CN115670561A - Medical device - Google Patents

Abstract

The invention relates to a medical device, which comprises a fixing part for fixing the medical device at a preset position, wherein a covering film is arranged on the surface of the fixing part, the covering film comprises at least one anchoring part, and the anchoring part is used for propping against human tissues after the medical device is implanted at the preset position so as to anchor the medical device at the preset position. According to the invention, by arranging the anchoring piece, after the medical device is implanted into a human body, the anchoring piece is clamped into a gap of human tissue or abuts against the inner wall of the human tissue to realize anchoring instead of puncturing the human tissue, so that the human tissue is prevented from being damaged, and further, the wound damage and enlargement caused by the movement of the human tissue are further avoided. The normal operation of the medical device is realized under the condition of ensuring good anchoring capability.

Description

Medical device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a medical device.

Background

Medical devices, and in particular medical implant devices, generally need to remain in the implanted position for a certain period of time after implantation into the body.

In recent years, stroke due to atrial fibrillation in non-valvular ward fibrillation patients, 90% of which are derived from the left atrial appendage. There are clinical data showing that when atrial fibrillation, the resection of the left atrial appendage during cardiac surgery can reduce the incidence of stroke, which suggests a hazard of the left atrial appendage in thromboembolism. Since the left atrial appendage is the pit for a thrombus, plugging the opening of the left atrial appendage can eliminate the basis for thrombus formation in the left atrial appendage. Generally, the left atrial appendage occluder is used as a medical implant device to occlude the opening of the left atrial appendage, which is an effective way to prevent stroke caused by atrial fibrillation.

In order to effectively block the left auricle, a left auricle blocking device needs to be implanted into the left auricle for a long time so as to realize the blocking effect. Therefore, the left atrial appendage occlusion device needs to have a certain anchoring structure, so that the left atrial appendage occlusion device can be stably occluded at the mouth of the left atrial appendage for a long time, and the problems of embolism of instruments and the like caused by falling of the left atrial appendage occlusion device are avoided.

In order to achieve long-term stability of the left atrial appendage occluder in occlusion of the left atrial appendage, a plurality of anchoring structures with sharp head ends, such as anchors or anchors hooks, are usually disposed on the left atrial appendage occluder support (at the junction of the left atrial appendage occluder and the atrial appendage wall) to penetrate into the atrial appendage wall, thereby achieving long-term implantation stability. However, the anchoring structure with the sharp head end in the shape of the anchor spike or the anchor hook is easy to puncture the wall of the auricle, which causes complications such as hydropericardium and the like, and endangers the life of the patient. Meanwhile, since the auricle moves with the heart in a systolic and diastolic manner, if the anchoring is performed in a puncturing manner, the anchoring position may cause greater breakage due to the movement of the auricle. Such problems also arise in other human implants, and therefore, there is a need to design an anchoring structure for medical devices that has long-term stability of anchoring while avoiding the introduction of sharp-tipped structures.

Disclosure of Invention

In view of the above, there is a need to provide a new medical device for the problem of the prior art that the anchoring structure of the medical device pierces the human tissue to cause injury to the human body.

A medical device comprises a fixing part used for fixing the medical device at a preset position, wherein a covering film is arranged on the surface of the fixing part, the covering film comprises at least one anchor, and the anchor is used for abutting against human tissues after the medical device is implanted at the preset position so as to anchor the medical device at the preset position.

In one embodiment, the anchor comprises at least one anchor unit.

In one embodiment, the anchor further comprises a connecting unit connecting the anchor unit to the cover film.

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

In one embodiment, the anchoring units are positioned on the outer side of the covering film, the anchoring units extend obliquely outwards relative to the covering film, and the opening angle of the anchoring units is 20-60 degrees.

In one embodiment, the anchoring unit is interposed between the fixing portion and the covering membrane, and the covering membrane at the position of the anchoring unit protrudes in a direction away from the axis of the medical device.

In one embodiment, the anchoring unit is provided with micro-thorns.

In one embodiment, a receiving cavity is formed in the covering film, and the receiving cavity receives or partially receives the anchoring unit when the medical device is in a compressed state.

In one embodiment, the receiving cavity comprises a first cavity that at least partially receives the anchoring unit when the medical device is in a compressed state and a second cavity that at least partially receives the connecting unit when the medical device is in a compressed state.

In one embodiment, the covering membrane comprises a plurality of the anchors, at least one of the anchors having a different opening angle and/or a different horizontal position than the anchor adjacent thereto.

