Thrombus protection system

Abstract

The present application provides a kind of thrombus protection system, the thrombus protection system includes: delivery unit, expansion sheath unit and thrombus protection device;The expansion sheath unit has the channel of being worn;The delivery unit includes delivery tube, the delivery tube is connected with the thrombus protection device, the delivery tube drives the thrombus protection device to the target lumen in the channel of being worn;The blood vessel protection device is configured as when the thrombus protection device is placed in target lumen, the thrombus protection device is attached with the cavity wall of target lumen, so that thrombus protection device is closely attached to blood vessel wall, not easy to produce gap, prevent small thrombus from gap, improve the efficiency of thrombus protection device intercepts and recovers thrombus.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a thrombosis protection system. Background Technology

[0002] During interventional vascular treatments and surgeries, thrombi or plaques at the lesion site can easily detach and, under the impact of blood flow, embolize downstream vessels, affecting blood flow. Most thrombus interception devices use vena cava filters placed in the inferior vena cava to intercept detached thrombi or plaques from the lesion site, preventing vascular embolism or pulmonary embolism. Due to its inherent structure, this type of vena cava filter can only intercept larger thrombi, not smaller ones.

[0003] Currently, among devices for intercepting small thrombi, one type of thrombus protection device has a skeleton structure that causes the membrane to be hexagonal in the cross-section of the blood vessel, making it difficult to completely adhere to the vessel wall. This allows small thrombi to pass through gaps between the thrombus protection device and the vessel wall. Another type of thrombus protection device includes a foam body attached to multiple flexible struts. The foam body has a roughly conical geometry with a roughly conical recess at the bottom. Blood cells can pass through the foam body, while larger materials, such as detached thrombi, are captured in the recess. Each flexible strut is connected along the periphery of the foam body and extends from one end of the foam body to a connection point near that end. However, the portion of this thrombus protection device that adheres to the blood vessel is small, lacks sufficient support, and is prone to gaps and displacement. Yet another type of thrombus protection device consists of a polygonal metal skeleton and a porous membrane. Polygonal metal skeletons are cut from metal tubing, but human blood vessels are not perfectly cylindrical. When a vessel is flattened, the skeleton does not fit tightly against the vessel wall, creating gaps that allow thrombi to pass through, affecting interception efficiency. Furthermore, none of these thrombus protection devices possess anti-displacement hooks or devices, making them prone to displacement during surgery. They also easily form autologous acute thrombi, which are difficult to recover. Gaps, easy displacement, and the tendency to form autologous acute thrombi all shorten the retrieval time window, thus reducing the efficiency of thrombus protection devices in intercepting and recovering thrombi.

[0004] Therefore, it is necessary to develop thrombus protection systems to improve the efficiency of thrombus protection devices in intercepting and recovering thrombi. Summary of the Invention

[0005] The purpose of this invention is to provide a thrombosis protection system to solve the problem that current thrombosis protection devices are prone to gaps between themselves and the blood vessel wall.

[0006] To address the aforementioned technical problems, the present invention provides a thrombosis protection system, comprising: a delivery unit, an dilating sheath unit, and a thrombosis protection device; the dilating sheath unit has a penetration channel; the delivery unit includes a delivery tube connected to the thrombosis protection device, the delivery tube driving the thrombosis protection device through the penetration channel to a target lumen; the vascular protection device is configured such that when the thrombosis protection device is placed in the target lumen, the thrombosis protection device fits against the wall of the target lumen.

[0007] Optionally, the thrombosis protection device has an indwelling wire.

[0008] Optionally, the thrombosis protection system further includes an indwelling wire storage component, which is connected to the proximal end of the delivery unit and is used to store the indwelling wire.

[0009] Optionally, the indwelling filament storage component includes a winding reel and a storage housing, wherein the winding reel is disposed inside the storage housing and is used for circumferentially winding the indwelling filament.

[0010] Optionally, the thrombosis protection system further includes an indwelling wire locking device, which is disposed at the proximal end of the delivery unit and is used to lock the indwelling wire.

[0011] Optionally, the thrombosis protection device includes a skeleton, a membrane, and a connecting ring; the membrane is attached to one axial end of the skeleton to receive thrombi; the connecting ring is disposed at the edge of the membrane and connected to the skeleton, and expands radially when the skeleton is opened.

[0012] Optionally, an indwelling wire connecting portion is provided at one end of the skeleton, and the indwelling wire is connected to the indwelling wire connecting portion; the indwelling wire connecting portion and the covering film are respectively provided at both ends of the skeleton, or the indwelling wire connecting portion and the covering film are provided at the same end.

[0013] Optionally, the connecting ring is connected to the support rod of the frame, and the connecting ring has at least one W-shaped structure between adjacent support rods.

