CN219331743U - Conveying puncture mechanism and repairing device - Google Patents

Abstract

The embodiment of the utility model provides a conveying puncture mechanism and a repairing device. The conveying puncture mechanism is used for conveying a to-be-conveyed piece, and the to-be-conveyed piece is used for anchoring a primary septum and a secondary septum of the oval foramen of the heart; the conveying puncture mechanism comprises a guide piece, a driving assembly and a puncture structure; the guide piece is provided with a first accommodating cavity for accommodating the piece to be conveyed, and the piece to be conveyed is arranged in the first accommodating cavity in a sliding manner; the driving assembly is configured to drive the to-be-conveyed piece to slide out of the guide piece; the puncture structure is arranged on the guide piece and is configured to puncture the primary septum and/or the secondary septum of the cardiac foramen ovale so that a part of the structure of the piece to be conveyed passes through the primary septum and/or the secondary septum of the cardiac foramen ovale in the process of sliding out of the guide piece. The conveying and puncturing mechanism has the functions of conveying and puncturing, mechanism replacement is not needed when conveying and puncturing steps are carried out, conveying and puncturing two repairing steps can be completed by only one mechanism, the operation process is simplified, and the repairing efficiency is improved.

Description

Conveying puncture mechanism and repairing device

Technical Field

The utility model relates to the technical field of medical equipment, in particular to a conveying puncture mechanism and a repairing device.

Background

The foramen ovale is an open area in the middle of the atrial septum of the heart, and is positioned at the junction of the primary septum and the secondary septum of the embryonic stage, and is the passage of fetal blood from the right atrium to the left atrium. After birth, with the establishment of the pulmonary circulation in the human heart, the foramen ovale will be anatomically closed within 1 year of age. If the patent foramen ovale remains unclosed after 3 years of age in a child, it is called a PFO (Patent Foramen Ovale ).

In recent years, many researches have found that patent foramen ovale has obvious relevance to various cardiovascular and cerebrovascular diseases, such as cerebral apoplexy, migraine, cerebral embolism and the like caused by unknown reasons.

At present, the main treatment method of the PFO is to anchor and plug the oval foramen by adopting minimally invasive interventional medical instruments, and finally realize the closure of the oval foramen, and the medical instruments are generally complicated in operation process and lower in repair efficiency.

Disclosure of Invention

The embodiment of the utility model aims to provide a conveying puncture mechanism and a repairing device, so as to simplify the operation process and further improve the repairing efficiency. The specific technical scheme is as follows:

embodiments of the first aspect of the present application provide a delivery penetration mechanism for delivering a member to be delivered for anchoring a primary septum and a secondary septum of a cardiac foramen ovale; the conveying and puncturing mechanism comprises a guide piece, a driving assembly and a puncturing structure; the guide piece is provided with a first accommodating cavity for accommodating the piece to be conveyed, and the piece to be conveyed is arranged in the first accommodating cavity in a sliding manner; the driving assembly is configured to drive the to-be-conveyed piece to slide out of the guide; the puncture structure is arranged on the guide piece and is configured to puncture the primary septum and/or the secondary septum of the heart foramen ovale, so that part of the structure of the to-be-conveyed piece passes through the primary septum and/or the secondary septum of the heart foramen ovale in the process of sliding out of the guide piece.

According to the conveying puncture mechanism, the conveying puncture mechanism is used for conveying a to-be-conveyed piece, the conveying puncture mechanism comprises a guide piece, a driving assembly and a puncture structure, the to-be-conveyed piece is arranged in a first accommodating cavity of the guide piece in a sliding mode, and the driving assembly drives the to-be-conveyed piece to slide out of the guide piece. The using process is as follows: the conveying puncture mechanism is arranged at a preset position of a primary septum or a secondary septum of the heart foramen ovale, the conveying puncture mechanism is operated to puncture the primary septum and/or the secondary septum of the heart foramen ovale, the puncture structure enters the left atrium from the right atrium, the driving assembly is operated to enable the part to be conveyed to slide along the first accommodating cavity, the part of the structure of the part to be conveyed passes through the primary septum and/or the secondary septum and is positioned in the left atrium, the rest of the structure of the part to be conveyed is positioned in the right atrium, then the guiding part of the conveying puncture mechanism is controlled to retract, the part to be conveyed finally slides out of the guiding part, and the conveying puncture mechanism completes the puncture of the primary septum and/or the secondary septum of the heart foramen ovale and the conveying of the part to be conveyed. According to the conveying and puncturing mechanism, the conveying and puncturing mechanism has the conveying and puncturing functions, compared with the mechanism with the conveying function and the puncturing function respectively, the conveying and puncturing mechanism does not need to be replaced when the conveying and puncturing steps are carried out, and only one mechanism can be used for completing the conveying and puncturing two repairing steps, so that the operation process is simplified, and the repairing efficiency is improved.

In addition, the conveying puncture mechanism according to the embodiment of the application can also have the following technical characteristics:

in some embodiments of the present application, the drive assembly includes a push rod slidably disposed in the first receiving cavity of the guide member and a drive member disposed at a proximal end of the guide member, the drive member being connected to the push rod for driving the push rod to slide along the first receiving cavity.

In some embodiments of the present application, the driving member includes a first handle and a driving button, the first handle is disposed at a proximal end of the guiding member, a first slide is disposed on the first handle, the driving button is slidably disposed in the first slide, and the driving button is connected with the push rod.

In some embodiments of the present application, the first slide has a first position thereon, a portion of the structure of the member to be delivered is located outside the guide and passes through a primary and/or secondary septum of the cardiac foramen ovale, and a remaining portion of the structure of the member to be delivered is located within the guide.

In some embodiments of the present application, the puncture structure is a guide wire, and the guide member is further provided with a second accommodating chamber for accommodating the guide wire, the second accommodating chamber being arranged in parallel with the first accommodating chamber.

In some embodiments of the present application, the piercing structure is a needle-like structure formed at the distal end of the guide.

In some embodiments of the present application, the member to be conveyed has a folded state and an elongated state, the member to be conveyed includes a tension adjustment member for adjusting the member to be conveyed from the elongated state to the folded state, and the conveying puncture mechanism further includes a pulling member disposed on the first handle, the pulling member being connected with the tension adjustment member, the pulling member being configured to pull the tension adjustment member to cause the member to be conveyed from the elongated state to the folded state.

In some embodiments of the present application, the pulling member includes a knob and a shaft, the shaft is rotatably disposed in the first handle, one end of the shaft extends out of the first handle and is connected to the knob, and the tension adjusting member is connected to the shaft.

