Blood vessel plugging device and application thereof

Abstract

The invention provides a blood vessel plugging device which comprises a pushing device and an outer sheath tube head clamp, the blood vessel plugging device is used in cooperation with a blood vessel sheath set and used for plugging 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 a sealing material to a blood vessel plugging 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, 4F-24F sealing materials of different sizes can be used and pushed in cooperation with 4F-24F blood vessel sheath sets of different sizes, and the manufacturing materials of the pushing head, the tail handle head and the outer sleeve are screened, so that the blood vessel plugging device composed of the pushing head, the tail handle head and the outer sleeve has the optimal performance. The device is simple in structure and convenient to operate, has universality, and has important significance on endovascular interventional operations.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and in particular, relates to a blood vessel occluder. Background Art

[0002] Bleeding, leakage / gas, etc. are common trauma and postoperative complications, which seriously affect wound healing and repair, easily induce the formation of sinus tracts and fistulas, and even lead to patient death. How to perform effective wound closure is the key to achieving rapid hemostasis, reducing leakage, accelerating healing, reducing the risk of infection and improving the overall treatment effect. With the changes in modern lifestyles, vascular diseases (such as aneurysms and arteriovenous malformations) are increasingly becoming major problems affecting people's health. Traditional treatments for vascular diseases include open surgery and endoscopic surgery, which are often accompanied by greater surgical risks (such as unstable occlusion effects, possible damage to the blood vessel wall, etc.) and a longer recovery period. In order to improve treatment efficiency and patient comfort, the medical community has been seeking more innovative and minimally invasive treatments.

[0003] Intravascular interventional surgery is an important treatment method in the field of modern medicine. It treats various diseases by performing minimally invasive operations within blood vessels. At present, although small-sized vascular sheath interventions (≤12F) can use suture-based closure devices such as ProGlide for vascular closure, such products have high technical requirements for the operator, and patients are also prone to complications such as vascular stenosis and pseudoaneurysm after surgery. Although large-sized vascular sheath interventions (>12F) can use suture products such as ProGlide for wound closure, they have a significantly high failure rate, and once they fail, the muscle 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 sealing materials, which not only increases the difficulty of the operation, but also may prolong the patient's recovery time. When delivering the sealing material, the puncture needle is first inserted into the guide wire into the blood vessel, and then the vascular sheath is inserted through the guide wire. After flushing the vascular sheath, the occluder is inserted. Because the inner core of the occluder is formed by a thin steel wire and a sealing strip and an inner pad membrane arranged at the head end of the built-in thin steel wire, when the doctor operates the thin steel wire to move, if the head of the thin steel wire needs to be fixed, it is necessary to press the head of the thin steel wire by hand to fix it. Such a setting is not convenient for other operations. At the same time, due to the need for two-handed operation and the need to add samples, the operator will have problems with uneven hand force or long-term hand spasm, which will lead to component slippage, inaccurate positioning, and hematoma formation.

[0005] The sponge-like biological tissue sealing material is made of sponge and biological tissue sealing material. The sponge is a porous columnar body made of molds such as polytetrafluoroethylene, PDMS, plastic, and rubber. The biological tissue sealing material is made of natural polysaccharides, proteins, etc. Compared with the commonly used hemostatic and filling materials medical gauze and sponges, the sponge-like biological tissue sealing material is suitable for situations such as oozing and other heavy bleeding. It can effectively stop heavy bleeding, does not rely on the patient's own coagulation, and is also effective for patients with coagulation disorders. At the same time, the sponge-like biological tissue sealing material can effectively seal the wound site. After application, the wound will not have continuous oozing of blood, tissue fluid outflow, etc. Although the sponge-like biological tissue sealing material has an excellent hemostatic effect, it needs to be used in conjunction with a specific vascular occluder, and ordinary vascular occluders are not applicable.

[0006] Therefore, it is urgent to find a vascular occluder to solve the above problems. Summary of the invention

[0007] In view of the deficiencies in the prior art, the present invention provides a vascular occluder, including a pushing device and an outer sheath head clamp. The vascular occluder is used in conjunction with a vascular sheath group to block a vascular wound. The pushing device includes a pushing head, a tail handle head, and an outer sleeve. The sheath shell of the vascular sheath group is inserted to push the sealing material to the vascular occlusion position, and the outer sheath head clamp fixes the vascular sheath group by a buckle. The present invention not only designs different types of vascular occluders for different blood vessels, and can be used in conjunction with vascular sheath groups of different sizes from 4F to 24F to push sealing materials of different sizes from 4F to 24F, but also screens the materials used to make the pushing head, tail handle head, and outer sleeve so that the vascular occluder composed of them has the best performance. The present invention has a simple structure, is easy to operate, and has versatility, and is of great significance to intravascular interventional surgery.

[0008] A blood vessel occluder comprises a pushing device and an outer sheath tube head clamp, wherein the pushing device is used to cooperate with a blood vessel sheath group to push a sealing material to seal a blood vessel wound, and the outer sheath tube head clamp is used to fix the blood vessel sheath group.

[0009] In some embodiments, the vascular sheath group includes a puncture needle, a catheter sheath, a dilator, a guide wire, etc., and the vascular occluder needs to be used together with the vascular sheath group when used. The vascular occluder can not only fix the sheath shell of the vascular sheath group placed in the tissue through the double-wing interlocking structure of the outer sheath 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 steps of delivering the sealing material and withdrawing the vascular occluder with one hand. In order to match the catheter sheath size of different vascular sheath groups, the vascular occluder designed by the present invention can be used in conjunction with vascular sheath groups of different sizes from 4F to 24F, and the vascular wounds include massive bleeding from arterial dissection rupture, bleeding in nerve-rich areas, venous bleeding, radial artery intervention bleeding, and carotid artery intervention bleeding.

