Blood vessel plugging device

Abstract

The utility model provides a blood vessel occluder which comprises a pushing device and an outer sheath tube head clamp, the blood vessel occluder is used in cooperation with a blood vessel sheath set and used for occluding a blood vessel wound, and the pushing device comprises a pushing head, a tail handle head and an outer sleeve and is used for being inserted into a sheath tube shell of the blood vessel sheath set to push sealing materials to a blood vessel occluding position. And the outer sheath tube head clamp fixes the blood vessel sheath group through a buckle. Different types of blood vessel plugging devices are designed according to different blood vessels, the blood vessel plugging device can be matched with blood vessel sheath sets with different sizes of 4F-24F to push sealing materials with different sizes of 4F-24F, and the blood vessel plugging device is simple in structure, convenient to operate, universal and significant to endovascular interventional operations.

Description

TECHNICAL FIELD

[0001] The utility model belongs to the field of medical apparatus and instruments, and particularly relates to a blood vessel plugging device. BACKGROUND

[0002] Bleeding, liquid / gas leakage and the like are common complications after trauma and surgery, which seriously affect incision healing and repair, easily induce the formation of sinus and fistula, and even lead to patient death. How to effectively close the wound is the key to achieving rapid hemostasis, reducing liquid leakage, accelerating healing, reducing the risk of infection and improving overall treatment effect. With the change of modern lifestyle, vascular diseases (such as aneurysm, arteriovenous malformation) and the like have increasingly become a major problem affecting people's health. Traditional vascular disease treatment methods include open surgery and endoscopic surgery, which are often accompanied by high surgical risks (such as unstable occlusion effect, possible damage to the blood vessel wall, etc.) and long recovery periods. In order to improve treatment efficiency and patient comfort, the medical community has been seeking more innovative and minimally invasive treatment methods.

[0003] Endovascular intervention surgery is an important treatment method in the field of modern medicine, which treats various diseases through minimally invasive operation in blood vessels. At present, although small-size vascular sheath intervention (≤12F) can use ProGlide and other occluders based on the principle of suturing to close the blood vessels, such products have high skill requirements for the operator, and the patient is also prone to complications such as vascular stenosis and pseudoaneurysm after surgery. Although large-size vascular sheath intervention (>12F) can use ProGlide and other suturing products to close the wound, it has a significantly high failure rate, and once it fails, it needs to be cut open for suturing, which increases the trauma to the patient.

[0004] At the same time, many existing technologies require additional auxiliary equipment when delivering the occlusion material, which not only increases the difficulty of the operation, but also may prolong the patient's recovery time. When delivering the occlusion material, the puncture needle is first placed into the guide wire into the blood vessel, and then the guide wire is placed into the vascular sheath. After flushing the vascular sheath, the occlusion device is inserted. The inner core of the occlusion device is formed by a thin steel wire and an occlusion strip and an inner pad film arranged at the head end of the thin steel wire. During the operation of the doctor moving the thin steel wire, if it is necessary to fix the head of the thin steel wire, the head of the thin steel wire needs to be fixed by pressing it with the hand. Such a setting is not convenient for other operations. At the same time, the operator needs to operate with both hands and needs to add samples, which may cause uneven force or cramps in the hands after a long time, resulting in component slippage, inaccurate positioning and hematoma formation and the like.

[0005] The sponge-like biological tissue sealing material is made of a sponge and a biological tissue sealing material, the sponge is a porous columnar body made of a polytetrafluoroethylene, PDMS, plastic, rubber or the like mold, and the biological tissue sealing material is made of natural polysaccharides, proteins and the like. Compared with the commonly used hemostatic and filling materials, medical gauze and sponge, the sponge-like biological tissue sealing material is suitable for bleeding and other large bleeding conditions, can effectively stop a large amount of bleeding, and is not dependent on the patient's own blood clotting, and is also effective for patients with coagulation dysfunction. At the same time, the sponge-like biological tissue sealing material can effectively seal the wound site, and after application, the wound will not appear continuous bleeding, tissue fluid outflow and the like. However, although the sponge-like biological tissue sealing material has excellent hemostatic effect, it needs to be matched with a specific blood vessel occluder, and an ordinary blood vessel occluder is not applicable.

[0006] Therefore, it is urgent to find a blood vessel occluder to solve the above problems. The utility model discloses a blood vessel occluder, which is matched with a blood vessel sheath group and is used for occluding a blood vessel wound.

[0007] In view of the deficiencies of the prior art, the utility model provides a blood vessel occluder which comprises a pushing device and an outer sheath head clamp, is matched with a blood vessel sheath group, is used for occluding a blood vessel wound, and comprises a push head, a tail handle head and an outer sleeve for inserting into a sheath shell of the blood vessel sheath group to push sealing material to a blood vessel occlusion position, and the outer sheath head clamp is used for fixing the blood vessel sheath group by clamping. The utility model is not only designed for different blood vessels with different types of blood vessel occluders, can be used with 4F-24F different size blood vessel sheath groups to push 4F-24F different size sealing material, and has the advantages of simple structure, convenient operation and universality, and has important significance for blood vessel interventional surgery.

[0008] The utility model discloses a blood vessel occluder, which comprises a pushing device and an outer sheath head clamp, is matched with a blood vessel sheath group, is used for occluding a blood vessel wound, and comprises a push head, a tail handle head and an outer sleeve for inserting into a sheath shell of the blood vessel sheath group to push sealing material to a blood vessel occlusion position, and the outer sheath head clamp is used for fixing the blood vessel sheath group by clamping.

