Degradable vascular occluder and occlusion method

Abstract

The application provides a degradable blood vessel occluder and an occlusion method, which comprise a delivery tube and an extraluminal locker. The distal end of the delivery tube is provided with an occlusion balloon, which is used to tightly adhere to the blood vessel wall inside the puncture port after being inflated inside the blood vessel. The extraluminal locker is slidingly assembled outside the delivery tube. The occlusion wool inside the extraluminal locker slides along the delivery tube. The occlusion wool is pushed to the puncture port by the extraluminal locker and is used to occlude the puncture port. The application adopts the intravascular occlusion balloon positioning and the degradable occlusion wool to cooperatively stop bleeding inside and outside. The inflated balloon realizes the accurate positioning and temporary occlusion of the inside of the puncture port, effectively reduces the risk of occlusion wool internal leakage and blocks the blood vessel, the implanted part adopts the completely degradable material, and the body fluid can be safely metabolized in the blood vessel and skin healing process. There is no metal residue, and there is no need for secondary surgery to extract, which effectively realizes the occlusion of the large-diameter (including small-diameter) blood vessel puncture port.

Description

Technical Field

[0001] This invention belongs to the technical field of medical vascular interventional devices, specifically relating to a biodegradable vascular occluder and occlusion method. Background Technology

[0002] Femoral artery puncture is a primary puncture route for peripheral interventional procedures, and hemostasis at the puncture site is always a crucial issue that cannot be ignored in interventional surgery. Improper handling of the puncture site can easily lead to postoperative complications such as hematoma, infection, and pseudoaneurysm, which can be life-threatening in severe cases. Hemostasis at the puncture site is often achieved through manual or mechanical compression, but these methods typically require a considerable amount of time and effort from medical personnel, and patients also need to remain in bed for an extended period after hemostasis. To address this clinical problem, vascular occluders have been developed. Commonly used vascular occluders involve pushing an absorbable sponge plug to the outside of the puncture site to assist in coagulation, or closing the puncture site with a metal clamp. Their operation is simple and rapid, significantly reducing surgical time and effectively decreasing the incidence of bleeding complications.

[0003] With the development of interventional surgery, larger equipment is used for more complex procedures, typically requiring puncture sites of 10 F (French, 1 Fr ≈ 0.33 mm) or larger. Therefore, the clinical demand for occlusion of large-diameter vascular puncture sites is increasing. Traditional vascular occluders are only suitable for 5-7 F arterial puncture sites. During use, the sponge plug outside the puncture site has limited hemostatic ability. When the puncture site is larger than 7 F or the arterial blood pressure is high, the sponge plug alone cannot completely close the vascular opening, requiring subsequent manual compression for hemostasis, significantly increasing surgical costs and prolonging the treatment period.

[0004] Therefore, there is a need to provide an improved technical solution that addresses the shortcomings of the existing technology. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the prior art. This invention provides a biodegradable vascular occluder and an occlusion method.

[0006] To achieve the above objectives, the present invention provides the following technical solution: A biodegradable vascular occluder includes a delivery tube and an extraluminal locking device. The distal end of the delivery tube is provided with an occlusion balloon, which is used to expand inside the blood vessel and adhere tightly to the blood vessel wall inside the puncture site. The external locking device is slidably mounted on the outside of the delivery tube, and a sealing cotton that slides along the delivery tube is provided inside the external locking device. The sealing cotton is pushed to the puncture site through the external locking device to seal the puncture site.

[0007] Preferably, the delivery pipe has an internal air guiding channel, and the sealing balloon is connected to the air guiding channel.

[0008] Preferably, the delivery pipe is further provided with a guide wire channel.

[0009] Preferably, a gas filling and releasing device is provided at the proximal end of the delivery pipe, and the gas filling and releasing device is connected to the gas guiding channel to control the expansion or contraction of the sealing balloon.

[0010] Preferably, the delivery tube has a handle at its proximal end, and the guide wire channel extends along the inside of the handle to the proximal end of the handle; The air guide channel extends to a preset position on the handle, and the charging / discharging device is connected to the air guide channel via a three-way pipe.

[0011] Preferably, the external locking device further includes a guide tube corresponding to the sealing cotton, the sealing cotton being located at the proximal end of the guide tube, and a pusher corresponding to the sealing cotton being provided at the proximal end of the guide tube.

