CN117814951A - Distal embolic protection device - Google Patents
Distal embolic protection device Download PDFInfo
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- CN117814951A CN117814951A CN202311742348.3A CN202311742348A CN117814951A CN 117814951 A CN117814951 A CN 117814951A CN 202311742348 A CN202311742348 A CN 202311742348A CN 117814951 A CN117814951 A CN 117814951A
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- embolic protection
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Abstract
The invention belongs to the technical field of medical appliances, and particularly relates to a distal embolic protection device. The distal embolic protection device of the present invention, for preventing distal embolism of a blood vessel, comprises: the main body of the filter screen consists of hollow tubes which are distributed in a staggered way and the inner cavities of the hollow tubes are communicated with each other, and the filter screen is used for filtering thrombus; the pushing rod is provided with a cavity section, the pushing rod of the cavity section is provided with a fluid conveying channel, and the fluid conveying channel is communicated with the inner cavity of the hollow pipe and is used for conveying fluid to the inner cavity of the hollow pipe so that the filter screen is converted into an unfolding state from a folding state under the pressure of the fluid. According to the distal embolic protection device, the filter screen can be opened in a mode of filling fluid into the hollow tube, and the attachment of the vascular cavity can be realized by controlling the filling pressure of the fluid, so that the plaque capturing efficiency is improved, and the plaque escape risk is reduced.
Description
Technical Field
The invention belongs to the technical field of medical appliances, and particularly relates to a distal embolic protection device.
Background
Atherosclerotic stenosis of peripheral blood vessels, coronary arteries and carotid arteries can be treated by balloon dilation and/or stent implantation to restore the original lumen and blood flow, but in the process, plaque at the stenosis part is subjected to the external force of a balloon and/or a stent and can be broken or shed, if the plaque drifts to a distal blood vessel along with blood, embolism can be caused, particularly when the plaque drifts to cerebral blood vessels, ischemic stroke can be caused, and great threat is caused to life health and safety of patients. Thus, distal embolic protection in stenotic treatment surgery is becoming a common and routine practice in the clinic.
The existing distal embolism protection device can be divided into a woven type and a film-covered type according to the manufacturing process, wherein a filter screen is a film with a metal frame surface covered with a polymer or other materials with a certain aperture; however, regardless of the wire material used for the woven protection device or the frame of the film-covered protection device, the material is generally nickel-titanium, and the principle of opening the filter screen is to utilize the super elasticity of nickel-titanium alloy. But the metal material weaves or the filter screen of cutting, its structural stress is great, exists further promotion space to the laminating degree of blood vessel, still probably leads to patient's vascular spasm at the in-process that the filter screen was opened, perhaps causes the damage to the vascular wall, causes intermediate layer, bleeding risk.
The existing distal embolic protection devices can be divided into eccentric and coaxial types according to the relative positions of the filter screen and the push rod. The eccentric protective device has the advantages that the opening of the filter screen is completely opened, no blocking exists, the plaque capturing rate is high, and the eccentric protective device has the defects that when the eccentric protective device is placed in a tortuous blood vessel, the pushing rod cannot be coaxial with the blood vessel, so that the filter screen cannot be well attached to the blood vessel, and the plaque is at risk of escaping from the gap between the filter screen and the blood vessel; the coaxial protective umbrella overcomes the defects of the eccentric protective umbrella, but in order to close the opening of the protective umbrella after the protective umbrella is used and recycle the protective umbrella, a plurality of connecting rods or connecting lines are required to be arranged between the opening of the filter screen and the pushing rod, so that the plaque capturing rate is reduced, and the plaque is collided with the connecting rods or the connecting lines and broken into smaller plaque, which possibly causes incapability of capturing and increases the risk of distal embolism.
Accordingly, there is a need to provide an improved solution to the above-mentioned deficiencies of the prior art.
Disclosure of Invention
The invention aims to provide a distal embolic protection device, which aims to solve or improve the problems of high plaque escape risk or low plaque capturing efficiency of a filter screen in the use process of the conventional distal embolic protection device.
In order to achieve the above object, the present invention provides the following technical solutions: a distal embolic protection device, comprising: the main body of the filter screen consists of hollow tubes which are distributed in a staggered way and the inner cavities of the hollow tubes are communicated with each other, and the filter screen is used for filtering thrombus; the pushing rod is provided with a cavity section, and the pushing rod of the cavity section is provided with a fluid conveying channel which is communicated with the inner cavity of the hollow pipe and used for conveying fluid to the inner cavity of the hollow pipe so that the filter screen is converted into an unfolding state from a folding state under the pressure of the fluid; the size of the screen in the folded state is smaller than the size of the screen in the unfolded state, at least in the radial direction.
