CN213489548U

CN213489548U - Embolic protection device

Info

Publication number: CN213489548U
Application number: CN202022071523.9U
Authority: CN
Inventors: 黄辉; 唐纯海
Original assignee: Juhui Medical Technology Shenzhen Co ltd
Current assignee: Juhui Medical Technology Shenzhen Co ltd
Priority date: 2020-09-18
Filing date: 2020-09-18
Publication date: 2021-06-22
Anticipated expiration: 2030-09-18

Abstract

The application relates to an embolism protection device, which comprises a conveying guide wire and a filter screen. The filter screen is arranged on the conveying guide wire, the filter screen comprises a mesh basket woven by metal wires, the mesh basket comprises a proximal section and a distal section, the proximal section is connected with the distal section, the proximal section is of an open structure, the distal section is of a closed structure, the proximal section and the distal section are respectively connected with the conveying guide wire, the filter screen further comprises a supporting wave ring, and the supporting wave ring is arranged at one end of the proximal section, which is far away from the distal section. Above-mentioned embolic protection device supports ripples circle and vascular wall contact, can increase the area of contact of filter screen and vascular wall to prevent that the filter screen from taking place to shift and leading to the embolus to reveal.

Description

Embolic protection device

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to a embolism protection device.

Background

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

At present, emboli are easy to generate in the operation process of cardiovascular and cerebrovascular interventional therapy modes, such as balloon expansion, rotary cutting of vascular plaques, stent expansion, valve operation and the like. These emboli are intravascular masses that can enter stenotic vessels in the direction of blood flow and cause blockage of vessels in distal body parts, for example in valve repair or replacement surgery where manipulation of a calcified valve can cause migration of calcified material, tissue particles and other debris that may form into masses and thus emboli. Embolism if located in the heart, aorta or brain, can cause infarction of any part of the body, embolic debris can migrate through the circulatory system and cause vascular occlusion, blood clots and cerebrovascular accidents, as well as stroke, and can lead to cerebral infarction, myocardial infarction, pulmonary embolism, and even death. One way to reduce these complications is to place an embolization device downstream of the surgical treatment site to capture any emboli that may occlude the vessel, such as plaque, thrombus, etc., that have become dislodged during the procedure, and to protect the distal stenosed vessel from occlusion. Once the emboli are captured, the embolic protection device also risks the emboli falling off during the process of withdrawing the sheath from the body of the patient, causing new vessel embolism and increasing the operation risk.

Products of existing embolic protection devices can be divided into suction-type devices and screen-type devices. The suction device occludes a far-end blood vessel by using an expansion balloon, and emboli and plaques are sucked out through a suction catheter after an operation, so that blood vessel embolism is avoided, but the mode can cause blood vessel ischemia, and the operation risk is increased; the filter screen type device is used for placing the filter screen in a far-end blood vessel to block emboli and plaque from flowing to a narrow blood vessel at the tail end, and then the filter with the emboli is recycled through the recycling catheter, so that the blood flow is not blocked, and the application is wide.

The existing filter screen type device is divided into two types according to the forming mode of the filter screen: one is formed by cutting and shaping a pipe into an umbrella shape, and a film with holes is covered outside the umbrella shape, so that emboli can be blocked from flowing to a far-end blood vessel, and the blood flow is not blocked; however, in this structure, the umbrella frame is hard, the recovery force is large, and the supporting force to the blood vessel is large, which may cause vasospasm, and the position of the bent blood vessel cannot conform to the shape of the blood vessel, and the adherence to the blood vessel is not good. The other structure is woven into a net basket shape, the net basket has better elasticity and can conform to the shape of a blood vessel due to the fact that the woven structure is softer, but the cross section of the net basket 11 is triangular, as shown in fig. 1, the contact area of the net basket 11 on the side far away from the guide wire 12 and the blood vessel is smaller, the net basket may have poor adherence at the position of the bent blood vessel and is easy to shift, and embolus can penetrate through a filter screen to cause embolism of the blood vessel at the far end to be narrow.