[0012] Preferably, the distal end of the guide tube is provided with a removable plug.

[0013] Preferably, the plug is an elastic tube fitted over the outside of the delivery pipe, and the side wall of the plug has a slit corresponding to the delivery pipe.

[0014] Preferably, the guide tube is a tapered tube with a smaller distal end and a larger proximal end.

[0015] A method for occluding a biodegradable vascular occluder, comprising the following steps: Step S1: The occlusion balloon is inserted into the blood vessel through the puncture site via the delivery tube; Step S2: Inflate the occlusion balloon so that it expands inside the blood vessel and adheres tightly to the blood vessel wall corresponding to the puncture site. Step S3: Slide the extracavitary locking device along the delivery tube to the outside of the blood vessel, and then push the occlusive cotton to the puncture site through the extracavitary locking device; Step S4: The occlusion balloon is contracted and pressed against the delivery tube by aspiration. The delivery tube is then retracted, causing the occlusion balloon to exit the blood vessel from inside the occlusion cotton. The occlusion cotton absorbs blood and expands to seal the puncture site.

[0016] Beneficial effects: This invention employs an intravascular occlusion balloon for positioning and biodegradable occlusive cotton for synergistic hemostasis, both internally and externally. The expansion balloon achieves precise positioning of the puncture site and temporary internal occlusion, effectively reducing the risk of occlusive cotton leakage and vascular blockage. The implanted portion is made of fully biodegradable material, which can be safely metabolized by body fluids during the healing process of the blood vessel and skin, leaving no metal residue and eliminating the need for secondary surgery for removal. This effectively achieves occlusion of large-diameter (including small-diameter) vascular puncture sites. Furthermore, its recyclability effectively avoids secondary damage caused by improper operation. Attached Figure Description

[0017] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. Wherein: Figure 1 This is a simplified structural diagram of the vascular occlusion device provided in a specific embodiment of the present invention; Figure 2 This is a schematic diagram of the handle assembly of the blood vessel occluder in a specific embodiment of the present invention; Figure 3 for Figure 1 Enlarged schematic diagram of the external locking device in the central cavity; Figure 4 This is a cross-sectional view of the conveying pipe in a specific embodiment provided by the present invention; Figure 5 This is a diagram showing the distal end of the delivery tube extending into a blood vessel in a specific embodiment of the present invention; Figure 6 This is a diagram showing the state of the sealing airbag after inflation in a specific embodiment of the present invention; Figure 7 This is a diagram showing the state of the sealing cotton being pushed into the puncture site in a specific embodiment of the present invention; Figure 8 This is a diagram showing the state of the blocked and retained puncture site in a specific embodiment of the present invention.

[0018] In the diagram: 1. Occlusion balloon; 2. Extracavitary locking device; 3. Delivery tube; 4. Handle; 5. T-connector; 6. Syringe; 21. Plug; 22. Occlusion cotton; 23. Guide tube; 24. Pusher; 31. Guide wire channel; 32. Air delivery channel. Detailed Implementation

[0019] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0020] In the description of this invention, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," and "bottom," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and do not require the invention to be constructed and operated in a specific orientation; therefore, they should not be construed as limitations on the invention. The terms "connected" and "linked" used in this invention should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; they can refer to a direct connection or an indirect connection through intermediate components. Those skilled in the art can understand the specific meaning of the above terms according to the specific circumstances.

[0021] The present invention will now be described in detail with reference to the accompanying drawings and embodiments. It should be noted that, unless otherwise specified, the embodiments and features described herein can be combined with each other.

