CN116077105A - Plugging device and plugging system - Google Patents

Abstract

The invention relates to a plugging device and a plugging system, wherein the plugging device comprises a plugging part, a fixing part and a first clamping part, the plugging part comprises a self-expanding body, the fixing part is positioned at one end of the plugging part, and the first clamping part is fixed on the plugging part through the fixing part. The plugging device provided by the invention has the advantages that on one hand, the plugging effect is not influenced by the shape of the left atrium wall and the right atrium wall, so that the plugging effect is better, and residual shunt is not caused; on the other hand, the plugging device has no double-disc structure, can make the instrument smaller, reduces the metal content of the implanted instrument, reduces the risk of human body allergy to nickel ions, and does not influence the possibility of the inter-atrial re-puncture; in yet another aspect, because the structure of the double occlusion discs is eliminated, for longer foramen ovale passages, the two disc occlusion devices can be prevented from squeezing the atrial septum tissue due to the fact that the occlusion discs are pulled into the foramen ovale passages due to the longer foramen ovale passages, thereby reducing the damage to the myocardium.

Description

Plugging device and plugging system

Technical Field

The invention relates to the field of medical instruments, in particular to a plugging device and a plugging system.

Background

This section provides merely background information related to the present disclosure and is not necessarily prior art.

Patent Foramen Ovale (PFO) is a common congenital heart disease, which is an abnormal passage of atrial septum between the left atrium and the right atrium, particularly because the primary septum and the secondary septum are not adhered to each other and merge, resulting in a diagonal passage of overlapping myocardium across between the left atrium and the right atrium. This channel can cause thrombus of the venous system to follow the blood flow to the left heart, which in turn can cause cerebral infarction and migraine. It is believed that the primary and secondary compartments of each individual overlap to different extents and the non-fused distances, making the PFO channels of different shapes and sizes.

In recent years, the potential hazard of patent foramen ovale has led the academy to pay more attention to it and to treat it more and more aggressively. Currently, the mainstay of treatment for PFO is percutaneous (femoral vein) occlusion using occluders.

The occluder used in the prior art is generally an "I" shaped occluder 60 having two occluding plates and a waist formed by braiding nickel titanium alloy wires, the occluder 60 comprising an occluding plate 61 and a barrier layer 62 disposed within the occluding plate, as shown in figures 1-3. On the one hand, in the existing i-shaped plugging device, the plugging discs 61 are made of nickel-titanium alloy and are made of dense metal frameworks, the metal frameworks are high in rigidity, the waist and the plugging discs are integrally woven, the waist compliance is poor, and the shape of the plugging discs and the waist are mutually influenced. Because the oval hole 91 channel is inclined to the atrial septum 90 to a certain extent, the shape adaptability of the plugging disc of the integrated I-shaped plugging device to the tissue is poor, and the tissue is easy to deform due to extrusion of the septum tissue, so that certain tissue damage is caused; on the other hand, after the occluder is released in the foramen ovale, the disc surface of the occluding disc forms an included angle alpha relative to the interatrial septum tissue, as shown in fig. 3, so that the occlusion effect is affected when the occluding disc surface is not tightly attached to the interatrial septum tissue and is pulled into the foramen ovale channel for long foramen ovale channels (the interatrial septum tissue wall is thicker), the tissue damage is serious due to the increase of tissue extrusion, and meanwhile, the disc surface is lifted, the alpha angle is increased, the attachment of the occluding disc and the interatrial septum is affected, and residual shunt (left atrium LA flows from right atrium RA) is caused, so that the occlusion effect is affected, as shown in fig. 3.

Therefore, there is a need for a plugging device that can adapt to the tissue morphology of the inter-atrial septum to reduce tissue damage, and can prevent residual shunt so as to have better plugging effect.

Disclosure of Invention

The invention solves the technical problem of how to provide a plugging device which not only can adapt to the tissue form of the inter-atrial septum to reduce tissue damage, but also can prevent residual shunting so as to have better plugging effect.

In one aspect, the present invention provides a plugging device comprising a plugging portion, a fixing portion and a first clip portion, wherein the plugging portion comprises a self-expanding body, the fixing portion is located at one end of the plugging portion, and the first clip portion is fixed to the plugging portion through the fixing portion.

In one embodiment, the self-expanding body comprises a main body part and a first constriction part, the plugging part comprises a first end part, the first constriction part is constricted at the first end part, and the fixing part is positioned at the first end part.

In one embodiment, the self-expanding body further includes a second converging portion disposed opposite to the first converging portion, the plugging portion further includes a second end portion, the second converging portion converges at the second end portion, at least two fixing portions are disposed on the fixing portion, and the plugging device further includes a second clamping portion, and another fixing portion is disposed on the second end portion so that the second clamping portion is fixed to the plugging portion through another fixing portion.

