CN113576599A - Thrombus retrieval device and self-expanding structure - Google Patents
Thrombus retrieval device and self-expanding structureDownload PDFInfo
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- CN113576599A CN113576599ACN202110874607.2ACN202110874607ACN113576599ACN 113576599 ACN113576599 ACN 113576599ACN 202110874607 ACN202110874607 ACN 202110874607ACN 113576599 ACN113576599 ACN 113576599A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22072—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22094—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for for crossing total occlusions, i.e. piercing
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Abstract
Description
Technical Field
The present disclosure relates to the field of medical devices, and more particularly, to a thrombus removal device and a self-expanding structure.
Background
Stroke is a serious disease that seriously threatens the health of our country and hinders the development of socioeconomic development, becomes the first cause of death, and is increasing at a rate of 8.7% per year. According to the data of world bank investigation, if no more effective measures are taken, 3177 ten thousand patients with cerebral apoplexy are expected in China by 2030, wherein Acute Ischemic cerebral Apoplexy (AIS) accounts for 70% of all cerebral apoplexy, and newly-released AIS patients in China exceed 200 ten thousand every year. The critical phase of AIS treatment is the acute phase, and intravenous thrombolysis can improve patient prognosis, but has poor therapeutic effect on large vessel occlusion. With the development of intravascular technologies and materials, positive tests prove that intravascular treatment can significantly improve the prognosis of intracranial macrovascular occlusion patients and reduce disability rate and mortality, so that national guidelines are updated successively, mechanical embolectomy is used as the primary treatment mode of acute anterior circulatory macrovascular occlusion patients, and highest-level recommendations are given. All government medical systems strive to improve AIS (automatic identification system) emergency procedures, determine related technical indexes and promote clinical popularization of the revolutionary technology.
At present, the device for taking thrombus on the market adopts a curling design, a far end is provided with a developing mark, unit grids on an effective area of the device are grids close to a uniform area, the grids have a better effect on catching soft thrombus, but have certain limitation on hard massive thrombus, the unit grids designed uniformly cannot be effectively embedded into the thrombus, so that the effect of catching the thrombus is unsatisfactory, and even the thrombus is failed to be caught.
Disclosure of Invention
In order to overcome the deficiencies of the prior art, it is an object of the present disclosure to provide a thrombus extraction device and a self-expanding structure to at least partially solve the above technical problems.
In order to achieve the above object, the present disclosure provides a thrombus removal device comprising:
a self-expanding structure comprising a mesh structure, the mesh structure comprising:
a plurality of first meshes;
a plurality of second meshes, the area of the second meshes being larger than the area of the first meshes;
and the first development mark is positioned on at least part of the second grid.
In some aspects, the second mesh includes distal ends, and the distal end of at least one of the second meshes has a first visualization mark disposed thereon.
In some aspects, the second mesh is formed from a single strand of alloy.
In some aspects, the first visualization marker is located proximal or distal to the second mesh.
In some aspects, the first visualization marker is located proximal and distal to the at least one second grid.
In some aspects, the thrombus removal device further comprises:
a delivery guidewire comprising a distal end and a proximal end;
a connecting member;
the self-expanding structure includes a proximal end and a distal end, and a linking member connects the distal end of the delivery guidewire with the proximal end of the self-expanding structure.
In some aspects, the self-expanding structure has a second visualization marker and a third visualization marker disposed on the proximal end and the distal end, respectively.
In some embodiments, the second lattice is located in a plurality of first regions of the self-expanding structure, the plurality of first regions being spaced apart.
In some aspects, the number of second grids is an even number; the second grids are oppositely arranged in pairs along the radial circumferential direction of the self-expansion structure.
In some embodiments, the second mesh has a curved surface structure, two opposite to each other, and has the same central axis.
In some embodiments, when the number of the second meshes is greater than two, the central axes of the curved surfaces of two adjacent pairs of the second meshes are perpendicular to each other.
In some embodiments, at least one first development mark is disposed on each pair of second grids.
