阅读说明：本技术 具有可伸缩锚定结构的植入器械 (Implanting instrument with retractable anchoring structure ) 是由 邵烨 李彪 于 2021-06-28 设计创作，主要内容包括：本发明涉及医疗器械领域,尤其涉及具有可伸缩锚定结构的植入器械,植入器械包括支撑架主体,支撑架主体至少包括锚定部,锚定部包括一个或多个重复锚定单元,其中,锚定单元包括组织接触部、连接部；组织接触部的远端部分能与腔体组织形成挂靠式锚定；当锚定单元受到径向挤压时,连接部发生弹性形变并带动组织接触部一起相对支撑架主体向径向中心内缩,对锚定部接触的组织形成无刺伤或低刺伤效果。(The invention relates to the field of medical instruments, in particular to an implantation instrument with a telescopic anchoring structure, which comprises a support frame main body, wherein the support frame main body at least comprises an anchoring part, the anchoring part comprises one or more repeated anchoring units, and the anchoring units comprise a tissue contact part and a connecting part; the distal end portion of the tissue contacting portion can form a depending anchor with the cavity tissue; when the anchoring unit is radially extruded, the connecting part is elastically deformed and drives the tissue contact part to retract towards the radial center relative to the support frame main body, and a non-puncture or low-puncture effect is formed on the tissue contacted with the anchoring part.)

1. An implantation instrument having a retractable anchoring structure, characterized in that: the implantation instrument comprises a scaffold body comprising at least an anchoring portion comprising one or more repeating anchoring units, wherein,

the anchoring unit comprises a tissue contact part and a connecting part; the distal end portion of the tissue contacting portion is capable of forming a depending anchor with the cavity tissue;

when the anchoring unit is radially extruded, the connecting part is elastically deformed and drives the tissue contact part to retract towards the radial center relative to the support frame main body, and a no-puncture or low-puncture effect is formed on the tissue contacted by the anchoring part.

2. The implantation instrument with telescopic anchoring structure according to claim 1, wherein: the anchoring part further comprises a limiting part used for limiting the relative position of the anchoring unit in the anchoring part; the outer side or the inner side of the outer surface of the support frame body is provided with one or the combination of an extending area and a retracting area; wherein the content of the first and second substances,

when the anchoring unit is radially compressed, the connecting portion is always in the retracted region and the distal end portion of the tissue contact portion is always in the extended region.

3. The implantation instrument with telescopic anchoring structure according to claim 2, wherein: when the anchoring unit is an elastic anchor, the retraction area is positioned on the inner side, and the extension area is positioned on the outer side; one end of the anchoring unit is fixedly connected with the limiting part, and the other end of the anchoring unit forms the telescopic anchoring structure after being dissociated.

4. The implantation instrument with telescopic anchoring structure according to claim 3, wherein: when the anchor thorn is radially extruded, the connecting part is elastically deformed and forms an expansion body with the limiting part in the retraction area.

5. The implantation instrument with telescopic anchoring structure according to claim 2, wherein: when the anchoring unit is of a spring structure, the retraction area and the extension area are both positioned at the outer side and are overlapped; and is

One end of the elastic sheet structure is fixedly connected with the limiting part, and the other end of the elastic sheet structure is free to face the outside of the support frame main body and obliquely extends along the near end of the support frame main body.

6. The implantation instrument with telescopic anchoring structure according to claim 5, wherein: the elastic sheet structure is radially closed or scattered or bent to adapt to the irregular cavity tissue by taking the central shaft of the support frame main body as the center; and is

The elastic sheet structure comprises a stress buffering structure, the stress buffering structure is in a corrugated shape or a V-shaped shape or an S-shaped shape, and the elastic sheet structure is integrated with the support frame through weaving, laser engraving or welding.

7. The implantation instrument with telescopic anchoring structure according to claim 1, wherein: the distal region of the tissue contacting portion is provided with a protective structure comprising a bulb, a fold-shaped structure.

8. The implantation instrument with telescopic anchoring structure according to claim 2, wherein: the connecting part and the tissue contact part are respectively in a folded shape, an arc shape, a hook shape or a combination of the three; wherein the connecting portion is capable of forming a rotational angle around the stopper portion and toward the tissue contacting portion.

9. The implantation instrument with telescopic anchoring structure according to claim 8, wherein: the support frame main body comprises a blocking piece used for limiting the rotation angle; and is

The blocking piece is a hole groove or is integrally formed with the support frame main body through laser engraving or is attached to the support frame main body; wherein the content of the first and second substances,

when the blocking piece is the hole groove, the connecting part can freely go in and out of the hole groove.

10. The implantation instrument with telescopic anchoring structure according to claim 9, wherein:

when the retractable anchoring structure is in a natural state, the distal end of the tissue contact part is positioned at the extending area and at the proximal end area of the blocking part, and the distal end of the tissue contact part is parallel to the axis of the support frame body or naturally faces the retracting area;

when the retractable anchoring structure is loaded into the delivery system, the distal end of the tissue contacting portion is positioned within the space defined by the scaffold body.

11. The implantation instrument with telescopic anchoring structure according to claim 3 or 10, wherein: when the anchor thorn is in a natural state, the connecting part is positioned at the near end side of the limiting part, the far end side of the limiting part and the inner side; the tissue contacting portion is located on the outer side; and is

When the anchor thorn has the turning angle, the connection portion on the distal end side, the connection portion partially on the inner side can be turned to the outer side.

