Vascular repair member and device

Abstract

The utility model relates to a blood vessel repairing piece and device, the blood vessel repairing piece comprises a body, the body is a film with ductility, and the body is used for being matched with a releasable stent for use and has an initial state and an unfolded state; in an initial state, the body is folded into a tube with a first inner diameter, the size of the first inner diameter is matched with the outer diameter of an unreleased stent, and the far end of the body is folded into a shape with the size smaller than the outer diameter of the unreleased stent; in the unfolding state, the body is unfolded into a through cylinder with a second inner diameter by the released stent, the size of the second inner diameter is matched with the outer diameter of the released stent, and the body is clamped between the stent and the blood vessel wall. The blood vessel perforation can be effectively blocked, and the cost is low.

Description

TECHNICAL FIELD

[0001] The utility model relates to blood vessel covering film technical field, especially in a kind of blood vessel repair and device. BACKGROUND

[0002] In the arterial intervention treatment, due to the size of stent, release pressure, post-dilation pressure or pre-dilation pressure is too large, often there is arterial perforation. Coronary artery perforation is a low incidence (0.1%-3%) but extremely dangerous complication during percutaneous coronary intervention (PCI) for patients with coronary heart disease, which can cause acute pericardial tamponade in a short time, and even death. Coronary artery perforation is usually divided into three types (Ellis classification), and type III perforation is the most dangerous, which can lead to acute pericardial tamponade and even death if not treated in time.

[0003] The current treatment method is as follows: when type III perforation occurs, a balloon matching the diameter of the blood vessel is rapidly expanded to seal the blood vessel hole, but in most cases, balloon expansion cannot stop bleeding, and if the sealing time is too long, myocardial ischemia or acute vascular occlusion may occur, causing acute myocardial infarction. If the balloon expansion cannot seal the perforation site, a PTFE membrane stent or even a surgical thoracotomy may be considered, and the membrane stent is currently the most effective method for sealing coronary perforation in interventional medicine, but the PTFE membrane stent is expensive and difficult to be widely used, therefore, when coronary artery perforation occurs, balloon low-pressure expansion is generally used, and heart surgery bypass or emergency PTEE membrane stent from other hospitals or transfer to higher-level hospitals for treatment is prepared, and the mortality rate of patients during this process is very high. UTILITY MODEL CONTENT

[0004] Therefore, the utility model provides a blood vessel repair and device, which can effectively seal the blood vessel perforation and has low cost.

[0005] Specifically, the utility model provides a blood vessel repair, which comprises a body, the body is a thin film with ductility, the body is used in cooperation with a releasable stent, and has an initial state and an expanded state.

[0006] In the initial state, the body is folded into a tubular shape with a first inner diameter, the size of the first inner diameter matches the outer diameter of the unreleased stent, and the distal end of the body is folded into a shape with a size smaller than the outer diameter of the unreleased stent.

[0007] In the expanded state, the body is supported by the released stent to form a through cylinder with a second inner diameter, the size of the second inner diameter matches the outer diameter of the released stent, and the body is clamped between the stent and the blood vessel wall.

[0008] In one embodiment, the distal end of the body is folded into a cone shape with a third inner diameter smaller than the first inner diameter in the initial state.

[0009] In one embodiment, the distal end of the body is left with a guide hole in the initial state.

[0010] In one embodiment, the length of the body is 40mm-80mm in the initial state; and / or,

[0011] The thickness of the body is 100um-500um; and / or,

[0012] The second inner diameter is 2.25mm-35mm in size in the deployed state.

[0013] In one embodiment, the second inner diameter is 2.25mm, 2.5mm, 2.75mm, 3.0mm, 3.25mm, 3.5mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm, 6.0mm, 10mm, 15mm, 20mm, 22mm, 25mm, 30mm, 33mm or 35mm in size.

[0014] In one embodiment, the length of the body is 45mm, 50mm, 55mm, 60mm, 65mm, 70mm or 75mm in the initial state.

[0015] In one embodiment, the thickness of the body is 150um, 200um, 250um, 300um, 350um, 400um or 450um.

[0016] In one embodiment, the distal end of the body has a radiopaque marker; and / or,

[0017] The inner wall of the body is attached with an anti-thrombotic drug.

[0018] A vascular repair device comprising a releasable stent and the vascular repair member, the vascular repair member being sleeved outside the unreleased stent in the initial state; the vascular repair member being expanded by the released stent in the deployed state.