In some aspects, the second mesh is disposed between the plurality of first meshes and is arranged at equal intervals in a radial direction of the self-expanding structure.
In some embodiments, the first development mark has a length of 0.5 to 1.2 mm.
In some schemes, the grid unit area of the second grid is 15-60 mm2。
In some aspects, the areas of each pair of second grids differ.
In some aspects, the areas of each pair of second meshes gradually decrease in a radial direction toward the distal end.
In some aspects, at least a portion of the curved surface of the second mesh is recessed inward on a circumferential surface of the self-expanding structure.
In some aspects, the second mesh is located in an active region of the self-expanding structure, the active region for capturing thrombus.
The present disclosure also provides a self-expanding structure comprising a mesh structure, the mesh structure comprising:
a plurality of first meshes;
a plurality of second meshes, the second meshes having an area larger than that of the first meshes;
and the first development mark is positioned on at least part of the second grid.
The embodiment of the disclosure provides a thrombus extraction device, wherein a first grid and a second grid are arranged on a self-expansion structure of a net structure, and the first grid and the second grid can capture thrombus with different sizes; a plurality of second grids with concave areas can be arranged on the circumference of the self-expansion structure, and the grids of the concave areas are distributed in a staggered manner in different spatial planes, so that the traditional soft thrombus can be captured, larger hard thrombus can be captured, and higher thrombus taking success rate is realized; meanwhile, the effective area of the device adopts a multipoint development design, and besides the development mark at the far end of the device, a plurality of discrete development marks are also arranged at the near end of the effective area, so that better positioning in the operation is realized.
Drawings
FIG. 1 is a schematic structural view of a thrombus removal device according to an embodiment of the present disclosure;
FIG. 2 is a schematic view of a deployed state of a self-expanding structure of a thrombus removal device according to an embodiment of the present disclosure;
FIG. 3 is a schematic view of an expanded state of a self-expanding structure of a thrombus removal device according to an embodiment of the present disclosure;
fig. 4 is a schematic diagram of a first development mark on a second grid provided by an embodiment of the disclosure.
Detailed Description
The technical solution of the present disclosure is further described in detail by the accompanying drawings and examples.
The embodiment of the disclosure provides a thrombus extraction device, which comprises a self-expansion structure, wherein the self-expansion structure comprises a first grid and a second grid, the size of the second grid is larger than that of the first grid, the second grid is used for capturing large-size hard or soft thrombus, and the second grid is provided with a developing mark so that the position of the second grid can be tracked. Still can set up a plurality of meshes that have the depressed area on network structure's the circumference from expanding structure, a plurality of depressed area meshes are the crisscross distribution of space antarafacial, except can catching traditional soft thrombus, can also catch bigger stereoplasm thrombus, realize higher success rate of emboliaing. The effective area of the device adopts a multi-point developing design, and besides the developing mark at the far end of the device, a plurality of discrete developing marks are also arranged at the near end of the effective area, so that better positioning in the operation is realized.
As discussed in this disclosure, the terms "distal segment" or "proximal end" are used hereinafter in reference to a position or orientation relative to a hand-held end of a treating physician or medical interventionalist. "distal" or "distal side" is a location that is distal to the direction of the hand-held end of the physician or interventionalist. "proximal" or "toward the proximal segment" or "at the distal end" is a location that is near the direction of the physician or interventionalist's hand-held end. The terms "occlusion", "thrombus" or "occlusion" are used interchangeably.
The present disclosure is described in detail below with reference to specific embodiments, but it should be understood that the following embodiments are not intended to limit the present disclosure, and those skilled in the art can conceive of other similar schemes based on the concept of the present disclosure by combining and arranging specific features in the embodiments.
FIG. 1 is a schematic structural view of a thrombus removal device according to an embodiment of the present disclosure; as shown in fig. 1, the thrombus removal device includes: self-expandingstructure 1,delivery guidewire 2, connectingmember 3 andsecond visualization marker 4.