Preferably, the filter screen is umbrella-shaped in the unfolded state, and the radial dimension of the filter screen gradually decreases from the proximal end to the distal end; memory alloy wires are arranged in the hollow tube at the proximal end of the filter screen, and the outer contour of the memory alloy wires is matched with the outer contour of the proximal end of the filter screen.
Preferably, a communication hole is arranged at the distal end of the fluid conveying channel, and the inner cavity of the hollow pipe at the distal end of the filter screen is communicated with the fluid conveying channel through the communication hole.
Preferably, the distal end of the filter screen is provided with a connector, the connector is in a horn mouth shape, one end of the connector is communicated with the hollow tube, and the other end of the connector is communicated with the communication hole; at least part of the connector is positioned in the fluid conveying channel and is in sealing connection with the inner wall of the pushing rod corresponding to the communication hole.
Preferably, one end of the filter screen, which is close to the communication hole, is provided with a connecting pipe, and the connecting pipe is communicated with the hollow pipe; the connecting pipe penetrates through the communication hole, stretches into the fluid conveying channel and is provided with a liquid inlet, and the connecting pipe and the hollow pipe are configured to generate capillary phenomenon; the outer wall of the connecting pipe is in sealing connection with the communication hole.
Preferably, the connecting pipe is in sealing connection with the communication hole through a sealing sleeve; the sealing sleeves are arranged in one-to-one correspondence with the connecting pipes; or, a plurality of connecting pipes are converged in the same sealing sleeve; the connecting pipe and the hollow pipe are integrally arranged.
Preferably, the hollow tube is a polymer hollow tube, and the filter screen and the pushing rod are coaxially arranged.
Preferably, the pusher bar further has a grinding section disposed at a distal end of the cavity section, the grinding section having an outer diameter that gradually decreases from a proximal end to a distal end.
Preferably, the grinding section is provided with a developing spring; and developing points are arranged on the memory alloy wires.
Preferably, the fluid is a contrast agent; the end of the cavity section, which is far away from the grinding section, is connected with a fluid supply device through a connecting piece.
The beneficial effects are that:
the main body of the filter screen of the distal embolic protection device is composed of a hollow tube, and the pushing rod is provided with a cavity section, and a fluid conveying channel of the cavity section is communicated with the inner cavity of the hollow tube, so that the filter screen can be converted from a folded state to an unfolded state under the fluid pressure in a mode of filling the inner cavity of the hollow tube, and the filter screen can play a role in capturing plaque. In addition, the above arrangement of the distal embolic protection device of the present invention allows for the degree of softness of the filter screen to be adjusted and better apposition to the lumen of the vessel to be achieved by controlling the amount of filling pressure of the fluid.
The distal embolic protection device can adopt coaxial design, and a short plate with poor filter screen adherence caused by the fact that the pushing rod and the blood vessel are not coaxial in the eccentric protection device is avoided. In addition, the distal embolic protection device is of a coaxial design, but no connection exists between the filter screen opening and the pushing rod, the filter screen opening is closed through the shape memory characteristic of the memory alloy wire in the hollow tube at the maximum diameter of the filter screen opening, and the filter screen can be closed without a catheter, so that the distal embolic protection device has the advantage of high capture rate of the eccentric protection device, and the defect that plaque is crashed into smaller plaque due to collision with a connecting rod or a connecting wire of the coaxial protection device is avoided, and the distal embolic protection device is safer.
The hollow tube in the distal embolic protection device is a polymer tube, and the polymer tube is connected and staggered to form the filter screen, so that the material is softer than the metal material, the stimulation to the blood vessel can be effectively reduced, and the damage to the blood vessel wall is avoided.
