CN113940784A

CN113940784A - Thrombus interception instrument

Info

Publication number: CN113940784A
Application number: CN202010682792.0A
Authority: CN
Inventors: 贾小乐; 张翠茹
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2020-07-15
Filing date: 2020-07-15
Publication date: 2022-01-18

Abstract

The invention relates to a thrombus intercepting apparatus, which comprises an intercepting part and an anchoring part connected with the intercepting part, wherein at least part of the surface of the anchoring part is provided with a protective layer, and the protective layer is made of tertiary amine modified polyether sulfone, heparinized polyether sulfone, poly-tetra-ethylene or polyethylene glycol terephthalate. The thrombus intercepting apparatus is easy to recover.

Description

Thrombus interception instrument

Technical Field

The invention relates to the field of medical instruments, in particular to a thrombus intercepting instrument.

Background

This section provides background information related to the present disclosure only and is not necessarily prior art.

Thromboembolism is a common potentially fatal emergency, e.g., deep vein thrombosis, with an incidence of 4% to 20%. If the deep vein thrombosis can not be removed in time, the deep vein thrombosis post-forming syndrome is formed for a long time, and the lesion part is obviously swollen, blackened and skin ulcer, thereby seriously affecting the life quality of patients. Therefore, it is a major challenge to remove deep venous thrombosis in time and prevent pulmonary embolism caused by thrombus falling off.

Clinically, a temporary device is usually implanted in a blood vessel to intercept thrombus, but because the device is stably anchored in the blood vessel during use, the device and the blood vessel wall must be contacted with a contact surface large enough to keep a holding state, so that endothelial cells inevitably climb over the device, the device is covered by endothelial cell membranes in a large area, and recovery is difficult.

Disclosure of Invention

Based on this, there is a need for a thrombus-intercepting device that is easy to retrieve.

The thrombus intercepting apparatus comprises an intercepting part and an anchoring part connected with the intercepting part, wherein at least part of the surface of the anchoring part is provided with a protective layer, and the protective layer is made of tertiary amine modified polyether sulfone, heparinized polyether sulfone, poly-tetra-ethylene or polyethylene glycol terephthalate.

In one embodiment, the thickness of the protective layer is 20-50 microns.

In one of them embodiment, anchor portion includes a plurality of edges the anchor pole that the circumference interval of intercepting portion set up, every the anchor pole has stiff end and free end, intercepting portion includes nearly heart-end intercepting net, far heart-end intercepting net and connecting rod, the connecting rod is connected nearly heart-end intercepting net with far heart-end intercepting net, just the stiff end of anchor pole with the connecting rod links to each other.

In one embodiment, at least one of the proximal end intercepting net and the distal end intercepting net is provided with a blocking line.

In one embodiment, the line comprises a body formed by converging a plurality of fiber lines and a plurality of threads disposed on an outer surface of the body.

In one embodiment, a protective layer is arranged on the connecting rod, and the material of the protective layer is tertiary amine modified polyethersulfone, heparinized polyethersulfone, polytetrafluoroethylene or polyethylene terephthalate.

In one embodiment, the anchoring portion includes a plurality of anchoring rods arranged along a circumferential direction of the intercepting portion at intervals, each of the anchoring rods has a fixed end and a free end, the fixed end of each of the anchoring rods is connected with the intercepting portion, and each of the anchoring rods has a shape memory property, and when the thrombus intercepting apparatus is changed from a constrained state to a deployed state, each of the anchoring rods is curled to have an arc-shaped surface for abutting against a blood vessel wall.

In one embodiment, the anchoring portion includes a first anchoring element disposed at an outer periphery of the intercepting portion, the first anchoring element includes a plurality of first anchoring rods disposed at intervals along a circumferential direction of the intercepting portion, each of the first anchoring rods has a free end facing a longitudinal central axis of the intercepting portion when the thrombus-intercepting apparatus is changed from the constrained state to the deployed state.

In one embodiment, the anchoring part further comprises a second anchor arranged at the periphery of the intercepting part, the first anchor and the second anchor are respectively located at two ends of the intercepting part, the second anchor comprises a plurality of second anchor rods arranged at intervals along the circumferential direction of the intercepting part, and each second anchor rod is formed with a barb.

In one embodiment, the thrombus intercepting apparatus further comprises a recovery part, wherein the recovery part comprises a support part connected with the intercepting part and a plurality of recovery hooks arranged at intervals along the circumferential direction of the support part; alternatively, the recovery part comprises a magnetic member connected to the intercepting part.

The anchor part of the thrombus interception instrument is provided with the protective layer made of the tertiary amine modified polyether sulfone, heparinized polyether sulfone, poly-tetra-ethylene or polyethylene glycol terephthalate, the protective layer is favorable for slowing down the creeping coverage of endothelial cells, and the area of the instrument coated by the endothelial cell membrane is reduced, so that the thrombus interception instrument is easy to recover.

