Implantable device with retractable anchoring structure

Abstract

The present invention relates to the field of medical devices, and in particular to an implantable device with a retractable anchoring structure. The implantable device comprises a support frame body, the support frame body at least comprises an anchoring portion, the anchoring portion comprises one or more repeated anchoring units, wherein the anchoring unit comprises a tissue contact portion and a connecting portion; the distal end portion of the tissue contact portion can form a hanging anchor with the cavity tissue; when the anchoring unit is subjected to radial compression, the connecting portion undergoes elastic deformation and drives the tissue contact portion to retract inwardly toward the radial center relative to the support frame body, thereby forming a non-puncture or low-puncture effect on the tissue contacted by the anchoring portion.

Description

Technical Field

[0001] The invention belongs to the field of medical devices, and in particular relates to an implant device with a retractable anchoring structure. Background Art

[0002] At present, atrial fibrillation (AF) is the most common persistent or paroxysmal arrhythmia, with a global incidence of about 2% of the total population. There are about 10 million AF patients in my country, and the prevalence increases with age, with the incidence rate of people over 65 years old as high as 84%. AF is the main risk factor for cardiac death and all-cause death. Chronic AF is prone to form left atrial mural thrombus, causing peripheral arterial thromboembolism. If the thrombus breaks off and enters the blood circulation, it will lead to complications such as stroke, peripheral vascular and organ embolism. At the same time, studies have shown that AF can easily form thrombus in the left atrial appendage after causing hemodynamic disorders, which is an independent risk factor for stroke and seriously endangers human health. Studies in recent years have shown that the risk of ischemic stroke caused by atrial fibrillation can be effectively prevented by blocking the left atrial appendage.

[0003] Patent CN110522486A provides an occluding stent for left atrial appendage, wherein the occluding stent comprises a mesh body and a tail connected to the mesh body, and the tail is folded inwardly into a blunt shape, which increases the contact area between the tail and the left atrial appendage, prevents the tail end of the stent from damaging the left atrial appendage wall and internal tissues during and after implantation, reduces the harm caused by the operation to the patient, and can also avoid risks such as pericardial effusion and perforation, making the operation safer. In addition, the tail is composed of a plurality of axially arranged tendons, and one end of all the tendons is folded inwardly into a blunt shape and then connected to the mesh body, and the other end of the tendon passes through the mesh body and protrudes from the outer surface of the mesh body to form an anchoring thorn, so that the operability of the occluder is also better. In the case where the implantation position is not ideal, the occluder can only be advanced to adjust the implantation position, thereby reducing the difficulty of operation and improving the medical effect. However, the anchoring thorn can easily cause vascular damage during the release of the stent.

[0004] Patent CN112022260A provides an implant device with a bionic micro-thorn attachment structure, which at least includes an attachment frame, which is a self-expanding stent or a ball-expanding stent. The attachment frame includes multiple skeletons and multiple bionic micro-thorn attachment structures. The bionic micro-thorn attachment structure is arranged on the outer surface of the skeleton. The shape of the bionic micro-thorn attachment structure is to imitate the sparse micro-thorns on the surface of plants. The bionic micro-thorn attachment structure includes thorn roots and micro-thorns. The micro-thorns are composed of a thorn body and a thorn tip. The micro-thorns are linear or J-shaped or a combination of the two. When the thorn body and / or the thorn tip of the micro-thorn contacts the cavity tissue, adaptive bending deformation can occur, which is conducive to the micro-thorn to attach to the cavity cavity tissue without loss, and enhance its attachment anchoring function. Although this design improves the overall anchoring of the stent, during the release of the stent, due to the large number of micro-thorns on the stent, the stimulation of the stent to the multi-vascular wall is increased, which is easy to cause postoperative complications. In addition, when entering and exiting the sheath, the J-shaped thorns are very likely to hook each other and cannot be unfolded to form an adverse event of effective anchoring.

[0005] Patent CN205758648U provides a left atrial appendage occluder, including a sealing disc, a mesh anchoring device and a thin film body connected to each other, wherein the anchoring device extends from the sealing disc to the distal end to form a conical portion with a distal opening, and the conical portion rolls up to the proximal end and then extends toward the proximal end to form an anchoring portion. The thin film body is fixed on at least part of the outer surface of the anchoring portion, and partially or completely covers the distal opening. The thin film body is arranged on the anchoring device to constrain the deformation of different parts thereof, and correspondingly improve the radial support force of the occluder to prevent the occluder from falling off after implantation. The anchoring portion has barbs, and the suspended end of the barbs faces the sealing disc, but the barbs can easily scratch the inner wall of the left atrial appendage cavity, causing postoperative complications.

[0006] Therefore, how to reduce or avoid the stimulation of the anchoring structure on the implant to the blood vessel wall, or even the puncture of the cavity wall, leakage of blood and other tissue fluids, and other postoperative complications after implantation has become a problem that needs to be solved urgently. Summary of the invention

[0007] The purpose of the present invention is to overcome the shortcomings of the prior art and provide an implant device with a retractable anchoring structure for patients with atrial fibrillation who require interventional treatment. The present invention solves the problem of micro-puncture of the implant during the release process to stimulate the blood vessel wall, improves the anchoring effect, and reduces the chance of postoperative complications.

