CN115670562A - Medical device - Google Patents

Abstract

The invention relates to a medical device, which comprises a fixing part and has a compressed state and a self-expanded state, wherein at least one anchoring part is arranged on the fixing part, and the anchoring part is used for clamping in a gap on internal body tissue after the medical device is implanted into the internal body tissue so as to anchor the medical device in the internal body. 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 the gap of the human tissue rather than puncturing the human tissue, so that the damage to the human tissue is avoided, and further the damage and enlargement of the wound 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 auricle occluder needs to have a certain anchoring structure, so that the left auricle occluder can be stably occluded in the left auricle for a long time, and the problems of embolism of instruments and the like caused by falling off of the left auricle occluder 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 atrial appendage moves in a systolic-diastolic manner with the heart, if it is anchored by means of puncture, the anchoring position may cause greater breakage due to the movement of the atrial appendage. Such problems also arise in other body implants, and therefore, there is a need to design an anchoring structure for a medical device that has anchoring stability while avoiding the introduction of sharp tip 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 penetrates the human tissue.

A medical device comprises a fixing part used for fixing the medical device at a preset position, wherein at least one anchoring part is arranged on the fixing part and 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, the fixing part comprises a support rod, and the connecting unit connects the anchoring unit to the support rod.

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

In one embodiment, the connecting unit comprises an axially telescopic rod, one end of the rod is connected with the anchoring unit, and the other end of the rod is fixed on the supporting rod.

In one embodiment, the anchor comprises a connecting rod and a connecting block, the supporting rod is provided with a first channel, the first channel penetrates through the inner side and the outer side of the supporting rod, one end of the connecting rod is connected with the protruding anchor unit, and the other end of the connecting rod penetrates through the first channel and then is connected with the connecting block.

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

In one embodiment, the support rod is provided with a receiving cavity which receives or partially receives the anchoring unit when the medical device is in a compressed state.

In one embodiment, the anchor further comprises a flexible connecting member connecting unit, the supporting rod is provided with at least one hole, the hole penetrates through the inner side and the outer side of the supporting rod, one end of the flexible connecting member connecting unit is movably fixed on the supporting rod after penetrating through the hole, and the convex anchoring unit is fixed on the flexible connecting member connecting unit.

In one embodiment, the fixing part comprises a plurality of the anchoring elements, and at least one of the anchoring elements and the anchoring element adjacent to the anchoring element have different opening angles and/or different horizontal positions.

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 view of a medical device according to embodiment 1 of the present invention;

FIG. 2 is a schematic view showing the structure of an anchor of the medical device according to embodiment 1 of the present invention;

FIG. 3 is a schematic structural view of an anchor of a medical device according to another embodiment of the invention;

FIG. 4 is a schematic structural view of an anchor of the medical device according to embodiment 2 of the present invention;

FIG. 5 is a schematic view of the anchoring member of the medical device of example 3 of the present invention;

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

FIG. 7 is a schematic structural view of an anchor of the medical device according to embodiment 4 of the present invention;

FIG. 8 is an exploded view of an anchor of the medical device of example 4 of the present invention;

FIG. 9 is a schematic view of the anchoring element of the medical device in accordance with embodiment 5 of the present invention;

FIG. 10 is a schematic view of the anchoring member of the medical device of example 6 of the present invention;

FIG. 11 is a schematic view of an alternative angle of the anchoring member of the medical device of example 6 of the present invention;

FIG. 12 is a schematic structural view of an anchor of the medical device of example 7 of the present invention;

FIG. 13 is a schematic view of an alternative angle of the anchoring element of the medical device according to embodiment 7 of the present invention;

fig. 14 is a schematic view of the anchoring member of the medical device of the present invention applied to a first left atrial appendage occluder;

fig. 15 is a schematic view of the anchoring member of the medical device of the present invention applied to a second left atrial appendage occluder;

figure 16 is a schematic view of the anchoring device of the medical device of the present invention applied to a third left atrial appendage occluder;

figure 17 is a schematic view of the anchoring device of the medical device of the present invention applied to a fourth left atrial appendage occluder.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further 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 for any component of the medical device in accordance with this principle.