[0014] Optionally, at least one of the membrane, skeleton, and connecting ring may be coated with a hydrophilic coating or a heparin coating.

[0015] Optionally, the outer surface of the indwelling thread is provided with a hydrophilic film, and / or the outer surface of the indwelling thread is coated with a hydrophilic coating or a heparin coating.

[0016] Optionally, the delivery unit further includes a handle and a storage tube, the skeleton of the thrombosis protection device is movably placed in the storage tube, the distal end of the delivery tube is connected to one end of the skeleton, and the proximal end of the delivery tube is connected to the handle.

[0017] Optionally, the dilating sheath unit includes a sheath assembly and a dilator assembly; the sheath assembly includes a sheath base and a sheath connected to the sheath base; the dilator assembly includes a dilator connector, a dilator tube connected to the dilator connector, a contrast ring, and a contrast port, the contrast ring and the contrast port being located at the distal end of the dilator tube, the dilator tube passing through the sheath base and inserted into the sheath; when the dilator assembly is separated from the sheath assembly, the sheath base is connected to the storage tube, the delivery tube actuates, and delivers the thrombus protection device to the target location.

[0018] This invention provides a thrombosis protection system, comprising: a delivery unit, an dilating sheath unit, and a thrombosis protection device; the dilating sheath unit has a penetration channel; the delivery unit includes a delivery tube connected to the thrombosis protection device, the delivery tube driving the thrombosis protection device through the penetration channel to a target lumen; the vascular protection device is configured such that when the thrombosis protection device is placed in the target lumen, the thrombosis protection device fits snugly against the lumen wall, making the thrombosis protection device tightly fitted to the vessel wall, preventing gaps from forming, and preventing small thrombi from flowing out through gaps, thereby improving the efficiency of the thrombosis protection device in intercepting and recovering thrombi. Attached Figure Description

[0019] Those skilled in the art will understand that the accompanying drawings are provided to better understand the invention and do not constitute any limitation on the scope of the invention. Wherein:

[0020] Figure 1 This is a schematic diagram of a thrombosis protection device according to an embodiment of the present invention.

[0021] Figure 2 This is a schematic diagram of a thrombosis protection system of the present invention implanted into a blood vessel via a transfemoral approach, according to an embodiment of the present invention.

[0022] Figure 3 This is a schematic diagram of a thrombosis protection system of the present invention implanted into a blood vessel via a transcervical approach, according to an embodiment of the present invention.

[0023] Figure 4 This is a schematic diagram of an embodiment of the indwelling wire clip of the present invention.

[0024] Figure 5 This is a schematic diagram of another state of the indwelling wire clip according to an embodiment of the present invention.

[0025] Figure 6This is a schematic diagram of a conveying unit according to an embodiment of the present invention.

[0026] Figure 7 This is a schematic diagram of the sheath assembly of an expansion sheath unit according to an embodiment of the present invention.

[0027] Figure 8 This is a schematic diagram of the expansion assembly of an expansion sheath unit according to an embodiment of the present invention.

[0028] Figure 9 This is a schematic diagram showing the connection between the delivery unit and the sheath assembly according to an embodiment of the present invention.

[0029] In the attached image:

[0030] A-Blood vessels;

[0031] 1- Thrombosis protection device,

[0032] 11-Skeleton, 111-Support, 12-Covering film, 13-Connecting ring, 14-Indwelling wire, 15-Indwelling wire connecting part, 16-Indwelling wire locking device, 17-Indwelling wire clamp, 171-Winding disc;

[0033] 2-Conveying unit, 21-Handle, 22-Conveying pipe, 23-Storage pipe;

[0034] 3-Expanding sheath unit,

[0035] 31-Sheath assembly, 311-Sheath base, 312-Sheath, 313-Sheath connector, 314-Sheath imaging ring, 315-Evacuation assembly.

[0036] 32-Expander assembly, 321-Expander connector, 322-Expander tube, 323-Reconstruction ring, 324-Contrast port. Detailed Implementation

[0037] To make the objectives, advantages, and features of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and are not drawn to scale, and are only used to facilitate and clarify the explanation of the embodiments of this invention. Furthermore, the structures shown in the drawings are often part of the actual structures. In particular, different figures may emphasize different aspects and may sometimes use different scales.