[0008] The object of the present invention is achieved through the following solutions:

[0009] An implant device with a retractable anchoring structure comprises a support frame body, the support frame body comprises at least an anchoring portion, the anchoring portion comprises one or more repeated anchoring units, wherein the anchoring unit comprises a tissue contact portion and a connecting portion; the distal end portion of the tissue contact portion can form a hanging anchor with the cavity tissue; when the anchoring unit is subjected to radial compression, the connecting portion undergoes elastic deformation and drives the tissue contact portion to retract inwardly toward the radial center relative to the support frame body, thereby forming a non-puncture or low-puncture effect on the tissue contacted by the anchoring portion.

[0010] The purpose of the present invention can be further achieved by the following technical solutions:

[0011] In one embodiment, the anchoring portion further includes a limiting portion, which is used to limit the relative position of the anchoring unit in the anchoring portion; the outer side or the inner side of the outer surface of the support frame body has one or a combination of an extended area and a retracted area; wherein, when the anchoring unit is subjected to radial compression, the connecting portion is always in the retracted area, and the distal part of the tissue contact portion is always in the extended area.

[0012] In one embodiment, when the anchoring unit is an elastic anchor, the retracted area is located on the inner side, the extended area is located on the outer side, one end of the anchoring unit is fixedly connected to the limiting portion, and the other end of the anchoring unit is freed to form a retractable anchoring structure.

[0013] In one embodiment, when the anchor is subjected to radial compression, the connecting portion undergoes elastic deformation and forms an extended body with the limiting portion in the retracted area. The extended body is always located in the retracted area. The extended body may have sufficient space to accommodate the deformation of the anchor, providing sufficient movement space for the connecting portion and preventing the anchor from scratching the tissue.

[0014] In one embodiment, the anchor barbs are made of elastic material, and are in a straight line, curved, J-shaped, folded, hooked, or a combination of the five; one or more circles of anchor barbs are circumferentially arranged around the surface of the support frame body.

[0015] In one embodiment, when the anchoring unit is a spring sheet structure, the retracted area and the extended area are both located on the outside, and the retracted area and the extended area overlap; and one end of the spring sheet structure is fixedly connected to the limiting portion, and the other end of the spring sheet structure is free to face the outside of the support frame body and extends obliquely along the proximal end of the support frame body.

[0016] In one embodiment, with the central axis of the support frame body as the center, the spring sheet structure can radially close together or spread out or bend to adapt to the irregular shape of cavity tissue; and the spring sheet structure includes a stress buffer structure, the shape of the stress buffer structure is a corrugated shape or a "v" shape or an "s" shape, and the spring sheet structure is made into one piece with the support frame by weaving, laser engraving or welding.

[0017] In one embodiment, a protective structure is provided in the distal region of the tissue contact portion, and the protective structure includes a ball head and a folded structure.

[0018] In one embodiment, if Figure 3h~3k As shown, the connecting portion and the tissue contact portion are in a folded shape, a circular shape, a hook shape, or a combination of the three; wherein the connecting portion can form a rotation angle around the limiting portion and toward the tissue contact portion.

[0019] In one embodiment, if Figure 3h~3k As shown, the support frame body includes a blocking member, which is used to limit the rotation angle; and the blocking member is a hole groove or the blocking member is integrally formed with the support frame body by laser engraving or the blocking member is attached to the support frame body; wherein, when the blocking member is a hole groove, the connecting part can freely enter and exit the hole groove.

[0020] In one embodiment, if Figure 3c As shown, when the retractable anchoring structure is in a natural state, the distal end of the tissue contact portion is located in the extended area and in the proximal area of ​​the blocking member, and the distal end of the tissue contact portion is parallel to the axis of the support frame body or naturally faces the retracted area; when the retractable anchoring structure is loaded into the conveying system, the distal end of the tissue contact portion is located inside the three-dimensional space surrounded by the support frame body.

[0021] In one embodiment, if Figure 3h~3k As shown, when the anchor is in a natural state, the connecting portion is located on the proximal side, the distal side, and the inner side of the limiting portion; the tissue contact portion is located on the outer side; and when the anchor has a rotation angle, the connecting portion located on the distal side and part of the connecting portion located on the inner side can be transformed to the outer side.

[0022] In one embodiment, after the connecting parts of the anchor barbs are squeezed against each other and rotated toward the tissue contact part, the distal end of the anchor barbs can smoothly enter the sheath without scraping the sheath wall. Figures 4a to 4d shown.

[0023] In one embodiment, the implant device is a left atrial appendage occluder, which includes a filling portion and an occluding portion, and the anchoring unit is located in the filling portion or the occluding portion or a combination of the two.

[0024] In one embodiment, the anchoring unit is located in the filling part, the surface of the support frame body is covered with a film body that blocks thrombus, and a limiting film hole is provided on the film body, and part of the connecting part can freely enter and exit the limiting film hole.

[0025] In another embodiment, the anchoring unit is located at the blocking portion, and when the blocking portion is in a trapezoidal cage-like structure, the anchoring unit is arranged on an inclined waist surface of the trapezoidal cage-like structure, and the inclined waist surface is in an arc shape.

[0026] In one embodiment, the retracted region is located on the inner side of the outer surface of the distal end of the support frame body, and the extended region is located on the outer side of the outer surface of the distal end of the support frame body.

[0027] In another embodiment, the retracted region and the extended region overlap and are both located outside the outer surface of the distal end of the support frame body.

[0028] In one embodiment, a protective structure is provided in the distal region of the tissue contact portion, and the protective structure includes a ball head and a folded structure.

