CN114431998A - Anti-embolism protection device and medical instrument - Google Patents

Anti-embolism protection device and medical instrument Download PDF

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Publication number
CN114431998A
CN114431998A CN202011226021.7A CN202011226021A CN114431998A CN 114431998 A CN114431998 A CN 114431998A CN 202011226021 A CN202011226021 A CN 202011226021A CN 114431998 A CN114431998 A CN 114431998A
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China
Prior art keywords
support
filter
protection device
embolic protection
opening
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Withdrawn
Application number
CN202011226021.7A
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Chinese (zh)
Inventor
孙健锋
张子衡
王石萍
陈宇芬
金巧蓉
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Shanghai Weidun Medical Technology Co ltd
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Shanghai Weidun Medical Technology Co ltd
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Priority to CN202011226021.7A priority Critical patent/CN114431998A/en
Publication of CN114431998A publication Critical patent/CN114431998A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/01Filters implantable into blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2/013Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/01Filters implantable into blood vessels
    • A61F2002/016Filters implantable into blood vessels made from wire-like elements

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  • 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 relates to an anti-embolism protection system and an anti-embolism protection device. The anti-embolism protection device comprises a support frame, a first support piece, a second support piece, a first filter piece and a second filter piece. Wherein, the first supporting piece and the second supporting piece are arranged at one side of the supporting frame at intervals. The first filter member is covered on the support frame. The second filter has an open end and a closed end, the open end being connected to the first support member and the closed end being connected to the second support member. The anti-embolism protection device is good in filtering effect and high in stability.

Description

Anti-embolism protection device and medical instrument
Technical Field
The invention relates to the technical field of medical instruments, in particular to an anti-embolism protection device and a medical instrument.
Background
Some procedures involving the heart and aorta, such as cardiac surgery, cardiopulmonary bypass, catheter-based interventional cardiology, aortic surgery, etc., involve the formation of platelet polymers (e.g., emboli, lipid droplets, bacterial clots and/or other foreign matter, tumor cells or other small tissue fragments) or broken off of arterial walls from blood by surgical instruments that are transported through the blood stream into the cerebral blood circulation and other important systemic arterial systems as embolizing vascular material. Embolic material entering the cerebral blood circulation can block arterioles, thereby causing local cerebral vascular embolization, which is now an important complication of cardiac and aortic surgery. While substances entering the downstream blood circulation can cause downstream organ embolism, which can lead to organ failure or organ failure.
Generally, to prevent complications from embolic particles, it is often necessary to divert, capture or collect plaque, debris or emboli flowing anteriorly during the procedure using an anti-embolic protection system to prevent the formation of an embolism. However, the conventional anti-embolism protection system has poor filtering effect and stability, and easily causes embolism to escape.
Disclosure of Invention
Accordingly, there is a need for an anti-embolism protection device and a medical apparatus with good filtering effect and high stability.
An anti-embolic protection device comprising:
the support device comprises a support frame, a first support and a second support, wherein the first support and the second support are arranged on one side of the support frame at intervals;
a first filter member overlying the support frame; and the number of the first and second groups,
a second filter having an open end and a closed end, the open end being connected to the first support member and the closed end being connected to the second support member.
In one embodiment, an openable or closable opening and closing opening is formed between the second filter element and the first filter element.
In one embodiment, when the opening and closing port is in an open state, a passage for a surgical instrument to pass through is formed between the first filter element and the second filter element; when the opening and closing port is in a closed state, the first filter piece is tightly attached to the second filter piece.
In one embodiment, the first filter element and/or the second filter element comprises one layer of filter mesh or at least two layers of filter mesh stacked in an alternating manner.
In one embodiment, one end of the first supporting piece, which is far away from the supporting frame, is of a closed structure, or one end of the first supporting piece, which is far away from the supporting frame, is provided with an opening; and/or the presence of a gas in the gas,
one end, far away from the first supporting piece, of the second supporting piece is of a closed structure, or one end, far away from the supporting frame, of the second supporting piece is provided with an opening.
In one embodiment, the support frame comprises a rim in the form of a closed loop, the periphery of the first filter element being connected to the rim.
In one embodiment, the first filter element and/or the second filter element is a woven or laser-perforated or elastic membrane.
In one embodiment, the first filter element has an arcuate configuration that projects away from the second filter element.
In one embodiment, the surface of the first filter element and/or the second filter element is provided with an anticoagulant coating.