In some embodiments of the present application, the driver further comprises a locking assembly comprising a securing knob and a locking lever;

a second slideway is arranged on the first handle and is provided with a second position and a third position;

The locking rod is arranged in the second slideway in a sliding way, one end of the locking rod stretches into the first handle, the other end of the locking rod stretches out of the first handle and is connected with the fixed button, and the fixed button is used for driving the locking rod to move between the second position and the third position along the second slideway;

in the second position, the locking rod is far away from the rotating shaft and locked on the second slideway so as to allow the rotating shaft to rotate;

in the third position, the locking rod is locked on the second slideway and is matched with the rotating shaft so as to limit the rotating shaft to rotate.

In some embodiments of the present application, the second runner includes a first section, a second section, and a third section connecting the first and second sections, the second runner having a first end and a second end, the first and second sections being non-collinear, the width of the first section tapering in a direction toward the first end, the width of the second section tapering in a direction toward the second end;

the second position is located at the first section, the third position is located at the second section, and the widths of the second position and the third position are smaller than the outer diameter of the locking rod;

The traction piece is characterized in that a gear is connected to the rotating shaft of the traction piece, the locking rod is clamped in the first section at the second position and is far away from the gear, the locking rod is clamped in the second section at the third position, and the locking rod is clamped between two adjacent teeth of the gear. In some embodiments of the present application, the second runner includes a first section, a second section, and a third section connecting the first section and the second section, the first section and the second section being non-collinear, the second runner having a first end and a second end;

the first end and the second end of the second slideway are respectively provided with a locking groove, the locking grooves are provided with inlets, the inlets of the two locking grooves are respectively connected with the first section and the second section, the two locking grooves respectively correspond to the second position and the third position, and the width of the inlets is smaller than the outer diameter of the locking rod.

Embodiments of the second aspect of the present application provide a prosthetic device comprising the delivery spike mechanism of the first aspect embodiment described above.

According to the repairing device of the embodiment of the application, the conveying and puncturing mechanism comprises two conveying and puncturing functions, and compared with the repairing process involving two mechanisms with the conveying function and the puncturing function respectively, the repairing device of the application does not need to replace the mechanism when conveying and puncturing steps, and can complete the conveying and puncturing two repairing steps by only one mechanism, so that the operation process is simplified, and the repairing efficiency is improved.

In some embodiments of the present application, the member to be conveyed has a folded state and an elongated state, the member to be conveyed includes a tension adjustment member for adjusting a transition of the member to be conveyed from the elongated state to the folded state.

In some embodiments of the present application, the prosthetic device further comprises an adjustable bend access catheter for transporting the piercing structure of the delivery piercing mechanism to a preset location of the primary or secondary septal foramen ovale, a lock delivery system comprising a lock assembly for securing the lock assembly to the tensioning member through the adjustable bend access catheter after the delivery member is anchored to the primary and secondary septal foramen ovale, to secure the delivery member to the primary and secondary septal foramen ovale, and a suture cutter for resecting excess of the tensioning member through the adjustable bend access catheter after the lock assembly is secured to the tensioning member.

Of course, it is not necessary for any one product to practice the utility model to achieve all of the advantages set forth above at the same time.

Drawings

In order to more clearly illustrate the embodiments of the utility model or the technical solutions in the prior art, the drawings used in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the utility model, and other embodiments may be obtained according to these drawings to those skilled in the art.

FIG. 1 is a schematic view of a transport lancing mechanism according to an embodiment of the present application;

FIG. 2 is a schematic diagram illustrating an assembly of a delivery spike mechanism and a member to be delivered according to an embodiment of the present application;

FIG. 3 is a front view of a first tissue anchor according to an embodiment of the present application (the tissue anchor being in an extended state);

FIG. 4 is a top view of a first tissue anchor according to an embodiment of the present application (the tissue anchor being in an elongated state);

FIG. 5 is a schematic structural view of a first tissue anchor according to an embodiment of the present application (the tissue anchor being in a folded state);

FIG. 6 is a front view of a second tissue anchor according to an embodiment of the present application (the tissue anchor in an extended state);

FIG. 7 is a top view of a second tissue anchor according to an embodiment of the present application (the tissue anchor being in an elongated state);

FIG. 8 is a schematic structural view of a second tissue anchor according to an embodiment of the present application (the tissue anchor being in a collapsed state);

FIG. 9 is a front view of a third tissue anchor according to an embodiment of the present application (the tissue anchor being in an extended state);

FIG. 10 is a schematic structural view of a second slide according to an embodiment of the present disclosure;

FIG. 11 is a schematic view of a second embodiment of the present disclosure;

FIG. 12 is a simplified schematic illustration of an adjustable bend interventional catheter according to an embodiment of the present application;

FIG. 13 is a diagram showing the connection between a pull wire and a pull ring in an adjustable bend interventional catheter according to an embodiment of the present application;

FIG. 14 is a schematic illustration of the structure of a tunable bending interventional catheter according to some embodiments of the present application;

FIG. 15 is a diagram showing the connection of a pull wire and a holder in a catheter of the present application;

FIG. 16 is a schematic view of a bendable interventional catheter according to further embodiments of the present application;

FIG. 17 is a diagram showing the connection of a pull wire and a movable frame in a catheter according to other embodiments of the present application;

FIG. 18 is a schematic structural view of a lock delivery system according to an embodiment of the present application;

fig. 19 is a partial enlarged view of fig. 17;

FIG. 20 is a schematic view of a suture cutter according to an embodiment of the present application;

fig. 21 is a partial enlarged view of fig. 19;

FIG. 22 is a schematic diagram of a heart;

FIG. 23 is a schematic illustration of an adjustable bend interventional catheter of an embodiment of the present application entering the heart via the superior vena cava;

FIG. 24 is a schematic view of an adjustable bend interventional catheter of an embodiment of the present application entering the heart through the inferior vena cava;

FIG. 25 is a diagram showing the usage state of the repairing device according to the embodiment of the present application (corresponding to step S5);

FIG. 26 is a usage state diagram of the repairing device according to the embodiment of the present application (corresponding to step S6);

FIG. 27 is a diagram showing the usage state of the prosthetic device according to the embodiment of the present application (corresponding to step S9);

FIG. 28 is a usage state diagram of the repairing device according to the embodiment of the present application (corresponding to step S10);

fig. 29 is another state diagram of the use of the prosthetic device of an embodiment of the present application (two tissue anchors anchored to the primary and secondary septa, respectively).