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

Example 1

As shown in fig. 1, fig. 1 is a schematic structural view of a medical device 100 according to example 1 of the present invention, and the medical device 100 according to this embodiment includes a fixing portion 10 and a sealing portion 20 connected to the fixing portion 10. The sealing portion 20 and the fixing portion 10 are provided at intervals in the 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 a distal plug 21 of the sealing part 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 head 11 of the fixing part and a plurality of support rods 12, and the distal head 21 of the sealing part is connected with the 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. 1, 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 support pole 12 may have an anchor member 13, and the anchor member 13 is typically welded, heat fused, tangled, adhered, etc. to the support pole 12, but it is not excluded that the anchor member 13 is cut directly at the same time as the support pole 12 is cut.

In this embodiment, the anchor 13 includes an anchor unit, preferably a protrusion 131, and a connecting unit, preferably a rod-shaped connecting member 132, wherein one end of the connecting member 132 is connected to the supporting rod 12, 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 clamped or extended into the gap of the pectinate muscle in the left atrial appendage, 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 protrusion 131 should meet a certain condition in size, 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 protrusion 131 is smaller than 1.5mm, the depth of the protrusion 131 clamped into the tissue is insufficient, and the anchoring ability is weak; when the size of the protrusion 131 is larger than 2.5mm, the difficulty of the protrusion 131 to be stuck into the tissue increases, and sometimes the protrusion cannot be stuck into the tissue gap completely. 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 exemplary embodiment, one anchoring element 13 is provided on each support rod 12, i.e. the anchoring elements 13 are distributed uniformly in the circumferential direction on the fastening part 10.

In another embodiment, a plurality of anchoring elements 13 may be disposed on one supporting rod 12 to achieve a better fixing effect, and since the anchoring elements 13 on the same supporting rod 12 have gaps therebetween, which are respectively engaged in the gaps of different pectinate muscles, the mutual interference does not occur.

In another embodiment, the anchoring elements 13 may be distributed on a plurality of supporting rods 12 at intervals, that is, the anchoring elements 13 are not arranged on each supporting rod 12 under the condition of sufficient supporting force, so as to reduce the number of the anchoring elements 13, thereby reducing the overall weight of the medical device 100 and the burden on the human body.

As for the specific structure of the anchor member 13, as shown in fig. 2, fig. 2 is a schematic structural view of the anchor member 13 in embodiment 1 of the present invention. The protrusion 131 is located on the outer side of the support rod 12, and the protrusion 131 extends obliquely outward relative to the support rod 12, taking the side close to the axis of the medical device 100 as the inner side and the side far from the axis as the outer side. The length of the connecting member 132 may be set to 0.2mm-4mm, in a natural state, the opening angle of the connecting member 132 relative to the axis of the medical device 100 is 0-90 °, and if 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 connecting member 132 (i.e., the opening angle of the anchoring member 13) is too small, the protrusions 131 will fit too closely against the support rods 12 and will not be able to snap into the tissue crevices or hold 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 to the anchoring member 13 by the tissue 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 member 13 along the axial direction to be small, thereby causing the anchoring capability of the medical device 100 to be reduced. 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 of the protrusions 131 may be welding, heat setting, hot melting, tangling, etc.

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 support bar 12 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 support shaft 12, and at different angles, so as to avoid excessive stress concentrations during sheath access, i.e., at least one anchoring element 13 may be positioned at a different angle and/or at a different horizontal position relative to the adjacent anchoring elements 13.

In another embodiment, referring to fig. 3, fig. 3 is a schematic structural view of an anchoring device 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 device 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 complications such as pericardial effusion caused by the puncture of the pericardial wall by the micro-puncture structure 133, 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 bonding mode of the micro-puncture structure 133 and the protrusion 131 is preferably an integrated molding mode such as mold and point contact melting, so that excellent bonding strength is ensured, and the bonding strength of the micro-puncture structure 133 and the protrusion 131 needs to be detected in the product preparation process, so that the bonding strength is ensured to be greater than 10N.

