CN109820548B - Plugging device, preparation method thereof and plugging system - Google Patents
Plugging device, preparation method thereof and plugging system Download PDFInfo
- Publication number
- CN109820548B CN109820548B CN201811575032.9A CN201811575032A CN109820548B CN 109820548 B CN109820548 B CN 109820548B CN 201811575032 A CN201811575032 A CN 201811575032A CN 109820548 B CN109820548 B CN 109820548B
- Authority
- CN
- China
- Prior art keywords
- plugging
- frame
- coating
- occlusion
- occluder
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Images
Landscapes
- Surgical Instruments (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention relates to an occluder, which comprises an occluder frame and a coating, wherein the occluder frame is of a net structure, the coating completely covers the occluder frame to form a sac-shaped structure with an opening, and in implantation, a liquid contrast agent is injected into the sac-shaped structure through the opening of the sac-shaped structure, so that the whole sac-shaped structure is visible under X-ray imaging equipment, and the whole shape of the occluder can be judged.
Description
Technical Field
The invention relates to the field of interventional medical instruments, in particular to an occluder, a preparation method thereof and an occlusion system.
Background
Atrial Septal Defects (ASD), Ventricular Septal Defects (VSD), and Patent Ductus Arteriasus (PDA) are common congenital heart Defect diseases. In recent years, heart defect occluders (hereinafter simply referred to as occluders) have been widely used for interventional therapy of congenital heart defect diseases such as ASD and VSD. The interventional therapy of the cardiac defect occluder has the advantages of slight trauma, safe and quick operation, exact near-term and medium-term curative effect and the like.
The occlusion device generally comprises an occlusion frame with a net structure and a flow blocking membrane fixed inside the occlusion frame by a suture. The treatment principle of the occluder is as follows: the occluder is delivered to the heart defect part of a patient through an interventional operation, the defect part is occluded after the occluder is released, tissues around the defect part grow inwards and cover, and endothelialization of the occluder is finally completed, so that the heart defect part is repaired.
The occlusion frame of conventional occluders is mostly made of shape memory alloys, for example, of nickel titanium alloy. When endothelialization is completed and the heart defect is repaired, the occluder implanted into the body can not be absorbed by human tissues and can only be permanently present at the defect part. As a result, long-term complications and adverse effects such as atrioventricular block, valve damage, residual shunting, heart abrasion, or metal ion allergy are easily generated.
After the occluder made of biodegradable high molecular polymer is implanted into a body for a period of time, the high molecular polymer is degraded and absorbed by the body, so that the adverse effect of the traditional occluder can be avoided. The high molecular polymer commonly used at present comprises polyamide, polyethylene, polypropylene, polylactic acid, polyglycolic acid, polycaprolactone and the like. However, these high molecular weight polymers have no or poor visibility under X-ray. For the smooth operation, the common solution at present is to add some marker structures on the occluder. However, in order to not increase the radial dimension of the occluding device after being stretched significantly, the size of the marking structure is usually small, and the marking structure is only arranged on a part of the occluding device, so that the overall shape and position of the occluding device are still difficult to judge in the implantation process, which may result in prolonged operation time, poor release position shape, and even failure of the operation, and may cause serious consequences.
Disclosure of Invention
Accordingly, there is a need for an occluder that can determine the overall shape.
An occluder comprises an occlusion frame which is of a net structure and a covering film, wherein the covering film completely covers the occlusion frame to form a bag-shaped structure with an opening.
In one embodiment, the plugging frame is woven from degradable woven filaments or cut from a degradable material, and the material of the covering membrane is a degradable polymer.
In one embodiment, the degradable polymer is at least one selected from the group consisting of poly-L-lactic acid, poly-dl-lactic acid, polyglycolic acid, poly-lactic-co-glycolic acid, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphoester, polyglycolic acid, polydioxanone, and polycarbonate.
In one embodiment, the coating further comprises an endothelialization promoting substance.
In one embodiment, the thickness of the coating is 10 to 50 μm.
In one embodiment, the coating film is provided with micropores, and the pore diameter of the micropores is 1-100 μm.
In one embodiment, the porosity of the coating is 0.1 to 15%.
In one embodiment, the cover film is an elastic film.
In one embodiment, the grid size of the plugging frame is in the range of 0.1mm2～16mm2。
In one embodiment, the plugging frame comprises a first plugging unit, a second plugging unit and a waist, two ends of the waist are respectively connected with the first plugging unit and the second plugging unit, and the first plugging unit, the second plugging unit and the waist are completely covered by the covering film.
In one embodiment, the plugging device further comprises a first sealing head and a second sealing head, the first sealing head is arranged on the first plugging unit, the second sealing head is arranged on the second plugging unit, the second sealing head is provided with a through hole, the coating film further covers the first sealing head and the second sealing head, and the coating film does not cover the through hole, so that the through hole forms the opening of the capsule structure.
A preparation method of the occluder comprises the following steps:
providing a plugging frame, wherein the plugging frame is of a net structure; and a process for the preparation of a coating,
and coating a covering film on the plugging frame so as to form a bag-shaped structure with an opening.
In one embodiment, the step of coating a film on the blocking frame to form a bag-like structure with an opening includes:
preparing a leaching solution, wherein the solute of the leaching solution is a material for forming the coating; and a process for the preparation of a coating,
immersing the plugging frame in the leaching solution, extracting the plugging frame from the leaching solution, and after drying, attaching the material for forming the coating film on the plugging frame to form a bag-shaped structure with an opening.
In one embodiment, in the step of immersing the plugging frame in the leachate, the time for immersing the plugging frame in the leachate is at least 5 seconds.
In one embodiment, in the step of withdrawing the plugging frame from the leach solution, the withdrawal speed of the plugging frame from the leach solution is 0.01 to 0.5 m/s.
In one embodiment, the solute of the leaching solution is a degradable polymer, and the concentration of the degradable polymer is greater than or equal to 1 mg/mL.
In one embodiment, after the step of immersing the plugging frame in the leachate and extracting the plugging frame from the leachate, the method further comprises a step of heat treatment, wherein the step of heat treatment comprises:
and (3) placing the plugging frame at the temperature of 45-110 ℃ and preserving heat for 5-60 min.
In one embodiment, the step of coating a film on the blocking frame to form a bag-like structure with an opening includes:
coating a covering film on the plugging frame, and forming a bag-shaped structure with an opening after hot melting; or, the covering film is fixed on the plugging frame by an adhesive method to form a bag-shaped structure with an opening.
A plugging system comprises the plugging device and a pushing device, wherein the pushing device comprises a conveying cable and a conveying conduit connected with the conveying cable, the conveying cable is detachably connected with the plugging device and is provided with an inner cavity, the conveying conduit is provided with a conveying cavity, and the inner cavity, the conveying cavity and the bag-shaped structure are communicated.
In one embodiment, the conveying cable is a hollow pipe formed by winding a plurality of metal wires, a sealing film is arranged on the conveying cable, and the sealing film is positioned on the inner wall of the conveying cable or is coated on the outer wall of the conveying cable.
The covering film of the occluder completely covers the occlusion frame to form a sac-shaped structure with an opening, and in implantation, a liquid contrast agent is injected into the sac-shaped structure through the opening of the sac-shaped structure, so that the whole sac-shaped structure is visible under an X-ray imaging device, and the whole shape of the occluder can be judged.