12. The implantation instrument with telescopic anchoring structure according to claim 1, wherein: the implantation instrument is a left atrial appendage occluder which comprises a filling part and an occlusion part, and the anchoring unit is positioned in the filling part or the occlusion part or the combination of the filling part and the occlusion part.

13. The implantation instrument with telescopic anchoring structure according to claim 12, wherein: the anchoring unit is positioned in the filling part, the surface of the support frame main body is covered with a thin film body for blocking thrombus, a limiting film hole is formed in the thin film body, and part of the connecting part can freely enter and exit the limiting film hole; or

The anchoring unit is positioned in the plugging part, and when the plugging part is in a trapezoidal cage-shaped structure, the anchoring unit is arranged on an oblique waist surface of the trapezoidal cage-shaped structure, and the oblique waist surface is in an arc surface shape.

14. The implantation instrument with telescopic anchoring structure according to claim 3, wherein: the anchor thorn is made of elastic materials and is in a linear shape, a bent shape, a J shape, a folded shape, a hook shape or a combination of the five shapes; the anchoring thorn is arranged for one circle or more around the surface of the support frame main body in the circumferential direction.

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to an implantation instrument with a telescopic anchoring structure.

Background

Currently, atrial fibrillation (abbreviated as atrial fibrillation) is the most common sustained or paroxysmal arrhythmia, and the incidence rate accounts for about 2% of the total population worldwide. About 1000 patients with atrial fibrillation exist in China, the prevalence rate increases with the age, and the incidence rate of people over 65 years old reaches 84%. Atrial fibrillation is a main risk factor causing cardiac death and all-cause death, chronic atrial fibrillation is easy to form left atrial appendage thrombus to cause peripheral artery thromboembolism, and if the thrombus falls off and enters blood circulation, complications such as cerebral apoplexy, peripheral blood vessel embolism and organ embolism are caused. Meanwhile, researches show that thrombus is easily formed at the left auricle after the hemodynamic disturbance caused by atrial fibrillation, the thrombus is an independent risk factor of cerebral apoplexy and seriously harms human health, and researches in recent years show that the risk of ischemic stroke caused by atrial fibrillation can be effectively prevented by plugging the left auricle.

Patent CN110522486A provides a plugging frame for left atrial appendage, wherein the plugging frame includes a net-shaped body and a tail portion connected to the net-shaped body, and the tail portion is turned inwards to form a blunt shape, so as to increase the contact area between the tail portion and the left atrial appendage, prevent the tail end of the frame from damaging the wall and the internal tissues of the left atrial appendage during and after the implantation, reduce the injury to the patient caused by the operation, and avoid the risks of pericardial effusion, perforation, etc., so that the safety of the operation is higher, in addition, the tail portion is composed of a plurality of axially arranged ribs, and one end of each rib is turned inwards to form a blunt shape and then connected to the net-shaped body, the other end of each rib passes through the net-shaped body and protrudes out of the outer surface of the net-shaped body to form an anchoring thorn, the operability of the plugging device is better, and under the condition that the implantation position is not ideal, the plugging device can be pushed only to adjust the implantation position, thereby reducing the operation difficulty and improving the medical effect, but the anchoring thorn can easily cause the damage of the blood vessel during the releasing process of the stent.

Patent CN112022260A provides an implantation apparatus with bionic micro-thorn attachment structure, which at least comprises an attachment frame, wherein the attachment frame is a self-expanding type support or a spherical expanding type support, the attachment frame comprises a plurality of skeletons and a plurality of bionic micro-thorn attachment structures, the bionic micro-thorn attachment structures are arranged on the outer surface of the skeletons, the bionic micro-thorn attachment structures are in the form of sparse micro-thorns on the surface of the bionic plants, the bionic micro-thorn attachment structures comprise thorns and micro-thorns, the micro-thorns are composed of thorns and thorns tips, the micro-thorns are in a straight line shape or a J shape or a combination of the straight thorns and the J-thorns, when the thorns and/or the thorns of the micro-thorns contact with the cavity tissues, adaptive bending deformation can be generated, the micro-thorns can be favorably attached to the cavity tissues nondestructively, the attachment anchoring function of the micro-thorns is enhanced, the integral anchoring of the support is improved by the design, but the quantity of the micro-thorns on the support is more in the release process, increased the stimulation of the many vascular walls of support, very easily arouse postoperative complication, in addition, when going out the sheath, the J-shaped thorn very easily takes place to catch on each other, can't expand the adverse event that forms effective anchoring.

Patent CN205758648U provides a left atrial appendage occluder, including the sealed dish of interconnect, netted anchoring device and film body, anchoring device certainly sealed dish extends to the distal end and forms the toper portion that has distal end open-ended, and this toper portion extends towards the proximal end after turning up to the proximal end and forms anchoring portion. The film body is fixed on the at least partial surface in anchor portion, and partial or whole covers distal end opening sets up the deformation that the film body can retrain its different positions on anchoring device to corresponding radial holding power that improves the plugging device drops after avoiding the plugging device to implant, anchor portion has the barb, the free end orientation of barb sealed dish, but this barb is the very easy scratch left auricle cavity inner wall, causes postoperative complication.