[0009] In some ways, the blood vessel sheath group comprises a puncture needle, a catheter sheath, a dilator, a guide wire and the like, and the blood vessel occluder needs to be used together with the blood vessel sheath group. The blood vessel occluder can not only be fixed and arranged in the sheath shell of the blood vessel sheath group in the tissue through the interlocking structure of the double wings of the outer sheath head clamp to deliver the sealing material to the target position, but also provide a sterile storage environment for the sealing material. In addition, the operator can operate the delivery of the sealing material, the withdrawal of the blood vessel occluder and the like with one hand. In order to cooperate with the catheter sheath of different sizes of the blood vessel sheath group, the blood vessel occluder designed by the utility model can be used with 4F-24F different size blood vessel sheath groups, and the blood vessel wound comprises an arterial dissection rupture massive hemorrhage, a rich nerve area hemorrhage, a venous from hemorrhage, a radial artery interventional hemorrhage and a carotid artery interventional hemorrhage.

[0010] In some ways, first select the appropriate size of the blood vessel occluder according to the needs of the operation, fill the sealing material in the outer sleeve, insert the push head into the outer sleeve and lock the push head by the buckle; then insert the outer sleeve into the sheath tube shell of the blood vessel sheath group, lock the outer sheath tube head buckle, fix the sheath tube shell of the blood vessel sheath group and the blood vessel occluder; rotate the push head to release its locked state, press the push head, push the sealing material to the target position, keep the outer sheath tube head buckle in the locked state, pull out the push device of the blood vessel occluder from the blood vessel sheath group as a whole, exit the closed tissue, and use it. The above-mentioned blood vessel occlusion operation can be completed by one hand within 1 min.

[0011] Further, the outer sheath tube head buckle includes a double-wing buckle head, which can be interlocked to form a circular cavity inside for fixing the blood vessel sheath group; the push device includes a push head, a tail handle head and an outer sleeve.

[0012] Further, the double-wing buckle head includes a first wing plate and a second wing plate, both of which are provided with a first buckle and a first slot, the first buckle of the first wing plate and the first slot of the second wing plate are interlocked, and the first buckle of the second wing plate and the first slot of the first wing plate are interlocked.

[0013] In some ways, the length of the first buckle is 3.29~4.8mm, the first wing plate has a buckle and a slot, the second wing plate has a buckle and a slot, the buckle of the first wing plate is opposite to the slot of the second wing plate, the buckle of the second wing plate is opposite to the slot of the first wing plate, the buckle of the first wing plate is interlocked with the slot of the second wing plate, the buckle of the second wing plate is interlocked with the buckle of the first wing plate, and the buckles of the first wing plate and the second wing plate have a circular arc structure on the left side, which will form a circular cavity when they are interlocked. The front end of the buckle has an upward bending structure, so when the buckle and the slot are interlocked, the first wing plate and the second wing plate are firmly clamped and cannot be easily released. The circular cavity is used to lock the sheath tube shell of the blood vessel sheath group, and the sheath tube shell is a reverse conical body, which is large at the top and small at the bottom. The diameter of the circular cavity matches the diameter of the pipeline at the lower end, and the circular cavity clamps the lower end of the sheath tube shell to fix the sheath tube shell and the blood vessel occluder. The diameter of the circular cavity is 4.80~9.60mm, and the included angle between the first buckle and the wing plate is 90° at this time. The length of the double-wing buckle head is 3.20~19.20mm, and the distance between the two wings is 15.33~30.66mm when the double-wing buckle head is opened, and the included angle between the first buckle and the wing plate is 105°.

[0014] Further, the tail handle head includes a cylindrical structure and a second slot, and the cylindrical structure is provided with a through hole; the push head includes a push tube and a push column; the push column passes through the through hole of the cylindrical structure, and the push tube clamps the second slot to lock the push head on the tail handle head, and the second slot is rectangular.

[0015] In some ways, the tail handle head is equivalent to a connector of the vascular occlusion device, the upper end of the tail handle head is provided with a second clamping groove connected with the push head, the cylindrical structure of the tail handle head is provided with a through hole connected with the outer sleeve, and the cylindrical structure of the tail handle head is further provided with a third clamping groove fixed with the second buckle of the upper end of the outer sheath head. Through the tail handle head, the push head, the outer sleeve, the outer sheath head and the tail handle head are assembled into the vascular occlusion device.

[0016] In some ways, the diameter of the through hole of the cylindrical structure is 1.20-7.90 mm.

[0017] Further, the third clamping groove is arranged on both sides of the cylindrical structure, the outer sheath head clamp further comprises a second buckle, and the third clamping groove and the second buckle are fixed to connect the outer sheath head clamp and the tail handle head.

[0018] In some ways, the second buckle is symmetrically arranged at the top end of the outer sheath head clamp and can be clamped and fixed with the third clamping groove on both sides of the cylindrical structure.

[0019] Further, the push tube is composed of an upper cylinder and a lower cylinder, the diameter of the lower cylinder is smaller than that of the upper cylinder, and two cuboid clamping heads are arranged on both sides of the lower cylinder for fixing with the second clamping groove.

[0020] In some ways, the height of the upper cylinder is 2.00 mm, the diameter is 8.00 mm, two cuboid clamping heads are arranged on both sides of the lower cylinder, the length is 5.33-32.00 mm, the width is 1.33-8.00 mm, and the height is 10.00 mm, which can be clamped into the second clamping groove of the tail handle head to lock the push head on the tail handle head, and the length of the second clamping groove is 5.33-32.00 mm and the width is 1.33-8.00 mm.

[0021] Further, the outer sleeve is fixed with the tail handle head as a whole, the diameter of the push column is smaller than the inner diameter of the outer sleeve, and the push column can be inserted into the outer sleeve for displacement.

[0022] In some ways, the outer sleeve is also a through hole structure, since it is fixed with the tail handle head as a whole, the through hole of the outer sleeve is connected with the through hole of the cylindrical structure of the tail handle head, and the diameter of the through hole of the outer sleeve is 1.20-7.90 mm. The push head can drive the push column to move back and forth in the outer sleeve, the push column is a solid cylindrical structure, the diameter is 1.20-7.70 mm, and the length is 152.50 mm.