Further, since the gap of the pectinate muscle and the auricle wall 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, considering the action of the protrusion 131 with the auricle wall and the pectinate muscle, the micro-prick structure 133 of the protrusion 131 can be regionalized, that is, the micro-prick structure is arranged 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; and the contact surface of the protrusion 131 and the pectinate muscle can be provided with a micro-thorn structure 133 to realize anchoring of the pectinate muscle and enhance the anchoring capability of the medical device 100.

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. In the present embodiment, since the comb-shaped muscles at the left auricle position are in a criss-cross mesh structure, the anchoring elements of the medical device in the present embodiment can be well held by the comb-shaped muscles when being clamped into the gaps between the comb-shaped muscles, and due to contraction and relaxation of the comb-shaped muscles, the anchoring elements that are not completely clamped into the gaps of the comb-shaped muscles will gradually and completely be clamped into the gaps along with the movement of the comb-shaped muscles during the implantation phase, and if there are anchoring units that are not clamped into the gaps during the implantation phase, the anchoring elements will also be adaptively clamped into the gaps along with the movement of the comb-shaped 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 comb-shaped muscles.

Example 2

The medical device of example 2 is different from that of example 1 in that the anchoring unit of the anchor is directly connected to the supporting rod, specifically referring to fig. 4, fig. 4 is a schematic structural view of the anchoring element 14 of example 2 of the present invention, the anchoring element 14 (i.e., the anchoring unit of this example) is disposed on the supporting rod 12 by welding, heat melting, entanglement, bonding, etc., the protruding structure of the anchoring element 14 may be a spherical structure, a hemispherical structure, a conical structure, a polyhedral structure, etc., and the material thereof may be metal, polymer, inorganic non-metal material, etc.

Example 3

Example 3 is provided based on example 1, and the medical device of example 3 differs from example 1 in the arrangement of the anchor of example 3, and referring to fig. 5, fig. 5 is a schematic structural view of the anchor 15 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 151 fail to enter the gaps between the comb muscles, the protrusions 151 press the comb muscles, which have a certain anchoring ability, but only when the protrusions 151 of the anchor 15 protrude or snap into the gaps, have a better anchoring ability. Therefore, in order to increase the probability of the projection 151 of the anchor 15 protruding into or getting caught in the gap, the anchor 15 is provided with a plurality of projections 151 on the same support bar 12.

Anchor 15 includes a flexible connector 152, and flexible connector 152 is connected in series with a plurality of projections 151. Specifically, the flexible connecting member 152 is first connected to the supporting rod 12 by welding, heat melting, twisting, bonding, or the like; or double holes are formed in the supporting rod 12 and then both ends of the flexible connecting member 152 are inserted into the double holes, in general, both ends of the flexible connecting member 152 are fixed to the supporting rod 12 to prevent the protrusion 151 from greatly swinging or moving to the inner side of the supporting rod 12, thereby losing the anchoring ability.

In addition, the relative position of the plurality of protrusions 151 is limited by the flexible connecting piece 152, so that stimulation of the protrusions on the wall of the auricle during contraction and relaxation of the auricle can be effectively reduced, namely, the protrusions 151 can move along with contraction and relaxation of the auricle.

The flexible connector 152 is selected from a wire or an elastic string having high toughness, elasticity and strength. In this embodiment, the flexible connecting member 152 is knotted or melted to form a knot at the end thereof, and the diameter of the knot is larger than the diameter of the hole, so that the flexible connecting member 152 does not separate from the supporting rod 12.

In another embodiment, as shown in FIG. 6, to increase the travel distance of the flexible linkage 162 and to avoid the risk of the knot coming loose, causing the projections 161 to fall into other tissues such as the atrial appendage wall. The ends of the flexible connector 162 may be connected to form a closed structure.

Example 4

Example 4 the arrangement is based on example 1, and the medical device of example 4 is different from example 1 in that the arrangement of the anchor of example 4 is different, and referring to fig. 7, a projection 171 is connected to the support 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. 8, fig. 8 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 medical device according to example 5 is configured based on example 1, and differs from example 1 in that the arrangement of the anchor according to example 5 is different, and referring to fig. 9, fig. 9 is a schematic view showing the structure of the anchor 19 according to example 5 of the present invention, and the anchor 19 includes a protrusion 191 and a connecting member 192 for connecting the protrusion 191 to the support rod 12, wherein the connecting member 192 is a spring structure. Due to the characteristics of the spring, the connecting member 192 can drive the protrusion 191 to move in multiple directions, but at the same time, applies restoring force to the protrusion 191 in the direction of restoring the original shape, so that the heart ear has good anchoring capability all the time when the heart ear contracts and relaxes.