In one embodiment, the self-expanding body includes a main body portion, a first converging portion and a second converging portion, the first converging portion is located at a proximal end of the main body portion, the second converging portion is located at a distal end of the main body portion, the end portion includes a first end portion and a second end portion, the first converging portion converges at the first end portion, the second converging portion converges at the second end portion, and the fixing portion is located at the second end portion.

In one embodiment, the end portion includes a first end portion, a side of the first end portion, which is close to the self-expanding body, includes a first open groove, the first open groove is used for converging a first converging portion of the self-expanding body, a side of the first end portion, which is far away from the self-expanding body, includes a second open groove, and an internal thread or a threaded connection member is disposed in the second open groove.

In one embodiment, the first clamping portion includes a connecting portion, an extending portion, a bending portion and a clamping piece, the connecting portion is connected with the fixing portion, the extending portion extends obliquely from the connecting portion and gradually away from the fixing portion, and the bending portion extends from one end of the extending portion away from the fixing portion in a bending manner and is connected with the clamping piece.

In one embodiment, the clip is at an acute angle to the extension.

In one embodiment, the extension extends from the connection toward a side remote from the self-expanding body.

In another aspect, the invention also provides an occlusion system comprising an occlusion device as described above, wherein the occlusion system comprises a delivery sheath and a delivery cable, the delivery cable being sleeved in the delivery sheath.

In one embodiment, the plugging system further comprises a delivery handle and a pull wire, the pull wire is used for being connected with the first clamping portion at the proximal end of the plugging device, the delivery handle comprises a first control piece, the pull wire is connected with the first control piece, and the first control piece is connected with the pull wire in the delivery handle to control retraction of the pull wire.

The technical effects of one embodiment of the invention are as follows: the plugging device provided by the invention consists of a plugging part comprising a self-expanding body and a first clamping part positioned at one end of the plugging part, wherein the plugging part self-expands to be self-adaptive and supported in the foramen ovale channel, so that the plugging effect of cutting off blood flow is achieved. On one hand, the plugging effect of the plugging part does not need to be attached to the shape of the left and right atrium walls, and the plugging or attaching performance of the plugging part is not influenced by the shape of the left and right atrium walls, so that the plugging effect is better, and residual shunt is not caused; on the other hand, as the plugging device provided by the invention has no double-disc structure, the device can be made smaller, and only the size of the oval foramen channel is required to be adapted to realize plugging, so that the metal content of the implanted device can be reduced, the risk of nickel ion allergy of a human body is reduced, and when a patient needs to reuse the atrial septum puncture due to other causes such as atrial fibrillation or mitral regurgitation, the situation that the plugging disc surface of the plugging device blocks the whole atrial septum is avoided, namely the possibility of the atrial septum re-puncture is not influenced; in still another aspect, the plugging device provided by the invention can avoid the extrusion of the atrial septum tissue caused by the fact that the plugging disc part close to the waist is pulled into the oval hole channel due to the longer oval hole channel for the longer oval hole channel, thereby reducing the damage to the myocardium caused by the implantation of the plugging device.

Drawings

FIG. 1 is a perspective view of an integrated I-shaped occluder in the prior art;

FIG. 2 is a atrial septum tissue morphology with patent foramen ovale;

FIG. 3 is a schematic illustration of the residual bypass caused by the occluder of the prior art;

fig. 4 is a schematic structural diagram of the plugging device according to embodiment 1 of the present invention in a natural state;

fig. 5 is a perspective view of the plugging device according to embodiment 1 of the present invention in a natural state;

fig. 6 is a schematic structural view of a first end portion according to embodiment 1 of the present invention;

FIG. 7 is a cross-sectional view taken along the direction A-A in FIG. 6;

fig. 8 is a schematic structural view of a second end portion according to embodiment 1 of the present invention;

FIG. 9 is a schematic view of the assembly structure of the first clamping portion and the second end portion according to embodiment 1 of the present invention;

fig. 10 is a schematic structural view of a first clip portion according to embodiment 1 of the present invention;

FIG. 11 is a schematic diagram of a fully loaded plugging system according to example 1 of the present invention;

fig. 12 is a schematic view of a structure in which a delivery sheath of the plugging system according to embodiment 1 of the present invention is retracted to a bending position of the first clip portion;

FIG. 13 is a schematic view of a first clamping portion of the plugging system according to the embodiment 1 of the present invention, wherein the first clamping portion clamps the spacer tissue on the left side of the left heart between the plugging portion and the first clamping portion;