[0038] As used herein, the singular forms “a,” “an,” and “the” include plural objects unless otherwise expressly indicated. As used herein, the term “or” is generally used to include “and / or” unless otherwise expressly indicated. The term “a number” is generally used to include “at least one,” and the term “at least two” is generally used to include “two or more.” Furthermore, the terms “first,” “second,” and “third” are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as “first,” “second,” or “third” may explicitly or implicitly include one or at least two of that feature. The terms “installed,” “connected,” and “joined” should be interpreted broadly; for example, they may refer to a fixed connection, a detachable connection, or an integral part; they may refer to a direct connection or an indirect connection through an intermediate medium; they may refer to the internal communication of two components or the interaction between two components. “Distal end” refers to the end furthest from the medical staff's operation, and “proximal end” refers to the end closest to the medical staff's operation. Furthermore, as used in this invention, the phrase "one element disposed on another element" generally only indicates a connection, coupling, cooperation, or transmission relationship between the two elements, and this connection, coupling, cooperation, or transmission can be direct or indirect through an intermediate element. It should not be construed as indicating or implying a spatial positional relationship between the two elements, i.e., one element can be located arbitrarily inside, outside, above, below, or to one side of another element, unless otherwise explicitly stated. Those skilled in the art will understand the specific meaning of the above terms in this invention according to the specific circumstances. Additionally, numerous specific details are set forth in the following description to provide a more thorough understanding of the invention. However, it will be apparent to those skilled in the art that the invention can be practiced without one or more of these details. In other instances, certain technical features well-known in the art have not been described to avoid confusion with this invention.

[0039] This invention provides a thrombosis protection system, comprising: a delivery unit, an dilating sheath unit, and a thrombosis protection device; the dilating sheath unit has a penetration channel; the delivery unit includes a delivery tube connected to the thrombosis protection device, the delivery tube driving the thrombosis protection device through the penetration channel to a target lumen; the vascular protection device is configured such that when the thrombosis protection device is placed in the target lumen, the thrombosis protection device fits snugly against the lumen wall, making the thrombosis protection device tightly fitted to the vessel wall, preventing gaps from forming, and preventing small thrombi from flowing out through gaps, thereby improving the efficiency of the thrombosis protection device in intercepting and recovering thrombi.

[0040] The following description refers to the accompanying drawings.

[0041] Please refer to Figures 1 to 9 , Figure 1 This is a schematic diagram of a thrombosis protection device according to an embodiment of the present invention; Figure 2 This is a schematic diagram of a thrombosis protection device of the present invention implanted into a blood vessel via a transfemoral approach, according to an embodiment of the present invention. Figure 3 This is a schematic diagram of a thrombosis protection device of the present invention implanted into a blood vessel via a transcervical approach, according to an embodiment of the present invention. Figure 4 This is a schematic diagram of an embodiment of the indwelling wire clip of the present invention; Figure 5 This is a schematic diagram of another state of the indwelling wire clip according to an embodiment of the present invention; Figure 6 This is a schematic diagram of a conveying unit according to an embodiment of the present invention; Figure 7 This is a schematic diagram of the sheath assembly of an expansion sheath unit according to an embodiment of the present invention; Figure 8 This is a schematic diagram of the expansion assembly of an expansion sheath unit according to an embodiment of the present invention; Figure 9 This is a schematic diagram showing the connection between the delivery unit and the sheath assembly according to an embodiment of the present invention.

[0042] like Figure 1 , Figures 6 to 9 As shown, this embodiment provides a thrombosis protection system. The thrombosis protection system is preferably suitable for patients requiring temporary thrombosis protection. The thrombosis protection system includes a delivery unit 2, a dilating sheath unit 3, and a thrombosis protection device 1. The dilating sheath unit 3 has a penetration channel. The delivery unit 2 includes a delivery tube 22. Preferably, the distal end of the delivery unit 2 has a connector that connects to the dilating sheath unit 3. The delivery tube 22 is connected to the thrombosis protection device 1, which extends through the penetration channel into a target lumen and protrudes from the dilating sheath unit 3. The vascular protection device 1 is configured such that when the thrombosis protection device 1 is placed in the target lumen, it conforms to the wall of the target lumen. Preferably, the target lumen is, for example, a blood vessel. Specifically, the thrombus protection device 1 is delivered to the distal end of the dilation sheath unit 3 via the delivery unit 2 and the dilation sheath unit 3. The thrombus protection device 1 is released and unfolded from the distal end of the dilation sheath unit 3, and the unfolded thrombus protection device 1 can fit tightly against the blood vessel wall. This arrangement allows the edges of the thrombus protection device 1 to fit tightly against the blood vessel wall, making it less likely to form gaps and preventing small thrombi from flowing out through gaps.