[0010] In some methods, firstly, a vascular occluder of a suitable size is selected according to the surgical needs, a sealing material is filled in the outer sleeve, a pusher head is inserted into the outer sleeve and locked by a buckle; then the outer sleeve is inserted into the sheath shell of the vascular sheath group, the outer sheath head clamp is locked, and the sheath shell of the sheath group is fixed to the vascular occluder; the pusher head is rotated to release its locking state, the pusher head is pressed, the sealing material is pushed out and placed in the target position, the outer sheath head clamp is kept locked, and the pushing device of the vascular occluder is pulled out of the vascular sheath group as a whole, withdrawn from the closed tissue, and the use is completed. The above vascular occlusion operation can be completed by the operator with one hand within 1 minute.

[0011] Furthermore, the outer sheath tube head clamp includes a double-wing clamp, which can be interlocked to form a circular cavity inside for fixing the vascular sheath group; the pushing device includes a pushing head, a tail handle head, and an outer sleeve; the double-wing clamp includes a first wing plate and a second wing plate, both the first wing plate and the second wing plate 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.

[0012] In some embodiments, the length of the first buckle is 3.29-4.8 mm, the first wing has a buckle and a slot, the second wing has a buckle and a slot, the buckle of the first wing is opposite to the slot of the second wing, the buckle of the second wing is opposite to the slot of the first wing, the buckle of the first wing is interlocked with the slot of the second wing, the buckle of the second wing is interlocked with the buckle of the first wing, and the buckle of the first wing and the buckle of the second wing have a circular arc structure on the left side, and when they are interlocked, the circular arc structure will form a circular cavity. The front end of the buckle has an upward bending structure, so when the buckle and the slot are interlocked, the first wing is firmly stuck with the second wing and will not easily break free. The circular cavity is used to lock the sheath shell of the vascular sheath group, and the sheath shell is an inverted cone, which is larger at the top and smaller at the bottom. The diameter of the circular cavity matches the diameter of the pipe at its lower end. The circular cavity clamps the lower end of the sheath shell to fix the sheath shell to the vascular occluder. The diameter of the circular cavity is 4.80-9.60 mm, and the angle between the first buckle and the wing plate is 90°. The length of the double-wing clamp is 3.20-19.20 mm, and when the double-wing clamp is opened, the distance between the two wings is 15.33-30.66 mm, and the angle between the first buckle and the wing plate is 105°.

[0013] The material selection of the vascular occluder is based on medical biocompatibility. The parts that contact the drug and the body should use commonly used materials in medical treatment as much as possible, so as not to cause adverse conditions such as circulatory diseases, allergic reactions, and infection risks. The toughness and certain hardness of the material should be taken into consideration to prevent breakage and damage as much as possible.

[0014] Furthermore, the material of the tail handle head includes one or more of nylon photosensitive resin, polymerized polyamide resin, and polycarbonate; the material of the push head includes one or more of polycarbonate, ordinary photosensitive resin, polymerized polyamide resin, polytetrafluoro material, ABS plastic, and polypropylene; the material of the outer sleeve includes one or more of silicone, polyethylene, polyethylene terephthalate, and polytetrafluoro material; the material of the outer sheath tube head card includes one or more of polycarbonate, polypropylene, and polymerized polyamide resin.

[0015] In some ways, polyethylene terephthalate (PET) has good creep resistance, fatigue resistance, friction resistance and dimensional stability, is cheap and has a high cost-effectiveness. Nylon (PA), polytetrafluoroethylene (PTFE) and alloys of PA and polyurethane (PU) or other materials are the preferred raw materials for the production of advanced interventional catheters. In addition to the advantages of high crystallinity, low friction coefficient, good heat resistance, high chemical stability, strong acids, strong bases and various organic solvents, PTFE also has unique properties in medical use, such as good biocompatibility, blood adaptability, no damage to human physiology, no adverse reactions when implanted in the body, and can be sterilized at high temperatures, so PTFE is widely used in biomedical engineering. Among the many fluoroplastics, tetrafluoroethylene and ethylene copolymers (F40) and polyperfluoroethylene propylene (F46) are the most commonly used. The surface of fluoroplastics originally has no antithrombotic properties. When it comes into contact with blood, a stable antithrombotic film will be formed on its surface, thereby inducing vascular endothelial cells to form a smooth biological layer, so that the polymer material that originally has no antithrombotic properties has natural antithrombotic properties. Polycarbonate (PC) has extremely high impact resistance, is not easy to break, and has 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, has high safety, and is suitable for use in the field of medical device manufacturing. Nylon photosensitive resin has fast molding speed, high mechanical strength, good dimensional stability, good light transmittance, strong impact resistance and light weight. Polyamide resin (PA66) has high mechanical strength and hardness, chemical resistance, excellent wear resistance and self-lubrication, and a low friction coefficient. 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 application scenarios that need to withstand impact and pressure, and has good resistance to many chemicals and can work stably in a variety of chemical environments. Ordinary photosensitive resins have fast curing speed, high energy utilization, good environmental protection and good biocompatibility, and are widely used in medical devices.

[0016] Preferably, the tail handle is made of one of polymerized polyamide resin (PA66) and polycarbonate (PC), and the pusher head and the outer sleeve are made of polytetrafluoroethylene (PTFE).