[0029] In one embodiment, the ball head is spaced apart at the distal end of the tissue contact portion, such as Figure 2d and Figure 3f As shown, the retractable anchoring structure is prevented from directly contacting the sheath wall when entering and exiting the sheath, thereby preventing the sheath from being scratched, ultimately achieving the recovery of the implanted device and reducing the resistance to sheath retraction.

[0030] In another embodiment, the folding structure is an arc-shaped curve, such as Figure 3g As shown, the distal end of the tissue contact portion is retracted toward the central axis of the support frame body, thereby preventing the retractable anchoring structure from scraping the inner wall of the sheath tube during the sheath retraction process, thereby achieving repeatable release.

[0031] In one embodiment, the distal portion of the tissue contact portion is bent and extended toward the proximal direction of the implant device. On the one hand, it has a guiding effect on the entry path of the implant device, can follow the anchoring direction, will not hinder the anchoring process, and makes the implant device more smoothly retracted and unsheathed. On the other hand, it improves the anchoring stability and firmness of the elastic anchor.

[0032] In one embodiment, multiple anchor barbs are arranged crosswise around the circumference of the support frame body, and the radial projections of the anchoring parts do not overlap. On the one hand, this can ensure that the anchor barbs can better hook the autologous tissue, ensure that the implant device is firmly fixed in the autologous tissue, and prevent the implant device from moving and tilting. On the other hand, when the implant device is in a compressed state in the sheath, the anchor barbs do not overlap, so as to facilitate the implant device to be sheathed and released.

[0033] In one embodiment, the implantable device is a left atrial appendage occluder, which is in the shape of a top hat after release, and the support frame main body includes a mesh support, and the mesh support includes a filling part and a sealing part; wherein the filling part is cylindrical, and the sealing part is a trapezoidal cage structure, wherein the filling part is located in the left atrial appendage and fixed to the wall of the left atrial appendage cavity, and the sealing part can fit with the wall surface of the opening of the left atrial appendage and seal the opening of the left atrial appendage, and along the axial direction of the filling part, the outer diameter of the sealing part gradually increases in the direction away from the filling part.

[0034] In one embodiment, one end of the anchoring unit is a connecting portion, and the other end of the anchoring unit is a tissue contacting portion.

[0035] In one embodiment, the limiting portion is a hole groove located on the anchoring portion, one end of the anchoring unit cooperates with the hole groove and at least a part of the area is located in the hole groove, and the anchoring unit and the hole groove correspond one to one in number and position.

[0036] In one embodiment, one end of the anchor barb is directly fixedly connected to the hole slot and at least a part of the area is located in the hole slot.

[0037] In another embodiment, the anchor barb is made of elastic and shape-memory wire that passes through corresponding holes and slots in sequence and is bent and shaped and woven. The anchor barb is fixed to two holes and slots through one end of the anchoring unit and has a circular or "U"-shaped structure. The circular or "U"-shaped structure is at least one circle.

[0038] In one embodiment, the diameter of each hole is larger than the maximum outer diameter of each anchor barb, and the spacing between adjacent holes is a multiple of the maximum outer diameter of the anchor barb of [2,20].

[0039] In some embodiments, the inner surface or outer surface of the occluding portion of the left atrial appendage occluder is provided with a coating, and when the occluding portion occludes the opening of the left atrial appendage, the occluding portion and the coating can effectively occlude the opening of the left atrial appendage.

[0040] In some embodiments, the elasticity, thickness, position, and angle of the anchor barb can be adjusted to adapt to cavity tissues of different shapes, and the anchor barb can withstand repeated stretching without breaking.

[0041] In some embodiments, the occluding portion of the left atrial appendage occluder is flexible and can undergo adaptive deformation in the central axis direction, thereby being able to adapt to different degrees of pulling force generated by the anchoring unit, and the shape of the occluding portion can change with the shape of the left atrial appendage opening.

[0042] In some embodiments, the deformation capacity of the occluding portion of the left atrial appendage occluder in the direction of the central axis is greater than the deformation capacity of the filling portion in the direction of the central axis, so that when the occluding portion can be transformed from a contracted state to an expanded state, its proximal and distal ends can approach each other and present a flat shape with a protrusion in the middle, thereby ensuring that the occluding portion can better seal the opening of the left atrial appendage.

[0043] In some embodiments, the deformation capacity of the occluding portion of the left atrial appendage occluder in the radial direction is greater than the deformation capacity of the filling portion in the radial direction, so that the occluding portion expands from a contracted state to a cage-like structure with a radial dimension greater than the radial dimension of the sealing portion, thereby ensuring that it can be sealed at the left atrial appendage orifice.

[0044] In some embodiments, the support frame body includes a winding body, which is wound around the support frame body and at least wraps a portion of the connecting portion that passes through and is fixed in the two hole slots, so as to enhance the connection strength between the anchor barb and the support frame body, avoid direct contact of a portion of the support frame body with the autologous tissue, reduce the amount of metal ion precipitation, increase the smoothness of the support frame body to a certain extent, avoid a sense of jamming, and prevent the support frame body from breaking.

[0045] In one embodiment, the anchor barb is made of elastic material. Firstly, it can ensure that the anchor barb undergoes adaptive bending deformation to ensure that the anchor barb is anchored intactly on the left atrial appendage inner cavity tissue. Secondly, when the implanted device is retrieved and repositioned, the anchor barb can be folded in the opposite direction and follow the direction of movement of the sheath to complete the retrieval process.

