesive.
4. The interventional combination ultrasound thrombolysis device according to claim 1, characterized in that the edge of the forward ultrasound transducer (6) does not exceed the outer side of the outer catheter (1) and/or that the outer side of the lateral ultrasound transducer (7) is flush with the outer side of the outer catheter (1).
5. The interventional combination ultrasound thrombolysis device according to claim 1, wherein the front end of the forward ultrasound transducer (6) is provided with an acoustic matching layer, the thickness of the acoustic matching layer is 0.5-1 mm.
6. An interventional combination ultrasound thrombolytic device according to claim 1, characterized in that the lateral ultrasound transducer (7) comprises a plurality of spaced piezoelectric ceramic rings arranged around the side wall of the outer catheter (1), the polarization direction of the piezoelectric ceramic rings being perpendicular to the axial direction of the outer catheter (1).
7. The interventional combination ultrasonic thrombolytic device of claim 6 wherein the spacing between adjacent two of said piezoceramic rings is 1-2 mm.
8. An interventional combination ultrasound thrombolytic device according to claim 1, characterized in that the suction bolt hole (2) is arranged between the forward ultrasound transducer (6) and the lateral ultrasound transducer (7).
9. The interventional combination ultrasound thrombolytic device according to claim 8, wherein the number of the embolic holes (2) is plural and arranged along the circumferential or axial direction of the outer catheter (1), the embolic holes (2) being of a circular or elliptical configuration.
10. An interventional combination ultrasound thrombolysis device according to claim 1, characterized in that the inner catheter (4) is threaded out from the side wall of the outer catheter (1) at an end remote from the forward ultrasound transducer (6) and diverges and forms a "Y" shaped double-way tube.
11. The interventional combination ultrasound thrombolysis device according to claim 1, wherein the electrical signal transmission line (3) is provided in the wall of the outer catheter (1).
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