CN114403983A - Thrombus extraction device and design method thereof - Google Patents
Thrombus extraction device and design method thereof Download PDFInfo
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- CN114403983A CN114403983A CN202111583890.XA CN202111583890A CN114403983A CN 114403983 A CN114403983 A CN 114403983A CN 202111583890 A CN202111583890 A CN 202111583890A CN 114403983 A CN114403983 A CN 114403983A
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- 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
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
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- 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
- A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
- A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
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- A—HUMAN NECESSITIES
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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Abstract
The invention provides a bolt taking device and a design method thereof, wherein the bolt taking device comprises a distal bolt locking bracket, a tail shaft, a first mark developing ring, a proximal bolt taking bracket, a second mark developing ring and a fixed connection outer tube; one end of the tail shaft is provided with a locking bolt support, the other end of the tail shaft is provided with a fixed connection outer pipe, the bolt taking support covers the periphery of the tail shaft, and two ends of the bolt taking support are respectively connected with the tail shaft; the tail end of the breaking bolt support is provided with a developing material. The thrombus taking device is suitable for various blood vessel environments including intracranial blood vessels, and has the advantages of small damage to blood vessel walls, accurate thrombus taking and positioning, clean thrombus taking and simple operation.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a thrombus removal device and a design method thereof.
Background
Cerebral thrombosis is one kind of ischemic cerebrovascular disease, and is caused by cerebral arteriosclerosis, rough lumen intima, narrow lumen, and coagulation factors coagulated into block in the lumen under certain conditions, such as blood pressure decrease, slow blood flow, high blood viscosity, high platelet aggregation, etc. to form thrombus and to block blood vessel and interrupt blood flow, so as to cause cerebral tissue in blood supply area to become ischemic, anoxic, softened and necrotic.
The current methods for treating all vascular embolic diseases have two types: drug thrombolysis and mechanical thrombus removal.
The drug thrombolysis is a therapeutic means for promoting fibrinolysis and dissolving thrombus by taking thrombolytic drugs. The advantages of rapid blood vessel opening of the patient, minimized nerve defect symptom of the patient, suitability for small thrombus, certain indication and contraindication, and occurrence of complications such as cerebral hemorrhage on patients with unsuitable physique.
The mechanical thrombus removal is a technical method for recovering blood flow of a blood vessel by puncturing the femoral artery, passing a thrombus removal device through the blood vessel to the position of blood vessel occlusion, then passing the blood vessel occlusion, and removing the thrombus through the thrombus removal device or a thrombus removal catheter. The mechanical embolectomy comprises the following methods: thrombectomy, which can achieve thorough thrombus removal but can damage the vessel wall to a great extent; the method has the advantages that the operability is not high, the requirement on the size of laser energy is severe, the laser energy is ineffective when the laser energy is too low, blood vessels are damaged when the energy is too high, and various inflammations are easily caused; the catcher is used for taking thrombus, so that the injury to the blood vessel wall is small, but blood clots can not be sleeved frequently; the thrombus supplementing net can not be used in intracranial blood vessels although the operation is simple.
Although the existing thrombus removal device can complete thrombus removal work, most devices cannot flexibly adjust the radial size, have poor capability of adapting to different blood vessel environments, are easy to damage blood vessel walls, cannot completely remove thrombus, and cause secondary blockage caused by broken thrombus flowing into other small blood vessels.
Disclosure of Invention
Aiming at the technical problems, the invention provides a thrombus taking device and a design method thereof, wherein the thrombus taking device is suitable for various blood vessel environments including intracranial blood vessels, and has the advantages of small damage to blood vessel walls, accurate thrombus taking and positioning, improvement of thrombus taking cleanness and simple operation.
The technical scheme of the invention is as follows:
a thrombus removal device comprises a distal locking thrombus support, a tail shaft, a first mark developing ring, a proximal thrombus removal support, a second mark developing ring and a fixed connection outer tube;
one end of the tail shaft is provided with a locking bolt support, the other end of the tail shaft is provided with a fixed connection outer pipe, the bolt taking support covers the periphery of the tail shaft, and two ends of the bolt taking support are respectively connected with the tail shaft; the tail end of the breaking bolt support is provided with a developing material.