[0046] In some embodiments, one or more fixing structures are disposed on the support frame body, and the fixing structures define the position of the proximal end and / or the distal end of the winding body.

[0047] In some embodiments, the winding body can, on the one hand, effectively control the depth of the anchor thorn penetrating into the left atrial appendage wall, reducing damage to the left atrial appendage wall due to uneven force; on the other hand, once the left atrial appendage wall is punctured by the anchor thorn, the winding body will immediately cover the puncture site and promote the formation of microthrombi nearby, thereby blocking the puncture hole through the thrombus and preventing blood from seeping into the pericardial cavity, reducing the risk of pericardial effusion or even cardiac arrest.

[0048] In some embodiments, the winding body is formed by winding sutures, and the suture material is made of elastic polymer material.

[0049] Compared with the prior art, the advantages of the present invention are:

[0050] 1. Different from the prior art, in the present invention, when the anchoring unit is subjected to radial compression, the connecting portion undergoes elastic deformation and drives the tissue contact portion to shrink inward toward the radial center relative to the support frame body, so as to adapt to cavity tissues of different regular shapes, reduce the pressure from the cavity tissue borne by the retractable anchoring structure, and form a non-puncture or low-puncture effect on the tissue contacted by the anchoring portion. On the one hand, after the implant device is released, it can also be pushed. On the other hand, when the implant device is not accurately positioned, it can be recovered and repositioned or directly moved without considering the damage to the cavity tissue, reducing the number of repeated releases, reducing the difficulty of operation, and improving the operation efficiency. When the implant device is pulled in the proximal direction, it can also reduce the damage to the cavity tissue and reduce the probability of directly piercing the cavity tissue.

[0051] 2. Different from the prior art, in the present invention, when the anchoring unit is an elastic anchoring thorn, firstly, one end of the anchoring unit is fixedly connected to the limiting part, which can ensure that the elastic anchoring thorn has a relatively stable structure, which is conducive to the opening of the elastic anchoring thorn and makes the implanted device stable at the target position; secondly, the other end of the anchoring unit is free to form a retractable anchoring structure. When the anchoring thorn is subjected to radial compression, the connecting part undergoes elastic deformation and forms an extended body with the limiting part in the retracted area. On the one hand, it can ensure that the elastic anchoring thorn has a large stretching space so that it can be randomly oriented within the range of movement, thereby achieving a good positioning effect, improving the positioning accuracy, and preventing the elastic anchoring thorn from scratching the blood vessel wall during the positioning process. On the other hand, without reducing the overall strength of the implanted device, it can prevent the anchoring thorn from breaking during the release and positioning process of the implanted device, thereby improving the fatigue resistance of the anchoring thorn and extending the service life of the implanted device.

[0052] 3. Different from the prior art, the anchor barb in the present invention can be in a straight line, a curved shape, a J shape, a folded shape, a hook shape, or a combination of the five; it can prevent the distal part of the tissue contact part from being unable to rebound, and prevent the anchor barb from getting stuck and affecting the anchoring effect.

[0053] 4. Different from the prior art, the present invention takes the central axis of the support frame body as the center, and the spring structure can be radially close together, spread out, or bend, so that it has good radial deformation ability, axial support force and bending ability, thereby providing different anchoring angles to adapt to irregular autologous tissue structures.

[0054] 5. Different from the prior art, the spring structure in the present invention includes a stress buffer structure, which is in the shape of a corrugated shape, a "v" shape, or an "s" shape. The stress buffer structure can absorb the force transmitted to the implant device itself, thereby preventing the implant device from being subjected to external stress for a long time, thereby causing the implant device to move at the implant site or cause fatigue failure.

[0055] 6. Different from the prior art, the distal region of the tissue contact portion in the present invention is provided with a protective structure, which includes a ball head and a folding structure, and can prevent the distal end of the tissue contact portion from scraping the sheath wall during the recovery process of the implanted device.

[0056] 7. Different from the prior art, the connecting part in the present invention is in a folded shape, a circular shape, a hook shape, or a combination of the three; wherein the connecting part can form a rotation angle around the limiting part and toward the tissue contact part; the blocking member is used to limit the rotation angle; when the retractable anchoring structure is in a natural state, the distal end of the tissue contact part is located in the extended area and in the proximal area of ​​the blocking member, and the distal end of the tissue contact part is parallel to the axis of the support frame body or naturally faces the retracted area; when the retractable anchoring structure is loaded into the conveying system, the distal end of the tissue contact part is located inside the three-dimensional space surrounded by the support frame body; all of the above can make the distal end of the tissue contact part enter the conveying sheath through a rotating action, ensuring that the distal end of the tissue contact part scrapes the sheath wall during the recovery of the implanted device, facilitating the recovery of the implanted device, and realizing repeated release and multiple position adjustments, and can also be withdrawn in time when the specifications of the implanted device are not selected properly.

[0057] 8. Different from the prior art, the thin film body of the present invention is provided with limited membrane holes, and the thin film body is used to prevent the thrombus in the left atrial appendage cavity from falling off, while allowing the connecting part to move in and out freely, thus realizing retractable anchoring and reducing damage to the cavity tissue.

