CN117257514A - Antithrombotic protection device and medical instrument - Google Patents
- ️Fri Dec 22 2023
CN117257514A - Antithrombotic protection device and medical instrument - Google Patents
Antithrombotic protection device and medical instrument Download PDFInfo
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Publication number
- CN117257514A CN117257514A CN202210681760.8A CN202210681760A CN117257514A CN 117257514 A CN117257514 A CN 117257514A CN 202210681760 A CN202210681760 A CN 202210681760A CN 117257514 A CN117257514 A CN 117257514A Authority
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- coarse mesh
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- protection device
- guide wire
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- 2022-06-15 Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 230000002785 anti-thrombosis Effects 0.000 title description 4
- 239000003146 anticoagulant agent Substances 0.000 title description 4
- 230000003073 embolic effect Effects 0.000 claims description 53
- 238000000034 method Methods 0.000 claims description 15
- 239000000463 material Substances 0.000 claims description 5
- 238000011161 development Methods 0.000 claims description 2
- 208000007536 Thrombosis Diseases 0.000 abstract description 15
- 208000005189 Embolism Diseases 0.000 abstract description 14
- 206010047163 Vasospasm Diseases 0.000 abstract description 2
- 238000009940 knitting Methods 0.000 description 16
- 210000004204 blood vessel Anatomy 0.000 description 13
- 230000008569 process Effects 0.000 description 8
- 238000009954 braiding Methods 0.000 description 4
- 230000008859 change Effects 0.000 description 3
- 238000013461 design Methods 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 230000002792 vascular Effects 0.000 description 3
- 230000009471 action Effects 0.000 description 2
- 230000005540 biological transmission Effects 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 230000008878 coupling Effects 0.000 description 2
- 238000010168 coupling process Methods 0.000 description 2
- 238000005859 coupling reaction Methods 0.000 description 2
- 239000012634 fragment Substances 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 238000012545 processing Methods 0.000 description 2
- 238000011084 recovery Methods 0.000 description 2
- 230000001732 thrombotic effect Effects 0.000 description 2
- 230000002455 vasospastic effect Effects 0.000 description 2
- 206010073734 Microembolism Diseases 0.000 description 1
- 208000031481 Pathologic Constriction Diseases 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 210000002376 aorta thoracic Anatomy 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 230000008081 blood perfusion Effects 0.000 description 1
- 210000001772 blood platelet Anatomy 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 238000007889 carotid angioplasty Methods 0.000 description 1
- 210000001715 carotid artery Anatomy 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 210000002889 endothelial cell Anatomy 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 239000007888 film coating Substances 0.000 description 1
- 238000009501 film coating Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 210000004969 inflammatory cell Anatomy 0.000 description 1
- 238000007917 intracranial administration Methods 0.000 description 1
- 230000023404 leukocyte cell-cell adhesion Effects 0.000 description 1
- 125000003473 lipid group Chemical group 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000004393 prognosis Methods 0.000 description 1
- 230000000750 progressive effect Effects 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 230000001012 protector Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 230000002966 stenotic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000002885 thrombogenetic effect Effects 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 238000009941 weaving Methods 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/0108—Both ends closed, i.e. legs gathered at both ends
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2002/016—Filters implantable into blood vessels made from wire-like elements
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Surgical Instruments (AREA)
Abstract
The invention provides an anti-embolism protection device and a medical instrument, wherein an umbrella-shaped structure of the anti-embolism protection device for capturing thrombus adopts a woven self-expansion coarse mesh framework, pipe cutting is not needed, stacking is not needed at two ends, space utilization rate is high, the anti-embolism protection device can be conveniently retracted into a sheath tube, and an edge port does not have excessive radial force to cause vasospasm.
Description
Technical Field
The invention relates to the technical field of medical treatment, in particular to an antithrombotic protection device and a medical instrument.
Background
In the interventional treatment of vascular stenoses, almost all patients have the release of thrombogenic substances at the stenotic site, and can lead to distal embolism of the blood vessel, which can cause the distal blood perfusion to be blocked. In the interventional treatment process, lipid fragments, matrix components, endothelial cells, inflammatory cells, platelets, leukocyte adhesion and the like in the plaque can cause distal vascular embolism, and influence the immediate or long-term prognosis of a patient. The vascular distal protection device is a system capable of filtering out thrombus or plaque, is initially applied to carotid angioplasty, can capture a large amount of plaque falling fragments and thrombotic substances, prevents the plaque falling fragments and thrombotic substances from blocking distal blood flow to form micro embolism, obviously reduces the incidence rate of stroke, and is conventionally applied to carotid interventional therapy.
At present, the far-end protection device is usually a far-end protection umbrella, and the manufacturing process for preparing the protection umbrella is usually two kinds of methods of attaching films and knitting dense nets. The film attaching technology generally carries out film coating on the cut framework of the pipe, so that the processing cost is high; the dense mesh type distal end protector requires treatment of one end of the tubular braid, stacking the wires into a ramp to facilitate retraction into the sheath. In this way the edge port will have excessive radial force, resulting in vasospasm. In addition, the stacking of the wires results in poor space utilization and inability to reach sites above carotid artery C2.
