A vascular closure device

Abstract

The application relates to the field of medical devices, in particular to a blood vessel closure device which comprises a guide unit, a plugging unit and a supporting unit, the supporting unit comprises a plurality of foldable supporting assemblies, each supporting assembly comprises a first supporting rod and a second supporting rod, the first supporting rod and the second supporting rod are movably connected through a first connecting part and a second connecting part respectively, the supporting unit further comprises a first sleeve and a second sleeve, the first sleeve and the second sleeve are coaxially arranged and connected with the first supporting rod and the second supporting rod respectively, and the first supporting rod and the second supporting rod are connected through a hinge to form a composite structure of "rigidity and flexibility combined".

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a vascular closure device. Background Technology

[0002] Percutaneous access to the vascular system for delivery of vascular devices is a common medical procedure. Typically, this involves puncturing a blood vessel using a hollow needle, then introducing a guide sheath to open the puncture site for the insertion of a catheter and guidewire, which are then guided through the vascular system to facilitate delivery. For example, in many cases, vascular access requires the insertion of the catheter and guidewire via the femoral artery. After the procedure, the vascular device needs to be removed from the patient and pressure applied to the puncture site to achieve hemostasis.

[0003] Manual compression hemostasis has been a common method for hemostasis at the puncture site after femoral artery intervention. While this method has been used clinically for a long time, prolonged compression and bed rest increase the workload of medical staff and patient discomfort. To overcome the shortcomings of manual compression hemostasis, percutaneous artery occlusion devices have been developed. These devices achieve rapid hemostasis without compressing the blood vessel or with minimal pressure, and are unaffected by continuous anticoagulation. The application of occlusion devices can shorten hemostasis time and bed rest time, while reducing patient discomfort and the intensity of medical care.

[0004] Current vascular occlusion devices suffer from poor adaptability. Existing closure devices are difficult to adapt to different diameter blood vessels (especially puncture sites of 10F and above), and deviations in release position can easily lead to occlusion failure.

[0005] Patent CN202222210430.9 discloses a balloon-assisted vascular closure device, including a balloon with a metal wire inserted through its center, forming a cavity between the balloon and the metal wire. Tubes are provided at both ends of the balloon, fitted onto the metal wire. An air inlet is formed between the tube on one side of the balloon and the metal wire, while the tube on the other side of the balloon is sealed to the metal wire. The balloon wall is inflatable, and the balloon wall includes several drug storage sections and connecting sections between adjacent drug storage sections. The drug storage sections and connecting sections are circumferentially distributed around the metal wire. Each drug storage section includes a drug reservoir with an openable and closable sealing port. The drawbacks of this design are that the balloon is prone to bursting and leakage, inflation takes time, and the operation is lengthy.

[0006] In summary, the existing technology has the following problems that urgently need to be solved: 1. Non-degradable materials: Traditional closure devices mostly use nickel-titanium alloys or metal clips, which may cause allergies, thrombosis or affect imaging examinations if left in the body for a long time; 2. Complex operation: Traditional closure devices rely on manual compression or complex suturing techniques, resulting in a high incidence of postoperative complications (such as pseudoaneurysms and hematomas); 3. Poor adaptability: Existing closure devices are difficult to adapt to different diameter blood vessels (especially puncture sites above 10F), and deviations in release position can easily lead to closure failure; 4. Insufficient imaging: Traditional closure devices only partially mark and visualize, making intraoperative positioning difficult and increasing surgical risks. Summary of the Invention

[0007] This application is made in view of the above and other ideas.

[0008] One of the objectives of this application is to overcome the shortcomings of the prior art and provide a vascular closure device that combines biodegradable materials with an adaptive support structure, enhances anchoring capability through mechanical interlocking design, and achieves complete postoperative degradation through material optimization.

[0009] The objective of this invention is achieved through the following approach: A vascular closure device includes: a guiding unit, an occlusion unit, and a support unit. The support unit includes a plurality of foldable support components. Each support component includes a first support rod and a second support rod. The first support rod and the second support rod each include a first connecting portion and a second connecting portion, which are movably connected. Furthermore, the support unit also includes a first kit and a second kit, which are coaxially arranged and respectively connected to the first support rod and the second support rod.