According to the medical device provided by the invention, the anchoring piece is arranged, after the medical device is implanted into a human body, the anchoring piece is clamped into a gap of human tissue or abuts against the inner wall of the human tissue to realize anchoring instead of puncturing the human tissue, so that the damage to the human tissue is avoided, and further the damage and enlargement of a wound caused by the movement of the human tissue are avoided. The normal operation of the medical device is realized under the condition of ensuring good anchoring capability.

Drawings

FIG. 1 is a schematic structural view of a medical device according to embodiment 1 of the present invention;

FIG. 2 is a schematic structural view of a main body of a medical device according to embodiment 1 of the present invention;

FIG. 3 is a schematic view of the anchoring member of the medical device of embodiment 1 of the present invention;

FIG. 4 is a schematic structural view of an anchor of a medical device according to another embodiment of the invention;

FIG. 5 is a schematic view of the anchor assembly of embodiment 1 of the medical device of the present invention after implantation;

FIG. 6 is a schematic structural view of an anchor member of the medical device according to embodiment 2 of the present invention;

FIG. 7 is a schematic cross-sectional view of an anchor of the medical device of example 2 of the present invention;

FIG. 8 is a schematic structural view of an anchor of a medical device according to another embodiment of the invention;

FIG. 9 is a schematic view of the anchoring member of the medical device of example 3 of the present invention;

FIG. 10 is a schematic view of the anchoring member of the medical device of example 4 of the present invention;

FIG. 11 is an exploded view of an anchor of the medical device of example 4 of the present invention;

FIG. 12 is a first perspective view schematically showing the structure of the anchor member in embodiment 5 of the present invention;

FIG. 13 is a structural view showing a second perspective of the anchor member in embodiment 5 of the present invention;

fig. 14 is a third perspective structural view of the anchor member in embodiment 5 of the present invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is 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 of the invention and do not limit the invention.

In the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to an operator is generally referred to as the "proximal end", the end farther from the operator is referred to as the "distal end", and the "proximal end" and the "distal end" of any component of the medical device are defined according to this principle. "axial" generally refers to the length of the medical device as it is being delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines both "axial" and "radial" directions of any component of the medical device in accordance with this principle.

The technical solution of the present invention will be further described in detail with reference to specific examples.

Example 1

As shown in fig. 1-2, fig. 1 is a schematic structural view of a medical device 100 according to an embodiment 1 of the present invention, and fig. 2 is a schematic structural view of a main body 200 of the medical device 100 according to the embodiment 1 of the present invention, the medical device includes the main body 200, the main body 200 includes a fixing portion 10 and a sealing portion 20 connected to the fixing portion 10, the fixing portion 10 is covered with a coating film 30, and the sealing portion 20 and the fixing portion 10 are spaced apart from each other in an axial direction of the medical device 100. 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 collapsed state housed within the sheath for delivery, and an expanded state extending from the distal end of the sheath and self-expanding and deployed as shown in fig. 1. The configuration of medical device 100 after release in the left atrial appendage cavity is identical or substantially identical to that of fig. 1.

The sealing part 20 can be formed by weaving a plurality of woven wires into a net tube, and the two ends of the net tube close and fix the ends of the woven wires through the bolt heads 21 at the far ends of the sealing part 20 respectively. The mesh tube is then heat set into a disc, cylinder or plug shape, etc., to obtain the seal 20 for sealing the left atrial appendage opening. The interior of the sealing portion 20 may be provided with at least one film body (not shown) whose edges are fixed to the woven filaments at the edges of the sealing portion 20. The membrane serves to prevent blood flow from one side of the seal 20 to the other, preventing blood flow communication between the left atrial appendage and the left atrium.

The fixing part 10 comprises a bolt head 11 of the fixing part and a plurality of support rods 12, and a distal bolt head 21 of the sealing part is connected with the bolt head 11 of the fixing part through a connecting piece 30. The support rod 12 of the fixing portion 10 may be a rod obtained by cutting a metal alloy tube or a polymer tube, or may be a rod made of a braided wire by braiding, winding, or the like.

As shown in fig. 2, the proximal ends of the plurality of support rods 12 are connected to the head 11 of the fixing portion, and the distal ends thereof extend radially outward from the central end portion and turn toward the sealing portion, thereby forming a support surface for contacting and supporting the wall of the left atrial appendage.