Drawings

FIG. 1 is a schematic structural view of an embodiment of a thrombus-blocking device;

FIG. 2 is a schematic structural diagram of a blocking portion according to an embodiment;

FIG. 3 is a schematic structural view of a barrier according to another embodiment;

FIG. 4 is a schematic structural view of a barrier according to yet another embodiment;

FIG. 5 is a schematic view of a cross-sectional line according to an embodiment;

FIG. 6 is a schematic view of an embodiment of a thrombus-blocking device anchored in a blood vessel;

FIG. 7 is a schematic structural view of another embodiment of a thrombus-intercepting apparatus;

fig. 8 is a partially enlarged view of fig. 1.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

In the field of interventional medical devices, the "proximal end" is defined as the end near the heart and the "distal end" is defined as the end away from the heart. "axial" refers to a direction parallel to the line joining the centers of the distal and proximal ends of the medical device, and "radial" refers to a direction perpendicular to the axial direction.

Referring to fig. 1, a thrombus block device 1 according to an embodiment includes a block portion 10 and at least one anchor portion 20 disposed on the block portion 10.

Referring to fig. 2, the intercepting part 10 has a proximal end and a distal end, and includes a proximal intercepting net 110, a distal intercepting net 120, and a connecting rod 130. The connection rod 130 connects the proximal intercepting net 110 and the distal intercepting net 120.

In one embodiment, the proximal interceptor net 110 comprises a plurality of proximal rails 111 and proximal joints 112, wherein one end of the plurality of proximal rails 111 converges on the proximal joints 112 to form a first tapered structure having an opening. The distal end intercepting net 120 comprises a plurality of distal end rails 121 and distal end joints 122, and one ends of the plurality of distal end rails 121 are converged on the distal end joints 122 to form a second conical structure with an opening.

In one embodiment, the connecting rod 130 is a substantially rod-shaped structure, and may be a cylindrical rod, a square rod, or other regular or irregular rod. The number of the connecting rods 130 is plural, and the number of the connecting rods 130 is matched with the number of the proximal end rails 111 and the distal end rails 121.

The opening of the proximal end intercepting net 110 is opposite to the opening of the distal end intercepting net 120, one end of the connecting rod 130 is connected with one end of the proximal end barrier rod 111 far away from the proximal end joint 112, and the other end of the connecting rod 130 is connected with one end of the distal end barrier rod 121 far away from the distal end joint 122, so that a structure with a small two ends and a large middle outline is formed. Each connecting rod 130 is parallel or substantially parallel to the longitudinal centre axis II-II of the intercepting part 10.

In one embodiment, proximal boom 111 includes a stem 1111 connected at one end to proximal fitting 112 and two branches 1112 connected at an end of stem 1111 distal to proximal fitting 112 to form a Y-shaped configuration. The distal rail 121 is a generally straight bar structure. One end of each connecting rod 130 is connected to two adjacent branches 1112, and the two adjacent branches 1112 are respectively derived from two adjacent proximal end rails 111, that is, one branch 1112 is a branch of one proximal end rail 111, and the other branch 1112 is a branch of the adjacent proximal end rail 111. The other end of each tie bar 130 is attached to the distal end rail 121. In this way, the intercepting part 10 has an asymmetric structure, and the rod density of the proximal intercepting net 110 is greater than that of the distal intercepting net 120. The proximal end intercepting net 110 with the higher rod density can intercept smaller thrombus, and the distal end intercepting net 120 with the lower rod density can intercept larger thrombus. In the using process, blood flows from the far-end to the near-end, so that the rod density of the far-end intercepting net 120 is smaller, smaller thrombus can pass through, and the near-end intercepting net 110 with higher rod density can block the smaller thrombus forming embolism, so that the intercepting function is guaranteed, the thrombus can be dispersed, and the blockage caused by the excessive thrombus accumulated on the near-end intercepting net 110 and the far-end intercepting net 120 is avoided, so that the blood flow is kept smooth.

In one embodiment, as shown in fig. 3, the proximal and

distal rails

111 and 121 are straight bar structures, and the number of proximal rails 111, distal rails 121 and connecting bars 130 is the same, so that the interceptors 10 are symmetrical structures. Therefore, the thrombus intercepting apparatus 1 has good stability in the blood vessel, is not easy to incline when being impacted by blood flow or acted by the action of blood vessel distortion and the like, and has stable thrombus intercepting effect. Moreover, the straight rod structure is convenient to process, so that the thrombus intercepting apparatus 1 can be conveniently prepared.

In one embodiment, the proximal barrier 111 and the distal barrier 121 are both Y-shaped, so that the blocking portion 10 is symmetrical to ensure the stability of the thrombus blocking device 1, thereby providing a more stable thrombus blocking effect.