[0010] The objective of this invention can also be further achieved through the following technical solutions: In one embodiment, the first kit is located at the distal end of the second kit, and the guide unit includes an inner core wire that pulls the first kit, causing the first kit to move relative to the inner core wire together with the support assembly.

[0011] In one embodiment, a pull member is included, which is connected to the first kit, with the connection point located inside the first kit; and the pull member is a tubular or filamentous member.

[0012] In one embodiment, the support unit is pre-installed inside the sleeve, and the angle between the first support rod and the second support rod is 0 degrees or 180 degrees.

[0013] In one embodiment, the support unit further includes a membrane attached to the first support rod and / or the second support rod, the support unit forming a foldable balloon that is shaped or restored as the first kit moves axially.

[0014] In one embodiment, the sleeve is retracted, and an obtuse angle is formed between the first support rod and the second support rod. In its natural state, an obtuse angle is formed between the first support rod and the second support rod.

[0015] In one embodiment, when the pulling member is pulled, the angle between the first support rod and the second support rod decreases, gradually changing from an obtuse angle to an acute angle; and the projected area of ​​the support assembly increases.

[0016] In one embodiment, the surface of the second support rod is covered with a film, and the second support rod and the film form a disc shape. The included angle between the second kit and the second support rod is in the range of 90° to 180°, and there is no acute angle between them, so as to prevent the second support rod from being excessively deformed and to prevent the disc-shaped part from being recessed into the blood vessel, which would cause the implant to enter the blood vessel excessively and affect the normal blood flow.

[0017] In one embodiment, the rigidity of the second support rod is greater than that of the first support rod; and the connection between the first connecting part and the second connecting part is a hinge connection.

[0018] In one embodiment, the first kit includes a first limiting part, and the second kit includes a second limiting part. When the first kit is pulled toward the proximal end, the support unit reaches its limit deformation when the first limiting part touches the second limiting part.

[0019] In one embodiment, the second kit is connected to a connecting pipe, and a sealing unit is disposed outside the connecting pipe. An outer pipe is disposed outside the sealing unit. Furthermore, during pre-installation, a top rod is disposed near the end of the sealing unit, and the top rod provides force to the sealing unit to make the sealing unit enter the target position.

[0020] In one embodiment, the support assembly is made of a biodegradable material containing barium sulfate to achieve overall imaging under X-rays.

[0021] In one implementation, the occlusion unit uses a PLGA braided mesh filled with clotting factors.

[0022] In one embodiment, the closure device is delivered to the puncture site via the guide unit; the cannula is retracted, and the support assembly unfolds to form an obtuse angle (120°~150°); the moving member is pulled, and the angle of the support rod changes to an acute angle (10°~30°), the second limiting part supports the first limiting part, and the top rod is pushed, the implant enters the blood vessel opening to be closed, the occlusion unit expands, and clamps the blood vessel wall; the support unit is retrieved; the PLGA material completely degrades within 6~12 months without residue.

[0023] In one embodiment, the occlusion unit has a double-layer structure: the inner layer is a PCL sponge (to promote coagulation), and the outer layer is a PLA membrane (to reduce tissue irritation).

[0024] In one embodiment, the sealing unit is made of collagen material.

[0025] In one embodiment, the first limiting portion and the second limiting portion are symmetrically arranged.

[0026] In one embodiment, the occlusion material employs a three-layer heterogeneous structure: outer layer: a PLGA / collagen nanofiber membrane prepared by electrospinning, with a heparin-chitosan sustained-release layer coated on the surface; middle layer: a porous PCL sponge (porosity 85%) loaded with prothrombin (10U / mg) and fibronectin; inner layer: an expandable hydrogel (polyethylene glycol diacrylate) that expands 300% in volume within 10 seconds upon contact with blood, filling microcracks in the blood vessel wall.

[0027] In one embodiment, the inner core wire adopts a nickel-titanium alloy / stainless steel double helix structure, and the outer layer is covered with a lubricating coating (polytetrafluoroethylene, 10μm thick), which increases the bending strength to 1.8 times that of conventional guide wires.

[0028] In one embodiment, an axial groove (0.3 mm deep) is provided on the inner wall of the sleeve to form a sliding fit with the hinge part (303) of the support component to prevent the component from getting stuck during the conveying process.

[0029] In one embodiment, the support unit includes four support components.

[0030] In one embodiment, the support unit includes six support components.