[0043] More preferably, the thrombosis protection device includes: a frame 11, a membrane 12, and a connecting ring 13. For example... Figure 1The membrane 12 is attached to one axial end of the skeleton 11 to receive the thrombus. It should be understood that the skeleton 11 is disposed in the blood vessel A, and its axial direction is aligned with the axial direction of blood vessel A, allowing blood to flow from one end of the skeleton 11 to the other. Preferably, the skeleton 11 has multiple support rods 111 that support the skeleton 11, allowing blood to circulate within it. The skeleton 11 can be, for example, a polygonal prism in the middle and polygonal pyramids at both ends. Preferably, the skeleton 11 can be a hexagonal prism in the middle and hexagonal pyramids at both ends. Of course, those skilled in the art can choose other skeleton structures from the prior art, which will not be elaborated upon here. The membrane 12 is attached to one end of the skeleton 11. For example, the membrane 12 can be attached to the polygonal pyramidal portion of one end of the skeleton 11, or it can extend axially along the polygonal pyramidal portion and be attached to the polygonal prism portion. This allows the membrane 12 to filter out blood clots from the blood after it flows out of the skeleton 11, collect the clots, and finally remove them from the body. Preferably, the membrane 12 can, for example, intercept clots larger than 1 mm. Of course, the size of the clots intercepted by the membrane 12 is not limited herein. The connecting ring 13 is disposed at the edge of the membrane 12 and connected to the support rod 111 of the skeleton 11. When the skeleton 11 is opened, the connecting ring 13 expands radially. This arrangement allows the membrane 12 to be fixed at its edge by the connecting ring 13, thereby ensuring that the connecting ring 13 and the edge of the membrane 12 fit tightly against the blood vessel wall, preventing gaps and small clots from flowing out through gaps. Preferably, the connecting ring 13 has at least one W-shaped structure between adjacent support rods 111. When the connecting ring 13 expands radially, at least one W-shaped structure between adjacent support rods 111 also expands radially synchronously. Specifically, when the W-shaped structure expands, compared to the case without a W-shaped structure, the vertices of the W-shaped structure are more flexible, and the vertices also expand synchronously, making it easier for the vertices of the entire connecting ring 13's W-shaped structure to expand. In this exemplary embodiment, there is one W-shaped structure between adjacent support rods 111. In another embodiment, there may be two, three, or four consecutive W-shaped structures between adjacent support rods 111. Furthermore, when the skeleton 11 contracts, the connecting ring 20 contracts along with the skeleton 11. When the connecting ring 20 with the W-shaped structure contracts, the W-shaped structure folds along the axial direction of the skeleton 11, thereby effectively tightening the edge of the covering 12 and preventing thrombus leakage due to insecure retraction of the edge of the covering 12 between adjacent support rods 111.

[0044] Preferred, such as Figure 1As shown, the thrombosis protection device has an indwelling wire 14. When the thrombosis protection device 1 passes through the interior of the dilating sheath unit 3, the indwelling wire 14 follows the thrombosis protection device 1 through the interior of the dilating sheath unit 3 and the delivery unit 2. More preferably, an indwelling wire connecting portion 15 is provided at one end of the skeleton 11, and the indwelling wire 14 is connected to the indwelling wire connecting portion 15. The indwelling wire 14 connects to the skeleton 11, thereby preventing the skeleton 11 from shifting. The indwelling wire connecting portions 15 provided at both ends of the skeleton 11 can be provided at the same end as the covering membrane 12, or they can be provided at different ends. Figure 2 As shown, when the thrombosis protection device adopts a transforaminal approach, the indwelling wire connector 15 and the covering membrane 12 are respectively disposed at both ends of the skeleton 11. (Combined) Figure 2 As shown, when using the femoral approach, the thrombus protection device is implanted from below, and the indwelling wire 14 needs to be connected to the lower end of the skeleton 11 to secure it. Therefore, the indwelling wire connection part 15 is located at the lower end of the skeleton 11. After the skeleton 11 is implanted into blood vessel A, since blood flows from below to above, the covering membrane 12 is located at the upper end of the skeleton 11, and the indwelling wire connection part 15 and the covering membrane 12 are respectively located at both ends of the skeleton 11. It should be noted that the "up" and "down" directions in this article are based on the human body, with the direction towards the feet being "down" and the direction towards the top of the head being "up." Specifically, the positional relationship between "up" and "down" can be determined using the heart area of ​​the human body as a reference. This arrangement allows the skeleton 11 to be fixed in position by the indwelling wire 14 when implanted in the human body. Furthermore, this arrangement allows the skeleton 11 to not only be implanted via the femoral approach but also retrieved via the femoral approach, greatly reducing the difficulty of retrieval and overcoming the limitation of the prior art where retrieval is only possible via the neck. Preferably, in another embodiment, as Figure 1 and Figure 3 As shown, when the thrombus protection device is implanted via the transcervical approach, the indwelling wire connector 15 and the covering membrane 12 are located at the same end. Since the thrombus protection device is implanted from above via the transcervical approach, the indwelling wire 14 needs to be connected to the upper end of the skeleton 11 to secure it. Therefore, the indwelling wire connector 15 is located at the upper end of the skeleton 11. After the skeleton 11 is implanted into blood vessel A, since blood flows from below to above, the covering membrane 12 is located at the upper end of the skeleton 11, and the indwelling wire connector 15 and the covering membrane 12 are located at the same end of the skeleton 11. In other embodiments, when the transcervical approach is used, such as... Figure 3 As shown, the skeleton 11 can be directly connected to a delivery tube 22 without the need for the indwelling wire 14. Those skilled in the art can choose the appropriate configuration based on the specific circumstances. This configuration allows the thrombosis protection device to have both transfemoral and transnural access routes, and provides both transnural and transfemoral retrieval methods.