SUMMERY OF THE UTILITY MODEL

The utility model aims at solving the problem that the embolism is caused by poor adherence and easy displacement of the embolism protection device. The purpose is realized by the following technical scheme:

embodiments of the present application provide an embolic protection device comprising:

a delivery guidewire, and

the filter screen is arranged on the conveying guide wire and comprises a basket woven by metal wires, the basket comprises a proximal section and a distal section, the proximal section is connected with the distal section, the proximal section is of an open structure, the distal section is of a closed structure, the proximal section is connected with the distal section respectively and is connected with the conveying guide wire, the filter screen further comprises a supporting wave ring, and the supporting wave ring is arranged at one end, far away from the distal section, of the proximal section.

According to the embolic protection device provided by the embodiment of the application, the support wave ring is arranged at the proximal end section of the basket, and after release, the support wave ring can be in contact with the vessel wall, so that the contact area between the filter screen and the vessel wall is increased, and the filter screen is prevented from shifting to cause embolus leakage; the better elasticity of support ripples circle can assist the basket shaping better, lets the opening of basket hug closely the vascular wall, and the separation embolus flows through from filter screen and vascular wall clearance, improves the operation security.

In addition, according to the embodiment of the present invention, the following additional technical features may be provided:

in one embodiment, the wire diameter of the support wave ring is larger than the wire diameter of the metal wires used for weaving the mesh basket.

In one embodiment, the wire diameter of the support wave ring is 5-10 times the wire diameter of the metal wires used to weave the basket.

In one embodiment, the supporting wave ring is woven by developing lines, and the developing lines comprise developing inner cores and shells coated on the developing inner cores.

In one embodiment, the developer core is platinum or an alloy thereof, gold or an alloy thereof, tungsten or an alloy thereof, tantalum or an alloy thereof.

In one embodiment, the outer shell is a nickel titanium alloy, stainless steel, or cobalt chromium alloy.

In one embodiment, the support wave ring comprises 8-15 waves.

In one embodiment, the width of the support wave ring is 5-8 mm.

In one embodiment, the filter screen further comprises an inner sleeve and an outer sleeve arranged outside the inner sleeve, and the basket is connected with the delivery guide wire through the inner sleeve and the outer sleeve.

In one embodiment, at least one of the inner sleeve and the outer sleeve is a metal developing material.

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 invention. Also, like reference numerals are used to refer to like parts throughout the drawings. In the drawings:

FIG. 1 is a schematic diagram of a prior art embolic protection device;

FIG. 2 is a schematic structural view of an embolic protection device according to a first embodiment of the present application;

FIG. 3 is a schematic view of the delivery guidewire of the embolic protection device of FIG. 2;

FIG. 4 is a schematic view of the construction of the screen of the embolic protection device of FIG. 2;

FIG. 5 is a schematic representation of the basket of the embolic protection device of FIG. 2 in cross-section perpendicular to the direction of extension of the delivery guidewire;

FIG. 6 is a schematic view of the basket of the embolic protection device of FIG. 2 during weaving;

FIG. 7 is a schematic illustration of a screen of a embolic protection device according to a second embodiment of the present application;

fig. 8 is a schematic structural view of the support wave ring shown in fig. 7.

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

The term "distal end" refers to an end away from the operator, and the term "proximal end" refers to an end closer to the operator. And defines the "proximal" and "distal" ends of any component of the stent according to this principle. "axial" generally refers to the length of the stent as it is delivered, and "radial" generally refers to the direction of the stent perpendicular to its "axial" direction, and defines both "axial" and "radial" directions for any component of the stent graft according to this principle.

Referring to fig. 2, an embolic protection device 10 according to a first embodiment of the present application includes a delivery guidewire 100 and a screen 200. The delivery guidewire 100 is used to push the screen 200 to the site of the vascular disorder while the delivery guidewire 100 does not affect the morphology of the vessel. The filter 200 serves to block emboli from flowing distally without blocking blood flow. In practice, the physician can manipulate the delivery guidewire 100 to deliver the filter mesh 200 to the lesion site, and use the filter mesh 200 to block emboli in the blood.

It should be noted that in order to facilitate the insertion or removal of the filter screen 200 from the blood vessel, the embolic protection device 10 of the present invention can be used with delivery systems known in the art, wherein the filter screen 200 is compressibly loaded into the delivery system and self-expands to an expanded state after release.

