WO2023124440A1 - 封堵器及封堵系统 - Google Patents

封堵器及封堵系统 Download PDF

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Publication number
WO2023124440A1
WO2023124440A1 PCT/CN2022/126333 CN2022126333W WO2023124440A1 WO 2023124440 A1 WO2023124440 A1 WO 2023124440A1 CN 2022126333 W CN2022126333 W CN 2022126333W WO 2023124440 A1 WO2023124440 A1 WO 2023124440A1
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Prior art keywords
braided
occluder
depression
proximal
disk
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PCT/CN2022/126333
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English (en)
French (fr)
Inventor
陈贤淼
雷霄越
赵冬阳
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先健科技(深圳)有限公司
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Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Priority to CN202280005493.0A priority Critical patent/CN116685273A/zh
Publication of WO2023124440A1 publication Critical patent/WO2023124440A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets

Definitions

  • the invention belongs to the technical field of interventional medical devices, in particular to an occluder and an occluder system with the occluder.
  • Atrial septal defect is a common congenital heart malformation in clinical practice. It is the abnormality of the original atrial septum during embryonic development, resulting in a gap between the left and right atrium. It is often treated clinically with an atrial septal defect occluder . As shown in Fig. 1, the existing occluder 100' is often braided with braided wires. The braided occluder is tightly braided, and the binding force between the braided wires is relatively large, resulting in the force required for deformation of the occluder 100'.
  • the size of the delivery sheath 50' is usually small (such as a delivery sheath with an inner diameter of 6F or less). Patient's life safety.
  • the purpose of the present invention is to provide an occluder, aiming to solve the problem of increasing the difficulty and risk of the operation due to the high sheathing resistance of the occluder in the prior art.
  • a kind of occluder comprises:
  • a braided body adopts a braided network tube formed by braiding wire with a shape memory function after being shaped;
  • the braided body is provided with a shrinkage deformation drag reduction structure that reduces the resistance of the braided body entering the pipeline; the shrinkage deformation drag reduction structure makes the braided body shrink and deform radially when entering the pipeline, The contact area between the braided body and the inner wall of the pipeline is reduced to reduce the pipe entry resistance of the braided body.
  • the shrinkage deformation drag reducing structure includes a depression provided on the braided main body, and the depression is concaved toward the inner side of the braided main body.
  • At least one depression is provided, and the depression passes through the proximal end and the distal end of the braided main body.
  • the braided body includes a distal disk and a constriction connected to the distal disk, the radial cross-sectional dimension of the constriction is smaller than the radial cross-sectional dimension of the distal disk; the depression proximate the transition junction of the distal disc and the constriction;
  • the depression is located at the transitional connection between the distal plate and the constriction.
  • the depressions are distributed in a helical track along the sidewall of the braided mesh tube.
  • the braided body includes a distal disk, a proximal disk, and a waist connected between the proximal disk and the distal disk, and the disk surfaces of the distal disk and the proximal disk have the same size.
  • the multiple depressions are distributed in the braided body at intervals, and each of the depressions has a different depth, and the proximal disk is close to the The depth of the depression of the longitudinal central axis of the proximal disk is less than the depth of the depression far away from the longitudinal central axis of the proximal disk, and the depth of the depression on the distal disk close to the longitudinal central axis of the distal disk is smaller than the depth of the depression far away from the longitudinal central axis of the distal disk.
  • the depth of the depression of the longitudinal central axis of the distal disc is described.
  • the occluder includes a proximal plug disposed at the proximal end of the braided body, the depression is disposed at the proximal end of the braided body, and the depression is connected to the proximal end
  • the bolt heads are relatively arranged.
  • the even number of depressions are arranged in pairs on the side wall of the braided mesh tube, and any pair of the depressions are arranged symmetrically with respect to the central axis of the braided mesh tube .
  • the present invention also provides an occlusion system comprising any one of the occluders described above.
  • the occluder provided by the present invention is provided with a shrinkage deformation drag reduction structure on the braided body of the occluder, and the shrinkage deformation drag reduction structure reduces the
  • the contact area between the braided main body and the inner wall of the delivery sheath tube can reduce the resistance of the braided main body into the tube, so that the braided main body of the occluder can smoothly enter the delivery sheath tube and other pipelines, which can reduce or avoid the entry of the occluder.
  • the sheath tube and other channels are blocked and stuck, the difficulty and risk of the operation are reduced.
  • Fig. 1 is the schematic diagram of the occluder of the prior art provided by the present invention in a natural state
  • Fig. 2 is the schematic diagram when the prior art occluder provided by the present invention enters the sheath
  • FIG. 3 is a schematic diagram of a double-disc occluder provided by an embodiment of the present invention.
  • Figure 3a is an enlarged schematic view of A in Figure 3;
  • Fig. 4 is a schematic diagram of an occluder without a distal head provided at the distal end according to an embodiment of the present invention
  • Fig. 5 is a schematic diagram of a single-disk occluder provided by an embodiment of the present invention.
  • Fig. 6 is a schematic diagram of an occluder provided by an embodiment of the present invention without a proximal plug head and a distal plug head;
  • Fig. 7 is a schematic diagram of the occluder provided in Embodiment 1 of the present invention in a stretched state
  • Fig. 8 is a schematic diagram of a braided mesh pipe provided in Embodiment 1 of the present invention.
  • Fig. 9 is an A-A sectional schematic view of the braided mesh pipe of Fig. 8.
  • Fig. 10 is a schematic diagram of the occluder provided in Embodiment 2 of the present invention in a natural state
  • Fig. 11 is a schematic cross-sectional view of the braided mesh tube provided by Embodiment 2 of the present invention before being finalized;
  • Fig. 12 is a schematic diagram of the occluder provided in Embodiment 3 of the present invention in a natural state
  • Fig. 13 is a schematic cross-sectional view of the braided mesh tube provided by Embodiment 3 of the present invention before being finalized;
  • Fig. 14 is a schematic diagram of the occluder provided in Embodiment 4 of the present invention being stretched;
  • Fig. 15 is a schematic cross-sectional view of the braided mesh tube provided by Embodiment 4 of the present invention before being finalized;
  • Fig. 16 is a schematic diagram of the occluder provided in Embodiment 5 of the present invention when it is stretched;
  • Fig. 17 is a schematic cross-sectional view of the braided mesh tube provided by Embodiment 5 of the present invention before being finalized;
  • Fig. 18 is a schematic diagram of the occluder provided by Embodiment 7 of the present invention being stretched;
  • Fig. 19 is a schematic cross-sectional view of the braided mesh tube provided by Embodiment 7 of the present invention before being finalized;
  • Fig. 20 is a schematic cross-sectional view of another braided mesh tube before being finalized according to Embodiment 7 of the present invention.