In the distal embolic protection device of the present invention, the fluid filling may be contrast media; that is, when the filled fluid in the distal embolic protection device is a contrast agent, the filter screen can be opened (the filter screen is in an unfolded state) by the filled contrast agent, so that the filter screen can be integrally developed under X-rays, a doctor can more conveniently judge the position, the opening state and the fitting condition of the filter screen with the vessel wall, and the safety of an operation can be effectively improved.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the invention. Wherein:
FIG. 1 is a schematic diagram of a front view of a distal embolic protection device according to an embodiment of the present invention (with a filter screen in an expanded state);
FIG. 2 is a schematic side view of a distal embolic protection device according to an embodiment of the present invention (with the filter screen in an expanded state);
fig. 3 is a schematic diagram of the overall structure of a push rod according to an embodiment of the present invention;
FIG. 4 is a schematic cross-sectional view of a push rod according to an embodiment of the present invention;
FIG. 5 is a schematic view of a filter screen according to an embodiment of the present invention;
FIG. 6 is a schematic view of a filter screen according to another embodiment of the present invention;
FIG. 7 is a schematic view showing an assembly structure of a connecting pipe (FIG. 6) and a communicating hole according to an embodiment of the present invention;
FIG. 8 is a schematic side view of a distal embolic protection device according to an embodiment of the present invention (with the filter screen in a folded state);
FIG. 9 is a schematic diagram showing a process of converting a memory alloy wire from a folded state to an unfolded state (the process is shown as a folded state, an intermediate state and an unfolded state in sequence from left to right);
FIG. 10 is a schematic diagram illustrating a process of transforming a memory alloy wire from an unfolded state to a folded state (the process is sequentially performed from left to right in the drawing, including an unfolded state, an intermediate state and a folded state);
fig. 11 is a schematic view of a connector (luer adapter) in a distal embolic protection device according to an embodiment of the present invention in different viewing angles.
Reference numerals:
1-a developing spring; 2-a filter screen; 3-pushing a rod; a 4-luer adapter;
21-hollow tube; 211-linker; 212-connecting pipes; 22-memory alloy wire; 23-development point;
31-a cavity section; 311-fluid delivery channel; 312-communicating holes; 32-grinding section.
Detailed Description
The following description of the technical solutions in the embodiments of the present invention will be clear and complete, and it is obvious that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which are derived by a person skilled in the art based on the embodiments of the invention, fall within the scope of protection of the invention.
In the description of the present invention, it should be understood that references to orientation descriptions such as upper, lower, front, rear, left, right, etc. are based on the orientation or positional relationship shown in the drawings, are merely for convenience of description of the present invention and to simplify the description, and do not indicate or imply that the apparatus or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the present invention.
In the description of the present invention, a number means one or more, a number means two or more, and greater than, less than, exceeding, etc. are understood to not include the present number, and above, below, within, etc. are understood to include the present number. The description of the first and second is for the purpose of distinguishing between technical features only and should not be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated or implicitly indicating the precedence of the technical features indicated.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, features defining "first" and "second" may explicitly or implicitly include one or more features.
In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the term "connected" should be construed broadly, and for example, it may be a fixed connection or an active connection, or it may be a detachable connection or a non-detachable connection, or it may be an integral connection; may be mechanically connected, may be electrically connected, or may be in communication with each other; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements, indirect communication or interaction relationship between the two elements.
The present invention will be described in detail with reference to examples. It should be noted that, without conflict, the embodiments of the present invention and features of the embodiments may be combined with each other.
In the use process of the distal embolic protection device, one end close to an operator is taken as a proximal end, and the end far away from the operator is taken as a distal end.
The invention provides a distal embolic protection device, aiming at the problems of large plaque escape risk or low plaque capturing efficiency of a filter screen in the use process of the conventional distal embolic protection device.
As shown in fig. 1-10, a distal embolic protection device of an embodiment of the present invention comprises: the main body of the filter screen 2 consists of hollow tubes 21 which are distributed in a staggered way and the inner cavities of the hollow tubes are communicated with each other, and the filter screen 2 is used for filtering thrombus; a pushing rod 3, the pushing rod 3 has a cavity section 31, the pushing rod 3 of the cavity section 31 has a fluid conveying channel 311, the fluid conveying channel 311 is communicated with the inner cavity of the hollow tube 21 and is used for conveying fluid to the inner cavity of the hollow tube 21 so as to enable the filter screen 2 to be converted from a folded state to an unfolded state under the pressure of the fluid; the size of the sieve 2 in the folded state is smaller than the size of the sieve 2 in the unfolded state, at least in the radial direction.
Wherein "folded state" means that the screen 2 is folded to have a smaller outer diameter at least in the radial direction; by "deployed state" is meant that the screen 2 expands, at least in the radial direction, to have a larger outer diameter.
Preferably, in the folded state, the sieve 2 is axially movable in the vessel; in the unfolded state, the filter screen 2 can be attached to the inner wall of the blood vessel so as to prevent thrombus from escaping from the gap between the filter screen 2 and the wall of the blood vessel. Preferably, the screen 2 has a certain flexibility so that it can be deformed.