[0017] In some embodiments, the function of the outer sheath tube head card is to fix the sheath tube shell of the vascular sheath group, so the outer sheath tube head card made of any material of polycarbonate, polypropylene, and polymerized polyamide resin meets the standard.

[0018] Furthermore, 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, so that the push head can be locked on the tail handle head, and the second slot is rectangular.

[0019] In some embodiments, the tail handle is equivalent to a connector of the vascular occluder, the upper end of the tail handle is provided with a second slot connected to the push head, the cylindrical structure of the tail handle is provided with a through hole connected to the outer sleeve, and the cylindrical structure of the tail handle is also provided with a third slot, which is fixed with the second buckle at the upper end of the outer sheath head. Through the tail handle, the push head, the outer sleeve, the outer sheath head and the tail handle are assembled together to form a vascular occluder.

[0020] In some embodiments, the diameter of the through hole of the cylindrical structure is 1.20-7.90 mm.

[0021] Furthermore, a third card slot is set on both sides of the cylindrical structure, and the outer sheath tube head card also includes a second buckle, and the third card slot and the second buckle fix the outer sheath tube head card to connect with the tail handle head; 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 rectangular card heads are set on both sides of the lower cylinder for fixing with the second card slot.

[0022] In some embodiments, the second buckles are symmetrically arranged on the top of the outer sheath tube head, and can be clamped and fixed with the third clamping grooves on both sides of the cylindrical structure.

[0023] In some embodiments, the upper cylinder is 2.00 mm high and 8.00 mm in diameter. The two rectangular clamps set on both sides of the lower cylinder are 5.33-32.00 mm long, 1.33-8.00 mm wide, and 10.00 mm high. They can be inserted into the second clamping slot of the tail handle head to lock the push head on the tail handle head. The length of the second clamping slot is 5.33-32.00 mm and the width is 1.33-8.00 mm.

[0024] Furthermore, the tail handle head is fixed to the outer sleeve as a whole, the diameter of the push rod is smaller than the inner diameter of the outer sleeve, and the push rod can be inserted into the outer sleeve for displacement; 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, and the push tube is pressed, so that the push rod can push the sealing material out of the outer sleeve; the outer sleeve and the push head are inserted into the vascular sheath group when in use, and will be slightly deformed.

[0025] In some embodiments, the outer sleeve is also a through-hole structure. Since it is fixed to the tail handle head as a whole, the through-hole of the outer sleeve is connected to the through-hole of the cylindrical structure of the tail handle head. The through-hole of the outer sleeve is 1.20-7.90 mm. Pushing the push head back and forth can drive the push column to move back and forth in the outer sleeve. The push column is a solid cylindrical structure with a diameter of 1.20-7.70 mm and a length of 152.50 mm.

[0026] In some ways, one function of the outer sleeve is to serve as a delivery channel for the sealing material, and another function is to aseptically store the sealing material. Before using the vascular occluder, first load the sealing material into the outer sleeve from the tail handle head or the front end of the through hole of the outer sleeve, insert the push column of the push head into the through hole of the cylindrical structure of the tail handle head and the outer sleeve, and push the sealing material to the front position of the outer sleeve. The push tube is clamped in the second card slot of the tail handle head. 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. The vascular occluder is sterilized as a whole using ethylene oxide. When the vascular occluder is inserted into the sheath shell of the vascular sheath group and the sheath shell is fixed to the vascular occluder through the outer sheath head card, the push head can be rotated with one hand to release the locking state of the push head, and the sealing material can be pushed out of the outer sleeve to the target position by pushing the push head. The locking structure of the above-mentioned push head and the second card slot of the tail handle head is to allow the sealing material to be stored in the front position of the outer sleeve, which is convenient for one-handed operation and makes it easier to push the sealing material to the target position.

[0027] In some methods, during use, the pusher head is inserted into the outer sleeve, and the outer sleeve is inserted into the sheath shell of the vascular sheath group placed in the tissue. The sheath shell has a certain bend, so in order to smoothly push out the sealing material, the outer sleeve and the pusher head must also be bent together with the sheath shell. Due to the particularity of the use environment, this requires not only that the material for manufacturing the outer sleeve and the pusher head must be flexible and deformable, but also resistant to chemical corrosion.

[0028] Furthermore, a method for using a vascular occluder comprises the following steps:

[0029] (1) Install the sealing material into the outer tube from the front end or the tail handle of the outer tube, insert the pusher into the outer tube and lock it, keep the pusher locked, and sterilize the whole tube;

[0030] (2) The outer sheath is inserted into the vascular sheath group, and the outer sheath head is clamped to fix the vascular sheath group;

[0031] (3) Rotate the push head to release the locking state and push out the sealing material;

[0032] (4) The vascular occluder is pushed out from the vascular sheath group.

[0033] Specifically, the method for using the vascular occluder of the present invention is as follows: first, a vascular occluder of a suitable size is selected according to surgical needs, a 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, a push head is inserted into the through hole and the outer sleeve, and the push head is locked by the rectangular clamp 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 vascular occluder is sterilized as a whole using ethylene oxide; then the outer sleeve is inserted into the sheath tube shell of the vascular sheath group, the first clamp and the first clamping groove are locked, and the circular cavity firmly clamps the vertebral lower end pipe of the sheath tube shell; the push tube of the push head is rotated to release its locking state, and the push tube is pressed to push out the sealing material and place it in the target position. After pushing the sealing material, the locking state of the first clamp and the first clamping groove is maintained, and the pushing device of the vascular occluder is pulled out of the sheath tube shell of the vascular sheath group as a whole, withdrawn from the closed tissue, and the use is completed.