Therefore, how to reduce or avoid the irritation of the anchoring structure on the vessel wall of the implant, even the puncture of the cavity wall, the leakage of tissue fluid such as blood, and other postoperative complications after the implant is implanted becomes a problem to be solved.

Disclosure of Invention

The invention aims to overcome the defects of the prior art, provides an implantation instrument with a telescopic anchoring structure for patients with atrial fibrillation and needing interventional therapy, solves the problem of stimulation of micro-puncture to the vessel wall in the release process of an implant, improves the anchoring effect and reduces the postoperative complication probability.

The purpose of the invention is realized by the following scheme:

the implantation instrument with the telescopic anchoring structure comprises a support frame main body, wherein the support frame main body at least comprises an anchoring part, and the anchoring part comprises one or more repeated anchoring units, wherein each anchoring unit comprises a tissue contact part and a connecting part; the distal end portion of the tissue contacting portion can form a depending anchor with the cavity tissue; when the anchoring unit is radially extruded, the connecting part is elastically deformed and drives the tissue contact part to retract towards the radial center relative to the support frame main body, and a non-puncture or low-puncture effect is formed on the tissue contacted with the anchoring part.

The purpose of the invention can be further realized by the following technical scheme:

in one embodiment, the anchoring portion further comprises a limiting portion for limiting the relative position of the anchoring unit at the anchoring portion; the outer side or the inner side of the outer surface of the support frame body is provided with one or the combination of an extending area and a retracting area; wherein the connecting portion is always in the retracted region and the distal end portion of the tissue contacting portion is always in the extended region when the anchoring unit is radially compressed.

In one embodiment, when the anchoring unit is an elastic anchor, the retraction area is located at the inner side, the extension area is located at the outer side, one end of the anchoring unit is fixedly connected with the limiting part, and the other end of the anchoring unit is free to form a telescopic anchoring structure.

In one embodiment, when the anchor thorn is radially extruded, the connecting part is elastically deformed and forms an expansion body with the limiting part in the retraction area, the expansion body is always positioned in the retraction area, and the expansion body can have enough space to accommodate the deformation of the anchor thorn, so that sufficient movement space is provided for the connecting part, and the anchor thorn is prevented from scratching tissues.

In one embodiment, the anchor is made of an elastic material, the anchor is in the shape of a straight line or a curve or a J or a fold or a hook or a combination of five; and one or more circles of anchoring thorns are arranged around the surface of the support frame main body in the circumferential direction.

In one embodiment, when the anchoring unit is of a leaf spring structure, both the retracted area and the extended area are located outside, the retracted area and the extended area overlapping; and the one end and the spacing fixed connection of portion of shell fragment structure, the other end of shell fragment structure is free outside the support frame main part and extend along the slope of support frame main part near-end.

In one embodiment, the elastic sheet structure can be radially closed or scattered or bent to adapt to the irregularly-shaped cavity tissue by taking the central axis of the support frame main body as the center; and the elastic sheet structure comprises a stress buffering structure, the stress buffering structure is in a corrugated shape or a V-shaped shape or an S-shaped shape, and the elastic sheet structure is integrated with the support frame through weaving, laser engraving or welding.

In one embodiment, the distal region of the tissue contacting portion is provided with a protective structure comprising a bulb, fold-shaped structure.

In one embodiment, as shown in FIGS. 3 h-3 k, the connecting portion and the tissue contacting portion are in the shape of a fold, or a circle, or a hook, or a combination of the three; wherein, the connecting portion can surround the spacing portion and form the rotation angle towards the tissue contact portion.

In one embodiment, as shown in fig. 3h to 3k, the support frame body includes a stopper for limiting a rotation angle; the blocking piece is a hole groove or is integrally formed with the support frame main body through laser engraving or is attached to the support frame main body; when the blocking piece is a hole groove, the connecting part can freely enter and exit the hole groove.

In one embodiment, as shown in fig. 3c, when the retractable anchor structure is in the natural state, the distal end of the tissue contacting portion is located at the extended region and at the proximal region of the stop, and the distal end of the tissue contacting portion is parallel to the stent body axis or naturally towards the retracted region; when the retractable anchoring structure is loaded into the delivery system, the distal end of the tissue contacting portion is positioned within the space defined by the main body of the scaffold.

In one embodiment, as shown in fig. 3 h-3 k, when the anchor is in a natural state, the connecting portion is located on the proximal side of the stop portion, the distal side of the stop portion, and the inner side; the tissue contact site is located on the outside; and when the anchor thorn has a turning angle, the connection part on the distal side, partly on the inside, can be turned to the outside.

In one embodiment, after the connection portions of the anchors are angled toward the tissue contacting portion by pressing against each other, the distal ends of the anchors can smoothly enter the sheath without scratching the wall of the sheath, as shown in FIGS. 4 a-4 d.

In one embodiment, the implantation instrument is a left atrial appendage occluder comprising a filling portion and an occluding portion, the anchoring unit being located in the filling portion or the occluding portion or a combination thereof.

In one embodiment, the anchoring unit is located in the filling part, the surface of the stent body is covered with a thin film body for blocking thrombus, a limiting film hole is formed in the thin film body, and part of the connecting part can freely enter and exit from the limiting film hole.

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

In one embodiment, the retraction region is located inside the outer surface of the distal end of the stent body and the extension region is located outside the outer surface of the distal end of the stent body.

In another embodiment, the retraction region and the extension region overlap and are both located outside of the outer surface of the distal end of the scaffold body.