[0045] Preferred, such as Figures 4 to 5 As shown, the thrombosis protection device further includes an indwelling wire storage component 17, which is connected to the proximal end of the delivery unit 2 and is used to store the indwelling wire 14. More preferably, the indwelling wire storage component 17 includes a winding disc 171 and a storage housing. The winding disc 171 is disposed inside the storage housing and is used for circumferentially winding the indwelling wire 14, thereby allowing the indwelling wire 14 located outside the body to be stored in the indwelling wire storage component 17, preventing the indwelling wire 14 from scattering and improving the patient's wearing comfort. Furthermore, when not performing surgery, the indwelling wire storage component 17 can store all the indwelling wires 14.

[0046] The thrombosis protection device further includes an indwelling wire locking device 16, which is disposed on a delivery unit 2. The indwelling wire 14 passes through the delivery unit, and the indwelling wire locking device 16 is used to lock the indwelling wire 14, thereby keeping the indwelling wire 14 stationary relative to the delivery unit, preventing relative displacement between the thrombosis protection device and blood vessel A, and reducing complications. Preferably, the indwelling wire locking device 16 can be a standard component.

[0047] Preferably, the outer surface of the indwelling cord 14 is provided with a hydrophilic film. For example, a layer of polymer film can be heat-shrinked to the outer surface of the indwelling cord 14 using heat-shrink technology. The polymer film is made of a hydrophilic material to prevent thrombus formation. And / or, the outer surface of the indwelling cord 14 can be coated with a hydrophilic coating or a heparin coating, which can also prevent thrombus formation. In one embodiment, the outer surface of the indwelling cord 14 may only have a single layer of hydrophilic film heat-shrinked. In another embodiment, the outer surface of the indwelling cord 14 may only have a single layer of hydrophilic coating or a heparin coating. In another embodiment, the outer surface of the indwelling cord 14 is first heat-shrinked with a hydrophilic film, and then coated with a hydrophilic coating or a heparin coating to prevent the coating from peeling off and causing thrombus formation. Of course, in another embodiment, the outer surface of the indwelling cord 14 may also first have a single layer of film heat-shrinked, which may be limited to a hydrophilic film, and then coated with a hydrophilic coating or a heparin coating on the outside of the film.

[0048] Preferably, at least one of the membrane 12, skeleton 11, and connecting ring 13 is coated with a hydrophilic coating or a heparin coating, which can inhibit the formation of autologous acute thrombosis, intercept small thrombi, and thus prolong the recovery time window and the residence time of the thrombosis protection device in the body. More preferably, the hydrophilic coating is made of a polymer material. Preferably, the outer surfaces of the membrane 12, skeleton 11, and connecting ring 13 are all coated with a heparin coating, so that the thrombosis protection device can remain in the body for up to 30 days without forming thrombi. Of course, the coating can be applied only to the membrane 12, or only to the skeleton 11, or only to the outer surface of the connecting ring 13. Alternatively, the coating can be applied to two of the membrane 12, skeleton 11, and connecting ring 13. Furthermore, due to the placement of the indwelling wire 14, the thrombus protection device of this embodiment allows the skeleton 11 to remain in the blood vessel A without displacement. The hydrophilic coating can inhibit the formation of autologous acute thrombi, thus providing multiple retrieval time windows. Consequently, the thrombus protection device has the function of retrieval after 3 hours, 24 hours, and 3 days of indwelling, providing flexible time windows and enabling patients to have a more flexible protection cycle.