In an embodiment, the proximal end bars 111 and the distal end bars 121 are straight bar structures, the proximal end bars 111, the distal end bars 121 and the connecting rods 130 are the same in number, and the proximal end blocking net 110 is provided with flexible blocking lines 113 (as shown in fig. 3), the blocking lines 113 are arranged on the proximal end bars 111 along the circumferential direction of the proximal end blocking net 110, so that the blocking performance of the proximal end blocking net 110 is improved, thrombus can be attached to the blocking lines 113 and the proximal end bars 111 at the same time, and before taking thrombolytic measures or suction measures, the thrombus is prevented from falling off under the action of blood flow impact or blood vessel distortion and embolism. Meanwhile, the intercepting line 113 improves the intercepting performance of the proximal intercepting net 110, so that when the proximal intercepting net 111 and the distal intercepting net 121 are the same in number and have the same diameter, the proximal intercepting net 110 and the distal intercepting net 120 can have a selective intercepting effect.

The connecting manner of the section line 113 and the proximal bars 111 is not limited, for example, in one embodiment, the section line 113 is wound around each proximal bar 111 along the circumference of the proximal net 110 by winding. In another embodiment, a fixing portion for fixing the block line 113 may be provided on the proximal end rail 111, and the fixing portion may be a fixing hole or a fixing buckle.

The material of the stop line 113 is a biocompatible material. In one embodiment, the material of the stop line 113 is PTFE or PET. In one embodiment, the stop line 113 is formed by a plurality of PTFE or PET filaments gathered together. For example, the yarn may be formed by interweaving a plurality of PTFE filaments or PET filaments. Or, the yarn can be formed by binding a plurality of PTFE yarns or PET yarns after being gathered by fixing yarns. The gauge of the stop line 113 is in the range of 30D/18F to 80D/144F, so that the stop line 113 has sufficient strength and the radial dimension of the thrombus-blocking device 1 after compression is not excessively large. The above specification means that each of the block lines 113 includes 18 fiber threads, for example, 50D/18F, and the total mass of the 18 fiber threads is 50 denier (D). Other specifications have the same meaning and are not described herein.

In one embodiment, the line 113 is wound one turn circumferentially of the proximal net 110. In another embodiment, the block line 113 is not limited to one turn, and may have a plurality of turns. For example, as shown in fig. 4, the stop line 113 has two turns.

When the intercepting line 113 is arranged, the number of the intercepting rods 111 at the proximal end can be correspondingly reduced, the overall reduction of the radial dimension of the thrombus intercepting apparatus 1 after stretching is facilitated, and meanwhile, the intercepting line 113 is a flexible wire, so that the resistance in the sheathing and sheathing-out process is also facilitated to facilitate sheathing and releasing. In order to achieve both the blocking effect and sheathing and unsheathing, a larger length of the line 113 may be used or a plurality of turns of the line 113 may be provided when the number of proximal bars 111 is small and/or the diameter of the proximal bars 111 is small. In one embodiment, the number of the proximal bars 111 is 4 or 5, the diameter of the proximal bars 111 is 0.2 to 2 mm, a circle of the section line 113 is provided, and the section line 113 has a specification of 50D/18F.

In another embodiment, the distal end intercepting net 120 is also provided with a section line 113, and the number of turns and specification of the section line 113 on the distal end intercepting net 120 may be the same as or different from the number of turns and specification of the section line 113 on the proximal end intercepting net 110.

In one embodiment, as shown in fig. 5, the block line 113 includes a main body 1131 formed by interlacing and weaving a plurality of fiber threads and a plurality of filaments 1132 provided on an outer surface of the main body 1131. The fiber thread may be a PTFE thread or a PET thread. Each of the filaments 1132 has a free end at an end thereof distal from the body 1131, and the plurality of filaments 1132 are in a radially spread-out state. The material of the filament 1132 may be the same as or different from the material of the body 1131. The stop line 113 of this structure is advantageous for absorbing thrombus and preventing thrombus attached to the proximal end barrier net 110 and/or the distal end barrier net 120 from being washed away by the impact of blood flow and causing embolism before thrombolysis or aspiration.

Referring back to fig. 1, the anchoring unit 20 includes a plurality of anchoring rods 210, and the plurality of anchoring rods 210 are disposed at intervals along the circumferential direction of the intercepting unit 10, that is, the plurality of anchoring rods 210 are disposed on the outer circumferential surface of the intercepting unit 10. Each anchor rod 210 has a fixed end 211 and a free end 212, the fixed end 211 and the free end 212 being opposite. The fixed end 211 of each anchor rod 210 is connected to the intercepting part 10.

The anchoring rod 210 is made of a shape memory material such that the anchoring rod 210 has a shape memory property. In a natural state, the anchoring rod 210 is curled, and a surface of the anchoring rod 210 away from the longitudinal central axis II-II of the intercepting part 10 is an arc-shaped surface. Here, the natural state refers to a state in which the thrombus blocking device 1 is not implanted in the body and is not bound at all.