In one embodiment, the distal region of the tissue contacting portion is provided with a protective structure comprising a bulb, fold-shaped structure.

In one embodiment, the ball is spaced at the distal end of the tissue contact portion, as shown in fig. 2d and 3f, so as to avoid the telescopic anchoring structure from directly contacting the wall of the sheath when entering or exiting the sheath, thereby preventing the sheath from being scratched, and finally realizing the recovery of the implantation instrument and reducing the sheath retraction resistance.

In another embodiment, the fold structure is a curved arc, as shown in fig. 3g, the distal end of the tissue contact portion is folded toward the central axis of the main body of the support frame, so that the inner wall of the sheath tube is prevented from being scratched by the retractable anchoring structure in the process of retracting the sheath, and the repeated releasing performance is realized.

In one embodiment, the distal end portion of the tissue contact portion extends in a bending manner towards the proximal direction of the implantation instrument, so that the tissue contact portion has a guiding effect on the approach of the implantation instrument, can conform to the anchoring direction, does not obstruct the anchoring process, enables the implantation instrument to be more smoothly withdrawn from the sheath, and improves the anchoring stability and firmness of the elastic anchoring thorn.

In one embodiment, the circumferential anchoring thorns are arranged in a mutually-crossed manner in the circumferential direction of the support frame main body, and the projections of the anchoring parts are not overlapped in the radial direction, so that on one hand, the anchoring thorns can be guaranteed to better hook the autologous tissue, the implantation instrument can be guaranteed to be firmly fixed on the autologous tissue, the implantation instrument is prevented from moving and inclining, and on the other hand, the anchoring thorns are not overlapped when the implantation instrument is in a pressing and holding state in the sheath tube, so that the implantation instrument can be conveniently inserted into the sheath and released.

In one embodiment, the implantation apparatus is a left atrial appendage occluder which is in a hat shape after being released, and the support frame main body comprises a mesh support which comprises a filling part and an occluding part; wherein, the filling part is cylindricly, and the shutoff portion is trapezoidal cage structure, and the filling part is located left auricle and is fixed in left auricle chamber wall, and the shutoff portion can laminate and shutoff the drill way in left auricle's drill way with the wall in left auricle's drill way, and along the axial of filling part, the external diameter of shutoff portion increases along the direction of keeping away from the filling part gradually.

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.

In one embodiment, the limiting part is a hole groove located on the anchoring part, one end of the anchoring unit is matched with the hole groove and at least part of the area of the anchoring unit is located in the hole groove, and the anchoring unit and the hole groove are in one-to-one correspondence in number and position.

In one embodiment, one end of the anchor is fixedly connected directly to the well and is at least partially located within the well.

In another embodiment, the anchor is formed by sequentially passing the wire with elasticity and shape memory through the corresponding hole grooves in a bending and shaping weaving mode, one end of the anchor unit penetrates through and is fixed on the two hole grooves and is in a shape like a Chinese character 'hui' or 'U', and the shape like the Chinese character 'hui' or 'U' is at least one circle.

In one embodiment, the diameter of each of the slots is greater than the maximum outer diameter dimension of each of the anchors, and the spacing between adjacent slots is related to the multiple of the maximum outer diameter dimension of the anchors [2,20 ].

In some embodiments, the inner surface or the outer surface of the occlusion part of the left atrial appendage occluder is provided with a covering film, and when the occlusion part occludes the orifice of the left atrial appendage, the occlusion part and the covering film can effectively occlude the orifice of the left atrial appendage.

In some embodiments, the resilience, thickness, position, and angle of the anchor can be adjusted to accommodate different shapes of cavity tissue, and the anchor can withstand repeated stretching without breaking.

In some embodiments, the plugging portion of the left atrial appendage plugging device has flexibility and can deform adaptively in the direction of the central axis, so that the plugging portion can adapt to pulling forces of different degrees generated by the anchoring unit, and the shape of the plugging portion can change along with the shape of the orifice of the left atrial appendage.

In some embodiments, the deformation capacity of the plugging portion of the left atrial appendage occluder in the central axis direction is greater than the deformation capacity of the filling portion in the central axis direction, so that when the plugging portion can be transformed from the contracted state to the expanded state, the proximal end and the distal end of the plugging portion can approach each other and present a flat shape protruding from the middle, thereby ensuring that the plugging portion can better seal the orifice of the left atrial appendage.

In some embodiments, the left atrial appendage occluder has a greater ability to deform in the radial direction than the filling portion so that the occluder expands from a contracted state to a cage-like structure having a radial dimension greater than the radial dimension of the sealing portion to ensure that it can seal against the left atrial appendage ostium.

In some embodiments, the support frame main body comprises a winding body, the winding body is wound on the support frame main body, at least part of the connecting part is wrapped and fixed at the positions of the two grooves in a penetrating manner, the connecting strength of the anchor stabs and the support frame main body is enhanced, part of the support frame main body is prevented from being in direct contact with autologous tissues, the precipitation amount of metal ions is reduced, the smoothness of the support frame main body is increased to a certain extent, the blocking and pause feeling is avoided, and the support frame main body is prevented from being broken.