[0022] like Figure 1 The biodegradable vascular occluder shown includes a delivery tube 3 and an extracorporeal locking device 2. The end of the biodegradable vascular occluder that extends into the blood vessel is the distal end, and the end with the handle 4 is the proximal end. An occlusion balloon 1 is located at the distal end of the delivery tube 3. After inflating inside the blood vessel, the occlusion balloon 1 adheres tightly to the vessel wall corresponding to the puncture site. The extracorporeal locking device 2 is axially slidably mounted on the outside of the delivery tube 3. An occlusion cotton 22, which slides along the delivery tube 3, is located inside the extracorporeal locking device 2. The occlusion cotton 22 is pushed to the puncture site through the extracorporeal locking device 2 to seal the puncture site. The occlusion balloon 1 at the distal end of the delivery tube 3 penetrates deep into the blood vessel and inflates to adhere to the inner wall of the puncture site, achieving precise positioning and temporary internal occlusion of the puncture site. Simultaneously, it prevents the occlusion cotton 22 from excessively penetrating into the blood vessel, avoiding vascular blockage. The externally slidable extracorporeal locking device 2 then precisely pushes the occlusion cotton 22 to the puncture site position on the outer wall of the blood vessel, achieving precise occlusion through internal and external coordination, significantly improving hemostasis. Meanwhile, the sealing cotton 22 is made of medical biodegradable polymer material, which can be gradually degraded and absorbed in the human blood and tissue fluid environment after the operation, without the need for secondary removal, thus completely avoiding the drawbacks of traditional devices being permanently left in the body.

[0023] In this embodiment, the delivery pipe 3 is provided with an air guide channel 32, and the sealing balloon 1 is connected to the corresponding air guide channel 32. The air guide channel 32 can realize the inflation and deflation of the sealing balloon 1, accurately control the working state of the balloon, and has a high degree of structural integration, without the need for additional external complex pipelines.

[0024] Furthermore, a gas charging / discharging device is provided near the end of the delivery pipe 3, such as... Figure 2As shown, the gas inflation / deflation device is connected to the gas delivery channel 32 to control the expansion or contraction of the occlusion balloon 1. The gas inflation / deflation device can achieve precise pressure control and adjust the balloon inflation degree according to the patient's blood vessel diameter and puncture site size to ensure that the balloon fits tightly against the blood vessel wall. At the same time, it can quickly complete the aspiration and depressurization, improving the efficiency of the operation.

[0025] A handle 4 is located near the proximal end of the delivery tube 3. The guide wire channel 31 extends along the inside of the handle 4 to the proximal end of the handle 4. The air delivery channel 32 extends to the front of the handle 4, and its specific position can be set according to the length of the handle 4. The filling and discharging device is connected to the air delivery channel 32 through a three-way pipe 5. The handle 4 is designed to facilitate hand operation by medical staff and to position the overall position of the occluder, thereby improving operational stability. The guide wire channel 31 and the air delivery channel 32 are arranged in separate sections to avoid mutual interference between the pipelines. The structure is reasonable and the operation is convenient.

[0026] The occlusion balloon 1 is made of a soft polymer material, such as polyamide elastomer, thermoplastic polyurethane, or silicone rubber. The connection between the occlusion balloon 1 and the delivery tube 3 is achieved through one or more methods, including adhesive bonding, welding, and fusion.

[0027] Furthermore, the occlusion balloon 1 material can be doped with X-ray contrast agents such as barium sulfate, bismuth subcarbonate, or bismuth trioxide to achieve precise positioning during interventional surgery; the contrast agent is uniformly dispersed in the polymer matrix in the form of microparticles.

[0028] The handle 4 is connected to the delivery pipe 3, and the connection method is one or more of the following: adhesive bonding, welding, Luer joint, internal and external thread connection, etc. The material of the handle 4 is one or more of the following: polyethylene, polypropylene, polyvinyl chloride, polyurethane, polytetrafluoroethylene, polycarbonate, polystyrene, acrylonitrile-butadiene-styrene graft copolymer, etc.

[0029] The three-way pipe 5 includes a connecting pipe and a three-way valve. One end of the connecting pipe is connected to the handle 4, and the connection method is one or more of the following: adhesive bonding, welding, Luer joint, internal and external thread connection, etc. The material of the connecting pipe is one or more of the following: polyethylene, polypropylene, polyvinyl chloride, polyurethane, polytetrafluoroethylene, polycarbonate, polystyrene, acrylonitrile-butadiene-styrene graft copolymer, etc. The other end of the connecting pipe is connected to the three-way valve, and the connection method is one or more of the following: adhesive bonding, welding, Luer joint, internal and external thread connection, etc. The material of the three-way valve is one or more of the following: polyethylene, polypropylene, polyvinyl chloride, polyurethane, polytetrafluoroethylene, polycarbonate, polystyrene, acrylonitrile-butadiene-styrene graft copolymer, etc.