[0031] In one embodiment, the vascular closure device can be widely used in cardiac procedures such as coronary intervention, radiofrequency ablation, structural heart disease, and cardiopulmonary bypass.

[0032] Compared with the prior art, the advantages of the technical solution of this application include at least the following: Existing balloon supports are mesh-like and require gas or liquid filling for formation, which can easily lead to balloon bursting and leakage, and also result in long surgical times. This application solves these problems by forming a foldable balloon with the support unit. The foldable balloon is formed or restored as the first component moves axially. The rapid mechanical movement allows the foldable balloon to be formed quickly without the need for liquid infusion, making it convenient for doctors to operate. On the other hand, the use of a foldable support rod allows for repeated forming and restoration, increasing the safety of clinical operations.

[0033] Existing vascular closure devices are difficult to implant properly due to insufficient support during occlusion, and cannot adapt to the closure of large puncture sites when using balloons or other methods for support. This application solves the above problems. First, in the support unit of this application, the first support rod (flexible) and the second support rod (high rigidity) are connected by a hinge to form a composite structure that combines rigidity and flexibility. During initial pre-installation, the support rod is linearly folded at 0° or 180°. After the cannula is withdrawn, it naturally unfolds to an obtuse angle (120°–150°). At this point, the high rigidity of the second support rod resists the rebound force of the vessel wall, forming initial anchoring. When the pulling component is further pulled, the flexibility of the first support rod sharpens its angle to 10°–30°, significantly increasing the projected area of ​​the support component. Combined with the top rod, it applies force to the occlusion unit, forming a mechanical locking effect between the inner and outer walls of the vessel, resulting in good support and a large projected area suitable for closure of vessels of different sizes. On the other hand, the occlusion material uses a PLGA / PCL / collagen composite system, whose degradation cycle (6–24 months) is highly synchronized with the tissue repair process. For example, the PLGA woven mesh maintains high strength for support and anchoring within 3 months post-surgery, and then gradually degrades, transferring the mechanical load to the newly formed tissue, avoiding the "stress shielding" effect of traditional metal occluders and significantly reducing the risk of vessel wall atrophy.

[0034] Unlike existing technologies, the first limiting part of the first kit and the second limiting part of the second kit in this application adopt a symmetrical slot design. When the pulling member pulls the proximal end of the first kit to move, the limiting part contacts and triggers mechanical locking at the instant, forcing the support unit to stop deforming. This design not only prevents the second support rod from puncturing blood vessels due to excessive bending (<90°), but also avoids the degradation rate of the occluder from running out of control due to excessive compression. On the other hand, the support component is made of polyesteramide / barium sulfate composite material, which presents a continuous imaging band under X-ray (instead of traditional dot-like markings). The operator can directly observe the angle change of the support rod (such as the process of obtuse angle to acute angle conversion). Combined with the platinum-iridium alloy marking ring embedded in the occluder, it achieves dual guidance of "structural imaging + position calibration" with small release position deviation.

[0035] Unlike existing technologies, this application utilizes a linked design between the pre-installed cannula and the push rod. A single cannula retraction by the surgeon triggers the obtuse-angle deployment of the support unit. Subsequently, the synchronized operation of the pulling component and the push rod precisely controls the acute-angle conversion and the delivery of the occluder. For large-diameter puncture sites of 12F or larger, the projected area of ​​the deployed support assembly can adaptively expand to 1.5 to 2 times the vessel diameter. Furthermore, the disc-shaped covering design of the second support rod (expanded diameter 8-15mm) seals the vessel wall, avoiding the "edge leakage" problem of traditional closure devices.

[0036] The embodiments of this application can achieve other advantageous technical effects not listed one by one, which may be partially described below; and these other technical effects can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0037] The above-described features and advantages of these embodiments, as well as other features and advantages, and the ways in which they are implemented, will become more apparent from the following description in conjunction with the accompanying drawings; and embodiments of this application can be better understood, in which: Figure 1 This is a schematic diagram of the overall structure of the vascular closure device of the present invention, including a guiding unit, a supporting unit, and a sealing unit.

[0038] Figure 2 This is a schematic diagram illustrating the principle and connection of the first and second support rods of the present invention.

[0039] Figure 3 This is a schematic diagram of the support unit of the present invention pre-installed in the sleeve.