In one embodiment, the anchoring thorn is made of elastic material, firstly, the anchoring thorn can be ensured to generate adaptive bending deformation, the anchoring thorn can be ensured to be anchored on the inner cavity tissue of the left auricle without damage, and secondly, when the implantation instrument is recycled and repositioned, the anchoring thorn can be reversely folded and folded along the moving direction of the sheath tube to complete the recycling process.

In some embodiments, one or more fixation structures are provided on the stent body, the fixation structures providing positional definition to the proximal and/or distal ends of the winding body.

In some embodiments, the winding body can effectively control the depth of the anchoring prick into the wall of the left auricle cavity on one hand, and reduce the damage to the wall of the left auricle cavity due to uneven stress, and on the other hand, once the wall of the left auricle cavity is pricked by the anchoring prick, the winding body can immediately cover the prick position, and simultaneously promote the formation of microthrombus nearby, so that the pricking hole is blocked by thrombus, blood is prevented from penetrating into the pericardial cavity, and the risk of pericardial effusion and even cardiac arrest is reduced.

In some embodiments, the winding body is formed by winding a suture, and the material of the suture is made of a high polymer material with elasticity.

Compared with the prior art, the invention has the advantages that:

1. different from the prior art, when the anchoring unit is radially extruded, the connecting part is elastically deformed and drives the tissue contact part to retract towards the radial center relative to the support frame main body, so as to adapt to cavity tissues with different regular forms, reduce the pressure from the cavity tissues born by the telescopic anchoring structure, the non-puncture or low-puncture effect is formed on the tissue contacted with the anchoring part, on one hand, the pushing can be carried out after the implantation instrument is released, on the other hand, when the implantation instrument is not accurately positioned, can be recycled and repositioned or directly move the implantation instrument without considering the damage to the cavity tissue, reduce the times of repeated release, reduce the operation difficulty and improve the operation efficiency, when the implantation instrument is pulled in the proximal direction, the damage to the cavity tissue can be reduced, and the probability of directly puncturing the cavity tissue is reduced.

2. Different from the prior art, when the anchoring unit is the elastic anchoring thorn, firstly, one end of the anchoring unit is fixedly connected with the limiting part, so that the elastic anchoring thorn can be ensured to have a relatively stable structure, the elastic anchoring thorn is favorably arranged, and the implantation instrument is stably fixed on a target position; secondly, the free scalable anchoring structure that forms of the other end of anchoring unit, when the anchor thorn receives radial extrusion, connecting portion take place elastic deformation and form the extension body in the retraction region with spacing portion, can guarantee on the one hand that the elasticity anchor thorn has very big extension space, so that it is directional at random in the home range, thereby reach fine location effect, improve the location accuracy, prevent in the positioning process elasticity anchor thorn scratch vascular wall, on the other hand is under the prerequisite that does not reduce implantation apparatus bulk strength, can prevent that implantation apparatus from taking place the fracture at release and positioning process anchor thorn, improve the anti fatigue life of anchor thorn, the live time of extension implantation apparatus.

3. Different from the prior art, the anchor thorn can be in a linear shape, a bent shape, a J shape, a folded shape, a hook shape or a combination of five shapes; the distal part of the tissue contact part can be prevented from rebounding, and the anchoring effect is prevented from being influenced by the clamping of the anchoring thorn.

4. Different from the prior art, the middle shaft of the main body of the support frame is taken as the center, and the elastic sheet structure can be radially drawn together or scattered or bent, so that the support frame has good radial deformation capacity, axial supporting force and bending capacity, and different anchoring angles can be provided to adapt to the irregular autologous tissue structure.

5. Different from the prior art, the elastic sheet structure comprises a stress buffering structure, the stress buffering structure is in a corrugated shape or a V-shaped shape or an S-shaped shape, the stress buffering structure can absorb the force transmitted to the implantation instrument, and the implantation instrument is prevented from moving at the implantation position or causing fatigue failure due to long-term external stress.

6. Different from the prior art, the distal region of the tissue contact part is provided with the protection structure, and the protection structure comprises the ball head and the fold-shaped structure, so that the distal end of the tissue contact part can be prevented from scratching the wall of the sheath tube in the recovery process of the implantation instrument.

7. Different from the prior art, the connecting part is in a folded shape or a round shape or a hook shape or the combination of the three; wherein the connecting part can surround the limiting part and form a rotation angle towards the tissue contact part; the blocking piece is used for limiting the rotating angle; when the retractable anchoring structure is in a natural state, the distal end of the tissue contact part is positioned in the extending area and positioned in the proximal end area of the blocking part, and the distal end of the tissue contact part is parallel to the axis of the support frame body or naturally faces the retracting area; when the retractable anchoring structure is loaded into the delivery system, the distal end of the tissue contacting portion is positioned inside the three-dimensional space enclosed by the main body of the support frame; all can make the tissue contact site distal end get into through the action of circling round and carry the sheath pipe, guarantee to implant the instrument and retrieve in-process tissue contact site distal end and scratch the sheath pipe wall, be convenient for implant the instrument and retrieve to realize repeatedly releasing and carry out position adjustment many times, also can in time withdraw when implanting the instrument specification selection improper.

8. Different from the prior art, the limiting membrane hole is formed in the membrane body, and the membrane body is used for preventing thrombus in the inner cavity of the left auricle from falling off and enabling the connecting part to freely enter and exit, so that telescopic anchoring is realized, and damage to cavity tissues is reduced.