  • Fig. 21 is a schematic cross-sectional view of the braided mesh tube provided by Embodiment 8 of the present invention before being finalized;
  • Fig. 22 is a schematic cross-sectional view of the braided mesh tube provided by Embodiment 9 of the present invention before being finalized;
  • Fig. 23 is a related picture of the prior art occluder provided by the present invention without shrinkage deformation drag reduction structure in the transparent pipeline;
  • Fig. 24 is a related picture of the occluder provided with the contraction deformation drag reduction structure provided by the embodiment of the present invention when it is in the transparent pipeline;
  • Figure 25 is a related picture of quantitative measurement of the waist under a laser confocal microscope when the occluder provided by the present invention without shrinkage deformation and drag reduction structure is stretched;
  • Fig. 26 is a diagram of the measurement results of the occluder in Fig. 25 provided by the present invention after being measured under a laser converging microscope;
  • Figure 27 is a related picture of quantitative measurement of the waist under a laser confocal microscope when the occluder provided with a shrinkage deformation drag reduction structure provided by an embodiment of the present invention is stretched;
  • Fig. 28 is a measurement result diagram of the occluder in Fig. 27 provided by an embodiment of the present invention after being measured under a laser converging microscope.
  • orientation terms such as left, right, up, and down in this embodiment are only relative concepts or refer to the normal use state of the product, and should not be regarded as limiting.
  • distal end is defined as the end away from the operator during the operation
  • proximal end is defined as the end close to the operator during the operation.
  • Axial refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device
  • radial refers to the direction perpendicular to the aforementioned axial direction.
  • FIG. 3 it is a schematic diagram of a double-disc occluder 100 provided by an embodiment of the present invention, including a braided main body 10, a proximal plug head 20, and a distal end cap 30.
  • the braided main body 10 adopts a shape-memory function.
  • the braided mesh tube formed by braiding wire braiding is shaped, such as nickel-titanium alloy wire, and the braided main body 10 has a proximal free end and a distal free end; Collect and fix the proximal free end of the braided main body 10, the distal head 30 is located at the far end of the braided main body 10, and is used to gather and fix the distal free end of the braided main body 10, and the braided main body 10 is provided with a shrinkage deformation drag reduction structure 40,
  • reduce the resistance of the braided body 10 entering the pipeline for example, reduce the resistance of the braided body 10 entering the delivery sheath tube, or reduce the free end of the braided body 10 entering the proximal plug 20 and the distal end cap 30
  • the resistance when inside; the shrinkage deformation drag reduction structure 40 realizes the reduction of the braided body by reducing the contact area between the braided body 10 and the inner wall of the pipe when the braided body 10 enters the pipeline and
  • the shrinkage deformation drag reducing structure 40 provided in this embodiment includes a depression 401 provided on the braided main body 10.
  • Arc-shaped depressions, V-shaped depressions, or rectangular depressions, etc. can be concave in any shape, or irregularly shaped depressions, as long as they are concave towards the inner side of the knitting main body 10 relative to the outer wall of the knitting main body 10, the knitting main body 10 When entering the delivery sheath and other narrow pipeline spaces, it needs to contract and cause a large radial pressure. At this time, it will abut against the inner wall of the delivery sheath tube.
  • the setting of the recess 401 can make the braided body 10 pass through the recess 401 to distribute a part of the stress toward the inner side of the braided body 10 when it shrinks and deforms, thereby reducing the contact with the inner wall of the pipeline of the delivery sheath.
  • the radial stress against the inner wall of the pipeline is small, so that the braided main body 10 can enter the delivery sheath and other pipelines more smoothly, avoiding sheathing jams and blockages, and reducing the risk and difficulty of surgical operations.
  • the occluder 100 may only be provided with the braided main body 10 and the proximal plug head 20 , and the shrinkage deformation drag reduction structure 40 is provided on the braided main body 10 . That is to say, in this embodiment, the distal end of the braided main body 10 of the occluder 100 can be bundled and fixed by braiding the braided wire of the braided main body 10 itself, and the distal end can also be bundled and fixed.
  • the occluder in this embodiment is not provided with a distal head; alternatively, the braided wires at the distal end of the occluder 100 can also be bundled and fixed by welding, which can also achieve the effect of bundling and fixing the distal end .
  • the braided main body 10 of the occluder 100 is single disc-shaped, that is, the braided main body 10 only includes distal The end plate 11, the waist portion 12 and the proximal plug head 20, the shrinkage deformation drag reduction structure 40 is arranged on the far end plate 11, and the shrinkage deformation drag reduction structure 40 is arranged on the distal end plate 11, which can also make the single disc seal
  • the stopper 100 is radially compressed and deformed into the sheath tube, the contact area with the inner wall of the tube is reduced, so the sheath entry resistance suffered is also reduced accordingly.
  • the occluder 100 may only include a braided body 10 , the braided body 10 includes a distal disc 11 and a waist 12 , and a contraction deformation drag reducing structure 40 is provided at the distal end of the braided body 10
  • the occluder 100 is not provided with a proximal plug head and a distal end cap, and its proximal and distal ends can be bundled by braiding and winding, or by welding way to close.
  • FIG. 8 it is a schematic diagram of the braided mesh tube before the braided body 10 a is finalized, and it is generally cylindrical before it is not finalized to form the braided body 10 a shown in FIG. 7 .
  • an auxiliary fixture can be used to form a depression 401a on the side wall of the braided mesh pipe, and the cross section of the braided mesh pipe presents a concave shape as shown in FIG.
  • the plurality of depressions 401a all pass through the proximal end and the distal end of the braided main body 10a, that is, the plurality of depressions 401a are arranged in parallel.
  • the specific manufacturing method of the depression 401a can be carried out in the following manner: the cylindrical braided mesh pipe as shown in Figure 8 is bound as a whole with thin copper wires, so that the cylinder as shown in Figure 8 The side wall of the braided mesh tube is sunken inside as a whole, forming a groove that runs through the proximal end and the far end of the braided mesh pipe.
  • the braided mesh tube is shaped to form the braided main body 10a, and the fine copper wire is released after the braided main body 10a is shaped.
  • the braided body 10a is concave as a whole, the braided body 10a is compressed and deformed due to the depression 401a on the braided body 10a.
  • the depression 401a of the braided main body 10a will be pressed to the inner side of the braided main body 10a, thereby relatively reducing the contact area between the braided main body 10a and the inner wall of the delivery sheath 50, and reducing the positive distance between the braided main body 10a and the delivery sheath 50.
  • the resistance of entering the delivery sheath tube 50 becomes smaller, and the occluder 100 can smoothly enter the delivery sheath tube 50 of a smaller size and be pushed inside the delivery sheath tube 50, making the pushing process smoother and smoother.
  • Due to the reduced resistance it is easier to unsheath, which can prevent the sudden increase of the sheath force when unsheathing, resulting in poor control of the force, resulting in sudden vibration and vibration of the occluder, avoiding excessive stimulation or damage to the human body Other tissues, improving the controllability and safety of surgery.
