Medical device

Abstract

The present application relates to a medical device for occluding a target cavity, the medical device comprising a fixing part having a net-like support structure, and at least one anchor provided on the fixing part, the anchor being configured to abut against an inner surface of the target cavity after the fixing part is implanted in the target cavity, so as to anchor the fixing part and the target cavity to each other. By providing the anchor, the anchor abuts against the surface of the human tissue after the medical device is implanted in the human body, instead of piercing the human tissue, so as to avoid damaging the human tissue, and further avoid the wound from being damaged and enlarged due to the movement of the human tissue.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to a medical device. Background Technology

[0002] Medical devices, especially implantable medical devices, generally need to remain in the implantation position for a certain period of time after being implanted in the human body.

[0003] In recent years, among patients with non-valvular atrial fibrillation, 90% of strokes caused by atrial fibrillation originate from the left atrial appendage. Clinical data shows that resection of the left atrial appendage during cardiac surgery in patients with atrial fibrillation can reduce the incidence of stroke, suggesting the danger of the left atrial appendage in thromboembolism. Since the left atrial appendage is a thrombus-forming site, occluding its opening can eliminate the basis for thrombus formation within the left atrial appendage. Typically, using a left atrial appendage occluder as a medical implant to seal the opening of the left atrial appendage is an effective way to prevent stroke caused by atrial fibrillation.

[0004] To effectively occlude the left atrial appendage, a left atrial appendage occluder needs to be implanted in the left atrial appendage long-term to achieve the occlusion effect. Therefore, the left atrial appendage occluder must have a certain anchoring structure to ensure its stable occlusion at the opening of the left atrial appendage for a long period of time, while preventing it from falling out and causing problems such as device embolism.

[0005] To achieve long-term stability of the left atrial appendage occluder at the left atrial appendage orifice, numerous anchoring structures with sharp tips, such as anchor spikes or hooks, are typically incorporated into the support portion of the occluder (the junction between the occluder and the atrial appendage wall) to penetrate the atrial appendage wall and ensure long-term implantation stability. However, these anchoring structures with sharp tips, such as anchor spikes or hooks, are prone to puncturing the atrial appendage wall, causing complications such as pericardial effusion and endangering the patient's life. Furthermore, since the atrial appendage undergoes contraction and relaxation movements with the heart, puncture-based anchoring may cause further damage to the anchoring site due to the movement of the atrial appendage. Similar problems exist in other implants; therefore, there is a need to design an anchoring structure that provides anchoring stability while avoiding the introduction of sharp tips for use in medical devices. Summary of the Invention

[0006] Therefore, it is necessary to provide a new medical device to address the problem of anchor-piercing structures in existing medical devices penetrating human tissue.

[0007] A medical device includes a fixing part having a mesh support structure, the fixing part having at least one anchoring member, the anchoring member being used to abut against the inner surface of the target cavity after the fixing part is implanted into the target cavity, so as to anchor the fixing part and the target cavity to each other.

[0008] In one embodiment, the anchoring element includes at least one anchoring unit.

[0009] In one embodiment, the anchoring element further includes a connecting unit that connects the anchoring unit to the fixing portion.

[0010] In one embodiment, the mesh support structure includes support wires, and the connecting unit is connected to the support wires by entanglement, and the connecting unit is fixedly connected to the support wires, or the connecting unit can slide relative to the support wires along the length direction of the support wires.

[0011] In one embodiment, when the connecting unit can slide relative to the support wire along the length direction of the support wire, a limiting unit is also provided on the support wire to which the connecting unit is connected, so as to limit the sliding range of the connecting unit on the support wire.

[0012] In one embodiment, the anchoring unit is rotatably connected to the connecting unit.

[0013] In one embodiment, the connecting unit includes a telescopic rod, one end of which is connected to the anchoring unit and the other end is fixedly connected to the fixing part.

[0014] In one embodiment, the mesh support structure includes multiple support wires, the anchoring unit is connected to the multiple support wires through a connecting unit, and when the fixing part is in a radially compressed state, the anchoring unit is located inside the mesh support structure, or the anchoring unit is at least partially located in the gap between adjacent support wires.

[0015] In one embodiment, the fixing part is provided with a plurality of anchoring units, and when the fixing part is in an unfolded state, the plurality of anchoring units are located on a plurality of cross sections of the fixing part; and / or, when the fixing part is in a radially compressed state, the plurality of anchoring units are located on a plurality of cross sections of the fixing part.

[0016] In one embodiment, the anchoring unit is provided with micro-barbs.

[0017] The medical device provided by this invention, by incorporating an anchoring element, achieves anchoring after implantation in the human body by engaging with gaps in the tissue or abutting against the inner wall of the tissue, rather than puncturing it. This avoids damage to the tissue and further prevents wound enlargement due to tissue movement. While ensuring good anchoring capability, the medical device functions normally. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the implantation state of the traditional Chinese medicine device in Embodiment 1 of the present invention;

[0019] Figure 2 This is a schematic diagram of the structure of the medical device in Embodiment 1 of the present invention;

[0020] Figure 3 This is a schematic diagram of the structure of the anchoring component of the traditional Chinese medicine device according to Embodiment 1 of the present invention;

[0021] Figure 4 This is a schematic diagram of the structure of the anchoring component of the traditional Chinese medicine device in Embodiment 2 of the present invention;

[0022] Figure 5 This is a schematic diagram of the structure of the anchoring component of the traditional Chinese medicine device in Embodiment 3 of the present invention;