The filter screen 2 of the distal embolic protection device of the invention mainly consists of hollow tubes 21 which are distributed in a staggered way and have mutually communicated inner cavities (the density among the hollow tubes 21 is good for allowing blood to smoothly pass through and avoiding plaque escaping from the pores of the filter screen 2), and the inner cavities of the hollow tubes 21 are communicated with the fluid conveying channel 311 of the pushing rod 3; when the fluid in the fluid conveying channel 311 flows to the inner cavity of the hollow tube 21, the filter screen 2 in the folded state is gradually relaxed under the pressure of the fluid until reaching the unfolded state, so as to achieve the fitting of the filter screen 2 and the blood vessel wall. Furthermore, the filter screen 2 can effectively capture the plaque, and the escape of the plaque can be reduced or avoided. Further, the distal embolic protection device of the present invention realizes the transition of the filter screen 2 from the folded state to the unfolded state by delivering the fluid into the hollow tube 21 of the filter screen 2, and compared with the coaxial distal embolic protection device, omits the connecting rod and the connecting wire between the opening of the filter screen 2 and the pushing rod 3 (the area of the opening of the filter screen 2 is larger), has higher plaque capturing efficiency, and can effectively avoid or reduce the distal embolism caused by the plaque unable to be captured due to the plaque crashing into smaller plaque by the connecting rod or the connecting wire. In addition, the hollow tube 21 of the filter screen 2 is filled with fluid so that the filter screen 2 is converted from a folded state to an unfolded state under the pressure of the fluid, the softness of the filter screen 2 can be adjusted by controlling the pressure of the fluid filling, and the better fitting of the blood vessel cavity is realized.
In the preferred embodiment of the present invention, the filter screen 2 is umbrella-shaped in the unfolded state, and the radial dimension of the filter screen 2 gradually decreases from the proximal end to the distal end; a memory alloy wire 22 is arranged in the hollow tube 21 at the proximal end of the filter screen 2, and the outer contour of the memory alloy wire 22 is matched with the outer contour of the proximal end of the filter screen 2. The memory alloy wire 22 is made of a memory alloy (e.g., nickel-titanium alloy, etc.). Wherein, the filter screen 2 is umbrella-shaped in the unfolded state, and the radial dimension of the filter screen 2 in the direction from the proximal end to the distal end is gradually reduced, so that the effect of attaching the filter screen 2 to the vessel wall is guaranteed, and the escape of plaque from the gap between the filter screen 2 and the vessel wall is reduced or avoided; by arranging the memory alloy wire 22 in the hollow tube 21 at the proximal end of the filter screen 2, when the radial dimension of the memory alloy wire 22 is changed, the memory alloy wire 22 can apply an acting force to the filter screen 2, so that the radial dimension of the filter screen 2 is also changed, and the switching between the folded state and the unfolded state of the filter screen 2 is facilitated. Further, by using the memory alloy wire 22 made of the memory alloy material, the memory alloy wire 22 can be restored to the original state without fluid pressure.
Preferably, the memory alloy wires 22 are pre-configured in a folded state (e.g., the memory alloy wires 22 may be pre-configured in a folded state by heat treating the memory alloy wires 22), the memory alloy wires 22 transition to an expanded state when fluid is delivered into the hollow tube 21 of the screen 2, and the properties of the memory alloy return the screen 2 to the folded state after fluid in the hollow tube 21 of the screen 2 flows out. By pre-configuring the memory alloy wire 22 in a collapsed state, the screen 2 is also in a collapsed state in its natural state, facilitating delivery of the distal embolic protection device of the present invention to a specific location of a target vessel via an interventional path. When the fluid in the filter screen 2 is released, the pressure inside the filter screen 2 disappears, and the shape memory property of the memory alloy wire 22 allows it to return to the original state (folded state) and closes the opening of the filter screen 2 (preferably, the proximal end of the filter screen 2 is fitted with the push rod 3 in the folded state; i.e., the proximal end inner diameter of the filter screen 2 is fitted with the outer diameter of the push rod 3 in the folded state), thereby preventing the captured plaque from escaping.