When the thrombus blocking device 1 is pushed into the blood vessel from the delivery sheath, the thrombus blocking device 1 has a tendency to change from the restrained state by the delivery sheath to the natural state, but since the thrombus blocking device 1 is pushed into the blood vessel, when the thrombus blocking device 1 is restored to a certain degree, it is restrained by the blood vessel wall, and the state at this time is defined as the deployed state. Compared with the natural state, the radial dimension of the thrombus blocking device 1 in the deployed state (for example, the diameter of a circumscribed circle of the thrombus blocking device 1) is slightly smaller, for example, the radial dimension of the thrombus blocking device 1 in the deployed state is 90% -95% of the radial dimension of the thrombus blocking device 1 in the natural state, so that the thrombus blocking device 1 can be well anchored in the blood vessel.

Each anchoring rod 210 is straightened when the thrombus intercepting apparatus 1 is in a constrained state by the delivery sheath, in which state each anchoring rod 210 is substantially parallel to the longitudinal central axis II-II of the intercepting part 10. Due to the shape memory properties of the anchoring rods 210, when the thrombus-intercepting device 1 is changed from the constrained state to the deployed state, each anchoring rod 210 is curled to be arc-shaped, having an arc-shaped face, so that the arc-shaped face of each anchoring rod 210 abuts against the blood vessel wall 2 to anchor the thrombus-intercepting device 1 in the blood vessel, as shown in fig. 6. In this anchoring manner, the arcuate surface of the anchoring bar 210 has a small contact surface with the vessel wall 2, and the covered area of the endothelial coating formed after implantation is small, and thus it is easily recycled.

Specifically, when the thrombus blocking device 1 is changed from the restrained state to the deployed state, each of the anchor rods 210 is rolled outward in a direction away from the longitudinal central axis II-II of the blocking portion 10 and then turned inward in a direction close to the longitudinal central axis II-II to be curled to form an arc-shaped surface.

In one embodiment, in a natural state, the anchoring rod 210 is curled, the angle of the anchoring rod 210 is 90-270 ° (the angle of the arc surrounded by the curled anchoring rod), and the rod diameter of the anchoring rod 210 is 0.2-3 mm, and these two parameters are reasonably set, so that the contact surface of the anchoring rod 210 and the vessel wall is small and close to point contact; on the other hand, the release resistance can be reasonably controlled, the difficulty in sheath outlet caused by overlarge radial direction of the thrombus blocking device 1 is avoided, and the release is influenced, so that the use of a conveying sheath tube with smaller specification is facilitated. In addition, in the releasing process, when the position is not accurate and the releasing is difficult after the recovery, the recovery is also easy.

In one embodiment, the anchor rod 210 is in a curled shape in a natural state, and the angle of the anchor rod 210 is 120 ° to 240 °.

Referring to fig. 2 and 6 together, the fixed end 211 of the anchor bar 210 is connected to the connection bar 130. Because the both ends of connecting rod 130 are connected respectively and are close to heart end intercepting net 110 and far away end intercepting net 120 and form the big structure in the middle of the both ends is little, make in the state of expanding, in radial direction, connecting rod 130 all is closer to the vascular wall than nearly heart end rail 111 and far away end rail 121, the stiff end 211 of anchoring rod 210 links to each other with connecting rod 130, when anchoring rod 210 and vascular wall 2 butt, vascular wall 2 can be kept away from to connecting rod 130, thereby be favorable to avoiding connecting rod 130 to be climbed by endothelial cell and cover, in order to facilitate the recovery.

In one embodiment, the number of anchor portions 20 is one, and one anchor portion 20 is connected to the intercepting portion 10. For example, the plurality of anchor rods 210 of one anchor part 20 are connected to the plurality of connecting rods 130 of the interceptor part 10, respectively. Set up an anchor portion 20, through size, the crooked degree etc. that rationally set up anchor pole 210, can make thrombus interception apparatus 1 anchor in the blood vessel betterly, and make the area of thrombus interception apparatus 1 and vascular wall contact less, conveniently retrieve.

In one embodiment, as shown in fig. 1, the number of the anchor portions 20 is two, and two anchor portions 20 are connected to both ends of the connecting rod 130, respectively. Specifically, each anchor portion 20 includes a plurality of anchor rods 210, each anchor rod 210 of one anchor portion 20 being connected to an end of the tie rod 130 near the proximal-end interceptor mesh 110, and each anchor rod 210 of another anchor portion 20 being connected to an end of the tie rod 130 near the distal-end interceptor mesh 120. So for the thrombus interception apparatus 1 self balance performance is better, can be relatively stably anchored in the blood vessel, is favorable to avoiding the emergence of the condition of slope.

