CN113440217A - Thrombectomy device and medical device - Google Patents
Thrombectomy device and medical device Download PDFInfo
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- CN113440217A CN113440217A CN202110850136.1A CN202110850136A CN113440217A CN 113440217 A CN113440217 A CN 113440217A CN 202110850136 A CN202110850136 A CN 202110850136A CN 113440217 A CN113440217 A CN 113440217A
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- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
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- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
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Abstract
本发明提供了一种取栓装置及医用装置，所述医用装置包括所述取栓装置，所述取栓装置包括推送轴、取栓支架及辅助机构，其中所述取栓支架为自膨式支架，并固定连接于所述推送轴的远端；所述辅助机构部分地设置在所述取栓支架的内部，并用于向所述取栓支架施加径向向外的扩张力，以使所述取栓支架在自扩张之后还能够沿径向执行第二次扩张。利用所述取栓装置抓捕血栓，若所述取栓支架的径向力不足导致不能有效抓捕血栓时，可利用所述辅助机构向所述取栓支架施加所述扩张力，以使所述取栓支架二次扩张并增强径向力，提高血栓抓捕效果。
The present invention provides a thrombectomy device and a medical device. The medical device includes the thrombectomy device, and the thrombectomy device includes a push shaft, a thrombectomy bracket and an auxiliary mechanism, wherein the thrombus retrieval bracket is a self-expanding type. The stent is fixedly connected to the distal end of the push shaft; the auxiliary mechanism is partially arranged inside the thrombus removal stent, and is used to apply radial outward expansion force to the thrombus removal stent, so that the The thrombectomy stent can also perform a second expansion in the radial direction after self-expansion. The thrombectomy device is used to capture the thrombus. If the radial force of the thrombectomy stent is insufficient to effectively capture the thrombus, the auxiliary mechanism can be used to apply the expansion force to the thrombectomy stent, so that the thrombectomy stent cannot be effectively captured. The thrombectomy stent is expanded twice and the radial force is enhanced to improve the thrombus capturing effect.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a thrombus removal device and a medical device.
Background
Acute stroke is a common cerebrovascular disease, has acute onset, rapid development, severe symptoms, high disability rate and high fatality rate, and belongs to a critical condition in cerebrovascular diseases. Generally, cerebral apoplexy can be divided into hemorrhagic type and ischemic type, wherein the proportion of ischemic cerebral apoplexy can reach 70-80%. The pathogenesis of acute ischemic stroke is that thrombus or arteriosclerosis plaque dropped from the wall of a diseased blood vessel causes acute occlusion of cerebral arteries, and further causes a series of physiological and pathological reactions such as inflammatory reaction, apoptosis and the like of ischemic brain tissues. If the blood perfusion of the occluded cerebral artery is recovered in a short time, the cell metabolism of the brain tissue can be recovered to be normal, and the development of an infarct area is avoided.
In the prior art, the main treatment methods of acute ischemic stroke include intravenous thrombolysis and interventional thrombus extraction. The intravenous thrombolysis is intravenous injection thrombolysis medicine, the treatment time window is within three hours after the disease occurs, however, most patients miss the treatment time window when arriving at a hospital after the disease occurs, the thrombolysis effect is seriously reduced, and the blocked blood vessel can not be effectively opened. The interventional thrombus removal is to introduce a thrombus removal device through the femoral artery and remove the thrombus by using the thrombus removal device. The time window for interventional embolectomy is within eight hours after onset of disease. In recent years, the interventional therapy of acute ischemic stroke is rapidly developed, and based on a series of clinical random control tests, the related international organization recommends that a treatment method for interventional embolectomy can be preferentially considered for patients with large vessel occlusion within six hours.
Interventional embolectomy can be broadly divided into two categories: mechanical embolectomy and aspiration embolectomy. Among them, mechanical embolectomy has been developed to date through iteration of first generation embolectomy devices MERCI, second generation embolectomy devices Penumbra (consisting of a reperfusion catheter and a separator), and Solitaire FR (closed loop stent sculpted by laser), third generation embolectomy devices Treo (fully visualized), and Revive (closed distal basket). The mainstream mechanical thrombus extraction method at present is to deliver a microcatheter embedded with a thrombus extraction stent into the body with the aid of a microcatheter, pass through the thrombus or pass through the gap between the thrombus and the blood vessel wall to reach the distal side of the thrombus, and then withdraw the microcatheter and release the thrombus extraction stent. Therefore, the thrombus can be sunk into the thrombus taking support, then the thrombus taking support is withdrawn into the micro catheter, the thrombus is carried into the micro catheter, and finally the thrombus can be moved out of the body by withdrawing the thrombus taking support and the micro catheter. The thrombus taking method mainly utilizes the radial extrusion and embedding effects of the thrombus taking support on thrombus to capture the thrombus, and when the radial force of the thrombus taking support is insufficient, the thrombus capturing effect is poor, so that the method has limitations on hard massive thrombus, large-size cardiogenic white thrombus or plaque thrombus exceeding a treatment time window.