Reference numerals illustrate:

2-left atrium; 3-right atrium; 4-primary septum; 5-secondary separation;

20-adjustable bend interventional catheter; 21-a second handle; 211-a handle body; 212-a handle support; 213-a drive rack; 214-drive knob; 215-tube holder; 216-a fixing frame; 217-a carriage; 22-guiding catheter; 23-a pull ring; 24-stay wire;

30-a piece to be conveyed; 31-a tension adjusting member; 32-an anchor member; 32 a-a first set of openings; 32 b-a second set of openings; 321-folding the board; 33-a developing assembly; 34—slip nodules;

40-lock delivery system; 41-a lock assembly; 411-side hole; 42-a catheter assembly; 421-an outer sheath; 422-an internal conduit; 423-traction wire; 43-a control assembly;

50-suture cutter; 51-an actuator; 52—an intermediate sleeve section; 53-a cutting assembly; 531-a movable cutting element; 532—an adjustable size cutting window;

100—a transport puncture mechanism; 110-a guide; 111-a first accommodation chamber; 120-a drive assembly; 121-push rod; 122-driving member; 1221-a first handle; 1222-drive button; 1223-a first slide; 1223 a-a first position; 1224—a fixed knob; 1225-locking bar; 1226-a second slide; 1226 a-a second position; 1226b—a third position; 1226c—a first end; 1226 d-a second end; 1226e—an inlet; 130-a pulling member; 140-piercing structure.

Detailed Description

The following description of the embodiments of the present utility model will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present utility model, but not all embodiments. Based on the embodiments of the present utility model, those of ordinary skill in the art will be able to devise all other embodiments that are obtained based on this application and are within the scope of the present utility model.

As shown in fig. 1 and 2, an embodiment of the first aspect of the present application proposes a delivery penetration mechanism 100, the delivery penetration mechanism 100 being used for delivering a member to be delivered 30, the member to be delivered 30 being used for anchoring a primary septum 4 and a secondary septum 5 of a cardiac foramen ovale. The delivery puncturing mechanism 100 includes a guide 110, a drive assembly 120, and a puncturing structure 140; the guide member 110 is provided with a first accommodating chamber 111 for accommodating the member to be conveyed 30, and the member to be conveyed 30 is slidably disposed in the first accommodating chamber 111; the drive assembly 120 is configured to drive the member to be delivered 30 to slide out of the guide 110; piercing structure 140 is disposed on guide 110, piercing structure 140 being configured to pierce primary septum 4 and/or secondary septum 5 of the cardiac foramen ovale, such that a portion of the structure of delivery member 30 passes through primary septum 4 and/or secondary septum 5 of the cardiac foramen ovale during sliding out of guide 110.

According to the conveying and puncturing mechanism 100 of the embodiment of the application, which is used for conveying the to-be-conveyed member 30, the conveying and puncturing mechanism 100 comprises a guide member 110, a driving assembly 120 and a puncturing structure 140, the to-be-conveyed member 30 is slidably arranged in the first accommodating cavity 111 of the guide member 110, and the driving assembly 120 drives the to-be-conveyed member 30 to slide out of the guide member 110. The using process is as follows: the delivery puncture mechanism 100 is arranged at a preset position of the primary septum 4 or the secondary septum 5 of the cardiac foramen ovale, the delivery puncture mechanism 100 is operated to puncture the primary septum 4 and/or the secondary septum 5 of the cardiac foramen ovale by the puncture structure 140, the puncture structure 140 enters the left atrium 2 from the right atrium 3, the driving assembly 120 is operated to slide the member 30 to be delivered along the first accommodating cavity 111, part of the structure of the member 30 to be delivered passes through the primary septum 4 and/or the secondary septum 5 and is positioned in the left atrium 2, the rest of the structure of the member 30 to be delivered is positioned in the right atrium 3, then the guide member 110 of the delivery puncture mechanism 100 is controlled to retract, the member 30 to be delivered finally slides out of the guide member 110, and the delivery puncture mechanism 100 completes the puncture of the primary septum 4 and/or the secondary septum 5 of the cardiac foramen ovale and the delivery of the member 30 to be delivered. According to the process, the conveying and puncturing mechanism 100 has two functions of conveying and puncturing, and compared with the fact that two mechanisms with the conveying function and the puncturing function are adopted to participate in the repairing process, the conveying and puncturing mechanism 100 does not need to be replaced when conveying and puncturing steps, and can complete conveying and puncturing two repairing steps by only one mechanism, so that the operation process is simplified, and the repairing efficiency is improved.

In this application, during the process of using the delivery puncture mechanism 100 and the repair device, the operator uses the delivery puncture mechanism 100 and the repair device itself, and the part included therein, the side close to the operator is the proximal end, the side far away from the operator is the distal end, and the terms "proximal end" and "distal end" referred to in this application are understood to mean that the to-be-delivered member 30 is used for anchoring other tissues to be anchored, in addition to the primary septum 4 and the secondary septum 5 for anchoring the oval foramen of the heart.

Further, the guide 110 may be a tubular structure, and the cross section of the tubular structure may be circular, rectangular, pentagonal, etc., which is not limited in this application.

In some embodiments of the present application, as shown in fig. 2, the driving assembly 120 includes a push rod 121 and a driving member 122, the push rod 121 is slidably disposed in the first receiving cavity 111 of the guide member 110, the driving member 122 is disposed at a proximal end of the guide member 110, the driving member 122 is connected to the push rod 121, and the driving member 122 is used to drive the push rod 121 to slide along the first receiving cavity 111. The driving member 122 drives the push rod 121 to act, the push rod 121 slides in the first accommodating cavity 111 of the guide member 110, and the push rod 121 pushes the member 30 to be conveyed to slide along the first accommodating cavity 111, so that the member 30 finally slides out of the guide member 110. As can be seen from the above process, the driving member 122 is only required to be operated to push the member 30 out of the guiding member 110, which is simple and convenient to operate.

Specifically, the push rod 121 may be a cylindrical rod, a four-prism rod, a five-prism rod, or the like, as long as the push rod 121 can push the member to be conveyed 30 to slide in the first accommodating chamber 111, which is not limited in this application.

In some embodiments of the present application, as shown in fig. 1 and 2, the driver 122 includes a first handle 1221 and a driver button 1222, the first handle 1221 is disposed at a proximal end of the guide 110, a first slide 1223 is disposed on the first handle 1221, the driver button 1222 is slidably disposed within the first slide 1223, and the driver button 1222 is coupled to the push rod 121. The driving button 1222 is disposed in the first slide 1223 on the first handle 1221 and connected to the push rod 121, and when the driving button 1222 slides in the first slide 1223, the push rod 121 connected thereto can be driven to slide synchronously in the first accommodating cavity 111, which is simple to operate and convenient to control the sliding distance of the push rod 121.