In addition, the existing distal embolic protection devices all require additional catheters to be used together to achieve closure of the filter screen, and risks such as damage to the vessel wall, displacement of the filter screen, escape of captured plaque, and the like may occur in the process. According to the distal embolic protection device, the memory alloy wire 22 made of the memory alloy is arranged in the hollow tube 21 at the proximal end of the filter screen 2 (namely, the memory alloy wire 22 is positioned at the proximal end opening of the filter screen 2), the filter screen 2 can be closed (namely, the filter screen 2 is in a folded state) through the memory alloy wire 22, an additional catheter is not needed, and risks of vessel puncture, plaque escape and the like in the process of closing the filter screen by the catheter can be effectively avoided.
In the preferred embodiment of the present invention, the distal end of the fluid delivery channel 311 is provided with a communication hole 312, and the inner cavity of the hollow tube 21 at the distal end of the strainer 2 is communicated with the fluid delivery channel 311 through the communication hole 312. The above arrangement makes it possible to conveniently realize the connection of the sieve 2 and the push rod 3 and to realize the filling or draining of the fluid in the hollow tube 21 of the sieve 2 by controlling the flow of the fluid in the cavity section 31 of the push rod 3 at the proximal end, thus realizing the adjustment of the outer diameter of the sieve 2. Specifically, the filter screen 2 and the pushing rod 3 may be connected by hot melting, dispensing or other means (the filter screen 2 and the pushing rod 3 are connected in a sealing manner, so as to avoid leakage of fluid).
In the preferred embodiment of the present invention, the distal end of the filter screen 2 has a connector 211, the connector 211 is bell-mouth shaped, one end of the connector 211 is communicated with the hollow tube 21, and the other end of the connector 211 is communicated with the communication hole 312; at least part of the joint 211 is positioned in the fluid conveying channel 311 and is in sealing connection with the inner wall of the push rod 3 at the corresponding communication hole 312. Preferably, the large mouth end of the fitting 211 is located within the fluid delivery channel 311; by making the joint 211 horn-shaped, it is advantageous for the fluid in the fluid conveying passage 311 to enter the hollow tube 21, and also for the sealing connection effect of the joint 211 and the inner wall of the push rod 3 at the corresponding communication hole 312 to be ensured.
In the preferred embodiment of the present invention, the end of the filter screen 2 near the communication hole 312 is provided with a connecting pipe 212, and the connecting pipe 212 is communicated with the hollow pipe 21; the connecting pipe 212 is arranged through the communication hole 312, extends into the fluid conveying channel 311 and is provided with a liquid inlet, and the connecting pipe 212 and the hollow pipe 21 are configured to generate capillary phenomenon (when the fluid conveying channel 311 is provided with liquid, the liquid can enter the connecting pipe 212 and the hollow pipe 21 under the action of capillary force under the action of the capillary force of the connecting pipe 212 and the hollow pipe 21, so that filling of the filter screen 2 can be conveniently realized, and the memory alloy wire 22 is converted into an unfolding state from a folding state); the outer wall of the connection pipe 212 is hermetically connected to the communication hole 312.
In the preferred embodiment of the present invention, the connection tube 212 is in sealing connection with the communication hole 312 through a sealing sleeve (not shown) (the sealing sleeve is provided to help ensure the sealing connection effect; for example, the sealing sleeve may be made of flexible materials, etc.); the sealing sleeves are arranged in one-to-one correspondence with the connecting pipes 212; or, a plurality of connecting pipes 212 are converged in the same sealing sleeve; the connection pipe 212 is integrally provided with the hollow pipe 21.
In the preferred embodiment of the present invention, hollow tube 21 is a polymeric hollow tube. The wire material or the frame of the film-covered type protective device used for the common woven type vascular embolism protective device in the prior art is generally made of nickel titanium, and the principle of opening the filter screen is to utilize the shape memory property of nickel titanium alloy. But the metal material weaves or the filter screen of cutting, and its structural stress is great, exists further promotion space to the laminating degree of blood vessel, still probably at the in-process that the filter screen was opened, leads to patient's vasospasm, perhaps causes the damage to the blood vessel wall, causes intermediate layer, bleeding risk. According to the invention, the filter screen 2 made of the polymer material (namely, the hollow tube 21 is a polymer hollow tube) is adopted, so that the polymer material is softer and more compliant than the metal material (such as nickel-titanium alloy) commonly used in the distal embolic protection device in the prior art, the stimulation to blood vessels can be effectively reduced, and the damage to the blood vessel walls is avoided.