[0034] Furthermore, the sterilization in the above step (1) includes ethylene oxide sterilization.

[0035] In some ways, ethylene oxide is considered to be the most effective chemical sterilant, capable of killing all microorganisms, including bacterial spores. Ethylene oxide has strong penetrability and can penetrate into various difficult-to-penetrate parts, especially for thinner and longer catheters and other difficult-to-sterilize items. Since ethylene oxide kills microorganisms through the alkylation principle, it causes very little damage to items and is particularly suitable for the sterilization of heat-sensitive precision instruments. In addition, ethylene oxide can not only be used to sterilize items that are not resistant to high temperatures and moisture, and can meet the sterilization needs of a variety of medical products, but also has standard chemical and biological monitoring methods, which can effectively control the sterilization quality and promptly detect packages that have failed sterilization.

[0036] Furthermore, a material composition is used for making a vascular occluder, the material composition includes polymerized polyamide resin and polytetrafluoro material, or polycarbonate and polytetrafluoro material; the vascular occluder includes a tail handle head, a push head and an outer sleeve; the polymerized polyamide resin or polycarbonate is used to prepare the tail handle head, and the polytetrafluoro material is used to prepare the push head and the outer sleeve.

[0037] Furthermore, a vascular occluder is used to prepare a device for delivering sponge-like biological tissue sealing material to a target location, comprising a pushing device and an outer sheath tube head clamp, wherein the pushing device is used to cooperate with a vascular sheath group to push the sealing material to seal a vascular wound, and the outer sheath tube head clamp is used to fix the vascular sheath group.

[0038] In some embodiments, the sponge-like biological tissue sealing material is a porous column made of sponge and natural polysaccharide or protein. The sponge is made of a mold such as polytetrafluoroethylene, PDMS, plastic, rubber, etc. 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. These tissue sealant materials can react chemically with tissues and / or body fluids, and these chemical reactions are achieved through the chemical inherent properties and group modifications of these materials. The chemical inherent properties include hydrophobicity, hydrogen bonding, electrostatic interaction, functional group effects, etc.; the group modifications include aldehyde, sulfhydrylation, carboxylation, hydroxylation, etc. Different sizes of vascular occluders are used in conjunction with sponge-like biological tissue sealing materials of corresponding sizes. The sizes of sponge-like biological tissue sealing materials available include 4F-24F.

[0039] Prior to this, the team had applied for a patent titled "A biological tissue sealing material and its preparation method", with patent number CN117860954A. The biological tissue sealing material is obtained by freeze-drying the aldehyde-modified polysaccharide in sections, and has a dense structure and small pores, and is not easy to absorb water and swell. When the biological tissue sealing material is in use, once it contacts the body fluid or tissue surface, it can react and cross-link with the amino / sulfhydryl groups on the cells or proteins in the body fluid or tissue surface to form a physical sealing layer, thereby effectively sealing the wound site. The biological tissue sealing material and the sponge are jointly made into a sponge-like biological tissue sealing material. The sponge-like biological tissue sealing material has adhesion. When a vascular occluder made of ordinary material is used to push it to the target position, the sponge-like biological tissue sealing material adheres to the wall of the conveying pipeline, resulting in a large resistance during the pushing process, and it 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 hemostasis effect. Therefore, in view of the above problems, the present invention selects the most suitable pipeline material to make a vascular occluder. The pushing pipeline of the vascular occluder will not be contaminated by particles, and has the advantages of strong propulsion, high strength, and smoothness. In practical applications, it is not only suitable for the above-mentioned sponge-like biological tissue sealing material, but also for sealing materials made of other raw materials. The other sealing materials include but are not limited to powders, hydrogels, semi-solids, solids, etc. As long as the size is appropriate, the present invention can be used universally.

[0040] The present invention has the following beneficial effects:

[0041] (1) A vascular occluder, comprising a pushing device and an outer sheath tube head clamp, which can fix the sheath tube shell of a vascular sheath group placed in tissue through the double-wing interlocking structure of the outer sheath clamp head to deliver the sealing material to the target position;

[0042] (2) The pushing device includes a pushing head, a tail handle head, and an outer sleeve, which forms a sealing device to provide a sterile storage environment for the sealing material;

[0043] (3) The vascular occluder designed in the present invention can be used in conjunction with vascular sheath sets of different sizes from 4F to 24F;

[0044] (4) The operator can operate the vascular occluder with one hand to complete the steps of delivering the sealing material and removing the vascular occluder;

[0045] (5) The present invention selects the materials for making the tail handle head, the push head, and the outer sleeve, so that the vascular occluder made of them has a better use effect. The tail handle head is made of one of polymerized polyamide resin (PA66) and polycarbonate (PC), and the push head and the outer sleeve are made of polytetrafluoroethylene (PTFE).