Disclosure of Invention
The invention aims to provide an embolectomy device and a medical device, wherein an embolectomy support of the embolectomy device can be expanded for the second time under the action of an auxiliary mechanism under the conditions of self-expansion and insufficient radial force so as to increase the radial force and improve the thrombus capture effect.
In order to achieve the above object, the present invention provides a thrombus removal device, comprising:
a push shaft;
the thrombus taking bracket is a self-expanding bracket and is fixedly connected to the far end of the pushing shaft; and the number of the first and second groups,
and the auxiliary mechanism is partially arranged inside the embolectomy stent and is used for applying an expansion force outwards in the radial direction to the embolectomy stent so that the embolectomy stent can also perform second expansion in the radial direction after self-expansion.
Optionally, the auxiliary mechanism comprises an auxiliary support and an expansion rod, the auxiliary support is at least partially arranged inside the embolectomy support; the expansion rod is connected with the auxiliary bracket;
the auxiliary mechanism is configured to drive the auxiliary support to expand in the radial direction when the expansion rod moves in the preset direction and generates axial relative motion with the pushing shaft, so that the auxiliary support applies the expansion force to the embolectomy support.
Optionally, the proximal end of the auxiliary stent is fixedly connected with the distal end of the pushing shaft and/or the proximal end of the embolectomy stent, and the distal end of the auxiliary stent is fixedly connected with the distal end of the expansion rod and moves synchronously with the expansion rod;
the auxiliary mechanism is configured to radially expand the auxiliary stent when the expansion rod is moved in a distal-to-proximal direction in an axial direction of the push shaft.
Optionally, the pusher shaft has a first lumen extending axially therethrough, the expansion rod being partially disposed through the first lumen and configured to be movable along the first lumen.
Optionally, the pushing shaft is of a cylindrical helical spring structure.
Optionally, the expansion rod is arranged in parallel with the push shaft.
Optionally, the proximal end and the distal end of the thrombectomy support are both closed ends.
Optionally, the proximal end of the embolectomy support is closed and the distal end is open.
Optionally, the thrombectomy stent is a braided stent or a cut stent.
To achieve the above object, the present invention further provides a medical device, comprising a microcatheter and the thrombectomy device according to any one of the above items; the microcatheter has a second lumen extending axially therethrough, the thrombectomy device for being partially disposed within the second lumen and configured to be movable along the second lumen.
Compared with the prior art, the thrombus taking device and the medical device have the advantages that:
the thrombus taking device comprises a pushing shaft, a thrombus taking support and an auxiliary mechanism, wherein the thrombus taking support is a self-expanding support and is fixedly connected to the far end of the pushing shaft; the assist mechanism is partially disposed within the embolic stent and is configured to apply a radially outward expansion force to the embolic stent such that the embolic stent is further capable of performing a second expansion in a radial direction after self-expanding. The thrombus taking device is used for capturing hard massive thrombus, large-size cardiogenic white thrombus or plaque thrombus, and when the radial force of the thrombus taking support during self-expansion is insufficient, the auxiliary mechanism can be used for driving the thrombus taking support to expand for the second time and improving the embedding effect between the thrombus taking support and the thrombus, so that the aim of effectively capturing the thrombus is fulfilled.
Drawings
The drawings are included to provide a better understanding of the invention and are not to be construed as unduly limiting the invention. Wherein:
FIG. 1 is a schematic structural view of a thrombus removal device according to an embodiment of the present invention, wherein a thrombus removal support and an auxiliary support are both in a compressed state;
FIG. 2 is a schematic structural view of an embolectomy device provided in accordance with one embodiment of the present invention, illustrating an embolectomy stent in an expanded state and a secondary stent in a compressed state;
FIG. 3 is a schematic structural view of an embolectomy device provided in accordance with one embodiment of the present invention, illustrating the embolectomy stent and the auxiliary stent in an expanded state;
FIG. 4 is a schematic structural view of a bolt-removing device according to an embodiment of the present invention, in which the auxiliary mechanism is not assembled with the bolt-removing support and the pushing shaft;
fig. 5a to 5d are schematic views illustrating a process of removing a plug from a medical device according to an embodiment of the present invention.