Referring to fig. 7, in another embodiment, anchor 20 includes a first anchor 220 and a second anchor 230. First anchor 220 is attached to the end of connecting member 130 adjacent to proximal screen 110 and second anchor 230 is attached to the end of connecting member 130 adjacent to distal screen 120. First anchor 220 and second anchor 230 are structurally different.

The first anchors 220 include a plurality of first anchor rods 221 provided at intervals along the circumference of the intercepting part 10. Each first anchor rod 221 includes a first connecting section 2211, a first supporting section 2212 and a protecting section 2213, both ends of the first supporting section 2212 are connected with the first connecting section 2211 and the protecting section 2213, respectively, one end of the first connecting section 2211, which is far away from the first supporting section 2212, is connected with the connecting rod 130, and one end of the protecting section 2213, which is far away from the supporting section 2212, is a free end.

The first connecting section 2211 serves as a connection and the first support section 2212 is used to abut the vessel wall to enable the thrombus-intercepting device 1 to be anchored in the vessel. The protection segment 2213 plays a protection role. In a natural state, the protection segment 2213 is inclined from the end connected with the first support segment 2212 to a direction close to the longitudinal central axis II-II. The arrangement is such that during release the first anchor rod 221 does not tip up to puncture the blood vessel.

The second anchors 230 include a plurality of second anchor rods 231 spaced apart along the circumference of the intercepting part 10. Each of the second anchor bars 231 includes a second connecting section 2311 and a second supporting section 2312 connected to the second connecting section 2311. One end of the second connecting section 2311 is connected to the connecting rod 130 and one end of the second supporting section 2312 remote from the connecting rod 130 is connected to the second connecting section 2311, but the connection point is not located at the end of the second connecting section 2311 but at a distance from the end, thereby forming a barb 2311A. In the deployed state, the second support segment 2312 abuts the vessel wall and the barbs 2311A penetrate into the vessel wall. Because the second support section 2312 supports with the vascular wall and holds, also restricted the depth that barb 2311A pierces in the vascular wall, can avoid barb 2311A to pierce the blood vessel, improve the security of using.

In one embodiment, the barbs 2311A are angled toward the second support segment 2312 relative to the second connecting segment 2311 to further facilitate controlling the depth of penetration into the vessel wall and thus improve safety.

This embodiment also enables the thrombus-intercepting apparatus 1 to be reliably anchored in the blood vessel, and the first support section 2212 and the second support section 2312 are anchored at both ends, so that the thrombus-intercepting apparatus 1 can well realize self-balancing, and therefore, the lengths of the first support section 2212 and the second support section 2312 can be small, thereby reducing the contact area with the blood vessel wall, slowing down the endothelial climbing, and facilitating recovery.

In one embodiment, the length of the first and

second support segments

2212 and 2312 is 2-10 mm.

In one embodiment, the axial length of first and

second support segments

2212 and 2312 is 3-6 millimeters.

In an embodiment, a protective layer is provided on a surface of each anchor rod 210, first anchor rod 221, or each second anchor rod 231. The protective layer is used to prevent or delay endothelial coating. The protective layer is made of tertiary amine modified polyether sulfone, heparinized polyether sulfone, poly-tetra-ethylene or polyethylene glycol terephthalate. The protective layer covers the entire surface of the anchoring stem 210 or at least the surface of the anchoring stem 210 that abuts the vessel wall. Alternatively, the protective layer at least partially covers the surface of the first anchor rod 221 and at least the surface of the second anchor rod 231. The protective layer is arranged, so that the endothelial climbing is avoided, the recovery window of the thrombus interception apparatus 1 is prolonged, and the recovery is convenient. Meanwhile, the endothelium is not or less coated, so that the condition of tearing of the intima of the blood vessel in the recovery process is avoided, and the safety is improved.

The polyether sulfone modified by the tertiary amine is that the molecular chain of the polyether sulfone is grafted with the tertiary amine, for example, the polyether sulfone is subjected to chlorosulfonation reaction, and then the tertiary amine is grafted between chlorosulfonic acid groups and hydroxyl groups. Heparinized polyethersulfones are molecular chains of polyethersulfones onto which heparin molecules are grafted, for example, via diamine space arms.

In one embodiment, the thickness of the protective layer is 20 to 50 μm.

In one embodiment, each of the anchor rods 210 is further provided with an anti-inflammatory drug coating on the surface thereof, and the anti-inflammatory drug coating and the protective layer are provided on the surface of the anchor rod 210 in a staggered manner from each other. The anti-inflammatory drug coating is arranged, on one hand, the anti-inflammatory drug has a certain delay effect on the creeping of endothelial cells, and on the other hand, when the phenomenon of endangium damage occurs, the anti-inflammatory drug can well play a role in anti-inflammation.