[0046] (6) The present invention can not only deliver sponge-like biological tissue sealing materials of 4F-24F size, but also deliver sealing materials of other materials that meet the size;

[0047] (7) The present invention has a simple structure, is easy to operate, and is universal, and is of great significance to intravascular interventional surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Figure 1 This is the overall structure diagram of the vascular occluder;

[0049] Figure 2 It is a schematic diagram of the push head structure;

[0050] Figure 3 Schematic diagram of the structure of the push head and tail handle head Figure 1 ;

[0051] Figure 4 Schematic diagram of the structure of the push head and tail handle head Figure 2 ;

[0052] Figure 5 This is the front view of the tail peduncle structure;

[0053] Figure 6 This is a top view of the tail peduncle structure;

[0054] Figure 7 This is a bottom view of the tail peduncle structure;

[0055] Figure 8 Schematic diagram of the outer casing structure Figure 1 ;

[0056] Fig. 9 Schematic diagram of the outer casing structure Figure 2 ;

[0057] Fig.10This is a physical picture of the sponge-like biological tissue sealing material;

[0058] Fig.11 Schematic diagram of the outer sheath tube head card structure Figure 1 ;

[0059] Fig.12 Schematic diagram of the outer sheath tube head card structure Figure 2 ;

[0060] Fig.13 It is a front view of the outer sheath tube head clamp structure;

[0061] Fig.14 It is a top view of the outer sheath tube head card structure;

[0062] Fig.15 It is a side view of the outer sheath tube head card structure;

[0063] Fig.16 This is a real picture of the vascular occluder;

[0064] Fig.17 Schematic diagram of inserting a sheath housing into a vascular occluder;

[0065] Fig.18 To tighten the outer sheath tube head clamp double wings Figure 1 ;

[0066] Fig.19 To tighten the outer sheath tube head clamp double wings Figure 2 ;

[0067] Fig. 20 Schematic diagram of the rotary pusher pushing out the sealing material Figure 1 ;

[0068] Fig.21 Schematic diagram of the rotary pusher pushing out the sealing material Figure 2 ;

[0069] Fig. 22 This is a schematic diagram of the vascular occluder being withdrawn from the sheath housing. DETAILED DESCRIPTION

[0070] The present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be pointed out that the embodiments described below are intended to facilitate the understanding of the present invention and do not have any limiting effect on the present invention.

[0071] Embodiment 1: A blood vessel occluder

[0072] 1. Structure of vascular occluder

[0073] like Figure 1 , 16As shown, a vascular occluder is used in conjunction with a vascular sheath group, and is composed of a pushing device 1 and an outer sheath tube head clamp 2, and the outer sheath tube head clamp 2 fixes the vascular sheath group through a buckle. In this embodiment, the delivery of a spongy biological tissue sealing material 14 is taken as an example, and the pushing device 1 pushes the spongy biological tissue sealing material 14 to the target position of the vascular sheath group.

[0074] like Figure 2-10 As 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 has a smaller diameter than the upper cylinder 8. Two rectangular parallelepiped clamps 10 are arranged on both sides of the lower cylinder 9. The rectangular parallelepiped clamps 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 cylindrical structure with a diameter of 1.20-7.70 mm and a length of 152.50 mm. 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. The length of the second clamping groove 12 is 5.33-32.00 mm and the width is 1.33-8.00 mm. The push column 7 passes through the through hole 13 of the cylindrical structure 11. The two rectangular clamping heads 10 of the push tube 6 clamp the second clamping groove 12. When the push head 3 is not working, the push head 3 is locked on the tail handle head 4. The outer sleeve 5 is connected to the through hole 13 of the cylindrical structure 11 as a whole, and the pipe diameter is consistent, which is 1.20-7.90 mm. Before using the vascular occluder, the spongy biological tissue sealing material 14 is first loaded into the outer tube 5 from the through hole 13 of the cylindrical structure 11 or the lower end of the through hole of the outer tube 5. The outer tube 5 is not only used to fill and store the spongy biological tissue sealing material 14, but also to provide a sterile environment for the spongy biological tissue sealing material 14, and to provide a pipeline for transporting the spongy biological tissue sealing material 14. The push rod 7 is inserted into the through hole 13 and locked in the second card slot 12. At this time, the spongy biological tissue sealing material 14 in the outer tube 5 is pushed to the front position of the outer tube 5, but not pushed out from the outer tube 5, and the whole is sterilized. When using the vascular occluder, the push tube 6 is rotated to release the locking state of the push tube 6, and the push tube 6 is pushed forward. The push rod 7 moves forward in the outer tube to push the spongy biological tissue sealing material 14 out of the outer tube 5 to the target position. The tail handle head 4 also includes a third card slot 23, which is arranged on both sides of the cylindrical structure 11.

[0075] like Figure 11-15As shown, the outer sheath tube 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 both 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, and 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 front end of the first clamp 19 has an upward bending structure 24. 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 will not easily break free. The first wing plate 17 and the first buckle 19 of the second wing plate 18 both have a circular arc structure 21 on their left sides. When the first wing plate 17 and the second wing plate 18 are interlocked, the two circular structures 21 form a circular cavity, which is used to fix the sheath tube housing 22 of the vascular sheath group ( Fig.17 ), the sheath tube housing 22 is an inverted cone, which is larger at the top and smaller at the bottom. The diameter of the circular cavity matches the diameter of the pipe at its lower end. The circular cavity clamps the lower end of the sheath tube housing 22 to fix the sheath tube housing 22 to the vascular occluder. The diameter of the circular cavity is 4.80-9.60mm. When the first buckle 19 and the first slot 20 are interlocked, the angle between the first buckle 19 and the first wing plate 17 and the second wing plate 18 is 90°. When the first buckle 19 and the first slot 20 are opened, the distance between the first wing plate 17 and the second wing plate 18 is 15.33-30.66mm. The angle between the first buckle 19 and the first wing plate 17 and the second wing plate 18 is 105° ( Fig.13 The second buckle 16 is symmetrically arranged at the top of the outer sheath tube head card 2, and the second buckle 16 and the third card slot 23 are fixed to connect the outer sheath tube head card 2 with the tail handle head 4.