Drawings
FIG. 1 is a schematic diagram of an embodiment of an occlusion system;
FIG. 2 is a schematic view of the occluding device of the occluding system shown in FIG. 1;
figure 3 is a schematic view of another state of the occluding device shown in figure 2;
FIG. 4 is a schematic view of a pusher of the plugging system of FIG. 1;
FIG. 5 is a schematic cross-sectional view of a transfer cable of the pushing device shown in FIG. 4;
FIG. 6 is a schematic view of the occluding device and pushing device of the occluding system shown in FIG. 1;
fig. 7 to 8 are schematic views illustrating a process of injecting a liquid contrast medium into the occluder shown in fig. 1.
Detailed Description
In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.
Referring to fig. 1, an embodiment of an occluding system 1 comprises an occluding device 100 and a pushing device 200. The occluder 100 is connected to a pushing device 200, and the pushing device 200 is used to push the occluder 100 to the defect site.
Referring to fig. 2, the occluding device 100 comprises an occluding frame 110 and a covering membrane (not shown). The plugging frame 110 has a mesh structure woven from woven filaments. In one embodiment, the material of the woven wire is a biodegradable material. For example, the biodegradable material may be polylactic acid (PLA), poly-racemic lactic acid (PDLLA), poly-D-lactic acid (PDLA), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), poly-lactic-co-glycolic acid (PLGA), Polyhydroxyalkanoate (PHA), Polydioxanone (PDO), Polycaprolactone (PCL), or the like.
In another embodiment, the material of the braided wire may be a non-degradable metal, for example, the braided wire may be a nitinol wire, a cobalt-chromium alloy wire, a stainless steel wire, or the like.
In another embodiment, the occluding frame 110 may also be cut and shaped from a biodegradable material or a non-biodegradable material. For example, the degradable polymer tube is cut and shaped to form the plugging frame 110 with a net structure.
In an embodiment, the occlusion frame 110 includes a first occlusion cell 112, a second occlusion cell 114, and a waist 116. The two ends of the waist 116 are respectively connected with the first plugging unit 112 and the second plugging unit 114, so as to form a two-disc and one-waist structure with two large ends and a small middle. The first plugging unit 112, the second plugging unit 114 and the waist 116 are of an integral structure.
It is understood that in other embodiments, the structure of the occluding frame 110 is not limited to a two-disk one-waist structure with large ends and small middle. For example, the number of the plugging units in the plugging frame 110 is one, and in this case, the plugging units are connected to the waist to form a plugging frame having a substantially T-shaped cross section.
Referring to fig. 2 again, the plugging device 100 further includes a first sealing head 113 disposed on the first plugging unit 112 and a second sealing head 115 disposed on the second plugging unit 114. The first seal head 113 and the second seal head 115 are used for gathering and fixing the braided wires. In addition, a movable connection assembly (not shown in fig. 2) is disposed on the second sealing head 115, and the movable connection assembly is used for being movably connected with the pushing device 200 to load and fix the occluding device 100, and releasing the occluding device 100 after the occluding device 100 is delivered to the lesion. Specifically, a thread, a plurality of threads, and the like may be disposed on the second sealing head 115 to be movably connected with the pushing device 200. In one embodiment, the outer wall of the second end cap 115 is provided with external threads (not shown). The second end socket 115 is provided with a through hole 117.
Referring again to fig. 2, in one embodiment, the occluding device 100 further comprises a locking member 118, wherein the locking member 118 is a generally rod-shaped structure. One end of the locking member 118 is fixedly connected to the first end plate 113, and the other end is a free end. In the sheathed state of the occluding device 100 (the state in which the occluding device 100 is stretched), one end of the locking member 118 remote from the first sealing head 113 is in a suspended state. After the occluder 100 is implanted into the heart defect, the locking member 118 is pulled so that the free end of the locking member 118 passes through the through hole 117 of the second sealing head 115 and is connected with the second sealing head 115, thereby locking the first occluding unit 112 and the second occluding unit 114 of the occluder 100 so that the distance between the first occluding unit 112 and the second occluding unit 114 is constant, as shown in fig. 3. One end of the locking member 118 may be fixedly connected to the first sealing head 113 by a connection method known to those skilled in the art, such as fusion welding, biological glue adhesion, or mechanical clinching. The locking element 118 engages the second head 115 by interference fit, friction, or the like, such that the proximal end of the locking element 118 remains fixedly attached to the second head 115. In one embodiment, one of the second head 115 and the locking member 118 is resilient such that pulling the locking member 118 proximally allows the locking member 118 to pass through the through hole 117 in the second head 115 and remain relatively fixed with respect to the second head 115.
The coating is a continuous film structure, and the coating completely covers the blocking frame 110 to form a bag-shaped structure with an opening. In one embodiment, the covering membrane completely covers the first occluding unit 112, the second occluding unit 114 and the waist 116. In another embodiment, the coating film further covers the first sealing head 113 and the second sealing head 115, and the coating film does not cover the through hole 117 in the second sealing head 115, so that the through hole 117 forms an opening of a capsule-shaped structure. In the implantation, a liquid contrast agent is injected into the capsular structure through the opening of the capsular structure formed by the covering film, so that the whole capsular structure is visible under the X-ray influence equipment, and the whole form of the occluder 100 can be judged. It should be noted that, when the coating film further covers the second sealing head 115 and the second sealing head 115 is provided with the external thread, the coating film does not cover the external thread.
The coating has a plurality of pores, so that the coating has a pore structure, and the liquid contrast agent slowly seeps out of the saccular structure after the implantation is completed. It should be noted that the pore size of the micropores and the number of micropores should ensure that during the implantation procedure, the liquid contrast agent can accumulate in the sac-like structure to make the occluding device 100 visible under the X-ray imaging equipment. Also, after the procedure is completed, the liquid contrast agent can permeate out of the capsular structure.
In one embodiment, the pores in the coating have a diameter of 1 to 100 μm. In this way, after the liquid contrast agent is injected into the capsular structure, the liquid contrast agent is prevented from flowing out of the capsular structure relatively quickly, which makes it difficult to achieve the effect of making the occluder 100 visible under an X-ray imaging device.
In one embodiment, the porosity of the coating is 0.1-15% to avoid the liquid contrast agent flowing from the sac-like structure faster and making it difficult to visualize the occluding device 100 under the X-ray imaging equipment after injecting the liquid contrast agent into the sac-like structure. The porosity is a percentage of the total volume of micropores of the coating film to the total volume of the coating film, wherein micropores refer to through holes.
In one embodiment, the pores in the coating have a pore diameter of 10 to 50 μm and a porosity of 0.1 to 5%. Therefore, on one hand, the liquid contrast agent can be ensured to be accumulated in the saccular structure formed by the covering film, so that the whole occluder 100 has enough radiopacity under an X-ray imaging device to obtain a clearer image, and the smooth implementation of the implantation, the good release form of the occluder 100 and the good fit of the occluder 100 and the defect part can be ensured; on the other hand, after the implantation is completed, the liquid contrast agent can slowly seep out of the sac-shaped structure, so that the liquid contrast agent can be prevented from flowing out of the sac-shaped structure in a short time in a large quantity, and the local concentration of the liquid contrast agent in blood is prevented from being too high to generate adverse effects on organisms; on the other hand, the internal pressure and the external pressure of the capsular structure can be well balanced, and the phenomenon that the capsular structure is broken due to overlarge internal pressure of the capsular structure, so that the visual effect of the occluder 100 under an X-ray imaging device is difficult to achieve is avoided.
In one embodiment, the thickness of the coating is 10 to 50 μm, on one hand, the difficulty in delivery and release due to too large sheathing resistance of the occluder 100 caused by too large thickness of the coating is avoided, or the increase of the size of the delivery sheath is avoided, so that the occluder 100 is limited to be applied to patients with thick blood vessels, namely, the application range of the occluder 100 is prevented from being limited; on the other hand, the phenomenon that the effective accumulation of the liquid contrast agent cannot be realized and the operation is difficult to smoothly carry out due to the fact that the capsular structure is broken due to the damage of the coating when the coating is too small in thickness and is scraped and rubbed in the conveying process and the releasing process is avoided.