In one embodiment, the second filter element is umbrella-shaped.
In one embodiment, the first support is connected to the distal end of the support frame and the second support is connected to the proximal end of the support frame.
In one embodiment, the first support member includes a first support section that is bent toward the first filter element, and at least a portion of an edge of the open end of the second filter element is connected to the first support section.
In one embodiment, the second support member includes a second support section that is curved toward the first filter element, the second support section being connected to the closed end at an end remote from the support frame.
In one embodiment, the first support and/or the second support comprises a connecting section which is bent towards the proximal or distal end of the support frame and which is connected with the support frame.
A medical device, comprising:
the anti-embolic protection device described above; and the number of the first and second groups,
the conveying mechanism comprises an outer sheath tube and a pushing element movably arranged in the outer sheath tube in a penetrating mode, the pushing element is connected with the supporting frame or the near end of the first filtering element, an opening and closing opening capable of being opened or closed is formed between the first filtering element and the second filtering element, and the pushing element penetrates out of the opening and closing opening.
In one embodiment, the pushing member is provided with a guide wire hole penetrating through the axial direction of the pushing member, and the guide wire hole is used for penetrating a guide wire.
In one embodiment, the delivery mechanism further comprises a visualization catheter movably disposed within the outer sheath and moving synchronously with the pusher member.
Above-mentioned embolism protection device and medical instrument are through setting up first filter piece on braced frame, first filter piece can cover the brachiocephalic trunk artery, the intercommunication mouth of artery and aorta under left common carotid artery and the left clavicle, thereby filter and flow into the brachiocephalic trunk artery from the aorta, the ascending blood flow of artery under left common carotid artery and the left clavicle, prevent embolus that the operation in-process produced via brachiocephalic trunk artery, artery entering brain under left common carotid artery and the left clavicle, patient's cerebral apoplexy's risk has been reduced. Simultaneously through set up first support piece and second support piece in braced frame one side, make the open end and the blind end of second filter piece fix respectively on first support piece and second support piece, when the blood flow flows to downstream organ or brain from patient's heart, a large amount of blood flows and embolus material can get into in the second filter piece from the open end of second filter piece, because the other end of second filter piece is the blind end, thereby through the filtering action of second filter piece, clear blood flow can be followed the second and filtered the outflow and embolus material then is caught by the second filter piece, thereby avoided embolus material to get into downstream organ along with blood flow in, downstream vascular failure has been avoided. And first support piece and second support piece can provide certain holding power for braced frame for first filter piece still can keep closely the laminating state with the inner wall under ascending blood stream's the washing, improved anti-embolism protection device's adherence nature, prevent to produce the embolus escape emergence that the gap leads to between first filter piece and the inner wall, first support piece and second support piece can also anchor the aorta bow simultaneously, prevent that anti-embolism protection device from taking place the displacement, improved anti-embolism protection device's stability.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the invention and, together with the description, serve to explain the invention and not to limit the invention.
In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings needed to be used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.
FIG. 1 is a schematic structural diagram of an anti-embolic protection device according to an embodiment of the present invention;
FIG. 2 is a schematic view of an anti-embolic protection device in an aortic arch according to an embodiment of the present invention;
FIG. 3 is a schematic cross-sectional view of the anti-embolic protection device shown in FIG. 2;
FIG. 4 is a schematic structural diagram of a support frame of an anti-embolic protection device according to an embodiment of the present invention;
FIG. 5 is a schematic structural view of a support frame of an anti-embolic protection device according to another embodiment of the present invention;
FIG. 6 is a schematic structural diagram of a support frame of an anti-embolic protection device according to yet another embodiment of the present invention;
FIG. 7 is a schematic structural diagram of the first support/the second support according to an embodiment of the present invention;
fig. 8 is a schematic structural view of a support frame and a first filter element according to an embodiment of the present invention;
fig. 9 is a schematic structural view of a first filter element and a support frame according to another embodiment of the present invention;
fig. 10 is a schematic structural diagram of an anti-embolic protection system according to an embodiment of the present invention.