[0023] Figure 6 This is a schematic diagram of the structure of the anchoring component of the traditional Chinese medicine device in Embodiment 4 of the present invention;

[0024] Figure 7 This is an exploded view of the anchoring component of the medical device in Embodiment 4 of the present invention;

[0025] Figure 8 This is a schematic diagram of the structure of the anchoring component of the traditional Chinese medicine device in Embodiment 5 of the present invention;

[0026] Figure 9 This is a schematic diagram of the structure of the anchoring component of the medical device in Embodiment 6 of the present invention;

[0027] Figure 10 This is a schematic diagram of the structure of the anchoring component of the medical device in another embodiment of the present invention;

[0028] Figure 11 This is a schematic diagram of the structure of the anchoring component of the traditional Chinese medicine device in Embodiment 7 of the present invention;

[0029] Figure 12 This is a schematic diagram of the structure of the anchoring component of the medical device in Embodiment 8 of the present invention;

[0030] Figure 13 This is a schematic diagram of the structure of the anchoring component of the medical device in another embodiment of the present invention;

[0031] Figure 14 This is a schematic diagram of the structure of the anchoring component of the medical device in Embodiment 9 of the present invention;

[0032] Figure 15 This is a schematic diagram of the structure of the anchoring component of the medical device in another embodiment of the present invention;

[0033] Figure 16 This is a schematic diagram of the structure of the traditional Chinese medicine device in Embodiment 10 of the present invention. Detailed Implementation

[0034] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0035] It should be noted that in the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined. "Axial direction" generally refers to the length direction of the medical device during delivery, and "radial direction" generally refers to the direction of the medical device perpendicular to its "axial direction." Based on this principle, the "axial direction" and "radial direction" of any component of a medical device are defined.

[0036] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0037] Example 1

[0038] Reference Figure 1 , Figure 1 This is a schematic diagram of the structure of the medical device 100 in Embodiment 1 of the present invention. The medical device 100 of this embodiment is disposed in the target cavity 200. The target cavity 200 can be any cavity within a living organism, or the cavity of other implants inserted into a living organism. The present invention does not limit the type of target cavity 200. For ease of understanding, the present invention uses the left atrial appendage as an example of the target cavity 200. The inner wall of the left atrial appendage contains a large number of pectinate muscles 210, which promote the contraction and relaxation of the left atrial appendage. Adjacent pectinate muscles 210 and the inner wall of the left atrial appendage (hereinafter referred to as the atrial appendage wall 220) form a concave region 230 with an opening.

[0039] Please refer to the following at the same time Figure 2 The medical device 100 includes a fixing portion 10 and a sealing portion 20 connected to the fixing portion 10. The fixing portion 10 and the sealing portion 20 are arranged along the axial direction of the medical device 100 and are connected by a connecting portion (e.g., a sheath, not shown). The sealing portion 20 is located at the proximal end of the medical device 100, and the fixing portion 10 is located at the distal end of the medical device 100. The medical device 100 has a compressed state, allowing it to be housed within a sheath for easy delivery to the occlusion position. Furthermore, when the radial constraint on the medical device 100 is released, the medical device 100 returns to its original position. Figure 1 The unfolded state shown.

[0040] The fixing part 10 includes a mesh support structure 11, which may be generally cylindrical, umbrella-shaped, plug-shaped, or similar in form. The mesh support structure 11 includes multiple support wires 111, which intersect to form mesh openings 113. In this invention, a "single" support wire 111 is defined as a virtual dividing point where the intersecting point 112 (or cross point) of the support wires 111 divides the mesh support structure 11 into multiple wires. For some mesh support structures 11 that are actually woven from only one continuous support wire 111, referring to the definition in this invention, they also include multiple support wires 111.

[0041] In this embodiment, the mesh support structure 11 can be woven from multiple support wires 111, or it can be obtained by cutting tubing (e.g., shape memory alloy tubing, polymer material tubing). The support wire 111 can be a single wire structure or multiple wires wound in a spiral. The material of the support wire 111 can be one or more of metallic materials (e.g., nickel-titanium), polymer materials, and inorganic non-metallic materials. This invention does not limit the material and structure of the mesh support structure 11, as long as the mesh support structure 11 has a certain radial supporting force.

[0042] The sealing portion 20 can be made of multiple braided filaments woven into a mesh tube, with each end of the mesh tube secured by a sealing portion distal plug (not shown). The mesh tube is then heat-set into a disc, column, or plug shape to obtain the sealing portion 20 for sealing the target cavity 200 (e.g., the left atrial appendage). The interior of the sealing portion 20 may contain at least one thin film (not shown), the edges of which are fixed to the braided filaments at the edges of the sealing portion 20. The thin film prevents blood flow from one side of the sealing portion 20 to the other.

[0043] Please refer to this again. Figure 2 At least one anchoring element 12 may be provided on the fixing part 10. The anchoring element 12 includes at least one anchoring unit 121. In this embodiment, the anchoring unit 121 is a protrusion, which can be spherical, hemispherical, teardrop-shaped, cylindrical, conical, polyhedral, or other structures. It should be noted that a protrusion is not the only form of the anchoring unit 121. The anchoring unit 121 can be set in various structural forms such as ring-shaped, umbrella-shaped, disc-shaped, and radial, as long as it can adaptively snap into or extend into the gaps in human tissue or abut against human tissue. The material used to make the anchoring unit 121 can be selected from one or more of metals, polymers, or inorganic non-metallic materials. For example, relatively hard materials such as nickel-titanium alloys, ceramics, PTFE, and PET can be selected, as well as soft materials such as silicone and wire.