FIG. 14 is a schematic view showing the self-expanding structure of the plugging device of the plugging system according to the embodiment 1 of the present invention, which is released from the binding of the delivery sheath;

fig. 15 is a schematic view showing the plugging device according to the embodiment 1 of the present invention implanted in the foramen ovale;

fig. 16 is a schematic structural view of the plugging device according to embodiment 2 of the present invention in a natural state;

fig. 17 is a schematic view of a structure of the plugging device according to embodiment 2 of the present invention at another angle in a natural state;

FIG. 18 is a schematic view showing the assembly of a delivery sheath, a delivery cable and a delivery handle according to embodiment 2 of the present invention;

FIG. 19 is a cross-sectional view taken in the direction B-B of FIG. 18;

FIG. 20 is a schematic structural view of a conveying handle and a partial internal structure of the conveying handle according to embodiment 2 of the present invention;

FIG. 21 is a schematic view showing the structure of the plugging device according to the embodiment 2 of the present invention;

fig. 22 is a schematic structural view of the embodiment 2 of the present invention, in which the first clip portion of the delivery sheath that is retracted to be folded is exposed at the distal end face of the delivery sheath;

FIG. 23 is a schematic view of a structure for adjusting the first knob release pull wire according to embodiment 2 of the present invention;

fig. 24 is a schematic structural diagram of the first clip portion in a natural clip state after the release of the traction wire according to embodiment 2 of the present invention is completed;

fig. 25 is a schematic view showing the embodiment of the plugging device according to the present invention in the foramen ovale passage;

FIG. 26 is a schematic view of an occlusion device according to another embodiment of the present invention;

fig. 27 is a schematic structural view of an occlusion device according to still another embodiment of the present invention.

Detailed Description

In order that the invention may be readily understood, a more complete description of the invention will be rendered by reference to the appended drawings. The drawings illustrate preferred embodiments of the invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "fixed to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "inner", "outer", "left", "right" and the like are used herein for illustrative purposes only and do not represent the only embodiment.

For convenience of description, the terms "distal" and "proximal" are defined herein, as are conventional terms in the art of interventional medical devices. Specifically, "distal" refers to the end of the procedure that is distal to the operator, and "proximal" refers to the end of the procedure that is proximal to the operator, typically from the right atrium to the left atrium. Axial "generally refers to the longitudinal direction of the medical device as it is being delivered," circumferential "generally refers to the direction about the" axial "direction, and" radial "generally refers to the direction of the medical device perpendicular to its" axial "direction and passing through the central axis, and defines the" axial "and" radial "directions of any component of the medical device in accordance with this principle.

Example 1

The present invention provides an occlusion device 10 and an occlusion system, as shown in fig. 4-15, wherein the occlusion device 10 comprises an occlusion part 11, a fixing part 1131 and a first clamping part 12, wherein the first clamping part 12 is fixedly connected to the occlusion part 11 through the fixing part 1131 so as to be clamped in a room septum tissue by the first clamping part 12, thereby fixing the occlusion part 11 in a passage of an oval hole 91, as shown in fig. 15.

In the present embodiment, as shown in fig. 4 to 7, the plugging portion 11 includes a self-expanding body 111 and an end portion, and the self-expanding body 111 includes a main body portion 1111, a first converging portion 1112, and a second converging portion 1114. The first constriction portion 1112 is disposed at a proximal end of the self-expanding body 111, the second constriction portion 1114 is disposed at a distal end of the self-expanding body 111, such that the first constriction portion 1112 and the second constriction portion 1114 are disposed at two ends of the self-expanding body opposite to each other, each of the first constriction portion 1112 and the second constriction portion 1114 includes a connection end connected to the main body portion 1111 and a tail end opposite to the connection end, and a radial width dimension of the tail end is smaller than a radial width dimension of the connection end so as to form a constriction shape at two ends of the self-expanding body 111, so that whether the constriction degrees (i.e., lengths in an axial direction from the connection end to the tail end) of the first constriction portion 1112 and the second constriction portion 1114 are the same is not limited. The tail end of the first converging portion 1112 of the self-expanding body 111 is converging in the first end portion 112, and the tail end of the second converging portion 1114 is converging in the second end portion 113. The tail end of the first converging portion 1112 may be directly converged in the first end portion 112, or the tail end of the first converging portion 1112 may be first converged in the embedding portion and then embedded in the first end portion 112 by the embedding portion, so that the plugging portion 11 is fixedly connected with the first end portion 112; similarly, the tail end of the second converging portion 1114 may be directly converged in the second end portion 113, or the tail end of the second converging portion 1114 may be first converged in the inserting portion and then inserted into the second end portion 113 through the inserting portion, so that the plugging portion 11 is fixedly connected to the second end portion 113, and the inserting portion may be a sealing head with a smaller size than the first end portion and the second end portion for converging the tail ends of the braided wires.