Description of reference numerals:
10. an anti-embolic protection device; 11. a support frame; 111. a proximal end; 112. a distal end; 12. a first filter member; 13. a first support member; 131. a first support section; 132. a connecting section; 133. an opening; 14. a second filter member; 141. an open end; 142. a closed end; 143. opening and closing the opening; 15. a second support member; 20. a conveying mechanism; 21. an outer sheath tube; 22. a pushing member; 23. a handle; 31. a visualization conduit; 32. a subsequent surgical instrument; 40. the aortic arch; 41. the left subclavian artery; 42. the left common carotid artery; 43. the brachiocephalic trunk artery.
Detailed Description
In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.
Referring to fig. 1-2, fig. 1 illustrates an anti-embolic protection device 10 in an embodiment of the present invention, the anti-embolic protection device 10 is adapted to be placed at the aortic arch 40 during cardiac and aortic surgery to divert, filter, and catch emboli generated during the surgery, preventing them from entering the brain and downstream organs. Specifically, fig. 2 illustrates a structural schematic diagram of the anti-embolism protection device 10 in a schematic diagram of an aortic arch 40, wherein 3 large arteries are communicated from the convex side of the aortic arch 40 and are sequentially divided into a brachiocephalic trunk 43, a left common carotid 42 and a left subclavian artery 41 from right to left, and the anti-embolism protection device 10 provided in this embodiment can be released to the ascending aorta and/or the aortic arch 40 and/or the descending aorta to play a role in filtering ascending blood flow of the brachiocephalic trunk 43, the left common carotid 42 and the left subclavian artery 41, so as to prevent emboli generated during an operation from entering the brain through the brachiocephalic trunk 43, the left common carotid 42 and the left subclavian artery 41.
Specifically, referring to fig. 1, the anti-embolic protection device 10 includes a support frame, a first filter element 12, and a second filter element 14. The supporting frame includes a supporting frame 11, a first supporting member 13 and a second supporting member 15, wherein the first supporting member 13 and the second supporting member 15 are disposed at one side of the supporting frame 11 at an interval. The first filter member 12 is covered on the support frame 11. The second filter member 14 has an open end 141 and a closed end 142, the open end 141 being connected to the first support member 13 and the closed end 142 being connected to the second support member 15.
Further, in order to describe the structural features of the present application more clearly, the terms "proximal end 111" and "distal end 112" are used as the directional terms, wherein "proximal end 111" represents the end close to the operator during the operation; "distal end 112" means the end that is distal to the operator. Specifically, the proximal end 111 of the support frame 11 is used to connect to a delivery mechanism 20, and the delivery mechanism 20 is used to deliver the anti-embolic protection device 10 to a target location within the aortic arch 40. Further, the inner wall of the supporting frame 11 fixed in the aortic arch 40 is used for supporting the first filtering element 12, the first filtering element 12 is tightly attached to the inner wall of the aortic arch 40, and the first filtering element 12 can cover the communication ports of the brachiocephalic trunk 43, the left common carotid artery 42 and the left subclavian artery 41 with the aorta, further, the second filtering element is umbrella-shaped, and the first supporting element 13 and the second supporting element 15 are both arranged on one side of the supporting frame 11 far away from the upper wall of the aortic arch 40. . First support member 13 serves to support open end 141 of second filter element 14 to ensure that open end 141 of second filter element 14 is open toward the heart side and to maintain second filter element 14 in an open state in response to blood flow. The second support member 15 is adapted to support the closed end 142 of the second filter element 14 to secure the closed end 142 of the second filter element 14 and prevent the closed end 142 of the second filter element 14 from interfering with a subsequent surgical instrument 32. Preferably, the closed end 142 of the second filter element 14 is fixed to the end of the second support element 15 remote from the support frame 11.
Above-mentioned anti embolism protection device 10 is through setting up first filter 12 on braced frame 11, first filter 12 can cover the intercommunication mouth of brachiocephalic trunk artery 43, left common carotid artery 42 and left subclavian artery 41 and aorta to filter the ascending blood flow that the aorta flowed into brachiocephalic trunk artery 43, left common carotid artery 42 and left subclavian artery 41, prevent that the embolic material that produces in the operation process from getting into the brain via brachiocephalic trunk artery 43, left common carotid artery 42 and left subclavian artery 41, the risk of patient's cerebral apoplexy has been reduced. Meanwhile, the first support part 13 and the second support part 15 are arranged on one side of the support frame 11, so that the open end 141 and the closed end 142 of the second filter part 14 are respectively fixed on the first support part 13 and the second support part 15, when blood flows from the heart of a patient to a downstream organ or brain, a large amount of blood flow and embolic substances can enter the second filter part 14 from the open end 141 of the second filter part 14, and due to the fact that the other end of the second filter part 14 is the closed end 142, clean blood flow can flow out of the second filter part 14 and the embolic substances are captured by the second filter part 14, so that the embolic substances are prevented from entering the downstream organ along with the blood flow, and the downstream vascular failure is avoided. And first support piece 13 and second support piece 15 can provide certain holding power for braced frame 11 for first filter 12 still can keep closely the laminating state with the inner wall under the washing of rising blood flow, improved anti-embolus protection device 10's adherence nature, prevent that the embolus that produces the gap and lead to between first filter 12 and the inner wall from escaping to take place, and first support piece 13 and second support piece 15 can also anchor aorta bow 40 simultaneously, prevent that anti-embolus protection device 10 from taking place the displacement, have improved anti-embolus protection device 10's stability.