[0044] The size of the anchoring unit 121 can be set according to the specific application scenario. In this embodiment, since the medical device 100 is used to occlude the left atrial appendage, the maximum size (diameter) of the anchoring unit 121 is between 0.1 mm and 3 mm. For example, the maximum size of the anchoring unit 121 is 1.5 mm to 2.5 mm. It should be noted that when the anchoring unit 121 is less than 1.5 mm, the depth of insertion into the tissue is insufficient, and the anchoring ability is weak; when the size of the anchoring unit 121 is greater than 2.5 mm, the difficulty of insertion into the tissue increases, and sometimes it cannot be completely inserted into the tissue gap. In summary, the anchoring unit 121 is generally selected to be around 2 mm in size.

[0045] In this embodiment, the anchoring unit 121 can be directly connected to the fixing part 10 by means of welding, hot melting, entanglement, bonding, etc. For example, please refer to Figure 3 The anchoring unit 121 is fixedly connected to the support wire 111.

[0046] In other embodiments, the anchoring unit 121 may be integrally formed with the support wire 111, for example, the anchoring unit 121 may be formed simultaneously when the support wire 111 is cut.

[0047] In other embodiments, a thin film (not shown) may also be provided on the mesh support structure 11. This thin film is located inside and / or outside the mesh support structure 11, and may completely or partially cover the mesh support structure 11. When the mesh support structure 11 is provided with a thin film, the anchoring unit 121 can be directly connected to the thin film on the inner or outer side of the mesh support structure 11. For example, the anchoring unit 121 passes through the mesh opening 113 of the mesh support structure 11 and is fixedly connected to the thin film located inside the mesh support structure 11. The advantage of this arrangement is that when the medical device 100 is radially compressed, the thin film located inside the mesh support structure 11 can drive the anchoring unit 121 to move inward, thereby reducing the radial dimension of the medical device 100 after radial compression.

[0048] In this embodiment, by setting the anchor 12, after the medical device 100 is delivered to the target cavity 200, as the fixing part unfolds, the anchor 12 is inserted into the recessed area 230 of the human tissue. Because the fixing part 10 has a certain radial support force, the anchor 12 is not easy to fall out of the recessed area 230, thereby anchoring the medical device 100 more stably to the target cavity 200 (such as the left atrial appendage). On the other hand, since the anchor 12 only abuts against the surface of the human tissue and does not pierce the human tissue, damage to the human tissue is avoided, and further, the wound damage caused by the movement of the human tissue is prevented from increasing.

[0049] It should be noted that, in addition to avoiding the introduction of sharp-tipped structures, the medical device 100 in this embodiment also has other technical effects. Since the pectinate muscle contracts and relaxes with the heart, the method of anchoring with barbs (i.e., sharp tips) is prone to causing the barbs to penetrate too deeply into the left atrial appendage wall or even puncture the left atrial appendage wall. In addition, the wound at the puncture site will inevitably expand due to movement, resulting in a decrease in anchoring ability. In this embodiment, since the pectinate muscles at the left atrial appendage have a crisscrossing mesh structure, the anchoring member 12 of the medical device 100 in this embodiment can be well held by the pectinate muscles when it is inserted into the gap between the pectinate muscles. Due to the contraction and relaxation of the pectinate muscles, the anchoring member 12 that is not completely inserted into the gap of the pectinate muscles during the implantation stage will gradually be completely inserted into the gap as the pectinate muscles move. If there are anchoring units 121 that fail to be inserted into the gap during the implantation stage, they will also adaptively be inserted into the gap as the pectinate muscles move. In other words, the medical device 100 in this embodiment will further and adaptively increase its anchoring ability after implantation, and maintain good anchoring ability in conjunction with the contraction and relaxation of the pectinate muscles.

[0050] Please refer to this again. Figure 1 In this embodiment, the anchoring unit 121 is generally spherical, ensuring that when the anchoring unit 121 is inserted into or extends into the gap of the pectinate muscle 210 in the left atrial appendage, it will not cause damage to the pectinate muscle 210 due to the presence of a sharp point. In addition, in order to further reduce the stimulation of the atrial appendage wall 220 and pectinate muscle 210 by the anchoring unit 121, the anchoring unit 121 can have a smooth outer surface by polishing or coating with a biocompatible smooth coating.

[0051] Please refer to this again. Figure 2 In this embodiment, multiple anchoring units 13 are located on the outer surface of the fixing part 10, and the multiple anchoring units 13 are distributed circumferentially at intervals, with the distance between each pair of adjacent anchoring units 13 being approximately equal. Since multiple anchoring units 13 are provided, the probability of the anchoring unit 13 being inserted into the recessed area 230 on the inner surface of the left atrial appendage can be increased, thereby obtaining a better anchoring effect.

[0052] In other embodiments, multiple anchoring units 13 are also spaced apart, but distributed on the outer surface of the fixing part 10. When the fixing part 10 is in the unfolded state, the multiple anchoring units 13 are located on multiple (i.e., at least two) cross-sections (i.e., planes perpendicular to the axial direction) of the fixing part 10. The advantage of this arrangement is that when the fixing part 10 is in the unfolded state, the multiple anchoring units 13 can be respectively inserted into different recessed areas 230 in the left atrial appendage (e.g., the gaps between different pectinate muscles 210), further improving the anchoring effect. In addition, when the fixing part 10 is in the radially compressed state, the multiple anchoring units 13 are also located on multiple cross-sections of the fixing part 10, so as to avoid the problem that when the fixing part 10 is in the radially compressed state, the multiple anchoring units 13 are gathered on the same cross-section, resulting in an excessively large radial dimension, making it impossible to retract into a sheath with a smaller radial dimension, or making it difficult to retract the sheath.