[0023] Further, the sealing material is loaded into the outer sleeve from the front end of the outer sleeve or the tail handle head, the push tube is unlocked by rotating, the push tube is pressed, and the push column can push the sealing material out of the outer sleeve.

[0024] In some ways, one of the functions of the outer sleeve is to act as a delivery channel for the sealing material, and the other is to store the sealing material aseptically. Before using the vascular occluder, the sealing material is loaded into the outer sleeve from the tail handle head or the front end of the outer sleeve hole, the push column of the push head is inserted into the through hole of the cylindrical structure of the tail handle head and the outer sleeve, and the sealing material is pushed to the front of the outer sleeve. The push tube is clamped in the second clamping groove of the tail handle head, and at this time the push head is locked on the tail handle head, and the sealing material is not pushed out of the outer sleeve, and the whole is sterilized with ethylene oxide. When the vascular occluder is inserted into the sheath tube shell of the vascular sheath group and fixed by the outer sheath tube head clamp, the push head can be rotated by one hand, the locked state is released, and the push head can push the sealing material out of the outer sleeve to the target position. The locking structure of the push head and the second clamping groove of the tail handle head is to store the sealing material at the front of the outer sleeve, so that it is easier to push the sealing material to the target position with one hand.

[0025] Further, the outer sleeve and the push head are slightly deformed when inserted into the vascular sheath group during use.

[0026] In some ways, during use, the push head is inserted into the outer sleeve, the outer sleeve is inserted into the sheath tube shell of the vascular sheath group placed in the tissue, and the sheath tube shell has a certain bending. Therefore, in order to smoothly push out the sealing material, the outer sleeve and the push head also need to bend with the sheath tube shell. Due to the particularity of the use environment, not only does the material used to manufacture the outer sleeve and the push head need to be flexible and deformable, but it also needs to be resistant to chemical corrosion.

[0027] The material selection of the vascular occluder is based on medical biocompatibility. The drug and body contact part is made of commonly used medical materials to avoid adverse conditions such as circulatory diseases, allergic reactions, and infection risks. The material also needs to have certain hardness and toughness to prevent breakage and damage.

[0028] Further, the tail handle head is made of one or more of nylon photosensitive resin, polyamide resin (PA66), and polycarbonate (PC); the outer sleeve is made of one or more of silicone (TPU), polyethylene (PE), polyethylene terephthalate (PET), and polytetrafluoro material (PTFE); the push head is made of one or more of polycarbonate (PC), ordinary photosensitive resin, polyamide resin (PA66), polytetrafluoro material (PTFE), ABS plastic, and polypropylene (PP); and the outer sheath tube head clamp is made of one or more of polycarbonate (PC), polypropylene (PP), and polyamide resin (PA66).

[0029] In some ways, polyethylene terephthalate (PET) has good creep resistance, fatigue resistance, friction resistance and dimensional stability, and is cheap, with high cost performance. Nylon (PA), polytetrafluoroethylene (PTFE) and PA and polyurethane (PU) or other material alloy are the first choice for producing high-grade interventional catheters. PTFE has high crystallinity, small friction coefficient, good heat resistance, high chemical stability, and is not affected by strong acid, strong base and various organic solvents. In addition, it has unique properties in medical use, such as good biocompatibility, blood adaptability, no harm to human physiology, no adverse reactions when implanted in the body, and high temperature disinfection. Therefore, PTFE is widely used in biomedical engineering. Among many fluoroplastics, tetrafluoroethylene and ethylene copolymer (F40) and polytetrafluoroethylene (F46) are most commonly used. Fluoroplastics originally have no antithrombotic properties, but when they come into contact with blood, a stable antithrombotic film will form on their surface, which will induce vascular endothelial cells to form a smooth biological layer, making high molecular materials originally without antithrombotic properties naturally antithrombotic. Polycarbonate (PC) has very high impact resistance and is not easy to break, as well as good thermal stability and mechanical properties. Polypropylene (PP) not only has good chemical corrosion resistance and high heat resistance, but also has low cost, does not contain harmful substances such as bisphenol A, and has high safety, which is suitable for use in the field of medical device manufacturing. The molding speed of nylon photosensitive resin is fast, the mechanical strength is high, the dimensional stability is good, the light transmission is good, the impact resistance is strong, and the weight is light. The mechanical strength and hardness of polyamide resin (PA66) are very high, the chemical resistance is good, the wear resistance and self-lubricity are excellent, the friction coefficient is small, and it is suitable for applications that require long-term friction. ABS plastic has high strength and good toughness, can withstand various mechanical stresses, is suitable for applications that need to withstand impact and pressure, and has good resistance to many chemicals, and can work stably in various chemical environments. Ordinary photosensitive resin has fast curing speed, high energy utilization rate, good environmental protection and good biocompatibility, and is widely used in medical devices.

[0030] Preferably, the tail handle head is made of one of polyamide resin (PA66) and polycarbonate (PC), and the push head and the outer sleeve are made of polytetrafluoroethylene (PTFE).

[0031] In some ways, the function of the outer sheath head clamp is to fix the sheath shell of the vascular sheath group, so the outer sheath head clamp made of any one of polycarbonate, polypropylene and polyamide resin meets the standard.

[0032] Further, a method for using a vascular occluder includes the following steps:

[0033] (1) the sealing material is loaded into the outer sleeve from the front end of the outer sleeve or the tail handle head, the push head is inserted into the outer sleeve and locked, the whole is sterilized while the push head is kept in the locked state;

[0034] (2) the outer sleeve is inserted into the blood vessel sheath group, and the outer sheath tube head is clamped to fix the blood vessel sheath group;

[0035] (3) the push head is rotated to release the locked state and push out the sealing material;

[0036] (4) the blood vessel occluder is pushed out from the blood vessel sheath group.