Further, referring to fig. 3, an openable or closable opening/closing port 143 is provided between the second filter member 14 and the first filter member 12. The side of the second filter element 14 adjacent to the first filter element 12 is a free side, which is not connected to the first support element 13 nor to the support frame 11 or the first filter element 12, so that an opening 143 is formed between the second filter element 14 and the first filter element 12. Further, when the opening/closing port 143 is in the open state, a passage for passing a surgical instrument can be formed between the first filter member 12 and the second filter member 14. When the opening 143 is in the closed position, the first filter member 12 is closely attached to the second filter member 14. Specifically, when the subsequent surgical instrument 32 passes through the closed end 142 of the second filter element 14 toward the open end 141, the subsequent surgical instrument 32 can apply a force to the second filter element 14 from the closed end 142 of the second filter element 14 toward the open end 141, thereby opening the opening/closing opening 143 to allow the surgical instrument 32 to pass through the opening/closing opening 143 for performing the subsequent surgical operation. Preferably, the second filter member 14 is a flexible web, when no subsequent surgical instrument 32 is inserted through the opening 143, the second filter member 14 can close the opening 143 under the effect of the ascending blood flow, and when the subsequent surgical instrument 32 is inserted through the opening 143, the second filter member 14 can wrap the subsequent surgical instrument 32, thereby reducing the risk of embolic material escaping from the opening 143.
Referring to fig. 4, in one embodiment, an end of the first support 13 away from the support frame 11 is in a closed configuration. Likewise, the end of the second support 15 remote from the support frame 11 may also be of a closed configuration. The shape of the channel formed by the second filter member 14 can be better maintained by the closed first support member 13 and the closed second support member 15, so that the second filter member 14 can be well attached to the aortic arch 40. It should be noted that, referring to fig. 5-6, in another embodiment, an opening 133 is provided at an end of the first supporting member 13 away from the supporting frame 11, and similarly, an opening 133 may be provided at an end of the second supporting member 15 away from the supporting frame 11. That is, the first support member 13 and/or the second support member 15 are/is in an open loop configuration, and the first support member 13 and/or the second support member 15 in the open loop configuration make the anti-embolic protection device 10 more easily compressible, thereby facilitating retraction of the anti-embolic protection device 10 back into the outer sheath 21 after the procedure is completed. It should be noted that, in other embodiments, one of the first supporting member 13 and the second supporting member 15 may be a closed structure, and the other one is an open structure, which is not described herein.
Referring to fig. 7, in an embodiment, the first support member 13 includes a first support section 131, the first support section 131 is bent toward the first filter member 12, and at least a part of an edge of the open end 141 of the second filter member 14 is connected to the first support section 131. Similarly, the second support element 15 comprises a second support segment bent towards the first filter element 12, which second support segment is connected, at the end remote from the support frame 11, to a closed end 142 of the second filter element 14. Further, the first support 13 and/or the second support 15 each include a connection section 132, the connection section 132 is bent toward the proximal end or the distal end of the support frame 11, and the connection section 132 is connected with the support frame 11. Further, the first support section 131 and the second support section may be a closed arc structure or an arc structure having an opening 133. Preferably, the first support segment 131 and the second support segment are formed by one or more different or identical arcs, which can be attached to the surface of the aortic arch 40. The connecting section 132 is connected with the supporting frame 11 by welding or by a metal pipe socket. Preferably, the connecting section 132 extends in a direction near the proximal end 111 or the distal end 112 of the support frame 11 to further facilitate retraction of the anti-embolic protection device 10 into the outer sheath 21. It should be noted that in some embodiments, the connecting section 132 may be omitted from the first support 13 and/or the second support 15, and the first support section 131 is directly connected to the support frame 11 or the first support section 131 is directly connected to the support frame 11 through an additional member.