[0040] Figure 4 This is a schematic diagram of the support unit of the present invention moving to its limit position.

[0041] The features represented by the numbers in the attached diagram are as follows: 1-Guiding unit, 11-Inner core wire, 2-Supporting unit, 21-Supporting assembly, 211-First support rod, 2111-First connecting part, 212-Second support rod, 2121-Second connecting part, 22-First kit, 221-First limiting part, 23-Second kit, 231-Second limiting part, 24-Membrane, 3-Pull member, 4-Connecting tube, 5-Sleeve, 6-Top rod member, 7-Sealing unit. Detailed Implementation

[0042] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0043] It should be understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0044] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0045] In this application, the terms "proximal" or "proximal" refer to the end or side closer to the surgeon, and "distal" or "distal" refer to the end or side farther from the surgeon. Example 1

[0046] like Figure 1 As shown, when used for vascular closure, the present invention illustrates a vascular closure device according to an embodiment of this application, including: a guiding unit 1, a sealing unit 7, and a support unit 2. The support unit 2 includes a plurality of foldable support components 21. Each support component 21 includes a first support rod 211 and a second support rod 212. The first support rod 211 and the second support rod 212 respectively include a first connecting portion 2111 and a second connecting portion 2121, which are movably connected. Furthermore, the support unit 2 also includes a first kit 22 and a second kit 23, which are coaxially arranged and respectively connected to the first support rod 211 and the second support rod 212.

[0047] The objective of this invention can also be further achieved through the following technical solutions: In this first embodiment, the first kit 22 is located at the far end of the second kit 23. The guide unit 1 includes an inner core wire 11. When the first kit 22 is pulled, the first kit 22 moves together with the support component 21 relative to the inner core wire 11.

[0048] In this first embodiment, a pulling member 3 is included. The pulling member 3 is connected to the first kit 22, and the connection point between the two is located inside the first kit 22. Furthermore, the pulling member 3 is a wire-like component, such as... Figure 2 As shown.

[0049] In this first embodiment, the support unit 2 is pre-installed inside the sleeve 5, and the angle between the first support rod 211 and the second support rod 212 is 0 degrees or 180 degrees. Figure 3 As shown.

[0050] In this first embodiment, when the sleeve 5 is retracted, an obtuse angle is formed between the first support rod 211 and the second support rod 212. In its natural state, an obtuse angle is formed between the first support rod 211 and the second support rod 212.

[0051] In this first embodiment, when the pulling member 3 is pulled, the angle between the first support rod 211 and the second support rod 212 decreases and gradually changes from an obtuse angle to an acute angle; and the projected area of ​​the support assembly 21 increases.

[0052] In this first embodiment, the surface of the second support rod 212 is covered with a film 24, such as... Figure 4As shown, the second support rod 212 and the membrane 24 form a disc shape, and the included angle between the second kit 23 and the second support rod 212 is in the range of 90° to 180°. There will be no acute angle between them, which prevents the second support rod 212 from being excessively deformed and prevents the disc-shaped part from being recessed into the blood vessel, causing the implant to enter the blood vessel excessively and affecting the normal blood flow.

[0053] In this first embodiment, the rigidity of the second support rod 212 is greater than that of the first support rod 211; and the connection between the first connecting part 2111 and the second connecting part 2121 is a hinge connection.

[0054] In this first embodiment, the first kit 22 includes a first limiting part 221, and the second kit 23 includes a second limiting part 231. When the first kit 22 is pulled to move towards the near end, the support unit 2 reaches the limit of deformation when the first limiting part 221 touches the second limiting part 231.

[0055] In this first embodiment, the second kit 23 is connected to the connecting pipe 4, and a sealing unit 7 is provided outside the connecting pipe 4. The sealing unit 7 is covered by an outer pipe. Furthermore, during pre-installation, a top rod 6 is provided near the end of the sealing unit 7. The top rod 6 provides force to the sealing unit 7 so that the sealing unit 7 enters the target position.

[0056] In this first embodiment, the support component 21 is made of a biodegradable material containing barium sulfate to achieve overall imaging under X-rays.

[0057] In this first embodiment, the support unit 2 includes four support components 21.

[0058] In this first embodiment, the occlusion unit 7 uses a PLGA braided mesh filled with clotting factors.

