WO2022095268A1 - 一种左心耳封堵器及其使用方法 - Google Patents
一种左心耳封堵器及其使用方法 Download PDFInfo
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- WO2022095268A1 WO2022095268A1 PCT/CN2020/142578 CN2020142578W WO2022095268A1 WO 2022095268 A1 WO2022095268 A1 WO 2022095268A1 CN 2020142578 W CN2020142578 W CN 2020142578W WO 2022095268 A1 WO2022095268 A1 WO 2022095268A1
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- anchoring
- atrial appendage
- left atrial
- fixing element
- limiting element
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- 210000005248 left atrial appendage Anatomy 0.000 title claims abstract description 193
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- 238000002513 implantation Methods 0.000 claims description 10
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- 238000007789 sealing Methods 0.000 claims description 3
- 238000010586 diagram Methods 0.000 description 36
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- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
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Definitions
- the invention relates to the field of medical devices, in particular to a left atrial appendage occluder and a method for using the same.
- Percutaneous left atrial appendage occlusion refers to the delivery of the left atrial appendage occluder to the left atrial appendage of the left atrium of the heart by means of a slender delivery sheath and release through percutaneous puncture. The channel with the left atrium is blocked, so that the blood in the atrium will no longer flow into the left atrial appendage, and the thrombus in the left atrial appendage will no longer flow into the blood circulation system, so as to achieve the purpose of preventing thromboembolism induced by atrial fibrillation. Since 2001, percutaneous left atrial appendage occluder has been used in clinical practice, and years of clinical use have shown that percutaneous left atrial appendage occlusion can effectively reduce the probability of stroke in patients with atrial fibrillation.
- the left atrial appendage occluder is basically completed with a nickel-titanium alloy and a polymer material blocking film, the nickel-titanium alloy mainly plays a role of fixing, and the polymer blocking film mainly plays a role of blocking blood flow.
- Common left atrial appendage occluder structures are plug-type and double-disc type.
- the left atrial appendage occluder with double-disc structure consists of a sealing device and a fixing device, which usually has the advantage of repeatable recovery and release, and is more practical.
- the left atrial appendage in the human body has various shapes, and the internal structure of the left atrial appendage is relatively complex.
- Clinical experience has proved that after using the existing left atrial appendage occluder to occlude the left atrial appendage, the common problems are as follows: (1) Using a plug occluder After occlusion, a residual cavity is likely to remain near the left atrial appendage orifice.
- the present invention provides a left atrial appendage occluder and a method for using the same, which achieves the purpose of flexible use of the device and improving the adaptability of the left atrial appendage occluder to various left atrial appendages.
- a left atrial appendage occluder comprising an anchoring part, a connecting part and a covering part which are connected in sequence in the axial direction
- the anchoring part comprises a radially shrinkable first support net and a second a fixing element
- the outer peripheral surface of the first support net is provided with a plurality of anchoring elements for grasping the tissue of the left atrial appendage
- the first fixing element is installed at one end of the first support net close to the connecting part, so
- the first fixing element is detachably connected to the connecting part
- the covering part includes a radially shrinkable second support net and a second fixing element, and in a natural state, the radial dimension of the covering part is not smaller than the the radial dimension of the anchoring part
- the second fixing element is installed at one end of the second support net away from the connecting part
- the first fixing element and the second fixing element are far away from the first support
- One end of the net is respectively provided with a connection position of the push device
- the present technical solution discloses a left atrial appendage occluder.
- This solution is different from the previous left atrial appendage occluder in that the first fixing element is provided at the end of the anchoring part close to the connecting part, and the first fixing
- the structure of the element and the connecting part realizes the detachable connection between the anchoring part and the connecting part. Therefore, the anchoring part can be used in combination with the connecting part and the covering part, or the anchoring part can be used alone. And in the actual test, according to the structure of different human atrial appendages, different combinations can be used.
- the above-mentioned anchoring part is used alone to avoid the influence of the covering part on the human tissue near the atrial appendage, such as the valve; the combined use of the anchoring part, the connecting part and the covering part can cover the residual cavity near the left atrial appendage to avoid the occurrence of thrombus in the residual cavity and endanger the health of the patient .
- the left atrial appendage occluder is flexible in use and improves the adaptability of the left atrial appendage occluder to various shapes of the left atrial appendage.
- the connecting part includes a threaded connector, a hollow limiting element and a snap-connecting element, wherein the two ends of the hollow limiting element are in an open structure with a spherical cavity inside; one end of the snap-connecting element can be rotatably installed Inside the spherical cavity, in cooperation with the spherical cavity, the other end has an anchoring part connecting structure; one end of the threaded connection is slidably installed in the hollow limiting element, and is located on the same axis, and the other end It has a cover connection structure.
- the technical solution further discloses the specific structure of the connecting part.
- the specific structure and connection relationship of the threaded connecting piece, the hollow limiting element and the clamping element Through the specific structure and connection relationship of the threaded connecting piece, the hollow limiting element and the clamping element, the effect that the relative distance and angle of the anchoring part and the covering part can be changed is realized, which further improves the The adaptability of the left atrial appendage occluder.
- the connecting portion includes a first limiting element, a second limiting element and an elastic element, wherein the first limiting element and the second limiting element have cavities disposed opposite to each other, and the first limiting element and the second limiting element have oppositely arranged cavities.
- a limiting element is installed inside the second limiting element with a gap, and a side of the first limiting element facing the second limiting element is provided with a first folding edge extending inwardly.
- the side of the two limiting elements facing the first limiting element is provided with a second folded edge extending outward, and the radial partial regions of the first folded edge and the second folded edge overlap each other to form an axial limit Positioning structure;
- the elastic element is installed between the first limiting element and the second limiting element, and the two ends are respectively connected with the first limiting element and the second limiting element, so
- the first limiting element and the second limiting element can be axially telescopic or relatively bent; the opposite sides of the first limiting element and the second limiting element are respectively provided with connecting structures.
- This technical solution further discloses another solution of the structure of the connecting portion.
- the first limiting element can communicate with the second limiting element.
- the relative distance and angle are changed, thereby realizing the effect that the relative distance and angle of the anchoring part and the covering part can be changed, which also improves the adaptability of the left atrial appendage occluder.