Thedelivery guidewire 2 has a proximal end and a distal end, and in this embodiment, the operator's hand-held end is used as the proximal end, the other end is used as the distal end, and the other components are used as the proximal end and the other end are used as the distal end. The length of the conveyingguide wire 2 is 180-200 cm, theconveying guide wire 2 is made of nickel-titanium alloy or 304 stainless steel, theconveying guide wire 2 is designed in a conical grinding mode, the diameter of a constant section at the near end of theconveying guide wire 2 is 0.35-0.50 mm, the diameter of a constant section at the far end of theconveying guide wire 2 is 0.08-0.15 mm, and the middle portion of theconveying guide wire 2 is a conical section and gradually becomes thinner from the near end to the far end.
The self-expandingstructure 1 may comprise a proximal end and a distal end, wherein the proximal end of the self-expandingstructure 1 is connected to the distal end of thepushwire 2 by means of a connectingmember 3, wherein the connectingmember 3 is connected to thepushwire 2 and the self-expandingstructure 1 by means of welding or riveting. The self-expandingstructure 1 can be a whole-body net structure made of memory alloy, can be compressed into a bundle shape during conveying so as to be beneficial to pushing, and can automatically expand and capture thrombus after the thrombus is released. Fig. 2 is a schematic view showing a deployed state of a self-expanding structure of a thrombus extraction device provided by an embodiment of the present disclosure, fig. 3 is a schematic view showing an expansion of the self-expanding structure of the thrombus extraction device provided by an embodiment of the present disclosure, and as shown in fig. 2 and fig. 3, the self-expandingstructure 1 may include: afirst mesh 11, asecond mesh 12, athird mesh 13, afirst development mark 15, and athird development mark 14.
The net structure of the self-expandingstructure 1 mainly comprises a plurality offirst grids 11, thefirst grids 11 are closed unit grids which are normally and basically designed uniformly, and the area of thefirst grids 11 can be 5-12 mm2. Thesecond mesh 12 is a mesh of depressed regions with a large area, and the curved surface of thesecond mesh 12 can be depressed inward on the circumferential surface of the self-expandingstructure 1, and is mainly used for capturing large thrombi (including soft and hard thrombi). Each grid unit of second net 12 is formed by the alloy of individual strand, and the alloy of individual strand does benefit to from expanding structure integrated into one piece when preparation, and the area of second net 12 is 15 ~ 60mm2。
The distal end of the self-expandingstructure 1 may be provided with third development marks 14, the third development marks 14 are used for positioning the distal end of the self-expandingstructure 1 in an operation, the length of the third development marks 14 is 0.5-1.5 mm, the number of the third development marks 14 is 3-4, different numbers of the third development marks 14 are mainly set according to different diameters of the self-expandingstructure 1 when the self-expandingstructure 1 is unfolded, the diameter of the self-expandingstructure 1 is 3.0-6.5 mm, the number of thefirst grid 11 at the distal end is different along with the difference of the diameter of the self-expandingstructure 1, and if the number of the peak points of thefirst grid 11 at the distal end is n, the number of the third development marks 14 is set to n-1, so that the plurality of the third development marks 14 are dislocated in the axial direction when the self-expandingstructure 1 is compressed into a bundle shape, and the pushing is prevented from being affected by an excessively large size.
The self-expandingstructure 1 may be functionally divided into an active area, which is an active area for capturing thrombus, and a non-active area, which is a sloped area of about 45 °, a transition area for connecting the active area to the connectingmember 3. The first developing marks 15 are arranged at the near end and/or the far end of thesecond grid 12 in the effective area, the number of the first developing marks 15 can be 2-3, the length of the first developing marks 15 can be 0.5-1.2 mm, and the first developing marks 15 are used for displaying the near end of the effective area in an operation and are convenient for capturing a large thrombus. Athird grid 13 is arranged at the near end of the self-expansion structure 1 in the non-effective area, thethird grid 13 is a reduced grid with the area less than 8mm2For a smooth transition of the inactive zone to the connectingpart 3, i.e. the mesh structure of the self-expandingstructure 1 is connected with the connectingpart 3 by means of thethird mesh 13.
