CN216365416U

CN216365416U - Embolic protection device

Info

Publication number: CN216365416U
Application number: CN202122959734.0U
Authority: CN
Inventors: 韦秋娟; 王高波
Original assignee: Juhui Medical Technology Shenzhen Co ltd
Current assignee: Juhui Medical Technology Shenzhen Co ltd
Priority date: 2021-11-26
Filing date: 2021-11-26
Publication date: 2022-04-26
Anticipated expiration: 2031-11-26

Abstract

The utility model provides a plug protection device which comprises a conveying guide wire and a filter screen, wherein the filter screen is arranged on the conveying guide wire and comprises a net basket and an outer cover, the net basket and the outer cover are of filter structures which are provided with pores and can be self-expanded, the near end of the net basket is provided with an opening facing to the near end, the far end of the net basket is of a closing structure, the near end of the net basket and the far end of the net basket are respectively connected with the conveying guide wire, the outer cover is annularly arranged on the outer side of the net basket, and the central angle of the outer cover corresponding to the circumferential direction is larger than or equal to 180 degrees. The embolic protection device of the present invention can capture thrombus between the small curved side of the blood vessel and the basket.

Description

Embolic protection device

Technical Field

The utility model relates to the technical field of medical instruments, in particular to an embolism protection device.

Background

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

Thrombi are masses within the blood vessel, and retention of thrombi in the stenosis of the blood vessel may cause blockage of the blood vessel. For example, in valve repair or replacement surgery, treatment of a calcified valve can result in the sloughing of calcified tissue, which can form clumps and thus thrombus. If the thrombus is in the heart or aorta, it can cause a local infarction. One way to reduce these complications is to place an embolic protector downstream of the valve repair or replacement procedure, thereby capturing any thrombus that may occlude the vessel, once captured, the embolic protection device must carefully close and exit the patient's body to avoid the captured thrombus from returning to the vessel.

As shown in fig. 1, the conventional screen apparatus 10 is woven into a basket 11 by weaving wires, and the basket 11 has a substantially conical structure. When the filter device 10 is implanted into a curved blood vessel 13, a gap is easily formed between the basket 11 and the small curved side of the blood vessel 13, and if a thrombus is trapped in the gap, the thrombus cannot be captured by the basket 11, and after the filter device 10 is withdrawn, the thrombus trapped in the gap may be embolized by the flow of blood.

SUMMERY OF THE UTILITY MODEL

The utility model aims to at least solve the technical problem that a gap is easy to generate between a filter screen device and a blood vessel. The purpose is realized by the following technical scheme:

an embodiment of the present application provides an embolic protection device, comprising:

delivering a guide wire;

the filter screen, the filter screen sets up on carrying the seal wire, the filter screen includes basket and dustcoat, basket and dustcoat are the filtration that has the hole, and can be from inflation, the near-end of basket has the opening towards the near-end, the distal end of basket is the binding off structure, the near-end of basket and the distal end of basket are connected with carrying the seal wire respectively, the basket outside is located to the dustcoat ring shape, the dustcoat is greater than or equal to 180 at the central angle that the circumferencial direction corresponds.

In one embodiment, the housing has a circumferential central angle equal to 360 ° and the porosity of the housing is greater than the porosity of the basket.

In one embodiment, the flexibility of the enclosure is greater than the flexibility of the basket.

In one embodiment, the proximal end of the housing forms a proximally facing shroud opening that passes over the opening at the proximal end of the basket, and the screen further comprises a plurality of pull cords having one end connected to the shroud opening and the other end connected to the delivery guidewire.

In one embodiment, the plurality of stay wires are interlaced to form a mesh, and the mesh formed by the plurality of stay wires is larger than the apertures of the basket and the housing.

In one embodiment, the filter screen further comprises a connector slidably connected to the guide wire, the proximal ends of the plurality of pull cords are connected to the connector, and the proximal ends of the plurality of pull cords are connected to the guide wire through the connector.

In one embodiment, the pushwire includes a first limiting member for limiting the position of the connecting member, the first limiting member is fixedly connected to the pushwire, the first limiting member is located at one side of the proximal end of the basket, and the first limiting member is located at one side of the distal end of the connecting member.

In one embodiment, the filter screen further comprises an inner sleeve and an outer sleeve, the inner sleeve and the outer sleeve are slidably sleeved on the guide wire, the proximal end of the basket is connected with the inner sleeve, the distal end of the basket is connected with the outer sleeve, and the inner sleeve and the outer sleeve are both located on one side of the distal end of the first limiting part.