[0053] Example 2

[0054] Please see Figure 5 ( Figure 5 (The fixing part connected to the anchoring member 13 is not shown in the diagram.) This embodiment is largely the same as the medical device 100 described in Embodiment 1, and the similarities will not be repeated here. The main difference is that the outer surface of the anchoring unit 131 is also provided with a micro-barb structure 133 to increase the friction between the anchoring member 13 and the recessed area 230 and improve the stability of the anchoring. The micro-barb structure 133 can be set on the outer surface of the anchoring unit 131 by processes such as adhesion, laser cutting, melting, and welding.

[0055] When the anchor 13 is located within the recessed area 230, the micro-thorn structure 133 can pierce into the pectinate muscle 210 or the atrial appendage wall 220. To prevent the micro-thorn structure 133 from piercing the atrial appendage wall 220 and causing complications such as pericardial effusion, on the one hand, the length of the micro-thorn structure 133 can be appropriately adjusted, for example, making the length of the micro-thorn structure 133 less than 1 mm. In this embodiment, the length of the micro-thorn structure 133 is 0.2 mm to 0.8 mm. On the other hand, the distribution area of ​​the micro-thorn structure 133 can be reasonably set. For example, the micro-thorn structure 133 can be set in the proximal and / or distal regions of the anchor unit 131 facing the pectinate muscle 210, while the micro-thorn structure 133 is not set in the lateral region of the anchor unit 131 facing the atrial appendage wall 220. In addition, to further reduce the stimulation of the atrial wall 220 by the anchor 13, the outer surface of the anchor unit 131 facing the atrial wall 220 can be made smooth by polishing or coating with a biocompatible smooth coating.

[0056] In this embodiment, the micro-spiky structure 133 and the anchoring unit 131 are integrally formed. For example, the anchoring unit 131 with the micro-spiky structure 133 is made by integral forming method such as mold combination and point contact melting, so as to avoid complications such as embolism caused by the micro-spiky structure 133 falling off during the insertion and exit of the sheath and implantation, and to ensure that it has excellent bonding strength. In addition, the bonding strength between the micro-spiky structure 133 and the anchoring unit 131 needs to be tested during the product preparation process to ensure that the bonding strength between the micro-spiky structure 133 and the anchoring unit 131 is greater than 10N.

[0057] Example 3

[0058] Please see Figure 5 This embodiment is largely the same as the medical device 100 described in embodiments 1 and 2. The parts that are the same will not be repeated here. The main difference is that the anchoring unit 141 in this embodiment is connected to the support wire 111 through the connecting unit 142.

[0059] In this embodiment, the connecting unit 142 can be made of hard metal, hard polymer material, or other materials. The connection unit 142 and the anchoring unit 141 can be joined by welding, heat setting, heat melting, entanglement, or other methods.

[0060] In other embodiments, the connecting unit 142 may also be made of a flexible soft material, such as a rod, filament, thread, or elastic rope structure formed from soft polymer materials, inorganic materials, or flexible metals. The connection method between the connecting unit 142 and the anchoring unit 141 can be welding, bonding, hot melting, entanglement, etc. The flexible connecting unit 142 allows the anchoring unit 141 to move within a certain area, enabling the anchoring unit 141 to be inserted into the gaps of the pectinate muscles 210 of different shapes and depths, enhancing the matching between the anchoring element 14 and the recessed area 230, while reducing the stimulation of the anchoring element 14 on the atrial appendage wall 220 and the pectinate muscles 210.

[0061] In this embodiment, the connecting unit 142 is generally rod-shaped, with one end connected to the fixing part 10 (such as a support wire 111 in the fixing part 10), and the other end extending outward toward the proximal end and connected to at least one anchoring unit 141. The length of the connecting unit 142 can be 0.2mm to 4mm, and in the unfolded state, the angle between the line connecting the two ends of the connecting unit 142 and the axis of the fixing part 10 (hereinafter referred to as the opening angle) is 0° to 90°. If the length of the connecting unit 142 is too long, the anchoring element 13 may not be able to fully enter the tissue gap, thus affecting the implantation diameter of the medical device 100 and its fit with human tissue, and also making it difficult to sheath the medical device 100. If the opening angle of the connecting unit 142 is too small, the anchoring unit 141 will be too close to the support wire 111, thus failing to engage with the tissue gap or hold the tissue. If the opening angle of the connecting unit 142 is too large, it will not only make it difficult to sheath the medical device 100, but also cause the force exerted by the tissue on the anchoring unit 141 to be along the direction of the connecting unit 142 after the anchoring unit 141 engages with the tissue gap or holds the tissue. In this case, the opening angle of the connecting unit 142 is too large, resulting in a smaller component of the anchoring force of the anchoring unit 141 along the axial direction, thus reducing the anchoring ability of the medical device 100. In this embodiment, the length of the connecting unit 142 is 0.5mm-2mm, and the opening angle is 20°-60°.

[0062] When multiple anchoring units 141 exist, to facilitate entry and exit of the sheath tube, the connection unit 142 and the fixing part 10 (see reference) can be adjusted. Figure 2 The connection position and parameters such as the length and opening angle of the connecting unit 142 are used to ensure that multiple anchoring units 141 are located in multiple cross sections of the fixing part 10, so as to avoid the problem of excessive stress concentration when entering and exiting the sheath tube.