In one embodiment, the surface of each tie bar 130 is also provided with a protective layer that covers at least a portion of the surface of the tie bar 130. The protective layer is made of tertiary amine modified polyether sulfone, heparinized polyether sulfone, poly-tetra-ethylene or polyethylene glycol terephthalate. In the state of expanding, the connecting rod 130 is nearer with the distance of vascular wall, and this distance is only less than the distance of anchoring rod 210 and vascular wall, sets up the inoxidizing coating that can avoid the endothelium to climb on the at least partial surface of connecting rod 130, is favorable to avoiding endothelial cell to climb along anchoring rod 210 or along first anchoring rod 221 and second anchoring rod 231 and cover to connecting rod 130 and form the adhesion to be favorable to prolonging the recovery window of thrombus interception apparatus 1 and conveniently retrieving.

The protective layer and the anti-inflammatory drug coating can be prepared by adopting methods such as spraying, dip coating or electrostatic spinning. In another embodiment, the protective layer has a film structure, and the tertiary amine modified polyethersulfone film, heparinized polyethersulfone film, poly-tetra-ethylene film or polyethylene terephthalate film is directly coated on the surface of the anchor rod 210.

Referring again to fig. 1, the thrombus-intercepting apparatus 1 further includes a recovery portion 30, and the recovery portion 30 is connected to the proximal end or the distal end of the intercepting portion 10, in the manner shown in fig. 1. The recovery portion 30 is provided to cooperate with the catching instrument to effect recovery of the thrombus intercepting instrument 1.

Referring to fig. 1 and 8, in one embodiment, the recycling portion 30 includes a supporting member 310 and a plurality of recycling hooks 311 disposed at intervals along a circumferential direction of the supporting member 310. The supporting member 310 is substantially cylindrical, and each recovery hook 311 has a gap with the outer circumferential surface of the supporting member 310. When the thrombus blocking device 1 is to be recovered, the recovery of the thrombus blocking device 1 can be conveniently realized by capturing any one recovery hook 311 with the capturing device. Because the plurality of recovery hooks 311 are arranged along the circumferential direction of the supporting member 310 at intervals, even if the thrombus intercepting device 1 inclines to cause the recovery part 30 to adhere to the wall obliquely, at least one recovery hook 311 can be caught by the catching device conveniently to realize recovery.

In another embodiment, the recovery part 30 is not a recovery hook structure, the recovery part 30 includes a magnetic component disposed on the proximal end or the distal end of the intercepting part 10, a capturing magnetic component is disposed on the capturing device, the polarities of the magnetic component and the capturing magnetic component are opposite, and the capturing of the thrombus intercepting apparatus 1 is realized by the attraction between the magnetic component and the capturing magnetic component, so as to facilitate the recovery. In this way, even when the thrombus-blocking device 1 is inclined and the collection unit 30 is attached to the wall obliquely, collection can be easily achieved by the polar adsorption method.

It will be appreciated that since the thrombus-intercepting apparatus 1 is a temporary apparatus which is withdrawn from the body after completion of the intended use, the provision of the magnetic member does not cause other adverse effects.

In one embodiment, the recovery portion 30 is attached to the distal end of the intercepting portion 10. For example, the recovery unit 30 is connected to the distal end fitting 122 of the barrier unit 10. Specifically, support 310 of recovery section 30 is connected to distal end fitting 122. In this case, the retrieval route of the thrombus block device 1 is retrieved from the femoral vein.

When the recovery part 30 is connected to the distal end of the intercepting part 10, as shown in fig. 6, in the deployed state, the free end 212 of the anchoring rod 210 is closer to the distal end than the fixed end 211, so that when the capturing device captures the recovery part 30, the delivery sheath continuously straightens the curved anchoring rod 210 and gradually separates the thrombus-intercepting device 1 from the blood vessel wall 2 to gradually recover the thrombus-intercepting device 1 into the delivery sheath in the process of continuously approaching the delivery sheath to the thrombus-intercepting device 1.

In another mode, when the recovery portion 30 is connected to the proximal end of the blocking portion 10, the recovery path of the thrombus blocking device 1 is recovered from the jugular vein. In the deployed state, the free end 212 of the anchoring rod 210 is axially closer to the proximal end than the fixed end 211 to facilitate retrieval of the thrombus-blocking device 1.

The thrombus interception apparatus 1 is anchored in the blood vessel through the contact that a plurality of anchor rods 210 of anchor portion 20 are less with the contact surface of vascular wall 2, and when rationally setting up the bending degree or the camber of anchor rod 210, the contact of anchor rod 210 and vascular wall is close to the point contact, is favorable to avoiding or slowing down the endothelium and climbs and cover, thereby is favorable to retrieving, and is favorable to avoiding retrieving the intimal tear of in-process, improves the security of using.

Or, thrombus interception apparatus 1 is through the less contact of the first anchor pole 221 of anchor portion 20 and second anchor pole 232 and the contact surface of vascular wall 2 and stabilize in the ground anchor in the blood vessel, through the length that rationally sets up first support section 2212 and second support section 2312, make the area of contact of thrombus interception apparatus 1 and vascular wall as little as possible, be favorable to avoiding or slowing down the endothelium and climb and cover, thereby be favorable to retrieving, and be favorable to avoiding retrieving the intimal tear of in-process, the security of using is improved.