In an embodiment, the delivery guidewire is further fixedly provided with a second limiting member, the second limiting member is disposed between the outer sleeve and the inner sleeve, and a distance between the inner sleeve and the second limiting member is greater than a distance between the connecting member and the first limiting member.

In one embodiment, the distal end of the guidewire is provided with a visualization spring.

When above-mentioned filter screen is placed in crooked blood vessel, produce the clearance easily between little curved side of blood vessel and the basket, and the dustcoat is located the outside of basket, and can be from the inflation, from inflation to the clearance between little curved side of packing blood vessel and the basket after the dustcoat release to the thrombus that will flow to this clearance is caught, and then takes this thrombus out of patient's is internal.

Drawings

Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the utility model. Also, like reference numerals are used to refer to like parts throughout the drawings. In the drawings:

FIG. 1 is a state view of a prior art embolic protection device implanted in a curved vessel;

FIG. 2 is a schematic structural diagram of an embolic protection device according to an embodiment of the present invention;

FIG. 3 is a schematic structural view of a pushwire according to an embodiment of the present invention;

FIG. 4 is a schematic structural view of a basket according to an embodiment of the present invention;

FIG. 5 is a schematic structural diagram of a housing according to an embodiment of the present invention;

FIG. 6 is a view of an embolic protection device according to an embodiment of the present invention implanted in a curved vessel;

FIG. 7 is a view of an embolic protection device according to an embodiment of the present invention received in a catheter.

Detailed Description

Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For convenience of description, spatially relative terms, such as "inner", "outer", "lower", "below", "upper", "above", and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" can include both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

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 herein in the description of the utility model is for the purpose of describing particular embodiments only and is not intended to be limiting of the utility model. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

In this application, the end closer to the operator is referred to as the "proximal end" and the end farther from the operator is referred to as the "distal end" in use, and the "proximal end" and the "distal end" of any component of the blood flow guide stent system are defined according to this principle.

As shown in FIG. 2, an embolic protection device 20 includes a delivery guidewire 210 and a filter screen 410, the filter screen 410 being disposed over the delivery guidewire 210. The delivery guidewire 210 is used to push the screen 410 to the vascular target site. The screen 410 serves to trap thrombus to prevent it from flowing distally without affecting the normal flow of blood. It should be noted that the embolic protection device 20 of embodiments of the present invention can be mated with delivery systems known in the art, where the screen 410 is compressibly loaded into the catheter 311 of the delivery system and self-expands upon release.

As shown in FIG. 3, the material of the delivery guidewire 210 is a metallic material with good biocompatibility, such as stainless steel, nickel titanium, etc. The delivery guidewire 210 has a diameter of 0.3-0.4mm and can deliver the embolic protection device 20. The surface of the pushwire 210 is provided with a polymer coating such as PTFE to reduce the resistance of the pushwire 210 during the pushing process.

As shown in fig. 3, the delivering wire 210 is provided with a first retaining member 211 and a second retaining member 212 for retaining the filter screen 410, the first retaining member 211 and the second retaining member 212 maintain a distance along the axial direction of the delivering wire 210, wherein the first retaining member 211 is located at one side of the proximal end of the second retaining member 212. The first limiting member 211 and the second limiting member 212 are both metal tubes, which can improve the strength of the delivery guide wire 210 and improve the adherence. The first retaining member 211 and the second retaining member 212 are fixed to the delivery guidewire 210 by laser welding or bonding. In one embodiment, in order to improve the accuracy of positioning the delivery guidewire 210 in the body, the materials of the first and second limiting

members

211 and 212 are developing metal materials, such as platinum-tungsten alloy, platinum-iridium alloy, and the like.

As shown in FIG. 3, the distal end of the delivery guidewire 210 is also provided with a visualization spring 213. The developing spring 213 is made of a metal having a good developing property, such as platinum-tungsten alloy or platinum-iridium alloy. The visualization spring 213 covers the distal end of the delivery guidewire 210 (i.e. a part of the delivery guidewire 210 is inserted into the visualization spring 213), and is fixed on the delivery guidewire 210 by gluing, so that the spring can be prevented from unwinding, the visualization of the delivery guidewire 210 in the patient can be increased by the cooperation of the visualization spring 213 and the DSA imaging device, and the visualization spring 213 has certain flexibility, so that the passability of the distal end of the delivery guidewire 210 can be increased, and the vascular wall can be prevented from being damaged by the distal end of the delivery guidewire 210.

As shown in FIG. 2, the proximal and distal ends of the screen 410 are traversed by the delivery guidewire 210. Screen 410 includes a basket 411, an outer shroud 413, an inner sleeve 415, and an outer sleeve 417.