[ reference numerals are described below ]:
100-pushing shaft, 200-bolt taking bracket, 300-auxiliary mechanism, 310-auxiliary bracket and 320-expanding rod;
10-microcatheter, 20-microcatheter;
1-thrombosis.
Detailed Description
The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the present invention, and the components related to the present invention are only shown in the drawings rather than drawn according to the number, shape and size of the components in actual implementation, and the type, quantity and proportion of the components in actual implementation may be changed freely, and the layout of the components may be more complicated.
Furthermore, each of the embodiments described below has one or more technical features, and thus, the use of the technical features of any one embodiment does not necessarily mean that all of the technical features of any one embodiment are implemented at the same time or that only some or all of the technical features of different embodiments are implemented separately. In other words, those skilled in the art can selectively implement some or all of the features of any embodiment or combinations of some or all of the features of multiple embodiments according to the disclosure of the present invention and according to design specifications or implementation requirements, thereby increasing the flexibility in implementing the invention.
As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural forms "a plurality" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention. The same or similar reference numbers in the drawings identify the same or similar elements.
Fig. 1 to 4 are schematic structural diagrams illustrating a thrombus removal device according to an embodiment of the present invention. Referring to fig. 1 to 4, the embolectomy device comprises a pushing shaft 100, an embolectomy support 200 and an auxiliary mechanism 300. The embolectomy stent 200 is a self-expandable stent and is fixedly connected to the distal end of the pushing shaft 100. The assist mechanism 300 is partially disposed within the embolic stent 200 and is configured to apply a radially outward expansion force to the embolic stent 200 such that the embolic stent 200 is also capable of performing a second expansion in the radial direction after self-expanding. When the thrombus 1 (as labeled in fig. 5a to 5 d) is caught by the thrombus taking device, especially when hard massive thrombus, large-sized cardiac white thrombus or plaque thrombus exceeding a treatment time window is caught, if the radial force generated by the self-expansion of the thrombus taking stent 200 is insufficient, so that the engagement between the thrombus taking stent 200 and the thrombus 1 is insufficient, and the thrombus cannot be effectively caught, an operator can apply an outward expansion force in the radial direction to the thrombus taking stent 200 by operating the auxiliary mechanism 300, so that the thrombus taking stent 200 is secondarily expanded, the engagement between the thrombus taking stent 200 and the thrombus 1 is improved, and the catching effect is improved. The self-expandable stent is a stent made of a highly elastic material, which is deformable when subjected to pressure and automatically restores its shape when the pressure is removed. The embolectomy stent 200 may be made of a shape memory alloy, such as nitinol, and may be a cutting stent or a braided stent, which is not limited in the embodiments of the present invention.
In a specific embodiment, the auxiliary mechanism 300 includes an auxiliary stent 310 and an expansion rod 320, wherein the auxiliary stent 310 is at least partially disposed inside the thrombectomy stent 200, the expansion rod 320 is connected to the auxiliary stent 310, and when the expansion rod 320 moves in a predetermined direction and generates an axial relative movement with respect to the pushing shaft 100, the expansion rod 320 drives the auxiliary stent 310 to radially expand, and when the auxiliary stent 310 continues to expand after radially expanding to a predetermined degree, the auxiliary stent 310 presses the thrombectomy stent 200 inside the thrombectomy stent 200 and applies the expansion force to the thrombectomy stent 200 to push the thrombectomy stent 200 to expand twice, so as to enhance the engagement between the thrombectomy stent 200 and the thrombus 1 and improve the thrombectomy effect.
Preferably, the proximal end of the auxiliary stent 310 is fixedly connected to the distal end of the pushing shaft 100 by welding or any other suitable means, the distal end of the auxiliary stent 310 is fixedly connected to the distal end of the expansion rod 320 by welding or any other suitable means, and when the expansion rod 320 moves, the distal end of the auxiliary stent 310 moves synchronously. In this embodiment, when the expansion rod 320 moves in the axial direction of the pushing shaft 100 in the distal-to-proximal direction (i.e., the predetermined direction is the distal-to-proximal direction), the auxiliary stent 310 expands in the radial direction, whereas when the expansion rod 320 moves in the axial direction of the pushing shaft 100 in the proximal-to-distal direction, the auxiliary stent 310 contracts in the radial direction. It is understood that the proximal end of the auxiliary support 310 may be fixedly connected to the proximal end of the thrombectomy support 200. And, the auxiliary stent 310 may be made of a shape memory alloy (e.g., nitinol alloy) or a high elastic polymer material and be pre-shaped in an expanded form such as a spherical or ellipsoidal shape.