- the anchoring part includes a fourth fixing element, and the fourth fixing element is installed at an end of the first supporting net away from the connecting part;
- the first supporting net includes a plurality of elastic metal wires, and the The elastic metal wires are interlaced with each other to form a hollow columnar structure, and the two ends in the axial direction are folded, respectively closed by the first fixing element and the fourth fixing element, and the first fixing element and the fourth fixing element are close to each other,
- the two axial ends of the anchoring portion are recessed, and the first fixing element is provided with a threaded structure matched with the connecting portion; or, the anchoring portion is a support rod formed by engraving an elastic metal tube, and the two axial ends are closed , respectively closed by the first fixing element and the fourth fixing element, or only one end of the anchoring part close to the connecting part is closed by the first fixing element, and the first fixing element is provided with the or, the anchoring portion is in the form of a cylindrical shape with substantially the same radial dimensions at both ends of the axial direction
- the covering part includes a third fixing element, the third fixing element is installed at one end of the second support net close to the connecting part, and the connecting part is connected to the connecting part through the third fixing element
- the cover part is detachably connected; wherein, the second support net includes several elastic metal wires, the elastic metal wires are interlaced with each other to form a hollow flat structure, and the two axial ends of the second support net are folded, respectively passing through the The second fixing element and the third fixing element are closed, and the second fixing element and the third fixing element are located on the same axis as the covering part; the middle part of one end of the covering part close to the connecting part faces the The connecting part protrudes and is sealed by the third fixing element; and/or; a polymer material flow blocking film is arranged inside the anchoring part and the covering part.
- the technical solution further discloses the specific structure of the second support net and the internal structures of the anchoring part and the covering part.
- a polymer material flow blocking film inside the anchoring part and the covering part, the blocking effect on blood flow is effectively increased .
- the requirements for the size of the covering part and the anchoring part are different.
- the covering parts of different sizes can be used in combination with the anchoring parts of different sizes, which further improves the adaptability of the left atrial appendage occluder to various shapes of the left atrial appendage.
- an outer thread or an inner thread is provided at one end of the snap-connecting element away from the hollow limiting element to form the anchoring portion connecting structure, and the first fixing element is matched with the anchoring portion connecting structure; And/or: an end of the threaded connecting piece away from the hollow limiting element is provided with an external thread or an internal thread, so as to form the covering portion connecting structure.
- the anchoring element includes a free end and a fixed end, the fixed end is fixedly connected with the anchoring portion, the free end extends outward, and a plurality of the anchoring elements surround the outer peripheral surface of the anchoring portion; the The length of the anchoring element is 1-4mm; a plurality of the anchoring elements are respectively located at 1-3 cross-sectional edges of the anchor portion, and each cross-sectional edge is provided with 4-10 anchoring elements; when the anchoring elements are not When located on the same cross section, the anchoring elements are radially staggered and distributed along the anchoring portion.
- connection between the first fixing element and the connecting portion is provided with a resistance element for increasing the connection strength of the connection;
- the resistance element includes: a number of first saw teeth and a number of second saw teeth, The first sawtooth is installed at the end of the first fixing element facing the connecting portion, the second sawtooth is installed at the end of the connecting portion facing the first fixing element, and in the connected state, The first sawtooth and the second sawtooth are locked with each other; or;
- the resistance element includes: a resistance washer, the resistance washer has a ring structure, and adopts polyester fiber film, polytetrafluoroethylene film, etc.
- the resistance washer is made of a flexible material, and the resistance washer is provided with a plurality of protrusions at both ends in the axial direction, and in the connection state, the resistance washer is pressed between the first fixing element and the connection portion.
- the resistance element includes: a first resistance washer and a second resistance washer, one axial end of the first resistance washer is connected to the first fixing element, and the other end is serrated; the second resistance washer may be The sliding sleeve is arranged outside the connection part, and one end of the second resistance washer away from the anchoring part is provided with a spring, and the other end is serrated. In the connection state, the first resistance washer is squeezed along the axis direction.
- the resistance The element includes: an internally threaded pipe, in the connected state, the internally threaded pipe is sleeved on the outside of the first fixing element and the connecting portion, and the surfaces of the first fixing element and the connecting portion are both provided with external threads , which is matched with the internally threaded pipe.
- the technical solution further discloses a resistance element.
- the present invention simply and reliably improves the connection strength between the anchoring part and the connecting part through the implementation of various resistance elements, so that the anchoring part and the connecting part can be pushed to the left by the pushing device.
- the connection between the anchoring part and the connecting part will not be affected even if a large external force is applied, such as the force generated when the pushing device is separated from the connecting position of the pushing device of the covering part.
- Step 1 The anchoring part, the connecting part and the covering part are connected in sequence, and the end of the covering part away from the connecting part is installed on the end of the pushing device, and the covering part and the anchoring part are pulled together. It is stretched and deformed into a linear shape, and is pushed by the pushing device to enter the human body through the delivery sheath;
- Step 2 At the implantation position, first push the anchoring part out of the delivery sheath, and gradually expand the anchoring part away from the support mesh of the connecting part to form a smaller plane for pre-positioning; the first support The remaining parts of the net are unfolded in sequence, so that the anchoring portion is gradually abutted against the left atrial appendage tissue, and the anchoring elements are simultaneously unfolded to grasp the left atrial appendage tissue;
- Step 3 Push the connecting portion and the covering portion out of the delivery sheath in sequence, so that the covering portion is unfolded to cover the left atrial appendage opening.
- the method uses the combined structure of the anchoring part, the connecting part and the covering part, so that the position where the anchoring part is implanted is far away from the left atrial appendage, and the left atrial appendage Effective occlusion of the left atrial appendage when there is still a large space near the mouth that cannot be sealed; Small plane, pre-positioned, and deployed in the left atrial appendage with a flat front end, effectively preventing potential damage to the left atrial appendage tissue by the instrument, and gradually restoring the preset shape of the first support net and anchoring element to abut against the left atrial appendage wall , to effectively grasp the left atrial appendage tissue to avoid damage.