The main body 1111 of the self-expanding body 111 is a self-expanding mesh tube structure with a size of an oval hole, and the choke film 1113 may be disposed in the main body 1111 or a converging portion of the mesh tube structure may be woven into a dense mesh to perform choke function, and the choke film 1113 may be fixed in the mesh tube structure by stitching or the like. The middle area of the waist can be provided with a choke film 1113, or two choke films can be arranged in the main body 1111 at intervals to increase choke reliability.

The end portions include a first end portion 112 and a second end portion 113, the first end portion 112 is located at a proximal end of the plugging portion 11, the second end portion 113 is located at a distal end of the plugging portion 11, and the first end portion 112 includes a first open groove 1121 and a second open groove 1122 disposed opposite to the first open groove 1121, so that the first end portion 112 has a groove structure with both ends open. The side of the first end 112 near the self-expanding body 111 is a first open slot 1121, the first open slot 1121 is used for converging the first converging portion 1112 of the self-expanding body 111, the side of the first end 112 far away from the self-expanding body 111 is a second open slot 1122, and the second open slot 1122 is used for providing an internal thread or a threaded connection (the threaded connection is internally provided with an internal thread), wherein the threaded connection can be integrally connected with the first end 112 or welded together in a split manner. The internal thread is flush with the end surface of the second open groove 1122 on the side away from the self-expanding body 111, or the internal thread is close to the end surface of the second open groove 1122 on the side away from the self-expanding body 111 so as to be connected with the external thread on the distal end of the delivery cable 60 of the delivery device, thereby realizing the delivery and release of the plugging device 10 through the internal and external threads.

As shown in fig. 8-10 and fig. 4-5, the second end 113 includes a fixing portion 1131, the first clamping portion 12 is fixed on the plugging portion 11 through the fixing portion 1131, in this embodiment, the fixing portion 1131 is provided with two slots 1131a along the circumferential direction, and the slots 1131a may be opposite to each other, and the first clamping portion 12 is fastened on the fixing portion 1131 of the second end 113 through the slots 1131 a.

In this embodiment, as shown in fig. 4, the first clamping portion 12 is disposed on the second end 113 at the distal end of the plugging portion 11 to form a clamping structure with the plugging portion 11, or the first clamping portion itself forms a clamping structure, so that the clamping structure can be used to clamp the atrial septum at the foramen ovale, and the first clamping portion itself forms a clamping structure with the plugging portion, which is not limited herein, so long as the clamping of the first clamping portion to the tissue to fix the plugging portion in the foramen ovale passage can be achieved. In other embodiments, the first clip portion may also be provided on the first end portion of the proximal end of the occluding portion, or the first clip portion may be provided on the first end portion and the second clip portion may be provided on the second end portion, respectively.

The plugging device 10 for patent foramen ovale provided by the invention consists of a plugging part 11 which is compressible in the radial direction and a first clamping part 12 clamped on tissues, wherein the size of the plugging part 11 is generally slightly larger than the radial size of the foramen ovale, so that the plugging part 11 is self-expanded to be self-adaptive and supported on a foramen ovale channel, thereby playing a role in plugging blood flow interception. On the one hand, the plugging effect of the plugging part 11 is better and residual shunt is not caused because the plugging or attaching performance of the plugging part is not affected by the shape of the left and right atrium walls without attaching the shape of the left and right atrium walls; on the other hand, as the plugging device 10 provided by the invention has no double-disc structure, the device can be made smaller, and only the size of the oval foramen channel is required to be adapted to realize plugging, so that the metal content of the implanted device can be reduced, the risk of the human body on nickel ion allergy is reduced, and when the patient needs to reuse the atrial septum puncture due to other causes such as atrial fibrillation or mitral regurgitation, the situation that the plugging disc surface of the plugging device blocks the whole atrial septum is avoided, namely the possibility of the atrial septum re-puncture is not influenced; in yet another aspect, because the dual occlusion disc structure is eliminated, the occlusion device 10 provided by the present invention can avoid the extrusion of the atrial septum tissue caused by the fact that the portion of the occlusion disc near the waist of the two disc occlusion devices 10 is pulled into the foramen ovale channel due to the longer foramen ovale channel, thereby reducing the damage to the myocardium caused by the implantation of the occlusion device 10.