In one embodiment, the mesh size of the occlusion frame 110 ranges from 0.1mm2～16mm2On the one hand, the plugging frame 110 has sufficient supporting performance and can resist the impact of blood flow without deformation, so as to ensure real-time and continuous plugging performance; on the other hand, the sheathing resistance of the occluding device 100 is ensured to be within an acceptable range, the delivery and the release of the occluding device 100 are not influenced, and the size of a delivery sheath is not increased remarkably; on the other hand, the plugging frame 110 with the size of the grid can better support the covering film, so that the covering film is not easy to break. It should be noted that the mesh size of the plugging frame 110 is uniform or non-uniform. 0.1mm when the mesh size of the occluding frame 110 is non-uniform2～16mm2Means that the mean value of the grid size of the plugging frame 110 is 0.1mm2～16mm2。
In one embodiment, the material of the covering membrane is a degradable polymer. In one embodiment, the degradable polymer is at least one selected from the group consisting of poly-L-lactic acid, poly-dl-lactic acid, polyglycolic acid, poly-lactic-co-glycolic acid, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphoester, polyglycolic acid, polydioxanone, and polycarbonate.
In another embodiment, the material of the covering film may also be a non-degradable polymer, for example, polyethylene terephthalate (PET) or polybutylene terephthalate (PBT) or the like.
In one embodiment, the cover film is an elastic film. For example, the covering film is made of an elastic material used for medical balloons. Specifically, the material of the cover film is thermoplastic polyurethane elastomer rubber (TPU). When the coating film is an elastic film, the coating film may be a single layer or a double layer. When the coating is a single layer, in one embodiment, the coating is located inside the sealing frame 110, i.e., the coating covers the inner wall of the sealing frame 110. In another embodiment, the coating is located outside the plugging frame 110, i.e. the coating covers the outer wall of the plugging frame 110. When the coating film is a double layer, one layer of the coating film is located outside the sealing frame 110, and one layer of the coating film is located inside the sealing frame 110.
In one embodiment, the covering membrane further comprises an endothelialization promoting substance, wherein the endothelialization promoting substance is dispersed in the degradable polymer and releases the endothelialization promoting substance along with the degradation of the degradable polymer, so that a long-acting and continuous endothelialization promoting effect is achieved, endothelial cells are promoted to quickly climb on the plugging device 100, and the formation of thrombus is avoided.
In one embodiment, the endothelialization promoting substance is selected from at least one of phospholipids, growth factors, proteins, polypeptides, and quaternary ammonium salts. Specifically, the phospholipid is at least one selected from lecithin, phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine and phosphatidylinositol. The growth factor is at least one selected from Epidermal Growth Factor (EGF), Fibroblast Growth Factor (FGF) and platelet derived factor (PDGF). The protein is laminin or fibronectin. The polypeptide is at least one selected from the group consisting of tyrosine-isoleucine-glycine-serine-arginine pentapeptide (YIGSR), loop (arginine-glycine-aspartic acid-tyrosine-lysine) (Tyr-RGD), and a polypeptide comprising an arginine-glycine-aspartic acid (RGD) sequence. Wherein the polypeptide containing arginine-glycine-aspartic acid (RGD) sequence may be arginine-glycine-aspartic acid (RGD) polypeptide, arginine-glycine-aspartic acid-serine (RGDS) polypeptide, etc. The endothelialization promoting substance has a good endothelialization promoting effect, is beneficial to endothelium to quickly climb on the plugging frame 110, and effectively avoids thrombosis.
Referring to fig. 4, the pushing device 200 includes a conveying cable 210 and a conveying conduit 220 connected to the conveying cable 210. Specifically, the conveying cable 210 has openings on a side wall thereof, the conveying duct 220 has openings at both ends thereof, the conveying duct 220 is connected to the side wall of the conveying cable 210, and one opening of the conveying duct 220 is opposite to the opening on the side wall.
The delivery cable 210 is removably connected to the occluding device 100 so as to be capable of being disconnected from the occluding device 100 after the occluding device 100 is delivered to the heart defect site. The transfer cable 210 has an inner lumen. Delivery catheter 220 is used to inject a liquid contrast agent. The delivery catheter 220 has a delivery lumen. When the occluding device 100 is connected with the delivery cable 210, the saccular structure formed by the covering membrane of the occluding device 100 on the occluding frame 110, the inner cavity of the delivery cable 210 and the delivery cavity of the delivery catheter 220 are communicated.
In one embodiment, the pushing device 200 further includes a three-way valve 230, the three-way valve 230 is disposed on the conveying conduit 220, and the three-way valve 230 is located at an end of the conveying conduit 220 far from the conveying cable 210. By adjusting the three-way valve 230, the opening of the delivery conduit 220 away from the delivery cable 210 is closed or opened.
In one embodiment, the distal end of the delivery cable 210 that is removably attached to the occluding device 100 is provided with internal threads (not shown) that mate with external threads on the second closure head 115 to removably attach the delivery cable 210 to the occluding device 100. In one embodiment, the transfer cable 210 includes a transfer body 212 and a locking sleeve 214 coupled to a distal end of the transfer body 212. The delivery body 212 is a hollow tube, the locking sleeve 214 is also a hollow structure, the locking sleeve 214 is fixedly connected to the distal end of the delivery body 212, and the locking sleeve 214 is communicated with the delivery body 212. The locking sleeve 214 may be fixedly attached to the delivery body 212 by welding or gluing, for example. The inner wall of the lock sleeve 214 is provided with internal threads which are matched with the external threads on the second end socket 115, so that the conveying cable 210 can be detachably connected with the plugging device 100. Referring to fig. 5, in one embodiment, the delivery body 212 is a hollow tube having a generally circular cross-section formed by winding and sizing a plurality of stainless steel wires 213. The lock sleeve 214 is made of a material that is well visible under X-ray imaging equipment, such as stainless steel or nitinol. In one embodiment, a sealing membrane 215 is disposed on the inner wall of the delivery body 212, and the sealing membrane 215 can improve the sealing performance of the delivery cable 210 and prevent the liquid contrast agent from leaking out during delivery. In another embodiment, the sealing membrane 215 covers the outer wall of the delivery body 212, so that the liquid contrast agent is prevented from leaking out during delivery and the processing is convenient. The sealing film 215 is a Polytetrafluoroethylene (PTFE) film, a polyethylene terephthalate (PET) film, a polyethylene (PP) film, a Polypropylene (PE) film, or the like.
Referring to fig. 4 again, the pushing device 200 further includes a handle 240 and a hemostasis valve 250, wherein the handle 240 is provided with a first operation member 241, a second operation member 242 and a third operation member 243. The end of delivery body 212 opposite locking sleeve 214, i.e., the proximal end of delivery body 212, is fixedly attached to handle 240. The delivery cable 210 is rotated by integrally rotating the handle 240, so that the internal thread on the lock sleeve 214 is separated from the external thread on the second sealing head 115, and the occlusion device 100 is released from the pushing device 200. In one embodiment, the delivery body 212 of the delivery cable 210 is rotatably coupled to the handle 240 by a coupling member 260, one end of the coupling member 260 being coupled to the proximal end of the delivery body 212 and the other end being coupled to the distal end of the handle 240. The hemostasis valve 250 is disposed between the connector 260 and the handle 240. The connector 260 is provided to securely connect the delivery cable 210 to the handle 240 to ensure smooth implantation. In the implantation, the hemostatic valve 250 can ensure that the liquid contrast agent and blood do not flow out, thereby further ensuring the implantation to be performed smoothly. After the delivery of the occluding device 100 to the site of the heart defect, the release of the occluding device 100 is accomplished by operating the first operating member 241, the second operating member 242 and the third operating member 243 of the handle 240.