Further, the range of the included angle between the first supporting member 13 and the distal end side of the supporting frame 11 is greater than 0 ° and less than or equal to 90 °, and the range of the included angle between the second supporting member 15 and the distal end side of the supporting frame 11 is greater than 0 ° and less than or equal to 90 °. Further, the first supporting member 13 and the second supporting member 15 are both closed arc structures, the diameter of each arc structure ranges from 10mm to 50mm, the length of each arc ranges from 30mm to 120mm, and the arc structures can be specifically changed according to the difference of the inner diameters of the aortic arches 40 at the positions of the first supporting member 13 and the second supporting member 15. Further, the distance between the connection points of the first support member 13 and the second support member 15 on the support frame 11 ranges from 40mm to 100mm, and the distance between the connection points of the first support member 13 and the second support member 15 on the support frame 11 is smaller than the distance between the far end point and the near end point of the support frame 11. Specifically, the distance from the connection point of the first support member 13 and the support frame 11 to the distal end point of the support frame 11 ranges from 10mm to 50mm, and the distance from the connection point of the second support member 15 and the support frame 11 to the proximal end point of the support frame 11 ranges from 10mm to 50 mm.
Further, the first supporting member 13 and the second supporting member 15 may be made of one or more of a composite wire material or a tube material wound by a single wire or multiple wires, or a sheet material cut by laser. The first supporting member 13 and the second supporting member 15 can be made of biocompatible materials such as metal, polymer, or inorganic nonmetal. The connection mode of the first support member 13 and the second support member 15 with the support frame 11 may be metal pipe sleeving, laser welding, ultrasonic welding, and the like. It should be noted that the first supporting member 13, the second supporting member 15 and the supporting frame 11 may also be integrally cut from a tube or a sheet by laser cutting or the like.
Specifically, referring to fig. 8, the support frame 11 includes a frame in a closed loop configuration, and the outer circumference of the first filter member 12 is connected to the frame. Preferably, the supporting frame 11 may be a closed ring structure with a circular, oval, heart or drop shape, and further, the supporting frame 11 is a closed ring structure composed of one or more different or same circular arcs, so that the supporting frame 11 can adapt to different aortic arch shapes and diameters, and can better fit the upper wall of the aortic arch 40 and support the first filtering member 12. The length between the far end point and the near end point of the supporting frame 11 is 40mm-120 mm. The transverse width is 40-120 mm. The support frame 11 may be made of one or more of a single wire, a composite wire wound with multiple strands, a tube, or a laser-cut sheet. Preferably, the material for making the supporting frame 11 may be metal or high molecular or inorganic non-metal biocompatible material.
Specifically, the first filter member 12 and/or the second filter member 14 includes one layer of filter mesh or at least two layers of filter mesh stacked in an alternating manner. That is, the first filter element 12 and/or the second filter element 14 may be a single-layer filter, thereby reducing consumables and costs. In other embodiments, the first filter member 12 and/or the second filter member 14 may also include at least two layers of filter mesh, and at least two layers may be alternately stacked to improve the filtering effect of the first filter member 12 and/or the second filter member 14. Furthermore, at least two layers of filter screens can be overlapped and combined in the modes of laser welding, glue bonding, hot pressing and the like. Further, the mesh size of the first filter member 12 and/or the second filter member 14 may be 50um to 250um, further 60um to 150um, and preferably 100um to 150 um.
Further, the first filter member 12 and/or the second filter member 14 are woven or laser-perforated films, such as PET (Polyethylene terephthalate), PEEK (polyether ether ketone), PA (Polyamide, nylon) and other high molecular materials. And may be a wire mesh of nickel titanium, stainless steel, tantalum, etc., preferably, the first filter member 12 and/or the second filter member 14 is an elastic membrane material, such as a knitted PET membrane, for example, the material of the first filter member 12 and/or the second filter member 14, so that when the anti-embolic protection device 10 is contracted inside the outer sheath 21, the elastic membrane material can be stretched, and when the anti-embolic protection device 10 is released out of the outer sheath 21, the elastic membrane material can be restored to its original shape. Compared with the first filter member 12 and the second filter member 14 which use non-elastic membrane materials, the first filter member 12 and the second filter member 14 which use elastic membrane materials can reduce the usage amount of the membrane materials, thereby reducing the whole volume of the anti-embolism protection device 10 and enabling the anti-embolism protection device 10 to enter the outer sheath tube 21 more easily.