In the preferred embodiment of the invention, the filter screen 2 is arranged coaxially with the push rod 3. According to the invention, the filter screen 2 and the pushing rod 3 are coaxially arranged, so that the state switching of the filter screen 2 between the folded state and the unfolded state (no connecting piece exists between the proximal end of the filter screen 2 and the pushing rod 3) can be realized in a mode of filling fluid into the hollow tube 21 of the filter screen 2 or discharging fluid, the defect of an eccentric protection umbrella (the defect that the pushing rod 3 cannot be coaxial with a blood vessel to cause poor adhesion of the filter screen 2 when the eccentric distal embolic protection device is released to a tortuous blood vessel) can be overcome, the advantage of high capture rate of the eccentric protection device is realized, the defects that plaque is broken into smaller plaque after collision with a connecting rod or connecting wire between a filter screen opening of the coaxial protection device and the pushing rod in the prior art, the plaque escape and the plaque capture difficulty are easy to cause are avoided, and the distal embolic protection device is safer.
In a preferred embodiment of the invention, the push rod 3 further has a grinding section 32, the grinding section 32 being arranged at the distal end of the cavity section 31, the outer diameter of the grinding section 32 decreasing gradually from the proximal end to the distal end. The grinding section 32 provides better flexibility to the distal end of the push rod 3, which helps to improve the in-place performance of the filter screen 2.
Preferably, the grinding segment 32 is solid. The grinding section 32 may be formed by multi-stage grinding, and may be made of nickel-titanium alloy, stainless steel, or the like.
In the preferred embodiment of the present invention, the grinding section 32 is provided with a developing spring 1; the memory alloy wire 22 is provided with a developing point 23. Specifically, the developing spring 1 can be wound by platinum iridium alloy wires, gold wires or other wires with good developing effect, and is used for indicating the position of the distal end of the distal embolic protection device in the blood vessel under X-ray; further, the developing spring 1 may be fixed to the distal end of the push rod 3 (i.e., at the grinding section 32) by soldering at the proximal end point and the distal end point of the developing spring 1, respectively, after being sleeved on the outer wall of the grinding section 32. The material of the developing points 23 on the memory alloy wire 22 can be platinum iridium alloy, gold or other metal materials with good effects, the number of the developing points 23 can be 3, 4, 6, 8 … … and the like, and the form of the developing points 23 can be hollow ring-shaped; after the developing point 23 is threaded on the memory alloy wire 22, it can be further fixed on the surface of the memory alloy wire 22 by pressing and holding.
The inventor found in the study that, because of the general development effect of the nickel-titanium material, the conventional distal embolic protection device (for example, the wire material used in the woven protection device or the frame material of the film-covered protection device is generally nickel-titanium), in order to achieve a better development effect, a development point is usually required to be additionally arranged on the filter screen, but the whole body development of the filter screen can not be achieved, and the surface bulge at the development point is caused, so that the risk of stimulating and scratching blood vessels exists. In order to solve the above-mentioned technical problem, in a preferred embodiment of the present invention, the fluid is a contrast agent. According to the invention, by adopting the contrast agent as the fluid, the contrast agent is filled in the filter screen 2, the expansion of the filter screen 2 can be realized, the whole body development can be realized under the X-ray, the position, the opening state, the fitting condition with the vessel wall and the like of the filter screen 2 can be more conveniently judged by a doctor, and the safety of an operation can be effectively improved.
In a further preferred embodiment of the invention, the end of the cavity section 31 remote from the grinding section 32 is connected to the fluid supply via a connection. The transfer of fluid (preferably contrast) in the push rod 3 (and the screen 2) is conveniently achieved by connecting the cavity section 31 of the push rod 3 to a fluid supply device using a connector.
More preferably, the connection is a luer adapter 4 (as shown in fig. 11); the fluid supply may be a syringe, balloon inflation pump, or the like.