9. Different from the prior art, when the implantation instrument is the left auricle occluder, the left auricle occluder is in a hat shape after being released, when the anchoring units are positioned on the oblique waist surface of the trapezoid cage-shaped structure of the occlusion part, the oblique waist surface is in an arc surface shape and can be better attached to the inner cavity wall of the left auricle, and the anchoring units can not easily puncture the inner cavity wall of the left auricle on the premise of not reducing anchoring resistance, so that the left auricle occluder can be better fixed, the overall stability of the left auricle occluder and the fatigue resistance of the anchoring units are improved, a good anchoring effect can be still achieved under the condition of reducing the using number of the anchoring units, the excessive stimulation damage of the anchoring units to the blood vessel wall is prevented, and postoperative complications are reduced.

Drawings

Fig. 1a is a schematic diagram of a left atrial appendage occluder in a top-hat shape after release in a first embodiment and a second embodiment of the present invention.

Fig. 1b is a schematic view of the telescopic anchoring structure of the left atrial appendage occluder in the embodiment of the present invention in the anchoring state.

Figure 1c is a schematic view of the telescopic anchoring structure of the left atrial appendage occluder in an embodiment of the present invention in an anchoring state.

Fig. 2a and 2b are schematic views illustrating the state of the retractable anchoring structure elastic sheet structure on the left atrial appendage occluder according to the second embodiment of the present invention.

Fig. 2c and fig. 2d are schematic views of the protection structure in the second embodiment of the present invention in a state of a bulb and a folded structure.

Fig. 3a to 3d are schematic views illustrating the state of the retractable anchoring structure on the left atrial appendage occluder in the third embodiment of the present invention.

Fig. 3e and 3f are schematic views of the retractable anchoring structure in a third embodiment of the present invention.

Fig. 3 g-3 k are schematic views illustrating the state of the anchor thorn with a turning angle according to an embodiment of the present invention.

Fig. 4 a-4 d are schematic views illustrating the process of inserting the anchor into the delivery sheath according to an embodiment of the present invention.

The names of the parts indicated by the numbers in the drawings are as follows: 1-left atrial appendage occluder, 2-anchoring portion, 21-anchoring thorn, 211-tissue contact portion, 212-connecting portion, 22-limiting portion, 23-hole groove, 3-filling portion, 31-occluding portion, 311-inclined waist surface, 4-winding body, 5-spring sheet structure, 61-proximal connecting rod, 62-middle independent rod, 63-distal ring body, 71-bulb, 72-fold structure, 8-expanding body, 9-delivery sheath, 91-outer side, 92-inner side, 93-proximal side, 94 distal side.

Detailed Description

The present invention will be described in further detail with reference to the accompanying drawings and examples.

The proximal end of the invention refers to the end close to the operator, and the distal end refers to the end far away from the operator.

The first embodiment is as follows:

an implantation instrument with a telescopic anchoring structure, the implantation instrument comprising a scaffold body, the scaffold body comprising at least an anchoring portion 2, the anchoring portion 2 comprising one or more repeating anchoring units, wherein the anchoring unit comprises a tissue contacting portion 211, a connecting portion 212; the distal portion of the tissue contacting portion 211 is capable of forming a hanging anchor with the cavity tissue; when the anchoring unit is radially extruded, the connecting portion 212 elastically deforms and drives the tissue contact portion 211 to retract toward the radial center relative to the support frame main body, so that a non-puncture or low-puncture effect is formed on the tissue contacted by the anchoring portion 2.

The components and connections of the present embodiment will be described in detail below with reference to the accompanying drawings:

in this embodiment, as shown in fig. 1b, the anchoring unit is an elastic barb 21, the retracted area is located on the inner side 92, and the extended area is located on the outer side 91; wherein the connecting portion 212 is always in the retracted region and the distal portion of the tissue contacting portion 211 is always in the extended region when the anchoring unit is radially compressed.

In this embodiment, as shown in fig. 1b, 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 with the limiting part 22, and the other end of the anchoring unit forms the telescopic anchoring structure after being dissociated.

In this embodiment, when the anchor 21 is radially compressed, the connecting portion 212 is elastically deformed and forms an expanding body with the limiting portion 22.

In this embodiment, the anchor 21 is made of an elastic material, and the anchor 21 may be curved; the anchoring barbs 21 may be circumferentially arranged around the surface of the main body of the cage for three weeks.

In this embodiment, the three circumferential anchoring thorns 21 are arranged to intersect with each other in the circumferential direction around the main body of the supporting frame, and the projections of the anchoring portions 2 where the three circumferential anchoring thorns are located in the radial direction do not overlap.

In this embodiment, the distal end of the tissue contact portion 211 is provided with a protection structure, which is a fold-shaped structure 72 to prevent the sheath wall from being scratched when the sheath is put in or taken out.

In this embodiment, the retraction region is located on the inside of the outer surface of the distal end of the main body of the scaffold and the extension region is located on the outside of the outer surface of the distal end of the main body of the scaffold.

In this embodiment, the connecting portion 212 and the tissue contacting portion 211 are each arc-shaped.

In this embodiment, as shown in fig. 1, the implantation device is a left atrial appendage occluder 1, which is in a hat shape after being released, the support frame main body includes a mesh support, the mesh support includes a filling portion 3 and a blocking portion 31, wherein the filling portion 3 is cylindrical, the blocking portion 31 is in a trapezoidal cage-shaped structure, along the axial direction of the filling portion 3, the outer diameter of the blocking portion 31 gradually increases along the direction away from the filling portion 3, the filling portion 3 is located in the left atrial appendage and fixed to the wall of the left atrial appendage, and the blocking portion 31 can be attached to the wall of the orifice of the left atrial appendage and block the orifice of the left atrial appendage.