[0019] In one embodiment, the stent comprises a first stent and a second stent, the vascular repair member being sleeved outside the unreleased first stent in the initial state; the vascular repair member being expanded by the released first stent and the second stent in the deployed state, the second stent being placed at the distal end of the vascular repair member.

[0020] The blood vessel repair device and the blood vessel repair device are simple to manufacture, the specification matched with the target blood vessel diameter is selected, and the blood vessel repair device is cut to a proper length and used in cooperation with a commonly used blood vessel stent. BRIEF DESCRIPTION OF DRAWINGS

[0021] The above and other objects, features and advantages of the exemplary embodiments of the present disclosure will be more apparent from the following detailed description read in conjunction with the accompanying drawings, in which:

[0022] Figure 1 is a side view of a blood vessel repair device in an initial state according to an embodiment;

[0023] Figure 2 is an end view of a blood vessel repair device in an initial state according to an embodiment;

[0024] Figure 3 is a side view of a blood vessel repair device in an expanded state according to an embodiment;

[0025] Figure 4 is a side view of a blood vessel repair device in an expanded state according to another embodiment;

[0026] Figure 5 is an end view of a blood vessel repair device in an expanded state according to an embodiment.

[0027] The reference signs are as follows:

[0028] 10. Body; 110. Distal end of body; 120. Guide port; 20. Stent; 210. First stent; 220. Second stent; 30. Blood vessel. Detailed Implementation

[0029] The technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this disclosure. All other embodiments obtained by those skilled in the art based on the embodiments of this disclosure without creative effort are within the scope of protection of this disclosure.

[0030] The specific embodiments of this disclosure will now be described in detail with reference to the accompanying drawings.

[0031] Reference Figures 1-5 This utility model provides a vascular repair device, including a releasable stent 20 and a vascular repair component. The vascular repair component of this embodiment includes a body 10, which is a stretchable thin film. The body 10 is used in conjunction with the releasable stent 20 and has an initial state and an deployed state. The stent 20 can be an existing vascular stent, which will not be described in detail here.

[0032] Reference Figure 1 , 2 In the initial state, the body 10 is folded into a tube with a first inner diameter, the size of which matches the outer diameter of the unreleased bracket 20, and the distal end of the body 10 is folded into a shape with a size smaller than the outer diameter of the unreleased bracket 20. Figure 2 This is a schematic diagram with the proximal end of the main body 10 facing the distal end, where the distal end refers to the end furthest from the operator during the implantation of the vascular repair device, and vice versa. Optionally, refer to... Figure 2 The body 10 is folded into a tubular shape using a spiral or other method. The first inner diameter of the tubular shape matches the outer diameter of the stent 20 in its unreleased state, allowing the stent 20 to be easily placed into the tubular space enclosed by the body 10. The distal end of the body 10 is folded into a shape smaller than the outer diameter of the unreleased stent 20, i.e., the distal end of the body 10 is in a contracted shape, used to fix it to the distal end of the stent 20, preventing the body 10 from detaching from the stent 20 during implantation. The vascular repair component is a tubular thin-film structure, soft in texture, and has good permeability, allowing it to smoothly pass through tortuous and calcified blood vessels to reach the target site.

[0033] Reference Figure 3 , 4, 5, in the expanded state, the body 10 is supported by the released stent 20 to be expanded into a through cylinder with a second inner diameter, the size of the second inner diameter matches the outer diameter of the released stent 20, and the body 10 is clamped between the stent 20 and the wall surface of the blood vessel 30. The body 10 is sleeved outside the stent 20 and sent to the desired position. By fully expanding the stent 20, the blood vessel repair device is clamped between the stent 20 and the wall surface of the blood vessel 30, forming a covered stent, and sealing the blood vessel 30. After the stent 20 is released, the diameter of the blood vessel repair device is consistent, which avoids the diameter of the body 10 being too small to cause the stent 20 to expand poorly or the diameter of the body 10 being too large to form a local fold and increase the risk of thrombosis.