Specifically, the material of the pushwire 100 is stainless steel, nickel titanium, or other metals. The delivery guidewire 100 has a diameter of 0.3-0.4mm and provides support for the embolic protection device 10. In one embodiment, the surface of the pushwire 100 is provided with a polymeric coating to reduce the resistance of the pushwire 100 during pushing.

Referring to fig. 3, the guide wire 100 is provided with a position-limiting sleeve 110 for limiting the movement of the filter screen 200. Specifically, two limiting sleeves 110 are provided, the two limiting sleeves 110 are disposed between two ends of the filter screen 200, the limiting sleeve 110 near the proximal end of the delivery guide wire 100 is used for limiting the proximal end of the filter screen 200 to continuously move towards the distal end of the delivery guide wire 100, and the limiting sleeve 110 near the distal end of the delivery guide wire 100 is used for limiting the distal end of the filter screen 200 to continuously move towards the proximal end of the delivery guide wire 100. Specifically, the limiting sleeve 110 is a metal tube, which can improve the strength of the delivery guide wire 100 and improve the adherence. In one embodiment, the stop collar 110 is secured to the delivery guidewire 100 by laser welding or adhesive.

With continued reference to fig. 3, the distal end of the delivery guidewire 100 is also provided with visualization markers 120. In the illustrated embodiment, the development marker 120 is a development spring. The developing spring is made of metals with good developing property, such as platinum-tungsten alloy or platinum-iridium alloy. The developing spring cladding is at the distal end of carrying seal wire 100 to fix on carrying the seal wire through sticky mode, can prevent that the spring from unwinding, can increase the visuality of carrying seal wire 100 moreover, increase the trafficability characteristic of carrying the distal end of seal wire 100, prevent to carry the distal end damage vascular wall of seal wire 100.

Referring to fig. 2, a screen 200 is attached to the delivery guidewire 100. Referring to fig. 4, the filter screen 200 includes a basket 210, an inner sleeve 220, an outer sleeve 230, and a developing wire 240. The outer sleeve 230 is disposed outside the inner sleeve 220, the basket 210 is connected to the delivery guidewire 100 via the inner sleeve 220 and the outer sleeve 230, and the developer wire 240 is disposed on the basket 210.

Specifically, the baskets 210 are woven from metal wire. In one embodiment, the basket 210 is woven from 36, 48, 54, or 72 wires having a diameter of 0.0016 to 0.0024 inches. In this embodiment, the wire diameters of the wires are identical. The metal wire is nickel-titanium alloy wire or cobalt-chromium alloy wire.

The basket 210 includes a proximal section 211, a distal section 212, and an intermediate section 213 connected to the proximal section 211 and the distal section 212, wherein the proximal section 211 is in an open configuration, the distal section 212 is in a closed configuration, the intermediate section 213 is in a cylindrical configuration, and the proximal section 211 and the distal section 212 are respectively connected to the delivery guidewire 100.

Referring to fig. 5, the projection of the basket 210 on the plane perpendicular to the extending direction of the delivering wire 100 includes a first oblique side 214, a first connecting side 215, a second oblique side 216 and a second connecting side 217 connected in sequence, wherein the proximal end section 211 corresponds to the first oblique side 214 and a portion of the second connecting side 217 connected to the first oblique side 214, the middle section 213 corresponds to the first connecting side 215 and a portion of the second connecting side 217 corresponding to the first connecting side 215, the distal end section 212 corresponds to the second oblique side 216 and a portion of the second connecting side 217 connected to the second oblique side 216, the first connecting side 215 is parallel to the second connecting side 217, and the length of the first connecting side 215 is 1/4-1/3 of the length of the second connecting side 217. After implanting, the position that first connecting edge 215 and second connecting edge 217 correspond can contact with the vascular wall, compares for triangular basket with current cross-section, and prior art's basket only has an limit to contact with the vascular wall promptly, and the area that embolic protection device 10 of this application contacted with the vascular wall is great, reduces the risk that takes place the aversion under the blood flow to reduce the possibility that the embolus was revealed. And first connection limit 215's length is suitable, if first connection limit 215's length is too big for the angle of second hypotenuse 216 and second connection limit 217 is too big, and the resistance is great when causing filter screen 200 to retrieve, and the adherence when filter screen 200 releases the crooked blood vessel is relatively poor simultaneously, and the embolus is easily blocked in the gap of filter screen 200 and vascular wall, treats that filter screen 200 retrieves the back, and the embolus can flow to the narrow and small blood vessel of distal end, causes the embolism. If the length of the first connecting edge 215 is too small, the contact area between the filter screen 200 and the blood vessel wall is small, the supporting strength at the opening of the proximal section 211 is small, and displacement is easy to occur under the impact of blood flow, so that embolus leakage is caused.