  • a depression is formed on the disk surface facing the blood flow, which can slow down the impact of the blood flow on the disk surface, so that the occluder can be implanted in the defect more stably, and endothelialization can be accelerated. speed.
  • the braided main body 10b has a distal disk 11b and a constricted portion 12b connected to the distal disk 11b, and the radial cross-sectional size of the constricted portion 12b is smaller than the radial direction of the distal disk 11b.
  • the sheathing resistance force generated at the transitional junction between the two is correspondingly larger, which is also the position where the occluder is more difficult to sheath.
  • the depression 401b is provided at or near the transitional connection between the distal disc 11b and the contraction portion 12b, which can greatly reduce the sheathing resistance of the braided main body 10b, making its sheathing and sheathing more smooth, thereby It can avoid the difficulty of getting out of the sheath due to the difficulty of getting into the sheath in the prior art, and then can prevent the situation that the occluder 100 suddenly shakes and vibrates due to the sudden increase of the sheathing force when the sheathing is out, resulting in poor control of the force, and avoids the occurrence of sudden vibration of the occluder 100
  • the human body produces excessive stimulation or damages other tissues of the human body, which improves the controllability and safety of the operation.
  • the braided body 10c includes a proximal disk 13c at the proximal end, and a proximal bolt head 20 located at the proximal end of the proximal disk 13c; in this embodiment, the depression 401c is located at the proximal Between the end bolt head 20 and the disk surface of the proximal disk 13c, the disk surface of the proximal disk 13c refers to the surface with the largest radial cross-sectional size of the proximal disk 13c.
  • the cross-section of the braided main body 10c The diameter size is a process of gradually increasing or suddenly increasing, so the section from the proximal plug head 20 to the proximal disc 13c is also a difficult position to enter the sheath when sheathing, and the recess 401c is set on the proximal plug
  • the contact area between the braided main body 10c and the inner wall of the sheath can be reduced, thereby reducing the sheathing resistance, enabling the occluder 100 to enter the sheath smoothly, improving the safety and security of the operation. Operability, reducing the difficulty and risk of surgery.
  • the depression 401c in this embodiment can also use thin copper wires to bind and position the braided network tube where the depression needs to be provided, so as to form a concave braided network tube, the cross section of which is shown in Figure 13. Shaping, after shaping, the corresponding position of the braided main body 10c can form a depression, even if the thin copper wire is released, it can still maintain the state of corresponding depression.
  • FIG. 15 shows a schematic cross-sectional view of the depression 401d corresponding to three positions A, B, and C in FIG. 14 . That is, in this embodiment, the depressions 401d are helically distributed around the central axis of the braided main body 10d.
  • the depressions 401d are helically distributed along the central axis, which disperses the impact force of the blood flow and avoids stress concentration, thereby reducing the occurrence of fatigue fracture of the wires of the metal mesh tube.
  • the side wall of the cylindrical braided mesh tube before processing and shaping can be processed with auxiliary tools such as thin copper wires to process the depressions distributed along the side wall of the cylindrical braided mesh tube in a spiral trajectory. It is then shaped to form the woven body.
  • the braided main body 10e includes a distal disk 11e, a waist 12e and a proximal disk 13e, the waist 12e is arranged between the distal disk 11e and the proximal disk 13e, and the distal disk 11e 1.
  • the size of the disk surface of the proximal disk 13e is greater than the radial cross-sectional size of the waist 12e.
  • multiple depressions 401e can be provided, and each depression 401e is distributed on the braided main body 10e at intervals. Each depression 401e has a different depth.
  • the depth of the depression closer to the surface of the distal disk 11e is deeper, that is, the depth of the depression near the longitudinal central axis of the distal disk 11e on the distal disk 11e is smaller than the depression far away from the longitudinal central axis of the distal disk 11e
  • the depth of the depression 401e at position A near the disc surface of the distal disc 11e is 1mm
  • the depth of the depression 401e at position B far from the disc surface of the distal disc 11e is 0.5mm.
  • the depth of the depression is greater than the depth of the depression at position B; on the proximal disk 13e, the depth of the depression near the disk surface of the proximal disk 13e is deeper, that is, the depth of the depression near the longitudinal central axis of the proximal disk 13e on the proximal disk 13e Less than the depth of the depression away from the longitudinal central axis of the proximal disk 13e.
  • the depth of the depression 401e near the position C of the disk surface of the proximal disk 13e is 1mm
  • the depth of the depression 401e of the position D far away from the disk surface of the proximal disk 13e on the proximal disk 13e is 0.5mm
  • the depth of the depression at the position C is The depth is greater than the depth of the depression at location D.
  • the cross-sectional dimensions of the disk surface of the distal disk 11e and the disk surface of the proximal disk 13e are larger than those of other parts, so the closer to the disk surface of the distal disk 11e and the proximal disk
  • the position of the disk surface of 13e is more likely to be blocked or stuck when it is sheathed, and in this embodiment, the depth of the depression 401e near the disk surface of the distal disk 11e and the proximal disk 13e is greater than that far away from the distal disk 11e and the proximal disk
  • the depth of the depression 401e on the disk surface of 13e is set in a targeted manner, so that most of the stress of the braided body 10e that is close to the disk surface of the proximal disk 13e and the distal disk 11e is directed towards the center of the braided body 10e when sheathing
  • the directions are moved closer to reduce the positive pressure between the side wall of the braided main body 10e and the
  • the specific manufacturing method of the depression 401e in this embodiment can be carried out with reference to the above-mentioned embodiments: firstly, the braided mesh pipe is positioned with tools such as thin copper wires to form the depression 401e, and then the shaping process is performed to remove the tools such as thin copper wires. After the implement, the braided body 10e having the depression 401e can be formed.
  • This structural arrangement can make the stress distribution of the braided main body 10g of the occluder 100 more balanced when it is sheathed, thereby also reducing the resistance when it is sheathed and reducing the operation cost. difficulty and risk.
  • the paired depressions 401g are arranged axisymmetrically, it can be as shown in Figure 19.
  • the paired depressions 401g have a positive symmetrical structure with respect to the central axis of the braided main body 10g, that is, the paired depressions 401g are positively symmetrical.
  • the paired depressions 401g are arranged symmetrically to the center of the knitted main body 10g. Right on set.
  • each depression 401h penetrates through the braided mesh tube 10h in the axial direction, and multiple depressions 401h are asymmetrically arranged on the side wall of the braided mesh tube 10h,
  • This kind of structural setting can also reduce the radial stress on the inner wall of the sheath tube that the occluder receives when it enters the delivery sheath tube, so that the occluder can enter the sheath tube more smoothly and reduce the operation time. difficulties and risks.
  • each depression 401i can also be provided, and each depression 401i is distributed in the shape of dots on the side wall of the braided mesh tube 10i.