As shown in fig. 8 to 10, the first clamping portion 12 includes a connection portion 121, an extension portion 122, a bending portion 123, and a clip 124, and the connection portion 121 of the first clamping portion 12 is partially disposed in the insertion groove 1131a of the fixing portion 1131. The connecting portion 121 includes two clamping portions 1211, the clamping portions 1211 include a connecting end connected to the extension portion 122 and a free end opposite to the connecting end, the free ends of the two clamping portions 1211 are close to each other on a side far away from the extension portion 122 so that the two clamping portions 1211 are encircling with respect to the fixing portion 1131, so that the clamping portions 1211 are fastened when being clamped to the fixing portion 1131, and a small gap is left between the free ends of the two clamping portions 1211 so that the connecting portion 121 can be clamped to the fixing portion 1131 along the caulking groove 1131a of the fixing portion 1131. In other embodiments, the connecting portion 121 may be welded to the second end 113 or integrally formed therewith.

The extension portion 122 extends from the connection portion 121 toward a side away from the self-expanding body 111 and gradually away from the fixing portion 1131, and the bending portion 123 bends from an end of the extension portion 122 away from the fixing portion 1131 and extends toward the first end 112, so that an acute angle is formed between the clip 124 and the extension portion 122, thereby maintaining the clamping force of the first clamping portion 12. The clip 124 extends from the end of the curved portion 123 away from the extending portion 122 toward an axis parallel to the main body portion 1111 or is slightly inclined toward the side of the self-expanding body 111 so as to be in contact with or nearly in contact with or slightly press against the main body portion 1111. The first clamping portion 12 uses an elastic material, so that the first clamping portion 12 is in an elastic clip structure, thereby forming a clamping structure with the self-expanding body 111, so as to clamp the spacing tissue between the first clamping portion 12 and the blocking portion 11, as shown in fig. 4 and 15.

As shown in fig. 11-14 in conjunction with fig. 4-10, the elasticity of the first clamping portion 12 may enable the clip 124 to fold away from the main body portion 1111 under the action of an external force, while maintaining a tendency to fold back, and as shown in fig. 11, when the clip 124 is loaded into the delivery sheath 50 in a state that the bending portion 123 is turned to a side of the second end 113 away from the self-expanding body 111 (in a radially compressed state when the blocking portion 11 is loaded into the delivery sheath 50), the clip 124 tends to fold back to a clamped state. When the delivery sheath 50 is withdrawn to release the clip 124 during the release of the occlusion device 10, the clip 124 returns to the clamped state after releasing the clip due to the elasticity of the first clamping portion 12 itself, thereby achieving the clamping of the tissue during the release of the occlusion device 10 in vivo, as shown in fig. 13.

Because the folding degree of the clamping piece 124 in the delivery sheath 50 is approximately 180 ° compared with the folding degree in a natural state, the stress at the folding fulcrum is too large, so that fatigue fracture is easily caused, the extension part 122 is reversely extended relative to the main body 1111 and matched with the bending part 123, when the clamping piece 124 is folded, the reversely extended extension part 122 can conform to the folding trend of the clamping piece 124, meanwhile, the bending of the bending part 123 is combined, the clamping force of the first clamping part 12 is maintained, the risk of fatigue fracture when the clamping piece 124 is folded is reduced, namely the failure risk of the first clamping part 12 is reduced, and the reliability of the first clamping part 12 released in the body to realize clamping is increased.

As shown in fig. 10 in combination with fig. 4-5, the clip 124 includes an inner side 1241 and an outer side 1242, and in the natural state of the plugging device 10, the side of the clip 124 near the main body 1111 is the inner side 1241, and the side of the clip 124 far from the main body 1111 is the outer side 1242. The inner side 1241 is provided with a plurality of anchors 1243 at intervals, and the anchors 1243 are inclined toward the fixing portion 1131 connected to the clip 124 to increase friction force against the tissue when the first clip portion 12 is clipped to the tissue.

In order to retract the occluding device 10 within the delivery sheath 50 such that the clip 124 has a tendency to return to a clamped condition, the inner side 1241 of the folded clip 124 is positioned adjacent to the inner wall of the sheath of the delivery sheath 50, and the end of the anchor 1243 adjacent to the main body 1111 is provided with a rounded chamfer to prevent thrombus from being caused by scraping debris generated by the inner wall of the delivery sheath 50 during movement of the anchor 1243 relative to the delivery sheath 50 during retraction of the delivery sheath 50 to release the occluding device 10.

As shown in fig. 11-14, the present embodiment further provides an occlusion system including the above occlusion device 10, and the occlusion system further includes a delivery cable 60, a delivery sheath 50, and a loader (not shown), wherein when the occlusion device is implanted in a body, the first end 112 is located on the right heart side and the second end 113 is located on the left heart side, so that the internal thread in the second opening groove 1122 of the first end 112 is in threaded connection with the external thread at the distal end of the delivery cable 60, based on the puncture direction from the right atrium RA to the left atrium LA.