[0034] The blood vessel repair device and device of the present embodiment are simple to manufacture. When an arterial perforation or arterial tear occurs during an interventional procedure, a blood vessel repair device with a diameter matching the target blood vessel 30 is selected, cut to the appropriate length, and used with a commonly used vascular stent 20. First, a common vascular balloon is sent to the target site for low-pressure expansion to seal and stop bleeding. The folded tubular blood vessel repair device with a first inner diameter is sleeved outside the unreleased stent 20. At this time, the distal end of the blood vessel repair device is outside the distal end of the stent 20 and is not supported by the stent 20. Since the distal end of the body 10 is folded to a size smaller than the outer diameter of the unreleased stent 20, the blood vessel repair device is firmly attached to the unreleased stent 20, with little risk of falling off, without the need for additional suturing of the covering or placing the covering in a specific temperature for shrinkage. Then, the balloon used for sealing is withdrawn, and the blood vessel repair device in the initial state is sent to the target site along the interventional guide wire. The stent 20 is expanded and released, and the blood vessel repair device is pressed against the inner wall of the blood vessel 30 by the stent 20, achieving the effect of sealing the perforation or tear of the blood vessel 30. Referring to Figure 4 Finally, another unreleased short stent can be sent in a conventional method and expanded and released at the distal end of the original stent to support the distal end of the blood vessel repair device and attach the covering to the blood vessel wall. The blood vessel repair device and device are inexpensive, easy to use and operate, have low catheter room inventory costs, are conducive to widespread use, have high safety and effectiveness, greatly improve the convenience and efficiency of medical personnel, increase the timeliness of rescue treatment, and can effectively improve the success rate of blood vessel perforation and rupture rescue during interventional procedures.

[0035] Traditional PTFE covered stent, which is made of two layers of 316 stainless steel tubular engraved stent and a layer of polytetrafluoroethylene (PTFE) sandwich structure, not only has high cost, but also has poor flexibility. It is often difficult to reach the target site in calcified or twisted lesions, and the release of PTFE covered stent can easily lead to the occlusion of the perforation site, increasing the risk of delayed thrombosis. And the self-made covered stent is made by wrapping the stent with sterile adhesive film (such as medical 3M adhesive film), stent outer sleeve balloon or autologous vascular graft, etc. Generally, the operator is difficult to master the length of the outer wrapping, the degree of winding and the adhesion tightness of the wrapping and the stent. Too loose will cause the wrapping to fall off, and too tight will cause the stent to be retracted by the elastic covering, resulting in poor stent expansion and stent unloading. The production process depends on experience, often takes too long time, and delays the valuable rescue opportunity of the patient. In addition, the liquid adhesive tape type coronary covered stent is coated with "liquid adhesive tape glue layer" on the surface of the balloon stent to achieve the effect of covered stent. However, the production process of "liquid adhesive tape liquid" is complex, time-consuming, and the thickness, length and other indicators of the glue layer are difficult to standardize. The thickness and integrity of the glue layer after expansion are uncontrollable.

[0036] Based on the current treatment situation of arterial perforation and the different degrees of shortcomings of various treatment technologies, the blood vessel repair device of the embodiment is a preformed covered stent made of non-rejection biochemical materials compatible with the human body, which can reduce rejection. According to different use scenarios, biodegradable materials (including but not limited to PLLA, etc.) or non-biodegradable materials (including but not limited to PETT, etc.) can be selected for use with the current market blood vessel stent 20. In the initial state, the preformed blood vessel repair device is sleeved outside the unreleased stent 20; in the expanded state, the blood vessel repair device is expanded by the released stent 20, and the blood vessel repair device and the device are high, stable, effective, fast and simple, which can quickly and easily be sent to the perforation of the blood vessel 30 when the arterial perforation occurs, and timely and effectively seal the break. It can significantly improve the prognosis of patients and reduce the mortality rate during and after surgery.

[0037] Optionally, the blood vessel repair device is made of biodegradable materials, which is absorbed by the human body within a certain time, reducing the risk of thrombosis, and the branch vessels at the occluded position can be reopened.

[0038] Reference Figure 1 Optionally, in one embodiment, the distal end of the body 10 is folded into a conical shape with a third inner diameter in the initial state, and the third inner diameter is smaller than the first inner diameter. On the one hand, the conical structure tightens the distal end of the body 10, so that the body 10 is firmly sleeved on the stent 20, reducing the risk of disengagement. On the other hand, it is convenient for the blood vessel repair device to be implanted into the blood vessel 30 from the distal end.

[0039] Further, reference Figure 1、 2 In one embodiment, the distal end 110 of the body 10 has a guide hole 120 in the initial state. That is, when the body 10 is folded into a conical shape or the like with a size smaller than the outer diameter of the unreleased stent 20, the guide hole 120 is left in the middle of the distal end of the body 10, and a corresponding blood vessel intervention operation guide wire passes through the guide hole 120.