In the above scheme, the locking bolt support is a horn-shaped structure with an open distal end formed by meshes.
Furthermore, the diameter of the far-end opening circle of the locking bolt support is 3-6 mm, the opening type horn-shaped structure can be opened and closed, and the opening and closing range is 1.5-6 mm.
Furthermore, the mesh shape of the bolt locking bracket is a trapezoid with curved edges.
In the scheme, the embolectomy support is in a shuttle-shaped structure formed by meshes.
In the scheme, the meshes of the bolt taking bracket are larger than those of the bolt locking bracket.
In the above scheme, the fixed connection outer pipe is of a hollow structure.
In the above scheme, the first mark developing ring and the second mark developing ring are both hollow structures.
In the scheme, the diameter of the inner circle of the mark developing ring is 1.2-1.3 times of the diameter of the tail shaft.
In the scheme, a covering film is arranged at the joint of the bolt locking bracket and the bolt taking bracket; the film is made of degradable high polymer material.
A design method of the thrombus removal device comprises the following steps:
s1, collecting three-dimensional scanning information data of the blood vessel pathological change part of the patient, and analyzing the characteristics of the pathological change part;
step S2, importing the three-dimensional scanning data of the vascular lesion part of the patient into a computer, restoring the three-dimensional image of the scanned part of the patient, analyzing the three-dimensional image to obtain the data of the thrombus removal device, and constructing a three-dimensional model of the thrombus removal device;
step S3, storing the three-dimensional model structure data of the thrombus taking device as a format file, wherein the structure data comprises the size of the stent, the surface coverage rate, the radial supporting force, the extensibility and the longitudinal shortening rate of the stent;
step S4, 3D printing the embolectomy device to obtain a physical model of the embolectomy device;
and S5, performing surface treatment on the physical model of the thrombus removal device according to the 3D printing effect, and spraying a hydrophilic nano coating.
Compared with the prior art, the invention has the beneficial effects that:
the thrombus taking device provided by the invention is suitable for various blood vessel environments including intracranial blood vessels, and has the advantages of small damage to blood vessel walls, accurate thrombus taking positioning, clean thrombus taking and simplicity in operation. The broken thrombus locking bracket adopts an open horn-shaped structure, so that a catching net of the broken thrombus locking bracket can be favorably paved on the whole section of a blood vessel, and the broken thrombus is prevented from escaping; the basic composition unit of the broken bolt locking bracket is a fine grid with a bent edge trapezoidal shape, so that the opening and closing action of the whole structure is favorably realized, and the broken bolt can be further locked by the fine grid; the garrulous bolt support of lock passes through behind first mark development ring, the first mark development ring assembly in connecing the outer tube surely through its tail shaft, and axial displacement through the artificial operation tail shaft in connecing the outer tube surely makes the garrulous bolt support of lock be axial displacement through first mark development ring, the tubaeform structure of the garrulous bolt support of lock can open and shut under the restraint of circle in first mark development ring when developing the ring through first mark, if the tail shaft is to the near-end removal then the garrulous bolt support of distal end be closed motion, if the tail shaft is to the distal end removal then the garrulous bolt support of distal end be the motion of opening to the change of the garrulous bolt support radial dimension of realization change distal end is in order to adapt to different vascular environment.
Drawings
FIG. 1 is a schematic structural view of a thrombus removal device according to an embodiment of the present invention;
FIG. 2 is a schematic view of the distal deadbolt bracket configuration shown in FIG. 1;
FIG. 3 is a schematic view of the distal end of the deadbolt bracket grid cell of FIG. 1.
Wherein: 1. a developing material; 2. breaking the bolt support; 3. a tail shaft; 4. a first mark development ring; 5. a thrombus taking support; 6. a second mark development ring; 7. and (4) fixedly connecting the outer pipe.
Detailed Description
Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention.
In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "axial," "radial," "vertical," "horizontal," "inner," "outer," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the present invention and for simplicity in description, and are not intended to indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting. Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.