- the anchoring portion can basically seal the opening of the left atrial appendage without leaving a residual cavity, including the use steps:
- Step 1 the anchoring part is connected with the pushing device through the first fixing element, the covering part is stretched and deformed into a linear shape, and is pushed through the delivery sheath into the human body by the pushing device;
- Step 2 at the implantation position, gradually push the anchoring portion out of the delivery sheath, and gradually expand the anchoring portion away from the support net of the connecting portion to form a smaller plane for pre-positioning;
- the remaining parts are unfolded in sequence, so that the anchoring portion is gradually abutted against the left atrial appendage tissue, and the anchoring elements are simultaneously unfolded to grasp the left atrial appendage tissue;
- Step 3 Operate the pushing device to separate the pushing device from the anchoring part, and use the anchoring part alone to block the left atrial appendage orifice.
- This technical solution further discloses the use method of the above-mentioned left atrial appendage occluder.
- the method uses the anchoring part and the connecting part alone, so that the position where the anchoring part is implanted is closer to the left atrial appendage, and the left atrial appendage opening can be anchored
- the anchoring part is gradually expanded away from the supporting mesh of the connecting part to form a smaller plane for pre-positioning.
- the front end is relatively flat and deployed in the left atrial appendage, which can effectively prevent the potential damage to the left atrial appendage tissue by the instrument, and gradually restore the preset shape of the first support net and the anchoring element against the left atrial appendage wall, effectively grasping the left atrial appendage tissue. , to avoid damage.
- the anchoring part can be used in combination with the connecting part and the covering part, or the anchoring part can be used alone, which is flexible in use and improves the ability of the left atrial appendage occluder to be used in various shapes of the left atrial appendage. adaptability.
- the detachable connection between the covering part and the connecting part is realized by using the third fixing element as the connecting hinge between the covering part and the connecting part.
- the relative distance and angle of the first limiting element and the second limiting element can be changed, thereby realizing the anchoring part and the covering part.
- the effect of changing the relative distance and angle can also improve the adaptability of the left atrial appendage occluder.
- This method uses the combined structure of the anchoring part, the connecting part and the covering part or uses the anchoring part alone, so that the position where the anchoring part is implanted is far away from the left atrial appendage, and there is still a large space near the left atrial appendage that cannot be sealed.
- effective occlusion of the left atrial appendage under the condition of The state is deployed in the left atrial appendage, which effectively prevents the potential damage of the instrument to the left atrial appendage tissue, and gradually restores the preset shape of the first support net and the anchoring element against the left atrial appendage wall, effectively grasping the left atrial appendage tissue and avoiding damage.
- connection structure between the anchoring part and the covering part makes the two have the flexibility of different axial states, and better adapts to the left atrial appendage of different shapes.
- the anchoring part and the covering part can be used together, or the anchoring part can be used alone, in clinical application, the surgeon can choose to use the anchoring part alone or the combination of the size of the anchoring part and the covering part according to the actual shape of the left atrial appendage.
- the specifications of the anchoring part and the covering part can be selected more flexibly, which can expand the scope of application and shorten the operation time.
- FIG. 1 is a schematic structural diagram of an embodiment of the device of the present invention.
- FIG. 2 is a schematic structural diagram of a first fixing element according to an embodiment of the present invention.
- FIG. 3 is a schematic structural diagram of an embodiment of a connecting portion in the present invention.
- FIG. 4 is a schematic structural diagram of an embodiment of the third fixing element in the present invention.
- FIG. 5 is a schematic structural diagram of an embodiment of a connecting portion in the present invention.
- FIG. 6 is a schematic structural diagram of an embodiment of a connecting portion in the present invention.
- FIG. 7 is a schematic structural diagram of an embodiment of the device of the present invention in a use state
- FIG. 8 is a schematic structural diagram of an embodiment of the connecting portion of the present invention in a use state
- FIG. 9 is a schematic structural diagram of an embodiment of the connecting portion of the present invention in a state of use
- Figure 10 is a schematic diagram of the interior of the heart
- Figure 11 is an effect diagram of using a left atrial appendage occluder in the present invention in the atrial appendage structure shown in Figure 10;
- Fig. 12 is a partial enlarged view of region a in Fig. 10;
- Fig. 13 is a partial enlarged view of region b in Fig. 11;
- Figure 14 is a partial schematic diagram of a left atrial appendage structure
- Figure 15 is an effect diagram of using a left atrial appendage occluder in the present invention in the atrial appendage structure shown in Figure 14;
- Figure 16 is a partial schematic diagram of a left atrial appendage structure
- Figure 17 is an effect diagram of using a left atrial appendage occluder in the present invention in the atrial appendage structure shown in Figure 16;
- Figure 18 is a partial schematic diagram of a left atrial appendage structure
- Fig. 19 is an effect diagram of using a left atrial appendage occluder in the present invention in the atrial appendage structure shown in Fig. 18;
- FIG. 20 is a schematic structural diagram of a covering portion according to an embodiment of the present invention.
- FIG. 21 is a schematic structural diagram of an embodiment of a connecting portion in the present invention.
- FIG. 22 is a schematic structural diagram of an embodiment of the connecting portion in the present invention.
- Figure 23 is a schematic structural diagram of the connection part of Figure 22 in a use state
- Figure 24 is a schematic structural diagram of an embodiment of the resistance element in the present invention.
- Figure 25 is a schematic structural diagram of an embodiment of the resistance element in the present invention.
- FIG. 26 is a schematic structural diagram of the resistance element of FIG. 25 in a connected state
- Figure 27 is a schematic structural diagram of an embodiment of the resistance element in the present invention.
- Fig. 28 is a schematic diagram of the device structure in which the resistance elements of Fig. 27 are matched;
- Figure 29 is a schematic structural diagram of an embodiment of the internally threaded pipe in the present invention.
- FIG. 30 is a schematic structural diagram of an embodiment of the first fixing element in the present invention.
- Figure 31 is a schematic diagram of the full cross-sectional structure of Figure 30;
- FIG. 32 is a schematic structural diagram of an embodiment of a connecting portion in the present invention.