The assembly mode of the far-end protecting device is important to the transportation of the far-end protecting device, and the volume of the far-end protecting device needs to be reduced as much as possible in order to enable the protecting umbrella to reach more finer blood vessels. In addition, the mechanical conduction of the delivery recovery action is better in order to allow for compatible use with different catheters.
Disclosure of Invention
The invention aims to provide an anti-embolism protection device and a medical instrument, which are used for solving the problems of high manufacturing process cost, low efficiency, potential safety hazard and the like of the traditional anti-embolism protection device.
In order to solve the above technical problems, the present invention provides an embolic protection device, comprising: a guide wire, a coarse net framework and two connecting pieces, wherein,
the two connecting pieces are movably sleeved on the guide wire, the guide wire is provided with a protruding part, the protruding part is positioned between the two connecting pieces, and when the guide wire moves to the state that the protruding part abuts against one of the connecting pieces, the guide wire drives the abutting connecting piece to move towards the moving direction of the guide wire;
the coarse mesh framework is a self-expansion woven umbrella structure with an opening at the proximal end, the coarse mesh framework is sleeved on the guide wire, and two ends of the coarse mesh framework are respectively fixed on one connecting piece and move along with the movement of the connecting piece.
Optionally, in the embolic protection device, the embolic protection device further comprises a dense mesh woven layer, the dense mesh woven layer at least covers a distal end portion of the coarse mesh framework along a circumferential direction of the coarse mesh framework, and at least a degree of folding and unfolding of a proximal end opening of the dense mesh woven layer is consistent with the coarse mesh framework.
Optionally, in the embolic protection device, a proximal portion of the coarse mesh scaffold includes a sloped mouth structure, and a sloped top of the sloped mouth structure forms a proximal point of the coarse mesh scaffold.
Optionally, in the embolic protection device, the slope mouth structure includes at least two bevel grooves evenly distributed along the circumferential direction.
Optionally, in the embolic protection device, the axial dimension of the ramp port structure is no greater than a distance between a maximum outer diameter of the coarse mesh scaffold and a proximal point of the coarse mesh scaffold.
Optionally, in the embolic protection device, the part of the coarse mesh skeleton except for the slope opening structure is formed by interweaving braided wires, and each hypotenuse of the slope opening structure comprises a plurality of braided wires.
Optionally, in the embolic protection device, both the connectors are developing rings.
Optionally, in the embolic protection device, a plurality of braided wires of the coarse mesh skeleton are developing wires, and a developing structure formed by the developing wires outlines the shape of the coarse mesh skeleton.
Optionally, in the embolic protection device, the distal end of the guide wire is a rounded head.
Optionally, in the embolic protection device, the distal end portion of the guide wire has a plurality of grooves, and the plurality of grooves are sequentially arranged along the axial direction of the guide wire.
Based on the same idea, the invention also provides an anti-embolism protection device, comprising: a guide wire, a coarse mesh bone frame and a connecting piece; wherein,
the guide wire comprises a first section and a second section which are sequentially connected, the second section is provided with a protruding part, the connecting piece is movably sleeved on the second section at the proximal end side of the protruding part, the distal end part of the second section is movably connected with the first section along the axial direction of the first section, the second section is driven to move when being abutted against the proximal end surface of the first section, and the second section is driven to move when being abutted against the connecting piece, and the protruding part is driven to move when being abutted against the connecting piece;
the coarse mesh framework is a self-expansion woven umbrella structure with an opening at the proximal end, the proximal end of the coarse mesh framework is fixed to the connecting piece and moves along with the movement of the connecting piece, and the distal end of the coarse mesh framework is fixed to the guide wire.
Optionally, in the embolic protection device, the distal end portion of the second section is a cavity structure with an enlarged radius relative to other portions of the second section, the cavity structure forms the protrusion, the second section is sleeved on the first section through the cavity structure, and moves along the axial direction of the first section, and when the second section moves until the first section abuts against the proximal end of the cavity structure, the second section is driven to move.
The present invention also provides a medical device comprising:
an embolic protection device as in any of the above; the method comprises the steps of,
a catheter for receiving the coarse mesh scaffold into the catheter or pushing the coarse mesh scaffold out of the catheter; when the coarse mesh framework is received in the catheter, the coarse mesh framework is in a furled state, and when the coarse mesh framework is pushed out of the outer sheath, the coarse mesh framework is in an opened state.
