CN112914679B - Radially deformable thrombus removal device - Google Patents

Radially deformable thrombus removal device Download PDF

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Publication number
CN112914679B
CN112914679B CN202110148740.XA CN202110148740A CN112914679B CN 112914679 B CN112914679 B CN 112914679B CN 202110148740 A CN202110148740 A CN 202110148740A CN 112914679 B CN112914679 B CN 112914679B
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nickel
catheter
titanium alloy
grinding mechanism
thrombus
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CN112914679A (en
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王成勇
吴茂忠
杨洋
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Guangdong University of Technology
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Guangdong University of Technology
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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • 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
    • A61B2017/22038—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 with a guide wire
    • 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
    • A61B2017/22079—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 with suction of debris
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320733—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320741—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A61B2017/320775—Morcellators, impeller or propeller like means

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Abstract

The present application relates to a radially deformable thrombectomy device. The apparatus comprises: the device comprises a guide wire, a grinding head, a nickel-titanium alloy rotary grinding mechanism, a driving shaft, a catheter and a catheter cavity; the guide wire penetrates through the grinding head and the driving shaft, and the grinding head is connected with the driving shaft; the inner cavity gap between the driving shaft and the catheter and the nickel-titanium alloy rotational grinding mechanism forms a catheter cavity which is used for conveying normal saline and sucking thrombus plaques; the catheter comprises a catheter front section and a catheter rear end. This application adopts the nickel titanium alloy material rotational grinding mechanism that has shape memory effect, and in nickel titanium alloy rotational grinding mechanism got into tiny pipeline (like, blood vessel) along with the thrombus clear away apparatus, the piece is heated the inflation uplift between nickel titanium alloy rotational grinding mechanism, and when the drive shaft was rotatory, the piece between after can driving the uplift rotated to can play the effect of clearance silt stifled thing. After the clogging objects are cleaned, the nickel-titanium alloy rotational grinding mechanism can be cooled through the heat transfer of the apparatus, so that the hollow cylindrical state is recovered, and the fine pipeline can be conveniently withdrawn.

Description

Radially deformable thrombus removal device
Technical Field
The application relates to the technical field of medical equipment, in particular to a radially deformable thrombus removing device.
Background
The blood vessel is very elastic, and the inner wall is very soft in order to make the blood flow smoothly; however, the arteriosclerotic blood vessel is thickened and hardened, and the inner wall of the blood vessel is silty (a congelation-like hardening nest), so that the lumen of the blood vessel is narrowed, the blood circulation is not smooth, and the blood vessel is completely blocked to form thrombus after continuous deterioration.
At present, the treatment methods of vascular thrombosis comprise anticoagulation treatment, surgical incision and thrombus removal, transcatheter direct thrombolysis treatment, balloon dilatation and stent implantation, and mechanical thrombectomy; the prior grinding head of the rotary grinding type mechanical thrombus removal instrument is easy to cause vascular injury in the process of arriving at and leaving from a focus, and has poor safety.
Disclosure of Invention
In order to overcome the problem that exists among the correlation technique, this application provides a but thrombus of radial deformation clears away apparatus, and this thrombus clears away apparatus utilizes 4D to print nickel titanium alloy, can radially change the apparatus size of volume to guarantee to get into and leave thrombus plaque focal area with minimum form, avoid the apparatus to cause the vascular damage.
The application adopts the following technical scheme:
a radially deformable thrombus removal device comprising: the device comprises a guide wire, a grinding head, a nickel-titanium alloy rotary grinding mechanism, a driving shaft, a catheter and a catheter cavity;
the guide wire penetrates through the grinding head and the driving shaft, and the grinding head is connected with the driving shaft;
the inner cavity gap between the driving shaft and the catheter and the nickel-titanium alloy rotational grinding mechanism forms a catheter cavity which is used for conveying normal saline and sucking thrombus plaques;
the catheter comprises a catheter front end and a catheter rear end;
the nickel-titanium alloy rotational grinding mechanism is positioned between the front end of the catheter and the rear end of the catheter;
the nickel-titanium alloy rotary grinding mechanism is a hollow cylinder consisting of a plurality of interlayer sheets, and can radially expand and deform at 25-37 ℃.