- Figure 33 is a schematic diagram of the full cross-sectional structure of Figure 32;
- Figure 34 is a schematic structural diagram of the components involved in Figures 29 to 33 in a connected state
- Figure 35 is a schematic structural diagram of the present invention during use in the state of combined use of the anchoring portion
- Figure 36 is a schematic structural diagram of the subsequent steps of Figure 35;
- Figure 37 is a schematic structural diagram of the subsequent steps of Figure 36;
- FIG. 38 is a schematic structural diagram of the subsequent steps of FIG. 37 .
- Anchoring part 11. First supporting net, 12. Fourth fixing element, 13. Anchoring element, 14. First fixing element;
- the terms “installed”, “connected” and “connected” should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection, or It can be connected integrally; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication between two components.
- installed should be understood in a broad sense, for example, it may be a fixed connection or a detachable connection, or It can be connected integrally; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication between two components.
- FIG. 1 and FIG. 7 it is a left atrial appendage occluder, comprising an anchoring part 10 , a connecting part 20 and a covering part 30 connected in sequence along the axial direction.
- the anchoring portion 10 includes a radially shrinkable first support mesh 11 and a first fixation element 14.
- the outer peripheral surface of the first support mesh 11 is provided with several anchoring elements 13 for grasping the tissue of the left atrial appendage.
- the first fixation element 14 is installed at one end of the first support net 11 close to the connecting part 20, and the first fixing element 14 is detachably connected with the connecting part 20, so that the anchoring part 10 can be placed at the left atrial appendage alone.
- one end of the first fixing element 14 has a cavity structure for fixing the first support net 11 , and the other end has an internal thread structure detachably connected to the connecting portion 20 .
- the covering part 30 includes a radially shrinkable second supporting mesh 33 and a second fixing element 32.
- the radial dimension of the covering part 30 is not smaller than the radial dimension of the anchoring part 10
- the second fixing element 32 is installed at one end of the second support net 33 away from the connecting portion 20, and one end of the second fixing element 32 away from the connecting portion 20 is provided with a connecting position 32-a of the pushing device.
- the connection position 32-a of the pushing device refers to the connection position between the device and the pushing device 60, and the specific connection structure may be a threaded connection, an interference fit connection or other forms of connection.
- the covering part 30 includes a third fixing element 31 , and the third fixing element 31 is installed at one end of the second supporting net 33 close to the connecting part 20 , and the connecting part 20 is connected to the connecting part 20 through the third fixing element 31 .
- the cover part 30 is detachably connected.
- the anchoring part 10 can be used alone or in combination with the connecting part 20 and the covering part 30. Specifically, in the state where the anchoring part is used alone, the anchoring part 10 is connected to the pushing device through the first fixing element 14. 60 Detachable connection, that is, the side of the first fixing element 14 away from the first support net 11 is set as the connection position of the pushing device. In the combined use state of the anchoring parts, the anchoring part 10 and the connecting part 20 are detachably connected, and one end of the connecting part 20 away from the anchoring part 10 is detachably connected to the covering part 30 through the third fixing element 31 . It should be noted that the connecting position of the pushing device at one end of the connecting portion 20 away from the anchor portion 10 is provided with a connecting structure matched with the pushing device 60 .
- the covering part 30 fixes the elastic wire used to form the second supporting net 33 by the second fixing element 32 and the third fixing element 31 , so that the covering part 30 forms a closed structure.
- the end of the connecting portion 20 is provided with an external thread structure
- the third fixing element 31 is provided with a nut structure inside, so that the third fixing element 31 is connected with the detachable connecting portion 20 .
- a flow blocking film of polymer material is provided inside the anchoring part 10 and the covering part 30, a flow blocking film of polymer material is provided inside the anchoring part 10 and the covering part 30, a flow blocking film of polymer material is provided inside the anchoring part 10 and the covering part 30, a flow blocking film of polymer material is provided inside the anchoring part 10 and the covering part 30, a flow blocking film of polymer material is provided inside the anchoring part 10 and the covering part 30, a flow blocking film of polymer material is provided inside the anchoring part 10 and the covering part 30, a flow blocking film of polymer material is provided inside the anchoring part 10 and the covering part 30, a flow
- the anchoring element 13 includes a free end and a fixed end, the fixed end is fixedly connected with the anchoring portion 10 , the free end extends outward, and a plurality of anchoring elements 13 surround the outer peripheral surface of the anchoring portion 10 .
- the anchoring element 13 is 1-4 mm in length.
- Several anchoring elements 13 are respectively located at 1-3 cross-sectional edges of the anchoring portion 10 , and each cross-sectional edge is provided with 4-10 anchoring elements 13 .
- the anchoring elements 13 are staggered and distributed along the radial direction of the anchoring portion 10 .
- the left atrial appendage 40 of a human body includes a left atrial appendage port 41 and a left atrial appendage cavity 42, and the left atrial appendage port 41 communicates with the left atrium.
- the tissue morphology of the left atrial appendage 40 varies from person to person, and its anatomical structure can be roughly classified into the following categories:
- the left atrial appendage orifice 41 and the adjacent left atrial appendage cavity 42 have a space close to the radial dimension;
- the radial dimension of the left atrial appendage opening 41 is smaller, and the radial dimension of the left atrial appendage cavity 42 adjacent to the left atrial appendage opening 41 is larger than that of the left atrial appendage opening 41, and has a large angle turn;
- the third type as shown in FIG. 16 , the radial dimension of the left atrial appendage opening 41 is large, and the radial dimension of the left atrial appendage cavity 42 is smaller than that of the left atrial appendage opening 41;
- the left atrial appendage cavity 42 has more than one lobe.
- the position where the anchoring portion 10 can be implanted is relatively close to the left atrial appendage opening 41 , and the left atrial appendage opening 41 can be basically sealed by the anchoring portion 10 , and Without leaving a residual cavity, the anchoring part 10 can be used alone, the left atrial appendage opening 41 has no residual cavity, and the channel between the left atrial appendage and the left atrium is blocked.
- the combined form of the covering part 30 , the connecting part 20 and the anchoring part 10 is used for occlusion.