Further, the surface of the first filter element 12 and/or the second filter element 14 is provided with an anti-coagulant coating. Preferably, the anticoagulant coating comprises an anticoagulant drug such as heparin, an anticoagulant drug, or the like, to prevent emboli from accumulating and clogging the first filter element 12 and/or the second filter element 14 during surgery. The anticoagulant coating may be formed on the surface of the first filter element 12 and/or the second filter element 14 by dip coating or spray coating. In other embodiments, the first filter member 12 and/or the second filter member 14 may be constructed of a material having an anti-clotting agent.
Further, referring to fig. 9, the first filter member 12 has an arch structure protruding away from the second filter member 14, and the arch structure of the first filter member 12 can better fit the inner wall of the aortic arch 40, thereby avoiding the problem that the first filter member 12 and the inner wall of the aortic arch 40 form a gap to cause the escape of embolic material.
Further, referring to fig. 10, an embodiment of the present application also provides a medical device. Specifically, the medical device includes the anti-embolic protection device 10 of any of the embodiments described above, and a delivery mechanism 20 for delivering the anti-embolic protection device 10 from the femoral vessel lumen into the aortic arch 40. The delivery mechanism 20 comprises an outer sheath 21 and a pushing member 22 movably disposed in the outer sheath 21, the anti-embolic protection device 10 has a contracted state where it is contracted in the outer sheath 21 and a released state where it is located outside the outer sheath 21, the pushing member 22 is connected with the anti-embolic protection device 10, and the pushing member 22 is used for driving the anti-embolic protection device 10 to switch between the contracted state and the released state. Further, the pushing member 22 is connected to the support frame 11 or the proximal end of the first filter member 12, an openable or closable opening 143 is provided between the first filter member 12 and the second filter member 14, and the pushing member 22 penetrates through the opening 143.
Specifically, during delivery, the anti-embolic protection device 10 is retracted within the outer sheath 21, thereby facilitating delivery of the anti-embolic protection device 10 to the aortic arch 40. When the anti-embolic protection device 10 is delivered to a predetermined location in the aortic arch 40, the anti-embolic protection device 10 is released to the aortic arch 40 into a released state by relative movement of the outer sheath 21 and the pusher. When the procedure is completed, the anti-embolic protection device 10 is again retracted within the outer sheath 21 by moving the outer sheath 21 and the pusher relative to each other, and during entry of the anti-embolic protection device 10 into the outer sheath 21, the first and second supports 13 and 15 are retracted towards the distal end 112 of the support frame 11, thereby reducing the resistance of the anti-embolic protection device 10 to enter the outer sheath 21.
Further, the pushing member 22 is provided with a guide wire hole penetrating through the axial direction of the pushing member, and the guide wire hole is used for penetrating a guide wire, so that the embolus protecting device can enter the aortic arch 40 along the guide wire pre-embedded in the aorta. In another embodiment, the pusher 22 may also be a solid rod with some rigidity. Preferably, the pusher 22 may be a stainless steel or nickel titanium or polymeric tube or rod. Further, the pusher member 22 is pre-shaped to have a curvature that allows the device to adhere more to the wall during delivery by shaping to different curvature angles to accommodate the shape of the aortic arch 40. The distal end 112 of the pusher member 22 may be attached to the distal end 112 or the proximal end 111 of the support frame 11, or the pusher member 22 may be attached to both the distal end 112 and the proximal end 111 of the support frame 11.
Further, the distal end 112 of the pusher member 22 may be provided with a flexible segment, such as a seawave cutting structure or a helical machining structure at the distal end 112 of the pusher member 22, such that the distal end 112 of the pusher member 22 forms the flexible segment. Further, the distance of the flexible segment on the pusher 22 may range from 100mm to 400mm, preferably from 140mm to 300 mm. The flexible segment of the pusher member 22 allows the pusher member 22 to freely conform to the curvature of the vessel in the aortic arch 40 and to conform to the superior wall of the aortic arch 40. Preferably, the pusher member 22 is attached to the proximal end 111 of the support frame 11 by adhesive, welding, or the like. Preferably, the pusher 22 may be a tube or rod of stainless steel, nitinol, or polymeric material.