The grinding head and the nickel-titanium alloy rotational grinding mechanism are driven by the driving shaft to rotate and are used for rotational grinding and removing thrombus.
In one embodiment of the present application:
the nickel-titanium alloy rotational grinding mechanism is made of a nickel-titanium alloy material, and 4D printing and repeated thermal mechanical cycle treatment in a phase change interval are respectively carried out, so that the nickel-titanium alloy rotational grinding mechanism has a two-way memory effect.
In one embodiment of the present application: two-way memory effects include the formation and maintenance of two stable forms:
the first form is that the nickel-titanium alloy rotary grinding mechanism is in a slender hollow cylinder shape and is tightly attached to the driving shaft so as to keep the minimum volume form;
the second form: the nickel-titanium alloy rotary grinding mechanism automatically expands and deforms from an original hollow cylinder shape into an oval shape so as to achieve the maximum volume shape;
the first form and the second form can be switched by changing the temperature.
In one embodiment of the present application:
the first form and the second form can be switched by changing the temperature, and the method comprises the following steps:
controlling the form change through the body fluid temperature and the temperature of the physiological saline;
when thrombus is removed, the catheter enters a target thrombus plaque focal region, the front end of the catheter in a connection state is separated from the rear end of the catheter, the nickel-titanium alloy rotational grinding mechanism is exposed in the blood vessel wall and the blood vessel inner cavity, the deformation temperature of the nickel-titanium alloy rotational grinding mechanism after repeated thermal mechanical circulation treatment in a phase change interval is consistent with the temperature of body fluid, and the nickel-titanium alloy rotational grinding mechanism automatically expands and deforms.
In one embodiment of the present application:
the first form and the second form can be switched by changing the temperature, and the method further comprises the following steps:
when the thrombus plaque is removed, normal saline is conveyed to the periphery of the inner cavity of the blood vessel through the catheter cavity, the deformation recovery temperature of the nickel-titanium alloy rotary grinding mechanism subjected to repeated thermal mechanical cycle treatment in the phase change interval is consistent with the temperature of the normal saline, the shape of the nickel-titanium alloy rotary grinding mechanism is recovered to be a hollow cylinder, and the front end of the catheter is connected with the rear end of the catheter, so that the nickel-titanium alloy rotary grinding mechanism is not exposed in blood of the blood vessel any more.
In one embodiment of the present application:
before the removal of the thrombus plaque is finished, the method further comprises the following steps:
if the thrombus plaque fragment formed by the rotational grinding exceeds the size of the absorbable particles of the human body, the thrombus plaque fragment is sucked out of the body through the negative pressure suction effect of the catheter cavity;
if the rotational atherectomy plaque fragments are of a particle size that can be absorbed by the body, the thrombotic plaque fragments are absorbed by the body.
In one embodiment of the present application:
before the removal of the thrombus plaque is finished, the method further comprises the following steps:
the high temperature generated by the high-speed rotary grinding is lubricated and cooled by normal saline conveyed by the catheter cavity.
In one embodiment of the present application:
the repeated thermomechanical cyclic treatment of the phase change interval comprises the following steps:
m of nickel-titanium alloy rotary grinding mechanism f (martensite finish temperature) point corresponds to physiological saline temperature, A f (austenite phase transition finishing temperature) point corresponds to the body temperature of a human body, the shape of a parent phase is an ellipse shape,the temperature of the material is reduced to the temperature of normal saline in vitro, and the material is deformed into a deformed phase, namely a hollow cylinder shape.
In one embodiment of the present application:
the diameter size of the grinding head is larger than that of the conduit.
In one embodiment of the present application:
the guide wire is used to guide movement of the instrument and rotation of the drive shaft.