  • the depressions 401i distributed in a shape can disperse and buffer the stress against the inner wall of the sheath, thereby reducing the resistance of the occluder entering the sheath, making the occluder enter the sheath more smoothly and smoothly, so as to reduce the difficulty and difficulty of the operation. risk.
  • the processing and manufacturing of the depressions 401g, 40h, and 40i in Embodiments 7, 8, and 9 can all be manufactured with reference to the manufacturing methods of the depressions in other embodiments, that is, using fine copper wires and other tools to first make the braided mesh tube Perform binding and positioning to form a corresponding concave structure on the braided network tube, and then carry out shaping processing to form the braided main body, and its specific manufacturing method will not be repeated here.
  • the setting size of the shrinkage deformation drag-reducing structure (depression) on the occluder is smaller, and it is usually impossible to observe obvious shrinkage deformation by naked eyes
  • the drag-reducing structure (depression) can be modeled, measured and observed through a confocal microscope at this time, and its difference is relatively obvious compared with an occluder of the same size without a shrinkage-deformed drag-reducing structure (depression).
  • the following compares the occluder provided with the shrinkage deformation drag reduction structure in the prior art with the same size and the occluder provided with the shrinkage deformation drag reduction structure provided by the embodiment of the present invention under a confocal microscope for comparison and description:
  • FIG. 23 it is the relevant picture of the prior art occluder provided by the present invention without shrinkage deformation drag reduction structure in the transparent pipeline.
  • the prior art occluder is pushed into In the transparent tube, the inner diameter of the transparent tube is equal to the inner diameter of the delivery sheath for delivering the occluder, so as to simulate the use environment when the occluder enters the delivery sheath during the interventional operation, and then magnified 20 to Observed at 100X.
  • the picture shown in FIG. 23 is obtained by observing at 20 times magnification.
  • the inner diameter of the transparent tube is equal to the inner diameter of the delivery sheath for delivering the occluder, so as to simulate the operation of the occluder
  • the picture shown in Figure 24 was obtained by magnifying 20 times; comparing Figure 23 and Figure 24, it can be seen that the waist of the occluder provided with shrinkage deformation and drag reduction structure (depression) has obvious The waist of the occluder without a shrinkage deformation drag-reducing structure (sag) does not change much, and no obvious indentation or depression is seen.
  • the occluder of the prior art provided by the present invention without a shrinkage deformation drag reduction structure is quantitatively measured under a laser confocal microscope when the waist is in a natural state (that is, without external force).
  • the relevant picture at the depth, in this figure no obvious depression is seen in the waist of the occluder; while Figure 27 is the occluder provided with the contraction deformation drag reduction structure (depression) in the natural state provided by the embodiment of the present invention
  • the waist was quantitatively measured under the laser confocal microscope, the relevant pictures of the depression depth are shown. In Figure 27, obvious depressions can be seen on the waist.
  • Fig. 26 is the result of measuring the occluder of Fig. 25 provided by the present invention under a laser converging microscope at 20 times magnification, wherein the abscissa indicates the partial length of the occluder, and the ordinate indicates the vertical depth of the corresponding position of the occluder , because the waist of the occluder in this figure is not provided with a depression (that is, a shrinkage deformation drag reduction structure), the depth difference is only 0.0483mm.
  • the abscissa indicates the axial length of the waist of the occluder in the natural state
  • the ordinate indicates the length of the corresponding position of the waist of the occluder. radial depth. It can be understood that if the shrinkage deformation drag-reducing structure is arranged on the outer end surface of the disc surface, the longitudinal central axis of the occluder is perpendicular to the stage plane of the microscope during measurement, and the abscissa indicates the distance of the disc surface in the natural state of the occluder. The radial length, the ordinate represents the axial depth of the corresponding position on the occluder disk.
  • Fig. 28 is a magnified 20-fold measurement result of the occluder in Fig. 27 provided by an embodiment of the present invention, where the abscissa represents the partial length of the occluder, and the ordinate represents the distance of the corresponding position of the occluder Radial width, because the waist of the occluder in this figure is provided with a depression (that is, a shrinkage deformation drag reduction structure), the depth difference reaches 0.5051mm.
  • a contraction deformation drag reduction structure is specially set up.
  • Modeling is carried out with a confocal microscope.
  • the principle is to identify the depth of the position where the braided body of the occluder is provided with a depression by measuring.
  • the difference between the highest point and the lowest point of the depression of the braided body of the occluder measured in Figure 27 is 0.5051mm. That is, the depth of the depression is 0.5051 mm, as shown in Figure 28; while the braided main body of the prior art occluder of the control group in Figure 26 is not provided with a shrinkage deformation drag-reducing structure (depression), its depth at the waist of the occluder It is only 0.0483 mm, almost no height difference, which is within the error range of the process, and there is a significant difference between the two groups.
  • the occluder provided with the shrinkage deformation drag-reducing structure of the present invention is a single-layer occluder (that is, both the proximal disk surface and the distal disk surface of the occluder disk are of a single-layer braided structure), and its According to actual needs, no blocking membrane can be provided (for example, braiding with more than or equal to 72 braided wires to form an occluder that can be loaded into a delivery sheath with an inner diameter of less than 6F), so that the inner diameter of the delivery sheath can be further reduced, so that Younger patients are less traumatic.