During operation, puncture is carried out from one femoral artery, and then a guide wire is sent to the left atrium position, so as to establish an in-vivo conveying track; the delivery sheath 50 is delivered along the guidewire to the spacer tissue 92 beyond the left heart for a length (in the corresponding procedure for the occluding device provided in this embodiment, the initial position of the delivery sheath to begin the occluding device release procedure is beyond the length of about one clip 124, as shown in reference to fig. 11); the occlusion device 10 is retracted by the loader after threading the internal thread of the second open groove 1122 of the first end 112 into the external thread of the distal end of the delivery cable 60, and the loader is connected to the proximal end of the delivery sheath 50, whereby the occlusion device 10 is loaded to the proximal end of the delivery sheath 50 in the retracted state (the occlusion portion 11 is radially compressed, the first clip portion 12 is folded away from the main body portion, as shown in fig. 11); the delivery cable 60 is then pushed distally to deliver the occluding device 10 to the distal end of the delivery sheath 50.

The release process into the occlusion device 10 is then as follows:

firstly, the delivery cable 60 is fixed, and at the same time, the distal end face of the delivery sheath 50 is retracted to the left heart side spacer tissue 92 to expose the bent portion (the bending portion 123) of the first clip portion 12 at the distal end of the delivery sheath 50, referring to the intermediate state of fig. 12 and 13, at this time, the folded state of the first clip portion 12 loses the restraint of the delivery sheath 50, and the clip 124 is rebounded toward the natural state due to the self elasticity of the first clip portion 12, so that the left heart side spacer tissue 92 is clamped between the blocking portion 11 and the first clip portion 12, as shown in fig. 13;

subsequently, the delivery sheath 50 is continued to be withdrawn, such that the occluding device self-expands out of the way of the delivery sheath, as shown in figure 14, such that the self-expanding body 111 self-expands within the foramen ovale and is supported against the foramen ovale passageway, such that the body portion 1111 of the occluding portion 11 is supported within the foramen ovale passageway;

and checking whether blood is shunted or not by ultrasound to judge the blocking effect of the blocking device 10, if the blocking effect is poor, the blocking device 10 can be reapped in the delivery sheath 50 by pushing the delivery sheath 50 forward, so that the adjustment and the re-release of the blocking device 10 are realized;

after confirming the plugging effect, the threaded delivery cable 60 is released from the plugging device 10 and the human body is withdrawn, thereby completing the operation.

Example 2

Embodiment 2 proposes another plugging device 20 and plugging system, as shown in fig. 16-25, the plugging device 20 of embodiment 2 is the same as or the same as the plugging device 10 of embodiment 1, and the characteristic parts will not be described herein, which is mainly different in that, in the plug plugging device 20 of embodiment 2, as shown in fig. 16-17 in combination with fig. 18, a fixing portion 2121 is provided at the first end 212, a first clip portion 22 is fixed on the first end 212 by the fixing portion 2121, one end of the clip 224 away from the bending portion 223 is further provided with a perforation 2243, and the perforation 2243 penetrates through the inner side 2241 and the outer side 2242 so as to be connected with a pull wire 71 provided in the delivery device when the plugging device 20 is retracted in the delivery sheath 50.

The present embodiment also provides an occlusion system including the occlusion device 20, and the feature parts of the occlusion system that are the same as or can be used in the embodiment 1 are not repeated herein, and the main difference is that, as shown in fig. 18-20 in conjunction with fig. 16-17, the occlusion system of the embodiment 2 further includes a delivery handle 70, the delivery handle 70 includes a first control member 72, an opening 73 and a second control member 74, the first control member 72 includes a first knob and is disposed at a proximal end of the delivery handle 70, the second control member 74 includes a second knob and is disposed at a distal end of the delivery handle 70, and the opening 73 is disposed at a proximal end of the second control member 74 and is disposed at a distal end side of the first control member 72. Wherein, the first control piece 72 is connected with the traction wire 71 in the conveying handle 70, the second control piece 74 is connected with the conveying steel cable 60 in the conveying handle 70, and the spacing device 75 is arranged in the opening 73, so that two wires formed by the reverse folding of the traction wire 71 can be separated at two sides of the spacing device 75 at a certain position of the conveying handle 70, one of the wires is convenient to be cut off, and then the connection between the perforation 2243 and the traction wire 71 is released, so that the traction wire 71 is recovered into the conveying handle 70, and the spacing device can prevent the two wires from being cut by mistake, thereby causing the recovery failure of the traction wire. The spacing means may be provided as a spacer or guide plate or other structure that serves as a spacing, so long as the folded back traction wires are spaced apart to prevent false cutting of the two wires.