In summary, the embolic protection device and the medical apparatus provided by the present invention include: the device comprises a guide wire, a coarse net framework and two connecting pieces, wherein the two connecting pieces are movably sleeved on the guide wire, the guide wire is provided with a protruding part, the protruding part is positioned between the two connecting pieces, when the protruding part abuts against one of the connecting pieces, the guide wire moves to drive the abutting connecting piece to move towards the direction of the movement of the guide wire, the coarse net framework is a self-expanding woven umbrella structure with an opening at the proximal end, the coarse net framework is sleeved on the guide wire, and two ends of the coarse net framework are respectively fixed on one connecting piece and move along with the movement of the connecting piece; alternatively, the embolic protection device comprises: the guide wire comprises a first section and a second section which are sequentially connected, the second section is provided with a protruding part, the connecting piece is movably sleeved on the second section at the proximal end side of the protruding part, the distal end part of the second section is movably arranged on the first section along the axial direction of the first section, the second section is driven to move when the protruding part abuts against the proximal end of the first section, and the second section is driven to move when the protruding part abuts against the connecting piece; the coarse mesh framework is a self-expansion woven umbrella structure with an opening at the proximal end, the proximal end of the coarse mesh framework is fixed to the connecting piece and moves along with the movement of the connecting piece, and the distal end of the coarse mesh framework is fixed to the guide wire. Compared with the prior art, the embolic protection device and the medical instrument provided by the invention have the following beneficial effects:
(1) The umbrella-shaped structure for capturing thrombus provided by the implementation adopts the woven self-expansion coarse mesh framework, so that pipe cutting is not needed, the process cost is low, the woven self-expansion coarse mesh framework is not needed to be stacked at two ends, the volume is smaller, the space utilization rate is high, the umbrella-shaped structure can be conveniently retracted into a sheath tube, and a smaller catheter system can be accessed, so that a finer blood vessel can be accessed;
(2) The edge radial force is prevented from being too large due to stacking of two ends, and the vasospastic closure is prevented;
(3) The current anti-embolism protection device only can be pumped back into the sheath, the micro-catheter cannot be pushed forward like an intracranial stent, and most of the anti-embolism protection device needs a special sheath tube during recovery.
Drawings
FIG. 1 is a schematic diagram of an embolic protection device according to an embodiment of the present invention;
FIG. 2 is a schematic view showing a distal movement of an embolic protection device according to a first embodiment of the present invention;
FIG. 3 is a schematic view showing a proximal movement of an embolic protection device according to a first embodiment of the present invention;
FIGS. 4a to 4c are schematic structural views of coarse mesh frameworks according to embodiments of the present invention;
FIG. 5 is a diagram showing a knitting structure of a middle portion of a coarse mesh skeleton in an embodiment of the present invention;
FIG. 6 is a schematic view of a wire separation from a slope opening structure of a coarse mesh skeleton to a middle portion in an embodiment of the present invention;
FIGS. 7a to 7c are schematic views of the structure of the mesh braid in the embodiment of the present invention;
FIG. 8 is a schematic view of a development portion of an embolic protection device according to an embodiment of the present invention;
FIG. 9 is a schematic view showing an embolic protection device in a blood vessel according to an embodiment of the present invention;
FIG. 10 is a schematic view of a guide wire according to an example of an embodiment of the present invention;
FIG. 11 is a schematic diagram of an embolic protection device according to a second embodiment of the present invention;
wherein, each reference sign is explained as follows:
11-coarse net framework; 12-a dense mesh braid; 13-a connector;
2-a guide wire; 3-a catheter; 4-coils;
121-slope mouth structure
100-a boss; 101-a guide portion; 102-arc head; 103-grooves;
200-developing structure;
21-a first stage; 22-second section.
Detailed Description
The anti-embolism protection device and the medical appliance proposed by the invention are further described in detail below with reference to the accompanying drawings and the specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments. The terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or the inclusion in the number of technical features indicated. As used herein, the terms "mounted," "connected," and "disposed" with respect to another element should be construed broadly and generally refer to the relationship of connection, coupling, engagement or transmission between two elements, and the connection, coupling, engagement or transmission between two elements may be direct or indirect through intervening elements, and should not be construed to indicate or imply that there is a spatial relationship between two elements, i.e., an element may be in any orientation, internal, external, above, below, or to one side of another element, unless specifically indicated otherwise. The specific meaning of the above terms in the present invention can be understood by those skilled in the art according to the specific circumstances.
It should be further understood that the terms "first," "second," "third," and the like in this specification are used merely for distinguishing between various components, elements, steps, etc. in the specification and not for indicating a logical or sequential relationship between the various components, elements, steps, etc., unless otherwise indicated.
In this document, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions relative to each other from the perspective of a physician using the medical device, although "proximal" and "distal" are not intended to be limiting, and "proximal" generally refers to the end of the medical device that is proximal to the physician during normal operation, and "distal" generally refers to the end that first enters the patient.
[ embodiment one ]
Referring to fig. 1, the embolic protection device provided in this embodiment includes: a guide wire 2, a coarse net framework 11 and two connecting pieces 13, wherein,
the two connecting pieces 13 are movably sleeved on the guide wire 2, the guide wire 2 is provided with a protruding part 100, the protruding part 100 is positioned between the two connecting pieces 13, and when the guide wire 2 moves to the state that the protruding part 100 abuts against one of the connecting pieces 13, the guide wire drives the abutting connecting piece 13 to move towards the moving direction of the guide wire 2;
the coarse mesh frame 11 is a self-expanding woven umbrella structure with an opening at the proximal end, is sleeved on the guide wire 2, and two ends of the coarse mesh frame are respectively fixed on one connecting piece 13 and move along with the movement of the connecting piece 13.