In some embodiments of the present application, as shown in fig. 1 and 2, the first slide 1223 has a first position 1223a thereon, and when the actuator button 1222 is in the first position 1223a, a portion of the structure of the member 30 to be delivered is located outside the guide member 110 and through the primary 4 and/or secondary 5 septa of the foramen ovale of the heart, and the remainder of the structure of the member 30 to be delivered is located within the guide member 110. Specifically, the first slide 1223 has a proximal end and a distal end, and the first location 1223a is located between the proximal end and the distal end of the first slide 1223. When the drive button 1222 is positioned at the proximal end of the first slide 1223, the entire structure of the delivery member 30 is within the guide member 110; when the drive button 1222 is positioned at the distal end of the first slide 1223, the entire structure of the delivery member 30 is outside of the guide member 110; when drive button 1222 is in first position 1223a, a portion of the structure of member 30 is positioned outside guide member 110 and through primary septum 4 and/or secondary septum 5 of the foramen ovale, and the remaining portion of the structure of member 30 is positioned within guide member 110. During sliding of the drive button 1222 from the proximal end of the first slideway 1223 to the distal end, the member to be delivered 30 slides from the proximal end of the guide 110 to the distal end of the guide 110, until it slides out of the guide 110.

Further, the first position 1223a may be a middle position of the first slide 1223, when the driving button 1222 is located at the first position 1223a, a half of the structure of the member to be delivered 30 is located inside the guide 110, and the other half of the structure is located outside the guide 110, so as to precisely control the length of the member to be delivered 30 extending out of the guide 110, that is, so as to control the length of the member to be delivered 30 passing through the primary septum 4 and/or the secondary septum 5, and when the driving button 1222 is located at the first position 1223a, a half of the member to be delivered 30 slides out of the guide 110 and passes through the primary septum 4 and/or the secondary septum 5 of the circular hole of the heart, that is, located at one side of the primary septum 4 and/or the secondary septum 5 of the circular hole of the heart, that is located inside the left atrium 2, and the other half of the member to be delivered 30 is located at the other side of the primary septum 4 and/or the secondary septum 5 of the circular hole of the heart, that is located inside the right atrium 3, so that the forces on both sides of the primary septum 4 and the secondary septum 5 of the circular hole of the heart are relatively evenly applied during anchoring, so as to facilitate protection of the primary septum 4 and the secondary septum 5 of the heart.

In some embodiments of the present application, the piercing structure 140 is a guide wire, and the guide 110 is further provided with a second receiving cavity (not shown) for receiving the guide wire, the second receiving cavity being arranged in parallel with the first receiving cavity 111. When the heart puncture mechanism is used, the guide wire is used for puncturing the primary septum 4 and/or the secondary septum 5 of the heart foramen ovale, the driving assembly 120 is operated to drive the to-be-conveyed part 30 to slide in the first accommodating cavity 111, and the guide wire is arranged in the second accommodating cavity as the to-be-conveyed part 30 is arranged in the first accommodating cavity 111, so that the first accommodating cavity 111 and the second accommodating cavity are arranged in parallel, and the puncture mechanism 100 can realize a puncture function and a conveying function.

In particular, the guidewire may be contacted with a source of radiofrequency energy, and the primary septum 4 and/or secondary septum 5 of the cardiac foramen ovale may be pierced by radiofrequency current.

In some embodiments of the present application, the piercing structure 140 is a needle-like structure formed at the distal end of the guide 110. In use, the needle-like structure formed at the distal end of guide 110 is used to pierce primary septum 4 and/or secondary septum 5 of the foramen ovale of the heart, and drive assembly 120 is operated to drive member 30 to be delivered to slide within first receiving chamber 111.

In other examples of the present application, as shown in fig. 1 and 2, the guide 110 may be a catheter with a beveled surface formed at the distal end of the catheter to form a piercing structure 140 of needle-like structure at the distal end of the catheter.

In some embodiments of the present application, as shown in fig. 1-9, the member to be delivered 30 has a folded state and an elongated state, the member to be delivered 30 includes a tension adjustment member 31, the tension adjustment member 31 is configured to adjust a transition of the member to be delivered 30 from the elongated state to the folded state, the delivery puncturing mechanism 100 further includes a pulling member 130, the pulling member 130 is disposed on the first handle 1221, the pulling member 130 is connected to the tension adjustment member 31, and the pulling member 130 is configured to pull the tension adjustment member 31 to transition the member to be delivered 30 from the elongated state to the folded state. When a part of the member to be delivered 30 is located at one side of the primary septum 4 and/or the secondary septum 5 of the cardiac foramen ovale, that is, located in the left atrium 2, and the rest of the member to be delivered 30 is located in the guide member 110, the tension adjusting member 31 is pulled by the pulling member 130, so that the part of the member to be delivered 30 located in the left atrium 2 is compressed at one side of the primary septum 4 or the secondary septum 5, then the guide member 110 of the delivery puncture mechanism 100 is controlled to be withdrawn, at this time, the rest of the member to be delivered 30 is completely slid out of the guide member 110, and then the tension adjusting member 31 is pulled continuously, so that the rest of the member to be delivered 30 located in the right atrium 3 is compressed at the other side of the primary septum 4 or the secondary septum 5, thereby achieving fixation between the member to be delivered 30 and the primary septum 4 and the secondary septum 5 of the cardiac foramen ovale.

As shown in fig. 3-9, the member 30 to be delivered may be a tissue anchor comprising a generally flexible elongate continuous anchor member 32 and a tensioning member 31. The anchor member 32 is insertable and passable through tissue and is switchable between an elongated condition and a collapsed condition adapted to anchor against at least one side of the tissue, the anchor member 32 having proximal and distal ends, the anchor member 32 having first and second sets of openings 32a, 32b formed therein at spaced apart locations along the length of the anchor member 32; the tensioning member 31 is operatively connected to the anchor member 32 such that the anchor member 32 is capable of sliding relative to the tensioning member 31, the tensioning member 31 extending proximally through the first set of openings 32a to the distal end and then returning to the proximal anchor point by passing through the second set of openings 32b, the tensioning member 31 being capable of causing the anchor member 32 to transition from the extended state to the collapsed state, wherein the anchor member 32 is capable of compressing along its length and thereby adjusting the proximal and distal ends according to the thickness of the tissue; pulling the tension adjustment member 31 to configure the anchor member 32 to form a plurality of folded plates 321, wherein in the folded state, the plurality of folded plates 321 includes a first set of plates oriented in a first direction and at least one second set of plates oriented in a second direction, wherein the first direction and the second direction are perpendicular to each other; wherein the second plate is parallel to at least one plate of the first set of plates.

As shown in fig. 3-9, the tissue anchor further includes a visualization component 33, in particular, the tensioning member 31 may be a suture, the anchor member 32 may be a strip, and the visualization component 33 may be a radiopaque band secured to the inside or outside of the suture and distal tip at the proximal end of the strip. Under fluoroscopy, the visualization component 33 will be displayed to the surgeon; during the surgical procedure, the tissue anchor may be deployed, actuated, and fully compressed and/or fastened as desired. The tip itself may optionally be formed of a radiopaque material. A sliding nub 34 is formed on the suture or other tensioning member 31 through which another portion of the suture slides during actuation of the tissue anchor.