[0063] In this embodiment, when a thin film (not shown) is provided on the outside of the support wire 111, the connecting unit 142 can penetrate the thin film, with one end connected to the support wire 111 and the other end connected to the anchoring unit 141.

[0064] In this embodiment, the anchoring unit 141 is connected to the fixing part 10 through the connecting unit 142. Compared with the method of directly connecting the anchoring unit 141 to the fixing part 10, the anchoring unit 141 can be more easily and firmly inserted into the recessed area 230, resulting in better anchoring performance.

[0065] Example 4

[0066] Please see Figure 6 This embodiment is largely the same as the medical device 100 described in Embodiment 3. The parts that are the same will not be described again here. The main difference is that the anchoring member 15 includes an anchoring unit 151 and a connecting unit 152, and the anchoring unit 151 and the connecting unit 152 are rotatably connected.

[0067] Please refer to Figure 7 , Figure 7 This is an exploded view of the anchoring member 15 in Embodiment 4. The anchoring unit 151 includes a first anchoring unit 1511 and a second anchoring unit 1512. The connecting unit 152 is provided with a receiving cavity 1521, which is used to receive the second anchoring unit 1512. The second anchoring unit 1512 is spherical. After the second anchoring unit 1512 is inserted into the receiving cavity 1521, it can rotate in multiple directions in the receiving cavity 1521. The diameter of the second anchoring unit 1512 is larger than the opening diameter of the receiving cavity 1521. Therefore, the second anchoring unit 1512 cannot be disengaged from the receiving cavity 1521 along the direction of the connecting unit 152, but it can rotate freely in the receiving cavity 1521.

[0068] The second anchoring unit 1512 can drive the first anchoring unit 1511 to rotate relative to the connecting unit 152 in multiple directions, thereby reducing the damage to the atrial appendage wall 220 and pectinate muscle 210 by the end of the anchor during the left atrial appendage's systole and diastole.

[0069] In other embodiments, a groove can be provided on the anchoring unit 151 and a protrusion (not shown) adapted to the groove can be provided on the connecting unit 152. The groove and the protrusion cooperate to make the anchoring unit 151 and the connecting unit 152 rotatably connected.

[0070] Example 5

[0071] Please see Figure 8 This embodiment is largely the same as the medical device 100 described in embodiments 3-4, and the similarities will not be repeated here. The main difference is that the connecting unit 162 is a retractable structure, for example, a spring structure. In this embodiment, the connecting unit 162 can drive the anchoring unit 161 to move in multiple directions, but at the same time applies a restoring force to the anchoring unit 161 in the direction of returning to its original state, thereby maintaining good anchoring ability during the contraction and relaxation of the atrial appendage.

[0072] Furthermore, since the left atrial appendage undergoes contraction and relaxation movements in response to the heartbeat, the anchoring unit 161 can adaptively shift with the contraction and relaxation of the atrial appendage, thus preventing damage or wear to the pectinate muscle 210 and / or the atrial appendage wall 220 due to the movement of the left atrial appendage.

[0073] Example 6

[0074] Please see Figure 9 This embodiment is largely the same as the medical device 100 described in embodiments 3-5. The parts that are the same will not be repeated here. The main difference is that the anchoring member 17 includes a flexible connection unit 172 and multiple anchoring units 171.

[0075] It should be clarified that the structure of the pectinate muscles 210 is relatively complex, and the distribution of their gaps is uneven. Generally speaking, when the anchoring unit 171 fails to enter the gaps between the pectinate muscles 210, the anchoring unit 171 presses the pectinate muscles 210, which has a certain anchoring ability. However, only when the anchoring unit 171 of the anchoring member 17 extends into or is engaged in the recessed area 230 (refer to...) Figure 1 Only when it is in this state can it have better anchoring ability. By including multiple anchoring units 171 in an anchoring member 17, the probability that the anchoring units 171 of the anchoring member 17 extend into or get stuck in the recessed area 230 is increased.

[0076] In this embodiment, the flexible connecting unit 172 is connected in series with multiple anchoring units 171. For example, the flexible connecting unit 172 is first connected to the support wire 111 by welding, hot melting, entanglement, bonding or other methods; or two through holes are opened on a support wire 111, and then the two ends of the flexible connecting unit 172 are passed through the two through holes respectively. Generally speaking, both ends of the flexible connecting unit 172 are fixed to the support wire 111 to prevent the anchoring unit 171 from swinging or moving to the inner position of the support wire 111, thereby losing its anchoring ability.

[0077] In addition, by restricting the relative positions of multiple anchoring units 171 through the flexible connection unit 172, the stimulation of the anchoring units on the atrial appendage wall 220 during the contraction and relaxation of the atrial appendage can be effectively reduced, that is, the anchoring unit 171 can move freely with the contraction and relaxation of the atrial appendage.

[0078] The flexible connecting unit 172 is made of wire or elastic rope with high toughness, elasticity and strength. In this embodiment, by knotting or melting, a knot 1721 is formed at the end of the flexible connecting unit 172, and the diameter of the knot 1721 is larger than the diameter of the through hole, so that the flexible connecting unit 172 will not fall off the support wire 111.

[0079] Please also refer to Figure 10 In other embodiments, to increase the range of motion of the flexible connecting unit 172 and to avoid the risk of the anchoring unit 171 falling into the atrial wall 220 or other tissues due to the loosening of the knot 1721, the flexible connecting units 172 can be connected end to end to form a closed structure.