[0059] In this first embodiment, the closure device is delivered to the puncture site via the guide unit 1; the cannula 5 is retracted, and the support component 21 unfolds to form an obtuse angle (120°~150°); the moving part is pulled, and the angle of the support rod changes to an acute angle (10°~30°), the second limiting part 231 supports the first limiting part 221, and the top rod 6 is pushed, the implant enters the blood vessel buckle to be closed, the implant expands, and clamps the blood vessel wall; the support unit 2 is retrieved; the PLGA material completely degrades within 6~12 months without residue.

[0060] In this embodiment, the occlusion unit 7 adopts a double-layer structure: the inner layer is PCL sponge (to promote coagulation), and the outer layer is PLA membrane 24 (to reduce tissue irritation).

[0061] In this first embodiment, the sealing unit 7 is made of collagen.

[0062] In this first embodiment, the first limiting part 221 and the second limiting part 231 are symmetrically arranged. The exemplary operation process of the vascular closure device in this first embodiment is as follows: (1) After puncture, the vascular closure device is inserted into the target position along the inner core wire 11, and the cannula 5 is withdrawn so that the first support rod 211 and the second support rod 212 form an obtuse angle; (2) Pull the pulling member 3 to sharpen the angle between the first support rod 211 and the second support rod 212 to 15°±2°, and the second support rod 212 and the membrane 24 covering its surface adhere to the blood vessel wall; (3) Push the top rod 6 to release the occluder, the hydrogel layer expands rapidly to seal the puncture site, and at the same time the PLGA / collagen membrane 24 adheres to the outer wall of the blood vessel; (4) Push the sleeve 5 to the far end, and the support unit 2 is retracted into the sleeve 5. Retrieve each pipe fitting, leaving only the sealing unit 7 in the target position.

[0063] The foregoing description of several embodiments of this application has been provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed; obviously, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. A vascular closure device, characterized in that, include: The system includes a guiding unit, a sealing unit, and a supporting unit. The supporting unit comprises several foldable supporting components, each including a first supporting rod and a second supporting rod. The first supporting rod and the second supporting rod each include a first connecting portion and a second connecting portion, which are movably connected. Furthermore, the supporting unit also includes a first kit and a second kit, which are coaxially arranged and connected to the first supporting rod and the second supporting rod, respectively.

2. The vascular closure device according to claim 1, characterized in that, The support unit also includes a membrane attached to the first support rod and / or the second support rod, the support unit forming a foldable balloon that is shaped or restored as the first kit moves axially.

3. The vascular closure device according to claim 1, characterized in that, The first kit is located at the far end of the second kit. The guiding unit includes an inner core wire. Pulling the first kit causes the first kit and the support assembly to move relative to the inner core wire. It also includes a pulling member connected to the first kit, with the connection point located inside the first kit. The pulling member is either a tubular or filamentous member.

4. The vascular closure device according to claim 3, characterized in that, It also includes a sleeve, and the support unit is pre-installed in the sleeve. The angle between the first support rod and the second support rod is 0 degrees or 180 degrees.

5. The vascular closure device according to claim 4, characterized in that, The sleeve is then retracted, forming an obtuse angle between the first support rod and the second support rod.

6. The vascular closure device according to claim 5, characterized in that, When the pulling member is pulled, the angle between the first support rod and the second support rod decreases, gradually changing from an obtuse angle to an acute angle; and the projected area of ​​the support assembly increases.

7. The vascular closure device according to claim 1, characterized in that, The included angle between the second kit and the second support rod is in the range of 90° to 180°, and there is no acute angle between them, which prevents the second support rod from being excessively deformed.

8. The vascular closure device according to claim 1, characterized in that, The rigidity of the second support rod is greater than that of the first support rod; and the connection between the first connecting part and the second connecting part is a hinge connection.

9. The vascular closure device according to claim 1, characterized in that, The first kit includes a first limiting part, and the second kit includes a second limiting part. When the first kit is pulled to move towards the proximal end, the support unit reaches its limit deformation when the first limiting part touches the second limiting part.

10. The vascular closure device according to claim 1, characterized in that, The second kit is connected to the connecting pipe, and a sealing unit is provided outside the connecting pipe. The sealing unit is covered by an outer pipe. Furthermore, during pre-installation, a top rod is provided near the end of the sealing unit, and the top rod provides force to the sealing unit to make the sealing unit enter the target position.

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