The anchor 13 is provided on the film 30, the material of the film 30 may be a polymer material, or an inorganic material or a metal material, and generally, the anchor 13 is provided on the film 30 by means of heat fusion, entanglement, adhesion, or the like.

In the present embodiment, the anchor 13 includes an anchor unit, preferably a protrusion 131, and a connecting unit, which is a rod-shaped connecting member 132, and one end of the connecting member 132 is connected to the covering film 30, and the other end is connected to the protrusion 131. The protrusion 131 may be in a spherical, hemispherical, cylindrical, conical, polyhedral, etc. structure, as long as it is ensured that the protrusion 131 can be snapped into or extend into the gap of the pectinate muscle in the left atrial appendage, i.e., the specific shape of the protrusion 131 should not be a limitation of its own.

In this embodiment, the protrusion 131 is spherical, so that when the protrusion 131 is inserted into or extends into the gap of the pectinate muscle in the left auricle, the pectinate muscle is not damaged due to the existence of the tip. The anchoring elements 13 reduce or prevent complications such as pericardial effusion from occurring as they do not puncture or abrade the left atrial appendage wall when securing the medical device 100 in the occluded position.

Since the protrusion 131 actually acts on the pectinate muscle in the left atrial appendage, the size of the protrusion 131 should meet a certain condition, specifically, the maximum size (diameter) of the protrusion 131 is between 0.1mm and 3mm, and preferably 1.5mm to 2.5mm, it should be noted that, when the size of the protrusion 131 is less than 1.5mm, the depth of the protrusion 131 clamped into the tissue is insufficient, and the anchoring capability is weak; when the size of the protrusion 131 is larger than 2.5mm, the difficulty of the protrusion 131 to be caught in the tissue is increased, and sometimes, the protrusion cannot be completely caught in the tissue gap. In summary, the protrusion 131 is generally about 2mm in size. .

In addition, the protrusion 131 may be made of metal, polymer or inorganic non-metal material, or soft material such as silica gel or wire.

In the present embodiment, the support rod 12 divides the coating film 30 into a plurality of regions, and the plurality of protrusions 131 are respectively distributed at the middle position of each region, that is, the anchors 13 are uniformly distributed on the surface of the coating film 30 in the circumferential direction.

In another embodiment, the film 30 is provided with a plurality of anchoring elements 13 not only along the circumferential direction, but also axially distributed with a plurality of anchoring elements 13, that is, each region is distributed with more than one protrusion 131, so as to obtain better fixing effect for the medical device 100, and since the anchoring elements 13 are provided with gaps, which are respectively clamped into the gaps of different comb-shaped muscles, the mutual interference can not occur.

In another embodiment, the struts 12 divide the covering membrane 30 into multiple regions, and the anchoring elements 13 are distributed at intervals on the multiple regions of the covering membrane 30, i.e., the number of anchoring elements 13 is reduced under the condition of sufficient supporting force, so that the overall weight of the medical device 100 is reduced, and the burden on the human body is reduced.

As for the specific structure of anchor member 13, as shown in fig. 3, fig. 3 is a schematic view of the structure of anchor member 13 in embodiment 1 of the present invention. With the side near the axis of the medical device 100 being the inside and the side away from the axis being the outside, the protrusions 131 are located on the outside of the cover film 30, and the protrusions 131 extend obliquely outward relative to the cover film 30. The length of the connecting member 132 may be set to 0.2mm to 4mm, and in a natural state, the opening angle of the connecting member 132 relative to the axis of the medical device 100 is 0 to 90 °, and when the length of the connecting member 132 is too long, the anchoring member 13 may not completely enter the tissue gap, thereby affecting the implantation diameter of the medical device 100 and the fit degree with the human tissue, and also causing the medical device 100 to be difficult to sheath; while the opening angle of the connector 132 (i.e., the opening angle of the anchor 13) is too small, the protrusion 131 fits too closely to the cover film 30 and cannot be snapped into the tissue gap or against the tissue; the too large opening angle of the connecting member 132 not only makes the sheathing of the medical device 100 difficult, but also causes the force applied by the tissue to the anchoring element 13 to be along the direction of the connecting member 132 after the protrusion 131 is stuck into a tissue gap or abuts against the tissue, and at this time, the too large opening angle of the connecting member 132 causes the component force of the anchoring element 13 in the axial direction to be reduced, thereby causing the reduction of the anchoring capability of the medical device 100. Therefore, in the present embodiment, the length of the connecting member 132 is preferably 0.5 to 2mm, and the opening angle is preferably 20 ° to 60 °.