- the double-layer support net of the main body of the covering part 30 is relatively close in the axial direction, and the covering part 30 is generally formed into a frustum shape as a whole, and maintains a certain radian that bulges out in the circumferential direction. , a hollow roughly frustum-shaped small space is formed at the distal end, and the height of the frustum is 3-6mm.
- the main body of the covering portion 30 may be substantially planar. When the structure of the left atrial appendage is shallow, the covering portion 30 is almost entirely located outside the left atrial appendage, and a relatively planar structure may be used. The above two structures are more suitable for the second type of left atrial appendage structure shown in FIG. 14 , and the occlusion effect is shown in FIG. 15 .
- the covering part 30 is axially provided with an annular step, which is designed to add an edge with a larger radial dimension to the covering part 30 to double block the left atrial appendage orifice 41 , Guaranteed blocking effect.
- annular step As shown in FIGS. 15 , 17 and 19 , the above-mentioned combined structure of the covering part 30 with annular steps, the connecting part 20 and the anchoring part 10 is suitable for the third and fourth types of left atrial appendage structures. Furthermore, the covering portion 30 is more likely to fit the left atrial appendage opening 41 to seal the left atrial appendage.
- This embodiment is a left atrial appendage occluder, and the main difference from the first embodiment is the specific structure of the connecting portion 20 , and the same parts will not be repeated here.
- the connecting part 20 includes a threaded connector 21 , a hollow limiting element 22 and a snap-connecting element 23 , wherein the two ends of the hollow limiting element 22 are open structures and have a spherical cavity inside.
- One end of the clamping element 23 is rotatably installed inside the spherical cavity and is matched with the spherical cavity, and the other end has an anchoring part connecting structure 23-a.
- One end of the threaded connector 21 is slidably installed in the hollow limiting element 22 and is located on the same axis, and the other end has a cover connecting structure 21-a.
- the anchor portion connecting structure 23-a and the covering portion connecting structure 21-a may adopt any one of an internal thread structure, an external thread structure and an interference fit connection structure.
- the anchoring portion 10 includes a fourth fixing element 12, and the fourth fixing element 12 is installed at one end of the first support net 11 away from the connecting portion 20; the first support net 11 includes a plurality of elastic wires, and the elastic wires are interlaced with each other. Weaving to form a hollow columnar structure, the two axial ends are folded and closed by the first fixing element 14 and the fourth fixing element 12 respectively. , and the first fixing element 14 is provided with a threaded structure matched with the connecting portion 20 .
- the concave range of the surface where the first fixing element 14 is located is larger than the concave range of the surface where the fourth fixing element 12 is located.
- a hollow tube made of an elastic metal tube is used in the middle of the connecting part 20 to form connecting units embedded with each other after engraving. There is a gap between them, so a certain bending space is formed, the length of the tubular element can be increased or shortened, and the gap of the connecting unit can be increased or decreased, so as to adjust the length and bending range of the main body.
- Two ends of the connecting portion 20 are respectively provided with connecting structures 28, and the connecting structures 28 may be any one of an internal thread structure, an external thread structure and an interference fit structure.
- the anchoring portion 10 is a support rod formed by engraving an elastic metal tube, and the two axial ends are folded and closed by the first fixing element 14 and the fourth fixing element 12 respectively, or only the anchoring portion 10 is close to the connection One end of the part 20 is closed by the first fixing element 14 , and the first fixing element 14 is provided with a threaded structure matched with the connecting part 20 .
- the anchoring portion 10 is cylindrical with substantially the same radial dimension at both ends in the axial direction.
- the second support mesh 33 includes a plurality of elastic metal wires, the elastic metal wires are interlaced to form a hollow flat structure, and the axial ends of the second support mesh 33 are gathered together through the second fixing element 32 and the third fixing element respectively. 31 is closed and fixed, the second fixing element 32 and the third fixing element 31 are located on the same axis as the covering part 30 ;
- the second supporting mesh 33 can be set as a substantially sheet-like structure, and set a certain arc in the radial direction, and the closer to the center, the smaller the radius of curvature, so that the covering portion 30 can move from the edge to the center, so as to be close to the second fixing element 32 the trend of.
- the left atrial appendage occluder is implanted into the left atrial appendage, there is preferably a slight tension between the covering part 30 and the anchoring part 10, so that the covering part 30 is close to the left atrial appendage orifice 41 and will not be displaced under the impact of blood flow.
- Residual shunt is generated, so the setting of the arc makes the center of the covering part 30 closer to the anchoring part 10, and the tension between the two makes the covering part 30 and the left atrial appendage 41 fit more easily, and it is less likely to generate residual shunt.
- This embodiment is a left atrial appendage occluder, which is in a parallel relationship with the structural scheme of the connecting portion 20 in the second embodiment, and the same parts are not repeated here.
- the connecting portion 20 includes a first limiting element 24 , a second limiting element 25 and an elastic element 26 , wherein the first limiting element 24 and the second limiting element 25 have The oppositely arranged cavities 27, the first limiting element 24 is installed inside the second limiting element 25 with a gap, and the side of the first limiting element 24 facing the second limiting element 25 is provided with an inwardly extending first limiting element 25.
- the folded edge 24-a, the side of the second limiting element 25 facing the first limiting element 24 is provided with a second folded edge 25-a extending outward, the first folded edge 24-a and the second folded edge 25- a Radial partial areas overlap each other to form an axial limit structure.
- the elastic element 26 is installed between the first limiting element 24 and the second limiting element 25, and the two ends are respectively connected to the first limiting element 24 and the second limiting element 25, and the first limiting element 24 and the second limiting element 25 can be axially retractable or relatively bent; the opposite sides of the first limiting element 24 and the second limiting element 25 are respectively provided with connecting structures 28 .
- the first limiting element 24 has enough clearance in the radial direction of the second limiting element 25 so that the first limiting element 24 and the second limiting element 25 can be bent
- the elastic element 26 is a spring , or an elastic metal sheet or wire, both ends of the elastic element 26 are clamped or welded on the opposite sides of the first limiting element and the second limiting element.
- the connecting portion 20 includes a first limiting element 24 , a second limiting element 25 and an elastic element 26 .
- first The limiting element 24 and the second limiting element 25 are engraved by a tubular member.