In one embodiment, the pushing device 200 further comprises a control wire 270, the control wire 270 is disposed through the conveying cable 210, a proximal end of the control wire 270 extends into the handle 240 and is connected to the first operating member 241 and the third operating member 243, and a distal end of the control wire 270 is detachably connected to an end of the locking member 118 of the occluder 100 away from the first sealing head 113. The control wire 270 includes a filamentous body 272 and a locking head 274 disposed at a distal end of the filamentous body 272. The filamentous body 272 is a solid filamentous structure, and the locking head 274 is fixedly connected to the filamentous body 272 by welding or gluing, which is known to those skilled in the art. The cross-sectional dimension of the filamentary body 272 decreases from the proximal end to the distal end to provide the filamentary body 272 with better flexibility and delivery characteristics. The filamentous body 272 and the locking head 274 are made of a material with good visibility under an X-ray imaging device, such as stainless steel, nitinol, or a high molecular polymer material. The cross-sectional dimension of the filamentary body 272 is less than the inner diameter of the delivery cable 210 so that there is sufficient clearance between the filamentary body 272 and the inner wall of the delivery cable 210.
The control wire 270 is removably connected to the locking member 118 of the occluding device 100 by a locking head 274. In one embodiment, the control wire 270 is advanced and retracted by operation of the first operating member 241 and the control wire 270 is rotated by operation of the second operating member 243 to disengage the control wire 270 from the locking member 118. The first operation element 241 is restricted by the second operation element 242, and erroneous operation is prevented.
Referring to fig. 6, the locking head 274 of the control wire 270 is detachably connected to the end of the locking member 118 away from the first sealing head 113, and the locking sleeve 214 of the conveying cable 210 is detachably connected to the second sealing head 115, so that the occluder 100 is detachably connected to the pushing device 200. In the delivery state, the occluder 100 is stretched and loaded in the delivery sheath, the control wire 270 and the delivery cable 210 are both contained in the delivery sheath, the locking head 274 of the control wire 270 is connected to the end of the locking member 118 away from the first closure head 113, and the locking sleeve 214 of the delivery cable 210 is connected to the second closure head 115. The locking member 118 is located inside the balloon-like structure, the filamentous body 272 of the control wire 270 passes through the second head 115, and the cross-sectional size of the filamentous body 272 is smaller than the aperture of the through hole 117, so that there is a gap between the filamentous body 272 and the inner wall of the second head 115. During delivery, delivery catheter 220 is always positioned externally to facilitate injection of the liquid contrast agent. The delivery catheter 220, the delivery cable 210, the second head 115 and the capsule-shaped structure formed by the covering film are in a communicated state.
The far end of the conveying sheath tube is provided with a marking structure which can be seen under the X-ray image equipment. For example, the marker structure may be a metal ring embedded in the inner wall of the delivery sheath. Since the control wire 270 and the delivery cable 210 are made of materials with better visibility under the X-ray imaging equipment, the position of the occluding device 100 can be indirectly judged through the marking structure of the delivery sheath, the control wire 270 and the delivery cable 210. After the occluder 100 is delivered to the heart defect site through the delivery sheath, the occluder 100 is pushed out of the delivery sheath by the pushing device 200, and after the occluder 100 comes out of the delivery sheath, the control wire 270 and the delivery cable 210 are both connected with the occluder 100, as shown in fig. 6.
Referring to fig. 7, further, the hemostasis valve 250 is locked, the three-way valve 230 is adjusted, and the liquid contrast medium is injected from the delivery catheter 220, and the liquid contrast medium 300 enters the interior of the occluder 100 through the delivery catheter 220, the connecting member 260, the delivery cable 210 and the second sealing head 115 in sequence (the arrow in fig. 7 indicates the flow direction of the liquid contrast medium 300). Due to the flow-blocking effect of the coating, the liquid contrast agent 300 will remain mostly within the capsular structure of the occluding device 100 within a short period of time, as shown in figure 8. In this manner, the action of the liquid contrast agent 300 allows the occluding device 100 to be entirely visible under radiation. Since the occluding device 100 is still connected with the pushing device 200, when the position of the occluding device 100 is not accurate enough, the position of the occluding device 100 can be adjusted by moving the handle 240 as a whole. In order to ensure that the occluding device 100 is clearly visible, if the operation time is too long, when the liquid contrast medium in the capsular structure can continuously seep out to cause poor visibility of the entire occluding device 100, the liquid contrast medium can be continuously replenished from the delivery catheter 220.
After the occluder 100 is in the correct position, the first operating part 241 on the handle 240 is operated, and the control wire 270 is withdrawn to drive the locking member 118 to pass through the through hole 117 and be fixedly connected with the second sealing head 115, so as to complete the locking. At the same time, the through-hole 117 is closed by the proximal end of the locking member 118, so that the capsular structure formed by the covering film is closed. Then, the third operating member 243 on the handle 240 is operated to rotate the control wire 270, so that the locking head 274 and the locking member 118 are disengaged, and then the entire handle 240 is rotated, so that the locking sleeve 214 and the second sealing head 115 of the occluder 100 are disengaged, and finally the entire pushing device 200 is withdrawn. The liquid contrast agent 300 inside the capsular structure of the occluding device 100 slowly permeates into the blood through the micropores in the cover membrane.
The covering film of the occluding device 100 of the occluding system 1 completely covers the occluding frame 110 to form a sac-like structure with an opening, and in the implantation, the liquid contrast agent is injected into the sac-like structure through the opening of the sac-like structure, so that the whole sac-like structure is visible under the X-ray imaging equipment, and the whole shape of the occluding device 100 can be judged. Therefore, the above-mentioned occlusion system 1 can accurately position the occluding device 100, so that the occluding device 100 can accurately occlude the defective portion of the heart, thereby improving the therapeutic effect.
Moreover, since the coating film is a continuous film structure, the coating film itself has a flow blocking effect, and the occluder 100 does not contain a flow blocking film, i.e., no flow blocking film is additionally provided inside the occlusion frame 110 of the occluder 100. Therefore, on one hand, in the preparation process, the step of sewing the flow resisting film on the blocking frame 110 by using a sewing line can be omitted, so that the preparation efficiency is improved; on the other hand, the phenomenon that after the implantation, when the flow resisting film is impacted by blood flow and bears tension, the suture thread cuts the flow resisting film to cause the tearing and even the falling of the flow resisting film, so that the blood flow is difficult to be blocked is avoided; on the other hand, the flow blocking film is fixed on the plugging frame 110 by sewing, and is sewn with the plugging frame 110 by limited stitches of the sewing thread, after the plugging device 100 is released, gaps exist at the edge of the flow blocking film, which can reduce the real-time plugging performance of the plugging device 100, and the plugging frame 110 is completely coated by a film, so that the defects can be avoided, and the good real-time plugging performance is achieved; on the other hand, the blocking membrane is sewn to the blocking frame 110 by sewing, and when the occluder 100 is stretched to be loaded in a delivery sheath, the blocking membrane is likely to be piled up into a mass, which results in a large sheath-entering resistance of the occluder 100 and may damage the blocking membrane. At the same time, the required size of the delivery sheath increases accordingly, making it difficult to adapt to individuals with thinner blood vessels. The defects can be avoided by completely coating the plugging frame 110, and the requirement on the size of the sheath tube is low.