Further, the connecting member 132 may be made of hard materials such as hard metal rods and hard polymer rods, and the connecting member 132 may also be made of flexible soft materials, such as rods, wires or elastic ropes formed of polymers, inorganic materials or flexible metals, in order to better adapt to the comb-shaped muscle structures with different shapes and depths. The combination mode of the protrusions 131 can be welding, heat setting, hot melting, tangling and the like.

In another embodiment, anchor 13 includes a projection 131 and a connector 132 connecting projection 131 to the cover film 30, wherein connector 122 is an elastic member. Due to the characteristics of the elastic member, the connecting member 122 can drive the protrusion 121 to move in multiple directions, but also can apply restoring force to the protrusion 121 in the direction of recovering, so that the good anchoring capability is always provided when the auricle contracts and relaxes.

In addition, since the auricle moves in the systolic and diastolic directions in accordance with the pulsation of the heart, the protrusion 121 can be adaptively displaced in accordance with the systolic and diastolic directions of the auricle, so that the pectinate muscle and/or the wall of the auricle is not damaged or abraded by the movement of the auricle.

For the present embodiment, the plurality of anchors 13 are arranged such that their protrusions 131 are located at the same level or at the same distance or at the same angle from the covering membrane 30 of the medical device 100. In order to facilitate sheath access, in other embodiments, the protrusions 131 of the plurality of anchoring elements 13 may be positioned at different levels, at different distances from the axis of the medical device 100, and at different angles, so as to avoid the problem of excessive stress concentrations during sheath access, i.e., at least one anchoring element 13 and adjacent anchoring elements 13 having different opening angles and/or different horizontal positions.

In another embodiment, referring to fig. 4, fig. 4 is a schematic structural view of an anchoring element 13 according to another embodiment of the present invention, in order to increase friction between the occluding device and the atrial appendage and stability of anchoring, a micro-piercing structure 133 may be disposed on the convex outer surface of the anchoring element by adhesion, laser cutting, melting, welding, or the like. When the protrusions 131 interact with the comb muscles, the micro-piercing structures 133 may be pierced into the comb muscles. In order to prevent the pericardial effusion and other complications caused by the puncture of the micro-puncture structure 133 on the wall of the auricle, the length of the micro-puncture structure 133 should be less than 1mm, and the preferred embodiment is 0.2-0.8mm. In order to avoid complications such as embolism caused by falling off of the micro-puncture structure 133 during sheath entering and exiting and implantation, the micro-puncture structure 133 and the protrusion 131 are preferably integrated by using a mold and point contact melting, so that excellent bonding strength is ensured, and the bonding strength between the micro-puncture structure 133 and the protrusion 131 needs to be detected in the product preparation process, so that the bonding strength is more than 10N.

Further, since the gap and the auricle wall of the pectinate muscle are in a concave shape, that is, the bottom of the gap is the auricle wall, in order to reduce the stimulation to the auricle wall in consideration of the action of the protrusion 131 with the auricle wall and the pectinate muscle, the micro-prick structure 133 of the protrusion 131 may be regionalized, that is, the micro-prick structure is disposed at the proximal end and the distal end region of the protrusion 131 contacting the auricle wall, while the region of the protrusion 131 contacting the outer side of the auricle wall is kept smooth. Specifically, the contact surface of the protrusion 131 and the atrial appendage wall is polished, coated with a biocompatible and smooth coating, so that the surface is smooth and does not irritate the atrial appendage wall; while the contact surface of the protrusion 131 and the pectinate muscle can be provided with a micro-thorn structure 133, so as to realize anchoring of the pectinate muscle and enhance the anchoring capability of the medical device 100.