[0058] 9. Different from the prior art, in the present invention, when the implanted device is a left atrial appendage occluder, it is in the shape of a top hat after being released. When the anchoring unit is located on the inclined waist surface of the trapezoidal cage structure of the occluding part, the inclined waist surface is in the shape of an arc, which can better fit the inner wall of the left atrial appendage. Under the premise of not reducing the anchoring resistance, the anchoring unit will not easily puncture the inner wall of the left atrial appendage, thereby better fixing the left atrial appendage occluder, improving the overall stability of the left atrial appendage occluder and the fatigue resistance of the anchoring unit, and can still play a good anchoring role when the number of anchoring units used is reduced, preventing the anchoring units from irritating and damaging the blood vessel wall too much, and reducing postoperative complications. BRIEF DESCRIPTION OF THE DRAWINGS

[0059] Figure 1a It is a schematic diagram of the state of the left atrial appendage occluder in Example 1 and Example 2 of the present invention after being released and in a top-hat shape.

[0060] Figure 1b It is a schematic diagram of the state when the retractable anchoring structure on the left atrial appendage occluder in the first embodiment of the present invention is an anchoring spike.

[0061] Figure 1c This is a schematic diagram of a state in which the retractable anchoring structure on the left atrial appendage occluder is an anchor spike in an embodiment of the present invention.

[0062] Figure 2a and 2b and are schematic diagrams of the state of the retractable anchoring structure on the left atrial appendage occluder in the second embodiment of the present invention when the retractable anchoring structure is connected to the spring structure.

[0063] Figure 2c Figure 2d and are schematic diagrams of the state when the protective structure in the second embodiment of the present invention is a ball head and a folding structure.

[0064] Figure 3a~3d It is a schematic diagram of the state when the retractable anchoring structure on the left atrial appendage occluder in the third embodiment of the present invention is an anchoring spike.

[0065] Figure 3e and Figure 3f This is a schematic diagram of the state in which the retractable anchoring structure in the third embodiment of the present invention is an anchor spike.

[0066] Figure 3g~3k It is a schematic diagram of the state when the anchor barb has a rotation angle in one embodiment of the present invention.

[0067] Figures 4a to 4d This is a schematic diagram of the process of the anchor barb being retracted into the delivery sheath in one embodiment of the present invention.

[0068] The names of the parts indicated by the numbers in the accompanying drawings are as follows: 1-left atrial appendage occluder, 2-anchoring part, 21-anchor thorn, 211-tissue contact part, 212-connecting part, 22-limiting part, 23-hole groove, 3-filling part, 31-occluding part, 311-oblique waist surface, 4-winding body, 5-spring structure, 61-proximal connecting rod, 62-middle independent rod, 63-distal ring body, 71-ball head, 72-folded structure, 8-expansion body, 9-delivery sheath, 91-outer side, 92-inner side, 93-proximal side, 94 distal side. DETAILED DESCRIPTION

[0069] The present invention is further described in detail below in conjunction with the accompanying drawings and embodiments.

[0070] The proximal end of the present invention refers to the end close to the surgical operator, and the distal end refers to the end far away from the surgical operator. Embodiment 1

[0071] An implant device with a retractable anchoring structure comprises a support frame body, the support frame body comprises at least an anchoring portion 2, the anchoring portion 2 comprises one or more repeated anchoring units, wherein the anchoring unit comprises a tissue contact portion 211 and a connecting portion 212; the distal end portion of the tissue contact portion 211 can form a hanging anchor with the cavity tissue; when the anchoring unit is subjected to radial compression, the connecting portion 212 undergoes elastic deformation and drives the tissue contact portion 211 to retract inwardly toward the radial center relative to the support frame body, thereby forming a non-puncture or low-puncture effect on the tissue contacted by the anchoring portion 2.

[0072] The composition and connection mode of each component in this embodiment will be described in detail below with reference to the accompanying drawings:

[0073] In this embodiment, Figure 1bAs shown, the anchoring unit is an elastic anchor 21, the retracted area is located on the inner side 92, and the extended area is located on the outer side 91; wherein, when the anchoring unit is subjected to radial compression, the connecting portion 212 is always in the retracted area, and the distal portion of the tissue contact portion 211 is always in the extended area.

[0074] In this embodiment, Figure 1b As shown, the anchoring portion 2 further includes a limiting portion 22 for limiting the relative position of the anchoring unit in the anchoring portion 2; one end of the anchoring unit is fixedly connected to the limiting portion 22, and the other end of the anchoring unit is freed to form the retractable anchoring structure.

[0075] In this embodiment, when the anchor barb 21 is radially squeezed, the connecting portion 212 undergoes elastic deformation and forms an extended body with the limiting portion 22 .

[0076] In this embodiment, the anchor thorns 21 are made of elastic material and can be curved. Three circles of the anchor thorns 21 can be circumferentially arranged around the surface of the support frame body.

[0077] In this embodiment, the three circles of anchor spikes 21 are cross-arranged around the circumference of the support frame body, and the projections of the anchoring parts 2 in the radial direction do not overlap.

[0078] In this embodiment, a protective structure is provided at the distal end of the tissue contact portion 211. The protective structure is a folded structure 72 to prevent the sheath tube wall from being scratched when entering and exiting the sheath.

[0079] In this embodiment, the retracted area is located on the inner side of the outer surface of the distal end of the support frame body, and the extended area is located on the outer side of the outer surface of the distal end of the support frame body.

[0080] In this embodiment, the connecting portion 212 and the tissue contacting portion 211 are both arc-shaped.