[0076] 2. How to use the vascular occluder

[0077] like Figure 17-22As shown, a method for using a vascular occluder that can deliver spongy biological tissue sealing materials, taking porcine femoral aneurysm as an example, an aneurysm model is manufactured in advance at the porcine femoral artery. First, a vascular occluder of appropriate size is selected according to the surgical needs, and the spongy biological tissue sealing material 14 is added 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, and the pusher head 3 is inserted into the through hole 13 and the outer sleeve 5, and the pusher head 3 is locked by the rectangular clamp 10 and the second clamping groove 12. At this time, the spongy biological tissue sealing material 14 has been pushed to the front position of the outer sleeve 5; the vascular occluder is sterilized with ethylene oxide, and after sterilization, the outer sleeve 5 is inserted into the vascular sheath The sheath tube housing 22 of the group is locked, the first buckle 19 and the first slot 20 are locked, and the circular cavity firmly clamps the vertebral lower end pipe of the sheath tube housing 22; the push tube 6 of the push head 3 is rotated to release its locking state, and the push tube 6 is pressed to push out the sponge-like biological tissue sealing material 14 and place it in the target position. After pushing the sealing material, the first buckle 19 and the first slot 20 are kept locked, and the pushing device 1 of the vascular occluder is pulled out of the sheath tube housing 22 of the vascular sheath group as a whole, withdrawn from the closed tissue, and the use is completed. The above-mentioned aneurysm cavity blocking operation can be completed within 1 minute, and the operator can operate it with one hand.

[0078] The vascular occluder of this embodiment takes the pushing of sponge-like biological tissue sealing materials as an example, but the pushing materials are not limited to sponge-like biological tissue sealing materials. 4F-24F sealing materials that meet the size requirements can be pushed to the target position using the vascular occluder provided by the present invention in combination with the corresponding vascular sheath group.

[0079] 3. Materials for making vascular occluders

[0080] The tail handle head is made of one of polymerized polyamide resin (PA66) and polycarbonate (PC), the pusher head and the outer sleeve are made of polytetrafluoroethylene (PTFE), and the outer sheath tube head card is made of one or more of polycarbonate (PC), polypropylene (PP), and polymerized polyamide resin (PA66).

[0081] Embodiment 2, the material screening of the tail handle

[0082] The material selection of the vascular occluder is based on medical biocompatibility. The parts that contact the drug and the body should use commonly used materials in medical treatment as much as possible, so as not to cause adverse conditions such as circulatory diseases, allergic reactions, and infection risks. The toughness and certain hardness of the material should be taken into consideration to prevent breakage and damage as much as possible.

[0083] The difference between this embodiment and embodiment 1 is the material of the tail handle head, and the selectable materials include one or more of nylon photosensitive resin, polymerized polyamide resin (PA66) and polycarbonate (PC), and the material combination is shown in Table 1. Each material combination is subjected to hardness test, flexibility test, elongation at break test, smoothness test, propulsion test, adhesion test with sealing material, particle contamination test and dissolution test, etc.

[0084] The hardness test method is: use Vickers hardness to measure the hardness of the vascular occluder. During the test, a diamond square pyramid indenter with a relative angle of 136° is used to press into the surface of the material with a specified test force F. After maintaining the test force for a specified time, the test force is removed and the hardness value is expressed as the average pressure per unit surface area of ​​the square pyramid indentation. In addition, the hardness of the vascular occluder needs to be compatible with the sealing material, so it is also necessary to actually test its hardness in the experiment. According to the test results of the sealing material hardness, the selected material hardness test results are within the range of 60-90 shore A.

[0085] The flexibility test method is as follows: The flexibility test is used to determine the behavior of the vascular occluder under axial tensile load. The test results mainly include elastic limit, tensile strength and yield strength. The elastic limit is the maximum stress point at which the device can still return to its original state after being stressed. Tensile strength refers to the crushing force per unit area. Yield strength is the stress value at which the device begins to undergo reversible plastic deformation during the stress process. In actual testing, the flexibility of the vascular occluder mainly refers to the flexibility of the outer sleeve and the push head.

[0086] The testing method of elongation at break is as follows: make each group of materials into standard strip specimens, usually with a width of 15mm and a length of 200mm; clamp the two ends of the specimen on the upper and lower clamps of the tensile testing machine respectively, and ensure that the long axis direction of the specimen coincides with the center line of the upper and lower clamps; set the appropriate test speed and other parameters according to the material type of the specimen and the expected elongation at break; start the testing machine, the specimen will deform during the stretching process until it finally breaks, and the instrument will automatically record and display the elongation at break.

[0087] The method for testing smoothness is: use a gloss meter for measurement. First, turn on the gloss meter and preheat it for 3-5 minutes to stabilize the instrument; calibrate the instrument, place the gloss meter on the blackboard, adjust the instrument angle so that it is perpendicular to the blackboard, and adjust the height so that the measuring port is parallel to the plane of the blackboard, press the calibration button, and the instrument will automatically calibrate; place the sample to be tested on the measuring port of the gloss meter, set the measuring angle to 60 degrees, press the measuring button, and the instrument will automatically measure the surface gloss of the sample and display the measurement results.

[0088] The pushability test method and the test method for whether the sealing material is adhered are as follows: a sponge-like biological tissue sealing material is selected as the experimental sealing material, because it has a certain viscosity, and it can be tested whether the outer wall of the material is adhered to the sealing material. The sealing material is loaded into the outer tube from the tail handle head or the lower end of the outer tube through hole, and it is observed whether the material can be completely and easily loaded into the outer tube. After the sealing material is stored in the outer tube for a certain period of time, the pusher head is pushed to detect whether the sealing material can be pushed out completely and whether it is adhered to the tube wall or the contact part of the pusher head.