It should be noted that, referring to fig. 5, fig. 5 is a schematic view of the operation of the anchoring element 13 after the medical device 100 is implanted according to embodiment 1 of the present invention, since the covering film 30 is of a flexible structure, when the medical device 100 is completely implanted, the protrusions 131 are clamped in the comb-shaped muscles, no matter whether the free ends of the protrusions 131 contact the wall of the left atrial appendage, the protrusions 131 serve as anchoring, the protrusions 131 are stressed by the comb-shaped muscles (or the combined action force of the comb-shaped muscles and the wall of the left atrial appendage), the stress is transmitted to the contact position of the covering film 30 and the connecting element 132 along the connecting element 132, and the contact position of the covering film 30 and the connecting element 132 is driven to move toward the axial direction of the medical device 100, so that a recessed area is formed at the contact position of the connecting element 132 and the covering film 30 by being pressed, and meanwhile, in order to compensate the stress at the contact position of the connecting element 132 and the covering film 30 (toward the axial direction of the medical device 100), the direction of the internal stress of the edge portion is far away from the axial direction of the medical device 100, that is close to the wall of the left atrial appendage. Therefore, the edge portion of the depressed region abuts against the inner wall of the left atrial appendage structure (including the comb-shaped muscle), resulting in a superior secondary sealing effect of the covering membrane 30.

Further, since the connection position of the connection member 132 and the coating film 30 is located at the center of the recessed area, if a small hole needs to be formed on the surface of the coating film by means of a sewing thread or the like, so that the coating film 30 is damaged, the small hole portion of the coating film 30 is located at the center of the recessed area, and the edge of the recessed area ensures the auxiliary sealing effect of the coating film 30.

It should be noted that, if the connecting element 132 is a flexible rope structure, the protrusion 131 will directly press against the film 30 to form a concave structure, and on this basis, the protrusion 131 is under the stress action of the pectinate muscle (or the combined force action of the pectinate muscle and the wall of the left atrial appendage), and the stress is transmitted to the surface of the film 30 along the protrusion 131 to form a concave structure, which can achieve the same technical effect.

It should be noted that, in addition to avoiding the introduction of the sharp-pointed end structure, the medical device 100 in this embodiment has other technical effects, since the comb-shaped muscle generates contraction and relaxation movements along with the heart movement, the solution of anchoring by using the barb (i.e. the sharp-pointed end) is easy to cause the problem of penetrating too deep into the wall of the left atrial appendage and even penetrating the wall of the left atrial appendage, and inevitably, the wound at the penetrating position is enlarged due to the movement, resulting in the reduction of the anchoring capability. As for the present embodiment, since the pectinate muscles at the position of the left atrial appendage are in a criss-cross mesh structure, the anchoring elements of the medical device in the present embodiment can be well held by the pectinate muscles when being clamped into the gaps between the pectinate muscles, and due to contraction and relaxation of the pectinate muscles, the anchoring elements that are not completely clamped into the gaps of the pectinate muscles will gradually and completely be clamped into the gaps along with the movement of the pectinate muscles in the implantation stage, and if there are anchoring units that cannot be clamped into the gaps in the implantation stage, the anchoring elements will also be adaptively clamped into the gaps along with the movement of the pectinate muscles, that is, the medical device in the present embodiment further and adaptively increases the anchoring capability after implantation, and maintains the good anchoring capability in cooperation with the contraction and relaxation of the pectinate muscles.

Example 2

The medical device of example 2 differs from example 1 in that the anchoring unit of the anchor is directly located on the surface of the covering membrane, specifically referring to fig. 6-7, fig. 6 is a schematic structural view of the anchor 14 in example 2 of the present invention, fig. 7 is a schematic sectional view of the anchor 14 in example 2 of the present invention, the anchor 14 (i.e., the anchoring unit of the present embodiment) is disposed on the covering membrane 30 by heat fusing, entangling, bonding, or the like, in the present embodiment, the heat fusing is selected, and the protruding structure of the anchor 14 may be a spherical structure, a hemispherical structure, a conical structure, a polyhedral structure, or the like, and the material thereof may be a metal, a polymer, an inorganic non-metal material, or the like.

In another embodiment, referring to fig. 8, fig. 8 is a schematic view of the anchor assembly 15 of a medical device according to another embodiment of the present invention, wherein the anchor assembly 15 is positioned between the shaft 12 and the film 30, and the film 30 is tightly adhered to the surface of the anchor assembly 15 to form a convex structure, thereby performing the anchoring function.

Example 3

Example 3 is configured based on example 1, and the medical device of example 3 differs from example 1 in that the connecting unit and the anchoring unit of the anchor of example 3 are configured differently, and referring to fig. 9, fig. 9 is a schematic structural view of the anchor 16 of example 3. It should be clear that the structure of the comb muscles is complex and the distribution of the gaps is not uniform, and that in general, when the protrusions 161 fail to enter the gaps between the comb muscles, the protrusions 161 press the comb muscles, which have a certain anchoring ability, but only when the protrusions 161 of the anchoring elements 16 protrude or snap into the gaps, a better anchoring ability is obtained. Thus, to increase the probability that the projections 161 of the anchor 16 will protrude or snap into the gap, a single anchor 16 includes a plurality of projections 161.