[0049] Preferred, such as Figure 6 The delivery unit 2 further includes a handle 21 and a storage tube 23. The storage tube 23 is the connecting element of the delivery unit 2. The delivery tube 22 passes through the storage tube 23 and is connected to the dilation sheath unit 3. The distal end of the delivery tube 22 is connected to the skeleton 11, allowing the delivery tube 22 to deliver the skeleton 11 to the dilation sheath unit 3 connected to the distal end of the storage tube 23. Specifically, the skeleton 11 is movably disposed within the storage tube 23. When the skeleton 11 needs to be moved to the target position, the delivery tube 22 moves distally relative to the storage tube 23, pushing the skeleton 11 into the dilation sheath unit 3 until the skeleton 11 is pushed to the target position. The distal end of the delivery tube 22 is mechanically connected to the skeleton 11, for example. The proximal end of the delivery tube 22 is connected to the handle 21. The target position is, for example, the optimal position for placing a thrombus protection device. Figure 3 As shown, when using the transcervical approach, the delivery tube 22 remains inside the body while the skeleton 11 is implanted. When it is necessary to retract the skeleton 11, the delivery tube 22 or the handle 21 is tightened to retract the delivery tube 22 and the skeleton 11 together. In this case, the indwelling wire 14 can be omitted, thus preventing movement of the skeleton 11 within blood vessel A. Alternatively, the indwelling wire 14 can be used. The method of using the indwelling wire 14 is described below. The delivery tube 22 has good flexibility and can be made of polymer materials or metal materials. The delivery tube 22 and the handle 21 can be mechanically connected or welded together.

[0050] Better, such as Figure 6As shown, the thrombosis protection device 1 also includes an indwelling wire 14 and an indwelling wire locking device 16. One end of the indwelling wire 14 is connected to the frame 11 of the thrombosis protection device 1. The indwelling wire 14 passes through at least the delivery tube 22 and the handle 21. The indwelling wire locking device 16 is located near the handle 21 and locks the other end of the indwelling wire 14. In this way, the other end of the indwelling wire 14 can be locked near the handle 21 by the indwelling wire locking device 16, preventing the frame 11 connected to one end of the indwelling wire 14 from shifting. At this time, the delivery tube 22 can be disconnected from the frame 11. After the frame 11 is implanted in the human body, the delivery tube 22 can be withdrawn from the body, and the indwelling wire 14 controls the movement of the frame 11. For example, this solution can be adopted in this embodiment via a transurethral approach.

[0051] Preferred, such as Figure 7 and Figure 8 As shown, the dilating sheath unit 3 includes a sheath assembly 31 and a dilator assembly 32. The sheath assembly 31 includes a sheath connector 313, a sheath base 311, a sheath 312 connected to the sheath base 311, and a sheath imaging ring 314, arranged sequentially from proximal to distal. The sheath assembly 31 also includes a drain assembly 315 disposed on the sheath base 311. The dilator assembly 32 includes a dilator connector 321, a dilator tube 322 connected to the dilator connector 321, an imaging ring 323, and an angiography port 324. The imaging ring 323 and the angiography port 324 are located at the distal end of the dilator tube 322, which passes through the sheath base 311 and is inserted into the sheath 312. The imaging ring 323 and the angiography port 324 allow for angiography and measurement of blood vessel A before and after implantation of the skeleton 11. The sheath 312 has good flexibility and can be made of polymer materials such as high-density polyethylene (HDPE) or nylon (PA). The developing ring 314 of the sheath uses a developing material, which can be tantalum, platinum-tungsten, or platinum-iridium. The expander tube 322 also has good flexibility and can be made of polymer materials such as high-density polyethylene (HDPE) or nylon (PA). The developing ring 323 uses a developing material, which can be tantalum, platinum-tungsten, or platinum-iridium. Figure 9 As shown, after the dilator assembly 32 separates from the sheath assembly 31, the sheath base 311 connects to the storage tube 23, thereby connecting the delivery unit 2 and the dilating sheath unit 3. The delivery tube 22 of the delivery unit 2 then operates, delivering the thrombus protection device 1 to the target location.

[0052] The following will combine Figures 1 to 9This section describes in detail the implantation and retrieval of the thrombus protection device in the thrombus protection system. It should be understood that the thrombus protection device provided in this embodiment can be implanted via the femoral or transcervical route, preferably via the femoral route for implantation and retrieval, but also via the transcervical route for implantation and retrieval. The thrombus protection device provided in this embodiment can have different retrieval windows, such as 3 hours, 24 hours, or 3 days. The following will describe the femoral and transcervical routes in detail, as well as the situations when using different time windows.

[0053] The procedure is performed via the femoral approach. In this embodiment, the thrombus protection device in the femoral approach includes an indwelling cord. The following describes the release and retrieval of the thrombus protection device when the indwelling cord is present.

[0054] The femoral vein A is punctured, and the dilator assembly 32 is inserted into the sheath assembly 31, then carried together along the guidewire to the distal end of the inferior vena cava. Angiography is performed under X-ray guidance through the angiography port 324 to confirm the size of vessel A and the optimal placement segment of vessel A for the thrombus protection device 1. The delivery tube 22 pushes the sheath 312 to the optimal placement position of the thrombus protection device 1, and the dilator assembly 32 is withdrawn. Once the thrombus protection device 1 reaches the optimal placement position, i.e., the target vessel A, the handle 21 and delivery tube 22 are kept stationary, and the sheath 312 is withdrawn until the thrombus protection device 1 is fully released and anchored within the vessel wall.