[0030] The gas filling and discharging device can be a syringe 6, which is used to inflate and evacuate the occlusion balloon 1. The syringe 6 is connected to the connecting tube via a three-way valve, and the connection method is one or more of Luer connectors and internal / external thread connections. The syringe 6 has a specification of 5mL~10mL; the syringe 6 is made of one or more of the following materials: PP, PC, glass, and nitrile rubber.

[0031] The gas filling and discharging device can also be a gas pump, which is controlled by a control switch to automatically draw and release gas.

[0032] The delivery tube 3 is also equipped with a guide wire channel 31, which runs through the delivery tube 3. It can be used in conjunction with the interventional guide wire to complete the intravascular introduction and positioning of the occluder. It is compatible with conventional interventional surgery procedures and does not require changes to existing surgical procedures, making it highly versatile.

[0033] In an optional embodiment, the external locking device 2 further includes a guide tube 23 corresponding to the sealing cotton 22, such as Figure 3 As shown, the sealing cotton 22 is located at the proximal end of the guide tube 23, and the proximal end of the guide tube 23 is provided with a corresponding pusher 24 for the sealing cotton 22. The guide tube 23 provides a precise sliding path for the sealing cotton 22, avoiding deviation and twisting of the sealing cotton 22 during the push process. The pusher 24 can smoothly push the sealing cotton 22 forward, ensuring that the sealing cotton 22 accurately covers the puncture site.

[0034] The distal end of the guide tube 23 is provided with a removable plug 21. The plug 21 can seal the distal end of the guide tube 23 during the insertion of the occluder, and is used to limit and fix the occluding cotton 22 before pushing, to prevent it from falling off or shifting; it can also prevent blood and tissue fluid from entering the channel and causing contamination, and at the same time limit the occluding cotton 22 to prevent it from falling off prematurely, ensuring the safety of the surgical operation.

[0035] The preferred design features an elastic tube body fitted over the delivery tube 3. A slit corresponding to the delivery tube 3 is provided on the side wall of the plug 21, extending along the normal of the plug 21. The elastic tube body structure possesses excellent deformation capability, allowing for a tight fit over the delivery tube 3 with good sealing performance. The side wall slit facilitates quick assembly and disassembly of the plug 21 without requiring complete disassembly of the delivery tube 3, making it convenient and suitable for rapid intraoperative procedures. A flange corresponding to the guide tube 23 is provided at the distal end of the plug 21, and the flange is integrally formed with the plug 21.

[0036] In this embodiment, the plug 21 is made of one or more of the following materials: polyethylene, polypropylene, polyvinyl chloride, polyurethane, polytetrafluoroethylene, polycarbonate, polystyrene, acrylonitrile-butadiene-styrene graft copolymer, silicone, rubber, and silicone rubber.

[0037] Furthermore, the guide tube 23 is a tapered tube with a smaller distal end and a larger proximal end, with a cone angle ranging from 2° to 8°. This tapered structure allows for the progressive shaping and pushing of the sealing cotton 22. During the pushing process, the sealing cotton 22 gradually contracts and conforms to the outer wall of the delivery tube 3, naturally expanding upon reaching the puncture site to completely cover the wound, effectively improving the sealing fit and avoiding blind spots. The guide tube 23 is made of one or more of the following materials: polyethylene, polypropylene, polyvinyl chloride, polyurethane, polytetrafluoroethylene, polycarbonate, polystyrene, acrylonitrile-butadiene-styrene graft copolymer, silicone, rubber, and silicone rubber.

[0038] The pusher 24 is a tube sleeved onto the delivery tube 3. The distal end of the pusher 24 extends into the guide tube 23 to push the sealing cotton 22. The pusher 24 is provided with scale marks or limiting protrusions to indicate the pushing depth of the sealing cotton 22 relative to the puncture site; or the distal end of the guide tube 23 is provided with a perceptible resistance change indicator. The pusher 24 is made of one or more of the following materials: polyethylene, polypropylene, polyvinyl chloride, polyurethane, polytetrafluoroethylene, polycarbonate, polystyrene, acrylonitrile-butadiene-styrene graft copolymer, silicone, rubber, and silicone rubber.