Referring to fig. 10, the delivery mechanism 20 may further comprise a handle 23, wherein the proximal end 111 of the outer sheath 21 is fixedly connected to the distal end 112 of the handle 23, and the proximal end 111 of the pushing member 22 is movably inserted through the handle 23 and connected to the distal end 112 of the handle 23, so that the pushing and pulling of the handle 23 can move the outer sheath 21 and the pushing member 22 relative to each other to release the anti-embolic protection device 10 out of the outer sheath 21 or shrink the anti-embolic protection device into the outer sheath 21.
Further, the conveying mechanism 20 may further include a developing catheter 31, and the handle 23 is further provided with a developing catheter inlet (not shown), through which the developing catheter 31 may be movably disposed in the sheath 21 and may move synchronously with the pushing member 22. The visualization catheter 31 can be imaged with medical images to facilitate the physician in confirming the positioning of the anti-embolic protection device 10 and the delivery mechanism 20 during the surgical procedure.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the invention and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the invention.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or to implicitly indicate the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.
In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
In the present invention, unless otherwise expressly stated or limited, the first feature "on" or "under" the second feature may be directly contacting the first and second features or indirectly contacting the first and second features through an intermediate. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature being "under," "below," and "beneath" a second feature may be directly under or obliquely under the first feature, or may simply mean that the first feature is at a lesser elevation than the second feature.
It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like as used herein are for illustrative purposes only and do not denote a unique embodiment.

Claims (11)

1. An anti-embolic protection device, comprising:
the support device comprises a support frame, a first support and a second support, wherein the first support and the second support are arranged on one side of the support frame at intervals;
a first filter covering the support frame; and the number of the first and second groups,
a second filter having an open end and a closed end, the open end being connected to the first support member and the closed end being connected to the second support member.
2. The embolic protection device of claim 1, wherein an opening and closing port is provided between the first filter element and the second filter element, which can be opened or closed.
3. The anti-embolic protection device of claim 2, wherein the first filter member and the second filter member form a passage therebetween for passage of a surgical instrument when the opening and closing port is in the open state; when the opening and closing port is in a closed state, the first filter piece is tightly attached to the second filter piece.
4. An anti-embolic protection device as in claim 1, wherein the first and/or second filter comprises one layer of filter mesh or at least two layers of filter mesh staggered.
5. The embolic protection device of claim 1, wherein an end of the first support member distal from the support frame is in a closed configuration, or an opening is provided at an end of the first support member distal from the support frame; and/or the presence of a gas in the gas,
one end, far away from the supporting frame, of the second supporting piece is of a closed structure, or one end, far away from the supporting frame, of the second supporting piece is provided with an opening.
6. An anti-embolic protection device as in claim 1, wherein the second filter is umbrella-shaped.
7. The anti-embolic protection device of claim 1, wherein the first support is connected at a distal end of the support frame and the second support is connected at a proximal end of the support frame.
8. An anti-embolic protection device as in claim 1, wherein the first support member comprises a first support section that is curved towards the first filter member, at least a portion of an edge of the open end of the second filter member being connected to the first support section.
9. An anti-embolic protection device as in claim 1, wherein the second support member comprises a second support section that is curved towards the first filter member, the second support section being connected to the closed end at an end remote from the support frame.
10. An anti-embolic protection device as in claim 1, wherein the first and/or second support comprises a connecting section that is bent towards the proximal or distal end of the support frame and connected with the support frame.
11. A medical device, comprising:
an anti-embolic protection device as in any of the preceding claims 1-10; and the number of the first and second groups,
the conveying mechanism comprises an outer sheath tube and a pushing element movably arranged in the outer sheath tube in a penetrating mode, the pushing element is connected with the supporting frame or the near end of the first filtering element, an opening and closing opening capable of being opened or closed is formed between the first filtering element and the second filtering element, and the pushing element penetrates out of the opening and closing opening.
CN202011226021.7A 2020-11-05 2020-11-05 Anti-embolism protection device and medical instrument Withdrawn CN114431998A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022237836A1 (en) * 2021-05-13 2022-11-17 深圳市先健呼吸科技有限公司 Embolic protection device

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022237836A1 (en) * 2021-05-13 2022-11-17 深圳市先健呼吸科技有限公司 Embolic protection device

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