The traction wire 71 comprises a first end and a second end, the first end of the traction wire 71 is connected with the first control piece 72 in a winding way, when the clamping piece 224 is in a turnover state, a release allowance is left between the traction wire 71 and the first knob so that when the first knob is rotated, the clamping piece 224 can be released to a state of natural clamping by the clamping piece through the traction wire 71; after the second end of the traction wire 71 penetrates the through hole 2243, the second end is folded back to the first knob and then connected with the first knob or the inner wall of the conveying handle 70 in the inner cavity of the conveying handle 70, so that the traction wire 71 forms two opposite folding lines and is connected with the clamping piece 224 through the through hole 2243, when the first knob is rotated, the traction wire 71 can be folded and unfolded, and then the release of the first clamping part 22 can be realized after the plugging part 21 is self-expanded, so that the first clamping part 22 clamps the spacing tissue 93 on one side of the right center between the main body part and the first clamping part 22.

As shown in fig. 19, an axial channel 61 is provided in the delivery sheath 50 for the pull wire 71 to penetrate, so that the pull wire 71 can move relatively along the axial channel, which is convenient for the first control member 72 to retract and release the pull wire and for the pull wire 71 to be recovered after cutting.

As shown in fig. 20, the first control member includes a first knob 721, a transmission shaft 722, and a worm gear structure, the first knob 721 is connected to a worm wheel of the worm gear structure 723 through the transmission shaft 722, so that the worm can rotate around a direction perpendicular to the transmission shaft 722, so that the first knob 721 can drive the worm winding and unwinding traction wire 71 by rotating around a central axis of the conveying handle 70 in a circumferential direction. The worm is supported at both ends thereof in the delivery handle by a fixing rod 724 and is rotatable on a fixing shaft about a central axis of the worm, and further includes two oppositely disposed wire spools 725, the two wire spools 725 being respectively fixed to the first and second ends of the traction wire 71, and the first and second ends of the traction wire 71 being wound around or released from the respective wire spools 725 as the first knob 721 is rotated.

Except for the difference between the procedure of penetrating the pull wire 71 and the procedure of folding the first clip portion 22 during loading, the loading procedure of the plugging device 20 provided in this embodiment is basically the same as that of embodiment 1, and is not repeated here, since the position of the first clip portion 22 of the plugging device 20 in this embodiment is different, the position of the delivery sheath 50 delivered in advance is different from that of embodiment 1, the delivery sheath 50 does not need to exceed the spacing tissue on the left heart side, the distal end face of the delivery sheath 50 is located in the oval foramen, and after the loading of the delivery device is completed, the position to be released can be adjusted according to the positions of the plugging device 20 and the first clip portion 22 relative to the spacing tissue 93 on the right heart side, as shown in fig. 21-24, the releasing procedure of the plugging device 20 provided in this embodiment is as follows:

first, referring to fig. 21 to 22, the delivery cable 60 is fixed while the distal end face of the delivery sheath 50 is retracted to the atrial septum tissue on the right heart side so that the self-expanding body self-expands in the foramen ovale to fit the foramen ovale, thereby supporting the main body portion of the occlusion portion 21 in the passage of the foramen ovale;

then, the delivery sheath 50 is continuously withdrawn, the folded first clamping part 22 is exposed out of the distal end of the delivery sheath 50, as shown in fig. 22 and fig. 18-20, then the first knob 721 is rotated to control the release of the traction wire 71, the clamping piece 224 rebounds towards the natural state along with the loss of the constraint of the traction wire 71 due to the elasticity of the first clamping part 22, the first clamping part can be slowly released by controlling the first knob, so that the atrial septum tissue on the right heart side is clamped between the blocking part 21 and the first clamping part 22, the first clamping part can be slowly released by adjusting the first control piece, and the damage to the myocardial membrane caused by the elasticity suddenly released by the first clamping part is prevented;

and checking whether blood is shunted or not by ultrasound to judge the plugging effect of the plugging device 20, if the plugging effect is poor, the first control member 72 can be adjusted to pull the traction wire 71 back to enable the first clamping part 22 to be folded to a state that the outer side surface of the clamping piece is attached to the conveying steel cable (a state shown in fig. 22), then the conveying sheath 50 is pushed forward, the plugging part 21 is bundled, and the plugging device 20 is integrally and re-bundled in the conveying sheath 50, so that the adjustment and re-release of the plugging device 20 are realized;

after confirming the occlusion effect, one of the spaced lines is cut at the opening 73 of the delivery handle 70 or the line that is not directly connected to the first control member 72 is cut, and then the pull wire 71 is recovered by rotating the first knob 721, and the threaded delivery cable 60 is released from the occlusion device 20, and then the human body is withdrawn, thereby completing the operation.