The technical scheme provided by the application can comprise the following beneficial effects: the nickel-titanium alloy material rotary grinding mechanism with the shape memory effect is adopted, when the nickel-titanium alloy rotary grinding mechanism enters a tiny pipeline (such as a blood vessel) along with a thrombus removal instrument, the nickel-titanium alloy rotary grinding mechanism is influenced by the body temperature of a human body, the interval pieces of the nickel-titanium alloy rotary grinding mechanism expand due to heating, gaps are formed between the interval pieces, and when the driving shaft rotates, the interval pieces after the expansion can be driven to rotate, so that the effect of cleaning silted up substances can be achieved. After the clogging objects are cleaned, the nickel-titanium alloy rotational grinding mechanism can be cooled through the heat transfer of the instrument, so that the state of the hollow cylinder is recovered, and the fine pipeline is convenient to draw away.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application.
Drawings
The foregoing and other objects, features and advantages of the application will be apparent from the following more particular descriptions of exemplary embodiments of the application, as illustrated in the accompanying drawings wherein like reference numbers generally represent like parts throughout the exemplary embodiments of the application.
FIG. 1 is a schematic view of a radially deformable thrombectomy device according to an embodiment of the present disclosure;
FIG. 2 is a schematic view of a thrombectomy device configured to perform rotational atherectomy to form a channel of a catheter according to an embodiment of the present application;
FIG. 3 is a schematic structural view of a thrombus removal device deformed after completion of a catheter channel according to an embodiment of the present application;
FIG. 4 is a schematic view of a thrombectomy device shown in an embodiment of the present application to remove thrombi plaque;
FIG. 5 is a schematic view of a thrombectomy device according to an embodiment of the present application, after removal of the thrombus;
Detailed Description
Preferred embodiments of the present application will be described in more detail below with reference to the accompanying drawings. While the preferred embodiments of the present application are shown in the drawings, it should be understood that the present application may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.
The first embodiment is as follows:
at present, the treatment methods of vascular thrombosis comprise anticoagulation treatment, surgical incision and thrombus removal, transcatheter direct thrombolysis treatment, balloon dilatation and stent implantation, and mechanical thrombectomy; the prior grinding head of the rotary grinding type mechanical thrombus removal instrument is easy to cause vascular injury in the process of arriving at and leaving from a focus and has poor safety.
In view of the above technical problems, the embodiments of the present application provide a radially deformable thrombus removal device.
Fig. 1 is a schematic view of a radially deformable thrombectomy device according to an embodiment of the present disclosure.
Referring to fig. 1, one embodiment of a radially deformable thrombus removal device in an embodiment of the present application comprises:
the device comprises a guide wire 1, a grinding head 2, a nickel-titanium alloy rotary grinding mechanism 3, a driving shaft 4, a catheter 5 and a catheter cavity 6;
the guide wire 1 is connected with the grinding head 2, and the grinding head 2 is connected with the driving shaft 4;
the inner cavity gap between the driving shaft 4 and the catheter 5 and the nickel-titanium alloy rotational grinding mechanism 3 forms a catheter cavity 6, and the catheter cavity 6 is used for delivering physiological saline and sucking thrombus;
the catheter 5 comprises a catheter front section 51 and a catheter rear end 52;
the nickel-titanium alloy rotational grinding mechanism 3 is positioned between the front end 51 of the catheter and the rear end 52 of the catheter;
the nickel-titanium alloy rotational grinding mechanism 3 is a hollow cylinder consisting of a plurality of interlayer sheets, and the nickel-titanium alloy rotational grinding mechanism 3 can radially expand and deform at 25-37 ℃.
It is understood that nitinol is a shape memory alloy that is a special alloy that automatically restores its plastic deformation to its original shape at a specific temperature, and is widely used in the field of interventional medicine.
In the embodiment of the application, the nickel-titanium alloy rotational grinding mechanism 3 is made of a nickel-titanium alloy material, and 4D printing and repeated thermal mechanical cycle processing of a phase change interval are respectively carried out, so that the nickel-titanium alloy rotational grinding mechanism has expansion deformation and a two-way memory effect.
4D printing is an additive manufacturing technology for realizing intelligent materials, and a sensitive element, a driving element and even a control element are integrated in a base material by utilizing an advanced material composite technology, so that the material structure has the capability of sensing external or internal state and characteristic changes and identifying according to the specific characteristics of the changes, thereby making reasonable response.