It is understood that the liquid contrast agent is a liquid contrast agent commonly used in the medical field, including but not limited to compound meglumine diatrizoate injection, meglumine iodide 370, meglumine iodide 350, iopamidol, and the like.
Further, a preparation method of the plugging device is provided, which comprises the following steps:
step 110: an occlusion frame is provided.
The plugging frame is a net structure woven by weaving wires. Two free ends of the braided wire of the plugging frame are fixed by a first sealing head and a second sealing head respectively.
Step 120: and coating a covering film on the plugging frame so as to form a bag-shaped structure with an opening.
In one embodiment, a coating for coating the plugging frame is formed by an immersion method. Firstly, preparing a leaching solution, wherein the solute of the leaching solution is a material for forming a coating. In one embodiment, the solute of the leaching solution is a degradable polymer. Dissolving the degradable polymer in a solvent to obtain a leaching solution.
And (3) soaking the whole plugging frame in the leaching liquor for a certain time, slowly lifting the plugging frame out of the leaching liquor, wherein the leaching liquor forms a liquid film to cover the plugging frame due to surface tension. After the solvent is volatilized, the degradable polymer is separated out and deposited on the plugging frame so as to form a coating film coated on the plugging frame and form a bag-shaped structure with one open end. At this time, the coating film was a continuous and dense thin film. In one embodiment, the concentration of the leaching solution is greater than 1mg/mL to ensure that a continuous film is formed and the film is not easily broken.
In one embodiment, the plugging frame is immersed in the leach solution and retained for at least 5 seconds(s) such that the leaching solution substantially infiltrates the plugging frame, and then slowly lifted to extract the plugging frame from the leach solution at a lifting speed of 0.01 to 0.5 meters per second (m/s).
In one embodiment, after immersing the entire plugging frame in the leaching solution for a certain time, the step of slowly extracting the plugging frame from the leaching solution is repeated a plurality of times, i.e., a plurality of times of immersing and extracting, to obtain a continuous thin film having a certain thickness. When the above-mentioned process is repeated after the first leaching operation and the second or later leaching operation, the soaking time is short, and is not preferably more than 5 seconds. This is because the solvent in the leaching solution will re-dissolve at least part of the degradable polymer precipitated for the first time when the operation is repeated. The lifting speed is also required to be fast when the operation is repeated, and is preferably 0.05-1 meter per second (m/s).
In one embodiment, after the primary leaching operation, the leaching solution is sprayed on the coating film by a spraying method in order to improve the continuity of the coating film.
In order to make the film have a pore structure, micropores are formed by piercing the surface of the film using an extremely fine micro-piercing needle. The size of the micro puncture needle is matched with the size of the micropore to be formed.
In one embodiment, the solute of the leaching solution is at least two degradable polymers with different solubility properties. Dissolving at least two degradable polymers with different solubility in a solvent to obtain a leaching solution.
And (3) soaking the whole plugging frame in the leaching liquor for a certain time, slowly lifting the plugging frame out of the leaching liquor, wherein the leaching liquor forms a liquid film to cover the plugging frame due to surface tension. After the solvent is volatilized, the degradable polymer is separated out and deposited on the plugging frame so as to form a coating film coated on the plugging frame and form a bag-shaped structure with one open end. At this time, the coating film is a continuous and dense thin film, and in order to make the coating film have a pore structure, the coating film is dissolved in another solvent so that one degradable polymer is at least partially dissolved and the other degradable polymer is not dissolved. One of the degradable polymers at least partially dissolves such that the coating becomes a porous structure.
It should be noted that, one degradable polymer is at least partially dissolved and the other degradable polymer is not dissolved, it is not necessarily required that the other degradable polymer is completely insoluble in the solvent, but it means that the solubility of the two degradable polymers is different greatly from the same solvent; or one degradable polymer has a higher dissolution speed in the solvent and the other degradable polymer has a lower dissolution speed, so that one degradable polymer can be quickly dissolved in the solvent and the other degradable polymer is slightly dissolved in the solvent within the contact time of the film and the solvent, and the continuity or integrity of the film cannot be damaged.
It can be understood that when the plugging frame, the first end socket and the second end socket need to be coated by the coating film, the plugging frame, the first end socket and the second end socket are wholly immersed in the leaching solution together, and then the leaching solution is slowly extracted. When the formed coating covers the through hole of the second sealing head, the portion of the coating covering the through hole needs to be cut off to make the through hole smooth.
In one embodiment, a coating for coating the plugging frame is formed by electrospinning.
In one embodiment, the coating film further contains an endothelialization-promoting substance, and the leaching solution contains an endothelialization-promoting substance, or the stock solution for electrospinning contains an endothelialization-promoting substance.
In one embodiment, the method further includes a step of heat treatment after the formation of the porous coating film. In one embodiment, the heat treatment step includes maintaining the temperature of the plugging frame coated with the coating at 45-110 ℃ for 5-60 min to improve the crystallization property of the degradable polymer, which is beneficial to improving the reliability of the coating attached to the plugging frame.
In one embodiment, when the covering film is an elastic film, the elastic film is covered on the blocking frame by using an existing elastic film to form a bag-shaped structure with an opening. In one embodiment, a sheet of TPU film is wrapped around the outside of the occluding frame and heat fused to form a bladder-like structure with an opening. In one embodiment, the woven wire is woven into a mesh pipe structure, then two layers of TPU films are respectively coated on the inner wall and the outer wall of the mesh pipe structure, after hot melting and sizing, a plugging frame coated by the two layers of TPU films is formed, and the plugging frame coated by the two layers of TPU films forms a bag-shaped structure with an opening. The temperature of hot melting is 150-250 ℃.
In another embodiment, whether the elastic membrane is a single layer or two layers, the elastic membrane can be adhesively secured to the occlusion frame to form a bladder-like structure having an opening.
The preparation method of the occluder is simple in process, and the occluder prepared by the method has good visibility under X-ray imaging equipment.
In addition, the preparation method of the stopper forms a coating film on the blocking frame by a leaching, spraying or electrostatic spinning method, avoids the mode that the traditional stopper adopts a suture method to fix the flow resisting film inside the blocking frame, and has high preparation efficiency.
The stopper and the method for manufacturing the stopper are further described below by specific examples.
The following examples were all examined for the thickness and porosity of the coating film using a Scanning Electron Microscope (SEM). The porosity testing method comprises the following steps: the total sum of the areas occupied by the openings of the micropores on the surface of the coating film S1 and the surface area of the coating film S2 (S1/S2) × 100% were calculated and regarded as the porosity.
Example 1
Using a group of 20 parallel poly-L-lactic acid (PLLA) braided filaments with the filament diameter of 0.40mm as longitudinal braided filaments and a group of 20 parallel poly-L-lactic acid (PLLA) braided filaments with the filament diameter of 0.40mm as latitudinal braided filaments to be vertically and alternately braided, fixing two free ends of the braided filaments by using a first sealing head and a second sealing head so as to form a braided net, carrying out heat setting on the braided net to form a plugging frame, wherein the plugging frame comprises a first plugging unit, a second plugging unit and waists respectively connected with the first plugging unit and the second plugging unit, the first sealing head is positioned on the first plugging unit, the second sealing head is positioned on the second plugging unit, and the mesh size of the plugging frame is 10mm2。
Dissolving poly-dl-lactic acid (PDLLA) in acetonitrile to prepare a leaching solution with the concentration of 30mg/mL, soaking the plugging frame, the first end socket and the second end socket in the leaching solution for 10s, extracting the plugging frame from the leaching solution at the speed of 0.5m/s, depositing poly-dl-lactic acid on the plugging frame, drying to form a coating film coating the plugging frame, the first end socket and the second end socket, wherein the coating film is not coated with through holes on the second end socket so as to form a bag-shaped structure with an opening. Then, a micropenetrating needle having a diameter of 100 μm was randomly used to pierce the film to form a plurality of through-holes having a diameter of 100. mu.m. The porosity of the coating film was measured by Scanning Electron Microscopy (SEM) to be 0.5%. The thickness of the coating was 50 microns. Further, the plugging frame coated by the coating film is subjected to heat treatment at 70 ℃ for 5min to obtain the plugging device.