The heart foramen ovale plugging device in the related art is mostly made of shape memory alloy materials, and the shape of the heart foramen ovale plugging device is round or umbrella-shaped, namely, the device is respectively placed at two sides of the foramen ovale, so that the foramen ovale can be plugged, and the plugging device can be permanently left in a human body after an operation. However, the biocompatibility of the metal material is not very good, and long-term implantation into human body may cause complications such as inflammation; in addition, the metal material may release toxic metal ions under long-term interaction with human blood, bringing new risks to patients; meanwhile, in order to realize the closure of the oval foramen, the size design of the plugging devices is larger, and the endothelialization process is not easy to complete in the body, so that the risk of thrombus formation in the body of a patient is increased; and if the design of the plugging device is unreasonable or the size selection is unreasonable, the plugging device is easy to fall off in the body to cause plugging failure.

The tissue anchor is made of soft high polymer materials with better biocompatibility with human tissues, such as nylon suture materials, polyester suture materials and the like used in the surgical operation process, so that potential injury to human bodies caused by using metal materials is avoided; the development components 33 are arranged on the two sides of the tissue anchor, so that doctors can conveniently identify and confirm the position of the tissue anchor in a human body in the operation process, the risk of misoperation is reduced, better anchoring supporting force is provided for the tissue anchor, and the falling risk is reduced; the tissue anchor of this application is the strip, has extension state and folding state, and its anchor is folding state when on the tissue, and the volume is less, and the endothelialization process in the patient's body is more easily realized to the less implant, has reduced the risk of thrombosis.

In some embodiments of the present application, the pulling member 130 includes a knob and a shaft rotatably disposed within the first handle 1221, and one end of the shaft extends outside the first handle 1221 and is connected to the knob, and the tension adjusting member 31 is connected to the shaft. When the knob is rotated, the rotating shaft and the knob synchronously rotate, the tension adjusting part 31 is connected to the rotating shaft, and is wound on the rotating shaft along with the rotation of the rotating shaft, so that the tension adjusting part 31 is pulled, and the operation is simple; meanwhile, the tension adjusting part 31 is wound on the rotating shaft, so that the occupied space is small, and the miniaturization of the conveying puncture mechanism 100 is facilitated.

In some embodiments of the present application, as shown in fig. 1, 2 and 10, the driver 122 further includes a locking assembly including a stationary button 1224 and a locking lever 1225; a second slide 1226 is provided on the first handle 1221, the second slide 1226 having a second position 1226a and a third position 1226b; the locking lever 1225 is slidably disposed in the second slide 1226, one end of the locking lever 1225 extends into the first handle 1221, and the other end extends outside the first handle 1221 and is connected to the fixed button 1224, the fixed button 1224 being configured to drive the locking lever 1225 along the second slide 1226 between the second position 1226a and the third position 1226b; in the second position 1226a, the locking lever 1225 is remote from the spindle and locked to the second slide 1226 to allow the spindle to rotate; in the third position 1226b, the locking bar 1225 is locked to the second slide 1226 and cooperates with the spindle to limit rotation of the spindle. The fixed button 1224 is fixedly connected to the locking lever 1225 for synchronous movement, and the fixed button 1224 drives the locking lever 1225 to move between the second position 1226a and the third position 1226b to control the state of the spindle.

When the tension adjusting component 31 needs to be pulled, the fixed button 1224 is driven to enable the locking rod 1225 to be located at the second position 1226a, at this time, the locking rod 1225 is far away from the rotating shaft and locked on the second slideway 1226, the rotating shaft can rotate, and the rotating knob realizes pulling of the tension adjusting component 31; when the tension adjusting member 31 is not required to be pulled, the fixed button 1224 is driven to enable the locking rod 1225 to be located at the third position 1226b, at this time, the locking rod 1225 is matched with the rotating shaft and locked on the second slideway 1226, the rotating shaft cannot rotate, the tension adjusting member 31 cannot be pulled continuously, and the operation is simple. In addition, when the tension adjusting member 31 is not required to be pulled, the lock lever 1225 is set at the third position 1226b to be engaged with the rotation shaft to restrict the rotation of the rotation shaft, so that erroneous operation can be prevented.

In some embodiments of the present application, as shown in fig. 1, 2, and 10, the second ramp 1226 includes a first section, a second section, and a third section connecting the first section and the second section, the second ramp 1226 having a first end 1226c and a second end 1226d, the first section and the second section being non-collinear, the width of the first section decreasing in a direction toward the first end 1226c, the width of the second section decreasing in a direction toward the second end 1226 d; the second position 1226a is located in the first section and the third position 1226b is located in the second section, the second position 1226a and the third position 1226b having a width less than the outer diameter of the locking lever 1225; the rotation shaft of the pulling member 130 is connected with a gear, in the second position 1226a, the locking rod 1225 is clamped in the first section, and the locking rod 1225 is far away from the gear; in the third position 1226b, the locking bar 1225 is jammed within the second segment, and the locking bar 1225 is jammed between adjacent two teeth of the gear.

The second slide 1226 includes a first section, a second section, and a third section connecting the first section and the second section, the first section and the second section being non-collinear, the non-collinear arrangement being such that the locking bar 1225 is positioned a greater distance from the tensioning member 31 when the locking bar 1225 is positioned in the second position 1226a than the first section and the second section, preventing the tensioning member 31 from interfering with the locking bar 1225 when the tensioning member 31 is pulled.

Since the width of the second section gradually decreases in the direction towards the second end 1226d, when the fixed knob 1224 moves along the second section towards the third position 1226b, the gap between the locking lever 1225 and the second slideway 1226 gradually decreases, when the width is equal to the outer diameter of the locking lever 1225, the locking lever 1225 just abuts against the second slideway 1226 and continues to move towards the second end 1226d of the second slideway 1226, when the locking lever 1225 reaches the third position 1226b, the locking lever 1225 can be blocked in the second slideway 1226, thereby realizing the position locking of the locking lever 1225, at this time, the locking lever 1225 is blocked between two adjacent teeth of the gear, the movement of the gear is limited, the movement of the spindle connected thereto is also limited, the spindle and the knob are rotated synchronously, and the movement of the knob is also limited; when the locking lever 1225 needs to move from the third position 1226b to the second position 1226a, a certain force is applied to the fixed button 1224 to release the position lock between the locking lever 1225 and the second slide 1226, the locking lever 1225 moves away from between the two teeth, and the fixed button 1224 is driven to slide, so that the locking lever 1225 moves from the second section to the first section, during which the locking lever 1225 gradually moves away from the gear, the gear can rotate, the principle of movement of the locking lever 1225 in the second section is the same as that of the first section, which will not be described herein, and when the locking lever 1225 reaches the second position 1226a, the rotation knob pulls the tension adjusting component 31, and the locking lever 1225 does not interfere with the tension adjusting component 31.