When the plugging device 20 is retracted into the delivery sheath 50, the proximal end of the folded clip 224 is connected to the traction wire 71, so that when the delivery sheath 50 is retracted until the folded clip 224 is completely exposed out of the delivery sheath 50, the clip 224 can still keep the outer side 2242 of the clip 224 attached to the delivery cable 60 under the traction of the traction wire 71, and the inner side 2241 faces outwards, and then the traction wire 71 is released by adjusting the first knob 721, so that the first clip 22 returns to a natural state, and the room tissue is clamped between the first clip 22 and the plugging portion 21.

In another embodiment, as shown in fig. 26, the self-expanding body 211 includes a main body portion 2111 and a converging portion, the converging portion is a first converging portion 2112 converging at a proximal end of the self-expanding body, a tail end of the first converging portion 2112 is converging in the first end portion 212, a side opposite to the first converging portion 2112 is in a non-converging open shape, one end of the open shape is not converging, binding of the converging portion in a circumferential direction of the main body portion is reduced, so that a contact area between the plugging portion 21 and the foramen ovale channel is increased, and since a size of the plugging portion is slightly larger than that of the foramen ovale channel, the contact area is increased, stability between the plugging portion and the foramen ovale channel is increased, and implantation stability of the plugging device is further increased together with a clamping effect of the first clamping portion.

In yet another embodiment, as shown in fig. 27, the fixing portion 2121 may be disposed at the first end 212 and the second end 213, respectively, so that both ends of the plugging portion 21 are provided with a clip portion, wherein the first clip portion 22 is disposed on the first end 212 of the proximal end of the plugging portion 11, and the second clip portion 23 is disposed on the second end 213 of the distal end of the plugging portion 11, so as to further increase the clamping reliability of the plugging device 20. The occlusion system and the surgical procedure can be referred to as an occlusion system and a surgical procedure which are combined with the above-described occlusion device having only one clip at one end. That is, the plugging device is not limited in that one clip portion is provided at the first end portion or the second end portion, or both end portions are provided with clip portions.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims (10)

1. The plugging device is characterized by comprising a plugging portion, a fixing portion and a first clamping portion, wherein the plugging portion comprises a self-expanding body, the fixing portion is located at one end of the plugging portion, and the first clamping portion is fixed to the plugging portion through the fixing portion.

2. The occlusion device of claim 1, wherein the self-expanding body comprises a body portion and a first constriction, the occlusion portion comprising a first end portion, the first constriction constricting at the first end portion, the securing portion being located at the first end portion.

3. The occlusion device of claim 2, wherein the self-expanding body further comprises a second constriction disposed opposite the first constriction, the occlusion device further comprising a second end, the second constriction constricting at the second end, the fixation means being provided with at least two, the occlusion device further comprising a second clip portion, a further fixation portion being located at the second end such that the second clip portion is fixed to the occlusion device by the further fixation portion.

4. The occlusion device of claim 1, wherein the self-expanding body comprises a body portion, a first constriction and a second constriction, the first constriction being located at a proximal end of the body portion, the second constriction being located at a distal end of the body portion, the end portion comprising a first end portion and a second end portion, the first constriction being constricted at the first end portion, the second constriction being constricted at the second end portion, the securing portion being located at the second end portion.

5. The occlusion device of claim 1, wherein the end comprises a first end comprising a first open slot on a side of the first end proximal to the self-expanding body for receiving a first constriction of the self-expanding body, the first end comprising a second open slot on a side distal from the self-expanding body, the second open slot having an internal thread or threaded connection disposed therein.

6. The occlusion device of claim 1, wherein said first clip portion includes a connecting portion, an extending portion, a bending portion and a clip, said connecting portion being connected to said fixing portion, said extending portion extending obliquely from said connecting portion and gradually away from said fixing portion, said bending portion extending curvedly from an end of said extending portion away from said fixing portion and connecting said clip.

7. The occlusion device of claim 6, wherein said clip is at an acute angle to said extension.

8. The occlusion device of claim 6, wherein the extension extends from the connection portion toward a side remote from the self-expanding body.

9. A plugging system comprising the plugging device of any one of claims 1-8, wherein the plugging system comprises a delivery sheath and a delivery cable, the delivery cable being nested within the delivery sheath.

10. The occlusion system of claim 9, further comprising a delivery handle and a pull wire, wherein the pull wire is configured to connect with the first clip portion of the proximal end of the occlusion device, wherein the delivery handle comprises a first control member, wherein the pull wire is configured to connect with the first control member, and wherein the first control member is configured to connect with the pull wire within the delivery handle to control retraction of the pull wire.

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