[0080] Example 7

[0081] Please see Figure 11 This embodiment is similar to the medical device 100 described in embodiments 3-6 (refer to...). Figure 2The two are largely the same, and the similarities will not be repeated here. The main difference lies in that the anchoring element 18 includes an anchoring unit 181 and a connecting unit 182 that connects the anchoring unit 181 to the support wire 111. The connecting unit 182 includes a connecting rod 1821 and a connecting block 1822. One end of the connecting rod 1821 passes through a channel (not shown) penetrating both the inner and outer sides of the support wire 111 and connects to the connecting block 1822. The other end connects to the anchoring unit 181. The diameter of the connecting block 1822 is larger than the diameter of the channel where the connecting rod 1821 is located, so that the connecting block 1822 is always located inside the support wire 111, thereby further controlling the anchoring unit 181 to be located outside the support wire 111. The connecting rod 1821 is made of a spring or a metal material with strong restoring ability, such as nickel-titanium wire.

[0082] Furthermore, the support wire 111 is provided with a first receiving groove 1111 that can at least partially accommodate the anchoring unit 181 and a second receiving groove 1112 that can at least partially accommodate the connecting block 1822. Its function is that when the medical device 100 is fully inserted into the sheath and transported in the sheath, the anchoring unit 181 and the connecting block 1822 are respectively at least partially housed in the first receiving groove 1111 and the second receiving groove 1112. This can greatly reduce the sheathing volume and facilitate the overall insertion and transportation of the medical device 100.

[0083] It should be noted that the first receiving groove 1111 and the second receiving groove 1112 are not necessary structures. When the medical device 100 is in a compressed state, since the connecting rod 1821 can slide along its own channel, as the support wire 111 is compressed, the anchoring unit 181 located outside the support wire 111 is also compressed in the direction of the axis of the medical device 100, which drives the connecting rod 1821 to slide a distance along the channel in the direction of the axis, thereby reducing the sheath volume of the medical device 100.

[0084] Furthermore, it should be noted that the connecting block 1822 is not a necessary structure. When the first receiving groove 1111 is present, the connecting rod 1821 can be directly connected to the support wire 111 by welding, bonding or other means to achieve the technical effect of reducing the sheath volume of the medical device 100.

[0085] Example 8

[0086] Please see Figure 12 This embodiment is largely the same as the medical device 100 described in embodiments 3-7. The parts that are the same will not be described again here. The main difference is that the connecting unit 192 is connected to the support wire 111 by entanglement.

[0087] In this embodiment, the main body of the connecting unit 192 can be made of hard metal, hard polymer material or other materials, or it can be made of flexible soft material, such as rod, wire, line or elastic rope structure formed by soft polymer material, inorganic material or flexible metal.

[0088] The connecting unit 192 is wound around the support wire 111 and is fixedly connected to the support wire 111. Alternatively, the connecting unit 192 can slide relative to the support wire 111 along the length direction of the support wire 111. In this embodiment, the connecting unit 192 is wound around the support wire 111 once. In other embodiments, the connecting unit 192 can be wound around the support wire 111 multiple times.

[0089] When the connecting unit 192 is fixedly connected to the support wire 111, in order to enhance the firmness of the connection between the connecting unit 192 and the support wire 111, the connecting unit 192 and the support wire 111 can be fixed again by welding, hot melting, bonding or other methods.

[0090] When the connecting unit 192 can slide relative to the support wire 111 along the length direction of the support wire 111, a limiting unit can be provided on the support wire 111 to prevent the connecting unit 192 from sliding too far on the support wire 111. For example, refer to Figure 13 Two third anchoring units 1113 can be provided on the inner side of the support wire 111 (i.e., the side of the support wire 111 closer to the central axis of the medical device 100 when the medical device 100 is in the deployed state). The two third anchoring units 1113 are respectively located on the proximal and distal sides of the connecting unit 192. In this embodiment, the third anchoring unit 1113 is spherical. In other embodiments, the third anchoring unit 1113 can be rod-shaped, and when the medical device 100 is in the deployed state, the third anchoring unit 1113 extends toward the inner side of the mesh support structure 11, and can be pressed onto the support wire 111 or into a preset receiving cavity on the support wire 111 under the action of radial force. When the radial force is removed, it returns to the state of extending toward the inner side of the mesh support structure 11. The advantage of this arrangement is that the radial compression dimension of the medical device 100 can be further reduced.

[0091] In other embodiments, a tapering region (not shown in the figure) can be provided on the support wire 111 as a limiting unit. The wire diameter of the tapering region is smaller than that of other regions on the support wire 111. When the connecting unit 192 is wound around the tapering region, it can prevent the connecting unit 192 from sliding to other regions on the support wire 111 with larger wire diameters.

[0092] For the connecting unit 192 made of rigid material, when it is fixedly connected to the support wire 111, the anchoring unit can provide better support when it contacts the atrial appendage wall 220. When the connecting unit 192 can slide relative to the support wire 111 along the length of the support wire 111, the left atrial appendage will contract and relax with the heartbeat. The connecting unit 192 can adaptively move with the contraction and relaxation of the atrial appendage, so that the movement of the left atrial appendage will not damage or wear the pectinate muscle 210 and / or the atrial appendage wall 220.

[0093] Example 9

[0094] Please see Figure 14 This embodiment is largely the same as the medical device 100 described in embodiments 3-8, and the similarities will not be repeated here. The main difference is that the anchoring member 24 includes a connecting unit 242 and at least one anchoring unit 241. The anchoring unit 241 is connected to multiple support wires 111 through the connecting unit 242. When the fixing part is in a radially compressed state, the anchoring unit 241 is located inside the mesh support structure 11, or the anchoring unit 241 is at least partially located in the gap between adjacent support wires 111.