[0089] The detection method for particle contamination is: refer to the requirements for particle size and quantity in the 2020 edition of the Pharmacopoeia of the People's Republic of China (0903 Insoluble Particle Inspection Method); refer to YY / T 1556-2017 "Medical Infusion and Blood Transfusion Syringe Equipment Particle Contamination Inspection Method" to specify the overall contamination index of the occluder and the delivery system. During the test, the shedding of particles during the entire process of pushing, releasing, and withdrawing the simulated product is evaluated separately.

[0090] The method for detecting dissolution is: many physiological reactions after medical devices come into contact with the human body are related to the presence of dissolution or exudate in the device. Therefore, the standard requires that chemical performance evaluation should be conducted for occluders and delivery systems containing medical polymer materials. Refer to GB / T 14233.1-2008 "Test methods for medical infusion, transfusion and injection equipment Part 1: Chemical analysis methods".

[0091] The performance test criteria of the shank head are as follows: hardness range is 60-90 shore A; flexibility range is 20-100Mpa; elongation at break is 10-30%; glossiness test value greater than 70GU is smooth, less than 70GU is rough; propulsion is divided into three levels: poor, general, and good; adhesion to the sealing material is divided into three conditions: non-adhesion, slight adhesion, and adhesion. The performance test results are shown in Table 2 below.

[0092] Table 1. Vascular occluders with different combinations of tail handle and head materials

[0093]

[0094] Table 2. Performance test results

[0095]

[0096] According to the analysis of the test results in Table 2, material combinations 1-3 are single component materials, and material combinations 4-7 are mixed component materials. From the perspective of hardness, flexibility and elongation at break, the hardness, flexibility and elongation at break of material combinations 1-7 all meet the screening criteria, and the surface and inner wall are smooth, without particle pollution and dissolution; but in the test of adhesion with the sealing material and the test of propulsion, the inner wall of the tail handle head of material combination 4 will adhere to the spongy biological tissue sealing material, resulting in poor propulsion, and the inner wall of the tail handle head of material combinations 1, 5, 6, and 7 will be slightly adhered to the spongy 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 completely non-adhesive to the spongy 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 polymerized polyamide resin (PA66) and polycarbonate (PC) is selected as the material for making the tail handle head.

[0097] Embodiment 3, push head material screening

[0098] The difference between this embodiment and embodiment 1 is the material of the pusher head. The pusher head can be made of one or more materials including polycarbonate (PC), ordinary photosensitive resin, polymerized polyamide resin (PA66), polytetrafluoroethylene (PTFE), ABS plastic and polypropylene (PP). The material combination is shown in Table 3. The hardness, flexibility, elongation at break, smoothness, smoothness / propulsion, adhesion to the sealing material, and particle contamination of each material combination are tested. The detection method is as described in embodiment 2.

[0099] The pusher performance test evaluation criteria are as follows: hardness range is 60-90 shore A; flexibility range is 20-60Mpa; elongation at break is 10-30%; glossiness test value greater than 70GU is smooth, less than 70GU is rough; pushability is divided into three levels: poor, general, and good; adhesion to the sealing material is divided into three conditions: non-adhesion, slight adhesion, and adhesion. The performance test results are shown in Table 4 below.

[0100] Table 3. Vascular occluders with different pusher head material combinations

[0101]

[0102] Table 4. Performance test results

[0103]

[0104]

[0105] According to the results of Table 4, material combinations 1-6 are pushers made of separate components, and material combinations 7-10 are pushers made of mixed components. The pusher heads made of material combinations 1-10 have smooth surfaces and no particle contamination, but dissolution was detected in material combinations 5, 8, and 10, which is speculated to be produced by ABS plastic, and the pusher heads of material combinations 5, 8, and 10 will adhere to the spongy biological tissue sealing material during the advancement process, resulting in poor or general advancement process. According to the screening criteria of hardness, flexibility, and elongation at break, only material combinations 2, 4, and 7 meet the screening criteria; although the pusher heads of material combinations 1 and 3 do not adhere to the spongy biological tissue sealing material and have good advancement during the advancement process, the flexibility does not meet the screening criteria; the pusher heads of material combinations 2 and 7 will slightly adhere to the spongy biological tissue sealing material during the advancement process, resulting in general advancement; only the pusher head of material combination 4 will not adhere to the spongy biological tissue sealing material during the advancement process, so the advancement is good, indicating that the self-lubricating property of PTFE material is good. Preferably, material combination 4 is selected as the material for making the pusher head, that is, polytetrafluoroethylene (PTFE) is selected as the material for making the pusher head.

[0106] Example 4: Material screening of outer sleeve

[0107] The difference between this embodiment and embodiment 1 is the material of the outer sleeve, and the outer sleeve can be made of one or more of silicone rubber (TPU), polyethylene (PE), polyethylene terephthalate (PET) and polytetrafluoroethylene (PTFE), and the material combination is shown in Table 5. The hardness, flexibility, elongation at break, smoothness, smoothness / propulsion, adhesion to the sealing material, and particle contamination of each material combination are tested, and the detection method is as described in embodiment 2.

[0108] The outer sleeve performance test evaluation criteria are as follows: hardness range is 60-90 shore A; flexibility range is 20-60Mpa; elongation at break is 10-30%; glossiness test value greater than 70GU is smooth, less than 70GU is rough; propulsion is divided into three levels: poor, general, and good; adhesion with the sealing material is divided into three conditions: non-adhesion, slight adhesion, and adhesion. The performance test results are shown in Table 6 below.