[0037] Specifically, the use method of the blood vessel occluder is as follows: firstly, according to the operation requirement, a blood vessel occluder with a proper size is selected, the sealing material is loaded into the outer sleeve from the through hole of the tail handle head or the front end of the outer sleeve, the push head is inserted into the through hole and the outer sleeve, and the push head is locked through the cuboid clamping head and the second clamping groove; at this time, the sealing material has been pushed to the front position of the outer sleeve, and the whole blood vessel occluder is sterilized by using ethylene oxide; then the outer sleeve is inserted into the sheath tube shell of the blood vessel sheath group, the first clamping buckle and the first clamping groove are locked, and the circular cavity clamps the pipeline at the lower end of the vertebral body of the sheath tube shell; the push tube of the push head is rotated to release the locked state, the push tube is pressed to push out the sealing material and place it to the target position, after the sealing material is pushed out, the locked state of the first clamping buckle and the first clamping groove is kept, and the push device of the blood vessel occluder is pulled out from the sheath tube shell of the blood vessel sheath group, and the closed tissue is withdrawn, and the use is completed.

[0038] In some ways, ethylene oxide is considered as a chemical sterilization agent with the best sterilization effect, which can kill all microorganisms, including bacterial spores. Ethylene oxide has strong penetration and can penetrate various difficult-to-penetrate parts, especially for thin and long catheters and other difficult-to-sterilize articles. Since ethylene oxide kills microorganisms by alkylation principle, the damage to the articles is very small, and it is particularly suitable for sterilization of heat-sensitive precision instruments. In addition, ethylene oxide can be used for sterilization of high-temperature-resistant and moisture-resistant articles, can meet the sterilization needs of various medical products, and has standard chemical and biological monitoring means, which can effectively control the sterilization quality and timely find the sterilization failure package.

[0039] Further, the use of a blood vessel occluder for preparing a device for delivering sponge-like biological tissue sealing material to a target position, including a push device and an outer sheath tube head clamp, the push device is used to push the sealing material with the blood vessel sheath group to occlude the blood vessel wound, and the outer sheath tube head clamp is used to fix the blood vessel sheath group.

[0040] In some ways, the sponge-like biological tissue sealing material is a porous columnar body made of a sponge and a natural polysaccharide or a protein. The sponge is made of a polytetrafluoroethylene, PDMS, plastic, rubber, etc. mold, the natural polysaccharide is a combination of one or more of hyaluronic acid, dextran, pullulan, chitosan, and carboxymethyl cellulose; the protein is a combination of one or more of gelatin and silk fibroin. These tissue sealing agent materials can chemically interact with tissues and / or body fluids, and these chemical interactions are achieved through the chemical inherent properties and group modifications of these materials, including hydrophobicity, hydrogen bonding, electrostatic interaction, functional group interaction, etc.; the group modification includes aldehyde group, sulfhydryl group, carboxyl group, hydroxyl group, etc. Different sizes of vascular occluders are used in cooperation with corresponding sizes of sponge-like biological tissue sealing materials, and the sizes of the sponge-like biological tissue sealing materials include 4F~24F.

[0041] Before this, the team has applied for a patent "a biological tissue sealing material and its preparation method", patent number CN117860954A, the above-mentioned biological tissue sealing material is prepared by segmental freeze-drying of aldehyde-modified polysaccharide, which has a dense structure and small pores and is not easy to absorb water and swell. The biological tissue sealing material, when in use, can react and cross-link with the amino groups / thiol groups on the cells or proteins in the body fluid or tissue surface as soon as it comes into contact with the body fluid or tissue surface, forming a physical sealing layer, so as to effectively seal the wound site. The above-mentioned biological tissue sealing material is made into a sponge-like biological tissue sealing material together with a sponge, and the sponge-like biological tissue sealing material has adhesion. When a common material vascular occluder is used to push the sponge-like biological tissue sealing material to the target position, the sponge-like biological tissue sealing material adheres to the wall of the delivery pipeline, resulting in a large pushing resistance and the sponge-like biological tissue sealing material cannot be pushed out smoothly. Even if it is pushed out, the sponge-like biological tissue sealing material is damaged during the pushing process, affecting the subsequent hemostatic effect. Therefore, the present utility model is aimed at the above-mentioned problems, and the most suitable pipeline material is selected to make a vascular occluder. The pushing pipeline of the vascular occluder does not appear particle pollution, has the advantages of strong pushing, high strength, smoothness, etc., and in practical application, it is not only suitable for the above-mentioned sponge-like biological tissue sealing material, but also universal for sealing materials made of other raw materials, including but not limited to powder, hydrogel, semi-solid, solid, etc. As long as the size is appropriate, the present utility model can be universal.

[0042] The present utility model has the following beneficial effects:

[0043] (1) A vascular occluder, comprising a pushing device and an outer sheath tube head clamp, which can be fixed and arranged in the sheath tube shell of the vascular sheath group in the tissue through the double-wing interlocking structure of the outer sheath tube head clamp, and the sealing material is delivered to the target position;

[0044] (2) The pushing device comprises a pushing head, a handle head and an outer sleeve, which form a sealing device to provide a sterile storage environment for the sealing material;

[0045] (3) The vascular occlusion device can be used in cooperation with vascular sheaths of different sizes of 4F~24F;

[0046] (4) The operator can operate the vascular occlusion device with one hand to complete the delivery of the sealing material and the removal of the vascular occlusion device and the like;

[0047] (5) The vascular occlusion device can not only deliver sponge-like biological tissue sealing materials of 4F~24F sizes, but also deliver sealing materials of other materials and sizes;

[0048] (6) The vascular occlusion device has the advantages of simple structure, convenient operation, universality and important significance for intravascular interventional surgery. BRIEF DESCRIPTION OF DRAWINGS

[0049] Figure 1 It is a whole structure diagram of the vascular occlusion device;

[0050] Figure 2 It is a pushing head structure schematic diagram;