The inner sleeve 415 and the outer sleeve 417 are slidably sleeved on the delivery guide wire 210, wherein the inner sleeve 415 is located between the first retaining member 211 and the second retaining member 212, and the outer sleeve 417 is located at a distal side of the second retaining member 212.

As shown in fig. 2 and 4, the basket 411 is a filtering structure having pores and capable of self-expansion. The basket 411 is substantially conical, the basket 411 is penetrated by a guide wire, a proximal end of the basket 411 is located at a proximal side of the second limiting member 212, and a distal end of the basket 411 is located at a distal side of the second limiting member 212. Specifically, the basket 411 is woven with shape memory metal wires, so that the basket 411 has pores, and the basket 411 can be self-expanded and radially compressed, so that the basket 411 can be radially compressed and loaded in the catheter 311 of the delivery system, and the basket 411 can be self-expanded after being released from the catheter 311, so that thrombus in blood can be captured. The material of the basket 411 in this embodiment may be nitinol wire or cobalt chromium alloy wire. In other embodiments, the basket 411 may also be a laser cut, heat set filter structure of a metal tube (e.g., nitinol tube).

As shown in FIG. 4, the braided wires at the proximal end of the basket 411 are fixedly attached to the inner sleeve 415, thereby slidably connecting the proximal end of the basket 411 to the delivery guidewire 210. The proximal end of the basket 411 is woven and shaped into an opening, and the opening is a hollow structure in a ring shape, so that thrombus can enter the basket 411 through the opening. The distal end of basket 411 is binding off structure, and binding off structure is woven for weaving the silk and is formed, have continuous grid structure, and then makes the thrombus unable to flow through from basket 411's distal end. The distal end of the basket 411 structure is attached to the outer sleeve 417 such that the distal end of the basket 411 is slidably attached to the delivery guidewire 210, and the basket 411 is slidable and rotatable circumferentially along the delivery guidewire 210. In use, when the delivery system reaches a desired position, the delivery guidewire 210 moves distally along the delivery system, and the second retaining member 212 slides relative to the outer sleeve 417 to push against the outer sleeve and drive the basket 411 to move out of the delivery system. After the basket 411 is completely released, the position and shape of the basket 411 will not be affected by the movement of the pushwire 210 within a certain range, since the pushwire 210 can slide and rotate circumferentially relative to the basket 411.

As shown in fig. 2 and 5, the outer cover 413 may be annularly sleeved outside the basket 411 by a seam (not shown), in the illustrated embodiment, the outer cover 413 is substantially in a circular truncated cone shape, and a central angle of the outer cover 413 in a circumferential direction is equal to 360 °. The outer cover 413 is a porous, self-expandable filter structure. Specifically, outer cover 413 is braided with shape memory wire such that outer cover 413 has pores and outer cover 413 is capable of self-expanding and being radially compressed. The term "annularly fitted" means that the annular ring is annularly arranged, and may be arranged along the circumferential direction of the basket 411 or may be irregularly annularly arranged.

As shown in fig. 6, when the filter screen 410 is placed in a curved blood vessel, a gap is easily formed between the small bent side of the blood vessel and the basket 411, the outer cover 413 is positioned outside the basket 411 and can be self-expanded, and the outer cover 413 is released and then self-expanded to fill the gap between the small bent side of the blood vessel and the basket 411, so that thrombus flowing to the gap is captured, and the thrombus is taken out of the body of a patient.

In other embodiments, the central angle of the outer cover 413 in the circumferential direction may not be equal to 360 °, and it is only necessary that the central angle of the outer cover 413 in the circumferential direction is greater than or equal to 180 °, and when releasing, the outer cover 413 is released at the position of the small bend side of the blood vessel, so that the outer cover 413 self-expands to the gap between the small bend side of the plugged blood vessel and the basket 411 after releasing, thereby capturing the thrombus flowing to the gap.

The porosity of the outer cover 413 is in this embodiment greater than the porosity of the basket 411, i.e. the total area of the apertures of the outer cover 413 per unit area is greater than the total area of the apertures of the basket 411. The flexibility of the outer cover 413 is greater than that of the basket 411, so that the outer cover 413 can better adapt to the shape of the blood vessel, and a gap between the outer cover 413 and the blood vessel is avoided.