[0040] In one embodiment, the length of the body 10 is 40mm to 80mm in the initial state. The length can be simply cut to different lengths according to the tear or perforation condition of the blood vessel 30 during the operation. Alternatively, the length of the body 10 is 45mm, 50mm, 55mm, 60mm, 65mm, 70mm, or 75mm.

[0041] The thickness of the body 10 is 100um to 500um. The thickness of the covering film can be made to be different thicknesses of 100um to 500um according to the blood vessel 30 applied at different parts. Alternatively, the thickness of the body 10 is 150um, 200um, 250um, 300um, 350um, 400um, or 450um.

[0042] In the expanded state, the second inner diameter is 2.25mm to 35mm. Alternatively, the second inner diameter is 2.25mm, 2.5mm, 2.75mm, 3.0mm, 3.25mm, 3.5mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm, 6.0mm, 10mm, 15mm, 20mm, 22mm, 25mm, 30mm, 33mm, or 35mm. The appropriate size of the blood vessel repair member is selected according to the size of the blood vessel, wherein the second inner diameter for coronary artery surgery is preferably 2.25mm to 6mm; the second inner diameter size is selected to match the diameter of the target blood vessel, such as intracranial artery, internal visceral artery, peripheral artery, or aorta, etc. The blood vessel repair member can be made into different specifications, and after being fully expanded, it is a cylindrical film with a diameter of 2.25mm, 2.5mm, 2.75mm, 3.0mm, 3.25mm, 3.5mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm, 6.0mm, 10mm, 15mm, 20mm, 22mm, 25mm, 30mm, 33mm, or 35mm or other sizes, and a length of 40mm to 80mm.

[0043] After fully expanded, the blood vessel repair member has certain extensibility and can accommodate a larger post-expanding balloon without shrinking. The blood vessel repair member has different diameter specifications, and the specification matching the target blood vessel diameter is selected, and is used with a common blood vessel stent 20, which can be used for the treatment of other arterial, venous blood vessels, aneurysm and arteriovenous fistula, including coronary artery. During intracranial vascular intervention and peripheral vascular intervention surgery, blood vessel rupture, perforation or aneurysm, arteriovenous fistula and other conditions requiring occlusion will also be encountered, which also belongs to the use scenarios of the blood vessel repair member and device.

[0044] Further, in one embodiment, the distal end 110 of the body has a radiopaque marker to accurately display the position of the device during surgery, facilitating positioning.

[0045] Optionally, in one embodiment, the inner wall of the body 10 is attached with an antithrombotic drug to reduce the risk of thrombosis in the stent 20.

[0046] Further, with reference to Figure 4 In one embodiment, the stent 20 includes a first frame 210 and a second frame 220. In the initial state, the blood vessel repair member is sleeved outside the unreleased first frame 210. In the expanded state, the blood vessel repair member is expanded by the released first frame 210 and the second frame 220, and the second frame 220 is placed at the distal end of the blood vessel repair member. The blood vessel repair member in the initial state is smoothly implanted into the blood vessel through the first frame 210, and after being implanted in place, the first frame 210 is released to expand the blood vessel repair member and block the blood vessel window. At this time, the distal end 110 of the body has a small amount of covering film in an unsupported state by the first frame 210. Then, the second frame 220 is implanted into the distal end of the first frame 210, and after being implanted in place, the second frame 220 is released to expand the distal end of the blood vessel repair member, ensuring that the entire blood vessel repair member is in a supported state by the stent 20, and ensuring the repair effect.

[0047] The implantation method of the blood vessel repair device of any of the above embodiments is as follows:

[0048] When blood vessel perforation or tearing occurs during interventional surgery,

[0049] (1) Send a common blood vessel balloon to the target site for low-pressure expansion to stop bleeding.

[0050] (2) According to the diameter of the blood vessel at the target site, select the corresponding specification of the blood vessel repair member and the blood vessel stent 20, and according to the condition of the blood vessel perforation or tearing, cut it to an appropriate length, and put the cut blood vessel repair member outside the blood vessel stent 20.

[0051] (3) Withdraw the balloon for occlusion, send the blood vessel repair member and the stent 20 to the target site along the interventional guide wire, and after accurate positioning under X-ray, expand and release the stent 20, the blood vessel repair member is pressed on the blood vessel wall by the blood vessel stent 20, and the effect of plugging the blood vessel perforation or tear is achieved.

[0052] (4) At this time, part of the cover film at the distal end of the blood vessel repair member is not covered by the stent, and another short stent of the same diameter is sent in a conventional method, expanded and released at the distal end of the original stent, and the free cover film is attached to the blood vessel wall.