[0051] Figure 3 It is a pushing head and handle head structure schematic diagram Figure 1 ;

[0052] Figure 4 It is a pushing head and handle head structure schematic diagram Figure 2 ;

[0053] Figure 5 It is a handle head structure front view;

[0054] Figure 6 It is a handle head structure top view;

[0055] Figure 7 It is a handle head structure bottom view;

[0056] Figure 8 It is an outer sleeve structure schematic diagram Figure 1 ;

[0057] Figure 9 It is an outer sleeve structure schematic diagram Figure 2 ;

[0058] Figure 10 It is an outer sheath tube head clamping structure schematic diagram Figure 1 ;

[0059] Figure 11 It is an outer sheath tube head clamping structure schematic diagram Figure 2 ;

[0060] Figure 12is a front view of the outer sheath head clamping structure;

[0061] Figure 13 is a top view of the outer sheath head clamping structure;

[0062] Figure 14 is a side view of the outer sheath head clamping structure;

[0063] Figure 15 is a schematic view of the blood vessel plugging device inserted into the sheath shell;

[0064] Figure 16 is a schematic view of the double wings of the compressed outer sheath head clamp Figure 1 ;

[0065] Figure 17 is a schematic view of the double wings of the compressed outer sheath head clamp Figure 2 ;

[0066] Figure 18 is a schematic view of the rotating push head pushing out the sealing material Figure 1 ;

[0067] Figure 19 is a schematic view of the rotating push head pushing out the sealing material Figure 2 ;

[0068] Figure 20 is a schematic view of the blood vessel plugging device withdrawn from the sheath shell. DETAILED DESCRIPTION

[0069] The utility model will be described in further detail below in combination with the drawings and examples, and it should be pointed out that the following examples are intended to facilitate the understanding of the utility model and do not limit it in any way.

[0070] Example 1, a blood vessel plugging device

[0071] 1, blood vessel plugging device structure

[0072] As shown in Figure 1 , a blood vessel plugging device, which is used in combination with a blood vessel sheath set, is composed of a push device 1 and an outer sheath head clamp 2, and the outer sheath head clamp 2 fixes the blood vessel sheath set through buckling. This example takes the delivery of sponge-like biological tissue sealing material as an example, and the push device 1 pushes the sponge-like biological tissue sealing material to the target position of the blood vessel sheath set.

[0073] As shown in Figures 2-9As shown, the pushing device 1 is composed of a pushing head 3, a tail handle head 4 and an outer sleeve 5. The pushing head 3 includes a pushing tube 6 and a pushing column 7. The pushing tube 6 is composed of an upper cylinder 8 and a lower cylinder 9. The upper cylinder 8 is 2.00 mm high and 8.00 mm in diameter. The lower cylinder 9 is smaller in diameter than the upper cylinder 8. Two cuboid clamping heads 10 are arranged on both sides of the lower cylinder 9. The cuboid clamping heads 10 are 5.33-32.00 mm long, 1.33-8.00 mm wide and 10.00 mm high. The pushing column 7 is a solid cylinder structure, 1.20-7.70 mm in diameter and 152.50 mm long. The tail handle head 4 includes a cylindrical structure 11 and a second clamping groove 12. The cylindrical structure 11 is provided with a through hole 13. The second clamping groove 12 is rectangular, 5.33-32.00 mm long and 1.33-8.00 mm wide. The pushing column 7 passes through the through hole 13 of the cylindrical structure 11. The two cuboid clamping heads 10 of the pushing tube 6 clamp the second clamping groove 12. When the pushing head 3 is not working, the pushing head 3 is locked on the tail handle head 4. The outer sleeve 5 is connected with the through hole 13 of the cylindrical structure 11 as a whole, and the pipe diameter is consistent, 1.20-7.90 mm. Before using the blood vessel occluder, the sponge-like biological tissue sealing material is first loaded into the outer sleeve 5 from the through hole 13 of the cylindrical structure 11 or the lower end of the through hole of the outer sleeve 5. The outer sleeve 5 is not only used for filling and storing the sponge-like biological tissue sealing material, but also provides a sterile environment for the sponge-like biological tissue sealing material and provides a pipeline for transporting the sponge-like biological tissue sealing material. The pushing column 7 is inserted into the through hole 13 and locked in the second clamping groove 12. At this time, the sponge-like biological tissue sealing material in the outer sleeve 5 is pushed to the front position of the outer sleeve 5, but is not pushed out of the outer sleeve 5, and is sterilized as a whole. When using the blood vessel occluder, the pushing tube 6 is rotated to release the locking state of the pushing tube 6, and the pushing tube 6 is pushed forward. The pushing column 7 displaces forward in the outer sleeve to push the sponge-like biological tissue sealing material out of the outer sleeve 5 to the target position. The tail handle head 4 further includes a third clamping groove 23 arranged on both sides of the cylindrical structure 11.