In one embodiment, the distance between the first connecting edge 215 and the second connecting edge 217 is 0-1mm larger than the diameter of the blood vessel, i.e. the diameter of the middle section 213 is 0-1mm larger than the diameter of the blood vessel, so as to increase the contact area between the filter screen 200 and the blood vessel wall, and at the same time, to increase the stability of the filter screen 200 in the blood vessel and prevent displacement.

In an embodiment, the included angle between the first inclined edge 214 and the second connecting edge 217 is 45-60 °, so that the recovery resistance of the filter screen 200 can be reduced, and the filter screen port has strong support performance.

Referring to fig. 6, the braiding angle of the middle section 213 is larger than that of the distal section 212, so that the mesh openings of the basket 210 of the middle section 213 are dense, the middle section 213 has better supporting performance, and the risk of displacement under blood flow impact of the middle section 213 is reduced, while the mesh openings of the distal section 212 become smaller to some extent due to the closed end, so as to achieve the purpose of blocking smaller emboli. If the braid angle of the distal section 212 is the same as that of the intermediate section 213, the distal section 212 may further reduce the mesh size when closing up, which may block the risk of blood flow. In one embodiment, the braid angle of the middle section 213 is 60-75 °, and the braid angle of the distal section 212 is 30-60 °, so that the middle section 213 can be well fixed in the blood vessel, the risk of displacement is reduced, and the distal end can achieve the purpose of blocking small emboli without affecting blood flow. In this embodiment, the braid angle of the proximal segment 211 is the same as the braid angle of the intermediate segment 213.

The outer sleeve 230 and the inner sleeve 220 are made of metal materials such as stainless steel, cobalt-chromium alloy, nickel-titanium alloy, platinum, tantalum, etc., wherein at least one of the outer sleeve 230 and the inner sleeve 220 is made of a metal developing material. The outer sleeve 230 and the inner sleeve 220 clamp the metal wires for weaving the basket 210 in the middle, that is, the metal wires at the two ends of the basket 210 are clamped between the inner sleeve 220 and the outer sleeve 230 to restrain the two ends of the basket 210, so as to prevent the basket 210 from being loose in shape, and simultaneously indicate the position of the filter screen 200 in the blood vessel, thereby facilitating judgment and operation of doctors and reducing operation difficulty.

The developing wire 240 is a single wire or a plurality of wires made of metal materials with good developing effects, such as gold and platinum, or a spring formed by winding the developing wire. In one embodiment, two developing wires 240 are wound around the end of the proximal section 211 away from the middle section 213, and another developing wire is wound around the joint of the middle section 213 and the distal section 212, so that whether the opening of the proximal section 211 is well formed and whether the middle section 213 is tightly attached to the blood vessel wall can be determined by the two developing wires 240.

Referring to fig. 7, a embolic protection device (not shown) according to a second embodiment of the present application includes a delivery guidewire (not shown) and a screen 200b, the screen 200b being disposed over the delivery guidewire. The structure of the pushwire is the same as that of the pushwire 100 of the first embodiment, and the description thereof is omitted.

The screen 200b includes a basket 210b, an inner sleeve 220b, an outer sleeve 230b, and a support wave ring 250. The outer sleeve 230b is disposed outside the inner sleeve 220b, the basket 210b is connected to the delivery guidewire via the inner sleeve 220b and the outer sleeve 230b, and the support wave ring 250 is disposed at the proximal end of the basket 210 b.