As shown in fig. 2, when the guide wire 2 moves from the proximal end to the distal end (i.e., the first direction shown in the drawing) in the catheter 3 to the abutment of the boss 100 with the connector 13 located at the distal end of the coarse mesh frame 11, the guide wire 2 is pushed to move in the first direction. As shown in fig. 3, when the guide wire 2 moves distally and proximally (i.e., in the second direction shown in the drawing) in the catheter 3, the protrusion 100 abuts against the connector 13 located at the proximal end of the coarse mesh frame 11, and the guide wire 2 is driven to move in the second direction. Therefore, the combined design of the protruding portion 100 and the connecting piece 13 of the embolic protection device provided in this embodiment can control the movement of the coarse mesh skeleton 11 in two directions, that is, the coarse mesh skeleton 11 can be pushed forward or pulled back into the sheath, without relying on a special sheath tube, and can be used with other various passage apparatuses.
In addition, the anti-embolism protection device provided by the embodiment does not need to cut a pipe, the process cost is low, the two ends of the woven self-expansion coarse mesh skeleton 11 do not need to be stacked, the space utilization rate is high, the self-expansion coarse mesh skeleton can be conveniently retracted into a sheath tube, a smaller catheter system can be entered, a thinner blood vessel can be entered, and the radial force of an edge opening caused by stacking of the two ends can be avoided, so that the spasmodic closure of the blood vessel is prevented.
With continued reference to fig. 1, in this embodiment, preferably, the embolic protection device further includes a dense mesh braid 12, the dense mesh braid 12 at least covers a distal end portion of the coarse mesh frame 11 along a circumferential direction of the coarse mesh frame 11, and at least a proximal opening of the dense mesh braid is folded and opened to a degree approximately consistent with that of the coarse mesh frame 11, so as to ensure that the dense mesh braid 12 remains attached to the coarse mesh frame 11 all the time during the expansion or folding process of the coarse mesh frame 11, no gap is generated between the dense mesh braid and the coarse mesh frame, and thrombus is prevented from escaping from the gap.
That is, in the preferred embodiment of the present embodiment, the embolic protection device adopts a double-layer capturing structure, the coarse mesh frame 11 can capture thrombus on one hand, and on the other hand, has high radial force so that it can rivet a blood vessel, has good adhesion performance, can prevent thrombus from escaping from the gap between the coarse mesh frame 11 and the blood vessel wall, and the dense mesh braid layer 12 at least surrounding the distal end portion of the coarse mesh frame 11 further improves the robustness of capturing thrombus.
Specifically, the coarse mesh frame 11 may be formed by coarse filament knitting, and the dense mesh layer 12 may be formed by filament knitting, and the smaller the wire diameter of the knitting wire, the smaller the mesh area of the tissue that can be formed by knitting. In the embolic protection device provided in this embodiment, when only the coarse mesh frame 11 is used to capture thrombus, the mesh area of the coarse mesh frame 11 formed by braiding may be as small as possible, and when the double-layer capturing structure of the coarse mesh frame 11 and the dense mesh braid 12 is used to capture thrombus, the mesh area of the coarse mesh frame 11 may not be particularly limited, and the mesh area of the dense mesh braid 12 may be as small as possible. To achieve the best capturing effect, the mesh area of the tight-mesh braid 12 may be in the range of 100 μm 2 ~4mm 2 。
When the embolic protection device provided in this embodiment adopts a double-layer capturing structure, after the coarse mesh frame 11 is formed, the dense mesh braid 12 may be fixed to the distal end of the coarse mesh frame 11, for example, the distal end of the dense mesh braid 12 may be fixed to the connecting piece 13 located at the distal end of the coarse mesh frame 11, or the dense mesh braid 12 may be directly fixed to the distal end of the coarse mesh frame 11, for example, fixed to the distal end of the coarse mesh frame 11 by bundling, integrally braiding, or the like.
As shown in fig. 4a to 4c, in this embodiment, the distal end portion of the coarse mesh frame 11 is umbrella-shaped in an open state, the top of the umbrella is the distal end point of the coarse mesh frame 11, the proximal end portion of the coarse mesh frame 11 includes a slope opening structure 121, and the slope top of the slope opening structure 121 forms the proximal end point of the coarse mesh frame 11. Therefore, the coarse net framework 11 is similar to a fishing net, a closing-in type bag and the like, and the knitting wires at the proximal end of the coarse net framework 11 are drawn to be folded, so that the coarse net framework 11 can be dragged into the guide pipe 3. Preferably, the slope opening structure 121 includes at least two slope openings uniformly distributed along the circumferential direction, for example, 2, 3, 4, 5, etc. Specifically, as shown in fig. 4a, when the number of the bevel ports of the bevel port structure 121 is 2, the bevel port structure 121 includes two bevel edges, as shown in fig. 4b, when the number of the bevel grooves of the bevel port structure 121 is 3, the bevel port structure 121 includes three bevel edges uniformly distributed in the circumferential direction, as shown in fig. 4c, when the number of the bevel grooves of the bevel port structure 121 is 4, the bevel port structure 121 includes four bevel edges uniformly distributed in the circumferential direction, and so on. When at least two slope openings of the slope opening structure 121 are uniformly distributed along the circumferential direction, the coarse mesh skeleton 11 is sleeved on the guide wire 2 and is coaxially and non-eccentrically distributed with the guide wire 2, so that the whole circumferential direction is good in adherence, and thrombus can be prevented from escaping from a gap between the antithrombotic protective device and a blood vessel wall in multiple directions.