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Abstract

本发明适用于介入医疗器械技术领域，提供了一种封堵器及具有该封堵器的封堵系统，包括编织主体，所述编织主体由采用具有形状记忆功能的编织丝编织形成的编织网管经过定型而成，所述编织主体上设置有减小所述编织主体进入管道内的阻力的收缩变形减阻结构；所述收缩变形减阻结构通过使得所述编织主体在进入所述管道内发生径向收缩变形时，减小所述编织主体与所述管道的内壁的接触面积而减小所述编织主体的入管阻力，从而使得封堵器可较顺滑及顺畅地进入输送鞘管管道内，可大大降低封堵器因入鞘不顺畅而导致的手术难度和风险。

Description

封堵器及封堵系统 技术领域
本发明属于介入医疗器械技术领域，尤其涉及一种封堵器及具有该封堵器的封堵系统。
背景技术
房间隔缺损(ASD)为临床上常见的先天性心脏畸形，是原始房间隔在胚胎发育过程中出现异常，致左、右心房之间遗留孔隙，临床上常采用房间隔缺损封堵器进行治疗。如图1所示，现有的封堵器100’常采用编织丝编织而成，编织型封堵器编织紧凑，编织丝之间的约束力较大，导致封堵器100’变形需要的力增大，从而增加了封堵器100’的入鞘阻力，使其较难适应较小的鞘管，当需要通过较小的鞘管输送封堵器100’时，例如如图2所示，给儿童实施介入手术时通常输送鞘管50’尺寸较小(比如内径为6F或者6F以下的输送鞘管)，此时若入鞘阻力过大则会增加手术的难度和风险，严重的甚至危及患者的生命安全。
发明内容
本发明的目的在于提供一种封堵器，旨在解决现有技术的封堵器入鞘阻力较大而导致增加手术的难度和风险的问题。
本发明是这样实现的：一种封堵器，包括：
编织主体，所述编织主体采用具有形状记忆功能的编织丝编织形成的编织网管经过定型而成；
所述编织主体设置有减小所述编织主体进入管道内的阻力的收缩变形减阻 结构；所述收缩变形减阻结构通过使得所述编织主体在进入所述管道内发生径向收缩变形时，减小所述编织主体与所述管道的内壁的接触面积而减小所述编织主体的入管阻力。
具体地，所述收缩变形减阻结构包括设于所述编织主体上的凹陷，所述凹陷朝向所述编织主体的内侧方向内凹。
在一些实施例中，所述凹陷设置有至少一个，且所述凹陷贯通所述编织主体的近端及远端。
在一些实施例中，所述编织主体包括远端盘及与所述远端盘相连的收缩部，所述收缩部的径向截面尺寸小于所述远端盘的径向截面尺寸；所述凹陷靠近所述远端盘与所述收缩部的过渡连接处；
或者，
所述凹陷设于所述远端盘与所述收缩部的过渡连接处。
在一些实施例中，所述凹陷沿所述编织网管的侧壁呈螺旋轨迹进行分布。
在一些实施例中，所述编织主体包括远端盘、近端盘及连接于所述近端盘及所述远端盘之间的腰部，所述远端盘、近端盘的盘面尺寸均大于所述腰部的径向截面尺寸；所述凹陷设置有多个，所述多个凹陷间隔分布于所述编织主体，且各所述凹陷具有不同的深度，所述近端盘上靠近所述近端盘的纵向中心轴的凹陷的深度小于远离所述近端盘的纵向中心轴的凹陷的深度，所述远端盘上靠近所述远端盘的纵向中心轴的凹陷的深度小于远离所述远端盘的纵向中心轴的凹陷的深度。
在一些实施例中，所述封堵器包括设于所述编织主体近端的近端栓头，所述凹陷设于所述编织主体的近端端部，且所述凹陷与所述近端栓头相对设置。
在另外一些实施例中，所述凹陷设置有偶数个，且所述偶数个凹陷成对设置于所述编织网管的侧壁，任一对所述凹陷均关于所述编织网管的中轴线对称设置。
在一些实施例中，所述凹陷设置有多个，各所述凹陷均沿轴向方向贯通所 述编织网管，且所述多个凹陷非对称设置于所述编织网管的侧壁。
在另外一些实施例中，所述凹陷设置有多个，且多个所述凹陷呈网点状间隔分布于所述编织网管。
在另外一些实施例中，本发明还提供包括上述任一所述封堵器的封堵系统。
本发明提供的封堵器,其通过在封堵器的编织主体上设置收缩变形减阻结构,所述的收缩变形减阻结构通过使得编织主体在进入管道内发生径向收缩变形时，减小编织主体与输送鞘管的管道的内壁的接触面积而实现减小编织主体的入管阻力,从而使得封堵器的编织主体可顺畅地进入输送鞘管等管道内,可减少或避免封堵器进入鞘管等管道内时发生阻滞、卡顿等情况，从而降低了手术的难度和风险。
附图说明
图1是本发明提供的现有技术的封堵器在自然状态下的示意图；
图2是本发明提供的现有技术的封堵器进入鞘管时的示意图；
图3是本发明实施例提供的双盘状的封堵器的示意图；
图3a是图3的A处放大示意图；
图4是本发明实施例提供的远端未设置远端封头的封堵器的示意图；
图5是本发明实施例提供的单盘状的封堵器的示意图；
图6是本发明实施例提供的未设置近端栓头及远端封头的封堵器的示意图；
图7是本发明实施例一提供的封堵器拉伸状态下的示意图；
图8是本发明实施例一提供的编织网管的示意图；
图9是图8的编织网管的A-A向剖视示意图；
图10是本发明实施例二提供的封堵器在自然状态下的示意图；
图11是本发明实施例二提供的在被定型前的编织网管的剖视示意图；
图12是本发明实施例三提供的封堵器在自然状态下的示意图；
图13是本发明实施例三提供的在被定型前的编织网管的剖视示意图；
图14是本发明实施例四提供的封堵器被拉伸时的示意图；
图15是本发明实施例四提供的在被定型前的编织网管的剖视示意图；
图16是本发明实施例五提供的封堵器被拉伸时的示意图；
图17是本发明实施例五提供的在被定型前的编织网管的剖视示意图；
图18是本发明实施例七提供的封堵器被拉伸时的示意图；
图19是本发明实施例七提供的在被定型前的编织网管的剖视示意图；
图20是本发明实施例七提供的另一在被定型前的编织网管的剖视示意图；
图21是本发明实施例八提供的在被定型前的编织网管的剖视示意图；
图22是本发明实施例九提供的在被定型前的编织网管的剖视示意图；
图23是本发明提供的现有技术的未设置收缩变形减阻结构的封堵器在透明管道内时的相关图片；
图24是本发明实施例提供的设有收缩变形减阻结构的封堵器在透明管道内时的相关图片；
图25是本发明提供的现有技术的未设置收缩变形减阻结构的封堵器被拉伸时腰部在激光共聚焦显微镜下进行定量测量的相关图片；
图26是本发明提供的图25的封堵器在激光共聚显微镜下测量后的测量结果图；
图27是本发明实施例提供的设有收缩变形减阻结构的封堵器被拉伸时腰部在激光共聚焦显微镜下进行定量测量的相关图片；