According to the embolic protection device of the embodiment, the support wave ring 250 is arranged at the proximal end of the basket 210, and after release, the support wave ring 250 can be in contact with the vessel wall, so that the contact area between the filter screen and the vessel wall is increased, and the filter screen is prevented from being displaced to cause embolus leakage; and support wave circle 250 can assist the shaping of basket 210b better, lets the opening of basket 210b hug closely the vascular wall, and the separation embolus flows through from filter screen 200b and vascular wall clearance, improves the operation security.

The baskets 210b are woven from metal wire. Referring to fig. 8, the basket 210b includes a proximal section 211b and a distal section 212b, the proximal section 211b is connected to the distal section 212b, and compared with the first embodiment, the basket 210b has no middle section, and the projection of the basket 210b on the cross section extending perpendicular to the delivery guidewire is a triangle. The supporting wave ring 250 is disposed at an end of the proximal end section 211b of the basket 210b far from the distal end section 212b, i.e., the supporting wave ring 250 is disposed at a position of a mesh opening of the proximal end section 211 b. The support wave ring 250 is wrapped around the proximal section 211b and secured to the inner sleeve 220b and the outer sleeve 230 b. The wire diameter of the support wave rings 250 is larger than that of the metal wires used to weave the basket 210 b. In one embodiment, the wire diameter of the support wave rings 250 is 5-10 times the wire diameter of the wires used to weave the basket 210 b. Specifically, the supporting wave ring 250 is woven by a developing wire, and the developing wire includes a developing inner core and a housing covering the developing inner core. The developing inner core is made of metal material which can be seen under X rays, such as platinum or alloy thereof, gold or alloy thereof, tungsten or alloy thereof, tantalum or alloy thereof. The outer shell is made of nickel-titanium alloy or stainless steel or cobalt-chromium alloy. In one embodiment, the developing core accounts for 30% of the developing line by mass, so that the supporting wave ring has good developing performance and elasticity. After the filter screen 200b is released, the supporting wave ring 250 can be observed to judge whether the opening at the near end of the filter screen 200b is tightly attached to the vessel wall, so that the visibility of the filter screen 200b is improved.

Referring to fig. 8, the supporting wave ring 250 includes 8-15 waves, the diameter of the supporting wave ring 250 is 1-2mm larger than the diameter of the blood vessel, and the width of the supporting wave ring 250 is 5-8mm, i.e. the distance between the adjacent wave crests and wave troughs (i.e. the wave height) of the supporting wave ring is 5-8 mm. In the illustrated embodiment, the wave heights of the support wave rings 250 are all equal.

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 represent some embodiments of the present invention, and the description thereof is specific and detailed, but not to be construed as limiting the scope of the present invention. It should be noted that, for those skilled in the art, without departing from the spirit of the present invention, several variations and modifications can be made, which are within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the appended claims.

Claims

1. An embolic protection device, comprising:

a delivery guidewire, and

2. The embolic protection device of claim 1, wherein the wire diameter of the support wave loops is greater than the wire diameter of the wires used to weave the basket.

3. The embolic protection device of claim 2, wherein the wire diameter of the support wave ring is 5-10 times the wire diameter of the metal wires used to weave the basket.

4. The embolic protection device of claim 3, wherein the support wave ring is woven from a visualization thread comprising a visualization core and a shell covering the visualization core.

5. The embolic protection device of claim 4, wherein the visualization core is platinum or an alloy thereof, gold or an alloy thereof, tungsten or an alloy thereof, tantalum or an alloy thereof.

6. The embolic protection device of claim 4, wherein the outer shell is a nickel titanium alloy, stainless steel, or cobalt chromium alloy.

7. The embolic protection device of claim 1, wherein the support wave ring comprises 8-15 waves.

8. The embolic protection device of claim 1, wherein the width of the support wave ring is 5-8 mm.

9. The embolic protection device of claim 1, wherein the filter screen further comprises an inner sleeve and an outer sleeve disposed outside the inner sleeve, and the basket is connected to the delivery guidewire through the inner sleeve and the outer sleeve.

10. The embolic protection device of claim 9, wherein at least one of the inner sleeve and the outer sleeve is a metal imaging material.