In a preferred embodiment, the portions of the coarse mesh frame 11 other than the slope opening structure 121 are interwoven by knitting yarns, and each hypotenuse of the slope opening structure 121 includes a plurality of knitting yarns. The knitting yarns on each bevel may be separated in different directions or at different positions, and the knitting yarns from different directions may be interwoven to form a plain weave or other portions of the coarse mesh frame 11 other than the bevel structure 121, for example, as shown in fig. 5, a 1-press 1, a 1-press 2, a 1-press 3, a 2-press 2, a 2-press 3, or a twist structure, etc.
As illustrated in fig. 6, for one oblique side a of the slope opening structure 121, two knitting yarns are cut toward an oblique side B adjacent thereto at a point a, and then two knitting yarns are cut toward the oblique side B at a point B, and similarly, the oblique side B is cut toward the oblique side a by the same yarn cutting method, so that a 2-press 2 knitting structure is formed at a middle portion of the coarse mesh frame 11.
Since the mesh holes of the slope opening structure 121 are large, in this embodiment, it is preferable that the axial dimension of the slope opening structure 121 is not larger than the distance between the maximum outer diameter of the coarse mesh frame 11 and the proximal end point of the coarse mesh frame 11, that is, the slope opening structure 121 remains located on the proximal end side of the maximum outer diameter of the coarse mesh frame 11. Thus, when the coarse mesh frame 11 captures thrombus, the thrombus does not escape from the slope opening 121, so that a better capturing effect can be achieved.
As described above, in the embolic protection device provided in the present embodiment, the dense mesh braid 12 covers at least the distal end portion of the coarse mesh frame 11 in the circumferential direction of the coarse mesh frame 11. Specifically, the mesh braid 12 may cover the outer surface and/or the inner surface of the coarse mesh frame 11 and may be matched to the contour of the distal portion of the coarse mesh frame 11.
For example, as shown in fig. 7a, the dense mesh braid 12 may be in a cone shape, or, as shown in fig. 7b, the distal end portion of the dense mesh braid 12 may be in a cone shape, and when the dense mesh braid 12 is designed in such a structure, the distal end of the dense mesh braid 12 may be fixed to the connector 13 provided at the distal end of the coarse mesh frame 11, and the proximal end of the dense mesh braid 12 may be directly fixed to the coarse mesh frame 11. In addition, when the dense mesh woven layer 12 covers the inner surface of the coarse mesh frame 11, the dense mesh woven layer 12 may be fixed only at the distal end, and in use, the dense mesh woven layer 12 is naturally opened by blood flow impact and attached to the inner wall of the coarse mesh frame 11.
In other embodiments, the mesh braid 12 may have other designs, such as a tubular structure with a gradually increasing radius from the distal end to the proximal end, as shown in fig. 7 c. When the dense mesh braid 12 is designed in such a structure, the dense mesh braid 12 may be directly fixed to the coarse mesh frame 11, for example, by being fixed to the distal end of the coarse mesh frame 11 in a strapping or the like. In the use, because coarse mesh skeleton 11 keeps the state of drawing in, the distal end is umbrella-shaped, so the aperture is less, and the effect of better catching thrombus can be played to the near-end itself, close net weaving layer 12 adopts the tubular structure that becomes gradually big from distal end to near-end radius, can not cover coarse mesh skeleton 11's distal end, thereby can not lead to because of coarse mesh skeleton 11 draws in the drawing in coarse mesh skeleton 11 stacks in the distal end, and then brings the too big problem of marginal mouth radial force.
As can be seen from the above description, in the embolic protection device provided by the embodiment of the present invention, after the coarse mesh frame 11 is formed, the dense mesh braiding layer 12 can be mechanically fixed at the distal end of the coarse mesh frame 11, and braiding is not required, so that the process difficulty is reduced and the processing efficiency is improved.
In this embodiment, the outer contour of the connecting member 13 is not particularly limited, for example, the outer contour of the connecting member 13 may be circular or square. However, in practice, the outer contour of the connecting element 13 may be designed to be circular for convenience, so that the coarse mesh frame 11, when fastened to the connecting element 13, may be distributed along the circumference of the connecting element 13 so as to remain coaxial with the guide wire 2. Specifically, as shown in fig. 1, the two ends of the coarse mesh frame 11 may be fixed to the outer circumference of the connector 13 by the coil 4, and while in fig. 1, only the distal end of the coarse mesh frame 11 is shown as being fixed to the outer circumference of the connector 13 disposed at the distal end by the coil 4, it should be understood that the proximal end of the coarse mesh frame 11 may be fixed to the outer circumference of the connector 13 disposed at the proximal end by the coil 4. In other embodiments, the coarse mesh frame 11 may also be fixed on the outer periphery of the connecting piece 13 by a heat shrinking tube, which is not described herein.
Further, in this embodiment, it is preferable that both the connectors 13 are developing rings, and the protruding portion 100 is made of developing materials, so that the relative positions of the protruding portion 100 and the two connectors 13 can be tracked in time, and thus, incorrect operations are avoided, for example, when the coarse screen frame 11 is not required to be pushed out or pulled back, the coarse screen frame 11 is prevented from being pushed out or pulled back by mistake due to the movement of the guide wire 2.