In some embodiments of the present application, as shown in fig. 1, 2, and 11, the second ramp 1226 includes a first section, a second section, and a third section connecting the first section and the second section, the first section and the second section being non-collinear, the second ramp 1226 having a first end 1226c and a second end 1226d; the first end 1226c and the second end 1226d of the second slideway 1226 are respectively provided with a locking groove, the locking groove is provided with an inlet 1226e, the width of the inlet 1226e is smaller than the outer diameter of the locking rod 1225, the inlets 1226e of the two locking grooves are respectively connected with the first section and the second section, the two locking grooves respectively correspond to the second position 1226a and the third position 1226b, and the width of the inlet 1226e of the locking groove is smaller than the outer diameter of the locking rod 1225. After the locking rod 1225 enters the locking groove, the locking rod 1225 cannot be pulled out of the locking groove under the condition that no certain external force is applied, so that the locking of the locking rod 1225 at the second position 1226a and the third position 1226b of the second slideway 1226 is realized, and the locking rod 1225 cannot enter the locking groove from the first section or the second section under the condition that no certain external force is applied, so that the accidental locking of the locking rod 1225 is avoided.

Further, the locking lever 1225 and the fixing button 1224 may be in an integral structure, or may be in a detachable structure, and the gear and the rotating shaft may be in an integral structure, or may be in a detachable structure, which is not limited in this application.

Embodiments of the second aspect of the present application provide a prosthetic device comprising the delivery spike mechanism 100 of the first aspect embodiment.

According to the repairing device of the embodiment of the application, the conveying and puncturing mechanism 100 has two functions of conveying and puncturing, and compared with the repairing process involving two mechanisms with conveying functions and puncturing functions respectively, the repairing device of the application does not need to replace the mechanism when conveying and puncturing steps, and can complete the conveying and puncturing two repairing steps by only one mechanism, so that the operation process is simplified, and the repairing efficiency is improved.

In some embodiments of the present application, the member to be conveyed 30 has a folded state and an elongated state, and the member to be conveyed 30 includes a tension adjusting member 31, and the tension adjusting member 31 is used to adjust the transition of the member to be conveyed 30 from the elongated state to the folded state.

In some embodiments of the present application, the prosthetic device further comprises an adjustable bend interventional catheter 20, a lock delivery system 40 and a suture cutter 50, the adjustable bend interventional catheter 20 being configured to deliver the piercing structure 140 of the delivery piercing mechanism 100 to a preset position of the primary 4 or secondary 5 septum of the cardiac foramen ovale, the lock delivery system 40 comprising a lock assembly 41, the lock delivery system 40 being configured to secure the lock assembly 41 to the tensioning member 31 via the adjustable bend interventional catheter 20 after the piece 30 to be delivered anchors the primary 4 and secondary 5 septum of the cardiac foramen ovale to secure the piece 30 to be delivered to the primary 4 and secondary 5 septum of the cardiac foramen ovale, the suture cutter 50 being configured to cut off the excess tensioning member 31 via the adjustable bend interventional catheter 20 after the lock assembly 41 is secured to the tensioning member 31.

As shown in fig. 12-15, in some embodiments of the present application, the adjustable bend interventional catheter 20 includes a second handle 21 and a guide catheter 22, the second handle 21 including a hub 215, a drive knob 214, a handle body 211, a handle support bracket 212, a drive bracket 213, and a mount 216. The handle support frame 212 is arranged in the handle main body 211, a driving knob 214 is arranged between the distal end and the proximal end in the handle main body 211, a driving frame 213 is arranged on the handle support frame 212 in a sliding mode, the driving knob 214 is arranged on the outer side of the driving frame 213, gear teeth on the driving frame 213 are meshed with gear teeth on the inner side face of the driving knob 214, and the driving frame 213 can axially move along the handle support frame 212 by rotating the driving knob 214. The proximal end of the guide catheter 22 is fixedly arranged on the handle support frame 212, a pull ring 23 is fixedly arranged at the distal end of the guide catheter 22, a pull wire 24 is arranged in the handle support frame 212 along the direction of the handle support frame 212, a fixed frame 216 is arranged in the driving frame 213, the proximal end of the pull wire 24 is fixed on the fixed frame 216, and the distal end of the pull wire 24 is fixedly connected with the pull ring 23. When the drive carriage 213 moves axially within the second handle 21, it translates into movement of the pull wire 24, thereby completing bending of the distal end of the guide catheter 22. A hub 215 is provided at the proximal end of the handle body 211, the hub 215 being accessible as an entry for other interventional instruments into the adjustable bend interventional catheter 20. The guide 110 of the delivery puncturing mechanism 100 is capable of being accessed through the hub 215 and along the guide catheter 22 into the patient, while the bending of the guide catheter 22 is adjustable so that the guide 110 moves and is positioned to the target location.

When in use, the driving knob 214 is rotated, the driving knob 214 is meshed with gear teeth on the driving frame 213 to drive the driving frame 213 to axially move along the handle supporting frame 212, and then the distal end of the guiding catheter 22 is driven to slowly bend by the stay wire 24; the second handle 21 is turned to gradually adjust the direction of the distal bent portion of the guide catheter 22 so that the guide catheter 22 is precisely positioned at a preset position.

As shown in fig. 12, 13, 16 and 17, in other embodiments of the present application, the adjustable bend interventional catheter 20 includes a second handle 21 and a guide catheter 22, the second handle 21 including a handle end assembly, a handle body 211, and a handle driver, the handle end assembly being disposed at a proximal end of the handle body 211, the handle driver being disposed on the handle body 211. The handle driver comprises a driving knob 214, a driving frame 213 and a sliding frame 217, wherein the sliding frame 217 is arranged in the handle main body 211 in a sliding manner, the driving frames 213 are symmetrically arranged on two sides of the sliding frame 217, the driving frame 213 is arranged in the handle main body 211 in a sliding manner, the driving knob 214 is arranged on the handle main body 211 and is positioned right above the driving frame 213, gear teeth on the upper end face of the driving frame 213 are meshed with gear teeth arranged on the inner side face of the driving knob 214, and the sliding frame 217 and the driving frame 213 can axially move along the handle main body 211 by rotating the driving knob 214. The proximal end of the guiding catheter 22 is fixedly arranged on the second handle 21, a pull ring 23 is fixedly arranged at the distal end of the guiding catheter 22, a pull wire 24 is arranged in the guiding catheter 22 along the guiding catheter 22 direction, the proximal end of the pull wire 24 is fixedly connected with the sliding frame 217, and the distal end of the pull wire 24 is fixedly connected with the pull ring 23. The handle end assembly includes a hub 215, the hub 215 being provided at the proximal end of the body of the second handle 21, the hub 215 being accessible as an access port for other interventional instruments into the adjustable bend interventional catheter 20. The guide 110 of the delivery puncturing mechanism 100 is capable of being accessed through the hub 215 and along the guide catheter 22 into the patient, while the bending of the guide catheter 22 is adjustable so that the guide 110 moves and is positioned to the target location.