图28是本发明实施例提供的图27的封堵器在激光共聚显微镜下测量后的测量结果图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施例，对本发明进行进一步详细说明。应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者可能同时存在居中元件。当一个元件被称为“连接于”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。
还需要说明的是，本实施例中的左、右、上、下等方位用语，仅是互为相对概念或是以产品的正常使用状态为参考的，而不应该认为是具有限制性的。
在介入医疗器械领域，定义“远端”为手术过程中远离操作者的一端，定义“近端”为手术过程中靠近操作者的一端。“轴向”指平行于医疗器械远端中心和近端中心连线的方向，“径向”指垂直于上述轴向的方向。
如图3所示，为本发明实施例提供的双盘状的封堵器100的示意图，包括编织主体10、近端栓头20、远端封头30，编织主体10采用具有形状记忆功能的编织丝编织形成的编织网管经过定型而成,例如镍钛合金金属丝，编织主体10具有近端自由端和远端自由端；其中,近端栓头20位于编织主体10的近端，用于集合固定编织主体10的近端自由端，远端封头30位于编织主体10的远端，用于集合固定编织主体10的远端自由端，编织主体10上设置有收缩变形减阻结构40，以减小编织主体10进入管道内的阻力，例如减小编织主体10进入输送鞘管管道内的阻力，或者减小编织主体10的自由端端部进入近端栓头20、远端封头30内时的阻力；所述的收缩变形减阻结构40是通过使得编织主体10在进入管道内发生径向收缩变形时，减小编织主体10与管道的内壁的接触面积而实现减小编织主体的入管阻力。
同时参见图3、图3a，本实施例提供的所述收缩变形减阻结构40包括设于编织主体10上的凹陷401，该凹陷401朝向编织主体10的内侧方向内凹，该凹陷401可为弧形凹陷、V形凹陷或者矩形凹陷等任一种形状的凹陷，或者 为不规则形状的凹陷，只要是相对于所述编织主体10的外壁面向编织主体10的内侧方向凹陷即可，编织主体10在进入输送鞘管等狭小管道空间内时需要进行收缩而导致径向压力较大，此时会与输送鞘管管道的内壁发生抵顶，若抵顶应力过大则会使得封堵器输送发生卡滞，凹陷401的设置可使得编织主体10在发生收缩变形时其可通过凹陷401使得一部分应力朝向编织主体10的内侧分布，从而减小与输送鞘管的管道的内壁的接触，即减小与管道的内壁抵顶的径向应力，从而使得编织主体10可更顺畅的进入输送鞘管等管道内，避免入鞘卡顿、阻滞等情况，降低手术操作的风险和难度。
如图4所示，在另外一些实施例中，封堵器100亦可只设置编织主体10和近端栓头20，收缩变形减阻结构40设于编织主体10上。即在本实施例中，封堵器100的编织主体10的远端可通过编织主体10本身的编织丝的编织缠绕束缚使其远端聚拢固定，同样可达到将其远端集束固定的作用，即本实施例中的封堵器并未设置远端封头；或者，封堵器100的远端的编织丝还可通过焊接的方式进行集束固定，同样可达到将其远端集束固定的作用。
如图5所示，在其它一些实施例中，与前述的实施例的双盘状的封堵器不同的是，封堵器100的编织主体10为单盘状，即编织主体10只包括远端盘11、腰部12及近端栓头20，收缩变形减阻结构40设于远端盘11上，将收缩变形减阻结构40设于远端盘11上，同样可使得单盘状的封堵器100在进入鞘管管道内径向压缩变形时与管道的内壁的接触面积减小，从而所受的入鞘阻力也随之减小。
如图6所示，在另外一些实施例中，封堵器100可只包括编织主体10，编织主体10包括远端盘11和腰部12，收缩变形减阻结构40设于编织主体10的远端盘11上，即在本实施例中封堵器100并未设置近端栓头及远端封头,其近端和远端可通过编织丝编织缠绕的方式进行收束,亦可通过焊接的方式进行收束。
以下，对于收缩变形减阻结构40在封堵器100上的具体设置方式进行举 例说明：
第一实施例
参见图7至图9，本实施例中，如图7所示，凹陷401a只设置一个，且凹陷401a贯通编织主体10a的近端及远端，即凹陷401a呈沟状于编织主体10a的侧壁从近端开始一直延伸到编织主体10a的远端。如图8所示，为编织主体10a未定型前的编织网管的示意图，其在未定型形成图7所示的编织主体10a之前，一般为圆筒状。此时可在编织网管的侧壁使用辅助夹具形成凹陷401a，则此时编织网管的截面呈现为如图9所示的内凹状，当然，本实施例中的凹陷401a也可设置为多个，该多个凹陷401a均贯通编织主体10a的近端及远端，即多个凹陷401a为平行设置。
在一些具体实施例中，凹陷401a的具体制造方法可采用如下方式进行：用细铜丝对如图8所示的圆筒状的编织网管整体进行捆绑束缚，使如图8所示的圆筒状的编织网管侧壁整体内部凹陷，形成贯通编织网管的近端及远端的凹槽，其截面如图9所示，编织网管由于捆绑被挤压，导致内部空腔的面积减小，然后对编织网管进行定型，形成编织主体10a，待编织主体10a定型后解除细铜丝的束缚。封堵器100进入图7所示的输送鞘管50内形成封堵系统200时，由于编织主体10a整体内凹，编织主体10a受挤压产生压缩变形，由于编织主体10a上的凹陷401a的设置，编织主体10a的凹陷401a处会向编织主体10a的内侧挤压，从而可相对减小编织主体10a与输送鞘管50的内壁接触的面积，降低编织主体10a与输送鞘管50之间的正压力，因此进入输送鞘管50的阻力变小，封堵器100可以顺利进入更小规格的输送鞘管50，并在输送鞘管50内进行推送，使得推送过程更顺滑、顺畅，此外，因降低了阻力使得出鞘较容易，进而可防止出鞘时突然增大出鞘力致使力度掌控不好而导致封堵器忽然发生抖动、颤动的情形发生，避免对人体产生过渡刺激或损伤人体其他组织，提高手术的可控性和安全性。再者，由于编织主体10a上的凹陷401a的设置，对着血流的盘面上形成有凹陷，可减缓血流对盘面的冲击，使 得封堵器更稳定的植入在缺损处，加快内皮化速度。
第二实施例
如图10和图11所示，本实施例中，编织主体10b具有远端盘11b及与远端盘11b相连的收缩部12b，收缩部12b的径向截面尺寸小于远端盘11b的径向截面尺寸；凹陷401b靠近远端盘11b与收缩部12b的过渡连接处而设置；或者，凹陷401b可刚好设于远端盘11b与收缩部12b的过渡连接处。