[0081] In this embodiment, the implantable device is a left atrial appendage occluder 1, which is in the shape of a top hat after release, and the support frame main body includes a mesh support, and the mesh support includes a filling part 3 and a sealing part 31, wherein the filling part 3 is cylindrical, and the sealing part 31 is a trapezoidal cage structure, along the axial direction of the filling part 3, the outer diameter of the sealing part 31 gradually increases in the direction away from the filling part 3, the filling part 3 is located in the left atrial appendage and fixed to the wall of the left atrial appendage cavity, and the sealing part 31 can fit with the wall surface of the opening of the left atrial appendage and block the opening of the left atrial appendage.

[0082] In this embodiment, Figure 1b As shown, the anchor spikes 21 are all located on the inclined waist surface 311 of the trapezoidal cage structure on the outer periphery of the blocking portion 31, and the inclined waist surface 311 is in an arc shape.

[0083] In this embodiment, one end of the anchoring unit is the connecting portion 212 , and the other end of the anchoring unit is the tissue contacting portion 211 .

[0084] In this embodiment, Figure 1b As shown, the support frame body is formed by a plurality of elastic and shape-memory wires that are interlaced and woven up and down to form a plurality of grid units, the limiting portion 22 is the grid unit, and one end of the anchoring unit is wound around and fixed on two adjacent vertices.

[0085] In this embodiment, the plurality of wires are respectively constrained and fixed by a distal fixing sleeve and a proximal fixing sleeve, wherein the distal end of the filling portion 3 is constrained and fixed by the distal fixing sleeve, and the proximal end of the filling portion 3 is constrained and fixed by the proximal fixing sleeve, and a distal concave cavity is provided at the distal end of the filling portion 3, and the distal fixing sleeve is located in the distal concave cavity, so as to collect thrombus tissue.

[0086] In this embodiment, the arc surface of the filling portion 3 is concave inwardly toward the central axis of the left atrial appendage occluder 1 to avoid abrasion of the edge of the pulmonary vein and the surrounding tissue of the left atrial appendage when the left atrial appendage occluder 1 is implanted.

[0087] In this embodiment, after the left atrial appendage occluder 1 is implanted, the filling portion 3 can be completely buried in the left atrial appendage opening, and the occluding portion 31 can cover the left atrial appendage opening and thus occlude the left atrial appendage, with good stability and fit, thereby improving the occluding effect on the left atrial appendage.

[0088] In this embodiment, the filling part 3 and the sealing part 31 of the left atrial appendage occluder 1 are an integrally formed structure, which has both anchoring and sealing functions. Compared with the prior art, the structure is simplified, so the left atrial appendage occluder 1 can be more easily and accurately positioned at the target position during the release process, thereby improving the success rate of the operation, facilitating the operation, and improving the stability of the left atrial appendage occluder 1.

[0089] In this embodiment, the inner surface or outer surface of the occluding portion 31 of the left atrial appendage occluder 1 is provided with a coating. When the occluding portion 31 occludes the opening of the left atrial appendage, the occluding portion 31 and the coating can effectively occlude the opening of the left atrial appendage.

[0090] In this embodiment, the elasticity, thickness, position and angle of the anchor barb 21 can be adjusted to adapt to cavity tissues of different shapes, and the anchor barb can withstand repeated stretching without breaking.

[0091] In this embodiment, the occluding portion 3 of the left atrial appendage occluder 1 is flexible and can be adaptively deformed in the central axis direction, so as to adapt to different degrees of pulling force generated by the anchoring unit. The shape of the occluding portion 3 can change with the shape of the left atrial appendage opening.

[0092] In this embodiment, the deformation capacity of the occluding portion 31 of the left atrial appendage occluder 1 in the central axis direction is greater than the deformation capacity of the filling portion in the central axis direction, so that when the occluding portion 31 can be transformed from a contracted state to an expanded state, its proximal and distal ends can approach each other and present a flat shape with a protrusion in the middle, thereby ensuring that the occluding portion 31 can better seal the opening of the left atrial appendage.

[0093] In this embodiment, the deformation capacity of the sealing part 31 of the left atrial appendage occluder 1 in the radial direction is greater than the deformation capacity of the filling part in the radial direction, so that the sealing part 31 expands from a contracted state to a cage-like structure with a radial dimension greater than the radial dimension of the sealing part, thereby ensuring that it can be sealed at the left atrial appendage opening. Embodiment 2

[0094] The difference from the first embodiment is that:

[0095] In this embodiment, Figure 2a and Figure 2b As shown, the anchoring unit is a spring sheet structure 5, the retracted area and the extended area are both located on the outer side 91, and the retracted area and the extended area overlap; and one end of the spring sheet structure 5 is fixedly connected to the limiting portion 22, and the other end of the spring sheet structure 5 is free to face the outside of the support frame body and extends obliquely along the proximal end of the support frame body. With the central axis of the support frame body as the center, the spring sheet structure 5 can be radially brought together or spread out or bent, so that it has good radial deformation ability, axial support force and bending ability, thereby providing different anchoring angles to adapt to irregular autologous tissue structures.

[0096] In this embodiment, a protective structure is provided at the distal end of the tissue contact portion 211, and the protective structure includes a ball head 71, such as Figure 2d As shown,

[0097] In this embodiment, the ball heads 71 ​​are disposed at intervals at the distal end of the tissue contacting portion 211 .