One or more first visualization marks 15 are disposed on at least a portion of thesecond grid 12, fig. 4 is a schematic view of the first visualization marks 15 on thesecond grid 12 provided in the embodiment of the present disclosure, as shown in fig. 4, the number of the first visualization marks 15 on eachsecond grid 12 may be 3, wherein the first visualization marks 15 may be disposed on both the proximal end and the distal end of eachsecond grid 12, so that the position of thesecond grid 12 can be better observed during the operation, which facilitates more accurate thrombus capture.
Thesecond grids 12 are distributed in the effective area, thesecond grids 12 can be arranged among thefirst grids 11, the periphery of thesecond grids 12 is respectively connected with thefirst grids 11, and thefirst grids 11 and thesecond grids 12 are arranged in a staggered mode, so that small thrombus and large thrombus can be captured alternately. In the effective area, the quantity of second net 12 is different along with the length difference of effective area, when the length of effective area is less than 30mm, contains one or more first regions in the effective area, can set up twosecond nets 12 in the first region, and specific arrangement is: the twosecond grids 12 are arranged in pairs in the middle of the effective area, and the curved surfaces of the twosecond grids 12 arranged in pairs can be in a facing state in the same circumferential direction of the self-expansion structure 1, have the same central axis, and are arranged at equal intervals in the radial direction of the self-expansion structure 1. In some embodiments, the curved surfaces of thesecond mesh 12 arranged in pairs may be in a non-diametrically opposed arrangement. When the length of active area is greater than 30mm, contain a plurality of first regions in the active area, a plurality of first region interval arrangements, can set up the even number second net 12 that is greater than 2 in a plurality of first regions, two liang of setting in pairs respectively of second net 12 in every first region, the second net 12 that appears in pairs can easily catch the bulk thrombus that length is greater than the circumference diameter of self-expandingstructure 1, specific arrangement mode can be: in the same circumferential direction of the self-expandingstructure 1, the curved surfaces of every twosecond grids 12 are in a facing state and have the same central axis, and the central axes of the curved surfaces of two adjacent pairs ofsecond grids 12 are perpendicular to each other, that is, the two adjacent pairs ofsecond grids 12 are distributed in a staggered manner in different planes in space, so that massive thrombus can be captured or held from different directions, and the success rate of capturing thrombus is effectively improved.
In some preferred embodiments, the areas of the pairs ofsecond mesh 12 are different, and the areas of the pairs ofsecond mesh 12 decrease gradually along the direction from the proximal end to the distal end of theexpandable structure 1, so that the design is favorable for capturing large thrombi with different sizes.
The joint of the near end of the self-expandingstructure 1 and the connectingpart 3 is further provided with a second developingmark 4 for positioning and displaying the near end position of the self-expandingstructure 1 in operation, and the length of the second developingmark 4 can be 1-30 mm.
Thefirst development mark 15, thesecond development mark 4, and thethird development mark 14 in the embodiment of the present disclosure may be made of platinum-iridium alloy (90% platinum-10% iridium), platinum-tungsten alloy (92% platinum-8% tungsten), platinum (100%), gold-plated tungsten, tantalum, or the like.
The specific working process of the thrombus extraction device provided by the embodiment of the disclosure is carried out as follows:
the self-expandable structure 1 compressed into a bundle reaches a lesion in a blood vessel along a microcatheter under the action of the delivery guide wire 2, wherein the distal end of the microcatheter passes through the lesion, and the third visualization mark 14 is aligned with the distal end mark of the microcatheter by observing the third visualization mark 14 at the distal end of the self-expandable structure 1; slowly withdrawing the microcatheter to release the self-expanding structure 1 at the lesion site, and observing that the distal marker of the microcatheter is flush with the second visualization marker 4 at the proximal end of the self-expanding structure 1, the self-expanding structure 1 is completely released; the self-expansion structure 1 is continuously opened, and the second grid 12 arranged in the effective area of the self-expansion structure 1 captures thrombus at a lesion part in the opening process of the self-expansion structure 1, so that the thrombus is embedded into the self-expansion structure 1 to form a whole; the self-expanding structure 1 for capturing thrombus is withdrawn into the middle catheter together with the micro catheter under the action of the delivery guide wire 2, and then the whole body is withdrawn out of the body together, so that the operation of taking out the thrombus in the blood vessel is realized.
