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WO2018121114A1 - Filtre destiné à être implanté dans un vaisseau sanguin - Google Patents

Filtre destiné à être implanté dans un vaisseau sanguin Download PDF

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Publication number
WO2018121114A1
WO2018121114A1 PCT/CN2017/111120 CN2017111120W WO2018121114A1 WO 2018121114 A1 WO2018121114 A1 WO 2018121114A1 CN 2017111120 W CN2017111120 W CN 2017111120W WO 2018121114 A1 WO2018121114 A1 WO 2018121114A1
Authority
WO
WIPO (PCT)
Prior art keywords
filter
blood vessel
rolled
implantation
vessel according
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.)
Ceased
Application number
PCT/CN2017/111120
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English (en)
Chinese (zh)
Inventor
张庭超
李阳
赵珺
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hangzhou Endonom Medtech Co Ltd
Original Assignee
Hangzhou Weiqiang Medical Technology Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Hangzhou Weiqiang Medical Technology Co Ltd filed Critical Hangzhou Weiqiang Medical Technology Co Ltd
Priority to CN201780076619.2A priority Critical patent/CN110325148A/zh
Publication of WO2018121114A1 publication Critical patent/WO2018121114A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/0105—Open ended, i.e. legs gathered only at one side
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/0103—With centering means

Definitions

  • the present invention relates to the field of medical devices, and more particularly to a filter for implantation into a blood vessel.
  • Pulmonary embolism is a common health problem and is the leading cause of death in all age groups. Most pulmonary embolisms are caused by deep vein thrombosis (DVT) in the lower extremities or pelvis. Blood clots formed in another part of the body may migrate back to the heart through the veins and into the lungs, causing pulmonary infarction due to loss of blood and oxygen supply to a portion of the lungs. According to statistics, the mortality rate of untreated pulmonary embolism is 20%-30%; the number of newly added cases accounts for 0.2% of the total population every year. According to China's 1.35 billion population, there are about 2.7 million new patients each year.
  • the filter structure mainly includes two types, a cage filter of TrapEase structure (such as Cordis TRAPEASE/OPTEASE and Lifetech Aegisy) and a support filter of Kimray-Greenfield structure (such as Boston Scientific Greenfield, St. Jude Amplatz, Bard Denali, COOK Celect and Rex Medical Option).
  • a cage filter of TrapEase structure such as Cordis TRAPEASE/OPTEASE and Lifetech Aegisy
  • Kimray-Greenfield structure such as Boston Scientific Greenfield, St. Jude Amplatz, Bard Denali, COOK Celect and Rex Medical Option
  • the filter of the TrapEase structure such as the publications of the publications CN2710575Y, CN105213065A, CN204909721U, CN2569700Y and CN104970900 A, has the disadvantage that the device increases the area of the struts that the instrument contacts the vessel wall in order to enhance the fixation effect in the inferior vena cava. However, this tends to cause the endothelium to climb the struts. It is easy to tear the endothelium during the process of recovering the instrument and damage the blood vessel wall, and even cause the device to be unrecyclable.
  • the filter of the Kimray-Greenfield structure such as the patent documents disclosed in CN104825247A, CN101031254A, CN101143114A, has the disadvantage that when the device is implanted In the inferior vena cava, due to the poor self-centering ability of the conical instrument, the instrument is easy to tilt after implantation into the inferior vena cava. After the instrument is tilted, the recovery head is closely attached to the vessel wall; during the recovery process, the recovery device cannot smoothly capture the recovery head. , will increase the surgical operation time of the device recovery, and even lead to the failure of the device recycling operation.
  • the general structural feature of the prior art filter has a central connecting portion, and a cage-type or strut-type filtering portion extends from one side of the central connecting portion, and in some filters, a rod-shaped connecting body is connected to the central connecting portion.
  • the support portion and the support portion are turned back toward the filter portion, but the end of the support portion is easily penetrated into the tissue too deep during the release process, thereby posing a safety hazard and affecting the normal release operation.
  • the present invention provides a filter for implantation into a blood vessel, by which the shape of the support portion is improved, and the end of the support can be rolled up in time to avoid stabbing the tissue.
  • a filter for implantation into a blood vessel comprising a central connection portion and a filter portion and a support portion connected to the central connection portion, wherein the support portion is a plurality of struts of radiation distribution, at least a portion of the struts being released
  • the lower curved turn section has a gradually increasing curvature from the side adjacent the center joint.
  • the curvature of the rolled section is gradually increased as an overall trend, and the curve which must be a gradual change is not strictly limited, or may be a combination of a plurality of straight segments, or a combination of a straight line and a curved line, due to the overall
  • the upper curvature gradually increases, and the trend toward the end of the roll is more obvious.
  • the rollover method of the roll section is:
  • the central connecting portion first extends toward the side of the filtering portion and is turned back toward the filtering portion;
  • the central connecting portion first extends away from the side of the filter portion and is rolled toward the filter portion.
  • the struts are extended from the central connecting portion to the side of the filtering portion.
  • the overall extension trend should be understood as extending in the axial direction, and also allowing a certain angle, that is, the extension has just begun. Rolling, the same reason to extend away from the side of the support, is also understood as the overall trend.
  • the end of the strut is a free end of the suspension.
  • the struts on the same filter can also be rolled in different ways.
  • the struts are divided into two groups, and the tumbling segments are respectively rolled according to mode A and mode B;
  • the central connecting portion first extends toward the side of the filtering portion and is turned back toward the filtering portion;
  • the central connecting portion first extends away from the side of the filter portion and is rolled toward the filter portion.
  • the struts are turned back toward the filter part, so that when released in the body, the first released end is rolled up to a certain angle when reaching the inner wall of the blood vessel, and the end of the end is directly contacted with the inner wall of the blood vessel, thereby further eliminating the safety hazard.
  • the struts are rolled toward the filter portion. According to the structure, it can be seen that the recovery problem of the filter is no longer considered, but it is desirable to form a permanent support in the blood vessel to meet the needs of some patients.
  • the description of the shape of the present invention is understood to mean the release of the unfolded shape in vivo, unless otherwise stated.
  • the rolled section is a smooth curve whose curvature changes continuously or intermittently.
  • the scrolling section can adopt a smooth curve.
  • the curvature can be continuously changed, or a certain middle section can be kept unchanged, and then become smaller, that is, intermittently changed, but in any case, the overall trend of the rolled section is The tendency to roll around the end is more obvious and should not be limited to local variations in a small size range.
  • the starting point of the rolled section is connected to the central connecting portion through a first straight line segment or directly connected to the central connecting portion.
  • One end of the scrolling section adjacent to the central connecting portion can be regarded as a starting point.
  • the first straight line segment can be connected to the central connecting portion, and the first straight straight section can be regarded as a transitional connection with the central connecting portion. In order to start rolling from a suitable axial position.
  • a cross-linking junction adjacent to the central connecting portion is provided between the adjacent struts in the circumferential direction. Structure.
  • the crosslinked structure is a deformable structure, for example, two adjacent struts are formed into a parallelogram or the like by a crosslinked structure at the cross-linking.
  • the crosslinked structure can further increase the stability of the support portion, and in order to avoid interference with the roll, the crosslinked structure is only increased at a position close to the center joint portion. At the same time, the cross-linked structure can filter out some small thrombus.
  • the end of the turning section is provided with an anchor thorn, which is anchored in the same direction as the turning section. Support and positioning can be further enhanced by setting the anchor.
  • the end point of the turning section is the end of the pole, or the second straight section is connected at the end point.
  • the second straight line segment should not be too long, only as an extension and auxiliary stabilization of the rolled section.
  • the rolled section should have a sufficient length in the struts in which it is located, preferably the length of the rolled section is at least 1/2 of the total length of the struts.
  • the length of the rolled section is at least 2/3 of the total length of the strut until the struts are integrally turned as a rolled section.
  • the rolled section When the rolled section is not a continuous curve, it can be regarded as being formed by sequentially connecting a plurality of segments, and the bending points of the adjacent segments are changed to achieve a change in the overall curvature.
  • the rolled section is divided into at least three sub-sections, and the connecting portion of the adjacent sub-section is an inflection point with a sudden change of curvature, and one end of the rolled-back section is a starting point and is directly connected to the central connecting portion, and the other end is an end point and directly extends to the branch.
  • the end of the rod; the starting point, the end point and all the inflection points, the arc determined between the adjacent three points is the reference arc, and the curvature of each reference arc from the starting point to the end point increases in turn.
  • different sub-segments are independent of straight segments or curved segments.
  • all sub-segments are straight segments.
  • the radius of curvature of the end portion of the tumbling section is 0.5 to 5 mm.
  • the angle of rollover should not be too small, otherwise the degree of tumbling at the end of the struts is insufficient to avoid penetration into the blood vessel.
  • the lap angle of the struts is greater than 180 degrees.
  • the angle of the roll can be referred to the direction of the end of the rod.
  • the end of the rod in the mode A is directed to the filter portion, which is 180 degrees. If it is greater than 180 degrees, the roll should be continued. If the roll is 360, the end of the rod points to the filter. Part B is the same.
  • the shape of the strut satisfies: D2 ⁇ D1 ⁇ D;
  • the tangential line at the end of the strut is the second boundary line, and the maximum width spanned by the strut relative to the second boundary line;
  • D1 ensures that the end of the rod is curled before it is released, and the roll angle is 180°. However, only D1 is defined, and there is still another risk that the end of the struts penetrates into the blood vessel during the release, so this problem is overcome by the preference of D2.
  • the maximum diameter of the blood vessel is 2D (16 to 34 mm interval, usually 24 mm), and in view of the usual size of the blood vessel, D1 ⁇ 17 mm and D2 ⁇ 8 mm are preferable.
  • each of the support rods is near the center
  • the area of the joint has a cross-linked structure, and the maximum diameter of the cross-linking position does not exceed 30 mm.
  • the cross-linked structure is a network structure, which can further enhance the support force and stability of each strut.
  • the filter part and the support part may be formed by cutting the pipe material, or may be directly shaped by the wire material; the material may be made of stainless steel having a shape memory function, a nickel-titanium alloy, a cobalt-chromium alloy or a titanium alloy, etc. One or more components.
  • the support portion of the filter of the invention has uniform and higher radial support force, so that the device has better self-centering performance, prevents the instrument from tilting, and reduces the endothelial climbing, which is beneficial to the device for capturing and recycling and prolonging the recovery time.
  • FIG. 1 is a schematic structural view of a filter of Embodiment 1;
  • Figure 2 is a schematic view of the contact portion of the struts with the blood vessel wall
  • Figure 3 is a schematic view of the shape of the strut
  • FIG. 4 is a schematic structural view of a filter of Embodiment 2;
  • Figure 5 is a schematic view showing the shape of the strut of the third embodiment
  • Figure 6 is a schematic view of the anchor thorn at the end of the strut
  • Figure 7 is a schematic view showing the shape of the strut of the fourth embodiment
  • Figure 8 is a schematic view of the comparative shape of the strut
  • FIG. 9 is a schematic structural view of a filter of Embodiment 5.
  • Figure 10 is a schematic view showing the structure of the filter of Embodiment 6;
  • Figure 11 is a schematic view showing the state of use of the filter of the embodiment 7;
  • Figure 12 is a schematic view showing the structure of the filter of Embodiment 7;
  • the filter 1000 of the present embodiment includes a filter portion 1100, a support portion 1200 and a central connecting portion 1300. After being laser-cut by an OD2.0 mm nickel-titanium tube, it is heat-set by a mold.
  • the filter portion 1100 is configured to capture the plug from the blood flow direction, and includes six filter portion rods 1100 extending outward from the central connecting portion 1300.
  • the filter portion rod 1100 has an angle of about 0 to 90 degrees from the central axis Y, at least two of which
  • the end of the root filter strut 1100 includes a barb 1110, and the filter portion 1100 may be a single-layer strut structure, and may also have a cage structure.
  • the support portion 1200 is used to prevent the instrument from tilting, and is extended outward from the central connecting portion 1300 and rolled upward toward the filter portion 1100 as a whole in the orientation of the drawing.
  • the support portion 1200 is a plurality of radial struts 1210 having at least three, and in this embodiment, six struts 1210.
  • the device of the present embodiment When in use, the device of the present embodiment is delivered to the lower part of the renal artery via the jugular vein, and the delivery catheter is withdrawn.
  • the filter filter portion 1100 is gradually released from the catheter, and self-expanding is deployed.
  • the barb 1110 at the end first adheres to the blood vessel and penetrates the blood vessel.
  • the wall is anchored, the delivery catheter is further retracted, the support portion 1200 is unfolded, and the wall is gradually attached.
  • the filter 1000 Under the action of the support portion 1200, the filter 1000 is less likely to be inclined, and the central connection portion 1300 is difficult to be attached, so that the device is easier to recycle, and the device is easier to recycle.
  • the filter is mainly in point contact with the blood vessel wall (see FIG. 2), and the tumbling portion of the struts is in contact with the blood vessel wall 2000 near the end, and is non-face contact, which can effectively reduce the endothelial climbing and prolong the filter recovery time.
  • each of the struts is a rolled portion that is bent away from the filter portion in a released state, and the curling portion gradually increases in curvature from a side adjacent to the central connecting portion, and the curvature gradually increases, which is understood as an overall trend, that is, The more obvious the tendency to roll near the end, the example is the strut 1210 in FIG. 3, the point A is the boundary, the straight line segment 1211 is connected to the central connecting portion, and the lower side of the point A is the rolled portion 1212, and the rolled portion 1212 is a smooth curve. The tendency of the curvature to change continuously and gradually increase toward the end is more obvious.
  • the shape of the strut 1210 satisfies: D2 ⁇ D1 ⁇ D;
  • D1 a maximum width spanned by the strut 1210 with respect to the second boundary line with the tangent L1 at the end of the strut 1210 as the second boundary line;
  • the end point of the strut 1210 is the intersection point B
  • the perpendicular line L2 passing through the second boundary line of the intersection point B is the boundary line, and the maximum distance spanned by the strut on the side of the boundary line facing away from the center connecting portion.
  • the difference in this embodiment is that there is a certain cross-linking structure at the position of each strut near the central connecting portion, which can improve the connection between the strut of the supporting portion and improve the radial direction. Supporting force while improving the filtering effect of the device.
  • the maximum outer diameter D3 of the cross-linked structure should not exceed 24 mm, so as to avoid contact between the position of the cross-section and the vessel wall. After the endothelium is climbed, the filter will be difficult to remove.
  • the difference in this embodiment is that the shape of the strut 1210 is different, and the rolled section is divided into four straight sections which are sequentially connected, which are a straight section 1213, a straight section 1214, and a straight section 1215.
  • the straight line segment 1216, the connecting portion of the adjacent segment is the inflection point of the sudden change of curvature, followed by the inflection point G1, the inflection point G2, the inflection point G3, the end of the scrolling section is the starting point G0, and the other end is the ending point G4; as a whole, it is not difficult to see that the end is rolled over.
  • the trend is even more pronounced, and the ever-increasing curvature of the flip-flop can solve the risk of the struts piercing the vessel wall during the release process.
  • the arc determined between the three points of the starting point G0, the inflection point G1 and the inflection point G2 is the reference arc C1;
  • the arc determined between the three points of the inflection point G1, the inflection point G2, and the inflection point G3 is a reference arc C2;
  • the arc determined between the inflection point G2, the inflection point G3, and the end point G4 is the reference arc C3;
  • the straight section 1216 can also be provided with an anchor 1217 that is in contact with the vessel wall 2000, in contact with the vessel wall 2000 to enhance the positioning effect.
  • an anchor 1217 that is in contact with the vessel wall 2000, in contact with the vessel wall 2000 to enhance the positioning effect.
  • One is to prevent the filter from shifting, and the other is to control the depth of the piercing of the blood vessel wall if the struts pierce the blood vessel wall because of the presence of the barbed bifurcation;
  • the difference of this embodiment is that the shape of the strut 1210 is different, and the rolled section is divided into six straight segments which are sequentially connected, and although the number of straight segments is increased, D2 ⁇ D1 is also satisfied. ⁇ D and the limitation that the curvature of each reference arc increases sequentially.
  • the rolled section is a smooth circular arc, but a straight section 1218 is extended at the end.
  • D2>D1 in Fig. 8 is visible according to the shape of the strut in the figure, and the straight section 1218 is too long, and is still at the end of the release period. There is a risk of stabbing blood vessels.
  • the filter 1000 of the present embodiment includes a filter portion 1100, a support portion 1200 and a central connecting portion 1300.
  • the main difference from the first embodiment is that the support portion 1200 is formed by using a wire of 0.1 to 0.6 mm.
  • Materials include, but are not limited to, one or more of stainless steel, nickel titanium alloy, cobalt chromium alloy, titanium alloy, and the like.
  • there are six 0.35mm nickel-titanium wires one end is sleeved with a steel sleeve, and then connected by argon arc welding, and then heat-shaped by a mold to form a continuous smooth curved support arm.
  • the vena cava filter is generally implanted under the renal artery.
  • This embodiment provides a technical solution for placing the filter, which may be above the renal artery, increasing the anchoring area of the filter, and expanding the use of the filter. range.
  • the filter portion 1100 is located below the renal artery 2100, and the support portion 1200 is located above the renal artery 2100.
  • FIG. 12 is a permanent implant filter.
  • the strut 1210 is rolled up according to the mode B, that is, the central connecting portion is first extended upward (ie, away from the side of the filter portion), and then rolled downward (ie, toward the filter).
  • the side is rolled up on one side, and the direction of the roll is exactly the opposite of the previous embodiments.
  • the filter can be implanted through the femoral vein, and the support portion is at the distal end. First, the support portion is gradually released, the support rod is bent and deployed, and finally the filter portion is deployed.
  • the rewinding of mode B no longer considers the recovery of the filter, but rather the desire to form a permanent support within the blood vessel.
  • the filter rod has a smaller contact area with the blood vessel wall, reduces endothelial climbing, has a lower probability of occlusion of blood vessels, improves the long-term normal rate of blood vessels, and has good self-centering performance to prevent tilting of the instrument.
  • the support portion in this embodiment may also be provided with an anchor thorn as in Embodiment 3 to prevent the filter from being displaced.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un filtre (1000) destiné à être implanté dans un vaisseau sanguin, comprenant une partie de raccordement centrale (1300) ainsi qu'une partie filtre (1100) et une partie support (1200) reliées à la partie de raccordement centrale (1300), la partie support (1200) étant constituée d'une pluralité de tiges de support (1210) réparties de manière rayonnante, au moins certaines des tiges de support (1210) étant des sections de roulement (1212) qui s'éloignent, en se courbant, de la partie filtre dans un état libéré, la courbure des sections de roulement (1212) augmentant progressivement depuis le côté le plus proche de la partie de raccordement centrale (1300). Grâce à la modification de la forme de la partie support (1200), lorsqu'elle est libérée, l'extrémité dudit filtre à implanter dans un vaisseau sanguin peut être immédiatement enroulée pour empêcher la perforation du tissu.
PCT/CN2017/111120 2016-12-26 2017-11-15 Filtre destiné à être implanté dans un vaisseau sanguin Ceased WO2018121114A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201780076619.2A CN110325148A (zh) 2016-12-26 2017-11-15 一种用于植入血管内的滤器

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201621442084 2016-12-26
CN201621442084.5 2016-12-26
CN201720196735.5 2017-03-02
CN201720196735.5U CN207220906U (zh) 2016-12-26 2017-03-02 一种用于植入血管内的滤器

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WO2018121114A1 true WO2018121114A1 (fr) 2018-07-05

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PCT/CN2017/075790 Ceased WO2018120414A1 (fr) 2016-12-26 2017-03-06 Filtre
PCT/CN2017/111120 Ceased WO2018121114A1 (fr) 2016-12-26 2017-11-15 Filtre destiné à être implanté dans un vaisseau sanguin

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PCT/CN2017/075790 Ceased WO2018120414A1 (fr) 2016-12-26 2017-03-06 Filtre

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CN114681107A (zh) * 2020-12-25 2022-07-01 深圳市科奕顿生物医疗科技有限公司 一种可植入管腔的滤器

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CN110882090A (zh) * 2019-12-20 2020-03-17 成都迈德克科技有限公司 可回收腔静脉滤器
CN111789697B (zh) * 2020-07-10 2023-10-24 埃文斯科技（北京）有限公司 一种具有防倾斜支撑臂的腔静脉滤器及其加工方法
CN113244018B (zh) * 2021-06-04 2025-07-25 上海蓝脉医疗科技有限公司 一种辅助装置及输送器
CN119837677A (zh) * 2025-01-20 2025-04-18 上海以心医疗器械有限公司 血栓过滤装置及其输送装置

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