When in use, the driving knob 214 is rotated, the driving knob 214 is meshed with the gear teeth on the driving frame 213 to drive the sliding frame 217 to axially move along the handle main body 211, and then the distal end of the guiding catheter 22 is driven to slowly bend by the stay wire 24; the second handle 21 is turned to gradually adjust the direction of the distal bent portion of the guide catheter 22 so that the guide catheter 22 is precisely positioned at the target site in the body.

As shown in fig. 18 and 19, the lock delivery system 40 includes a lock assembly 41, a catheter assembly 42, and a control assembly 43. The lock assembly 41 may be configured to lock at least one tensioning member 31, and the tensioning member 31 may be a suture; the catheter assembly 42 comprises a distal end and a proximal end, wherein the distal end of the catheter assembly 42 is configured to be connectable to the lock assembly 41; the catheter assembly 42 includes an outer sheath 421, an inner catheter 422, and a pulling wire 423; the inner catheter 422 is slidably disposed within the elongate lumen of the outer sheath 421; the traction wire 423 is slidably disposed in the elongated lumen of the inner catheter 422; the pulling wire 423 includes a thin wire having a wire loop at a distal end; the wire loop extends through a side aperture 411 in lock assembly 41 and control assembly 43 may be coupled to the proximal end of catheter assembly 42, may apply tension to the suture described above, may trigger locking of the suture described above by lock assembly 41, and may release lock assembly 41.

As shown in fig. 20 and 21, suture cutter 50 is used to cut tensioning member 31 within a patient, suture cutter 50 including actuator 51, intermediate sleeve portion 52, and cutting assembly 53. The actuator 51 is manipulated by medical personnel; the intermediate sleeve portion 52 is operatively coupled with the actuator 51; the cutting assembly 53 is operatively coupled with the intermediate cannula portion 52 and the actuator 51, the cutting assembly 53 including a movable cutting element 531 and an adjustable size cutting window 532, the movable cutting element 531 cutting the tensioning member 31 received inside the adjustable size cutting window 532 as the adjustable size cutting window 532 is reduced in size upon actuation of the actuator 51, the tensioning member 31 may be a suture.

As shown in fig. 22 to 28, the repair device according to the embodiment of the present application may be used for repairing an oval foramen of a heart. The heart includes left atrium 2, right atrium 3, primary septum 4 and secondary septum 5, and primary septum 4 and secondary septum 5 are located between left atrium 2 and right atrium 3, and primary septum 4 is located left atrium 2 side, and secondary septum 5 is located right atrium 3 side. The prosthetic device may be used to access the heart from a blood vessel such as the jugular vein, the femoral vein, etc.

The following describes the steps of using the prosthetic device to repair a cardiac foramen ovale using a tissue anchor as the delivery member 30. The method specifically comprises the following steps:

S1, arranging a conveying puncture mechanism 100 with a tissue anchor in an adjustable bending interventional catheter 20;

s2, extending the bendable interventional catheter 20 with the delivery puncture mechanism 100 into the right atrium 3;

s3, bending the distal end of the guide catheter 22 by the driving knob 214 of the bendable interventional catheter 20 until the distal end of the guide catheter 22 reaches a preset position;

s4, pushing the conveying puncture mechanism 100, and sequentially puncturing the secondary septum 5 and the primary septum 4 by the puncture structure 140 of the conveying puncture mechanism 100, wherein the puncture structure 140 of the guide member 110 enters the left atrium 2 from the right atrium 3 from the puncture position;

s5, operating the driving assembly 120 to drive the tissue anchor to slide along the first accommodating cavity 111 of the guide member 110, wherein part of the structure of the tissue anchor slides out of the guide member 110 and passes through the secondary septum 5 and the primary septum 4, and the rest of the structure of the tissue anchor is positioned in the guide member 110 (at this time, the part of the structure of the tissue anchor positioned outside the guide member 110 is distributed in the left atrium 2);

s6, operating the pulling piece 130, and pulling the tension adjusting component 31 by the pulling piece 130 to enable the tissue anchor positioned in the left atrium 2 to be converted into a folded state from an extended state and be compressed on the tissue wall of the primary septum 4 close to the left atrium 2;

s7, retracting the delivery puncture mechanism 100, wherein the rest structure of the tissue anchor completely slides out of the guide 110 (at this time, the rest structure of the tissue anchor is positioned in the right atrium 3);

S8, operating the pulling piece 130, and pulling the tension adjusting component 31 by the pulling piece 130 to enable a tissue anchor positioned in the right atrium 3 to be converted into a folded state from an elongated state and compressed on a tissue wall of the secondary septum 5 close to the right atrium 3 until the primary septum 4 and the secondary septum 5 are closely attached;

s9, operating a control assembly 43 in the lock conveying system 40, locking the lock assembly 41 on the tension adjusting component 31, releasing the lock assembly 41 to enable the lock assembly 41 to be separated from the lock conveying system 40, and anchoring the tissue anchor on the primary septum 4 and the secondary septum 5, so that the primary septum 4 and the secondary septum 5 are fixed;

s10, operating the suture cutter 50 to cut the redundant tension adjusting member 31.

The above is a procedure for repairing a cardiac foramen ovale using a tissue anchor, which is anchored to the primary 4 and secondary 5 septa. When two tissue anchors are used to repair the foramen ovale of the heart, as shown in fig. 29, one tissue anchor is anchored on the primary septum 4, the other tissue anchor is anchored on the secondary septum 5, the tension adjusting member 31 is pulled to tightly attach the primary septum 4 and the secondary septum 5, and the tension adjusting member 31 of the two tissue anchors is locked together by the lock assembly 41, so that the fixation of the primary septum 4 and the secondary septum 5 is realized. Compared with the way of plugging the heart foramen ovale by adopting two tissue anchors, the implant adopting the plugging way of one tissue anchor has smaller volume, and the smaller implant is easier to realize the endothelialization process in the patient, thereby reducing the risk of thrombus formation.

It is noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.

In this specification, each embodiment is described in a related manner, and identical and similar parts of each embodiment are all referred to each other, and each embodiment mainly describes differences from other embodiments. In particular, for system embodiments, since they are substantially similar to method embodiments, the description is relatively simple, as relevant to see a section of the description of method embodiments.

The foregoing description is only of the preferred embodiments of the present utility model and is not intended to limit the scope of the present utility model. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present utility model are included in the protection scope of the present utility model.