As shown in FIGS. 2 and 5, the proximal end of the housing 413 defines a proximally facing shield port 414, allowing thrombus to flow into the space between the housing 413 and the basket 411, thereby capturing the thrombus. The shroud 414 passes over the opening at the proximal end of the basket 411, and the screen 410 further includes a plurality of cables 418, one end of the plurality of cables 418 being connected to the shroud 414 and the other end of the plurality of cables 418 being connected to the delivery guidewire 210. When the filter screen 410 is retracted, the delivery guidewire 210 is pulled proximally, the end of the plurality of pull wires 418 connected to the guidewire is first retracted into the catheter 311, and the outer cover 413 is gradually pulled into the catheter 311 by pulling the plurality of pull wires 418 on the outer cover 413.

As shown in fig. 5, the plurality of pulling cables 418 are interlaced with each other to form a mesh, and the mesh formed by the plurality of pulling cables 418 is larger than the apertures of the basket 411 and the housing 413, so that a relatively slender thrombus can be captured.

As shown in fig. 2 and 5, the filter screen 410 further includes a connector 419, the connector 419 being slidably coupled to the guidewire, the proximal ends of the plurality of cables 418 being coupled to the connector 419, the proximal ends of the plurality of cables 418 being coupled to the pushwire 311 via the connector 419, the proximal ends of the plurality of cables 418 being slidably coupled to the pushwire 210 via the connector 419 when the pushwire 210 is pushed distally to release the filter screen 410, thereby preventing the outer perimeter and the cables 418 from being too concentrated and being kinked.

The distance between the inner sleeve 415 and the second retaining member 212 is greater than the distance between the connecting member 419 and the first retaining member 211, as shown in fig. 7, so that when the filter screen 410 is recovered, the outer cover 413 is recovered first and then the basket 411 is recovered. Specifically, during recovery, a part of the guy wires 418 is firstly taken into the guide tube 311 by the guide tube 311, and since the guy wires 418 have a pulling effect on the outer cover 413, the cover opening 414 of the outer cover 413 is radially contracted and deformed, and the basket 411 is still in a self-expansion state at the moment, the contraction deformation of the cover opening 414 forms a door closing effect, so that an originally opened gap between the outer cover 413 and the basket 411 is changed into a closed net cavity, and therefore thrombus is locked in the net cavity, and the thrombus which is captured by the outer cover 413 is prevented.

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 utility model. 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. An embolic protection device, comprising:

delivering a guide wire;

the filter screen, the filter screen set up in carry on the seal wire, the filter screen includes basket and dustcoat, the basket with the dustcoat is the filtration that has the hole, and can be from inflation, the near-end of basket has the opening towards the near-end, the distal end of basket is binding off the structure, the near-end of basket with the far-end of basket respectively with carry the seal wire to connect, the dustcoat is located annularly the basket outside, the dustcoat is greater than or equal to 180 at the central angle that the circumferencial direction corresponds.

2. The embolic protection device of claim 1, wherein said outer cover has a circumferential radius equal to 360 °, and wherein said outer cover has a porosity greater than a porosity of said basket.

3. The embolic protection device of claim 1, wherein the flexibility of the outer cover is greater than the flexibility of the basket.

4. The embolic protection device of claim 1, wherein the proximal end of the housing forms a proximally facing shield opening that passes over the opening at the proximal end of the basket, the screen further comprising a plurality of pull cables, one end of the plurality of pull cables connected to the shield opening and the other end of the plurality of pull cables connected to the delivery guidewire.

5. The embolic protection device of claim 4, wherein the plurality of ripcords are interlaced to form a mesh, the plurality of ripcords forming a mesh larger than the apertures of the basket and the housing.

6. An embolic protection device as in claim 4 or 5, wherein the screen further comprises a connector slidably connected to the guidewire, the proximal ends of the plurality of cables connected to the connector, the proximal ends of the plurality of cables connected to the guidewire through the connector.

7. The embolic protection device of claim 6, wherein said delivery guidewire comprises a first stop for stopping said connector, said first stop being fixedly attached to said delivery guidewire, said first stop being located on a proximal side of said basket, said first stop being located on a distal side of said connector.

8. The embolic protection device of claim 7, wherein the filter screen further comprises an inner sleeve and an outer sleeve, the inner sleeve and the outer sleeve are slidably disposed over the guidewire, the proximal end of the basket is connected to the inner sleeve, the distal end of the basket is connected to the outer sleeve, and the inner sleeve and the outer sleeve are disposed on a distal side of the first retainer.

9. The embolic protection device of claim 8, wherein a second stop is fixedly disposed on the delivery guidewire, the second stop being disposed between the outer sleeve and the inner sleeve, the inner sleeve being spaced from the second stop by a distance greater than the connector is spaced from the first stop.

10. An embolic protection device as in claim 9, wherein the distal end of the guidewire is provided with a visualization spring.