- first limiting element 24 and the second limiting element 25 themselves have a certain bending ability, thereby increasing the overall connection of the connecting portion 20 . ability to apply.
- the structure of the connecting portion 20 in the above embodiment can make the anchoring
- the part 10 and the covering part 30 are in a non-axial state during implantation, and there is more flexibility between the two, and the occlusion effect is not affected by the special structure of the left atrial appendage.
- one end of the snap element 23 away from the hollow limiting element 22 is provided with an external thread or an internal thread to form an anchor portion connecting structure 23-a, and the first fixing element 14 is matched with the anchor portion connecting structure 23-a.
- An end of the threaded connector 21 away from the hollow limiting element 22 is provided with an external thread or an internal thread to form a cover connecting structure 21-a, and the third fixing element 31 is matched with the cover connecting structure 21-a.
- This embodiment is a left atrial appendage occluder, and the main difference from the first to third embodiments is that this embodiment adds a resistance element 50 on the basis of the above-mentioned embodiment, and the same parts are not repeated here.
- a resistance element 50 for increasing the connection strength of the connection is provided at the connection between the first fixing element 14 and the connecting portion 20 .
- the resistance element 50 includes: a number of first saw teeth 51 and a number of second saw teeth 52 , the first saw teeth 51 is arranged on the end of the first fixing element 14 facing the connecting part 20 , The second sawtooth 52 is installed on the end of the connecting portion 20 facing the first fixing element 14 , and in the connected state, the first sawtooth 51 and the second sawtooth 52 are locked to each other.
- a resistance element 50 is provided to strengthen the connection firmness between the two.
- the resistance element 50 is roughly triangular in shape, and a resistance element, namely a first sawtooth 51, is disposed at the first fixing element 14, and a plurality of resistance elements, namely, a second sawtooth 52, may be disposed at the anchor portion connecting structure 23-a.
- the anchoring part connecting structure 23-a When the anchoring part connecting structure 23-a is connected to the first fixing element 14 for the last turn, the first serration 51 is in contact with a certain second serration 52, and the torque is increased at this time, and the anchoring part connecting structure 23-a is further fed , so that the first sawtooth 51 is located between any two of the second sawtooth 52 .
- the resistance element 50 includes: a resistance washer 53 .
- the resistance washer 53 has a ring-shaped structure and adopts a biocompatible flexible material such as a polyester fiber film, a polytetrafluoroethylene film, etc. Material, the axial ends of the resistance washer 53 are respectively provided with a plurality of protrusions 54, as shown in FIG.
- the upper and lower sections of the resistance washer 53 are respectively provided with a circle of protrusions 54 in the radial direction to increase the friction between the resistance element 50 and the adjacent elements. , when the anchoring portion connecting structure 23-a is connected in place with the first fixing element 14, the resistance element 50 is pressed between them.
- the resistance element 50 includes: a first resistance washer 55 and a second resistance washer 56 , and an axial end of the first resistance washer 55 is connected to the first fixing element 14 , the other end is serrated; the second resistance washer 56 is slidably sleeved on the outside of the connecting portion 20, and the end of the second resistance washer 56 away from the anchoring portion 10 is provided with a spring 57, and the other end is serrated.
- the first resistance washer 55 squeezes the second resistance washer 56 along the axial direction
- the spring 57 shrinks axially under the pressure of the second resistance washer 56
- the serrated ends of the first resistance washer 55 and the second resistance washer 56 mesh with each other.
- the first fixing element 14 and the anchoring portion connecting structure 23-a are provided with resistance elements 50, namely, a first resistance washer 55 and a second resistance washer 56, with intermeshing serrated ends therebetween.
- the second resistance washer 56 is sleeved on the outer periphery of the anchoring portion connecting structure 23-a, and the root portion of the anchoring portion connecting structure 23-a can perform a small relative displacement to form a step shape.
- an elastic element ie a spring 57
- the first fixing element is connected to the anchoring portion connecting structure, the first resistance washer 55 and the second resistance washer 56 are engaged with each other, and the elastic element is in a compressed state and has a supporting force to ensure that the resistance element is in an engaged state.
- the resistance element 50 includes: an internally threaded pipe 58 .
- the internally threaded pipe 58 is sleeved on the outside of the first fixing element 14 and the connecting part 20 , as shown in FIG.
- the surfaces of the first fixing element 14 and the connecting portion 20 are both provided with external threads, which are matched with the internally threaded pipes 58 . In this way, the connection reliability between the anchoring part 10 and the connecting part 20 is improved.
- connection state refers to the state in the process of pushing the left atrial appendage occluder through the pushing device, wherein, when the anchoring part is used alone, the connection state is that the anchoring part 10 is directly connected to the pushing device 60;
- the connection state is a state in which the anchoring part 10 , the connecting part 20 and the covering part 30 are connected in sequence, and the pusher 60 is connected to the covering part 30 in this state.
- the above-mentioned resistance element can also be used for the connection between the connecting part 20 and the covering part 30 .
- This embodiment is a method of using a left atrial appendage occluder, which is used for the left atrial appendage occluder in any of the above embodiments.
- This method first uses ultrasound to evaluate the structure of the left atrial appendage, and then selects the appropriate shape and specification of the left atrial appendage occluder.
- the steps of use include:
- Step 1 As shown in FIG. 35, the anchoring part 10, the connecting part 20 and the covering part 30 are connected in sequence, and the end of the covering part 30 away from the connecting part 20 is installed on the end of the pushing device 60, and the covering part 30 and the anchoring part 10 are pulled It is stretched and deformed into a linear shape, pushed through the pushing device 60, and penetrated internally through the delivery sheath 61 to enter the human body;
- Step 2 As shown in Figure 36 and Figure 37, at the implantation position, the anchoring part 10 is pushed out of the delivery sheath 61 first, and the anchoring part 10 is gradually expanded away from the support net of the connecting part 20 to form a smaller plane, and pre-positioning is performed; The rest of the support mesh is unfolded in sequence, so that the anchoring portion 10 is gradually abutted against the left atrial appendage tissue, and the anchoring element 13 is simultaneously unfolded to grasp the left atrial appendage tissue;
- Step 3 As shown in FIG. 38 , push the connecting portion 20 and the covering portion 30 out of the delivery sheath 61 in sequence, so that the covering portion 30 is unfolded to cover the left atrial appendage opening 41 .