In addition, since the auricle moves in a systolic and diastolic manner along with the pulsation of the heart, the protrusion 191 can be adaptively displaced along with the systolic and diastolic movement 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.

Example 6

Example 6 the arrangement according to example 1 is based on the medical device according to example 6 differing from example 1 in that the arrangement of the anchor according to example 6 is different, with reference to fig. 10-11, fig. 10 is a schematic structural view of the anchor 23 according to example 6 of the present invention; fig. 11 is a structural view showing another angle of the anchor 23 in embodiment 6 of the present invention.

The anchor 23 includes a protrusion 231 and a connecting member 232 for connecting the protrusion 231 to the supporting rod 12, the connecting member 232 includes a connecting rod 2321 and a connecting block 2322, wherein the connecting rod 2321 passes through a channel penetrating through the inner side and the outer side of the supporting rod 12 and is connected to the connecting block 2322, and the diameter of the connecting block 2322 is larger than that of the channel in which the connecting rod 2321 is located, so that the connecting block 2322 is always located at the inner side of the supporting rod 12, thereby further controlling the protrusion 231 to be located at the outer side of the supporting rod 12. The connecting rod 2321 is made of a spring or a metal material with strong restitution capability, such as a nickel-titanium wire.

Further, the supporting rod 12 is provided with a receiving groove 2311 capable of at least partially receiving the protrusion 231 and a receiving groove 2323 capable of at least partially receiving the connecting block 2322, which is used for receiving the protrusion 231 and the connecting block 2322 respectively at least partially in the receiving groove 2311 and the receiving groove 2323 when the medical device is integrally received in the sheath tube and transported in the sheath tube, so that the volume of the medical device can be greatly reduced, and the medical device can be conveniently integrally sheathed and transported.

It should be noted that the receiving grooves 2311 and 2323 are not necessarily configured, and when the medical device is in a compressed state, since the connecting rod 2321 can slide along the channel where the connecting rod 2321 is located, as the supporting rod 12 is compressed, the protrusion 231 located outside the supporting rod 12 is also compressed toward the axial direction of the medical device, so as to drive the connecting rod 2321 to slide along the channel toward the axial direction for a certain distance, thereby reducing the sheathing volume of the medical device.

Further, it should be noted that the connecting block 2322 is not necessarily structured, and the connecting rod 2321 is directly connected to the supporting rod 12 by welding, bonding or the like when the accommodating groove 2311 exists, so that the technical effect of reducing the sheathing volume of the medical device can be achieved.

Example 7

Example 7 the arrangement according to example 1 is based on, the medical device according to example 7 differs from example 1 in the arrangement of the anchor according to example 7, with reference to fig. 12-13, fig. 12 being a schematic structural view of the anchor 24 according to example 7 of the present invention; FIG. 13 is a structural view showing another angle of the anchor member 24 in the embodiment 7 of the present invention;

the anchor member 24 includes a projection 241 and a connecting member 242 connecting the projection 241 to the support rod 12. It should be noted that a through hole 243 is provided in the support rod 12, wherein the diameter of the through hole 243 is larger than the diameter of the projection 241.

When the medical device is wholly put into the sheath and transported in the sheath, the protrusion 241 is pressed into the through hole 243, and at least part of the protrusion 241 is put into the through hole 243, so that the whole sheathing volume of the medical device can be greatly reduced, and sheathing and transportation of the medical device are facilitated.

It should be noted that in other embodiments, the through hole 243 may be configured as a groove structure opening toward the protrusion 241, which also functions to at least partially receive the protrusion 241 when the medical device is in a compressed state. Thus, both the through hole 243 and the groove structure are receiving cavities for receiving or partially receiving the protrusion 241, the receiving cavities receiving or partially receiving the protrusion 241 when the medical device is in a compressed state.