[0098] In this embodiment, the spring sheet structure 5 includes a stress buffer structure, and the shape of the stress buffer structure is a "V" shape. The spring sheet structure 5 is formed as a whole by cutting the support frame through a braided tube.

[0099] In this embodiment, the limiting portion 22 is the main body grid of the support frame.

[0100] In this embodiment, the spring structure 5 is arranged around the circumference of the support frame surface and is located on the inclined waist surface 311 of the trapezoidal cage structure on the outer periphery of the blocking portion 31 . Embodiment 3

[0101] The difference from the first embodiment is that:

[0102] In this embodiment, Figure 3aAs shown, the implantable device is a left atrial appendage occluder 1, the support frame body includes a self-centering structure, the self-centering structure includes a center piece, the self-centering structure is a three-dimensional structure formed by the center piece radiating outward, and in a natural unconstrained state, the center piece is located inside the self-centering structure.

[0103] In this embodiment, along the direction of outward divergence from the central piece, the self-centering structure includes a proximal connecting rod 61, a middle independent rod 62, and a distal ring-shaped body 63 in sequence.

[0104] In this embodiment, the three-dimensional structure is in a "bowl shape" in a natural and unconstrained state.

[0105] In this embodiment, the three-dimensional structure includes a curled structure with a small curvature radius.

[0106] In this embodiment, the distal ring-shaped body 63 is located in the outer contour area of ​​the curled structure. In this area, the outer surface of the curled structure is provided with multiple circles of elastic anchor spikes 21.

[0107] In this embodiment, the plane where each of the curled structures is located is coplanar with the central axis of the support frame.

[0108] In this embodiment, the curling direction of the curled structure is inward curling, which can prevent the left atrial appendage occluder 1 from damaging the inner wall of the autologous tissue during the release process.

[0109] In this embodiment, the left atrial appendage occluder 1 also includes an occluding disk and a connector, the occluding disk and the self-centering structure are connected via the connector, the occluding disk is a three-dimensional cage-like structure, and a first coating is provided on the inner or outer surface of the occluding disk.

[0110] In this embodiment, Figure 3d As shown, when the anchor barb 21 is subjected to radial compression, the connecting portion 212 undergoes elastic deformation and forms an expansion body 8 with the limiting portion 22 .

[0111] In this embodiment, Figure 3c As shown, the support frame body includes a winding body 4, which is wound on the support frame body and at least wraps a part of the connecting part and passes through and is fixed at the position of the two hole grooves 23, so as to enhance the connection strength between the anchor thorn 21 and the support frame body, avoid direct contact of part of the support frame body with the autologous tissue, reduce the precipitation of metal ions, increase the smoothness of the support frame body to a certain extent, avoid the feeling of jamming, and prevent the support frame body from breaking.

[0112] In this embodiment, one or more fixing structures are provided on the support frame body, and the fixing structures limit the position of the proximal end and / or the distal end of the winding body 4.

[0113] In this embodiment, the winding body 4 can, on the one hand, effectively control the depth of the anchor thorn 21 penetrating into the wall of the left atrial appendage, thereby reducing damage to the wall of the left atrial appendage due to uneven force; on the other hand, once an extremely thin area of ​​the wall of the left atrial appendage is punctured by the anchor thorn 21, the winding body 4 will immediately cover the puncture site and promote the formation of microthrombi nearby, thereby blocking the puncture hole through the thrombus and preventing blood from seeping into the pericardial cavity, thereby reducing the risk of pericardial effusion or even cardiac arrest.

[0114] In this embodiment, the winding body 4 is formed by winding sutures, and the suture material is made of elastic polymer material.

[0115] In this embodiment, the delivery system of the implant device includes a delivery cable and a delivery sheath. The distal end of the distal ring 63 touches the wall of the left atrial appendage. The delivery cable is further pushed, and the distal ring moves toward the inside of the left atrial appendage. Part of the anchor thorn 21 begins to contact the wall of the left atrial appendage. When it reaches the appropriate position, the delivery cable is continued to be pushed and the delivery sheath is withdrawn to allow the distal ring 63 to gradually expand inside the left atrial appendage. The anchor thorn 21 that first contacts the wall of the left atrial appendage may be detached from the anchor and be in a "suspended" state, but more anchor thorns 21 that expand with the distal ring 63 gradually contact the wall of the left atrial appendage and achieve anchoring. During the whole process, the anchor thorn 21 does not contact the delivery system, which is conducive to the recovery of the implant device.

[0116] In this embodiment, the limiting portion 22 is a hole groove 23 located on the distal ring-shaped body 63 .

[0117] In this embodiment, Figure 3b and Figure 3c As shown, the anchor barb 21 is made of elastic and shape-memory wire that passes through the corresponding holes and slots in sequence and is bent and shaped and woven. A partial connecting portion 212 passes through and is fixed in the two holes and slots 23 and presents a circular structure, which is a circle.

[0118] In this embodiment, one end of the anchoring unit matches with the hole groove 23 and at least a part of the area is located in the hole groove 23 .

[0119] In this embodiment, the anchoring unit is located in the filling part 3, and the surface of the support frame body is covered with a thin film body that blocks thrombus. The thin film body is provided with a limited film hole, and part of the connecting part 212 can freely enter and exit the limited film hole.

[0120] In this embodiment, the anchoring units and the holes 23 correspond one to one in number and position.