在实际应用中，由于远端盘11b和收缩部12b的截面尺寸差异较大，二者过渡连接处所产生的入鞘阻滞力也相应较大，亦是封堵器较难入鞘的位置，将凹陷401b设于远端盘11b与收缩部12b的过渡连接处或靠近该过渡连接处而设置，可使得编织主体10b入鞘阻力大大减小，使得其入鞘及出鞘变得更顺畅，从而可避免现有技术中的因入鞘困难而出鞘困难，进而可防止出鞘时突然增大出鞘力致使力度掌控不好而导致封堵器100忽然发生抖动、颤动的情形发生，避免对人体产生过渡刺激或损伤人体其他组织，提高手术的可控性和安全性。
第三实施例
参见图12和图13，本实施例中，编织主体10c包括位于近端的近端盘13c、位于近端盘13c近端的近端栓头20；在本实施例中，凹陷401c设于近端栓头20与近端盘13c的盘面之间，此处近端盘13c的盘面是指近端盘13c的径向截面尺寸最大的面。在进行介入手术时，由于封堵器100的近端与近端盘13c的盘面的径向尺寸相差较大，从封堵器100的近端到近端盘13c的盘面，编织主体10c的截面直径尺寸为逐渐增大或突然增大的过程，因而在入鞘时近端栓头20至近端盘13c的盘面这一段亦是较难入鞘的位置，而将凹陷401c设于近端栓头20与近端盘13c的盘面之间，可减小编织主体10c与鞘管的内壁接触面积，从而减小入鞘阻力，使封堵器100顺畅地进入鞘管内，提高手术的安全性和可操作性，降低手术的难度和风险。
同样地，本实施例中的凹陷401c亦可采用细铜丝对编织网管需要设置凹 陷的位置进行相应束缚定位，形成具有内凹的编织网管,其截面如图13所示,然后对编织网管进行定型，定型后，编织主体10c的相应位置即可形成凹陷，即使解除细铜丝其仍然可保持具有相应凹陷的状态。
第四实施例
参见图14、图15，本实施例与上述实施例的区别在于凹陷401d设置的位置不同，凹陷401d沿编织主体10d的侧壁呈螺旋轨迹进行分布，编织主体10d包括远端盘11d、近端盘13d及设于远端盘11d和近端盘13d之间的腰部12d，图15给出了凹陷401d分别对应于图14中的A、B、C三个位置的剖视示意图。即在本实施例中，凹陷401d围绕编织主体10d的中轴线呈螺旋状分布。凹陷401d沿着中轴线呈螺旋分布，分散了血流的冲击力，避免了应力集中，从而减少金属网管的丝线疲劳断裂的发生。在具体制造时，可先在未加工定型前的圆筒状的编织网管的侧壁采用细铜丝等辅助工装器具加工出沿该圆筒状的编织网管的侧壁呈螺旋轨迹分布的凹陷，然后进行定型形成编织主体。
第五实施例
参见图16、图17，在本实施例中，编织主体10e包括远端盘11e、腰部12e及近端盘13e，腰部12e设于远端盘11e和近端盘13e之间，远端盘11e、近端盘13e的盘面尺寸均大于腰部12e的径向截面尺寸，本实施例中的凹陷401e可设置多个，且各凹陷401e间隔分布在编织主体10e上，各个凹陷401e具有不同的深度，远端盘11e上越靠近远端盘11e的盘面的凹陷其深度越深，即远端盘11e上靠近远端盘11e的纵向中心轴的凹陷的深度小于远离远端盘11e的纵向中心轴的凹陷的深度,例如，靠近远端盘11e的盘面的位置A的凹陷401e的深度为1mm，远端盘11e上远离远端盘11e的盘面的位置B的凹陷401e的深度为0.5mm，位置A处的凹陷的深度大于位置B处的凹陷的深度；近端盘13e上越靠近近端盘13e的盘面的凹陷其深度越深，即近端盘13e上靠近近端盘13e纵向中心轴的凹陷的深度小于远离近端盘13e的纵向中心轴的凹陷的深度。例如，靠近近端盘13e的盘面的位置C的凹陷401e的深度为 1mm，近端盘13e上远离近端盘13e的盘面的位置D的凹陷401e的深度为0.5mm，位置C处的凹陷的深度大于位置D处的凹陷的深度。由于编织主体10e在进入鞘管内时，其远端盘11e的盘面、近端盘13e的盘面的截面尺寸相较于其它部位的截面尺寸较大，因而越靠近远端盘11e盘面和近端盘13e盘面的位置入鞘时就越容易出现阻滞或卡顿，而本实施例中使得靠近远端盘11e和近端盘13e的盘面的凹陷401e的深度大于远离远端盘11e和近端盘13e的盘面的凹陷401e的深度，采取了有针对性的设置，可使得靠近近端盘13e和远端盘11e的盘面的编织主体10e在入鞘时的大部分应力向朝向编织主体10e的中心方向靠拢，减小编织主体10e侧壁与鞘管内壁之间的正压力，从而减小入鞘阻力。
本实施例中的凹陷401e的具体制造方法可参考上述实施例进行：先采用细铜丝等工装器具对编织网管进行定位，使其形成凹陷401e，然后再进行定型加工，解除细铜丝等工装器具后即可，即可形成具有凹陷401e的编织主体10e。
第七实施例
参见图18、图19、图20，本实施例中，如图18所示，凹陷401g设置有偶数个，且偶数个凹陷401g成对设置于编织主体10g的侧壁，即任一对凹陷401g均关于编织主体10g的中轴线对称设置，此种结构设置可使得封堵器100的编织主体10g入鞘时应力分布更均衡，从而亦可很好地减轻其入鞘时的阻力，降低手术的难度和风险。当成对的凹陷401g为轴对称设置时，其既可以如图19所示，此时成对设置的凹陷401g为关于编织主体10g的中轴线为正对称结构，即成对设置的凹陷401g其正对编织主体10g的中心，也可如图22所示，成对设置的凹陷401g偏离于编织主体10g的中心而呈镜像对称设置，即此时凹陷401g偏离了编织主体10g的中心而没有与之正对设置。
第八实施例
在其它一些实施例中，如图21所示，凹陷401h可设置有多个，各凹陷 401h均沿轴向方向贯通编织网管10h，且多个凹陷401h非对称设置于编织网管10h的侧壁，此种结构设置同样可起到减小封堵器进入输送鞘管的管道内时所受到的与鞘管内壁相抵顶的径向应力，从而使封堵器更顺滑地进入鞘管内，降低手术的难度和风险。
第九实施例
如图22所示，在另外一些实施例中，凹陷401i亦可设置多个，各凹陷401i呈网点状分布于编织网管10i的侧壁，此时当定型后的编织主体入鞘时，呈网点状分布的凹陷401i可分散缓冲与鞘管内壁相抵顶的应力，从而减小封堵器进入鞘管内的阻力，使封堵器更顺畅地、顺滑地进入鞘管内，以降低手术的难度和风险。
值得说明的是，实施例七、八、九中的凹陷401g、40h、40i的加工制造均可参考其它实施例中的凹陷的制造方法进行制造，即采用细铜丝等工装器具先对编织网管进行束缚定位，使编织网管上形成相应的凹陷结构，然后再进行定型加工形成编织主体，对其具体的制造方法在此不予赘述。
对于尺寸较小的封堵器而言,由于其本身尺寸较小,而封堵器上的收缩变形减阻结构(凹陷)的设置尺寸更小,通过肉眼观察通常无法观察到较明显的收缩变形减阻结构(凹陷),此时可通过共聚焦显微镜进行建模测量观察,其差异性相比同尺寸的未设置收缩变形减阻结构(凹陷)的封堵器而言相对较明显。下面将同尺寸的现有技术的未设置收缩变形减阻结构的封堵器与本发明实施例提供的设置有收缩变形减阻结构的封堵器在共聚焦显微镜下测量进行对比说明：