Anchor 16 includes a flexible connector 162, and flexible connector 162 is connected in series with a plurality of projections 161. Specifically, the flexible connecting member 162 is first connected to the supporting rod 12 by welding, heat melting, twisting, bonding, or the like; alternatively, a double hole may be formed in the position of the membrane 30, and then both ends of the flexible connecting element 162 may be passed through the double holes, respectively, in which both ends of the flexible connecting element 162 are generally fixed to the membrane 30 to prevent the protrusions 161 from swinging significantly and losing the anchoring ability, and further, both ends of the flexible connecting element 162 may be passed through the holes of the membrane 30 and connected to the inside of the membrane 30, or one end of the flexible connecting element 162 may be passed through the hole of the membrane 30 and tied to fix the flexible connecting element 162 to the membrane 30 movably.

In addition, the relative position of the plurality of bulges 161 is limited by the flexible connecting piece 162, so that the stimulation of the bulges on the wall of the auricle during the contraction and relaxation of the auricle can be effectively reduced, namely, the bulges 161 can move along with the contraction and relaxation of the auricle.

The flexible connecting member 162 is made of a wire or an elastic rope having high toughness, elasticity and strength. In this embodiment, the end of the flexible connecting member 162 is knotted or melted to form a knot, and the diameter of the knot is larger than the diameter of the hole, so that the flexible connecting member 162 does not separate from the supporting rod 12.

In another embodiment, to increase the travel distance of the flexible connector 162 and to avoid the knot loosening, the risk of the projection 161 falling into other tissues such as the wall of the auricle is created. The ends of the flexible connector 162 may be connected to form a closed structure.

Example 4

Example 4 the medical device of example 4 is configured based on example 1, and differs from example 1 in that the connecting unit and the arrangement of the anchoring unit of the anchor of example 4 are different, and referring to fig. 10, a protrusion 171 is connected to a supporting rod 12 by a connecting member 172.

To further illustrate the combination manner of the protrusion 171 and the connecting member 172, referring to fig. 11, fig. 11 is an exploded view of the anchor 17 of embodiment 4, the anchor 17 includes the protrusion 171 and the connecting member 172, the protrusion 171 includes a first protrusion 1711 and a second protrusion 1712, the proximal end of the connecting member 172 is provided with a receiving cavity 1721, wherein the receiving cavity 1721 is used for receiving the second protrusion 1712, the second protrusion 1712 is spherical, the second protrusion 1712 is clamped into the receiving cavity 1721 and can rotate in multiple directions in the receiving cavity 1721, and the diameter of the second protrusion 1712 is larger than the opening diameter of the receiving cavity 1721, so that the second protrusion 1712 cannot be separated from the receiving cavity 1721 in the direction of the connecting member 172 but can rotate freely in the receiving cavity 1721.

The second protrusion 1712 can drive the first protrusion 1711 to rotate relative to the connecting member 172 along multiple directions, so as to reduce the damage of the anchoring member end to the wall of the auricle and the pectinate muscle during the contraction and relaxation of the auricle.

Example 5

Example 5 the arrangement is based on example 1, and the medical device of example 5 is different from that of example 1 in that the arrangement of the connecting unit and the anchoring unit of the anchor of example 5 is different, referring to fig. 12-14, fig. 12 is a first perspective structural view of the anchor 18 in example 6 of the present invention; FIG. 13 is a structural view showing a second perspective of the anchor member 18 in embodiment 6 of the present invention; fig. 14 is a third perspective view schematically showing the anchor member 18 according to embodiment 6 of the present invention.

The anchor 18 includes a protrusion 181 and a connecting member 182 for securing the protrusion 181 to the membrane 30, the connecting member 182 includes a first link 1821 and a second link 1822, and in this embodiment, the connecting member 182 is an elastic member, and the connecting member 182 supports the protrusion 181 in a natural state.

The surface of the coating film 30 is provided with the receiving groove 233, and the receiving groove 233 includes a first groove 2331 corresponding to the protrusion 181 and a second groove 2332 corresponding to the connecting member 182, and it should be noted that the receiving groove 233 may be a through groove penetrating through the coating film 30.