In the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
Fig. 1 and 2 show a preferred embodiment of the embolectomy device of the invention, which comprises a distal locking bolt support 2, a tail shaft 3, a first mark development ring 4, a proximal embolectomy support 5, a second mark development ring 6 and a fixed outer tube 7; one end of the tail shaft 3 is provided with a locking bolt support 2, the other end of the tail shaft is provided with a fixed connection outer tube 7, a bolt taking support 5 covers the periphery of the tail shaft 3, and two ends of the bolt taking support 5 are respectively connected with the tail shaft 3, the first mark developing ring 4 is arranged between the bolt taking support 5 and the locking bolt support 2, and the second mark developing ring 6 is arranged between the bolt taking support 5 and the fixed connection outer tube 7; the developing material 1 is arranged at the tail end of the breaking bolt support 2.
According to the present embodiment, the tumbler holders 2 are preferably in the form of a mesh-like flared structure with open distal ends. The bolt locking bracket 2 is connected with a tail shaft 3 in a flexible connection mode. The bracket 2 for locking the broken thrombus adopts an open horn-shaped structure, which is beneficial to the catching net to fully cover the whole section of the blood vessel and prevent the broken thrombus from escaping.
According to this embodiment, it is preferred, the diameter of the distal end opening circle of broken bolt support 2 of lock is 3 ~ 6mm, and open type horn structure can open and shut, and open and shut the scope and be 1.5 ~ 6mm to make the support have low extrusion rigidity, good adherence, thereby make get the bolt more thorough, do not omit marginal thrombus.
According to the present embodiment, it is preferable that the mesh shape of the cylinder tumbler bracket 2 is a curved trapezoid. The basic composition unit of the bolt locking bracket 2 is a fine grid with a curved trapezoid shape, which is beneficial to realizing the opening and closing effect of the whole structure, and the fine grid can further lock the bolt.
According to the present embodiment, the embolectomy stent 5 is preferably a shuttle-shaped structure formed by meshes, and plays a main embolectomy role.
According to the present embodiment, it is preferable that the mesh of the thrombectomy stent 5 is larger than the mesh of the thrombectomy stent 2.
According to the present embodiment, preferably, the fixed outer tube 7 has a hollow structure. The tail shaft 3 passes through the first developing marking ring 4 and the second developing marking ring, is arranged in the fixed outer tube 7 and can move along the axial direction.
According to the present embodiment, it is preferable that the first mark development ring 4 and the second mark development ring 6 are both hollow structures.
According to the embodiment, preferably, the diameter of the inner circle of the mark developing ring 1 is 1.2 to 1.3 times of the diameter of the tail shaft 3, and the mark developing ring and the tail shaft 3 move in a matched mode to complete opening and closing of the whole structure.
According to the embodiment, a covering film is preferably arranged at the joint of the bolt locking bracket 2 and the bolt removing bracket 5; the film is made of degradable high polymer material.
The bolt support 2 is matched with the fixed connection outer tube 7 through the tail shaft 3 of the bolt support to form an integral support structure through the first mark developing ring 4 and the second mark developing ring 6. The integral structure of the bolt locking support 2 is in a horn-shaped structure, so that the bolt locking support can pass through the matching movement of the tail shaft 3 and the first mark developing ring 4 to complete the opening and closing of the integral structure, namely the expansion and contraction of the radial size of the integral support. The composition grid of the bolt locking support 2 adopts a curved-edge trapezoidal basic structure, and the horn-shaped structure and the characteristic of free contraction and opening of the support are ensured through the change of radians of two curved edges of the curved-edge trapezoidal basic structure.
The basic composition grid shape of the bolt locking bracket 2 is a curved edge trapezoidal structure as shown in fig. 3, wherein the radian of the curved edge is variable, so that the opening and closing of the whole structure are realized; the basic composition grid size of the locking bolt bracket 2 at the far end is smaller than that of the bolt taking bracket 5, so that the missing bolt blocks of the bolt taking bracket at the near end can be locked.
The structure of the integral device is formed by connecting a distal bolt locking bracket 2 and a proximal bolt taking bracket 5 in series. The distal locking bolt support 2 is a horn-shaped structure formed by meshes, and the opening size can be automatically changed according to the diameter of a located blood vessel so as to adapt to different working environments; the thrombus taking bracket 5 at the near end is a main thrombus taking working device, and the thrombus taking device has the advantages of simple structure, wide applicability and complete thrombus taking.