Meanwhile, the incorporation of the shielding layer at least partially covering the surface of the anchor rod 210 or the surfaces of the first and

second anchor rods

221 and 231 not only facilitates the recovery, but also extends the recovery window of the thrombus intercepting apparatus 1.

This is further illustrated by the more specific examples below.

Example 1

A thrombus intercepting apparatus includes an intercepting part and an anchoring part. The intercepting part comprises a near-core end intercepting net, a connecting rod and a far-core end intercepting net, the near-core end intercepting net comprises 5Y-shaped rods, and the far-core end intercepting net comprises 5 straight rods. The diameters of the Y-shaped rod (the diameters of the main rod and the branches are equal to each other) and the straight rod are both 1 mm. The anchor portion is two, and the anchor portion includes that 5 poles footpath is 2.5 millimeters anchor poles for each anchor portion, when the thrombus interception apparatus changes from the restraint state to the state of expansion, each anchor pole takes place to curl and has the arcwall face, and the arcwall face is used for with the vascular wall butt. The angle of the crimped anchor rod is 120 °.

And a tertiary amine modified polyether sulfone coating is formed on each anchoring rod by adopting a spraying method, and the thickness of the tertiary amine modified polyether sulfone coating is 20 micrometers.

The thrombus interception device is implanted into the inferior vena cava of sheep and is recovered after 3 months, and the recovery process is smooth.

Example 2

A thrombus intercepting apparatus includes an intercepting part and an anchoring part. The intercepting part comprises a near-core intercepting net, a connecting rod and a far-core intercepting net, the near-core intercepting net comprises 5 straight rods, and the far-core intercepting net comprises 5 straight rods. The diameter of the straight rod is 1 mm. The anchor portion is two, and the anchor portion includes that 5 poles of each anchor portion are 1.5 millimeters footpath, and when the thrombus interception apparatus changed from the restraint state to the state of expansion, each anchor pole took place to curl and has the arcwall face, and the arcwall face is used for with the vascular wall butt. The angle of the crimped anchor rod is 150 °. A circle of barrier line is wound on the proximal end intercepting net, the barrier line is made of PTFE fiber line and has the specification of 50D/18F.

A heparinized polyether sulfone coating is formed on each anchoring rod by adopting a spraying method, and the thickness of the heparinized polyether sulfone coating is 50 microns.

Example 3

A thrombus intercepting apparatus includes an intercepting part and an anchoring part. The intercepting part comprises a near-core end intercepting net, a connecting rod and a far-core end intercepting net, the near-core end intercepting net comprises 5Y-shaped rods, and the far-core end intercepting net comprises 5 straight rods. The diameters of the Y-shaped rod (the diameters of the main rod and the branches are equal to each other) and the straight rod are both 2 mm. The anchoring portion includes a first anchor including 5 first anchoring rods arranged at intervals in a circumferential direction of the intercepting portion and a second anchor. Every first anchor pole includes first linkage segment, first support section and protection section, and the both ends of first support section link to each other with first linkage segment and protection section respectively, and the one end of keeping away from first support section of first linkage segment links to each other with the connecting rod, and the one end of keeping away from the support section of protection section is the free end, and this free end is towards the longitudinal central axis of intercepting part. Wherein the axial length of the first support section is 3 mm. The second anchor members include 5 second anchor rods arranged at intervals in the circumferential direction of the intercepting part. Every second anchor pole includes the second linkage segment and supports the section with the second that the second linkage segment links to each other, is formed with the barb on the second linkage segment. Wherein the axial length of the second support section is 3 mm.

And a PTFE coating is formed on all the first anchoring rod, the second anchoring rod and the connecting rod by adopting a spraying method, and the thickness of the PTFE coating is 30 microns.

Example 4

A thrombus intercepting apparatus includes an intercepting part and an anchoring part. The intercepting part comprises a near-core intercepting net, a connecting rod and a far-core intercepting net, the near-core intercepting net comprises 5 straight rods, and the far-core intercepting net comprises 5 straight rods. The diameter of the straight rod is 1 mm. The anchor portion is two, and the anchor portion includes that 5 poles of each anchor portion are 1.5 millimeters footpath, and when the thrombus interception apparatus changed from the restraint state to the state of expansion, each anchor pole took place to curl and has the arcwall face, and the arcwall face is used for with the vascular wall butt. The angle of the crimped anchor rod is 150 °. Two circumference intercepting lines are wound on the proximal intercepting net, the intercepting lines are made of PTFE fiber lines with the specification of 50D/18F.

A PTFE membrane is wrapped over each anchor rod.