Example 2
One group comprises a filament diameter 030 parallel poly-L-lactic acid (PLLA) braided filaments of 10mm as longitudinal braided filaments and a group of 30 parallel poly-L-lactic acid (PLLA) braided filaments of 0.10mm filament diameter as latitudinal braided filaments are braided in an up-and-down staggered manner, two free ends of the braided filaments are fixed by a first sealing head and a second sealing head so as to form a braided net, the braided net is subjected to heat setting to form a plugging frame, the plugging frame comprises a first plugging unit, a second plugging unit and waists respectively connected with the first plugging unit and the second plugging unit, the first sealing head is positioned on the first plugging unit, the second sealing head is positioned on the second plugging unit, and the size of meshes of the plugging frame is 16mm2。
Dissolving poly-racemic lactic acid (PDLLA) in acetone to prepare a saturated poly-racemic lactic acid solution, and dissolving phosphatidylcholine in ethanol to prepare a saturated phosphatidylcholine solution; mixing a poly-dl-lactic acid solution and a phosphatidylcholine solution according to a volume ratio of 9:1 to obtain a leaching solution, soaking the plugging frame, the first end socket and the second end socket in the leaching solution for 1min, extracting the plugging frame from the leaching solution at a speed of 0.1m/s, depositing poly-dl-lactic acid and phosphatidylcholine on the plugging frame, drying to form a coating film for coating the plugging frame, the first end socket and the second end socket, wherein the coating film does not coat through holes on the second end socket so as to form a capsule structure with an opening. Then, a micro-puncture needle having a diameter of 50 μm was randomly punctured into the cover film to form a plurality of through-holes having a diameter of 50 μm in the cover film. The porosity of the coating film was measured by Scanning Electron Microscopy (SEM) to be 5%. The thickness of the coating was 40 microns. Further, the plugging frame coated by the coating film is subjected to heat treatment at 60 ℃ for 30min to obtain the plugging device.
Example 3
A group of nickel-titanium alloy braided wires which are arranged in parallel and have the wire diameter of 30 wires and the wire diameter of 0.05mm are used as longitude braided wires and a group of nickel-titanium alloy braided wires which are arranged in parallel and have the wire diameter of 30 wires and the wire diameter of 0.05mm are used as latitude braided wires to be braided in an up-and-down staggered manner, two free ends of the braided wires are fixed by a first sealing head and a second sealing head, so that a braided net is formed, the braided net is subjected to heat setting to form a plugging frame, and the plugging frame comprises a first plugging unit and a second plugging unitAnd the waist part is respectively connected with the first plugging unit and the second plugging unit, the first sealing head is positioned on the first plugging unit, the second sealing head is positioned on the second plugging unit, and the grid size of the plugging frame is 8mm2。
Dissolving poly-dl-lactic acid (PDLLA) and Polyhydroxyalkanoate (PHA) in chloroform to prepare a leaching solution with the concentration of poly-dl-lactic acid of 10mg/mL and the concentration of polyhydroxyalkanoate of 10mg/mL, immersing the plugging frame, the first end enclosure and the second end enclosure in the leaching solution, extracting the plugging frame from the leaching solution at the speed of 0.05m/s after immersing for 1min, depositing poly-dl-lactic acid and polyhydroxyalkanoate on the plugging frame, and repeating the leaching step for 2 times in order to maintain continuity of a film, wherein in the repeating step, the whole plugging frame, the first end enclosure and the second end enclosure are immersed in the leaching solution continuously for 2s, and then are quickly lifted at the speed of 0.2m/s, and the next time is repeated after full drying is needed each time. And after drying, forming a coating film for coating the plugging frame, the first seal head and the second seal head, wherein the coating film does not coat the through hole on the second seal head so as to form a bag-shaped structure with an opening. Further, when the film was immersed in acetone for 5 seconds, PDLLA dissolved but PHA did not dissolve, thereby forming micropores in the film, and the pore diameter of the micropores was 2 μm and the porosity of the film was 1% as measured by Scanning Electron Microscopy (SEM). The thickness of the coating was 50 microns. Further, the plugging frame coated by the coating film is subjected to heat treatment at 45 ℃ for 15min to obtain the plugging device.
Example 4
A group of polyethylene terephthalate (PET) which is arranged in parallel and comprises 20 filaments with the diameter of 0.05mm is taken as a longitude knitting filament, a group of polyethylene terephthalate (PET) which is arranged in parallel and comprises 20 filaments with the diameter of 0.05mm is taken as a latitude knitting filament, the polyethylene terephthalate (PET) is woven in a vertically staggered mode, two free ends of the knitting filament are fixed by a first sealing head and a second sealing head, a knitting net is formed, the knitting net is subjected to heat setting to form a plugging frame, the plugging frame comprises a first plugging unit, a second plugging unit and waists which are respectively connected with the first plugging unit and the second plugging unit, the first sealing head is positioned on the first plugging unit, the second sealing head is positioned on the second plugging unit, and the plugging frame is provided with a first plugging unit and a second plugging unitThe size of the grid is 0.1mm2。
Dissolving Polyhydroxybutyrate (PHB) in chloroform to prepare a leaching solution with the concentration of 1mg/mL, soaking the plugging frame, the first end socket and the second end socket in the leaching solution for 1min, extracting the plugging frame from the leaching solution at the speed of 0.1m/s, depositing polyhydroxybutyrate on the plugging frame, drying to form a coating film for coating the plugging frame, the first end socket and the second end socket, wherein the coating film is not coated with through holes on the second end socket so as to form a capsule-shaped structure with an opening. Then, a micropenetrating needle having a diameter of 100 μm was randomly used to pierce the film to form a plurality of through-holes having a diameter of 100. mu.m. The porosity of the coating film was measured by Scanning Electron Microscopy (SEM) to be 15%. The thickness of the coating was 10 microns. Further, the plugging frame coated by the coating film is subjected to heat treatment at 45 ℃ for 15min to obtain the plugging device.
Example 5
Using a group of 30 parallelly arranged poly-L-lactic acid (PLLA) braided filaments with the filament diameter of 0.10mm as longitude braided filaments and a group of 30 parallelly arranged poly-L-lactic acid (PLLA) braided filaments with the filament diameter of 0.10mm as latitude braided filaments to be vertically staggered and braided, fixing two free ends of the braided filaments by using a first sealing head and a second sealing head so as to form a braided net, carrying out heat setting on the braided net to form a plugging frame, wherein the plugging frame comprises a first plugging unit, a second plugging unit and waists respectively connecting the first plugging unit and the second plugging unit, the first sealing head is positioned on the first plugging unit, the second sealing head is positioned on the second plugging unit, and the mesh size of the plugging frame is 12mm2。
Firstly, slightly stretching the plugging frame tube to ensure that the first plugging unit and the second plugging unit do not shield the waist and are grounded; then adding a polyethylene terephthalate (PET) raw material into a hopper, heating and melting the PET raw material, and conveying the PET raw material to a nozzle under the action of self weight and an air compressor; under the action of a high-voltage positive power supply connected with a nozzle, the polymer melt is stretched into filaments and deposited on the grounded plugging frame, the first end socket and the second end socket to form a coating film for coating the plugging frame, the first end socket and the second end socket, so that a bag-shaped structure with an opening is formed. The pore size of the micropores of the film was 1 μm, the porosity of the film was 3%, and the thickness was 40 μm.