The above-mentioned embodiments, objects, technical solutions and advantages of the present disclosure are described in further detail, it should be understood that the above-mentioned embodiments are merely illustrative of the present disclosure and are not intended to limit the scope of the present disclosure, and any modifications, equivalent substitutions, improvements and the like made within the spirit and principle of the present disclosure should be included in the scope of the present disclosure.
Claims (20)
1. A thrombus extraction device, the device comprising:
a self-expanding structure comprising a mesh structure, the mesh structure comprising:
a plurality of first meshes;
a plurality of second meshes, the second meshes having an area larger than that of the first meshes;
and the first development mark is positioned on at least part of the second grid.
2. A thrombus extraction device according to claim 1, wherein the second mesh comprises a distal end, at least one of the second mesh having the first visualization marker disposed on the distal end.
3. The thrombus extraction device of claim 1, wherein the second mesh is formed from a single strand of alloy.
4. The thrombus extraction device of claim 1, wherein the first visualization marker is located proximal or distal to the second mesh.
5. The thrombus extraction device of claim 1, wherein the first visualization markers are located proximal and distal to at least one of the second meshes.
6. A thrombus extraction device according to claim 1, further comprising:
a delivery guidewire comprising a distal end and a proximal end;
a connecting member;
the self-expanding structure includes a proximal end and a distal end, and the linking member connects the distal end of the pushwire to the proximal end of the self-expanding structure.
7. The thrombus extraction device of claim 6, wherein the proximal and distal ends of the self-expanding structure are provided with second and third visualization markers, respectively.
8. A thrombus extraction device according to claim 1, wherein the second lattice is located at a plurality of first regions of the self-expanding structure, the plurality of first regions being arranged at intervals.
9. A thrombus extraction device according to claim 1, wherein the number of the second meshes is an even number; the second grids are oppositely arranged in pairs along the radial circumferential direction of the self-expansion structure.
10. A thrombus extraction device according to claim 9, wherein the second mesh is of a curved configuration, opposed in pairs, and having the same central axis.
11. The thrombus extraction device according to claim 10, wherein when the number of the second meshes is more than two, central axes of the curved surfaces of two adjacent pairs of the second meshes are perpendicular to each other.
12. A thrombus extraction device in accordance with claim 9, wherein each pair of the second grids is provided with at least one first visualization marker.
13. A thrombus extraction device according to claim 9, wherein the second mesh is disposed between the plurality of first meshes and arranged at equal intervals in a radial direction of the self-expandable structure.
14. A thrombus extraction device according to claim 1,
the length of the first developing mark is 0.5-1.2 mm.
15. The thrombus extraction device according to claim 1, wherein the second mesh has a mesh unit area of 15 to 60mm2。
16. A thrombus extraction device according to claim 9, wherein the areas of the respective pairs of the second meshes differ.
17. A thrombus extraction device according to claim 16, wherein the areas of each pair of the second meshes gradually decrease in a radial direction toward the distal end.
18. A thrombus extraction device in accordance with claim 1, wherein at least a portion of the curved surface of the second mesh is recessed inwardly on the circumferential surface of the self-expanding structure.
19. A thrombus extraction device in accordance with claim 1, wherein the second mesh is located at an active region of the self-expanding structure.
20. A self-expanding structure comprising a mesh structure, the mesh structure comprising:
a plurality of first meshes;
a plurality of second meshes, the second meshes having an area larger than that of the first meshes;
and the first development mark is positioned on at least part of the second grid.
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| CN202110874607.2ACN113576599A (en) | 2021-07-30 | 2021-07-30 | Thrombus retrieval device and self-expanding structure |
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| CN202110874607.2ACN113576599A (en) | 2021-07-30 | 2021-07-30 | Thrombus retrieval device and self-expanding structure |
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