Claims (14)

1. A delivery penetration mechanism (100), characterized in that the delivery penetration mechanism (100) is used for delivering a piece (30) to be delivered, and the piece (30) to be delivered is used for anchoring a primary septum (4) and a secondary septum (5) of a cardiac foramen ovale;

the delivery lancing mechanism (100) includes a guide (110), a drive assembly (120), and a lancing structure (140);

the guide piece (110) is provided with a first accommodating cavity (111) for accommodating the piece (30) to be conveyed, and the piece (30) to be conveyed is arranged in the first accommodating cavity (111) in a sliding manner;

the drive assembly (120) is configured to drive the member (30) to be conveyed out of the guide (110);

the puncturing structure (140) is arranged on the guide (110), and the puncturing structure (140) is configured to puncture a primary septum (4) and/or a secondary septum (5) of a cardiac foramen ovale, so that a part of the structure of the member (30) to be conveyed passes through the primary septum (4) and/or the secondary septum (5) of the cardiac foramen ovale during sliding out of the guide (110).

2. The delivery puncture mechanism (100) according to claim 1, wherein the drive assembly (120) comprises a push rod (121) and a driving member (122), the push rod (121) being slidably arranged in the first receiving cavity (111) of the guide member (110), the driving member (122) being arranged at the proximal end of the guide member (110), the driving member (122) being connected to the push rod (121), the driving member (122) being adapted to drive the push rod (121) to slide along the first receiving cavity (111).

3. The delivery puncture mechanism (100) according to claim 2, wherein the driver (122) comprises a first handle (1221) and a drive button (1222), the first handle (1221) being arranged at the proximal end of the guide (110), a first slide (1223) being arranged on the first handle (1221), the drive button (1222) being slidably arranged in the first slide (1223), the drive button (1222) being connected to the push rod (121).

4. A delivery piercing mechanism (100) as claimed in claim 3, wherein the first slideway (1223) has a first position (1223 a) on which the drive button (1222) is located, a part of the structure of the member to be delivered (30) is located outside the guide (110) and passes through the primary (4) and/or secondary (5) septa of the foramen ovale of the heart, the remainder of the structure of the member to be delivered (30) being located within the guide (110).

5. The delivery penetration mechanism (100) of claim 1, wherein the penetration structure (140) is a guidewire, the guide (110) further being provided with a second receiving cavity for receiving the guidewire, the second receiving cavity being arranged in parallel with the first receiving cavity (111).

6. The delivery piercing mechanism (100) of claim 1, wherein the piercing structure (140) is a needle-like structure formed at a distal end of the guide (110).

7. A delivery penetration mechanism (100) according to claim 3, wherein the member (30) to be delivered has a folded state and an elongated state, the member (30) to be delivered comprising a tension adjustment member (31), the tension adjustment member (31) being adapted to adjust the transition of the member (30) to be delivered from the elongated state to the folded state, the delivery penetration mechanism (100) further comprising a pulling member (130), the pulling member (130) being provided on the first handle (1221), the pulling member (130) being connected to the tension adjustment member (31), the pulling member (130) being configured to pull the tension adjustment member (31) to transition the member (30) to be delivered from the elongated state to the folded state.

8. The delivery puncture mechanism (100) according to claim 7, wherein the pulling member (130) comprises a knob and a rotation shaft rotatably provided in the first handle (1221), one end of the rotation shaft extending outside the first handle (1221) and being connected to the knob, and the tension adjustment member (31) is connected to the rotation shaft.

9. The delivery spike mechanism (100) of claim 8 wherein,

the driver (122) further comprises a locking assembly comprising a stationary button (1224) and a locking lever (1225);

a second slideway (1226) is arranged on the first handle (1221), and the second slideway (1226) is provided with a second position (1226 a) and a third position (1226 b);

the locking rod (1225) is slidably arranged in the second slideway (1226), one end of the locking rod (1225) extends into the first handle (1221), the other end extends out of the first handle (1221) and is connected with the fixed button (1224), and the fixed button (1224) is used for driving the locking rod (1225) to move between the second position (1226 a) and the third position (1226 b) along the second slideway (1226);

in the second position (1226 a), the locking lever (1225) is remote from the spindle and locked to the second slideway (1226) to allow rotation of the spindle;

in the third position (1226 b), the locking bar (1225) is locked to the second slide (1226) and cooperates with the spindle to limit rotation of the spindle.

10. The delivery spike mechanism (100) of claim 9 wherein,

The second runner (1226) comprising a first section, a second section, and a third section connecting the first and second sections, the second runner (1226) having a first end (1226 c) and a second end (1226 d), the first and second sections being non-collinear, the width of the first section decreasing in a direction toward the first end (1226 c) and the width of the second section decreasing in a direction toward the second end (1226 d);

-the second position (1226 a) is located in the first section and the third position (1226 b) is located in the second section, the second position (1226 a) and the third position (1226 b) having a width smaller than the outer diameter of the locking bar (1225);

a gear is connected to the rotating shaft of the traction piece (130), in the second position (1226 a), the locking rod (1225) is clamped in the first section, and the locking rod (1225) is far away from the gear;

in a third position (1226 b), the locking bar (1225) is clamped within the second segment, and the locking bar (1225) is clamped between adjacent two teeth of the gear.

11. The delivery spike mechanism (100) of claim 9 wherein,

the second slideway (1226) comprising a first section, a second section and a third section connecting the first and second sections, the first and second sections being non-collinear, the second slideway (1226) having a first end (1226 c) and a second end (1226 d);

The first end (1226 c) and the second end (1226 d) of the second slideway (1226) are respectively provided with a locking groove, the locking groove is provided with an inlet (1226 e), the inlets (1226 e) of the two locking grooves are respectively connected with the first section and the second section, the two locking grooves respectively correspond to the second position (1226 a) and the third position (1226 b), and the width of the inlet (1226 e) is smaller than the outer diameter of the locking rod (1225).

12. A prosthetic device comprising the delivery puncture mechanism (100) according to any one of claims 1-11.

13. A prosthetic device according to claim 12, characterized in that said piece (30) to be delivered has a folded state and an elongated state, said piece (30) to be delivered comprising a tension adjustment member (31), said tension adjustment member (31) being adapted to adjust the transition of said piece (30) to be delivered from said elongated state to said folded state.

14. The prosthetic device of claim 13, further comprising an adjustable bend access catheter (20), a lock delivery system (40) and a suture cutter (50), the adjustable bend access catheter (20) being configured to deliver a piercing structure (140) of the delivery piercing mechanism (100) to a preset location of a primary (4) or secondary (5) of the cardiac foramen ovale, the lock delivery system (40) comprising a lock assembly (41), the lock delivery system (40) being configured to secure the lock assembly (41) to the tension adjustment member (31) via the adjustable bend access catheter (20) after the delivery member (30) anchors the primary (4) and secondary (5) of the cardiac foramen ovale, the suture cutter (50) being configured to cut off the excess tension adjustment member (31) via the adjustable bend access catheter (20) after the lock assembly (41) is secured to the tension adjustment member (31).

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