In addition, for the holding cavity, when the diameter of the holding cavity is greater than or equal to the maximum diameter of the protrusion 241, the holding cavity can theoretically receive all the protrusions 241 (when the holding cavity is in a through hole structure or when the holding cavity is in a groove structure with sufficient depth), and the technical effect of optimally reducing the sheathing volume is achieved. However, when the diameter of the accommodating cavity is smaller than the protrusion 241, the accommodating cavity can also partially accommodate the protrusion 241, and the technical effect of reducing the sheathing volume of the medical device can be achieved to a certain extent. Therefore, there may be no limitation on the diameter of the accommodation chamber.

By utilizing 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 pectinate muscles, and due to the structural arrangement of the protrusion, the weak pectinate muscles can not be damaged by the protrusion, and the pericardial effusion caused by puncturing the auricle wall can not be caused. The medical device is fixed at a 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.

In addition to the improvements of the various embodiments described above with respect to the anchor, it should be noted that the anchor can also be adapted to a variety of left atrial appendage occluders, and reference is made to fig. 14-17 which illustrate one application of the anchor to a first left atrial appendage occluder, a second left atrial appendage occluder, a third left atrial appendage occluder, and a fourth left atrial appendage occluder, respectively.

Referring to fig. 14, fig. 14 is a schematic structural view of the anchoring element 33 of the present invention applied to a first left atrial appendage occluder, and when the anchoring element 33 is applied to the first left atrial appendage occluder, the angle of the opening of the axis 2 of the medical device of the anchoring element 33 is the included angle (acute angle) between the straight line of the anchoring element 33 and the axis.

Referring to fig. 15, fig. 15 is a schematic structural view of the anchoring element 43 of the present invention applied to a second left atrial appendage occluder, wherein fig. 15 omits the membrane structure, the membrane structure of the second left atrial appendage occluder is located at the end where the plurality of support rods 12 converge, i.e. the support rods 12 play both a sealing role and a fixing role, and in fact, the proximal end (i.e. the converging end) of the support rods 42 plays a sealing role, the distal end plays a fixing role as a fixing part, and the fixing part includes the support rods 42, so that it can be considered that the second left atrial appendage occluder includes a fixing part, and the anchoring element 43 is located at the side of the fixing part close to the distal end. It is understood that in other embodiments, the plurality of support rods 12 may be connected to each other to form a grid-shaped sidewall, and the plurality of support rods 12 are not limited to being separated from each other except for the end points in the present embodiment. It will also be appreciated that in other embodiments, a plurality of anchors 43 may be interconnected to form a ring anchor around the plurality of support rods 42.

Referring to fig. 16, fig. 16 is a schematic structural view of the anchoring member 53 of the present invention applied to a third left atrial appendage occluder, the anchoring member 53 being disposed on the support rod 52.

Referring to fig. 17, fig. 17 is a schematic structural view of an anchoring member 63 according to the present invention applied to a fourth left atrial appendage occluder, which includes a sealing portion 61 and a fixing portion 62, wherein the fixing portion 62 is provided with a covering membrane 64, and the anchoring member 63 passes through the covering membrane 64 and extends toward the outer side of the left atrial appendage occluder.

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 specific and detailed, but not to be understood 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 part used for fixing the medical device at a preset position, and is characterized in that at least one anchoring part is arranged on the fixing 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.

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, the fixation portion comprising a support rod, the connecting unit connecting the anchor unit to the support rod.

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 connection unit comprises an axially retractable rod, one end of which is connected to the anchoring unit and the other end of which is fixed to the support rod.

6. The medical device of claim 3, wherein the anchor member comprises a connecting rod and a connecting block, the supporting rod is provided with a first channel, the first channel penetrates through the inner side and the outer side of the supporting rod, one end of the connecting rod is connected with the anchoring unit, and the other end of the connecting rod penetrates through the first channel and then is connected with the connecting block.

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

8. The medical device according to any one of claims 3-6, wherein a receiving cavity is provided on the support rod, 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 3, wherein the anchor further comprises a flexible connecting unit, the supporting rod is formed with at least one hole, the hole penetrates through the inner side and the outer side of the supporting rod, one end of the flexible connecting unit is movably fixed on the supporting rod after penetrating through the hole, and the anchor unit is fixed on the flexible connecting unit.

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

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