In some implementations, the proximal end and the distal end of the embolectomy support 200 are both closed ends, the auxiliary support 310 is disposed entirely within the embolectomy support 200, and the length of the auxiliary support 310 is less than or equal to the length of the embolectomy support 200. In other implementations, the proximal end of the embolectomy support 200 is closed and the distal end is open, the auxiliary support 310 may be disposed entirely inside the embolectomy support 200, or the length of the auxiliary support 310 is greater than the length of the embolectomy support 200, and the auxiliary support 310 is disposed partially inside the embolectomy support 200, i.e., the distal end of the auxiliary support 310 extends to the outside of the embolectomy support 200. It is understood that closed end as used herein means that the respective ends, e.g., proximal ends, of the embolectomy support 200 converge such that the proximal end of the embolectomy support 200 is formed as a tapered structure. In addition, the auxiliary stent 310 may be either a braided stent or a cut stent.
Alternatively, the expansion rod 320 may be a solid structure, a hollow structure, a single wire, or a multi-strand wire, which is not limited in the embodiments of the present invention. The expanding rod 320 may be disposed in parallel with the pushing shaft 100, and thus, the pushing shaft 100 may be a solid rod body. The material of the pushing shaft 100 and the expanding rod 320 may be selected from a metal material or a polymer material, wherein the metal material includes but is not limited to nitinol, and the polymer material includes but is not limited to nylon, PTFE (polytetrafluoroethylene), Pebax (block polyether amide elastomer).
Preferably, the pushing shaft 100 has a first inner lumen extending axially therethrough, and the expansion rod 320 is partially penetrated in the first inner lumen and configured to be movable along the first inner lumen to radially expand or contract the auxiliary stent 310. In some implementations, the pushing shaft 100 is a tube, a single lumen tube or a multi-lumen tube, which is selected according to actual needs, and in other implementations, the pushing shaft 100 is a cylindrical helical spring structure formed by wires around an axis, which has the advantages of good pushing performance and flexibility and is easier to pass through tortuous blood vessels.
It should be noted that, when the distal end of the embolectomy support 200 is a closed end, and the expansion rod 320 is partially and movably disposed in the first lumen of the pushing shaft 100, the distal end of the auxiliary support 310 can be fixedly connected to the distal end of the embolectomy support 200, and the proximal end of the auxiliary support 310 is fixedly connected to the distal end of the expansion rod 320. When the expansion rod 320 is moved in a proximal-to-distal direction (i.e., the predetermined direction is a proximal-to-distal direction), the auxiliary stent 310 may be radially expanded, and when the expansion rod 320 is moved in a distal-to-proximal direction, the auxiliary stent 310 may be radially contracted.
Further, embodiments of the present invention also provide a medical device, including a micro-catheter 10 (shown in fig. 5a to 5 d) and the embolectomy device described above, wherein the micro-catheter 10 has a second lumen extending axially therethrough, and the embolectomy device is configured to be partially disposed in the second lumen and to be movable along the second lumen.
Next, the use of the medical device will be described in connection with simulation experiments.
Preparation of the experiment:
the middle brain segment of the intracranial vascular model was opened. The experimental rabbit was sampled at 5ml in the auricular vein of the rabbit, and the sampled blood was mixed with thrombin and immediately injected into the middle brain segment of the blood vessel model. Waiting for about 3-5 min, confirming that blood coagulates to form thrombus, and then closing the middle brain section of the intracranial vascular model.
Thrombus extraction experiment:
first, a micro-wire 20 is introduced into the vascular model at the location where the thrombus 1 is formed.
The distal end of the microcatheter 10 is then delivered along the micro-wire 20 to the distal side of the thrombus 1 (as shown in fig. 5 a).
Thereafter, the micro-guidewire 20 is withdrawn from the vascular model, and the distal end of the thrombectomy device is introduced into the second lumen of the micro-catheter 10, and the distal end of the thrombectomy stent 200 is delivered to the distal side of the thrombus 1 along the second lumen (as shown in fig. 5 b). It can be appreciated that in this process, the thrombectomy support 200 and the auxiliary support 310 are both in a contracted state.