Referring to fig. 8, in this embodiment, it is further preferable that a plurality of the knitting yarns of the coarse mesh frame 11 are developing yarns, and the developing structure 200 formed by the developing yarns outlines the shape of the coarse mesh frame 11. Therefore, the position change and the shape change of the coarse mesh skeleton 11 in the blood vessel can be observed in time, and the judgment and the operation of the traditional Chinese medicine in the operation are convenient. For example, as shown in fig. 9, in a blood vessel, a doctor can clearly observe the states of the coarse mesh frame 11 and the connecting members 13, and the coarse mesh frame 11 is held in place against the wall by its own supporting force.
The guide wire 2 of this embodiment may be a mandrel with a diameter from the proximal end to the distal end being thicker, or a mandrel with a uniform diameter. The guide wire 2 is not only a push rod during conveying of the coarse mesh skeleton 11, but also an exchange guide wire 2 of other rapid exchange instruments.
As illustrated in fig. 10, the protruding portion 100 may be a protruding ring sleeved on the guide wire body, the proximal portion of the protruding ring is a guiding portion 101 of the guide wire 2, and the diameter of the protruding portion may be, for example, 0.014inch, and may be compatible with a pushing system of various balloons and stents on the market. In addition, as shown in fig. 10, the distal end of the guide wire 2 may be provided with a circular arc head 102, and the distal end portion of the guide wire 2 is provided with a plurality of grooves 103, and the plurality of grooves 103 are sequentially arranged along the axial direction of the guide wire 2, so that the guide wire 2 can be prevented from being scratched and puncturing a blood vessel in the moving process.
The present embodiment also provides a medical device including:
the embolic protection device as provided in the present embodiment; the method comprises the steps of,
a catheter 3, wherein the guide wire 2 is used for taking the coarse mesh skeleton 11 into the catheter 3 or pushing the coarse mesh skeleton 11 out of the catheter 3; when the coarse mesh frame 11 is received in the catheter 3, the coarse mesh frame 11 is in a folded state, and when the coarse mesh frame 11 is pushed out of the outer sheath, the coarse mesh frame 11 is in an open state.
Specifically, during the delivery process, the coarse mesh frame 11 of the embolic protection device is folded in the catheter 3, and after the coarse mesh frame 11 reaches a target position, such as an aortic arch, the guide wire 2 pushes the coarse mesh frame 11 out of the catheter 3, and the coarse mesh frame 11 expands and opens to be umbrella-shaped. When the operation is completed, the guide wire 2 is withdrawn, and the coarse mesh frame 11 is again retracted into the catheter 3, thereby being withdrawn.
[ example two ]
As shown in fig. 11, the embolic protection device provided in this embodiment includes: a guide wire 2, a coarse net framework 11 and a connecting piece 13, wherein,
the guide wire 2 comprises a first section 21 and a second section 22 which are sequentially connected, the second section 22 is provided with a convex part 100, the connecting piece 13 is movably sleeved on the second section 22 at the proximal end side of the convex part 100, the distal end part of the second section 22 is movably connected with the first section 21 along the axial direction of the first section 21, the second section 22 is driven to move when the convex part 100 abuts against the proximal end surface of the first section 21, and the second section 22 is driven to move when the convex part 100 abuts against the connecting piece 13;
the coarse mesh frame 11 is a self-expanding woven umbrella structure with an opening at the proximal end, the proximal end of the coarse mesh frame 11 is fixed on the connecting piece 13 and moves along with the movement of the connecting piece 13, and the distal end of the coarse mesh frame 11 is fixed on the guide wire 2.
In contrast, unlike the first embodiment, in this example, the guide wire 2 is in a segmented structure, and the coarse mesh skeleton 11 is only sleeved on the guide wire 2 at its proximal end via the connecting member 13, and moves along with the movement of the connecting member 13, and its distal end is fixed to the guide wire 2 and remains relatively fixed to the guide wire 2. The guide wire 2 adopts a sectional design, and the distal end of the coarse mesh skeleton 11 and the guide wire 2 are kept relatively fixed without a gap or with a small gap, so that thrombus can be prevented from escaping from the gap between the connecting piece 13 and the guide wire 2 during relative sliding.
Referring to fig. 11, in a preferred implementation manner of this embodiment, the distal end portion of the second section 22 is a cavity structure with an enlarged radius relative to other portions of the second section 22, the cavity structure forms the boss 100, the second section 22 is sleeved on the first section 21 through the cavity structure, and moves along the axial direction of the first section 21, and when the second section 22 moves until the first section 21 abuts against the proximal end of the cavity structure, the first section 21 is driven to move. When the distal end portion of the second section 22 is provided with a cavity, which is sleeved on the first section 21, the second section 22 and the first section 21 can be coaxially arranged, so that the guide wire 2 has good compliance during operation, and the radial dimension of the guide wire 2 is minimum.