Example 6
A group of polyethylene terephthalate knitting yarns which are arranged in parallel and have the yarn diameter of 14 filaments and the yarn diameter of 0.30mm are used as longitude knitting yarns, a group of polyethylene terephthalate knitting yarns which are arranged in parallel and have the yarn diameter of 14 filaments and the yarn diameter of 0.30mm are used as latitude knitting yarns, the polyethylene terephthalate knitting yarns are woven in a vertically staggered mode, two free ends of the knitting yarns are fixed by a first sealing head and a second sealing head, a knitting net is formed, the knitting net is subjected to heat setting to form a plugging frame, the plugging frame comprises a first plugging unit, a second plugging unit and waists respectively connected with the first plugging unit and the second plugging unit, the first sealing head is positioned on the first plugging unit, the second sealing head is positioned on the second plugging unit, and the size of each grid of the plugging frame is 5mm2。
Dissolving Polyhydroxybutyrate (PHB) in chloroform to prepare a leaching solution with the concentration of 1mg/mL, soaking the plugging frame, the first end socket and the second end socket in the leaching solution for 30s, extracting the plugging frame from the leaching solution at the speed of 0.1m/s, depositing polyhydroxybutyrate on the plugging frame, drying to form a coating film for coating the plugging frame, the first end socket and the second end socket, wherein the coating film is not coated with through holes on the second end socket so as to form a capsule-shaped structure with an opening. Then, a micro-puncture needle having a diameter of 10 μm was randomly punctured into the cover film to form a plurality of through-holes having a diameter of 10 μm in the cover film. The porosity of the coating film was measured by Scanning Electron Microscopy (SEM) to be 10%. The thickness of the coating was 10 microns. Further, the plugging frame coated by the coating film is subjected to heat treatment at 50 ℃ for 10min to obtain the plugging device.
Example 7
A group of nickel-titanium alloy braided wires which are arranged in parallel and have the diameter of 50 wires and 0.05mm are used as longitude braided wires and a group of nickel-titanium alloy braided wires which are arranged in parallel and have the diameter of 50 wires and have the diameter of 0.05mm are used as latitude braided wires and are braided in a vertically staggered manner, two free ends of the braided wires are fixed by a first end socket and a second end socket, so that a braided net is formed, and the braided net is subjected to heat settingForming a plugging frame, wherein the plugging frame comprises a first plugging unit, a second plugging unit and a waist part respectively connected with the first plugging unit and the second plugging unit, a first seal head is positioned on the first plugging unit, a second seal head is positioned on the second plugging unit, and the size of a grid of the plugging frame is 10mm2。
Dissolving poly-L-lactic acid in chloroform to prepare a leaching solution with the concentration of 20mg/mL, soaking the plugging frame, the first end enclosure and the second end enclosure in the leaching solution for 45s, then extracting the plugging frame from the leaching solution at the speed of 0.01m/s, depositing the poly-L-lactic acid on the plugging frame, drying to form a coating film for coating the plugging frame, the first end enclosure and the second end enclosure, wherein the coating film does not coat through holes on the second end enclosure, thereby forming a bag-shaped structure with an opening. Then, a micro-puncture needle having a diameter of 50 μm was randomly punctured into the cover film to form a plurality of through-holes having a diameter of 50 μm in the cover film. The porosity of the coating film was measured by Scanning Electron Microscopy (SEM) to be 0.1%. The thickness of the coating was 40 microns. Further, the plugging frame coated by the coating film is subjected to heat treatment at 110 ℃ for 5min to obtain the plugging device.
Example 8
The nickel-titanium alloy is cut and shaped to form a plugging frame, the plugging frame comprises a first plugging unit, a second plugging unit, a waist part, a first seal head and a second seal head, the waist part is connected with the first plugging unit and the second plugging unit respectively, the first seal head is located on the first plugging unit, and the second seal head is located on the second plugging unit. The grid size of the plugging frame is 16mm2。
Dissolving poly-dl-lactic acid (PDLLA) in acetonitrile to prepare a leaching solution with the concentration of 30mg/mL, soaking the plugging frame, the first end socket and the second end socket in the leaching solution for 15s, extracting the plugging frame from the leaching solution at the speed of 0.2m/s, depositing polyhydroxybutyrate on the plugging frame, further spraying the leaching solution on the plugging frame by adopting a spraying method, drying to form a coating film for coating the plugging frame, and forming a capsule-shaped structure with an opening by not coating through holes on the second end socket with the coating film. Then, a micro-puncture needle having a diameter of 10 μm was randomly punctured into the film to form a plurality of through-holes having a diameter of 1 μm in the film. The porosity of the coating film was measured by Scanning Electron Microscopy (SEM) to be 0.8%. The thickness of the coating was 50 microns. Further, the plugging frame coated by the coating film is subjected to heat treatment at 70 ℃ for 60min to obtain the plugging device.
Example 9
A group of nickel-titanium alloy braided wires which are arranged in parallel and have the wire diameter of 25 wires and the wire diameter of 0.05mm are used as longitude braided wires, a group of nickel-titanium alloy braided wires which are arranged in parallel and have the wire diameter of 25 wires and the wire diameter of 0.05mm are used as latitude braided wires, the nickel-titanium alloy braided wires are vertically staggered and braided to form a braided net pipe, then two TPU films with the thickness of 25 micrometers are respectively coated on the inner wall and the outer wall of the braided net pipe, the TPU films are hot melted at the temperature of 200 ℃, then the TPU films are shaped, a plugging frame which comprises a first plugging unit, a second plugging unit and a waist part respectively connecting the first plugging unit and the second plugging unit is obtained, and the mesh size2And the blocking frame is coated by two TPU films, and a bag-shaped structure with an opening is formed on the frame. Further, a micro-puncture needle having a diameter of 30 μm was randomly punctured on the cover film to form a plurality of through-holes having a diameter of 30 μm on the cover film. The porosity of the coating film was 1.5% as measured by Scanning Electron Microscopy (SEM).
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (20)
1. An occluder comprises an occluder frame which is of a net structure, and is characterized by further comprising a covering film, wherein the covering film completely covers the occluder frame to form a bag-shaped structure with an opening, the covering film is provided with micropores, the micropores can balance the internal pressure and the external pressure of the bag-shaped structure, and a liquid contrast agent can flow out of the bag-shaped structure through the micropores.
2. The occlusion device of claim 1, wherein the occlusion frame is woven from degradable woven filaments or cut from a degradable material, and the material of the covering membrane is a degradable polymer.
3. The occlusion device of claim 2, wherein said degradable polymer is selected from at least one of poly-L-lactic acid, poly-dl-lactic acid, polyglycolic acid, poly-lactic-co-glycolic acid, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphoester, polydioxanone, and polycarbonate.
4. The occlusion device of claim 2, wherein the covering membrane further comprises a pro-endothelialization substance.
5. The occluder of claim 1, wherein said membrane has a thickness of 10 to 50 μm.
6. The occlusion device of claim 1, wherein the pores have a pore size of 1-100 μm.
7. The occlusion device of claim 6, wherein the porosity of the covering membrane is 0.1-15%.
8. The occlusion device of claim 1, wherein the covering membrane is an elastic membrane.
9. The seal of claim 1The plugging device is characterized in that the grid size range of the plugging frame is 0.1mm2~16mm2。
10. The occlusion device of claim 1, wherein the occlusion frame comprises a first occlusion unit, a second occlusion unit, and a waist, wherein the first occlusion unit and the second occlusion unit are connected to two ends of the waist, respectively, and wherein the covering membrane completely covers the first occlusion unit, the second occlusion unit, and the waist.