- the surgeon usually first uses ultrasound to evaluate the structure of the left atrial appendage, and then selects an appropriate occluder for surgery.
- the anchoring portion 10 needs to be used in conjunction with the covering portion 30 .
- Both ends of the connecting portion 20 are screwed with the anchoring portion 10 and the covering portion 30 respectively.
- the covering part 30 and the supporting mesh of the anchoring part 10 are stretched and deformed into a linear shape, and then the occluder is pushed into the human body through the elongated delivery sheath 61 in a linear shape.
- the end of the anchoring portion 10 away from the connecting portion 20 is pushed out of the delivery sheath 61 first, so that the fourth fixing element 12 is pushed out first.
- the support mesh in the vicinity of the fourth fixing element 12 gradually forms a plane with a smaller radial dimension.
- the anchoring portion 10 is further deployed in the left atrial appendage with the distal end as a plane, which can effectively prevent the potential damage of the occluder to the left atrial appendage tissue, and can be more widely adapted to the left atrial appendage of different structures.
- the anchoring portion 10 As the anchoring portion 10 is pushed out further, the anchoring portion 10 gradually abuts against the upper left atrial appendage tissue, and the anchoring element 13 unfolds to grasp the left atrial appendage tissue without damaging the left atrial appendage tissue; finally, the covering portion 30 is pushed out to cover the left atrial appendage orifice 41.
- the anchoring portion 10 when the position where the anchoring portion 10 can be implanted is relatively close to the left atrial appendage, the anchoring portion 10 can substantially seal the left atrial appendage orifice 41 without leaving a residual cavity, including the use steps:
- Step 1 the anchoring part 10 is connected with the pushing device 60, the covering part 30 is stretched and deformed into a linear shape, and is pushed through the delivery sheath 61 into the human body by the pushing device 60;
- Step 2 At the implantation position, the anchoring portion 10 is first pushed out of the delivery sheath 61, and the anchoring portion 10 is gradually expanded away from the support net of the connecting portion 20 to form a smaller plane for pre-positioning; The anchoring portion 10 is gradually pressed against the left atrial appendage tissue, and the anchoring element 13 is simultaneously deployed to grasp the left atrial appendage tissue;
- Step 3 operate the pushing device 60 to separate the pushing device 60 from the anchoring portion 10, and use the anchoring portion 10 alone to block the left atrial appendage opening 41.
- the left atrial appendage opening 41 can be basically sealed by the anchoring portion 10 and no residual cavity is left, the anchoring portion 10 can be used alone.
- the pusher 60 is first connected to the anchoring portion 10 and implanted into the left atrial appendage. After implantation, as shown in FIGS. 11 and 13 , the left atrial appendage orifice 41 has no residual cavity, and the channel between the left atrial appendage and the left atrium is blocked.
- the occluder can be retracted into the delivery sheath 61, replaced with a suitable size, and implanted again.
- the anchoring part 10 and the covering part 30 are used together, one part of the anchoring part 10 or the covering part 30 may be suitable and the other part is not. enter. Therefore, the detachable and segmented design of the left atrial appendage occluder can give the operator a sufficiently flexible choice to achieve a better occlusion effect and at the same time help to shorten the operation time.