如图23所示，是本发明提供的现有技术的未设置收缩变形减阻结构的封堵器在透明管道内时的相关图片，为方便实验观察，将现有技术的封堵器推入透明管道内，该透明管道的内径与输送该封堵器的输送鞘管的内径相等，以模拟封堵器在介入手术时进入输送鞘管时的使用环境，然后在普通光学显微镜下放大20至100倍下观察。本实施例中，放大20倍观察得到图23所示的图片。
将腰部设有收缩变形减阻结构(凹陷)的封堵器推入透明管道内，该透明管道的内径与输送该封堵器的输送鞘管的内径相等，以模拟封堵器在介入手术时进入输送鞘管时的使用环境，然后在普通光学显微镜下放大20至100倍下观察。本实施例中，放大20倍观察得到图24所示的图片；对比图23和图24可知，设有收缩变形减阻结构(凹陷)的封堵器在普通光学显微镜下观察其腰部有明显的凹陷，而未设置收缩变形减阻结构(凹陷)的封堵器其腰部变化不大，未看出有明显的内凹或凹陷。
如图25所示，是本发明提供的现有技术的未设置收缩变形减阻结构的封堵器在自然状态下(即不受外力作用下)时腰部在激光共聚焦显微镜下进行定量测量凹陷深度时的相关图片，在该图中，封堵器的腰部未见明显凹陷；而图27则是本发明实施例提供的设有收缩变形减阻结构(凹陷)的封堵器在自然状态下时腰部在激光共聚焦显微镜下进行定量测量凹陷深度的相关图片，在图27中，腰部可见明显的凹陷。
图26是本发明提供的图25的封堵器在激光共聚显微镜放大20倍下测量后的结果图，其中，横坐标表示封堵器的局部长度，纵坐标表示封堵器相应位置的垂直深度，由于该图中的封堵器的腰部未设置凹陷(即收缩变形减阻结构)，其深度差只有0.0483mm。本实施例中，测量时，封堵器的纵向中心轴与显微镜的载台平面平行，横坐标表示封堵器在自然状态下的腰部的轴向长度，纵坐标表示封堵器腰部相应位置的径向深度。可以理解的是，若收缩变形减阻结构设置于盘面的外端面上，测量时，封堵器的纵向中心轴与显微镜的载台平面垂直，则横坐标表示封堵器自然状态下的盘面的径向长度，纵坐标表示封堵器盘面相应位置的轴向深度。图28是本发明实施例提供的图27的封堵器在激光共聚显微镜下放大20倍测量后的结果图，其中，横坐标表示封堵器的局部长度，纵坐标表示封堵器相应位置的径向宽度，由于该图中的封堵器的腰部设置了凹陷(即收缩变形减阻结构)，其深度差达0.5051mm。需要说明是是，只要在激光共聚显微镜放大5至50倍的范围内，若有一处测量深度大 于0.1毫米，则证明其特意设置了收缩变形减阻结构。
通过共聚焦显微镜进行建模，其原理是通过测量识别封堵器的编织主体设置有凹陷的位置的深度，图27中测得封堵器编织主体的凹陷处最高处与最低处相差0.5051mm，即凹陷的深度为0.5051mm，见图28；而图26的对照组的现有技术的封堵器的编织主体由于没有设置收缩变形减阻结构(凹陷)，在封堵器的腰部处其深度仅为0.0483毫米，几乎没有高度差，属于工艺的误差范围内，两组具有显著性差异。
需要说明的是，本发明的设置收缩变形减阻结构的封堵器为单层封堵器(即封堵器的封堵盘的近端盘面和远端盘面均为单层编织结构)，其可以根据实际需要不设置阻流膜(比如采用大于或者等于72根的编织丝进行编织，形成可载入内径小于6F的输送鞘的封堵器)，如此更降低输送鞘管的内径尺寸，使得幼小患者的创伤更小。
以上仅为本发明的较佳实施例而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换或改进等，均应包含在本发明的保护范围之内。

Claims (13)

  1. 一种封堵器，其特征在于：包括：
    编织主体，所述编织主体采用具有形状记忆功能的编织丝编织形成的编织网管经过定型而成；
    所述编织主体设置有减小所述编织主体进入鞘管内的阻力的收缩变形减阻结构；所述收缩变形减阻结构通过使得所述编织主体在进入所述鞘管内发生径向收缩变形时，减小所述编织主体与所述鞘管的内壁的接触面积而减小所述编织主体的入管阻力。
  2. 如权利要求1所述的封堵器，其特征在于：所述收缩变形减阻结构包括设于所述编织主体上的凹陷，所述凹陷朝向所述编织主体的内侧方向内凹。
  3. 如权利要求2所述的封堵器，其特征在于：所述凹陷设置有至少一个，且所述凹陷贯通所述编织主体的近端及远端。
  4. 如权利要求2所述的封堵器，其特征在于：所述编织主体包括远端盘及与所述远端盘相连的收缩部，所述收缩部的径向截面尺寸小于所述远端盘的径向截面尺寸；所述凹陷靠近所述远端盘与所述收缩部的过渡连接处；
    或者，
    所述凹陷设于所述远端盘与所述收缩部的过渡连接处。
  5. 如权利要求2所述的封堵器，其特征在于：所述编织主体包括位于近端的近端盘、及设于所述近端盘近端的近端栓头；所述凹陷设于所述近端栓头与所述近端盘的盘面之间。
  6. 如权利要求3所述的封堵器，其特征在于：所述凹陷沿所述编织网管的侧壁呈螺旋轨迹进行分布。
  7. 如权利要求2所述的封堵器，其特征在于：所述编织主体包括远端盘、近端盘及连接于所述近端盘及所述远端盘之间的腰部，所述远端盘、近端盘的盘面尺寸均大于所述腰部的径向截面尺寸；所述凹陷设置有多个，所述多个凹陷间隔分布于所述编织主体，且各所述凹陷具有不同的深度，所述近端盘上靠 近所述近端盘纵向中心轴的凹陷的深度小于远离所述近端盘的纵向中心轴的凹陷的深度，所述远端盘上靠近所述远端盘的纵向中心轴的凹陷的深度小于远离所述远端盘的纵向中心轴的凹陷的深度。
  8. 如权利要求2所述的封堵器，其特征在于：所述凹陷设置有偶数个，且所述偶数个凹陷成对设置于所述编织网管的侧壁，任一对所述凹陷均关于所述编织网管的中轴线对称设置。
  9. 如权利要求3所述的封堵器，其特征在于：所述凹陷设置有多个，各所述凹陷均沿轴向方向贯通所述编织网管，且所述多个凹陷非对称设置于所述编织网管的侧壁。
  10. 如权利要求2所述的封堵器，其特征在于：所述凹陷设置有多个，且多个所述凹陷呈网点状间隔分布于所述编织网管。
  11. 如权利要求1所述的封堵器，其特征在于：所述封堵器为无阻流膜结构的单层结构。
  12. 如权利要求11所述的封堵器，其特征在于：所述封堵器经内径小于6F的鞘管输送。
  13. 一种封堵系统，包括如权利要求1至12中任一所述的封堵器及用于输送所述封堵器的输送鞘管。
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