11. The occluder of claim 10, further comprising a first cap and a second cap, wherein the first cap is disposed on the first occlusion unit, the second cap is disposed on the second occlusion unit, the second cap is provided with a through hole, the coating further covers the first cap and the second cap, and the coating does not cover the through hole, so that the through hole forms the opening of the capsule structure.
12. The preparation method of the occluder is characterized by comprising the following steps:
providing a plugging frame, wherein the plugging frame is of a net structure; and a process for the preparation of a coating,
coating a covering film on the plugging frame so as to form a bag-shaped structure with an opening;
micropores are formed on the surface of the covering film, the micropores can balance the internal pressure and the external pressure of the saccular structure, and the liquid contrast agent can flow out of the saccular structure through the micropores.
13. The method of claim 12, wherein the step of applying a coating to the occluding frame to form a capsular structure having an opening comprises:
preparing a leaching solution, wherein the solute of the leaching solution is a material for forming the coating; and a process for the preparation of a coating,
immersing the plugging frame in the leaching solution, extracting the plugging frame from the leaching solution, and after drying, attaching the material for forming the coating film on the plugging frame to form a bag-shaped structure with an opening.
14. The method of claim 13, wherein the step of immersing the plugging frame in the leaching solution comprises immersing the plugging frame in the leaching solution for a period of time of at least 5 seconds.
15. The method of claim 13 or 14, wherein in the step of extracting the plugging frame from the leach solution, the rate of extraction of the plugging frame from the leach solution is 0.01 to 0.5 meters per second.
16. The method for preparing an occluder according to claim 13 or 14, wherein the solute of said leachate is a degradable polymer, and the concentration of said degradable polymer is greater than or equal to 1 mg/mL.
17. The method of manufacturing a stopper according to claim 13 or 14 wherein the step of immersing the stopper frame in the leach solution and extracting the stopper frame from the leach solution is followed by a heat treatment step comprising:
and (3) placing the plugging frame at the temperature of 45-110 ℃ and preserving heat for 5-60 min.
18. The method of claim 12, wherein the step of applying a coating to the occluding frame to form a capsular structure having an opening comprises:
coating a covering film on the plugging frame, and forming a bag-shaped structure with an opening after hot melting; alternatively, the first and second electrodes may be,
and fixing the covering film on the plugging frame by an adhesive method to form a bag-shaped structure with an opening.
19. An occlusion system, comprising the occlusion device of any of claims 1-11, and further comprising a pushing device, wherein the pushing device comprises a delivery cable and a delivery conduit connected to the delivery cable, wherein the delivery cable is adapted to be detachably connected to the occlusion device, wherein the delivery cable has an inner lumen, wherein the delivery conduit has a delivery lumen, and wherein the inner lumen, the delivery lumen, and the bladder-like structure are in communication.
20. The occlusion system of claim 19, wherein the delivery cable is formed by winding a plurality of wires to form a hollow tube, and a sealing membrane is disposed on the delivery cable, the sealing membrane being disposed on an inner wall of the delivery cable or coated on an outer wall of the delivery cable.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811575032.9A CN109820548B (en) | 2018-12-21 | 2018-12-21 | Plugging device, preparation method thereof and plugging system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201811575032.9A CN109820548B (en) | 2018-12-21 | 2018-12-21 | Plugging device, preparation method thereof and plugging system |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN109820548A CN109820548A (en) | 2019-05-31 |
| CN109820548B true CN109820548B (en) | 2020-11-17 |
Family
ID=66859928
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201811575032.9A Active CN109820548B (en) | 2018-12-21 | 2018-12-21 | Plugging device, preparation method thereof and plugging system |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN109820548B (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113925544B (en) * | 2020-06-29 | 2024-03-19 | 上海微创医疗器械（集团）有限公司 | Plugging device and preparation method thereof |
| CN114366183A (en) * | 2021-12-24 | 2022-04-19 | 杭州德诺电生理医疗科技有限公司 | Plugging device and plugging system |
| CN116059021A (en) * | 2021-12-31 | 2023-05-05 | 元心科技(深圳)有限公司 | Tectorial membrane bracket system and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103690228A (en) * | 2013-12-12 | 2014-04-02 | 宁波华科润生物科技有限公司 | Centrum expansion ball bag system |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040254594A1 (en) * | 2003-01-24 | 2004-12-16 | Arthur Alfaro | Cardiac defect occlusion device |
| US20090209999A1 (en) * | 2008-02-14 | 2009-08-20 | Michael Afremov | Device and Method for Closure of Atrial Septal Defects |
| WO2012092354A1 (en) * | 2010-12-30 | 2012-07-05 | Cook Medical Technologies Llc | Occlusion device |
| IN2014CN03396A (en) * | 2011-10-27 | 2015-10-09 | Occlutech Holding Ag | |
| CN103110444A (en) * | 2013-01-22 | 2013-05-22 | 陈平根 | Biodegradable fabric body capable of being developed and conveying device |
| CN203763296U (en) * | 2014-03-14 | 2014-08-13 | 徐州亚太科技有限公司 | Novel degradable plugging device implanted through catheter and conveying system thereof |
| CN104720854B (en) * | 2015-02-25 | 2017-04-26 | 上海形状记忆合金材料有限公司 | Sectioned degradable plugging device |
| CN205322404U (en) * | 2015-12-31 | 2016-06-22 | 上海锦葵医疗器械有限公司 | Degradable heart acleistocardia of can developing plugging device |
-
2018
- 2018-12-21 CN CN201811575032.9A patent/CN109820548B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103690228A (en) * | 2013-12-12 | 2014-04-02 | 宁波华科润生物科技有限公司 | Centrum expansion ball bag system |
Also Published As
| Publication number | Publication date |
|---|---|
| CN109820548A (en) | 2019-05-31 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US8480707B2 (en) | Closure device and method for occluding a bodily passageway | |
| US8734483B2 (en) | Spider PFO closure device | |
| CN109820548B (en) | Plugging device, preparation method thereof and plugging system | |
| CN109770964B (en) | Plugging device and preparation method thereof | |
| US20170119362A1 (en) | Device and Method for Closure of Atrial Septal Defects | |
| US9554783B2 (en) | Closure device and method of closing a bodily opening | |
| US20070118176A1 (en) | Radiopaque bioabsorbable occluder | |
| US9332977B2 (en) | Closure device | |
| US9295456B2 (en) | Occlusion device for closing anatomical defects | |
| BR112018014246B1 (en) | WARP MESH FABRIC, AND, MEDICAL MATERIAL | |
| CN101185582A (en) | Mechanical tissue device and method | |
| EP3361961A1 (en) | Devices and methods for excluding the left atrial appendage | |
| US20230032647A1 (en) | Devices and methods for excluding the left atrial appendage | |
| US10905405B2 (en) | Occlusion device for closing anatomical defects | |
| CN215994080U (en) | Novel plugging instrument | |
| CN111297411B (en) | Implantable device and method of making same | |
| CN110882016B (en) | Plugging device, preparation method thereof and implanting instrument | |
| WO2020233523A1 (en) | Implantable instrument and preparation method therefor | |
| CN114680951A (en) | Plugging device and preparation method thereof | |
| CN114680950A (en) | Implantable device and preparation method thereof | |
| CN109770965A (en) | A kind of choked flow film and its manufacturing method and plugging device | |
| Yu-feng et al. | Animal experimental study of the fully biodegradable atrial septal defect (ASD) occluder |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |