WO2022252990A1 - 一种滤器及医用装置 - Google Patents
一种滤器及医用装置 Download PDFInfo
- Publication number
- WO2022252990A1 WO2022252990A1 PCT/CN2022/093663 CN2022093663W WO2022252990A1 WO 2022252990 A1 WO2022252990 A1 WO 2022252990A1 CN 2022093663 W CN2022093663 W CN 2022093663W WO 2022252990 A1 WO2022252990 A1 WO 2022252990A1
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- WO
- WIPO (PCT)
- Prior art keywords
- filter
- anchor
- recovery
- filter rod
- rods
- Prior art date
Links
- 238000011084 recovery Methods 0.000 claims description 110
- 238000005520 cutting process Methods 0.000 claims description 23
- 210000001631 vena cava inferior Anatomy 0.000 description 17
- 238000010586 diagram Methods 0.000 description 13
- 208000007536 Thrombosis Diseases 0.000 description 11
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- 238000004873 anchoring Methods 0.000 description 5
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- 206010051055 Deep vein thrombosis Diseases 0.000 description 4
- 206010014522 Embolism venous Diseases 0.000 description 4
- 230000008901 benefit Effects 0.000 description 4
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- 238000012986 modification Methods 0.000 description 4
- 230000004048 modification Effects 0.000 description 4
- 208000004043 venous thromboembolism Diseases 0.000 description 4
- 208000010378 Pulmonary Embolism Diseases 0.000 description 3
- 238000006073 displacement reaction Methods 0.000 description 3
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- 206010047249 Venous thrombosis Diseases 0.000 description 2
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- 229940127219 anticoagulant drug Drugs 0.000 description 2
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- 210000001147 pulmonary artery Anatomy 0.000 description 2
- 238000004064 recycling Methods 0.000 description 2
- 210000003462 vein Anatomy 0.000 description 2
- 208000005189 Embolism Diseases 0.000 description 1
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 1
- 239000000956 alloy Substances 0.000 description 1
- 230000010100 anticoagulation Effects 0.000 description 1
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- 229910001000 nickel titanium Inorganic materials 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
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Images
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
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
Definitions
- the invention relates to the technical field of medical devices, in particular to a filter and a medical device.
- VTE Venous thromboembolism
- DVT deep vein thrombosis
- PE pulmonary embolism
- DVT deep vein thrombosis
- PE pulmonary embolism
- Anticoagulant therapy has always been the gold standard in the treatment of VTE, the purpose of which is to prevent thrombosis, prevent PE, and restore the smooth flow of embolized veins.
- a filter vena cava filter, VCF
- VCF vena cava filter
- the filter in the prior art is prone to inclination when implanted in the inferior vena cava, and cannot achieve the expected thrombus interception effect.
- the filters in the prior art are prone to displacement after being implanted into the inferior vena cava, which is not conducive to subsequent recovery of the filter.
- the purpose of the present invention is to provide a filter and a medical device.
- the centering of the filter can be improved through the gradual release of the filter rod, and the thrombus interception effect can be improved.
- the present invention provides a filter, including a plurality of filter rod groups, each of which includes several filter rods; the lengths of the filter rods in different filter rod groups are not equal ; all the filter rods in the same filter rod group have the same length, and all the filter rods in the same filter rod group are symmetrically arranged around the axis of the filter.
- the filter is used for release in the target lumen, and during the release process, all the filter rod groups are sequentially released according to the length of the filter rods in order from short to long.
- the filter rod with the shortest length is used to contact the wall line of the lumen of the target, and the distal ends of the remaining filter rods are formed with anchors for penetrating into the target the wall of the lumen.
- the filter rod with the shortest length includes a first part, a second part and a third part which are sequentially connected from the proximal end to the distal end, and the distance from the first part to the axis of the filter is along the proximal The direction from the end to the distal end gradually increases, and the distance from the third portion to the axis of the filter is greater than the distance from the first portion to the axis of the filter.
- the anchor includes a first anchor and a second anchor, and the first anchor and the second anchor are formed on different filter rods;
- the filter is configured such that when the anchor penetrates the wall of the target lumen, the first anchor is used to prevent the filter from moving in a direction from the proximal end to the distal end, and the second anchor is The two anchors are used to prevent the filter from moving in the direction from the distal end to the proximal end.
- the length of the filter rod formed with the second anchor is shorter than the length of the filter rod formed with the first anchor.
- the first anchor is a linear structure, and the proximal end of the first anchor is connected to the corresponding distal end of the filter rod, and the distal end of the first anchor is The heart end is a free end; the second anchor is a barb structure, and the free end of the second anchor is arranged toward the proximal end of the filter.
- an anti-puncture member is formed on the filter rod at least partially formed with the anchor, and the anti-puncture member is used to prevent the anchor from piercing the wall of the target lumen.
- At least one filter rod set is cut from a first pipe body, at least one filter rod set is cut from a second pipe body, and the second pipe body is arranged on the first pipe body inside.
- one filter rod group is formed by cutting the first pipe body, and the length of the filter rod formed by cutting the first pipe body is the shortest.
- the number of the filter rods formed by cutting the first pipe body is 3-9, and the width of each filter rod is 0.3mm-1mm; the filter rods formed by cutting the second pipe body The number of the filter rods is 4-9, and the width of each filter rod is 0.5mm-1mm.
- the filter further includes a recovery hook, and the recovery hook is formed by cutting the first pipe body and/or the second pipe body.
- the number of the recovery hooks is at least one; when the number of the recovery hooks is multiple, a plurality of the recovery hooks are evenly arranged in the circumferential direction of the filter, each of the recovery hooks faces The inside of the filter is curved, and the tops of all the recovery hooks are staggered from each other in the axial direction of the filter.
- At least one of the free end of the recovery hook, the top of the recovery hook and the fixed end of the recovery hook is provided with a developing element.
- the present invention also provides a medical device, comprising a transport assembly and the filter according to any one of the preceding items; the transport assembly is used to load the filter and transport the filter to a predetermined position and the conveying assembly is configured to sequentially release all the filter rod groups in sequence from short to long according to the length of the filter rods.
- the present invention also provides another filter, comprising a plurality of filter rods and a plurality of recovery hooks, a plurality of the recovery hooks are connected to the proximal ends of all the filter rods; a plurality of the recovery hooks Evenly arranged in the peripheral direction of the filter, each of the recovery hooks is bent towards the inner side of the filter, and the tops of all the recovery hooks are staggered from each other in the axial direction of the filter.
- the filter and medical device of the present invention have the following advantages:
- the aforementioned medical device includes a filter and a delivery assembly, the filter includes a plurality of filter rod groups, each filter rod group includes several filter rods; the lengths of the filter rods in different filter rod groups are not equal; All the filter rods in the same filter rod group have the same length, and all the filter rods in the same filter rod group are symmetrically arranged around the axis of the filter.
- the delivery assembly is used to load the filter, and is configured to deliver the filter to the target lumen, and sequentially release all the filter rod groups in sequence from short to long according to the length of the filter rods, not only It avoids inaccurate positioning of the filter caused by jumping forward during the release process, and also enables the filter to have good centering in the target lumen, thereby improving the efficiency of thrombus interception.
- the filter rod with the shortest length is used to contact the wall line of the target lumen, and the distal ends of the remaining filter rods are formed with anchors, and the anchors are used to penetrate into the target lumen. This design can effectively ensure the centering of the filter in the target lumen, and also reduce the recovery resistance when the filter is recovered later.
- At least one filter rod group is cut from a first pipe body, at least one filter rod group is cut from a second pipe body, and the second pipe body is arranged on the first pipe body , that is, the filter is cut from double-layer tubing, with the same number of rods and the same diameter of the filter in the compressed state, as compared to a filter cut from single-layer tubing
- the filter rod of the filter of the present invention has a larger width, which can improve the filter's interception effect on thrombus, and can also increase the support force of the filter on the blood vessel wall, and improve the positioning stability of the filter.
- Fig. 1 is a schematic structural view of a filter provided by the present invention according to an embodiment
- Fig. 2 is a schematic diagram of a partial structure of a filter according to an embodiment of the present invention, in which a first anchor and a puncture-proof member are shown;
- Fig. 3 is a schematic diagram of a partial structure of a filter according to an embodiment of the present invention, which shows that the filter is cut from a double-layer pipe;
- Fig. 4 is a partial structural schematic diagram of a filter provided by the present invention according to an embodiment, in which the filter includes a recovery hook;
- Fig. 5 is a schematic diagram of a partial structure of a filter provided by the present invention according to an embodiment, in which the filter includes two recovery hooks;
- Fig. 6 is a schematic diagram of a partial structure of a filter provided by the present invention according to an embodiment, and the viewing directions of Fig. 6 and Fig. 5 are different;
- Fig. 7 is a schematic diagram of a partial structure of a filter according to an embodiment of the present invention, which shows that the filter includes two recovery hooks, and the shape of the recovery hooks is different from that shown in Fig. 5;
- Fig. 8 is a schematic diagram of a partial structure of a filter according to an embodiment of the present invention, in which the filter includes three recovery hooks;
- Fig. 9 is a schematic diagram of a partial structure of a filter provided by the present invention according to an embodiment, and Fig. 9 and Fig. 8 are viewed in different orientations;
- Fig. 10 is a schematic diagram of a partial structure of a filter according to an embodiment of the present invention, which shows that the filter includes three recovery hooks, and the shape of the recovery hooks is different from that shown in Fig. 8;
- Fig. 11 is a schematic diagram of a partial structure of a filter according to an embodiment of the present invention, the free end of the filter shown in a) is provided with a developing element, the top of the filter shown in b) is provided with a developing element, c) The fixed end of the shown filter is provided with a developing element;
- Fig. 12 is a schematic structural view of a medical device according to an embodiment of the present invention, the sheath is not shown in the figure, and the second filter rod has been released.
- each embodiment of the content described below has one or more technical features respectively, but this does not mean that the inventor must implement all the technical features in any embodiment at the same time, or can only implement different embodiments separately. Some or all of the technical features. In other words, on the premise that the implementation is possible, those skilled in the art can selectively implement some or all of the technical features in any embodiment according to the disclosure of the present invention and depending on design specifications or implementation requirements, or Selectively implement a combination of some or all of the technical features in multiple implementations, thereby increasing the flexibility of the implementation of the present invention.
- the singular forms “a”, “an” and “the” include plural objects, and the plural form “a plurality” includes two or more objects, unless the content clearly states otherwise.
- the term “or” is generally used in the sense including “and/or”, unless the content clearly indicates otherwise, and the terms “install”, “connect” and “connect” should be To understand it in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediary, and it can be the internal communication of two elements or the interaction relationship between two elements. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.
- distal end and proximal end refer to the positional relationship of the medical device relative to the patient's heart after the medical device is implanted in the patient's body.
- distal end refers to the The end of the heart
- proximal means the end near the heart.
- Fig. 1 shows a schematic structural diagram of a filter 100 provided by an embodiment of the present invention.
- the filter includes a plurality of filter rod groups, and each filter rod group includes several filter rods 110 .
- the lengths of the filter rods 110 in different filter rod groups are not equal.
- All the filter rods 110 in the same filter rod set have the same length, and all the filter rods 110 in the same filter rod set are arranged symmetrically around the axis of the filter 100 .
- the filter 100 can be delivered to a target lumen by a delivery assembly and released.
- the target lumen is the inferior vena cava.
- the filter 100 is delivered transfemorally to the inferior vena cava by the delivery assembly and released to intercept the thrombus, preventing the thrombus from entering the heart and then entering the pulmonary artery and causing pulmonary embolism.
- the conveying assembly sequentially releases each of the filter rod groups according to the length of the filter rods 110 in the order of short first and then long. It should be noted that the length of the filter rod 110 refers to the dimension of the filter rod 110 in the axial direction of the filter 100 when the filter 100 is compressed.
- the filter 100 is generally a self-expanding structural member, which is pre-shaped during production, and when it is subjected to radial extrusion force, it shrinks in the radial direction to be in a compressed state with a smaller radial dimension , and when the radial extrusion force is canceled, the filter 100 can expand radially and return to the predetermined shape under the action of its own elasticity.
- the material of the self-expanding structure can be a shape memory alloy material such as nickel-titanium metal or other superelastic material.
- the filter 100 includes four filter rod groups as an example for introduction, but those skilled in the art should understand that the number of the filter rod groups can be less than four (for example, two or three), or There may be more than four (eg five).
- the four filter rod groups are respectively the first filter rod group, the second filter rod group, the third filter rod group and the fourth filter rod group, wherein the first filter rod group includes six The first filter rod 110a, the second filter rod group includes two second filter rods 110b, the third filter rod group includes two third filter rods 110c, and the fourth filter rod group includes two fourth filter rods The filter rod 110d, and the length of the first filter rod 110a, the length of the second filter rod 110b, the length of the third filter rod 110c and the length of the fourth filter rod 110d increase sequentially.
- the filter 100 when the filter 100 is delivered to the inferior vena cava (that is, the aforementioned target lumen) and released, the first filter rod set is released first, then the second filter rod set is released, and then the second filter rod set is released. three filter rod groups, and finally release the fourth filter rod group. Each of the filter rod groups is released successively. On the one hand, it can prevent the filter 100 from jumping forward during the release process and cause the filter 100 to be positioned inaccurately.
- the filter 100 can be centrally positioned in the inferior vena cava, so as to improve the trapping effect of embolism and improve the curative effect.
- centering here means that the filter 100 is arranged coaxially with the inferior vena cava. The specific release method of the filter 100 will be described in detail later.
- the first filter rod 110a (that is, the filter rod 110 with the shortest length) is used to contact the wall line of the inferior vena cava, so that after the first filter rod 110a is released, the first filter rod 110a can provide a greater radial support force to the vessel wall, so that the filter 100 can be relatively stably maintained in the inferior vena cava.
- Anchor pieces are respectively formed on the distal ends of the remaining filter rods 110 (that is, the second filter rod 110b, the third filter rod 110c and the fourth filter rod 110d), and the anchor pieces Used to penetrate the blood vessel wall to assist the positioning of the filter 100, avoiding the displacement of the filter 100 under the impact of blood flow, and the filter rod 110 provided with the anchor is in the subsequent recovery process of the filter 100 Generates less recovery resistance, which is conducive to recovery. That is to say, the filter 100 provided in this embodiment has both stability and recyclability, and has better performance.
- the first filter rod 110a includes a first part 111 , a second part 112 and a third part 113 which are sequentially connected from the proximal end to the distal end.
- the first portion 111 and the third portion 113 are arranged at an angle, and the second portion 112 is actually an arc segment for making the first portion 111 and the third portion 113
- the smooth transition prevents the first filter rod 110a from having a sharp corner and damaging blood vessels.
- the distance from the first portion 111 to the axis of the filter 100 gradually increases along the direction from the proximal end to the distal end, and the distance from the third portion 113 to the axis of the filter 100 is greater than the distance from the first portion 111 to the axis of the filter 100.
- the distance of the axis of the filter 100 at least a part of the third portion 113 can be in linear contact with the vessel wall.
- the distal end of the third part 113 can also be provided with a fourth part 114, the fourth part 114 is arranged at an angle to the third part 113, and the fourth part 114 is connected to the filter
- the distance of the axis of 100 decreases gradually along the direction away from the third portion 113 .
- the rest of the filter rods 110 are all in a straight line configuration, and in the expanded state, the rest of the filter rods
- the distance from the filter rod 110 to the axis of the filter 100 gradually increases along the direction from the proximal end to the distal end, so that the corresponding distal end of the filter rod 110 is in contact with the blood vessel under the action of the anchor. wall contact.
- first anchors 121 and second anchors 122 There are two types of anchors, namely first anchors 121 and second anchors 122, and the first anchors 121 and the second anchors 122 are formed on different filters.
- the first anchor 121 and the second anchor 122 are not located on the same filter rod 110, in other words, when one filter rod 110 is formed with the When the first anchor 121 is used, the second anchor 122 is not formed on the filter rod 110, and correspondingly, when the second anchor 122 is formed on the filter rod 110 122, the first anchoring member 121 is not formed on the filter rod 110.
- the filter 100 is configured such that when the anchor penetrates into the vessel wall, the first anchor 121 is used to prevent the filter 100 from moving in the direction from the proximal end to the distal end, and the second anchor
- the fixed piece 122 is used to prevent the filter 100 from moving in the direction from the distal end to the proximal end. Displacement of the filter 100 is prevented by the cooperation of the first anchor 121 and the second anchor 122 .
- the first anchoring member 121 can be a linear structure, and the proximal end of the first anchoring member 121 is connected to the corresponding distal end of the filter rod 110. end connection, and the distal end of the first anchor 121 is a free end.
- the second anchor 122 is a barb structure, and the free end of the second anchor 122 is arranged toward the proximal end of the filter 100 .
- the same type of anchors are formed on all the filter rods 110 in the same filter rod group. In this way, the force on the filter 100 can be balanced, and the stability and centering can be further improved. sex.
- the length of the filter rod 110 formed with the first anchor 121 is longer than the length of the filter rod 110 formed with the second anchor 122, that is, the longest The first anchor 121 is formed on the distal end of the filter rod 110 , and the second anchor 122 is formed on the distal end of the filter rod 110 whose length is the third. In this way, in the filter 100 shown in FIG.
- the first anchors 121 are formed on the distal ends of all the fourth filter rods 110d, and the distal ends of all the second filter rods 110b are formed on the distal ends.
- the second anchor 122 is described.
- the second anchors 122 are formed on the distal ends of all the third filter rods 110c, or the first anchors (not shown in the figure) are formed on the distal ends of all the third filter rods. ).
- the first anchor member 121 may be provided on a part of the filter rods 110 in the same filter rod group, and the first anchor member 121 may be provided on another part of the filter rods 110. Two anchors 122, but it should be noted that no matter how the first anchor 121 and the second anchor 122 are arranged, the force on the filter 100 should be balanced as much as possible.
- the anti-puncture member 131 is also formed on the filter rod 110 on which the anchor is at least partly formed, for example, the anti-puncture member 131 is formed on the distal end of the fourth filter rod 110d, or The anti-puncture member 131 is formed on the second filter rod 110b, the third filter rod 110c, and the fourth filter rod 110d, and the anti-puncture member 131 is used to prevent the anchor from being pierced. Piercing the blood vessel wall, causing blood vessel damage.
- the structure of the anti-puncture member 131 is not particularly limited, as long as it can prevent and limit the penetration depth of the anchor member into the blood vessel wall.
- At least one filter rod set is formed by cutting the first pipe body 101 , at least one filter rod set is cut from the second pipe body 102 , and The second pipe body 102 is disposed inside the first pipe body 101 and can be connected to the first pipe body 101 by welding or any other suitable means. That is to say, the filter rod 110 of the filter 100 is formed by cutting two nested tubular bodies.
- the filter rods 110 can have a larger width, which is beneficial to improve its supporting performance, improve the positioning stability of the filter 100 in the inferior vena cava, and also improve the filter 100's ability to intercept thrombus and improve the therapeutic effect.
- the first pipe body 101 is cut to form one filter rod group, and the filter rod 110 in the filter rod group formed by cutting the first pipe body 101 has the shortest length .
- the first filter rod 110a is formed by cutting the first pipe body 101
- the second filter rod 110b the third filter rod 110c
- the fourth filter rod 110d is formed by cutting the second pipe body 102 .
- the number of the first filter rods 110a is not limited to six, it may be less than six, or more than six, usually the number of the first filter rods 110a is selected from 3 to 9, and The width of each of the first filter rods 110a is 0.3 mm ⁇ 1 mm.
- the second pipe body 102 can only be cut to form the second filter rod 110b, or the second filter rod 110b and the third filter rod 110c can be formed. According to the actual situation, the The number of filter rods 110 formed by cutting the second pipe body 102 is 4 to 9, and the width of each filter rod 110 is 0.5 mm to 1 mm.
- the filter 100 provided by the embodiment of the present invention further includes a recovery hook 140 .
- the recovery hook 140 can be cut and shaped by the first pipe body 101 and/or the second pipe body 102 , the advantage of this setting is to avoid the occurrence of the recovery hook 140 and the recovery hook 140 in the process of recycling the filter 100 . Describe the problem of disintegration of the filter rod 110.
- the part of each tubular body located at the proximal end side of the filter rod 110 is not cut and used as a connecting segment 150, so that all the filter rods 110 obtained by cutting the tubular body
- the connection is via the connection section 150 .
- the recovery hook 140 is connected to the corresponding filter rod 110 through the connection section 150 .
- the filter 100 includes a recovery hook 140, the recovery hook 140 can be formed by cutting a pipe body (the first pipe body 101 or the second pipe body 102) and is double
- the layer structure may also be a four-layer structure formed by cutting two pipe bodies (the first pipe body 101 and the second pipe body 102 ) together.
- the proximal end of the corresponding tubular body close to the filter rod 110 is reserved as the connecting section 150 , and then the corresponding tubular body is inserted along the axial direction of the filter 100
- the proximal end of the connecting section 150 is cut into two halves, and then cut respectively on the two half tubes to form two symmetrical sub-recovery hooks, and then attach the two sub-recovery hooks Closed together and shaped, one of said retrieval hooks 140 is obtained.
- the recovery hook 140 has a larger size in the radial direction of the filter 100, and when the filter 100 is recovered, the recovery noose can be conveniently used to cover the housing. Describe recovery hook 140. Not only that, the single recovery hook 140 will not increase the radial dimension of the filter 100 in the compressed state, and thus will not increase the recovery resistance.
- the filter 100 includes two recovery hooks 140, and the two recovery hooks 140 can both be cut from the first pipe body 101, or both can be It is cut and formed by the second pipe body 102 , or one of the recovery hooks 140 is cut and formed by the first pipe body 101 , and the other recovery hook 140 is cut and formed by the second pipe body 102 .
- Each of the retrieval hooks 140 can be bent and formed by cutting a strip-shaped structure formed by cutting the proximal end of the corresponding tubular body.
- the two recovery hooks 140 are symmetrically arranged in the circumferential direction of the filter 100, and preferably each of the recovery hooks 140 is bent toward the inside of the filter 100, so as not to increase the pressure of the compressed state.
- the radial size of the filter 100 and the center line of the recovery hook 140 can coincide with the axis of the filter 100 to prevent the filter 100 from tilting during the recovery process and lead to recovery failure. Further, please refer to FIG. 5 and FIG.
- the distal ends of the two recovery hooks 140 are aligned (for example, the two recovery hooks 140 are obtained by cutting the same tube, that is, the two recovery hooks 140 pass through The same connecting section 150 is connected to the corresponding filter rod 110), and the axial dimensions of the two recovery hooks 140 are not equal, so that the tops of the two recovery hooks 140 are in the axial direction of the filter 100 stagger each other, so that there is no interference between the two recovery hooks 140, and the size of the recovery hooks 140 in the radial direction of the filter 100 can be maximized, so that the recovery noose can quickly entangle any one of the recovery hooks.
- the top of the recovery hook 140 refers to the area on the recovery hook 140 closest to the heart.
- the arrangement of the two recovery hooks 140 enables the recovery noose to selectively hook at least one recovery hook 140 when the filter 100 is recovered, making it easier for the recovery noose to be connected to the filter 100 , so as to improve the recycling efficiency.
- the filter 100 includes three recovery hooks 140, and the three recovery hooks 140 are evenly arranged in the circumferential direction of the filter 100, and three The tops of the recovery hooks 140 are staggered in the axial direction of the filter 100.
- the three recovery hooks 140 can further improve recovery efficiency.
- the recovery hook 140 there is no special limitation on the specific shape of the recovery hook 140 , which may be U-shaped or a continuous curved structure.
- the greater the depth of the recovery hook 140 the less likely the recovery noose will fall off after the recovery hook 140 is encased, and the recovery process of the filter 100 is more reliable.
- the depth of the recovery hook 140 refers to the dimension of the gap between the recovery hook 140 and the connecting section 150 in the axial direction of the filter 100 .
- a developing element 161 may also be provided on the recovery hook 140 .
- the free end of the recovery hook, the top of the recovery hook 140 and the fixed end of the recovery hook 140 (that is, the joint between the recovery hook 140 and the connecting section 150)
- the developing element 161 is provided at the position.
- the free end of the recovery hook 140 is provided with the developing element 161, it can be used to determine the entry direction of the recovery noose, so that the recovery noose can quickly wrap around the recovery hook, thereby shortening the recovery time.
- the recovery time of the filter 100 is described above.
- the developing element 161 is disposed on the top of the recovery hook 140 and/or the fixed end of the recovery hook 140 , it is used to assist in determining the position of the recovery hook 140 , and the developing element 161 is not easy to fall off.
- the embodiment of the present invention also provides a medical device, the medical device includes a transport assembly and the aforementioned filter 100, the transport assembly is used to load the filter 100, and transport the filter 100 to the target tube release at a predetermined position in the cavity, and the conveying assembly is configured to sequentially release all the filter rod groups in sequence from short to long according to the length of the filter rods.
- the delivery assembly includes a sheath (not shown in the figure) and a pusher, and the pusher can be movably threaded in the sheath, and the The pusher includes a push tube 210 and a rear release mechanism 220, and the rear release mechanism 220 is connected to the push tube 210.
- the filter 100 is used to be compressed in the sheath and is detachably connected to the rear release mechanism 220 .
- the delivery assembly is used to deliver the filter 100 from the femoral vein to the inferior vena cava.
- the rear release mechanism 220 may include a limit sleeve 221, a binding piece and a connecting piece (not shown in the figure), the limit sleeve 221 is connected to the distal end of the push tube 210, and is connected to the push tube 210.
- the push pipe 210 communicates with each other.
- the binding member is a binding slider 222, and the binding slider 222 is used to be movably arranged in the limiting sleeve 221, and the binding slider 222 is provided with a limiting groove 222a, and the limiting groove 222a and the inner wall of the limiting sleeve 221 together form a limiting space.
- the connecting piece is partially passed through the pushing tube 210, and the distal end of the connecting piece is connected to the proximal end of the binding slider 222, when the connecting piece creates an axis relative to the pushing tube 210 When moving relatively, the binding slider 222 moves axially relative to the limiting sleeve 221 .
- the "distal end” mentioned here refers to the end of each component of the delivery assembly that first enters the patient's body during use, and the "proximal end” refers to the end of the corresponding component that is close to the user.
- the distal end of the delivery component is equivalent to the proximal end
- the proximal end of the delivery component is equivalent to the distal end.
- the first filter rod 110a is used to be compressed in the sheath tube, and the distal ends of the remaining filter rods 110 are used to extend into the spacer sleeve 221, and the distal end of the fourth filter rod 110d
- the sheath After the distal end of the sheath is introduced into the inferior vena cava via the femoral vein, the sheath is withdrawn first, so that the first filter rod 110a of the filter 100 is released, and the first filter rod 110a is released. Some segments of the filter rod 110a are in linear contact with the vessel wall.
- the restraining slider 222 is recovered into the limit sleeve 221 (realized by pushing the push tube 210 forward or withdrawing the restraining slider 222), and then Recover the limiting sleeve 221 into the sheath. Finally, the conveying assembly is withdrawn.
- the filter is designed to include a plurality of filter rod groups, and the lengths of the filter rods in different filter rod groups are not equal, so that the filter can be connected with the conveying assembly
- all the filter rod groups can be successively released according to the length of the filter rods in order from short to long.
- the sudden release of the filter can prevent premature
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Abstract
一种滤器(100)和医用装置,医用装置包括滤器(100)和输送组件,滤器(100)包括多个滤杆组,每个滤杆组内包括若干滤杆(110);不同的滤杆组中的滤杆(110)的长度不相等;同一个滤杆组中的所有滤杆(110)的长度相等,且同一个滤杆组中的所有滤杆(110)围绕滤器(100)的轴线对称地布置。输送组件用于将滤器(100)输送至预定位置并释放,且在释放滤器(100)时,根据滤杆(110)的长度以先短后长的顺序依次释放所有滤杆组,提高滤器(100)的居中性和定位性。
Description
本发明涉及医疗器械技术领域,具体涉及一种滤器及医用装置。
静脉血栓栓塞症(venous thromboembolism,VTE)是临床上的常见疾病,有着较高的发病率和病死率。VTE包括深静脉血栓形成(deep vein thrombosis,DVT)和肺动脉栓塞(pulmonary embolism,PE),其中,DVT常发生于下肢静脉,PE则主要是由于静脉系统或右心血栓形成后脱落进入肺动脉所致,是致病和致死的主要原因。
抗凝治疗一直是VTE治疗的金标准,目的是预防血栓形成、防止PE以及恢复栓塞静脉的畅通等。当患者具有抗凝禁忌或者出现血合并症而不得不终止抗凝时,可以通过在下腔静脉植入滤器(vena cava filter,VCF)来拦截脱落的血栓,预防致死性的PE的发生。现有技术中的滤器在植入下腔静脉时容易发生倾斜,不能达到预期的血栓拦截效果。此外,现有技术中的滤器在植入下腔静脉后还容易发生移位,不利于后续滤器的回收。
发明内容
本发明的目的在于提供一种滤器及医用装置,该滤器在植入下腔静脉时可通过滤杆的逐级释放来提高滤器的居中性,改善血栓拦截效果。
为实现上述目的,本发明提供了一种滤器,包括多个滤杆组,每个所述滤杆组内包括若干滤杆;不同的所述滤杆组中的所述滤杆的长度不相等;同一个所述滤杆组中的所有所述滤杆的长度相等,且同一个所述滤杆组中的所有所述滤杆围绕所述滤器的轴线中心对称地布置。
可选地,所述滤器用于释放在目标管腔中,且在释放过程中,所有所述滤杆组按照所述滤杆的长度以由短到长的顺序依次释放。
可选地,长度最短的所述滤杆用于与目标管腔的壁线接触,其余的所述滤杆的远心端形成有锚定件,所述锚定件用于刺入所述目标管腔的壁。
可选地,长度最短的所述滤杆包括沿近心端到远心端依次连接的第一部分、第二部分和第三部分,且所述第一部分到所述滤器之轴线的距离沿近心端到远心端的方向逐渐增大,所述第三部分到所述滤器之轴线的距离大于所述第一部分到所述滤器之轴线的距离。
可选地,所述锚定件包括第一锚定件和第二锚定件,所述第一锚定件和所述第二锚定件形成于不同的所述滤杆上;
所述滤器被配置为当所述锚定件刺入所述目标管腔的壁时,所述第一锚定件用于阻止所述滤器沿近心端向远心端的方向移动,所述第二锚定件用于阻止所述滤器沿远心端向近心端的方向移动。
可选地,形成有所述第二锚定件的所述滤杆的长度小于形成有所述第一锚定件的所述滤杆的长度。
可选地,所述第一锚定件为直线型结构,且所述第一锚定件的近心端与相应的所述滤杆的远心端连接,所述第一锚定件的远心端为自由端;所述第二锚定件为倒刺结构,所述第二锚定件的自由端朝向所述滤器的近心端布置。
可选地,至少部分形成有所述锚定件的所述滤杆上还形成有防穿刺构件,所述防穿刺构件用于防止所述锚定件刺穿所述目标管腔的壁。
可选地,至少一个所述滤杆组由第一管体切割而成,至少一个所述滤杆组由第二管体切割而成,所述第二管体设置于所述第一管体的内侧。
可选地,所述第一管体切割形成一个所述滤杆组,且由所述第一管体切割所形成的所述滤杆的长度最短。
可选地,由所述第一管体切割所形成的所述滤杆数量为3~9,每根所述滤杆的宽度为0.3mm~1mm;由所述第二管体切割所形成的所述滤杆的数量为4~9,每根所述滤杆的宽度为0.5mm~1mm。
可选地,所述滤器还包括回收钩,所述回收钩由所述第一管体和/或所述第二管体切割形成。
可选地,所述回收钩的数量至少为一个;当所述回收钩的数量为多个时,多个所述回收钩在所述滤器的周向上均匀布置,每个所述回收钩均朝向所述滤器的内侧弯曲,且所有所述回收钩的顶部在所述滤器的轴向上相互错开。
可选地,所述回收钩的自由端、所述回收钩的顶部以及所述回收钩的固定端中的至少一者处设置有显影元件。
为实现上述目的,本发明还提供了一种医用装置,包括输送组件和如前中任一项所述的滤器;所述输送组件用于装载所述滤器,并将所述滤器输送至预定位置处释放,且所述输送组件被配置用于根据所述滤杆的长度以由短到长的顺序依次释放所有所述滤杆组。
为实现上述目的,本发明还提供了另一种滤器,包括多个滤杆及多个回收钩,多个所述回收钩连接于所有所述滤杆的近心端;多个所述回收钩在所述滤器的周向上均匀布置,每个所述回收钩均朝向所述滤器的内侧弯曲,且所有所述回收钩的顶部在所述滤器的轴向上相互错开。
与现有技术相比,本发明的滤器和医用装置具有如下优点:
前述的医用装置包括滤器和输送组件,所述滤器包括多个滤杆组,每个所述滤杆组包括若干滤杆;不同的所述滤杆组中的所述滤杆的长度不相等;同一个所述滤杆组中的所有所述滤杆的长度相同,且同一个所述滤杆组中的所有所述滤杆围绕所述滤器的轴线中心对称地布置。所述输送组件用于装载所述滤器,并被配置为将所述滤器输送至目标管腔,并按照所述滤杆的长度以由短到长的顺序依次释放所有所述滤杆组,不仅避免所述滤器在释放过程中发生前跳现象导致定位不准确,还使得所述滤器在所述目标管腔内具有良好的居中性,提高血栓拦截效率。
进一步地,长度最短的所述滤杆用于与目标管腔的壁线接触,其余的所述滤杆的远心端形成有锚定件,所述锚定件用于刺入目标管腔的壁,这样设计可有效保障滤器在目标管腔内的居中性,并还降低后期回收滤器时的回收阻力。
再进一步地,至少一个所述滤杆组由第一管体切割而成,至少一个所述滤杆组由第二管体切割而成,所述第二管体设置于所述第一管体的内侧,也就是说,所述滤器由双层管材切割而成,相较于由单层管材切割得到的滤器来说,在滤杆的数量相同、以及滤器在压缩态的直径也相同的情况下,本发明的所述滤器的滤杆具有较大的宽度,能够提高滤器对血栓的拦截效果,还 能够提高滤器施加于血管壁上的支撑力,提高滤器的定位稳定性。
附图用于更好地理解本发明,不构成对本发明的不当限定。其中:
图1是本发明根据一实施例所提供的滤器的结构示意图;
图2是本发明根据一实施例所提供的滤器的局部结构示意图,图中示出第一锚定件及防穿刺构件;
图3是本发明根据一实施例所提供的滤器的局部结构示意图,图示中示出滤器由双层管体切割而成;
图4是本发明根据一实施例所提供的滤器的局部结构示意图,图中显示滤器包括一个回收钩;
图5是本发明根据一实施例所提供的滤器的局部结构示意图,图中显示滤器包括二个回收钩;
图6是本发明根据一实施例所提供的滤器的局部结构示意图,图6与图5的观察方位不同;
图7是本发明根据一实施例所提供的滤器的局部结构示意图,图中显示滤器包括二个回收钩,且回收钩的形状与图5所示不同;
图8是本发明根据一实施例所提供的滤器的局部结构示意图,图中显示滤器包括三个回收钩;
图9是本发明根据一实施例所提供的滤器的局部结构示意图,图9与图8的观察方位不同;
图10是本发明根据一实施例所提供的滤器的局部结构示意图,图中显示滤器包括三个回收钩,且回收钩的形状与图8所示不同;
图11是本发明根据一实施例所提供的滤器的局部结构示意图,图中a)所示的滤器的自由端设置有显影元件,b)所示的滤器的顶部设置有显影元件,c)所示的滤器的固定端设置有显影元件;
图12是本发明根据一实施例所提供的医用装置的结构示意图,图中未示出鞘管,且第二滤杆已释放。
[附图标记说明如下]:
100-滤器,110-滤杆,110a-第一滤杆,110b-第二滤杆,110c-第三滤杆,110d-第四滤杆,111-第一部分,112-第二部分,113-第三部分,121-第一锚定件,122-第二锚定件,131-防穿刺构件,101-第一管体,102-第二管体,140-回收钩,150-连接段,161-显影元件;
210-推送管,220-后释放机构,221-限位套,222-束缚滑块,222a-限位槽;
以下通过特定的具体实例说明本发明的实施方式,本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,本说明书中的各项细节也可以基于不同观点与应用,在没有背离本发明的精神下进行各种修饰或改变。需要说明的是,本实施例中所提供的图示仅以示意方式说明本发明的基本构想,遂图式中仅显示与本发明中有关的组件而非按照实际实施时的组件数目、形状及尺寸绘制,其实际实施时各组件的型态、数量及比例可为一种随意的改变,且其组件布局型态也可能更为复杂。
另外,以下说明内容的各个实施例分别具有一或多个技术特征,然此并不意味着使用本发明者必需同时实施任一实施例中的所有技术特征,或仅能分开实施不同实施例中的一部或全部技术特征。换句话说,在实施为可能的前提下,本领域技术人员可依据本发明的公开内容,并视设计规范或实作需求,选择性地实施任一实施例中部分或全部的技术特征,或者选择性地实施多个实施中顶部分或全部的技术特征的组合,借此增加本发明实施时的弹性。
如在本说明书中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,复数形式“多个”包括两个以上的对象,除非内容另外明确指出外。如在本说明书中所使用的,术语“或”通常是以包括“和/或”的含义而进行 使用的,除非内容另外明确指出外,以及术语“安装”、“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接。可以是机械连接,也可以是电连接。可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本发明中的具体含义。
为使本发明的目的、优点和特征更加清楚,以下结合附图对本发明作进一步详细说明。需说明的是,附图均采用非常简化的形式且均使用非精准的比例,仅用以方便、明晰地辅助说明本发明实施例的目的。附图中相同或相似的附图标记代表相同或相似的部件。
本文中所述及的“远心端”、“近心端”是以所述医疗器械植入患者体内后相对于患者的心脏的位置关系而言的,通常,“远心端”是指远离心脏的一端,“近心端”是指靠近心脏的一端。
图1示出本发明实施例所提供的滤器100的结构示意图。请参考图1,所述滤器包括多个滤杆组,每个所述滤杆组中包括若干滤杆110。其中,不同的所述滤杆组中的所述滤杆110的长度不相等。同一个所述滤杆组中的所有所述滤杆110的长度相等,且同一个所述滤杆组中的所有所述滤杆110围绕所述滤器100的轴线对称地布置。所述滤器100可被一输送组件输送至目标管腔并进行释放,在一个典型的实施例中,所述目标管腔为下腔静脉。也即,所述滤器100被所述输送组件经股输送至下腔静脉,并释放以拦截血栓,防止血栓进入心脏进而进入肺动脉并引发肺栓塞。在释放所述滤器100的过程中,所述输送组件根据所述滤杆110的长度按照先短后长的顺序依次释放各个所述滤杆组。需要说明的是,所述滤杆110的长度,是指所述滤器100被压缩时,所述滤杆110在所述滤器100的轴向上的尺寸。本发明实施例中, 所述滤器100通常为自膨式结构件,其在生产时被预定型,且其在受到径向挤压力时沿径向收缩而处于具有较小径向尺寸的压缩态,而当所述径向挤压力被取消时,所述滤器100又能够在自身的弹性的作用下沿径向扩张并恢复至预定型的形态。所述自膨式结构件的材料可为镍钛金属等形状记忆合金材料或其他具有超弹性的材料。
本文以所述滤器100包括四个所述滤杆组为例进行介绍,但本领域技术人员应当理解,所述滤杆组的数量可以少于四个(例如为两个或三个),也可以多于四个(例如为五个)。
请继续参考图1,四个所述滤杆组分别为第一滤杆组、第二滤杆组、第三滤杆组及第四滤杆组,其中所述第一滤杆组内包括六根第一滤杆110a,所述第二滤杆组包括两根第二滤杆110b,所述第三滤杆组包括两根第三滤杆110c,所述第四滤杆组包括两根第四滤杆110d,且所述第一滤杆110a的长度、所述第二滤杆110b的长度、所述第三滤杆110c的长度及所述第四滤杆110d的长度依次增大。那么,当所述滤器100被输送至下腔静脉(即前述的目标管腔)并释放时,首先释放所述第一滤杆组,之后释放所述第二滤杆组,然后释放所述第三滤杆组,最后释放所述第四滤杆组。各个所述滤杆组逐次释放,一方面可避免所述滤器100在释放过程中发生前跳现象而导致所述滤器100定位不准确,另一方面,先短后长的释放顺序,有助于使所述滤器100能够居中地定位在下腔静脉中,提高栓塞捕获效果,改善疗效。此处所述“居中”的含义是指所述滤器100与下腔静脉同轴地布置。所述滤器100的具体释放方法将在后文中详述。
进一步地,所述第一滤杆110a(即长度最短的所述滤杆110)用于与下腔静脉的壁线接触,如此在所述第一滤杆110a释放后,所述第一滤杆110a能够向血管壁提供较大的径向支撑力,以使所述滤器100较为稳定的保持在下腔 静脉中。其余的所述滤杆110(即所述第二滤杆110b、所述第三滤杆110c以及所述第四滤杆110d)的远心端上分别形成有锚定件,所述锚定件用于刺入血管壁,以辅助所述滤器100定位,避免所述滤器100在血流冲击下移位,并且设置有所述锚定件的所述滤杆110在后续的滤器100回收过程中产生较小的回收阻力,有利于回收。也就是说,本实施例所提供的滤器100兼顾稳定性与可回收性,具有较好的使用性能。
更为详细地,请继续参考图1,所述第一滤杆110a包括沿近心端到远心端依次连接的第一部分111、第二部分112和第三部分113。在扩张状态,所述第一部分111与所述第三部分113成角度地布置,所述第二部分112实际上为一弧形段,用于使所述第一部分111和所述第三部分113平滑地过渡,避免所述第一滤杆110a出现尖锐的折角而损伤血管。所述第一部分111到所述滤器100之轴线的距离沿近心端到远心端的方向逐渐增大,且所述第三部分113到所述滤器100之轴线的距离大于所述第一部分111到所述滤器100之轴线的距离。这样一来,所述第三部分113的至少部分节段可与血管壁线接触。不仅如此,所述第三部分113的远心端还可以设置第四部分114,所述第四部分114与所述第三部分113成角度地布置,并且所述第四部分114到所述滤器100之轴线的距离沿远离所述第三部分113的方向逐渐减小。此外,其余的所述滤杆110(包括所述第二滤杆110b、所述第三滤杆110c及所述第四滤杆110d)均成直线构型,且在扩张状态时,其余的所述滤杆110到所述滤器100之轴线的距离沿近心端到远心端的方向逐渐增大,以使相应的所述滤杆110的远心端在所述锚定件的作用下与血管壁点接触。
所述锚定件有两种类型,分别为第一锚定件121和第二锚定件122,所述第一锚定件121和所述第二锚定件122形成于不同的所述滤杆110上,也即所述第一锚定件121和所述第二锚定件122不位于同一根所述滤杆110上, 换句话说,当一个所述滤杆110上形成有所述第一锚定件121时,则这一根所述滤杆110上不形成所述第二锚定件122,相应地,当一根所述滤杆110上形成有所述第二锚定件122时,这一根所述滤杆110上不形成所述第一锚定件121。所述滤器100被配置为当所述锚定件刺入血管壁时,所述第一锚定件121用于阻止所述滤器100沿近心端向远心端的方向移动,所述第二锚定件122用于阻止所述滤器100沿远心端向近心端的方向移动。通过所述第一锚定件121和所述第二锚定件122的共同作用来避免所述滤器100移位。为实现此目的,请参考图1及图2,所述第一锚定件121可以为直线型结构,所述第一锚定件121的近心端与相应的所述滤杆110的远心端连接,且所述第一锚定件121的远心端为自由端。所述第二锚定件122为倒刺结构,且所述第二锚定件122的自由端朝向所述滤器100的近心端布置。
可选地,同一个所述滤杆组中的所有所述滤杆110上形成有同类型的所述锚定件,这样做,可使所述滤器100受力均衡,进一步提高稳定性和居中性。可选地,形成有所述第一锚定件121的所述滤杆110的长度大于形成有所述第二锚定件122的所述滤杆110的长度,也就是说,长度最长的所述滤杆110的远心端上形成的是所述第一锚定件121,长度为第三位的所述滤杆110的远心端所形成的是所述第二锚定件122。如此,在图1所示的滤器100中,所有所述第四滤杆110d的远心端上形成所述第一锚定件121,所有所述第二滤杆110b的远心端上形成所述第二锚定件122。所有所述第三滤杆110c的远心端上形成所述第二锚定件122,或者所有所述第三滤杆的远心端上形成所述第一锚定件(图中未示出)。当然,在替代性的实施例中,同一个所述滤杆组中的一部分所述滤杆110上可以设置所述第一锚定件121,另一部分所述滤杆110上可设置所述第二锚定件122,但需要注意的是,不论所述第一锚定件121及所述第二锚定件122如何布置,都应当尽可能地使所述滤器100受 力均衡。
更进一步地,至少部分形成有所述锚定件的所述滤杆110上还形成有防穿刺构件131,例如所述第四滤杆110d的远心端形成有所述防穿刺构件131,或者所述第二滤杆110b、所述第三滤杆110c、以及所述第四滤杆110d上均形成有所述防穿刺构件131,所述防穿刺构件131用于防止所述锚定件刺穿血管壁,造成血管损伤。本发明实施例对所述防穿刺构件131的结构没有特别限制,只要其能够防止限制所述锚定件刺入血管壁的深度即可。
请返回参考图1并结合图3,本发明实施例中,至少一个所述滤杆组由第一管体101切割形成,至少一个所述滤杆组由第二管体102切割而成,且所述第二管体102设置于所述第一管体101的内侧,并可通过焊接或其他任意合适的方式与所述第一管体101连接。也就是说,所述滤器100的所述滤杆110通过两个嵌套设置的管体切割形成。相较于采用单一管体切割得到所有滤杆的滤器来说,在滤器的外径相同且滤杆的数量相同的情况下,本实施例所提供的所述滤器100中,所述滤杆110可具有较大的宽度,有利于提高其支撑性能,改善所述滤器100在下腔静脉中的定位稳定性,以及还可改善所述滤器100对血栓的拦截功能,提高治疗效果。
在一个具体的实施例中,所述第一管体101切割形成一个所述滤杆组,且由所述第一管体101切割所形成的所述滤杆组中的滤杆110的长度最短。换句话讲,于图1所示的所述滤器100中,所述第一滤杆110a由所述第一管体101切割形成,所述第二滤杆110b、所述第三滤杆110c及所述第四滤杆110d由所述第二管体102切割形成。可以理解的是,所述第一滤杆110a的数量不限于六根,其可以少于六根,也可以多于六根,通常所述第一滤杆110a的数量在3根~9根中选择,且每根所述第一滤杆110a的宽度为0.3mm~1mm。在替代性的实施例中,所述第二管体102可仅切割形成所述第二滤杆110b, 或者形成所述第二滤杆110b和所述第三滤杆110c,根据实际情况,所述第二管体102所切割形成的滤杆110的数量为4根~9根,每根所述滤杆110的宽度为0.5mm~1mm。
类似于现有技术中的滤器,本发明实施例所提供的所述滤器100还包括回收钩140。所述回收钩140可由所述第一管体101和/或所述第二管体102切割成型,这样设置的好处是,避免在回收所述滤器100的过程中发生所述回收钩140与所述滤杆110解体的问题。
本领域技术人员可理解,每一管体的位于所述滤杆110的近心端侧的部分节段未被切割并作为连接段150,以使该管体切割得到的所有所述滤杆110通过所述连接段150连接。所述回收钩140通过所述连接段150与相应的所述滤杆110连接。在一些实施例中,所述滤器100包括一个所述回收钩140,该回收钩140可以是由一个管体(所述第一管体101或所述第二管体102)切割形成并为双层结构,也可以是由两个管体(所述第一管体101和所述第二管体102)共同切割后形成的四层结构。具体地,在成型所述回收钩140时,将相应管体的近心端靠近所述滤杆110的部分保留以作为所述连接段150,然后沿所述滤器100的轴向将相应管体的近心端位于所述连接段150之近端侧的部分切割成两半,再分别在两半管体上切割以形成两个对称的子回收钩,之后将两个所述子回收钩贴靠在一起并定型,可得到一个所述回收钩140。所述滤器100仅具有一个所述回收钩140时,所述回收钩140在所述滤器100的径向上具有较大的尺寸,在回收所述滤器100时,可使回收套索方便地套住所述回收钩140。不仅如此,单个所述回收钩140还不会增大压缩态的所述滤器100的径向尺寸,进而不会增大回收阻力。
请参考图5至图7,在另一些实施例中,所述滤器100包括两个所述回收钩140,两个所述回收钩140可均由所述第一管体101切割成型,或均由所述 第二管体102切割成型,或者,一个所述回收钩140由所述第一管体101切割成型,另一个所述回收钩140由所述第二管体102切割成型。每个所述回收钩140可由相应管体的近端切割形成的长条形结构弯曲形成。
请重点参考图6,两个所述回收钩140在所述滤器100的周向上对称布置,并优选每个所述回收钩140均朝向所述滤器100的内侧弯曲,以不增大压缩态的所述滤器100的径向尺寸,并且所述回收钩140的中线能够与所述滤器100的轴线相重合,防止在回收过程中所述滤器100发生倾斜导致回收失败。进一步地,请参考图5及图7,两个所述回收钩140的远心端对齐(例如两个所述回收钩140由同一个管体切割得到,也即两个所述回收钩140通过同一个所述连接段150与相应的滤杆110连接),且两个所述回收钩140的轴向尺寸不相等,以使两个所述回收钩140的顶部在所述滤器100的轴向上相互错开,如此两个所述回收钩140之间不产生干扰,并可使所述回收钩140在所述滤器100之径向上的尺寸最大化,便于回收套索快速地套住任一个所述回收钩140。此处所述回收钩140的顶部,是指所述回收钩140上距离心脏最近的区域。此外,两个所述回收钩140的设置可使回收套索在回收所述滤器100时选择性地勾住至少一个所述回收钩140,使得所述回收套索更容易与所述滤器100连接,从而提高回收效率。