Subsequently, the microcatheter 10 is withdrawn (i.e., the microcatheter 10 is moved in a distal to proximal direction) causing the thrombectomy stent 200 to self-expand (as shown in FIG. 5 c).
Then, the expansion rod 320 is retracted (i.e. the expansion rod 320 is moved in the distal-to-proximal direction), so that the auxiliary stent 310 is radially expanded, the auxiliary stent 310 presses the thrombectomy stent 200 in the thrombectomy stent 200, and a radial expansion force is applied to the thrombectomy stent 200, so that the thrombectomy stent 200 is secondarily expanded (as shown in fig. 5 d) and effectively catches the thrombus 1.
After confirming that the thrombectomy device completely captures the thrombus 1, the expansion rod 320 is pushed forward (i.e., the expansion rod 320 is moved in the proximal-to-distal direction), and the auxiliary stent 310 is contracted in the radial direction. The thrombectomy device is then withdrawn until the thrombectomy device is retracted into the microcatheter 10. Finally, the micro-catheter 10 and the thrombus 1-carrying thrombus taking device are integrally withdrawn from the blood vessel model.
It is understood that when the radial force of the thrombectomy stent 200 is large enough and the thrombectomy stent 200 can effectively capture thrombi, the auxiliary stent 310 is not used to perform the second expansion of the thrombectomy stent 200, i.e. the auxiliary stent 310 is always in the compressed state during the process of capturing thrombi.
According to the technical scheme provided by the embodiment of the invention, when the radial force of the thrombus taking support is insufficient and thrombus is difficult to be effectively caught, the auxiliary mechanism can be used for providing the radial expansion force for the thrombus taking support in the thrombus taking support and secondarily expanding the thrombus taking support, so that the embedding effect of the thrombus taking support and the thrombus is improved, the thrombus catching capacity is enhanced, and the thrombus taking effect is improved. The thrombus taking device provided by the embodiment of the invention is particularly suitable for catching hard massive thrombus, large-size cardiogenic thrombus and plaque thrombus.
Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.
Claims (10)
1. A thrombectomy device, comprising:
a push shaft;
the thrombus taking bracket is a self-expanding bracket and is fixedly connected to the far end of the pushing shaft; and the number of the first and second groups,
and the auxiliary mechanism is partially arranged inside the embolectomy stent and is used for applying an expansion force outwards in the radial direction to the embolectomy stent so that the embolectomy stent can also perform second expansion in the radial direction after self-expansion.
2. The embolectomy device of claim 1, wherein the secondary mechanism comprises a secondary stent and an expansion rod, the secondary stent being disposed at least partially within the embolectomy stent; the expansion rod is connected with the auxiliary bracket;
the auxiliary mechanism is configured to drive the auxiliary support to expand in the radial direction when the expansion rod moves in the preset direction and generates axial relative motion with the pushing shaft, so that the auxiliary support applies the expansion force to the embolectomy support.
3. The embolectomy device of claim 2, wherein the proximal end of the auxiliary stent is fixedly connected with the distal end of the pushing shaft and/or the proximal end of the embolectomy stent, and the distal end of the auxiliary stent is fixedly connected with the distal end of the expansion rod and moves synchronously with the expansion rod;
the auxiliary mechanism is configured to radially expand the auxiliary stent when the expansion rod is moved in a distal-to-proximal direction in an axial direction of the push shaft.
4. The embolectomy device of claim 2 or 3, wherein the pusher shaft has a first lumen extending axially therethrough, the expansion rod being partially disposed through the first lumen and configured to be movable along the first lumen.
5. The embolectomy device of claim 4, wherein the pusher shaft is of a cylindrical coil spring configuration.
6. The embolectomy device of claim 2 or 3, wherein the expansion rod is disposed in parallel with the push shaft.
7. The embolectomy device of claim 1, wherein the proximal and distal ends of the embolectomy support are closed ends.
8. The embolectomy device of claim 1, wherein the proximal end of the embolectomy support is closed end and the distal end is open end.
9. The embolectomy device of claim 1, wherein the embolectomy stent is a braided stent or a cut stent.
10. A medical device comprising a microcatheter and the thrombectomy device of any of claims 1-9; the microcatheter has a second lumen extending axially therethrough, the thrombectomy device for being partially disposed within the second lumen and configured to be movable along the second lumen.
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