[0074] As Figures 10-14As shown, the outer sheath head clamp 2 is composed of a double-wing clamp 15 and a second clamp 16, the double-wing clamp 15 includes a first wing plate 17 and a second wing plate 18, the length of the first wing plate 17 and the second wing plate 18 is 3.20-19.20 mm, the first wing plate 17 and the second wing plate 18 are provided with a first clamp 19 and a first clamping groove 20, the length of the first clamp 19 is 3.29-4.8 mm. The first clamp 19 of the first wing plate 17 and the first clamping groove 20 of the second wing plate 18 are interlocked, the first clamp 19 of the second wing plate 18 and the first clamping groove 20 of the first wing plate 17 are interlocked, the first clamp 19 has an upward bending structure 24 at the front end, when the first clamp 19 and the first clamping groove 20 are interlocked, the first wing plate 17 and the second wing plate 18 are firmly clamped and cannot be easily broken. The first clamp 19 of the first wing plate 17 and the second wing plate 18 has a circular arc structure 21 on the left side, when the first wing plate 17 and the second wing plate 18 are interlocked, the two circular arc structures 21 form a circular cavity, the circular cavity is used to fix the sheath tube shell 22 of the vascular sheath group Figure 15 ), the sheath tube shell 22 is a reverse cone, large at the top and small at the bottom, the diameter of the circular cavity matches the diameter of the pipeline at the lower end, the circular cavity clamping the lower end of the sheath tube shell 22 can fix the sheath tube shell 22 and the vascular occluder, the diameter of the circular cavity is 4.80-9.60 mm. When the first clamp 19 and the first clamping groove 20 are interlocked, the angle between the first clamp 19 and the first wing plate 17 and the second wing plate 18 is 90°, when the first clamp 19 and the first clamping groove 20 are opened, the distance between the first wing plate 17 and the second wing plate 18 is 15.33-30.66 mm, the angle between the first clamp 19 and the first wing plate 17 and the second wing plate 18 is 105° Figure 12 ). The second clamp 16 is symmetrically arranged at the top end of the outer sheath tube head clamp 2, the second clamp 16 is fixed with the third clamping groove 23 to connect the outer sheath tube head clamp 2 and the handle head 4.

[0075] 2. The use method of the vascular occluder

[0076] As Figures 15-20As shown, a method for using a vascular occlusion device for delivering sponge-like biological tissue sealing material is provided, taking a pig femoral artery aneurysm as an example. First, select a vascular occlusion device with appropriate size according to the needs of the operation, add the sponge-like biological tissue sealing material into the outer sleeve 5 from the through hole 13 of the tail handle head 4 or the front end of the outer sleeve 5, insert the push head 3 into the through hole 13 and the outer sleeve 5, and lock the push head 3 through the cuboid clamping head 10 and the second clamping groove 12. At this time, the sponge-like biological tissue sealing material has been pushed to the front of the outer sleeve 5; sterilize the vascular occlusion device with ethylene oxide, and after sterilization, insert the outer sleeve 5 into the sheath tube shell 22 of the vascular sheath group, lock the first clasp 19 and the first clamping groove 20, and the circular cavity tightly clamps the lower end of the sheath tube shell 22. Rotate the push tube 6 of the push head 3 to release its locked state, press the push tube 6, push the sponge-like biological tissue sealing material to the target position, complete the pushing of the sealing material, keep the locked state of the first clasp 19 and the first clamping groove 20, and pull out the push device 1 of the vascular occlusion device from the sheath tube shell 22 of the vascular sheath group as a whole, and exit the closed tissue. The above aneurysm lumen occlusion operation can be completed within 1 min, and the operator can operate with one hand.

[0077] The vascular occlusion device of the present embodiment takes the pushing of sponge-like biological tissue sealing material as an example, but the pushing material is not limited to sponge-like biological tissue sealing material. Sealing materials with sizes of 4F~24F can be pushed to the target position by the vascular occlusion device provided by the present application in cooperation with the corresponding vascular sheath group.

[0078] 3. Material for making the vascular occlusion device

[0079] The tail handle head is made of one of polyamide resin (PA66), polycarbonate (PC), the push head and the outer sleeve are made of polytetrafluoroethylene material (PTFE), and the outer sheath tube head clamp is made of one or more of polycarbonate (PC), polypropylene (PP), and polyamide resin (PA66).

[0080] Example 2, material selection of tail handle head

[0081] The material selection of the vascular occlusion device is based on medical biological compatibility. The drug and body contact part is made of commonly used materials in medical treatment, which does not cause adverse conditions such as circulatory diseases, allergic reactions, and infection risks. The material toughness and certain hardness are considered, and the breakage and damage are prevented as much as possible.

[0082] The difference between this embodiment and embodiment 1 is the material of the tail handle head. The material can be selected from one or more of nylon photosensitive resin, polyamide resin (PA66) and polycarbonate (PC). The material combination is shown in Table 1. The hardness test, flexibility test, elongation at break test, smoothness test, propulsion test, whether the sealing material is adhered, whether there is particle pollution test and eluate detection are carried out.

[0083] The hardness detection method is to use Vickers hardness to measure the hardness of the vascular plug. During the test, a diamond right tetrahedral pyramid indenter with an included angle of 136° is used to press into the surface of the material at a specified test force F, and after a specified time, the test force is removed. The average pressure on the unit surface of the right tetrahedral pyramid indentation represents the hardness value. In addition, the hardness of the vascular plug needs to be matched with the sealing material, so the hardness needs to be actually detected in the experiment. According to the hardness test results of the sealing material, the hardness test results of the selected material are in the range of 60-90 shore A.

[0084] The flexibility detection method is to determine the behavior of the vascular plug under axial tensile load. The test results mainly include the elastic limit, tensile strength and yield strength. The elastic limit is the maximum stress point at which the device can still recover to its original state after being stressed. The tensile strength refers to the breaking force per unit area. The yield strength is the stress value at which the device begins to undergo reversible plastic deformation during stress. In actual detection, the flexibility of the vascular plug mainly refers to the flexibility of the outer sleeve and the push head.

[0085] The elongation at break detection method is to make each group of materials into a standard strip-shaped sample, usually with a width of 15mm and a length of 200mm; clamp the two ends of the sample on the upper and lower clamps of the tensile testing machine, respectively, to ensure that the long axis direction of the sample coincides with the center line of the upper and lower clamps; set appropriate test speed and other parameters according to the material type and expected elongation at break of the sample; start the testing machine, the sample will deform during the stretching process until it finally breaks, and the instrument will automatically record and display the elongation at break.