请再参考图8至图10,在替代性的实施例中,所述滤器100包括三个所述回收钩140,三个所述回收钩140在所述滤器100的周向上均匀布置,且三个所述回收钩140的顶部在所述滤器100的轴向上错开。三个所述回收钩140可进一步提高回收效率。
此外,本发明实施例对所述回收钩140的具体形状没有特殊限定,其可以呈U型,也可以是连续的曲线结构。但本领域技术人员可以理解,所述回收钩140的深度越大,所述回收套索在套住所述回收钩140后发生脱落的可 能性就越小,所述滤器100的回收过程就越可靠。这里,所述回收钩140的深度,是指所述回收钩140与所述连接段150之间的间隙在所述滤器100之轴向上的尺寸。
此外,请参考图11,所述回收钩140上还可以设置显影元件161。具体地,所述回收钩的自由端、所述回收钩140的顶部以及所述回收钩140的固定端(即所述回收钩140与所述连接段150的相接处)中的至少一者处设置有所述显影元件161。当所述回收钩140的自由端上设有所述显影元件161时,可用于确定所述回收套索的入路方向,使得所述回收套索能够快速地套住所述回收钩,进而缩短所述滤器100的回收时间。当所述回收钩140的顶部和/或所述回收钩140的固定端设置所述显影元件161时,用于辅助确定所述回收钩140的位置,且所述显影元件161不易脱落。
进一步地,本发明实施例还提供了一种医用装置,所述医用装置包括输送组件和前述的滤器100,所述输送组件用于装载所述滤器100,并将所述滤器100输送至目标管腔内的预定位置处释放,且所述输送组件被配置用于根据所述滤杆的长度以由短到长的顺序依次释放所有所述滤杆组。
请参考图12,在一个非限制性的实施例中,所述输送组件包括鞘管(图中未示出)和推送器,所述推送器可活动地穿设于所述鞘管内,且所述推送器包括推送管210和后释放机构220,所述后释放机构220连接于所述推送管210上。所述滤器100用于压缩于所述鞘管中,并与所述后释放机构220可分离地连接。本实施例中,所述输送组件用于从股静脉将所述滤器100输送至下腔静脉。
详细来说,所述后释放机构220可包括限位套221、束缚件和连接件(图中未示出),所述限位套221连接于所述推送管210的远端,并与所述推送管210相贯通。所述束缚件为束缚滑块222,所述束缚滑块222用于可活动地设 置在所述限位套221内,且所述束缚滑块222上设有限位槽222a,所述限位槽222a与所述限位套221的内壁共同围合成一限位空间。所述连接件部分地穿设在所述推送管210内,且所述连接件的远端与所述束缚滑块222的近端连接,当所述连接件相对于所述推送管210产生轴向相对移动时,所述束缚滑块222相对于所述限位套221做轴向移动。此处所述的“远端”是指所述输送组件的各个部件在使用过程中首先进入患者体内的一端,“近端”则是指相应部件靠近使用者的一端。在经股静脉入路的使用场景中,输送组件的远端相当于近心端,输送组件的近端相当于远心端。
所述第一滤杆110a用于压缩于所述鞘管内,其余的所述滤杆110的远心端均用于伸入所述限位套221内,且所述第四滤杆110d的远心端的第二锚定件(图12中未示出)和/或所述防穿刺构件(图12中未示出)伸入所述限位空间内。
接下去介绍所述滤器100经股静脉输送至下腔静脉后的释放过程。
经股静脉将所述鞘管的远端导入下腔静脉的预定位置后,首先回撤所述鞘管,以使所述滤器100的所述第一滤杆110a释放,并使所述第一滤杆110a的部分节段与血管壁线接触。
然后,使所述连接件保持不动,并回撤所述推送管210,以使所述第二滤杆110b释放,并使所述第二滤杆110b远心端的所述锚定件(具体为第二锚定件122)刺入血管壁。
执行同样的操作,以使所述第三滤杆110c释放。
继续回撤所述推送管210,以使所述束缚滑块222上的所述限位槽222a至少部分地从所述限位套221的远端露出,以使所述束缚滑块222和所述限位套221的内壁解除对所述第四滤杆110d上的所述第一锚定件121和/或防穿刺构件131的束缚,从而所述第四滤杆110d被释放。
释放完成后,先将所述束缚滑块222回收至所述限位套221内(通过向前推送所述推送管210的方式或者回撤所述束缚滑块222的方式来实现),然后再将所述限位套221回收至所述鞘管内。最后回撤所述输送组件。
综上,本发明实施例所提供的技术方案,通过将滤器设计为包括多个滤杆组,且不同所述滤杆组中的滤杆的长度不相等,以使所述滤器在与输送组件相配合并被输送至下腔静脉时,可根据所述滤杆的长度以由短到长的顺序逐次释放所有所述滤杆组,这样做,一方面可避免所述滤器因突然释放而发生前跳现象导致的定位不准确的问题,另一方面还有利于提高所述滤器在下腔静脉中的居中性,改善血栓拦截效率,进而提高疗效。
虽然本发明披露如上,但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样,倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内,则本发明也意图包含这些改动和变型在内。
Claims (17)
- 一种滤器,其特征在于,包括多个滤杆组,每个所述滤杆组内包括若干滤杆;不同的所述滤杆组中的所述滤杆的长度不相等;同一个所述滤杆组中的所有所述滤杆的长度相等,且同一个所述滤杆组中的所有所述滤杆围绕所述滤器的轴线对称地布置。
- 根据权利要求1所述的滤器,其特征在于,所述滤器用于释放在目标管腔中,且在释放过程中,所有所述滤杆组按照所述滤杆的长度以由短到长的顺序依次释放。
- 根据权利要求1所述的滤器,其特征在于,长度最短的所述滤杆用于与目标管腔的壁线接触,其余的所述滤杆的远心端形成有锚定件,所述锚定件用于刺入所述目标管腔的壁。
- 根据权利要求3述的滤器,其特征在于,长度最短的所述滤杆包括沿近心端到远心端依次连接的第一部分、第二部分和第三部分,且所述第一部分到所述滤器之轴线的距离沿近心端到远心端的方向逐渐增大,所述第三部分到所述滤器之轴线的距离大于所述第一部分到所述滤器之轴线的距离。
- 根据权利要求3所述的滤器,其特征在于,所述锚定件包括第一锚定件和第二锚定件,所述第一锚定件和所述第二锚定件形成于不同的所述滤杆上;所述滤器被配置为当所述锚定件刺入所述目标管腔的壁时,所述第一锚定件用于阻止所述滤器沿近心端向远心端的方向移动,所述第二锚定件用于阻止所述滤器沿远心端向近心端的方向移动。
- 根据权利要求5所述的滤器,其特征在于,形成有所述第二锚定件的所述滤杆的长度小于形成有所述第一锚定件的所述滤杆的长度。
- 根据权利要求5所述的滤器,其特征在于,所述第一锚定件为直线型结构,且所述第一锚定件的近心端与相应的所述滤杆的远心端连接,所述第一锚定件的远心端为自由端;所述第二锚定件为倒刺结构,所述第二锚定件的自由端朝向所述滤器的近心端布置。
- 根据权利要求3所述的滤器,其特征在于,至少部分形成有所述锚定件的所述滤杆上还形成有防穿刺构件,所述防穿刺构件用于防止所述锚定件刺穿所述目标管腔的壁。
- 根据权利要求1-8中任一项所述的滤器,其特征在于,至少一个所述滤杆组由第一管体切割而成,至少一个所述滤杆组由第二管体切割而成,所述第二管体设置于所述第一管体的内侧。
- 根据权利要求9所述的滤器,其特征在于,所述第一管体切割形成一个所述滤杆组,且由所述第一管体切割所形成的所述滤杆的长度最短。
- 根据权利要求9所述的滤器,其特征在于,由所述第一管体切割所形成的所述滤杆数量为3~9,每根所述滤杆的宽度为0.3mm~1mm;由所述第二管体切割所形成的所述滤杆的数量为4~9,每根所述滤杆的宽度为0.5mm~1mm。
- 根据权利要求9所述的滤器,其特征在于,所述滤器还包括回收钩,所述回收钩由所述第一管体和/或所述第二管体切割形成。
- 根据权利要求12所述的滤器,其特征在于,所述回收钩的数量至少为一个。
- 根据权利要求13所述的滤器,其特征在于,所述回收钩的数量为多个,多个所述回收钩在所述滤器的周向上均匀布置,每个所述回收钩均朝向所述滤器的内侧弯曲,且所有所述回收钩的顶部在所述滤器的轴向上相互错开。
- 根据权利要求12所述的滤器,其特征在于,所述回收钩的自由端、所述回收钩的顶部以及所述回收钩的固定端中的至少一者处设置有显影元件。
- 一种医用装置,其特征在于,包括输送组件和如权利要求1-15中任一项所述的滤器;所述输送组件用于装载所述滤器,并将所述滤器输送至预定位置处释放,且所述输送组件被配置用于根据所述滤杆的长度以由短到长的顺序依次释放所有所述滤杆组。
- 一种滤器,其特征在于,包括多个滤杆及多个回收钩,多个所述回 收钩连接于所有所述滤杆的近心端;多个所述回收钩在所述滤器的周向上均匀布置,每个所述回收钩均朝向所述滤器的内侧弯曲,且所有所述回收钩的顶部在所述滤器的轴向上相互错开。
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