[0095] Reference Figure 11 The anchoring unit 241 is connected to the first connecting unit 242a and the first support wire 111a, and is also connected to the second connecting unit 242b and the second support wire 111b. The first connecting unit 242a and the second connecting unit 242b form an angle of 10° to 90°. The connection method of the first connecting unit 242a and the first support wire 111a, and the connection method of the second connecting unit 242b and the second support wire 111b, include one or more of welding, hot melting, entanglement, and bonding.

[0096] The first connecting unit 242a and the second connecting unit 242b described above can be an integral structure, extending through the anchoring unit 241; alternatively, the first connecting unit 242a and the second connecting unit 242b can be separate structures. The anchoring unit 241 is fixedly or movably connected to the first connecting unit 242a and the second connecting unit 242b. In other embodiments, multiple anchoring units 241 can be connected in series on the first connecting unit 242a and the second connecting unit 242b.

[0097] In medical device 100 (reference) Figure 2During radial compression, the anchoring unit 241 is pressed into the gap between the first support wire 111a and the second support wire 111b, and falls into the inner side of the mesh support structure 11; or, during radial compression of the medical device 100, the anchoring unit 241 is only partially pressed into the gap between the first support wire 111a and the second support wire 111b. This reduces the radial dimension of the medical device 100 after compression.

[0098] The first connecting unit 242a and the second connecting unit 242b can be made of hard metals (such as nickel-titanium), hard polymer materials, or flexible soft materials, such as rods, wires, lines or elastic rope structures formed by soft polymer materials, inorganic materials or flexible metals.

[0099] Reference Figure 15 In other embodiments, the anchoring unit 241 can also be connected via a third connecting unit 111c and a third support wire 242c, via a fourth connecting unit 111d and a fourth support wire 242d, via a fifth connecting unit 111e and a fifth support wire 242e, and via a sixth connecting unit 111f and a sixth support wire 242f. The connection methods include one or more of welding, hot melting, entanglement, and bonding.

[0100] The aforementioned third connecting unit 111c, fourth connecting unit 111d, fifth connecting unit 111e, and sixth connecting unit 111f cannot all be made of hard metal, hard polymer materials, or similar materials. At least one of them must be made of a flexible, soft material, such as a rod, wire, thread, or elastic rope structure formed from a soft polymer material, inorganic material, or flexible metal. This ensures that during the radial compression of the medical device 100, the anchoring unit 241 is pressed into the mesh 113 formed by the third connecting unit 111c, fourth connecting unit 111d, fifth connecting unit 111e, and sixth connecting unit 111f, and falls into the inner side of the mesh support structure 11; or, during the radial compression of the medical device 100, the anchoring unit 241 is only partially pressed into the mesh 113. The anchoring unit 241 is connected to two or more support wires 111 in multiple directions through two or more connecting units 242, which can make the force on the anchoring unit 241 more balanced, and ensure that the anchoring unit 241 is pressed into the mesh 113 during the radial compression of the medical device 100.

[0101] Example 10

[0102] Please see Figure 16This embodiment is largely the same as the medical device 100 described in Embodiments 1-9, and the similarities will not be repeated here. The main difference is that in this embodiment, the medical device 300 is a plug-type structure, including a fixing part 30, a membrane body (not shown), and at least one anchoring member 22. The fixing part 30 includes a mesh support structure 31. The membrane body may only cover the proximal portion of the mesh support structure 31, or it may completely cover the entire mesh support structure 31. The membrane body may be disposed inside or outside the mesh support structure 31. The anchoring member 22 may be connected to the mesh support structure 31 and / or the membrane body. The specific shape, structure, and connection method of the anchoring member 22 with the fixing part 30 can be referred to Embodiments 1-9, and will not be repeated here.

[0103] In this embodiment, the aforementioned fixing part 30 not only serves to anchor the medical device 300 but also has a sealing effect. In other embodiments, there is another type of medical device 300, which includes an integral mesh structure with a fixing plate and a sealing plate formed at both ends, and a waist connecting the fixing plate and the sealing plate. Similarly, the anchoring element 22 can be provided on this medical device 300 with reference to any of the above embodiments.

[0104] It is understood that, in addition to the various embodiments described above for use in the left atrial appendage, the medical device can be applied in many different environments. For example, in intracranial aneurysm surgery, an occluder can be used to seal the aneurysm, and the anchoring element in the above embodiments can also be used in conjunction with this occluder. Furthermore, it should be noted that, besides use in medical devices, the anchoring element in the above embodiments can also be applied to various implants such as vascular stents and filters; that is, the structure of the anchoring element is not affected by the structure of the medical device itself.

[0105] For a target cavity whose inner surface does not have a recessed area, under the radial force of the medical device of the present invention, the inner surface of the target cavity will deform to a certain extent in accordance with the shape of the anchor, thereby forming a recessed area, so as to realize that the anchor abuts against the inner surface of the target cavity and realizes the anchoring of the fixing part and the target cavity.

[0106] It should be noted that the technical features of the above embodiments can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments have been described; however, as long as the combination of these technical features does not contradict each other, it should be considered within the scope of this specification.