Comparative example 1

A thrombus intercepting apparatus includes an intercepting part and an anchoring part. The intercepting part comprises a near-core end intercepting net, a connecting rod and a far-core end intercepting net, the near-core end intercepting net comprises 5Y-shaped rods, and the far-core end intercepting net comprises 5 straight rods. The diameters of the Y-shaped rod (the diameters of the main rod and the branches are equal to each other) and the straight rod are both 1 mm. The anchor portion is two, and the anchor portion includes that 5 poles of each anchor portion are 0.8 millimeters footpath, and when the thrombus interception apparatus changed from the restraint state to the state of expansion, each anchor pole took place to curl and has the arcwall face, and the arcwall face is used for with the vascular wall butt. The angle of the crimped anchor rod is 120 °. The rod diameter of the anchoring rod is 2.5 mm. The anchor portion is not provided with a protective layer.

The thrombus interception instrument is implanted into the inferior vena cava of a piglet and can be recovered after 3 months, but the recovery process is difficult, and the intima of a blood vessel is seriously torn.

Comparative example 2

A thrombus blocking device comprises a blocking part. The intercepting part comprises a near-core end intercepting net, a connecting rod and a far-core end intercepting net, the near-core end intercepting net comprises 5Y-shaped rods, and the far-core end intercepting net comprises 5 straight rods. The diameters of the Y-shaped rod (the diameters of the main rod and the branches are equal to each other) and the straight rod are both 1 mm. This thrombus interception apparatus does not additionally be equipped with anchor portion, realizes anchoring in the blood vessel through connecting rod and vascular wall butt.

The thrombus interception device is implanted into the inferior vena cava of a piglet and can not be recovered after 3 months, and the connecting rod of the thrombus interception device is completely covered by an endothelial cell layer.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A thrombus intercepting device, characterized in that it comprises an intercepting part and an anchoring part connected with the intercepting part, at least part of the surface of the anchoring part is provided with a protective layer, and the material of the protective layer is a tertiary amine Modified polyethersulfone, heparinized polyethersulfone, polytetraethylene or polyethylene terephthalate.

2 . The thrombus intercepting device according to claim 1 , wherein the protective layer has a thickness of 20-50 μm. 3 .

3. The thrombus interception device of claim 1, wherein the anchoring portion comprises a plurality of anchoring rods spaced apart along the circumference of the blocking portion, each of the anchoring rods having a fixed end and the free end, the intercepting part includes a proximal end intercepting net, a distal end intercepting net and a connecting rod, the connecting rod connects the proximal end intercepting net and the distal end intercepting net, and the anchoring The fixed end of the rod is connected with the connecting rod.

4 . The thrombus interception device according to claim 3 , wherein an interception wire is provided on at least one of the proximal end interception net and the distal end interception net. 5 .

5 . The thrombus interception device according to claim 4 , wherein the interception wire comprises a main body formed by converging a plurality of fiber wires and a plurality of silk wires arranged on the outer surface of the main body. 6 .

6 . The thrombus interception device according to claim 3 , wherein a protective layer is provided on the connecting rod, and the material of the protective layer is tertiary amine-modified polyethersulfone, heparinized polyethersulfone, polyethersulfone, and polyethersulfone. 7 . Tetraethylene or polyethylene terephthalate.

7. The thrombus interception device of claim 1, wherein the anchoring portion comprises a plurality of anchoring rods spaced apart along the circumference of the blocking portion, each of the anchoring rods having a fixed end and a free end, the fixed end of each of the anchor rods is connected to the intercepting portion, and each of the anchor rods has shape memory properties when the thrombus blocking device changes from a restrained state to a deployed state , each of the anchor rods is crimped to have an arcuate surface, and the arcuate surface is used for abutting with the vessel wall.

8 . The thrombus intercepting device according to claim 1 , wherein the anchoring portion comprises a first anchoring member disposed on the outer periphery of the intercepting portion, the first anchoring member comprising a plurality of A plurality of first anchor rods are arranged at intervals in the circumferential direction of the intercepting portion, each of the first anchor rods has a free end, and when the thrombus interception device changes from a restrained state to a deployed state, the free end faces toward the longitudinal center axis of the intercepting portion.

9 . The thrombus intercepting device according to claim 8 , wherein the anchoring portion further comprises a second anchoring member disposed on the outer periphery of the intercepting portion, the first anchoring member and the second anchoring member. 10 . The fixing pieces are respectively located at both ends of the intercepting part, and the second anchoring piece includes a plurality of second anchoring rods arranged at intervals along the circumferential direction of the blocking part, each of the second anchoring rods Barbs are formed on it.

10 . The thrombus intercepting device according to claim 1 , wherein the thrombus intercepting device further comprises a recovery part, and the recovery part comprises a support member connected to the interception part and a plurality of thrombus interception parts along the support member. 11 . Circumferentially spaced recovery hooks; alternatively, the recovery portion includes a magnetic component connected to the intercepting portion.