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Abstract
Description
Claims (11)
- 一种左心耳封堵器,其特征在于,包括沿轴向依次连接的锚固部、连接部以及覆盖部,其中,所述锚固部包括第一固定元件和可径向收缩的第一支撑网,所述第一支撑网外周面设置有若干用于抓持左心耳组织的锚固元件,所述第一固定元件装设在所述第一支撑网靠近所述连接部的一端,所述第一固定元件与所述连接部可拆卸连接;所述覆盖部包括第二固定元件和可径向收缩的第二支撑网,在自然状态下,所述覆盖部的径向尺寸不小于所述锚固部的径向尺寸,所述第二固定元件装设在所述第二支撑网远离所述连接部的一端,所述第一固定元件和所述第二固定元件远离所述第一支撑网的一端分别设置有推送装置连接位,使所述锚固部具有两种使用状态;其中,在锚固部单独使用状态下,所述锚固部与所述连接部断开连接,推送装置与所述第一固定元件远离所述锚固部的一端进行对接;在锚固部组合使用状态下,所述锚固部和所述覆盖部通过所述连接部可拆卸连接,推送装置与所述第二固定元件远离所述覆盖部的一端进行对接。
- 根据权利要求1所述的一种左心耳封堵器,其特征在于,所述连接部包括螺纹连接件、中空限位元件以及卡接元件,其中,所述中空限位元件两端呈开口结构,内部具有球形腔;所述卡接元件一端可转动装设在所述球形腔内部,与所述球形腔相配合,另一端具有锚固部连接结构;所述螺纹连接件一端可滑移装设在所述中空限位元件内,且位于同一轴线,另一端具有覆盖部连接结构。
- 根据权利要求1所述的一种左心耳封堵器,其特征在于,所述连接部包括第一限位元件、第二限位元件以及弹性元件,其中,所述第一限位元件和所述第二限位元件具有相向设置的空腔,所述第一 限位元件间隙装设在所述第二限位元件内部,且所述第一限位元件朝向所述第二限位元件的一侧设置有向内延伸的第一折边,所述第二限位元件朝向所述第一限位元件的一侧设置有向外延伸的第二折边,所述第一折边与所述第二折边径向部分区域相互重叠,形成轴向限位结构;所述弹性元件装设在所述第一限位元件与所述第二限位元件之间,两端分别与所述第一限位元件与所述第二限位元件连接,所述第一限位元件和所述第二限位元件可轴向伸缩或相对弯曲;所述第一限位元件和所述第二限位元件的相反侧分别设置有连接结构。
- 根据权利要求1所述的一种左心耳封堵器,其特征在于,所述锚固部包括第四固定元件,所述第四固定元件装设在所述第一支撑网远离所述连接部的一端;所述第一支撑网包括若干弹性金属丝,所述弹性金属丝相互交错编织形成中空柱状结构,轴向两端收拢,分别通过所述第一固定元件和所述第四固定元件封闭,所述第一固定元件和所述第四固定元件相互靠近,使所述锚固部轴向两端凹陷,且第一固定元件设置有与所述连接部相配合的螺纹结构;或,所述锚固部为弹性金属管雕刻形成的支撑杆,轴向两端收拢,分别通过所述第一固定元件和所述第四固定元件封闭,或仅所述锚固部靠近所述连接部的一端通过所述第一固定元件封闭,且第一固定元件设置有与所述连接部相配合的螺纹结构;或,所述锚固部呈轴向两端的径向尺寸基本相同的圆柱形。
- 根据权利要求1所述的一种左心耳封堵器,其特征在于,所述覆盖部包括第三固定元件,所述第三固定元件装设在所述第二支撑网靠近所述连接部的一端,所述连接部通过所述第三固定元件与所述覆盖部可拆卸连接;其中,所述第二支撑网包括若干弹性金属丝,所述弹性金属丝相互交错编织形 成中空扁平状结构,所述第二支撑网轴向两端收拢,分别通过所述第二固定元件和所述第三固定元件封闭,所述第二固定元件和所述第三固定元件与所述覆盖部位于同一轴线;所述覆盖部靠近所述连接部的一端中部向所述连接部突出,通过所述第三固定元件密封;和/或;所述锚固部和所述覆盖部内部,设置有高分子材料阻流膜。
- 根据权利要求2所述的一种左心耳封堵器,其特征在于,所述卡接元件远离所述中空限位元件的一端设置有外螺纹或内螺纹,以形成所述锚固部连接结构,所述第一固定元件与所述锚固部连接结构相配合;和/或;所述螺纹连接件远离所述中空限位元件的一端设置有外螺纹或内螺纹,以形成所述覆盖部连接结构。
- 根据权利要求1所述的一种左心耳封堵器,其特征在于,所述锚固元件包括自由端与固定端,所述固定端与所述锚固部固定连接,所述自由端向外延伸,多个所述锚固元件环绕所述锚固部外周面;所述锚固元件长度为1-4mm;若干所述锚固元件分别位于所述锚固部的1-3个横截面边缘,每个横截面边缘设置有4-10个所述锚固元件;当所述锚固元件不位于同一横截面上时,所述锚固元件沿所述锚固部径向错落分布。
- 根据权利要求1所述的一种左心耳封堵器,其特征在于,所述第一固定元件和所述连接部的连接处,设置有用于增加所述连接处连接强度的阻力元件;其中,所述阻力元件包括:第一锯齿和若干第二锯齿,所述第一锯齿装设在所述 第一固定元件朝向所述连接部的一端,所述第二锯齿装设在所述连接部朝向所述第一固定元件的一端,且在连接状态下,所述第一锯齿和所述第二锯齿相互锁紧;或;所述阻力元件包括:阻力垫圈,所述阻力垫圈呈环形结构,采用聚酯纤维膜、聚四氟乙烯膜等具有生物相容性的柔性材料,所述阻力垫圈轴向两端分别设置有若干凸起,且在连接状态下,所述阻力垫圈压置在所述第一固定元件和所述连接部之间。
- 根据权利要求8所述的一种左心耳封堵器,其特征在于,所述阻力元件包括:第一阻力垫圈和第二阻力垫圈,所述第一阻力垫圈轴向一端与所述第一固定元件连接,另一端呈锯齿状;所述第二阻力垫圈可滑移套设在所述连接部外部,且所述第二阻力垫圈远离所述锚固部的一端设置有弹簧,另一端呈锯齿状,在连接状态下,所述第一阻力垫圈沿轴线方向挤压所述第二阻力垫圈,所述弹簧在所述第二阻力垫圈的压力作用下轴向收缩,所述第一阻力垫圈和所述第二阻力垫圈的锯齿端相互啮合;或;所述阻力元件包括:内螺纹管,在连接状态下,所述内螺纹管套设在所述第一固定元件和所述连接部外部,所述第一固定元件和所述连接部表面均设置有外螺纹,与所述内螺纹管相配合。
- 一种左心耳封堵器的使用方法,用于权利要求1-9任一所述的左心耳封堵器,其特征在于,检测患者左心耳结构;当所述锚固部需要植入的位置距离左心耳较远,左心耳口附近还剩余较大的空间无法被密封的情况下,包括使用步骤:步骤一:所述锚固部、所述连接部以及所述覆盖部依次连接,且所述覆盖 部远离所述连接部的一端装设在推送装置端头,所述覆盖部和所述锚固部拉伸变形为线形,通过推送装置推送经过输送鞘管进入人体;步骤二:在植入位置,先将所述锚固部推出所述输送鞘管,所述锚固部远离所述连接部的第一支撑网逐渐展开形成较小的平面,进行预定位;所述第一支撑网的其余部分依次展开,使所述锚固部逐渐贴靠在左心耳组织,所述锚固元件同时展开,抓持左心耳组织;步骤三:将所述连接部与所述覆盖部依次推出所述输送鞘管,使所述覆盖部展开覆盖住左心耳口。
- 根据权利要求10所述的一种使用方法,其特征在于,当所述锚固部可以植入的位置距离左心耳较近,所述锚固部可以基本密封左心耳口,并不留下残余腔的情况下,包括使用步骤:步骤一:所述锚固部通过第一固定元件与推送装置连接,所述覆盖部拉伸变形为线形,通过所述推送装置推送经过输送鞘管进入人体;步骤二:在植入位置,将所述锚固部逐渐推出所述输送鞘管,所述锚固部远离所述连接部的第一支撑网逐渐展开形成较小的平面,进行预定位;所述第一支撑网的其余部分依次展开,使所述锚固部逐渐贴靠在左心耳组织,所述锚固元件同时展开,抓持左心耳组织;步骤三:操作所述推送装置,使所述推送装置与所述锚固部分离,单独使用锚固部封堵左心耳口。
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KR1020237019173A KR20230104920A (ko) | 2020-11-06 | 2020-12-31 | 좌심방이 폐색 장치 및 그 사용방법 |
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US20230389931A1 (en) | 2023-12-07 |
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