In this embodiment, the coarse mesh frame 11 may have the structure as described in embodiment one, that is, the proximal portion of the coarse mesh frame 11 is knitted into the slope opening structure 121 by a Y-type knitting method. The embolic protection device may further include a dense mesh woven layer 12, and description of the coarse mesh frame 11, the dense mesh woven layer 12, and the relationship therebetween is referred to in embodiment one, and will not be repeated here.
In this embodiment, the distal ends of the coarse mesh frame 11 and the fine mesh braid 12 may be directly fixed to the guide wire 2 by the coil 4 made of a developing material, or the distal end of the coarse mesh frame 11 may be directly fixed to the guide wire 2 by the coil 4 made of a developing material, and the fine mesh braid 12 may be disposed on the coarse mesh frame 11 as described in the first embodiment.
In addition, as in the first embodiment, the connection member 13 may be a developing ring, and the protrusion 100 may be made of a developing material, so that the movement of the guide wire 2 is determined by the change of the relative positions of the protrusion 100 and the distal ends of the connection member 13 and the coarse mesh frame 11. With the embolic protection device provided in the first embodiment, when the boss 100 is shown against the connector 13 at the proximal end of the coarse mesh frame 11, it is indicated that the guide wire 2 will push the coarse mesh frame 11, whereas with the embolic protection device provided in the present embodiment, when the distance between the boss 100 and the coil 4 for fixing the distal end of the coarse mesh frame 11 is shown to reach the target distance, it is indicated that the guide wire 2 will push the coarse mesh frame 11.
The present embodiment also provides a medical device including:
the embolic protection device as provided in the present embodiment; the method comprises the steps of,
a catheter 3, wherein the guide wire 2 is used for taking the coarse mesh skeleton 11 into the catheter 3 or pushing the coarse mesh skeleton 11 out of the catheter 3; when the coarse mesh frame 11 is received in the catheter 3, the coarse mesh frame 11 is in a folded state, and when the coarse mesh frame 11 is pushed out of the outer sheath, the coarse mesh frame 11 is in an open state.
The mutual relationship among the guide wire 2, the coarse mesh skeleton 11 and the catheter 3 is the same as that of the first embodiment, and the related content is referred to the first embodiment, and will not be described herein.
In summary, the embolic protection device and the medical apparatus provided by the present invention include: the guide wire is provided with a bulge part, the bulge part is positioned between the two connecting pieces, when the guide wire moves to the bulge part to abut against one of the connecting pieces, the abutting connecting pieces are driven to move towards the direction of the movement of the guide wire, the coarse mesh framework is a self-expansion woven umbrella structure with an opening at the near end, the coarse mesh framework is sleeved on the guide wire, and two ends of the coarse mesh framework are respectively fixed on one connecting piece and move along with the movement of the connecting piece; alternatively, the embolic protection device comprises: the guide wire comprises a first section and a second section which are sequentially connected, the second section is provided with a protruding part, the connecting piece is movably sleeved on the second section at the proximal end side of the protruding part, the distal end part of the second section is movably arranged on the first section along the axial direction of the first section, the second section is driven to move when the protruding part abuts against the proximal end of the first section, and the second section is driven to move when the protruding part abuts against the connecting piece; the coarse mesh framework is a self-expansion woven umbrella structure with an opening at the proximal end, the proximal end of the coarse mesh framework is fixed to the connecting piece and moves along with the movement of the connecting piece, and the distal end of the coarse mesh framework is fixed to the guide wire. Namely, the umbrella-shaped structure for capturing thrombus of the embolic protection device adopts a woven self-expansion coarse mesh framework, pipe cutting is not needed, the process cost is low, the woven self-expansion coarse mesh framework is not needed to be stacked at two ends, the volume is smaller, the space utilization rate is high, the embolic protection device can be conveniently retracted into a sheath tube, and can enter a smaller catheter system, so that finer blood vessels can be accessed, and the phenomenon that the radial force of the edge is overlarge due to stacking of the two ends can be avoided, so that the vasospastic closure is prevented; in addition, the anti-embolism protection device is designed through the combination of the protruding part and the connecting piece, so that the movement of the coarse mesh framework can be controlled in a two-way mode, namely, the coarse mesh framework can be pushed forward and can be drawn back into the sheath, a special sheath tube is not needed, and the anti-embolism protection device can be matched with other various passage instruments to use.
In this specification, each embodiment is described in a progressive manner, and each embodiment is different from other embodiments in that the same similar parts of each embodiment are mutually referred to, and in addition, different parts of each embodiment can be mutually combined for use, which is not limited by the invention.
The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the appended claims.
Claims (13)
1. An embolic protection device, comprising: a guide wire, a coarse net framework and two connecting pieces, wherein,
the two connecting pieces are movably sleeved on the guide wire, the guide wire is provided with a protruding part, the protruding part is positioned between the two connecting pieces, and when the guide wire moves to the state that the protruding part abuts against one of the connecting pieces, the guide wire drives the abutting connecting piece to move towards the moving direction of the guide wire;
the coarse mesh framework is a self-expansion woven umbrella structure with an opening at the proximal end, the coarse mesh framework is sleeved on the guide wire, and two ends of the coarse mesh framework are respectively fixed on one connecting piece and move along with the movement of the connecting piece.