[0086] The smoothness detection method is to use a gloss meter to measure. First, preheat the gloss meter for 3-5 minutes to stabilize the instrument; calibrate the instrument, place the gloss meter on the blackboard, adjust the angle of the instrument to make it perpendicular to the blackboard, and adjust the height to make the measurement port parallel to the blackboard plane, press the calibration button, and the instrument will automatically calibrate; place the sample to be measured on the measurement port of the gloss meter, set the measurement angle to 60 degrees, press the measurement button, and the instrument will automatically measure the surface gloss of the sample and display the measurement result.

[0087] The method for detecting the propulsion and the adhesion of the sealing material is as follows: sponge-like biological tissue sealing material is selected as the experimental sealing material, because it has certain adhesiveness, and whether the outer wall of the material is adhered to the sealing material can be tested. The sealing material is loaded into the sleeve from the tail handle head or the lower end of the outer sleeve hole, and whether the material can be completely and easily loaded into the sleeve is observed. After the sealing material is stored in the sleeve for a certain period of time, the push head is pushed to detect whether the sealing material can be completely pushed out and whether it is adhered to the contact part of the pipe wall or the push head.

[0088] The detection method for whether there is particle pollution is as follows: the size and quantity requirements of the particles are referred to the 2020 edition of the People's Republic of China Pharmacopoeia (0903 insoluble particle inspection method); the overall pollution index of the occluder and the delivery system is regulated according to YY / T 1556-2017 medical infusion and blood transfusion injection appliances particle pollution test method. When detecting, the particle shedding during the whole process of simulating product pushing, releasing and withdrawing is evaluated respectively.

[0089] The dissolution detection method is as follows: many physiological reactions of medical devices after contacting with the human body are related to the existence of dissolution or exudation in the device. Therefore, the standard requires that the occluder and the delivery system containing medical polymer materials should be subjected to chemical performance evaluation. GB / T 14233.1-2008 medical infusion, blood transfusion and injection appliances test methods part 1: chemical analysis method is referred to.

[0090] The tail handle head performance detection evaluation standard is as follows: the hardness range is 60-90 shore A; the flexibility range is 20-100 Mpa; the elongation at break is 10-30%; the gloss detection value is greater than 70GU for smoothness, and less than 70GU for roughness; the propulsion is divided into three levels of poor, general and good; and whether the sealing material is adhered is divided into three cases of no adhesion, slight adhesion and adhesion. The performance detection results are shown in Table 2.

[0091] Table 1, different tail handle head material combination of vascular occluder

[0092]

[0093] Table 2, performance detection results

[0094]

[0095] According to the analysis of the test results in Table 2, material combination 1-3 is a single component material, and material combination 4-7 is a mixed component material. In terms of hardness, flexibility and elongation at break, the hardness, flexibility and elongation at break of material combinations 1-7 all meet the screening standards, and the surface and inner wall are smooth, without particle contamination and eluate; but in the test of whether the sealing material is adhered and the test of the propulsion, the inner wall of the tail handle head of material combination 4 will be adhered to the sponge-like biological tissue sealing material, resulting in poor propulsion, the inner wall of the tail handle head of material combinations 1, 5, 6 and 7 will be slightly adhered to the sponge-like biological tissue sealing material, resulting in general propulsion, and only the inner wall of the tail handle head of material combinations 2 and 3 is not adhered to the sponge-like biological tissue sealing material, so the propulsion is good. Preferably, material combinations 2 and 3 are selected as the material for preparing the tail handle head, that is, one of polyamide resin (PA66) and polycarbonate (PC) is selected as the material for preparing the tail handle head.

[0096] Example 3, material selection of the push head

[0097] The difference between this embodiment and Example 1 is the material for preparing the push head. The push head can be selected from one or more of polycarbonate (PC), ordinary photosensitive resin, polyamide resin (PA66), polytetrafluoro material (PTFE), ABS plastic and polypropylene (PP), and the material combinations are shown in Table 3. The hardness, flexibility, elongation at break, smoothness, smoothness / propulsion, whether the sealing material is adhered, whether there is particle contamination and other properties of each material combination are tested, and the testing method is described in Example 2.

[0098] The performance detection evaluation criteria of the push head are as follows: the hardness range is 60-90 shore A; the flexibility range is 20-60 Mpa; the elongation at break is 10-30%; the gloss detection value greater than 70GU is smooth, and less than 70GU is rough; the propulsion is divided into three levels of poor, general and good; and whether the sealing material is adhered is divided into three cases of no adhesion, slight adhesion and adhesion. The performance detection results are shown in Table 4.

[0099] Table 3, different push head material combinations of the vascular occluder

[0100]

[0101] Table 4, performance test results

[0102]

[0103] According to the analysis of the results in Table 4, material combination 1-6 is a pusher made of a single component, and material combination 7-10 is a pusher made of a mixed component. The pushers made of material combinations 1-10 are all smooth in surface and have no particle contamination, but material combinations 5, 8 and 10 are detected to have eluates, which are presumably generated by ABS plastic, and the pushers of material combinations 5, 8 and 10 may be adhered to the sponge-like biological tissue sealing material during the pushing process, resulting in poor or general pushing effect. According to the screening criteria of hardness, flexibility and elongation at break, only material combinations 2, 4 and 7 meet the screening criteria; the pushers of material combinations 1 and 3 are not adhered to the sponge-like biological tissue sealing material and have good pushing performance during the pushing process, but the flexibility does not meet the screening criteria; the pushers of material combinations 2 and 7 are slightly adhered to the sponge-like biological tissue sealing material during the pushing process, resulting in general pushing performance; only the pusher of material combination 4 is not adhered to the sponge-like biological tissue sealing material during the pushing process, so it has good pushing performance, indicating that the self-lubricating property of PTFE material is good. Preferably, material combination 4 is selected as the material for making the pusher, i.e., polytetrafluoroethylene (PTFE) is selected as the material for making the pusher.