[0055] Release and retrieval of thrombosis protection device 1. For cases where the device has been in place for 3 hours, during release, keep the sheath 312 and delivery unit 2 stationary within the body. Tighten the indwelling wire locking device 16 to lock the indwelling wire 14 and prevent displacement of the skeleton 11. The indwelling wire locking device 16 can be tightened until it is in axial contact with the handle 21, allowing the handle 21 to limit the movement of the indwelling wire locking device 16. After coiling the indwelling wire 14 remaining outside the body, store it with the indwelling wire clip 17 and clamp it against the thigh. During retrieval, first remove the adhesive tape from the body, open the indwelling wire clamp 17, loosen the indwelling wire locking device 16 and separate it from the delivery unit 2; then completely remove the delivery tube 22 and handle 21 from the body; at this point, push the sheath 312 proximally until it is in contact with the distal end of the thrombus protection device, tighten the indwelling wire 14, and continue to push the sheath 312 proximally until the thrombus protection device 1 is completely retracted into the sheath 312. The entire thrombus protection system can then be removed from the body.

[0056] For cases where the catheter is left in place for 24 hours or 3 days, during release, loosen the indwelling wire locking device 16 and remove it, keeping the thrombus protection device 1 in place. First, remove the delivery tube 22 and handle 21 from the body, then remove the sheath 312. Reinsert the indwelling wire locking device 16, tighten it, and attach it to the puncture sheath. It should be understood that the puncture sheath is the device first inserted into the body during the puncture process, and the blood circulation protection system is implanted into blood vessel A under the protection of the puncture sheath. The structure and principle of the puncture sheath can be found in existing technology and will not be elaborated here. Finally, coil the indwelling wire 14 outside the body and clamp it with the indwelling wire clip 17, attaching it to the thigh. During retrieval, first remove the adhesive tape attached to the body, open the indwelling wire clamp 17, loosen the indwelling wire locking device 16 and separate it from the delivery unit 2; then, reinsert the sheath 312 along the indwelling wire 14 into the body until it reaches the vicinity of the thrombus protection device; push the sheath 312 proximally until it is against the distal end of the thrombus protection device 1, tighten the indwelling wire 14, and continue pushing the sheath 312 proximally until the thrombus protection device 1 is completely retracted into the sheath 312. At this point, the entire thrombus protection system can be removed from the body. This setup allows for transfemoral implantation and transfemoral retrieval, overcoming the current technical limitation that thrombus protection devices can only be retrieved via the neck.

[0057] The procedure is performed via the transcervical approach. In this embodiment, the thrombus protection device in the transcervical approach does not have an indwelling wire. The following describes the release and retrieval of the thrombus protection device when the distal end of the delivery tube 22 is connected to the skeleton 10 without an indwelling wire.

[0058] The jugular vein A is punctured, and the dilator assembly 32 is inserted into the sheath assembly 31, then carried together along the guidewire to the distal position of the inferior vena cava. Angiography is performed under X-ray guidance through the angiography port 324 to confirm the size of vessel A and the optimal placement segment of vessel A for the thromboprotection device. The delivery tube 22 pushes the sheath 312 to the optimal placement position of the thromboprotection device 1, and the dilator assembly 32 is withdrawn. Once the thromboprotection device reaches the target vessel A, the handle 21 and delivery tube 22 are kept stationary, and the sheath 312 is withdrawn until the thromboprotection device is fully released and anchored within the vessel wall.

[0059] Release and retrieval of the thromboprotection device 1. When the distal end of the delivery tube 22 is connected to the skeleton 10, it is preferably left in the body for 3 hours. During release, keep the sheath 312 and delivery unit 2 in place in the body, and then attach the external handle 22 to the body. During retrieval, first peel off the adhesive tape attached to the body, push the sheath 312 proximally until it is close to the distal end of the thromboprotection device 1, tighten the delivery tube 22 or handle 21, and continue to push the sheath 312 proximally until the thromboprotection device 1 is completely retracted into the sheath 312. At this point, the entire thromboprotection device can be withdrawn from the body. Using the thromboprotection device of this embodiment, through both transcervical and transfemoral methods, the delivery unit 2 can easily and quickly introduce the thromboprotection device 1 into the body, and can effectively and quickly retrieve the thromboprotection device 1 from the body at the end of the operation, thereby meeting the clinical needs for thromboprotection systems. Furthermore, the thrombus protection device of this embodiment can be conveniently inserted into the inferior vena cava to intercept small thrombi that have become loose and moved during interventional procedures such as mechanical thrombectomy and thrombolysis in vascular A, thus preventing fatal pulmonary embolism and other pulmonary complications in the short term.