Make the garrulous bolt support of lock 2 through the axial displacement of artificial operation tail-shaft 3 in the butt joint outer tube 7 and do axial displacement through first mark development ring 4, the tubaeform structure of the garrulous bolt support of lock 2 can open and shut under the restriction of circle in first mark development ring 4 when passing through first mark development ring 4, if tail-shaft 3 moves to the near-end then the garrulous bolt support of lock 2 of distal end is closed motion, if tail-shaft 3 moves to the distal end then the garrulous bolt support of lock 2 of distal end do open the motion to the change of the garrulous bolt support of lock 2 radial dimension of distal end is realized changing in order to adapt to different vascular environment.
The design of the thrombus removal device is as follows: collecting three-dimensional scanning information data of a blood vessel pathological change part of a patient, and analyzing the structural characteristics of the three-dimensional scanning information data; accurately restoring by a computer to obtain a three-dimensional image of a scanned part of a patient; analyzing the anatomical three-dimensional image to obtain reverse data of the scanned part, and storing the reverse data into a database; designing a three-dimensional model of the bolt taking device for preventing the broken bolt from falling off through a computer according to the reverse data; storing the structure data as a format file; the data is compared with other data in the database for detection, and the improvement and optimization are carried out; 3D printing a bolt taking device for preventing the broken bolt from falling off quickly realizes a physical model; according to the 3D printing effect, appropriate surface treatment is carried out to meet the use requirement. The mechanical movement function of the thrombus removal device for preventing thrombus from falling off is realized by individually designing and manufacturing the thrombus removal support according to the difference of lesion parts of different patients based on the individual three-dimensional structure data and characteristics.
The design method of the thrombus removal device specifically comprises the following steps:
step S1, collecting three-dimensional scanning information data of a diseased part of a blood vessel of a patient, analyzing characteristics of the diseased part, and reporting the size, the thickness, the size, the elasticity and the like of the diseased part;
step S2, importing the three-dimensional scanning data of the blood vessel pathological change part of the patient into a computer, and restoring the three-dimensional image of the scanned part of the patient; analyzing the three-dimensional image to obtain data of the thrombus removal device and constructing a three-dimensional model of the thrombus removal device;
step S3, storing the three-dimensional model structure data of the thrombus removal device as a format file for transmission, storage, browsing, inspection, modification and processing production, wherein the structure data comprises the size of the stent, the surface coverage rate, the radial supporting force, the extensibility and the longitudinal shortening rate of the stent;
step S4, 3D printing the embolectomy device to obtain a physical model of the embolectomy device;
and S5, carrying out appropriate surface treatment on the physical model of the thrombus removal device according to the 3D printing effect, and spraying a hydrophilic nano coating to meet the use requirement.
The sprayed hydrophilic nano coating can greatly reduce the friction resistance coefficient after contacting with aqueous solution or body fluid, thereby reducing the discomfort of patients, reducing the damage to human tissues, improving the operability of equipment and reducing the operation time.
The design method is characterized in that the thrombus removal device is designed and manufactured in a personalized manner according to the difference of lesion parts of different patients, so that the thrombus removal device is more suitable for the requirements of the patients, the injury to the vascular wall is small, the thrombus removal positioning is accurate, and the thrombus removal cleanness is further improved.
The thrombus taking device provided by the invention has the use process that:
step S1, manufacturing a blood vessel embolectomy stent with proper stent expansion size according to the information of the size and the like of the diseased blood vessel, and connecting the stent with a delivery wire;
s2, grasping the blood vessel thrombus-taking support 5, and contracting the thrombus-taking support 5 to the tightest to ensure that the radial size of the support is the smallest, so as to prevent the injury of the blood vessel wall when releasing the support;
step S3, pushing the thrombus taking support 5 by using a conveying wire, releasing the support, enabling the thrombus to be taken to be positioned between the first mark developing ring 4 and the second mark developing ring 6 according to position feedback given by the first mark developing ring 4 and the second mark developing ring 6, and enabling the distal locking thrombus support 2 to perform opening movement when the pushing tail shaft 3 moves towards the distal end, so that the thrombus taking support 5 is self-expanded and is fused into the thrombus;
step S4, the thrombus-taking stent 5 fused with the thrombus is slowly pulled out, most thrombus fragments can not pass through the meshes and can not drift to a far-end blood vessel along with the blood flow, and therefore the function of far-end protection is achieved.