In the preferred embodiment of the invention, as shown in fig. 1, the distal embolic protection device mainly comprises a developing spring 1, a filter screen 2 and a push rod 3; the developing spring 1 is formed by winding a platinum iridium alloy wire, a gold wire or other metal wires with good developing effects, and is used for indicating the position of the distal end of the embolic protection device in a blood vessel under X-ray, and the developing points 23 of the proximal end and the distal end are used as welding points and fixed on the distal end of the push rod 3 in a soldering manner. The filter screen 2 is in a net structure formed by high polymer pipes with hollow inner cavities, contrast agent can be introduced into the filter screen 2 and the filter screen 2 is opened under the pressure of the contrast agent, so that the filter screen 2 is umbrella-shaped with large proximal end diameter and small distal end diameter; the developing points 23 are made of platinum iridium alloy, gold or other metal materials with good developing effect, the number of the developing points can be 3, 4, 6, 8, … … and the like, and the developing points are hollow annular, penetrate through the nickel-titanium memory alloy wire 22 and are fixed on the surface of the memory alloy wire 22 by pressing and holding or other modes; the developing point 23 and the memory alloy wire 22 are both positioned inside the polymeric hollow tube 21 at the maximum opening diameter of the screen 2. FIG. 2 is a right side view of the overall structure of the distal embolic protection device of the present embodiment in an open state; fig. 3 is a schematic structural view of the push rod 3, wherein the grinding section 32 at the distal end is of a solid structure and is formed by multi-stage grinding, and the material is nickel-titanium alloy or stainless steel; the part of the push rod 3 except the grinding section 32 is a cavity section 31; a communication hole 312 is located at the distal end of the cavity section 31, i.e. the sieve 2 in fig. 1 is sealingly connected to the push rod 3 via the communication hole 312. As shown in fig. 4, which is a cross-sectional view of the connection between the filter screen 2 and the push rod 3 in fig. 1, the polymer hollow tube 21 of the filter screen 2 enters the push rod 3 through the communication hole 312 shown in fig. 3, the end (distal end) of the polymer hollow tube 21 is opened in a horn shape, and is fixed on the push rod 3 through hot melting, dispensing or other manners (sealing connection with the communication hole 312), the contrast agent can enter the polymer hollow tube 21 of the filter screen 2 through the cavity section 31, and the pressure of the contrast agent can cause the filter screen 2 to open in an umbrella shape shown in fig. 1 and 2. As shown in fig. 8, a right side view of the distal embolic protection device in a folded state of the screen 2; when the contrast agent is filled into the filter screen 2 through the cavity of the pushing rod 3, the filter screen 2 will support the memory alloy wire 22 into a circular ring shape to be opened under the pressure of the contrast agent, and the memory alloy wire 22 is umbrella-shaped as shown in fig. 1, and the shape change of the memory alloy wire 22 in the process is shown in fig. 9. The nickel-titanium alloy has shape memory property, the qualitative process of heat treatment and the morphological change in the process are shown in figure 10, the memory alloy wire 22 is straightened and penetrated into the macromolecule hollow tube 21 at the position with the largest diameter of the filter screen 2, and the filter screen 2 of the distal embolic protection device is in a folded state shown in figure 8 in a natural state, so that the filter screen is convenient to be conveyed to a specific position of a target blood vessel through an interventional path. After the contrast medium is released, the pressure inside the filter screen 2 disappears, the memory alloy wire 22 (made of nickel titanium alloy) is restored to the original state due to the shape memory property of the material, and the opening of the filter screen 2 is contracted and closed, so that the captured plaque can be prevented from escaping. The distal embolic protection device may be connected to a syringe or balloon filling pump or the like via luer adapter 4 or other connection as shown in fig. 11, and contrast media may be filled into screen 2 via the syringe or balloon filling pump, thereby effecting the opening of screen 2.
The distal embolic protection device of the above embodiment has the following advantages over the prior art: (1) The coaxial design of the filter screen 2 and the pushing rod 3 can effectively avoid poor adhesion of the filter screen 2 caused by the fact that the pushing rod 3 and a blood vessel cannot be coaxial when the eccentric distal embolic protection device is released in a tortuous blood vessel; (2) According to the distal embolic protection device, the filter screen 2 is opened by filling the contrast agent, no connection is needed between the opening of the filter screen 2 and the pushing rod 3, the capturing efficiency can be effectively improved, plaque is prevented from being broken, and the risk of distal embolic is reduced; (3) The filter screen 2 is formed by adopting the macromolecule hollow tube 21, compared with nickel titanium and other metal materials, the filter screen 2 is softer and has better compliance, the stimulation to blood vessels can be reduced, and the full fitting of the filter screen 2 to the blood vessels at the target part can be realized by adjusting the pressure of the contrast agent; (4) The filter screen 2 is closed through the nickel titanium wires (namely, the memory alloy wires 22) at the opening, no additional catheter is needed, and risks such as puncture of blood vessels by the catheter, plaque escape in the process of closing the filter screen 2 by the catheter are avoided. (5) The filter screen 2 is opened by contrast agent, and the whole filter screen 2 is visible under X-ray, so that the judgment and operation of doctors are facilitated.