The grinding head 2 and the nickel-titanium alloy rotary grinding mechanism 3 are driven by the driving shaft 4 to rotate and are used for rotary grinding and removing thrombus.
In this application embodiment, owing to adopt nickel titanium alloy material that has shape memory effect to grind mechanism 3 soon, in nickel titanium alloy grinds mechanism 3 soon and gets into tiny pipeline (for example, blood vessel lumen 10) along with the thrombus clearance apparatus, nickel titanium alloy grinds mechanism 3 soon and receives the body temperature influence of human body, nickel titanium alloy grinds mechanism 3's piece thermal expansion uplift soon between piece for produce the clearance between piece and the piece between, when drive shaft 4 was rotatory simultaneously, can drive the piece between after the uplift and rotate, thereby can play the effect of clearance silt blockage thing. After the clogging objects are cleaned, the nickel-titanium alloy rotational grinding mechanism 3 can be cooled through the heat transfer of the apparatus, so that the hollow cylindrical state is recovered, and the fine pipeline is convenient to draw away.
The second embodiment:
in a practical application scenario, aiming at the way of removing thrombus plaque of a totally-occluded blood vessel, the application provides a thrombus removal device capable of radial deformation.
FIG. 1 is a schematic view of a radially deformable thrombectomy device according to an embodiment of the present disclosure;
FIG. 2 is a schematic view of a thrombectomy device configured to perform rotational atherectomy to form a channel of a catheter according to an embodiment of the present application;
FIG. 3 is a schematic structural view of a thrombus removal device deformed after completion of a catheter channel according to an embodiment of the present application;
FIG. 4 is a schematic view of a thrombectomy device according to an embodiment of the present application;
FIG. 5 is a schematic view of the thrombectomy device shown in the embodiment of the present application, shown after the thrombectomy device has cleared the thrombus;
referring to fig. 1-5, one embodiment of a radially deformable thrombus removal device in an embodiment of the present application comprises:
detecting the focus position of the target thrombus plaque 8 by means of intravascular ultrasound (IVUS) or Optical Coherence Tomography (OCT) and other detection means, performing 4D printing on the nickel-titanium alloy rotational grinding mechanism 3 by using nickel-titanium alloy powder according to the detection condition, and performing repeated thermal mechanical cycle processing on a phase change interval of the nickel-titanium alloy rotational grinding mechanism 3 after printing is completed, so that the nickel-titanium alloy rotational grinding mechanism 3 has a two-way shape memory effect which can generate first form and second form changes through external temperature changes;
in the embodiment of the application, the phase change region of the nickel-titanium alloy rotational grinding mechanism 3 is subjected to repeated thermal mechanical cycle treatment M f (martensite finish temperature) point was set to physiological saline temperature (25 ℃ C.), A f The point (austenite phase transition finishing temperature) is set to be the body temperature (37 degrees), so that the shape of the mother phase of the nickel-titanium alloy rotational grinding mechanism 3 is an elliptical shape, namely, the shape I is expanded into a plurality of interlayer sheets; the material is cooled to 25 degrees in vitro and then deformed into a deformed phase, namely the shape II is a hollow cylinder shape formed by closely attaching a plurality of interlayer sheets;
at this time, the nitinol rotational atherectomy mechanism 3 is assembled into the entire thrombectomy device, and the catheter front end 51 and the catheter rear end 52 of the catheter 5 are connected at both ends, such that the nitinol rotational atherectomy mechanism 3 is enclosed within the lumen of the catheter 5.
For a completely occluded blood vessel, under the guidance of a guide wire 1, the whole thrombus removal device reaches the focus of a target thrombus plaque 8, a driving shaft 4 drives a grinding head 2 at the front end of a catheter 5 to rotate at a high speed, the grinding head 2 is a traditional nickel-plated diamond grinding head, the diameter of the grinding head 2 is larger than the diameter (1.0-1.5 mm) of the catheter 5, and the rotating speed of the grinding head can reach 100000r/min-140000r/min.