[0039] This application provides an occluder suitable for puncture sites of 5-24 Fr. The occluder 22 has a through hole in the center for the delivery tube 3 to pass through, and is thus slidably assembled in the gap between the delivery tube 3 and the guide tube 23. When the balloon contracts and withdraws, the through hole gradually closes after the occluder 22 expands and withdraws, and quickly absorbs blood and tissue exudate. The absorbent swelling adheres to the tissue for coagulation. The occluder 22 is made of one or more absorbable materials such as polylactic acid, polycaprolactone, collagen, agarose, chitosan, cellulose, gelatin, starch, graphene oxide, hyaluronic acid, alginate, polyethylene glycol, silk fibroin, mesoporous silica nanoparticles, and silica nanoparticles. The blood-absorbing sponge is prepared by one or more of the following methods: 3D printing, freeze-thaw process, microfiber aggregation, fiber bonding and entanglement, freeze drying, salt elution, gas foaming, phase separation, emulsion freeze drying, and particle sintering.

[0040] The occlusive foam 22 can be loaded with thrombin and calcium ions, which synergistically activate the coagulation cascade reaction, significantly improving local hemostasis efficiency. The active ingredients are immobilized in the sponge matrix through physical adsorption or chemical cross-linking. Preferably, the occlusive foam 22 may contain one or more of the following: antiplatelet adhesion drugs, anticoagulants, antiproliferative drugs, and anti-infective drugs. Antiplatelet adhesion drugs include one or more of aspirin, clopidogrel, ticagrelor, tirofiban, cilostazol, dipyridamole, prostaglandins, dipyridamole, etc.; anticoagulants include one or more of heparin, hirudin, dicumarol, warfarin sodium, and vitamin K antagonists; antiproliferative drugs include one or more of rapamycin and its derivatives, paclitaxel, dexamethasone, docetaxel, probucol, colchicine, etc.; and anti-infective drugs include one or more of penicillins, cephalosporins, atypical β-lactams, aminoglycosides, macrolides, and tetracyclines.

[0041] In another optional embodiment, the delivery tube 3 has two parallel inner cavities serving as an air guide channel 32 and a guide wire channel 31, respectively. Figure 4 As shown, the gas delivery channel 32 extends to the occlusion balloon 1. An air vent is provided on the side wall of the delivery tube 3 corresponding to the portion of the occlusion balloon 1 for inflating and deflating the occlusion balloon 1. The guidewire channel 31 extends to the distal end of the delivery tube 3. The delivery tube 3 is made of one or more materials selected from polyethylene, polypropylene, polyvinyl chloride, polyurethane, polytetrafluoroethylene, polycarbonate, polystyrene, and acrylonitrile-butadiene-styrene graft copolymer. The outer wall of the occlusion balloon 1 is coated with a lubricating coating, and the wall thickness and material elasticity should ensure that it can be completely folded and adhered to the outer wall of the delivery tube 3 after vacuuming, facilitating retraction without damaging blood vessels.

[0042] This invention also provides a method for sealing a biodegradable vascular occluder, which involves sealing a vascular puncture site using a biodegradable vascular occluder based on any of the above-mentioned technical solutions, comprising the following steps: Step S1: The delivery tube 3 is inserted into the blood vessel along the pre-placed guidewire through the guidewire channel 31, thereby advancing the occlusion balloon 1 from the puncture site into the blood vessel. The balloon is advanced along the surgical guidewire path throughout the process, ensuring that the occlusion balloon 1 accurately reaches the inner side of the blood vessel corresponding to the puncture site. The advancement process is smooth to avoid damage to the inner wall of the blood vessel. See [link to relevant documentation]. Figure 5 .

[0043] Step S2: Inflate the occlusion balloon 1 through the gas delivery channel 32 using the gas inflation / deflation device. This causes the balloon 1 to inflate inside the blood vessel and adhere tightly to the vessel wall corresponding to the puncture site. The inflated balloon forms a temporary occlusion on the inner side of the puncture site. Slowly retract the handle 4 to ensure the inflated occlusion balloon 1 remains firmly against the vessel wall. Once a significant reduction in blood flow at the puncture site is observed, the occlusion is confirmed to be in place. (See also...) Figure 6 .