2. The embolic protection device of claim 1, further comprising a dense mesh braid covering at least a distal portion of the coarse mesh armature in a circumferential direction of the coarse mesh armature, and wherein at least a proximal opening of the dense mesh braid is gathered and opened to a degree approximately consistent with the coarse mesh armature.
3. The embolic protection device of claim 1, wherein the proximal portion of the coarse mesh scaffold comprises a beveled structure, a crest of the beveled structure constituting a proximal point of the coarse mesh scaffold.
4. An embolic protection device as in claim 3, wherein the sloped mouth structure comprises at least two sloped grooves evenly distributed along the circumference.
5. An embolic protection device as in claim 3, wherein the axial dimension of the sloped mouth structure is no greater than the distance between the maximum outer diameter of the coarse mesh frame and the proximal point of the coarse mesh frame.
6. An anti-embolic holding device as in claim 3, wherein portions of the coarse mesh frame other than the ramp port structure are interwoven by braided wires, each hypotenuse of the ramp port structure comprising a plurality of the braided wires.
7. An embolic protection device as in claim 1, wherein both of the connectors are developer rings and the protrusions are of a developer material.
8. The embolic protection device of claim 1, wherein a plurality of the braided filaments of the coarse mesh skeleton are developed filaments, and a development structure formed by a plurality of the developed filaments delineates the shape of the coarse mesh skeleton.
9. The embolic protection device of claim 1, wherein the distal end of the guidewire is a rounded tip.
10. An embolic protection device as in claim 1, wherein the distal portion of the guidewire has a plurality of grooves, the plurality of grooves disposed in sequence along the axial direction of the guidewire.
11. An embolic protection device, comprising: a guide wire, a coarse net framework and a connecting piece; wherein,
the guide wire comprises a first section and a second section which are sequentially connected, the second section is provided with a protruding part, the connecting piece is movably sleeved on the second section at the proximal end side of the protruding part, the distal end part of the second section is movably connected with the first section along the axial direction of the first section, the second section is driven to move when being abutted against the proximal end surface of the first section, and the second section is driven to move when being abutted against the connecting piece, and the protruding part is driven to move when being abutted against the connecting piece;
the coarse mesh framework is a self-expansion woven umbrella structure with an opening at the proximal end, the proximal end of the coarse mesh framework is fixed to the connecting piece and moves along with the movement of the connecting piece, and the distal end of the coarse mesh framework is fixed to the guide wire.
12. An embolic protection device as in claim 11, wherein the distal portion of the second section is a hollow structure of enlarged radius relative to the other portions of the second section, the hollow structure forming the boss, the second section being sleeved on the first section by the hollow structure, the second section moving axially of the first section, the second section moving when the second section moves until the first section abuts the proximal end of the hollow structure.
13. A medical device, comprising:
an embolic protection device as in any of claims 1-12; the method comprises the steps of,
a catheter for receiving the coarse mesh scaffold into the catheter or pushing the coarse mesh scaffold out of the catheter; when the coarse mesh framework is received in the catheter, the coarse mesh framework is in a furled state, and when the coarse mesh framework is pushed out of the outer sheath, the coarse mesh framework is in an opened state.
Priority Applications (2)
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CN202210681760.8A CN117257514A (en) | 2022-06-15 | 2022-06-15 | Antithrombotic protection device and medical instrument |
PCT/CN2023/094973 WO2023241300A1 (en) | 2022-06-15 | 2023-05-18 | Anti-thrombus protection device and medical instrument |
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CN202210681760.8A CN117257514A (en) | 2022-06-15 | 2022-06-15 | Antithrombotic protection device and medical instrument |
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US6974469B2 (en) * | 1997-03-06 | 2005-12-13 | Scimed Life Systems, Inc. | Distal protection device and method |
US6468291B2 (en) * | 1999-07-16 | 2002-10-22 | Baff Llc | Emboli filtration system having integral strut arrangement and methods of use |
US6656202B2 (en) * | 2000-07-14 | 2003-12-02 | Advanced Cardiovascular Systems, Inc. | Embolic protection systems |
US6616680B1 (en) * | 2000-11-01 | 2003-09-09 | Joseph M. Thielen | Distal protection and delivery system and method |
CN201595959U (en) * | 2010-02-09 | 2010-10-06 | 北京泰杰伟业科技有限公司 | Embolism protector for protecting blood vessels of brain |
CN106491174A (en) * | 2016-12-20 | 2017-03-15 | 北京久事神康医疗科技有限公司 | A kind of callable blood flow guider |
CN111839806A (en) * | 2020-07-31 | 2020-10-30 | 上海心玮医疗科技有限公司 | High-compliance plug protector and filter screen manufacturing method thereof |
CN112790827A (en) * | 2021-02-04 | 2021-05-14 | 北京华脉泰科医疗器械有限公司 | Adherent filter plug umbrella and plug protection device |
CN113081382B (en) * | 2021-04-08 | 2023-01-03 | 珠海通桥医疗科技有限公司 | Plug protection device and recovery method |
CN114209958A (en) * | 2021-11-29 | 2022-03-22 | 中国人民解放军总医院第一医学中心 | Embolic protection device |
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