Meanwhile, the normal saline 9 is conveyed to the catheter cavity 6, and because the front end 51 of the catheter is connected with the rear end 52 of the catheter, the normal saline 9 can flow out of the foremost end of the catheter 5, and has the lubricating and cooling effects on the grinding head 2 of the high-speed rotary grinding.
When the grinding head 2 forms a conduit channel after being rotationally ground, the whole thrombus removing device moves backwards to the front end of the thrombus plaque 8, the normal saline 9 is stopped being conveyed to the conduit cavity 6, the front end 51 of the conduit is separated from the rear end 52 of the conduit, the nickel-titanium alloy rotational grinding mechanism 3 is exposed in the inner cavity 10 of the blood vessel and is deformed under the influence of the body temperature of a human body, and the nickel-titanium alloy rotational grinding mechanism is restored to a parent phase ellipsoid shape; at the moment, the driving shaft 4 drives the middle piece of the nickel-titanium alloy grinding head 3 to carry out rotary grinding, and the rotating speed is less than 50000r/min.
If the rotational atherectomy plaque debris 11 exceeds the size of the human body's absorbable particles, the atherectomy plaque debris 11 is removed from the body by the negative pressure suction from the catheter lumen 6.
After the thrombus plaque 8 which can not be absorbed by the human body is removed, the negative pressure suction function of the catheter cavity 6 is stopped, the physiological saline 9 with the temperature of 25 degrees is conveyed to the catheter cavity 6, the physiological saline 9 with the specific temperature enables the interlayer of the nickel titanium rotational grinding mechanism 3 to generate the shape change, the interlayer is deformed into a deformation phase again, namely, a hollow cylinder shape, at the moment, the two ends of the front end 51 of the catheter and the two ends of the rear end 52 of the catheter are connected, the physiological saline 9 is stopped being conveyed to the catheter cavity 6, and the whole thrombus removal device is taken out from the body under the guidance of the guide wire 1.
In the embodiment of the application, the grinding head 2 is arranged at the front end of the catheter 6, so that the completely occluded blood vessel can be conducted through the grinding head 2 in a rotary grinding way, and the occluded thrombus 8 can be conveniently crushed and removed.
In the process of removing the thrombus plaque 8, the inter-piece of the nickel-titanium alloy grinding head 3 is self-expanded to the target diameter, thereby being beneficial to further rotatably grinding and removing the thrombus plaque 8.
When the thrombus cleaning device reaches and keeps away from the 8 focus areas of thrombus plaque, the inter-piece self-recovery through the nickel-titanium alloy grinding head 3 is the minimum shape, namely the hollow cylinder shape, which is beneficial to the thrombus cleaning device to enter and leave the body, avoids the device from causing vascular injury, and improves the operability and the safety.
Example three:
in a practical application scenario, aiming at a way of removing thrombus and plaque of a non-completely occluded blood vessel, the application provides a thrombus removal device capable of deforming radially.
FIG. 1 is a schematic view of a radially deformable thrombectomy device according to an embodiment of the present application;
FIG. 4 is a schematic view of a thrombectomy device shown in an embodiment of the present application to remove thrombi plaque;
FIG. 5 is a schematic view of the thrombectomy device shown in the embodiment of the present application, shown after the thrombectomy device has cleared the thrombus;
referring to fig. 1, 4 and 5, one embodiment of a radially deformable thrombus removal device in an embodiment of the present application comprises:
and detecting the focus part of the target thrombus plaque 8 by means of blood vessel ultrasound (IVUS) or Optical Coherence Tomography (OCT) and other detection means, performing 4D printing on the nickel-titanium alloy rotational grinding mechanism 3 by using nickel-titanium alloy powder according to the detection condition, and performing repeated thermal mechanical cycle processing on the phase change interval of the nickel-titanium alloy rotational grinding mechanism 3 after printing is completed, so that the nickel-titanium alloy rotational grinding mechanism 3 has a two-way shape memory effect which can generate first and second changes of shape through external temperature change.
In the embodiment of the present application, the steps of repeating the thermo-mechanical cycle processing and assembling to the whole thrombectomy device in the phase transition region of the nitinol rotational atherectomy mechanism 3 are the same as those in example 2, and the details of the embodiment of the present application are not repeated.