[0044] Step S3: Holding the handle 4 still, after removing the plug 21, smoothly slide the extracavitary locking device 2 along the outer wall of the delivery tube 3 to the corresponding position of the puncture site outside the blood vessel. Then, guided by the holding and fixing locking device, push the pusher 24 forward until the sealing cotton 22 is pushed into the blood vessel puncture site, so that the sealing cotton 22 blocks the blood vessel puncture site; see also Figure 7 .

[0045] Step S4: Air is depressurized from the occlusion balloon 1 using the gas inflation / deflation device, causing the balloon to contract and adhere to the outer wall of the delivery tube 3. Before the occlusion cotton 22 absorbs a large amount of blood and expands, the delivery tube 3 is slowly retracted, causing the contracted occlusion balloon 1 to exit the blood vessel from inside the occlusion cotton 22. Upon contact with human blood, the occlusion cotton 22 rapidly absorbs water, expands, and coagulates, solidifying to tightly adhere to the puncture site on the outer wall of the blood vessel, achieving permanent occlusion and hemostasis. Post-procedure, the occlusion cotton 22 can be gradually degraded and absorbed in the body. See also... Figure 8 .

[0046] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention shall be within the scope of protection of the pending claims of the present invention.

Claims

1. A biodegradable vascular occlusion device, characterized in that, It includes a delivery tube and an extracavitary locking device. The distal end of the delivery tube is provided with an occlusion balloon, which is used to expand inside the blood vessel and adhere tightly to the blood vessel wall inside the puncture site. The external locking device is slidably mounted on the outside of the delivery tube, and a sealing cotton that slides along the delivery tube is provided inside the external locking device. The sealing cotton is pushed to the puncture site through the external locking device to seal the puncture site.

2. The biodegradable vascular occlusion device according to claim 1, characterized in that, The delivery pipe has an internal air guiding channel, and the sealing balloon is connected to the air guiding channel.

3. The biodegradable vascular occlusion device according to claim 2, characterized in that, The delivery pipe is also equipped with a guide wire channel.

4. The biodegradable vascular occlusion device according to claim 3, characterized in that, A gas inflation / deflation device is provided at the proximal end of the delivery pipe. The gas inflation / deflation device is connected to the gas guiding channel to control the expansion or contraction of the occlusion balloon.

5. The biodegradable vascular occlusion device according to claim 4, characterized in that, The delivery tube is provided with a handle at its proximal end, and the guide wire channel extends along the inside of the handle to the proximal end of the handle; The air guide channel extends to a preset position on the handle, and the charging / discharging device is connected to the air guide channel via a three-way pipe.

6. The biodegradable vascular occluder according to claim 1, characterized in that, The external locking device also includes a guide tube corresponding to the sealing cotton, the sealing cotton being located at the proximal end of the guide tube, and a pusher corresponding to the sealing cotton being provided at the proximal end of the guide tube.

7. The biodegradable vascular occluder according to claim 6, characterized in that, The distal end of the guide tube is provided with a removable plug.

8. The biodegradable vascular occluder according to claim 7, characterized in that, The plug is an elastic tube that is fitted onto the outside of the delivery pipe, and the side wall of the plug has a slit corresponding to the delivery pipe.

9. The biodegradable vascular occluder according to claim 6, characterized in that, The guide tube is a tapered tube with a smaller distal end and a larger proximal end.

10. A method for occluding a biodegradable vascular occluder, comprising occluding a vascular puncture site using the biodegradable vascular occluder as described in any one of claims 1-9, characterized in that, Includes the following steps: Step S1: The occlusion balloon is inserted into the blood vessel through the puncture site via the delivery tube; Step S2: Inflate the occlusion balloon so that it expands inside the blood vessel and adheres tightly to the blood vessel wall corresponding to the puncture site. Step S3: Slide the extracavitary locking device along the delivery tube to the outside of the blood vessel, and then push the occlusive cotton to the puncture site through the extracavitary locking device; Step S4: The occlusion balloon is contracted and pressed against the delivery tube by aspiration. The delivery tube is then retracted, causing the occlusion balloon to exit the blood vessel from inside the occlusion cotton. The occlusion cotton absorbs blood and expands to seal the puncture site.

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