[0107] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. Furthermore, it should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A medical device, characterized in that, The medical device includes a fixing part with a mesh support structure, and the fixing part is provided with at least one anchoring member. The anchoring member is used to abut against the inner surface of the target cavity after the fixing part is implanted into the target cavity, so as to anchor the fixing part and the target cavity to each other. The anchoring component includes at least one anchoring unit, and the anchoring component further includes a connecting unit that connects the anchoring unit to the fixing part; The anchoring unit includes a first anchoring unit and a second anchoring unit. The connecting unit is provided with a receiving cavity. The second anchoring unit is spherical and can be inserted into the receiving cavity and rotated in multiple directions within the receiving cavity.

2. The medical device according to claim 1, characterized in that, The connecting unit includes a telescopic rod, one end of which is connected to the anchoring unit, and the other end is fixedly connected to the fixing part.

3. The medical device according to claim 1, characterized in that, The mesh support structure includes support wires, and the connecting unit is connected to the support wires by entanglement. The connecting unit is fixedly connected to the support wires, or the connecting unit can slide relative to the support wires along the length direction of the support wires.

4. The medical device according to claim 3, characterized in that, When the connecting unit can slide relative to the support wire along the length direction of the support wire, a limiting unit is also provided on the support wire to which the connecting unit is connected, so as to limit the sliding range of the connecting unit on the support wire.

5. The medical device according to claim 1, characterized in that, The fixing part is provided with a plurality of anchoring units. When the fixing part is in the unfolded state, the plurality of anchoring units are located on a plurality of cross sections of the fixing part; and / or, when the fixing part is in the radially compressed state, the plurality of anchoring units are located on a plurality of cross sections of the fixing part.

6. The medical device according to any one of claims 1 to 5, characterized in that, The anchoring unit is equipped with micro-barbs.

7. A medical device, characterized in that, The medical device includes a fixing part with a mesh support structure, and the fixing part is provided with at least one anchoring member. The anchoring member is used to abut against the inner surface of the target cavity after the fixing part is implanted into the target cavity, so as to anchor the fixing part and the target cavity to each other. The anchoring component includes at least one anchoring unit, and the anchoring component further includes a connecting unit that connects the anchoring unit to the fixing part; The mesh support structure includes support wires, which include a first support wire and a second support wire. The connecting unit includes a first connecting unit and a second connecting unit. The anchoring unit is connected to the first support wire through the first connecting unit and to the second support wire through the second connecting unit. When the fixing part is in a radially compressed state, the anchoring unit is pressed into the gap between the first support wire and the second support wire and falls into the inner side of the mesh support structure.

8. The medical device according to claim 7, characterized in that, The connecting unit includes a telescopic rod, one end of which is connected to the anchoring unit, and the other end is fixedly connected to the fixing part.

9. The medical device according to claim 7, characterized in that, The mesh support structure includes support wires, and the connecting unit is connected to the support wires by entanglement. The connecting unit is fixedly connected to the support wires, or the connecting unit can slide relative to the support wires along the length direction of the support wires.

10. The medical device according to claim 9, characterized in that, When the connecting unit can slide relative to the support wire along the length direction of the support wire, a limiting unit is also provided on the support wire to which the connecting unit is connected, so as to limit the sliding range of the connecting unit on the support wire.

11. The medical device according to claim 7, characterized in that, The fixing part is provided with a plurality of anchoring units. When the fixing part is in the unfolded state, the plurality of anchoring units are located on a plurality of cross sections of the fixing part; and / or, when the fixing part is in the radially compressed state, the plurality of anchoring units are located on a plurality of cross sections of the fixing part.

12. The medical device according to any one of claims 7 to 11, characterized in that, The anchoring unit is equipped with micro-barbs.

13. A medical device, characterized in that, The medical device includes a fixing part with a mesh support structure, and the fixing part is provided with at least one anchoring member. The anchoring member is used to abut against the inner surface of the target cavity after the fixing part is implanted into the target cavity, so as to anchor the fixing part and the target cavity to each other. The anchoring component includes at least one anchoring unit, and the anchoring component further includes a connecting unit that connects the anchoring unit to the fixing part; The mesh support structure includes support wires, which further include a third support wire, a fourth support wire, a fifth support wire, and a sixth support wire. The connecting unit includes a third connecting unit, a fourth connecting unit, a fifth connecting unit, and a sixth connecting unit. The anchoring unit can be connected to the third support wire via the third connecting unit, the fourth support wire via the fourth connecting unit, the fifth support wire via the fifth connecting unit, and the sixth support wire via the sixth connecting unit. During the radial compression of the medical device, the anchoring unit is pressed into the mesh formed by the third, fourth, fifth, and sixth connecting units and falls into the inner side of the mesh support structure.

14. The medical device according to claim 13, characterized in that, The connecting unit includes a telescopic rod, one end of which is connected to the anchoring unit, and the other end is fixedly connected to the fixing part.

15. The medical device according to claim 13, characterized in that, The mesh support structure includes support wires, and the connecting unit is connected to the support wires by entanglement. The connecting unit is fixedly connected to the support wires, or the connecting unit can slide relative to the support wires along the length direction of the support wires.

16. The medical device according to claim 15, characterized in that, When the connecting unit can slide relative to the support wire along the length direction of the support wire, a limiting unit is also provided on the support wire to which the connecting unit is connected, so as to limit the sliding range of the connecting unit on the support wire.

17. The medical device according to claim 13, characterized in that, The fixing part is provided with a plurality of anchoring units. When the fixing part is in the unfolded state, the plurality of anchoring units are located on a plurality of cross sections of the fixing part; and / or, when the fixing part is in the radially compressed state, the plurality of anchoring units are located on a plurality of cross sections of the fixing part.

18. The medical device according to any one of claims 13 to 17, characterized in that, The anchoring unit is equipped with micro-barbs.

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