For a non-completely occluded blood vessel, after the phase change interval of the nickel-titanium alloy rotational grinding mechanism 3 is completed, the thermal mechanical cycle treatment is repeated and the whole thrombus clearing device is assembled, under the guidance of the guide wire 1, the whole thrombus clearing device 3 directly reaches the focus part of the target thrombus plaque 8, the thrombus plaque is not required to be rotationally ground by the grinding head 2 at the foremost end of the catheter 5 to form a catheter channel, but the front end 51 of the catheter is separated from the rear end 52 of the catheter, so that the nickel-titanium alloy rotational grinding mechanism 3 is exposed in the blood vessel inner cavity 10 and is subjected to morphological change under the influence of the body temperature of a human body, namely, the shape is recovered to the parent phase ellipsoid.
The driving shaft 4 drives the inter-piece of the nickel-titanium alloy grinding head 3 to carry out rotary grinding at the rotating speed of less than 50000r/min, and thrombus plaque fragments 11 formed after the rotary grinding are sucked out of the body under the negative pressure suction effect of the catheter 6.
After the thrombus plaque 8 is removed, normal saline 9 with the temperature of 25 degrees is also conveyed to the guide tube cavity 6, the normal saline 9 with the specific temperature enables the interlayer of the nickel titanium rotational grinding mechanism 3 to change the shape and deform into a deformed phase, namely a hollow cylinder shape, at the moment, the two ends of the front end 51 of the guide tube and the rear end 52 of the guide tube are connected, the normal saline 9 is stopped to be conveyed to the guide tube cavity 6, and the whole thrombus removal device is taken out of the body under the guidance of the guide wire 1.
Aiming at a non-completely-occluded blood vessel, the whole thrombus clearing device 3 directly reaches the focus position of a target thrombus plaque 8 under the guidance of the guide wire 1, and a catheter channel is formed without adopting the grinding head 2 at the foremost end of the catheter 5 to grind the thrombus plaque 8 in a rotating mode.
The thrombus clearing device capable of deforming radially provided by the embodiment of the application is beneficial to the rotational grinding clearing of the thrombus plaque 8 by self-expanding the inter-piece of the nickel-titanium alloy grinding head 3 to the diameter of a target in the process of clearing the thrombus plaque 8.
Meanwhile, when the thrombus removing device reaches and is far away from the lesion area of the thrombus plaque 8, the spacer self-recovers to the minimum shape through the nickel-titanium alloy grinding head 3, namely the hollow cylinder shape, so that the thrombus removing device can enter and leave the body, the vascular injury caused by the device is avoided, and the operability and the safety are improved.
The foregoing description of the embodiments of the present application has been presented for purposes of illustration and description and is not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen in order to best explain the principles of the embodiments, the practical application, or improvements made to the technology in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

Claims (9)

1. A radially deformable thrombectomy device, comprising: the device comprises a guide wire (1), a grinding head (2), a nickel-titanium alloy rotary grinding mechanism (3), a driving shaft (4), a catheter (5) and a catheter cavity (6);
the guide wire (1) penetrates through the grinding head (2) and the driving shaft (4), and the grinding head (2) is connected with the driving shaft (4);
the inner cavity gap between the driving shaft (4) and the catheter (5) and the nickel-titanium alloy rotational grinding mechanism (3) forms a catheter cavity (6), and the catheter cavity (6) is used for conveying normal saline and sucking thrombus;
the catheter (5) comprises a catheter front end (51) and a catheter rear end (52);
the nickel-titanium alloy rotational grinding mechanism (3) is positioned between the front end (51) of the catheter and the rear end (52) of the catheter;
the nickel-titanium alloy rotational grinding mechanism (3) is a hollow cylinder consisting of a plurality of interlayer sheets, and the nickel-titanium alloy rotational grinding mechanism (3) can radially expand and deform at 25-37 ℃;
the grinding head (2) and the nickel-titanium alloy rotary grinding mechanism (3) are driven by the driving shaft (4) to rotate and are used for rotary grinding and removing thrombus;
the diameter size of the grinding head (2) is larger than that of the conduit (5).