[0121] In this embodiment, the diameter of each hole groove 23 is larger than the maximum outer diameter of each anchor barb 21 , and the spacing between adjacent hole grooves 23 and the multiple of the maximum outer diameter of the anchor barb 21 is [2,20].

[0122] In this embodiment, the connecting portion 212 can form a rotation angle around the limiting portion 22 and toward the tissue contacting portion 211 .

[0123] In this embodiment, the support frame body includes a blocking member, which is used to limit the rotation angle; and the blocking member is a hole groove 23, and the connecting part can freely enter and exit the hole groove.

[0124] In this embodiment, when the retractable anchoring structure is in a natural state, the distal end of the tissue contact portion 211 is located in the extended area and in the proximal area of ​​the blocking member, and the distal end of the tissue contact portion 211 is parallel to the axis of the support frame body or naturally faces the retracted area; when the retractable anchoring structure is loaded into the conveying system, the distal end of the tissue contact portion 211 is located inside the three-dimensional space surrounded by the support frame body.

[0125] In this embodiment, when the anchor 21 is in a natural state, the connecting portion is located on the proximal side of the limiting portion, the distal side of the limiting portion, and the inner side 92; the tissue contact portion 211 is located on the outer side 91; and when the anchor 21 has the said rotation angle, the connecting portion 212 located on the distal side and the connecting portion 212 partially located on the inner side 92 can extend to the outer side 91.

[0126] The above contents are only preferred embodiments of the present invention. For ordinary technicians in this field, according to the concept of the present invention, there will be changes in the specific implementation methods and application scopes. The content of this specification should not be understood as limiting the present invention.

Claims

1. An implantable device having a retractable anchoring structure, characterized in that: The implant device includes a support frame body, which includes at least an anchoring part and a blocking member, and the anchoring part includes one or more repeated anchoring units and a limiting part, wherein the anchoring unit includes a tissue contact part and a connecting part; the distal end of the tissue contact part can form a hanging anchor with the cavity tissue, and the connecting part can form a rotation angle around the limiting part and toward the tissue contact part, and the blocking member is used to limit the rotation angle, and the blocking member is a hole groove, and the connecting part can freely enter and exit the hole groove; the limiting part is used to limit the relative position of the anchoring unit to the anchoring part; when the anchoring unit is subjected to radial compression, the connecting part undergoes elastic deformation and drives the tissue contact part to retract inward toward the radial center relative to the support frame body, thereby forming a no-puncture or low-puncture effect on the tissue contacted by the anchoring part.

2. The implant device with a retractable anchoring structure according to claim 1, characterized in that: The outer side or inner side of the outer surface of the support frame body has one or a combination of an extended area and a retracted area; wherein, when the anchoring unit is subjected to radial compression, the connecting portion is always in the retracted area, and the distal end portion of the tissue contact portion is always in the extended area.

3. The implant device with a retractable anchoring structure according to claim 2, characterized in that: The anchoring unit is an elastic anchoring barb, the retracted area is located on the inner side, and the extended area is located on the outer side; one end of the anchoring unit is fixedly connected to the limiting portion, and the other end of the anchoring unit is freed to form the retractable anchoring structure.

4. The implant device with a retractable anchoring structure according to claim 3, characterized in that: When the anchor barb is radially squeezed, the connecting portion undergoes elastic deformation and forms an expansion body with the limiting portion in the retracted area.

5. The implant device with a retractable anchoring structure according to claim 1, characterized in that: A protective structure is arranged in the distal region of the tissue contact portion, and the protective structure comprises a ball head or a folded structure.

6. The implant device with a retractable anchoring structure according to claim 3, characterized in that: The connecting portion and the tissue contact portion are respectively in a folded shape, an arc shape, a hook shape, or a combination of the three.

7. The implant device with a retractable anchoring structure according to claim 2, characterized in that: When the retractable anchoring structure is in a natural state, the distal end of the tissue contact portion is located in the extended area and in the proximal area of ​​the blocking member, and the distal end of the tissue contact portion is parallel to the axis of the support frame body or naturally faces the retracted area; the retractable anchoring structure is loaded into the conveying system, and the distal end of the tissue contact portion is located inside the three-dimensional space surrounded by the support frame body.

8. The implant device with a retractable anchoring structure according to claim 3, characterized in that: When the anchor is in a natural state, the connection portion is located on the proximal side of the limiting portion, the distal side of the limiting portion, and the inner side; the tissue contact portion is located on the outer side; and when the anchor has the rotation angle, the connection portion located on the distal side and part of the connection portion located on the inner side can be transformed to the outer side.

9. The implant device with a retractable anchoring structure according to claim 1, characterized in that: The implantable device is a left atrial appendage occluder, which includes a filling portion and an occluding portion, and the anchoring unit is located at the filling portion or the occluding portion or a combination of the two.

10. The implant device with a retractable anchoring structure according to claim 9, characterized in that: The anchoring unit is located in the filling part, the surface of the support frame body is covered with a thin film body that blocks blood clots, and a limited film hole is arranged on the thin film body, and part of the connecting part can freely enter and exit the limited film hole; or, the anchoring unit is located in the blocking part, and the blocking part is a trapezoidal cage-like structure, and the anchoring unit is arranged on the inclined waist surface of the trapezoidal cage-like structure, and the inclined waist surface is an arc surface.

11. The implant device with a retractable anchoring structure according to claim 3, characterized in that: One or more circles of anchor spikes are circumferentially arranged around the surface of the support frame body.

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