When the medical device is wholly put into the sheath and transported in the sheath, the protrusion 181 is pressed into the accommodating groove 233, and at least part of the protrusion 181 is accommodated into the accommodating groove 233, so that the whole sheathing volume of the medical device can be greatly reduced, and sheathing and transportation of the medical device are facilitated. Most importantly, because the receiving groove 233 partially receives the projection 181, it effectively provides a stop for the projection 181, which also prevents the projection 181 from binding with other structures of the medical device.

Furthermore, for the receiving groove 233, when the diameter of the receiving groove 233 is greater than or equal to the maximum diameter of the protrusion 181, the receiving groove 233 can theoretically receive all the protrusions 181 (when the receiving cavity is a through hole structure or when the receiving cavity is a groove structure with sufficient depth), which achieves the optimal technical effect of reducing the volume of the sheathing. However, when the diameter of the receiving groove 233 is smaller than the protrusion 181, the receiving groove 233 can partially receive the protrusion 181, and the technical effect of reducing the sheathing volume of the medical device can be achieved. Therefore, there may be no limitation on the diameter of the receiving cavity.

By using the medical device of the embodiment, after the medical device is released from the sheath tube, the protrusion is clamped into the gap between the comb-shaped muscles, and due to the structural arrangement of the protrusion, the weak comb-shaped muscles cannot be damaged by the protrusion, and the pericardial effusion caused by puncturing the auricle wall is avoided. The medical device is fixed at the preset position by means of the gaps among the pectinate muscles, so that the medical device is ensured to have good anchoring capability under the condition of avoiding or greatly reducing the damage to the preset implantation position, and then the normal plugging function is realized.

It should be noted that the protrusion is not the only expression form of the anchoring unit, and the anchoring unit may be configured in various structural forms such as a ring, an umbrella, a disc, a radial shape, etc., as long as it is ensured that the anchoring unit can be adaptively clamped into or extend into a gap in the human tissue or abut against the human tissue. In addition, the technical features of the above embodiments can be combined arbitrarily, and can also be applied to the various left atrial appendage occluders described above and the left atrial appendage occluders with similar structures. For the sake of brevity, all possible combinations of features in the above-described embodiments will not be described, but rather, the scope of the description should be construed as broadly as the claims, so long as there is no contradiction between the combinations of features.

In addition to the various embodiments described above for use in the left atrial appendage, it should also be noted that medical devices can be used in a number of different environments, such as, for example, in intracranial aneurysm surgery, where an aneurysm can be occluded using an occluding device, and the anchors of the embodiments described above can also be used with such occluding devices. Furthermore, it should be noted that the anchor of the above embodiments can be applied to various implants such as vascular stents, filters, etc., in addition to being used in medical devices, that is, the structure of the anchor is not affected by the structure of the medical device itself.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims (10)

1. A medical device comprises a fixing portion used for fixing the medical device at a preset position, wherein a covering film is arranged on the surface of the fixing portion, and the covering film comprises at least one anchoring piece which is used for propping against human tissues after the medical device is implanted at the preset position so as to anchor the medical device at the preset position.

2. The medical device of claim 1, wherein the anchor comprises at least one anchor unit.

3. The medical device of claim 2, wherein the anchor further comprises a connecting unit connecting the anchor unit to the covering membrane.

4. The medical device of claim 3, wherein the anchoring unit is rotatably connected to the connection unit.

5. The medical device of claim 3, wherein the anchoring unit is located outside the covering membrane and extends obliquely outward relative to the covering membrane, and the expansion angle of the anchoring unit is 20 ° -60 °.

6. The medical device of claim 3, wherein the anchoring unit is interposed between the fixing portion and the covering membrane, the covering membrane at the position of the anchoring unit projecting in a direction away from an axis of the medical device.

7. The medical device according to any one of claims 2-6, wherein the anchoring unit is provided with micro-spikes.

8. The medical device according to any of claims 3-6, wherein a receiving cavity is provided on the cover, said receiving cavity receiving or partially receiving the anchoring unit when the medical device is in a compressed state.

9. The medical device of claim 8, wherein the receiving cavity comprises a first cavity that at least partially receives the anchoring unit when the medical device is in a compressed state and a second cavity that at least partially receives the connecting unit when the medical device is in a compressed state.

10. The medical device of claim 3, wherein said covering membrane comprises a plurality of said anchors, at least one of said anchors having a different angle of opening and/or a different horizontal position than an adjacent anchor.

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