2. A radially deformable thrombus removal device according to claim 1, comprising:
the nickel-titanium alloy rotary grinding mechanism (3) is made of nickel-titanium alloy materials, and 4D printing and repeated thermal mechanical cycle processing in a phase change interval are respectively carried out, so that the nickel-titanium alloy rotary grinding mechanism has a two-way memory effect.
3. A radially deformable thrombus removal device according to claim 2, comprising:
the two-way memory effect comprises the formation and the maintenance of two stable forms:
the first form is that the nickel-titanium alloy rotational grinding mechanism (3) is in a shape of a slender hollow cylinder and is tightly attached to the driving shaft (4) so as to keep the minimum volume form;
the second form: the nickel-titanium alloy rotary grinding mechanism (3) automatically expands and deforms from an original hollow cylinder shape to an oval shape so as to achieve the maximum volume form;
the first form and the second form can be switched by changing the temperature.
4. A radially deformable thrombectomy device according to claim 3,
the first form and the second form can be switched by changing the temperature, and the method comprises the following steps:
controlling the morphological change by the body fluid temperature and the temperature of the physiological saline (9);
when thrombus is removed, the catheter (5) enters a lesion area of a target thrombus plaque (8), the front end (51) and the rear end (52) of the catheter in a connection state are separated, the nickel-titanium alloy rotational grinding mechanism (3) is exposed in a blood vessel wall (7) and a blood vessel inner cavity (10), the deformation temperature of the nickel-titanium alloy rotational grinding mechanism (3) subjected to repeated thermomechanical circulation treatment in a phase change interval is consistent with the temperature of body fluid, and the nickel-titanium alloy rotational grinding mechanism (3) is subjected to automatic expansion deformation.
5. A radially deformable thrombectomy device according to claim 4,
the first form and the second form can be switched by changing the temperature, and the method further comprises the following steps:
when the thrombus and plaque are removed, normal saline (9) is conveyed to the periphery of the inner cavity (10) of the blood vessel through the catheter cavity (6), the deformation recovery temperature of the nickel-titanium alloy rotational grinding mechanism (3) subjected to repeated thermal mechanical circulation treatment in a phase change interval is consistent with the temperature of the normal saline, the shape of the nickel-titanium alloy rotational grinding mechanism (3) is recovered to be in a hollow cylindrical shape, and two ends of the front end (51) of the catheter are connected with two ends of the rear end (52) of the catheter, so that the nickel-titanium alloy rotational grinding mechanism (3) is not exposed in blood of the blood vessel any more.
6. A radially deformable thrombectomy device according to claim 5,
before the removal of the thrombus plaque is finished, the method further comprises the following steps:
if the thrombus plaque fragment (11) formed by the rotational grinding exceeds the size of absorbable particles of a human body, the thrombus plaque fragment (11) is pumped out of the body through the negative pressure suction effect of the catheter cavity (6);
if the rotational grinding formed thrombus plaque fragments (11) can be absorbed by the human body, the thrombus plaque fragments (11) can be absorbed by the human body.
7. A radially deformable thrombectomy device according to claim 5,
before the removal of the thrombus plaque is finished, the method further comprises the following steps:
the high temperature generated by the high-speed rotational grinding is lubricated and cooled by the physiological saline (9) conveyed by the catheter cavity (6).
8. A radially deformable thrombectomy device according to claim 2,
the repeated thermal mechanical cycle treatment of the phase change interval comprises the following steps:
m of the nickel-titanium alloy rotary grinding mechanism (3) f (martensite finish temperature) point corresponds to the temperature of the physiological saline (9), A f The (austenite phase transition finishing temperature) point corresponds to the body temperature of a human body, the shape of the parent phase is an elliptical shape, and the parent phase is cooled to the temperature of normal saline in vitro and is deformed into a deformed phase, namely a hollow cylinder shape.
9. A radially deformable thrombectomy device according to claim 1,
the guide wire (1) is used for guiding the movement of the instrument and the rotation of the driving shaft (4).
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