In this embodiment, as shown in fig. 1b, the anchors 21 are all located on the oblique waist surface 311 of the trapezoidal cage-like structure at the periphery of the plugging portion 31, and the oblique waist surface 311 is arc-shaped.

In this embodiment, one end of the anchor unit is a connecting portion 212, and the other end of the anchor unit is a tissue contact portion 211.

In this embodiment, as shown in fig. 1b, the supporting frame body is formed by weaving a plurality of elastic and shape memory wires in an up-down penetrating manner to form a plurality of mesh units, the position-limiting portion 22 is the mesh unit, and one end of the anchoring unit is wound around and fixed to two adjacent vertices.

In this embodiment, many the silk material is fixed by the fixed cover restraint of the fixed cover of distal end and near-end respectively, wherein the distal end of filling portion 3 passes through the fixed cover restraint of distal end is fixed, 3 near-ends of filling portion pass through the fixed cover restraint of near-end is fixed, 3 distal ends of filling portion are equipped with the distal end cavity, the fixed cover of distal end is located in the distal end cavity, can play the effect of collecting the thrombus tissue.

In this embodiment, the arc curved surface of the filling portion 3 is recessed towards the direction close to the central axis of the left atrial appendage occluder 1, so as to avoid abrasion to the pulmonary vein edge and the peripheral tissue of the left atrial appendage when the left atrial appendage occluder 1 is implanted.

In this embodiment, after left auricle occluder 1 implantation finishes, left auricle opening can be buried completely to filling part 3, and shutoff portion 31 can cover left auricle opening and then the shutoff left auricle, and stability and laminating nature are fine, have improved the shutoff effect to left auricle.

In this embodiment, the filling part 3 and the plugging part 31 of the left atrial appendage plugging device 1 are of an integrally formed structure, and have the functions of anchoring and plugging, compared with the prior art, the structure is simplified, so the left atrial appendage plugging device 1 can be more easily and accurately positioned at a target position in the release process, the operation success rate is improved, the operation is convenient, and the stability of the left atrial appendage plugging device 1 is improved.

In this embodiment, the inner surface or the outer surface of the occlusion part 31 of the left atrial appendage occlusion device 1 is provided with a coating, and when the occlusion part 31 occludes the orifice of the left atrial appendage, the occlusion part 31 and the coating can effectively occlude the orifice of the left atrial appendage.

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

In this embodiment, the shutoff portion 3 of left atrial appendage occluder 1 itself has the compliance, can take place adaptability deformation in the axis direction to can adapt to the pulling force of the different degrees that the anchoring unit produced, the shape of shutoff portion 3 can change along with the shape in left atrial appendage drill way.

In this embodiment, the deformation capability of the plugging portion 31 of the left atrial appendage plugging device 1 in the central axis direction is greater than that of the filling portion in the central axis direction, so that when the plugging portion 31 can be transformed from the contracted state to the expanded state, the proximal end and the distal end of the plugging portion can approach each other and present a flat shape protruding in the middle, thereby ensuring that the plugging portion 31 can better seal the orifice of the left atrial appendage.

In this embodiment, the deformability of the occluding portion 31 of the left atrial appendage occluder 1 in the radial direction is greater than the deformability of the filling portion in the radial direction, so that the occluding portion 31 expands from a contracted state to a cage-like structure having a radial dimension greater than that of the sealing portion, thereby ensuring that it can seal the orifice of the left atrial appendage.

Example two:

the difference from the first embodiment is that:

in this embodiment, as shown in fig. 2a and 2b, the anchoring unit is a spring structure 5, the retraction area and the extension area are both located on the outer side 91, and the retraction area and the extension area are overlapped; and the one end and the spacing portion 22 fixed connection of shell fragment structure 5, the other end of shell fragment structure 5 is free to extend towards the support frame main part outside and along the slope of support frame main part near-end, with support frame main part axis is the center, shell fragment structure 5 can radially draw close or scatter or take place to buckle, makes it have fine radial deformability, axial holding power and the ability of buckling to can provide different anchor angles, in order to adapt to the irregular autologous organizational structure of form.

In this embodiment, the distal region of the tissue contacting portion 211 is provided with a protective structure comprising a ball head 71, as shown in figure 2d,

in this embodiment, the ball head 71 is spaced distally from the tissue contacting portion 211.

In this embodiment, the elastic sheet structure 5 includes a stress buffering structure, the stress buffering structure is in a v shape, and the elastic sheet structure 5 is integrally formed by cutting the support frame through a braided tube.

In this embodiment, the limiting portion 22 is the support frame main body grid.

In this embodiment, a circle of the spring structure 5 is circumferentially arranged around the surface of the support frame and is located on the inclined waist surface 311 of the trapezoidal cage-shaped structure at the periphery of the blocking portion 31.

Example three:

the difference from the first embodiment is that:

in this embodiment, as shown in fig. 3a, the implantation apparatus is a left atrial appendage occluder 1, the support frame main body includes a self-centering structure, the self-centering structure includes a central piece, the self-centering structure is a three-dimensional structure formed by the outward divergence of the central piece, and in a natural unconstrained state, the central piece is located inside the self-centering structure.