[0109] Table 5. Vascular occluders with different outer sleeve material combinations

[0110]

[0111] Table 6. Performance test results

[0112]

[0113] According to the results of Table 6, material combination 1-4 is an outer sleeve made of a single component, and material combination 5 is an outer sleeve made of a mixed component. The outer sleeves of material combination 1-5 are free of particle pollution and dissolution, and the inner wall is smooth, but according to the screening criteria of hardness, flexibility and elongation at break, the hardness of material combination 1-5 meets the screening criteria, the flexibility and elongation at break of material combination 1, 3, 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 meet the screening criteria; the inner wall of the outer sleeve of material combination 1 adheres to the spongy biological tissue sealing material, resulting in poor propulsion, the inner wall of the outer sleeve of material combination 2, 3, 5 adheres to the spongy biological tissue sealing material slightly, and the propulsion is general, only the inner wall of the outer sleeve of material combination 4 does not adhere to the spongy biological tissue sealing material, so the propulsion is good, indicating that the self-lubricating property of PTFE material is better. Preferably, material combination 4 is selected as the material for making the outer sleeve, that is, tetrafluoro material (PTFE) is selected as the material for making the outer sleeve.

[0114] Example 5: Sterilization method of vascular occluder

[0115] After the sealing material is installed on the vascular occluder, it needs to be sterilized. The difference between this embodiment and embodiment 1 lies in the sterilization method. The sterilization method can be electron beam irradiation sterilization and ethylene oxide sterilization. Different sterilization methods will have different effects on the material. The vascular occluders sterilized by different sterilization methods are subjected to physical property tests such as hardness test, flexibility test, and elongation at break test. The test method refers to embodiment 2. The test results are shown in Table 7 below.

[0116] Table 7. Physical performance test results of vascular occluder after sterilization

[0117]

[0118] According to the results in Table 7, after electron beam irradiation, the vascular occluder will become brittle, and its hardness and toughness strength will decrease significantly, and it will break during use. However, when sterilized with ethylene oxide, the physical properties of the vascular occluder remain good without obvious changes, so ethylene oxide is selected to sterilize the vascular occluder.

[0119] Although the present invention is disclosed as above, the present invention 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 invention. Therefore, the protection scope of the present invention shall be subject to the scope defined by the claims.

Claims

1. A vascular occluder, characterized in that: It comprises a pushing device and an outer sheath tube head clamp, wherein the pushing device is used to cooperate with the vascular sheath group to push the sealing material to seal the vascular wound, and the outer sheath tube head clamp is used to fix the vascular sheath group.

2. The vascular occluder according to claim 1, characterized in that: The outer sheath tube head clamp includes a double-wing clamp, which can be interlocked and form a circular cavity inside for fixing the vascular sheath group; the pushing device includes a pushing head, a tail handle head, and an outer sleeve; the double-wing clamp 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.

3. The vascular occluder according to claim 2, characterized in that: The material of the tail handle head includes one or more of nylon photosensitive resin, polymerized polyamide resin, and polycarbonate; the material of the push head includes one or more of polycarbonate, ordinary photosensitive resin, polymerized polyamide resin, polytetrafluoro material, ABS plastic, and polypropylene; the material of the outer sleeve includes one or more of silicone, polyethylene, polyethylene terephthalate, and polytetrafluoro material; the material of the outer sheath tube head card includes one or more of polycarbonate, polypropylene, and polymerized polyamide resin.

4. The vascular occluder according to claim 2, characterized in that: 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, so that the push head can be locked on the tail handle head, and the second slot is rectangular.

5. The vascular occluder according to claim 4, characterized in that: A third card slot is set on both sides of the cylindrical structure, and the outer sheath tube head card also includes a second card buckle. The third card slot and the second card buckle fix the outer sheath tube head card to connect with the tail handle head; 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 rectangular card heads are set on both sides of the lower cylinder for fixing with the second card slot.

6. The vascular occluder according to claim 5, characterized in that: The tail handle head is fixed to the outer sleeve as a whole, the diameter of the push rod is smaller than the inner diameter of the outer sleeve, and the push rod can be inserted into the outer sleeve for displacement; 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, and the push tube is pressed, so that the push rod can push the sealing material out of the outer sleeve; the outer sleeve and the push head are inserted into the vascular sheath group when in use, and will be slightly deformed.

7. A method for using a vascular occluder, characterized in that: The following steps are involved: (1) Install the sealing material into the outer tube from the front end or the tail handle of the outer tube, insert the pusher into the outer tube and lock it, keep the pusher locked, and sterilize the whole tube; (2) The outer sheath is inserted into the vascular sheath group, and the outer sheath head is clamped to fix the vascular sheath group; (3) Rotate the push head to release the locking state and push out the sealing material; (4) The vascular occluder is pushed out from the vascular sheath group.

8. The method of use according to claim 7, characterized in that: The sterilization in step (1) includes ethylene oxide sterilization.

9. Use of a material composition for making a vascular occluder, characterized in that: The material composition comprises polymerized polyamide resin and polytetrafluoro material, or polycarbonate and polytetrafluoro material; the vascular occluder comprises a tail handle head, a push head and an outer sleeve; the polymerized polyamide resin or polycarbonate is used to prepare the tail handle head, and the polytetrafluoro material is used to prepare the push head and the outer sleeve.

10. Use of a vascular occluder for preparing a device for delivering a sponge-like biological tissue sealing material to a target location, characterized in that: It comprises a pushing device and an outer sheath tube head clamp, wherein the pushing device is used to cooperate with the vascular sheath group to push the sealing material to seal the vascular wound, and the outer sheath tube head clamp is used to fix the vascular sheath group.

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