The above description is only of the preferred embodiments of the present invention and is not intended to limit the present invention, but various modifications and variations can be made to the present invention by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. A distal embolic protection device for preventing distal embolization of a blood vessel, comprising:
the main body of the filter screen consists of hollow tubes which are distributed in a staggered way and the inner cavities of the hollow tubes are communicated with each other, and the filter screen is used for filtering thrombus;
the pushing rod is provided with a cavity section, and the pushing rod of the cavity section is provided with a fluid conveying channel which is communicated with the inner cavity of the hollow pipe and used for conveying fluid to the inner cavity of the hollow pipe so that the filter screen is converted into an unfolding state from a folding state under the pressure of the fluid;
the size of the screen in the folded state is smaller than the size of the screen in the unfolded state, at least in the radial direction.
2. The distal embolic protection device of claim 1, wherein said screen is umbrella-shaped in an expanded state, said screen decreasing in radial dimension from proximal to distal;
memory alloy wires are arranged in the hollow tube at the proximal end of the filter screen, and the outer contour of the memory alloy wires is matched with the outer contour of the proximal end of the filter screen.
3. The distal embolic protection device of claim 2, wherein a communication hole is provided at the distal end of said fluid delivery channel, and wherein the lumen of the hollow tube at the distal end of said filter screen is in communication with said fluid delivery channel through said communication hole.
4. A distal embolic protection device as in claim 3, wherein the distal end of the screen has a nipple, the nipple being flared, one end of the nipple being in communication with the hollow tube, the other end of the nipple being in communication with the communication hole; at least part of the connector is positioned in the fluid conveying channel and is in sealing connection with the inner wall of the pushing rod corresponding to the communication hole.
5. A distal embolic protection device as in claim 3, wherein an end of the screen adjacent the communication hole has a connecting tube in communication with the hollow tube;
the connecting pipe penetrates through the communication hole, stretches into the fluid conveying channel and is provided with a liquid inlet, and the connecting pipe and the hollow pipe are configured to generate capillary phenomenon;
the outer wall of the connecting pipe is in sealing connection with the communication hole.
6. The distal embolic protection device of claim 5, wherein said connection tube is sealingly connected to said communication hole by a sealing sleeve;
the sealing sleeves are arranged in one-to-one correspondence with the connecting pipes; or, a plurality of connecting pipes are converged in the same sealing sleeve;
the connecting pipe and the hollow pipe are integrally arranged.
7. The distal embolic protection device of any of claims 1-6, wherein the hollow tube is a polymeric hollow tube, and the filter screen is coaxially disposed with the pusher rod.
8. The distal embolic protection device of claim 2, wherein said pusher rod further comprises a grinding segment disposed distally of said cavity segment, said grinding segment having an outer diameter that gradually decreases from proximal to distal.
9. The distal embolic protection device of claim 8, wherein a development spring is provided on said ground section;
and developing points are arranged on the memory alloy wires.
10. The distal embolic protection device of any of claims 1-9, wherein said fluid is a contrast agent;
the end of the cavity section, which is far away from the grinding section, is connected with a fluid supply device through a connecting piece.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311742348.3A CN117814951A (en) | 2023-12-18 | 2023-12-18 | Distal embolic protection device |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311742348.3A CN117814951A (en) | 2023-12-18 | 2023-12-18 | Distal embolic protection device |
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| CN117814951A true CN117814951A (en) | 2024-04-05 |
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| CN202311742348.3A Pending CN117814951A (en) | 2023-12-18 | 2023-12-18 | Distal embolic protection device |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050096691A1 (en) * | 2003-10-29 | 2005-05-05 | Medtronic Vascular, Inc. | Distal protection device for filtering and occlusion |
| US20060100662A1 (en) * | 1997-03-06 | 2006-05-11 | Daniel John M K | Distal protection device and method |
| CN217744698U (en) * | 2021-12-29 | 2022-11-08 | 聚辉医疗科技(深圳)有限公司 | Embolic protector and embolic system |
-
2023
- 2023-12-18 CN CN202311742348.3A patent/CN117814951A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060100662A1 (en) * | 1997-03-06 | 2006-05-11 | Daniel John M K | Distal protection device and method |
| US20050096691A1 (en) * | 2003-10-29 | 2005-05-05 | Medtronic Vascular, Inc. | Distal protection device for filtering and occlusion |
| CN217744698U (en) * | 2021-12-29 | 2022-11-08 | 聚辉医疗科技(深圳)有限公司 | Embolic protector and embolic system |
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