[0104] Example 4, Material Screening of the Sheath Tube

[0105] The difference between this example and Example 1 is the material for making the sheath tube. The materials that can be selected for making the sheath tube include one or more of silicone (TPU), polyethylene (PE), polyethylene terephthalate (PET) and polytetrafluoroethylene (PTFE), and the material combinations are shown in Table 5 below. The hardness, flexibility, elongation at break, smoothness, smoothness / pushing performance, adhesion to the sealing material, particle contamination and other properties of each material combination are tested, and the testing method is described in Example 2.

[0106] The performance detection evaluation criteria for the sheath tube are as follows: the hardness range is 60-90 shore A; the flexibility range is 20-60 Mpa; the elongation at break is 10-30%; the gloss detection value greater than 70GU is smooth, and less than 70GU is rough; the pushing performance is divided into three levels of poor, general and good; and the adhesion to the sealing material is divided into three cases of no adhesion, slight adhesion and adhesion. The performance detection results are shown in Table 6 below.

[0107] Table 5, Vascular Occluder with Different Sheath Tube Material Combinations

[0108]

[0109] Table 6, Performance Detection Results

[0110]

[0111] According to the result analysis of Table 6, material combination 1-4 is the outer sleeve made of separate components, and material combination 5 is the outer sleeve made of mixed components. The outer sleeves of material combinations 1-5 have no particle contamination and eluate, and the inner wall is smooth, but according to the screening criteria of hardness, flexibility and elongation at break, the hardness of material combinations 1-5 all meet the screening criteria, the flexibility and elongation at break of material combinations 1, 3 and 5 do not meet the screening criteria, the elongation at break of material combination 2 does not meet the screening criteria, and only the hardness, flexibility and elongation at break of material combination 4 all meet the screening criteria; the inner wall of the outer sleeve of material combination 1 is adhered to the sponge-like biological tissue sealing material, resulting in poor propulsion, the inner wall of the outer sleeve of material combinations 2, 3 and 5 is slightly adhered to the sponge-like biological tissue sealing material, resulting in general propulsion, and only the inner wall of the outer sleeve of material combination 4 is not adhered to the sponge-like biological tissue sealing material, so the propulsion is good, which shows that the self-lubricating property of PTFE material is good. Preferably, material combination 4 is selected as the material for making the outer sleeve, that is, fluorine material (PTFE) is selected as the material for making the outer sleeve.

[0112] Example 5, sterilization method of the vascular occluder

[0113] After the vascular occluder is provided with the sealing material, sterilization is needed, and the difference between the present embodiment and example 1 lies in the sterilization method. The sterilization method can be electron beam irradiation sterilization and ethylene oxide sterilization, and different sterilization methods will have different effects on the material. The vascular occluder sterilized by different sterilization methods is subjected to physical property tests such as hardness test, flexibility test and elongation at break test, and the test method refers to example 2, and the test results are shown in Table 7.

[0114] Table 7, physical property test results of the vascular occluder after sterilization

[0115]

[0116] According to the result analysis of Table 7, after electron beam irradiation, the vascular occluder will be brittle, and the hardness and toughness will decrease significantly, and will be broken in use, while using ethylene oxide sterilization, the physical properties of the vascular occluder remain good without obvious change, so ethylene oxide is selected for sterilizing the vascular occluder.

[0117] Although the present application is disclosed as above, the present application is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present application, and therefore the protection scope of the present application should be subject to the scope defined by the claims.

Claims

1. A vascular occlusion device, comprising: The application relates to a push device and an outer sheath head clamp, wherein the push device is used for cooperating with a blood vessel sheath group to push sealing material to seal a blood vessel wound, and the outer sheath head clamp is used for fixing the blood vessel sheath group.

2. The vascular occlusion device of claim 1, wherein, The outer sheath head clamp comprises a double-wing clamp head which is interlocked and internally forms a circular cavity for fixing the blood vessel sheath group; the push device comprises a push head, a tail handle head and an outer sleeve.

3. The vascular occlusion device of claim 2, wherein, The double-wing clamp head comprises a first wing plate and a second wing plate, and the first wing plate and the second wing plate are provided with first buckles and first clamping grooves; the first buckle of the first wing plate and the first clamping groove of the second wing plate are interlocked, and the first buckle of the second wing plate and the first clamping groove of the first wing plate are interlocked.

4. The vascular occlusion device of claim 2, wherein, The tail handle head comprises a cylindrical structure and a second clamping groove, and the cylindrical structure is provided with a through hole; the push head comprises a push tube and a push column; the push column passes through the through hole of the cylindrical structure, the push tube clamps the second clamping groove, and the push head can be locked on the tail handle head; and the second clamping groove is rectangular.

5. The vascular occlusion device of claim 4, wherein the at least one of the plurality of struts is configured to be more flexible than the other struts of the plurality of struts. Third clamping grooves are arranged on both sides of the cylindrical structure, and the outer sheath head clamp further comprises a second buckle; the third clamping grooves and the second buckle are used for fixing and connecting the outer sheath head clamp and the tail handle head.

6. The vascular occlusion device of claim 4, wherein, The push tube is composed of an upper cylindrical body and a lower cylindrical body, the diameter of the lower cylindrical body is smaller than that of the upper cylindrical body, and two cuboid clamping heads are arranged on both sides of the lower cylindrical body and used for fixing the second clamping groove.

7. The vascular occlusion device of claim 4, wherein the at least one of the first and second arms is configured to be at least partially flexible. The tail handle head is fixedly connected with the outer sleeve, and the diameter of the push column is smaller than the inner diameter of the outer sleeve; and the push column can be inserted into the outer sleeve and displaced.

8. The vascular occlusion device of claim 7, wherein, The sealing material is loaded into the outer sleeve from the front end of the outer sleeve or the tail handle head, the push tube is rotated to release the locking state, the push tube is pressed, and the push column pushes the sealing material out of the outer sleeve.

9. The vascular occlusion device of claim 8, wherein, The outer sleeve and the push head are inserted into the blood vessel sheath group during use and slightly deformed.

Images