The thrombus taking device provided by the invention is suitable for various blood vessel environments including intracranial blood vessels, and has the advantages of small damage to blood vessel walls, accurate thrombus taking positioning, clean thrombus taking and simplicity in operation.
It should be understood that although the present description has been described in terms of various embodiments, not every embodiment includes only a single embodiment, and such description is for clarity purposes only, and those skilled in the art will recognize that the embodiments described herein may be combined as suitable to form other embodiments, as will be appreciated by those skilled in the art.
The above-listed detailed description is only a specific description of a possible embodiment of the present invention, and they are not intended to limit the scope of the present invention, and equivalent embodiments or modifications made without departing from the technical spirit of the present invention should be included in the scope of the present invention.
Claims (10)
1. The thrombus removal device is characterized by comprising a distal-end bolt locking bracket (2), a tail shaft (3), a first mark developing ring (4), a proximal-end bolt removal bracket (5), a second mark developing ring (6) and a fixed connection outer tube (7);
one end of the tail shaft (3) is provided with a bolt locking bracket (2), the other end of the tail shaft is provided with a fixed connection outer tube (7), the bolt taking bracket (5) covers the periphery of the tail shaft (3), the two ends of the bolt taking bracket are respectively connected with the tail shaft (3), the first mark developing ring (4) is arranged between the bolt taking bracket (5) and the bolt locking bracket (2), and the second mark developing ring (6) is arranged between the bolt taking bracket (5) and the fixed connection outer tube (7); the tail end of the breaking bolt support (2) is provided with a developing material (1).
2. The embolectomy device of claim 1, wherein the breaking bolt support (2) is a flared structure with open distal end formed by mesh.
3. The embolectomy device of claim 2, wherein the diameter of the distal opening circle of the breaking bolt support (2) is 3-6 mm, and the opening type trumpet-shaped structure can be opened and closed within the range of 1.5-6 mm.
4. The embolectomy device of claim 2, wherein the mesh shape of the tumbler holder (2) is a curved trapezoid.
5. The embolectomy device of claim 1, wherein the embolectomy support (5) is a shuttle-shaped structure formed of mesh.
6. The embolectomy device of claim 2, wherein the mesh of the embolectomy support (5) is larger than the mesh of the locking embolus support (2).
7. The embolectomy device of claim 1, wherein the first marker development ring (4), the second marker development ring (6) and the outer fixation tube (7) are all hollow structures.
8. The embolectomy device of claim 7, wherein the diameter of the inner circle of the mark development ring (1) is 1.2-1.3 times the diameter of the tail shaft (3).
9. The embolectomy device of claim 1, wherein a coating is arranged at the joint of the broken bolt support (2) and the embolectomy support (5); the film is made of degradable high polymer material.
10. A method for designing a thrombus removal device according to any one of claims 1 to 9, comprising the steps of:
s1, collecting three-dimensional scanning information data of the blood vessel pathological change part of the patient, and analyzing the characteristics of the pathological change part;
step S2, importing the three-dimensional scanning data of the vascular lesion part of the patient into a computer, restoring the three-dimensional image of the scanned part of the patient, analyzing the three-dimensional image to obtain the data of the thrombus removal device, and constructing a three-dimensional model of the thrombus removal device;
step S3, storing the three-dimensional model structure data of the thrombus taking device as a format file, wherein the structure data comprises the size of the stent, the surface coverage rate, the radial supporting force, the extensibility and the longitudinal shortening rate of the stent;
step S4, 3D printing the embolectomy device to obtain a physical model of the embolectomy device;
and S5, performing surface treatment on the physical model of the thrombus removal device according to the 3D printing effect, and spraying a hydrophilic nano coating.
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| CN202111583890.XA CN114403983A (en) | 2021-12-22 | 2021-12-22 | Thrombus extraction device and design method thereof |
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| CN202111583890.XA CN114403983A (en) | 2021-12-22 | 2021-12-22 | Thrombus extraction device and design method thereof |
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| CN202111583890.XA Pending CN114403983A (en) | 2021-12-22 | 2021-12-22 | Thrombus extraction device and design method thereof |
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