[0060] In summary, the thrombosis protection system provided by this invention includes: a delivery unit, a dilating sheath unit, and a thrombosis protection device; the dilating sheath unit has a penetration channel; the delivery unit includes a delivery tube connected to the thrombosis protection device, the delivery tube driving the thrombosis protection device through the penetration channel to the target lumen; the vascular protection device is configured such that when the thrombosis protection device is placed in the target lumen, the thrombosis protection device fits snugly against the wall of the target lumen, making the thrombosis protection device tightly fitted to the vessel wall, preventing gaps from forming, preventing small thrombi from flowing out from gaps, and improving the efficiency of the thrombosis protection device in intercepting and recovering thrombi.

[0061] Furthermore, it should be understood that although the present invention has been disclosed above with reference to preferred embodiments, these embodiments are not intended to limit the present invention. For any person skilled in the art, many possible variations and modifications can be made to the technical solutions of the present invention based on the disclosed technical content, or equivalent embodiments can be modified accordingly, without departing from the scope of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention without departing from the content of the present invention shall still fall within the scope of protection of the present invention.

Claims

1. A thrombosis protection system, characterized in that, include: Delivery unit, dilation sheath unit, and thrombus protection device; The expansion sheath unit has a through-hole; The delivery unit includes a delivery pipe, which is connected to the thrombus protection device. The delivery pipe drives the thrombus protection device through the penetration channel to the target lumen. The thrombosis protection device has an indwelling wire; The thrombosis protection device includes a skeleton, a covering, and a connecting ring. The covering is attached to one axial end of the skeleton to receive thrombi. The connecting ring is located at the edge of the covering and connected to the skeleton. When the skeleton is opened, the connecting ring expands radially. An indwelling wire connection is provided at one end of the skeleton, and the indwelling wire is connected to the indwelling wire connection to prevent the skeleton from shifting during use. The indwelling wire connection and the covering are respectively located at both ends of the skeleton, or the indwelling wire connection and the covering are located at the same end, so that the thrombosis protection device has two access methods: transfemoral and transnular, and can provide two retrieval methods: transnular and transfemoral. The thrombosis protection device is configured such that when the thrombosis protection device is placed in the target lumen, the thrombosis protection device fits snugly against the wall of the target lumen, so that the connecting ring and the continuous covering can fit tightly against the vessel wall, making it less likely to produce gaps.

2. The thrombosis protection system according to claim 1, characterized in that, The thrombosis protection system also includes an indwelling wire storage component, which is connected to the proximal end of the delivery unit and is used to store the indwelling wire.

3. The thrombosis protection system according to claim 2, characterized in that, The indwelling filament storage component includes a winding reel and a storage housing. The winding reel is disposed inside the storage housing and is used for circumferential winding of the indwelling filament.

4. The thrombosis protection system according to claim 1, characterized in that, The thrombosis protection system also includes an indwelling wire locking device, which is located at the proximal end of the delivery unit and is used to lock the indwelling wire.

5. The thrombosis protection system according to claim 1, characterized in that, The connecting ring is connected to the support rod of the frame, and the connecting ring has at least one W-shaped structure between adjacent support rods.

6. The thrombosis protection device according to claim 1, characterized in that, At least one of the membrane, skeleton, and connecting ring is coated with a hydrophilic coating or a heparin coating.

7. The thrombosis protection device according to claim 1, characterized in that, The outer surface of the indwelling wire is provided with a hydrophilic film, and / or the outer surface of the indwelling wire is coated with a hydrophilic coating or a heparin coating.

8. The thrombosis protection system according to claim 1, characterized in that, The delivery unit also includes a handle and a storage tube. The skeleton of the thrombosis protection device is movably placed in the storage tube. The distal end of the delivery tube is connected to one end of the skeleton, and the proximal end of the delivery tube is connected to the handle.

9. The thrombosis protection system according to claim 8, characterized in that, The dilating sheath unit includes a sheath assembly and a dilator assembly; the sheath assembly includes a sheath base and a sheath connected to the sheath base; the dilator assembly includes a dilator connector, a dilator tube connected to the dilator connector, a contrast ring, and a contrast port, the contrast ring and the contrast port being located at the distal end of the dilator tube, the dilator tube passing through the sheath base and inserted into the sheath; when the dilator assembly is separated from the sheath assembly, the sheath base is connected to the storage tube, the delivery tube actuates, and delivers the thrombus protection device to the target location.

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