In this embodiment, the self-centering structure comprises, in order from the direction of outward divergence of the central member, a proximal connecting rod 61, a central independent rod 62, and a distal collar 63.

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

In this embodiment, the three-dimensional structure includes a curled structure with a smaller curvature radius.

In this embodiment, the distal collar 63 is located in the peripheral contour region of the crimp-like structure, in which region the outer surface of the crimp-like structure is provided with a plurality of circumferential resilient anchoring barbs 21.

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

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.

In this embodiment, the left atrial appendage occluder 1 further comprises an occluding disc and a connecting piece, the occluding disc and the self-center structure are connected through the connecting piece, the occluding disc is of a three-dimensional cage-shaped structure, and a first covering film is arranged inside or on the outer surface of the occluding disc.

In this embodiment, as shown in fig. 3d, when the anchor 21 is radially pressed, the connecting portion 212 is elastically deformed and forms an expanding body 8 with the position-limiting portion 22.

In this embodiment, as shown in fig. 3c, the support frame main body includes a winding body 4, the winding body 4 is wound on the support frame main body, and at least a part of the connection portion is wrapped and fixed at two positions of the hole grooves 23, so as to enhance the connection strength between the anchor 21 and the support frame main body, avoid a part of the support frame main body directly contacting with the autologous tissue, reduce the precipitation amount of metal ions, increase the smoothness of the support frame main body to a certain extent, avoid the feeling of sticking and breaking, and prevent the support frame main body from breaking.

In this embodiment, one or more fixing structures are disposed on the support frame main body, and the fixing structures implement position limitation on the proximal end and/or the distal end of the winding body 4.

In this embodiment, winding body 4 can effectively control the degree of depth that anchor thorn 21 pierces the left auricle chamber wall on the one hand, reduces and injures left auricle chamber wall because the atress is uneven, and on the other hand in case the extremely thin region of left auricle chamber wall is stabbed by anchor thorn 21, this winding body 4 can cover the position of stabbing immediately, promotes the formation of microthrombus near simultaneously, blocks up the stab hole through the thrombus, prevents that blood from permeating the pericardial cavity, reduces the risk of pericardial effusion even cardiac arrest.

In this embodiment, the winding body 4 is formed by winding a suture made of an elastic polymer material.

In this embodiment, the delivery system of the implantation device includes a delivery cable and a delivery sheath, the end of the distal ring 63 touches the wall of the left atrial appendage, the delivery cable is further pushed, the distal ring moves towards the inside of the left atrial appendage, part of the anchors 21 begin to touch the wall of the left atrial appendage, when the end reaches a proper position, the delivery cable is continuously pushed and the delivery sheath is withdrawn, so that the distal ring 63 gradually expands inside the left atrial appendage, the anchors 21 which initially touch the wall of the left atrial appendage may be separated from the anchors and are in a suspended state, but more anchors 21 which gradually touch the wall of the left atrial appendage following the expansion of the distal ring 63 gradually touch the wall of the left atrial appendage to realize the anchors, and in the whole process, the anchors 21 do not touch the delivery system, which is beneficial to the recovery of the implantation device.

In this embodiment, the position-limiting part 22 is a hole 23 located on the distal ring 63.

In this embodiment, as shown in fig. 3b and 3c, the anchor 21 is formed by sequentially passing the wire material with elasticity and shape memory through the corresponding hole slots to be bent, shaped and woven, and a part of the connecting portion 212 penetrates through and is fixed to the two hole slots 23 and takes a shape of a loop, and the loop takes one turn.

In this embodiment, one end of the anchoring unit is engaged with the hole 23 and at least a part of the anchoring unit is located in the hole 23.

In this embodiment, the anchoring unit is located in the filling portion 3, the surface of the main body of the supporting frame is covered with a thin film body for blocking thrombus, a limiting film hole is formed in the thin film body, and part of the connecting portion 212 can freely enter and exit the limiting film hole.

In this embodiment, the anchor units and the hole grooves 23 correspond one-to-one in number and position.

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

In this embodiment, the connecting portion 212 can form a rotation angle around the stopper portion 22 and toward the tissue contact portion 211.

In this embodiment, the support frame body includes a blocking member for limiting a rotation angle; the blocking member is a hole groove 23, and the connecting portion can freely enter and exit the hole groove.

In this embodiment, when the retractable anchoring structure is in the natural state, the distal end of the tissue contacting portion 211 is located at the protruding region and at the proximal region of the blocking member, and the distal end of the tissue contacting portion 211 is parallel to the axis of the main body of the scaffold or naturally faces the retracted region; when the retractable anchoring structure is loaded into the delivery system, the distal end of the tissue contacting portion 211 is positioned within the space defined by the main body of the scaffold.

In this embodiment, when the anchor 21 is in a natural state, the connecting portion is located on the proximal end side of the stopper portion, the distal end side of the stopper portion, and the inner side 92; tissue contacting portion 211 is located on outer side 91; and when the anchoring spike 21 has said angle of rotation, the connection portion 212 at the distal side, partly the connection portion 212 at the inner side 92, may extend to the outer side 91.

The above description is only a preferred embodiment of the present invention, and for those skilled in the art, the present invention should not be limited by the description of the present invention, which should be interpreted as a limitation.