[0053] In the above description of the present specification, unless otherwise explicitly specified and limited, the terms "fixed", "mounted", "connected" or "linked" and the like should be understood in a broad sense. For example, as to the term "connected", it can be fixed connection, detachable connection, or integral; it can be mechanical connection, electrical connection; it can be direct connection, or indirect connection through an intermediate medium, or it can be internal communication of two elements or interaction relationship between two elements. Therefore, unless otherwise explicitly limited in the present specification, the above terms can be understood in the specific meaning in the present application by the person skilled in the art according to the specific circumstances.

[0054] According to the above description of the present specification, the person skilled in the art can also understand the terms used as follows, for example, the terms indicating the orientation or positional relationship such as "upper", "lower", "front", "rear", "left", "right", "length", "width", "thickness", "vertical", "horizontal", "top", "bottom", "inner", "outer", "axial", "radial", "circumferential", "center", "longitudinal", "transverse", "clockwise" or "counterclockwise" are based on the orientation or positional relationship shown in the drawings of the present specification, which is only for the purpose of facilitating the description of the scheme of the present application and simplifying the description, and is not explicitly or implicitly indicated that the devices or elements involved must have the specific orientation, be constructed and operated in the specific orientation, therefore the above orientation or positional relationship terms cannot be understood or interpreted as a limitation on the scheme of the present application.

[0055] In addition, the terms "first" or "second" and the like used in the present specification are terms used to refer to numbers or ordinal numbers only for the purpose of description, and cannot be understood as indicating relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined with "first" or "second" can explicitly or implicitly include at least one of the features. In the description of the present specification, the meaning of "plurality" is at least two, for example, two, three or more, etc., unless otherwise explicitly specified and limited.

[0056] While the present application has been shown and described with reference to various embodiments thereof, it will be understood by those skilled in the art that various changes in form and details can be made therein without departing from the spirit and scope of the application. It is therefore intended that the application not be limited to the exact form and details herein shown and described, except as defined in the appended claims.

Claims

1. A vascular repair device, comprising: The device comprises a body, which is a thin film with ductility, and is used in cooperation with a releasable stent, and has an initial state and an expanded state. In the initial state, the body is folded into a tubular shape with a first inner diameter, which matches the outer diameter of the unreleased stent, and the distal end of the body is folded into a shape with a size smaller than the outer diameter of the unreleased stent. In the expanded state, the body is expanded by the released stent into a through cylinder with a second inner diameter, which matches the outer diameter of the released stent, and the body is clamped between the stent and the blood vessel wall.

2. The vascular repair device according to claim 1, wherein, In the initial state, the distal end of the body is folded into a conical shape with a third inner diameter, which is smaller than the first inner diameter.

3. The vascular repair device according to claim 1, wherein, In the initial state, the distal end of the body has a guide hole.

4. The vascular repair device according to claim 1, wherein, In the initial state, the length of the body is 40mm-80mm; and / or, The thickness of the body is 100um-500um; and / or, In the expanded state, the size of the second inner diameter is 2.25mm-35mm.

5. The vascular repair device according to claim 1, wherein, The size of the second inner diameter is 2.25mm, 2.5mm, 2.75mm, 3.0mm, 3.25mm, 3.5mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm, 6.0mm, 10mm, 15mm, 20mm, 22mm, 25mm, 30mm, 33mm or 35mm.

6. The vascular repair device according to claim 1, wherein, In the initial state, the length of the body is 45mm, 50mm, 55mm, 60mm, 65mm, 70mm or 75mm.

7. The vascular repair device according to claim 1, wherein, The thickness of the body is 150um, 200um, 250um, 300um, 350um, 400um or 450um.

8. The vascular repair device according to claim 1, wherein, The distal end of the body has an X-ray opaque marker; and / or, The inner wall of the body is attached with an antithrombotic drug.

9. A vascular repair device, comprising: The device comprises a releasable stent and the vascular repair device of any one of claims 1-8, in the initial state, the vascular repair device is sleeved outside the unreleased stent; in the expanded state, the vascular repair device is expanded by the released stent.

10. The vascular repair device of claim 9, wherein, The stent comprises a first stent and a second stent, in the initial state, the vascular repair device is sleeved outside the unreleased first stent; in the expanded state, the vascular repair device is expanded by the released first stent and the second stent, and the second stent is placed at the distal end of the vascular repair device.

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