阅读说明：本技术 心房分流器械 (Atrium shunting device ) 是由 潘晓彤 高国庆 王永胜 于 2020-12-17 设计创作，主要内容包括：本发明提供了一种心房分流器械,包括支架和输送器；支架为整体可径向收缩和膨胀的结构,包括可植入并定位于房间隔以构建造口的支架主体以及连接于支架主体上的回收部；输送器包括鞘管组件、抓取组件和手柄；鞘管组件的远端供所述支架可拆卸地连接于其上,并可以收容呈收缩状态的支架；抓取组件可沿径向合拢或张开,其近端固定连接于所述鞘管组件的远端,其远端为自由端并具有沿径向向内延伸的抓取部,以与所述支架的回收部相结合或相分离；手柄连接于所述鞘管组件的近端,其包括与所述抓取组件相连以控制所述抓取部开合的调节组件以及用于带动所述鞘管组件轴向移动以释放或收容所述支架的输送组件。本发明可以方便地进行支架的回收。(The invention provides an atrial shunt apparatus, which comprises a bracket and a conveyor; the stent is a structure which can be radially contracted and expanded as a whole and comprises a stent main body which can be implanted and positioned in the interatrial septum to construct a stoma and a recovery part connected to the stent main body; the conveyor comprises a sheath tube component, a grabbing component and a handle; the distal end of the sheath tube component is used for detachably connecting the bracket and can accommodate the bracket in a contraction state; the grasping component can be folded or unfolded along the radial direction, the proximal end of the grasping component is fixedly connected with the distal end of the sheath component, the distal end of the grasping component is a free end and is provided with a grasping part extending inwards along the radial direction so as to be combined with or separated from the recovering part of the bracket; the handle is connected to the near end of the sheath assembly, and comprises an adjusting assembly and a conveying assembly, wherein the adjusting assembly is connected with the grabbing assembly to control the grabbing part to open and close, and the conveying assembly is used for driving the sheath assembly to axially move to release or accommodate the stent. The invention can conveniently recover the bracket.)

1. An atrial shunt apparatus, comprising:

a stent, which is a radially contractible and expandable structure as a whole, including a stent main body implantable and positioned in the atrial septum to construct a stoma, and a retrieval portion connected to the stent main body;

a conveyor, comprising:

the distal end of the sheath tube component is detachably connected with the bracket and can accommodate the bracket in a contraction state;

a grasping member which can be folded or unfolded in a radial direction, a proximal end of which is fixedly connected to a distal end of the sheath member, and a distal end of which is a free end and has a grasping portion extending inward in the radial direction so as to be combined with or separated from the retrieving portion of the stent;

the handle is connected to the near end of the sheath tube assembly, and comprises an adjusting assembly and a conveying assembly, wherein the adjusting assembly is connected with the grabbing assembly to control the grabbing part to open and close, and the conveying assembly is used for driving the sheath tube assembly to axially move to release or accommodate the stent.

2. The atrial shunt instrument of claim 1, wherein the grasping assembly comprises a plurality of grasping rods distributed circumferentially about the sheath assembly; the proximal end of each grabbing rod is fixedly connected with the sheath tube assembly, and the distal end of each grabbing rod is provided with the grabbing part; each grabbing rod can be elastically opened and closed relative to the sheath tube assembly along the radial direction, and the opening and the closing are controlled by the adjusting assembly.

3. The atrial shunt device of claim 2, wherein said grasping rod further comprises a caudal portion, a lumbar portion, and a anterior portion connected in series from a proximal end to a distal end; the near end of the tail collecting part is fixedly connected with the sheath tube assembly, the waist part is connected with the adjusting assembly, and the far end of the front part extends out of the grabbing part.

4. The atrial shunt instrument of claim 3, wherein the strength of the grasping portion and the anterior portion is greater than the strength of the caudal portion.

5. The atrial shunt device of claim 3, wherein the caudal portion extends in a straight line or an arc and the anterior portion extends in a straight line or an arc.

6. The atrial shunt device of claim 3, wherein the waist is recessed toward the sheath assembly for connection of the adjustment assembly.

7. The atrial shunt device of claim 2, wherein a plurality of said grasping rods are uniformly circumferentially arranged about said sheath assembly.

8. The atrial shunt device of claim 2, wherein said gripping rods are an even number, said gripping rods being diametrically opposed in pairs.

9. The atrial shunt device of claim 2, wherein said adjustment assembly comprises:

the adjusting wire penetrates through the sheath tube assembly, and the far ends of the adjusting wire are respectively connected with the plurality of grabbing rods so as to drive the grabbing rods to synchronously open and close along the radial direction;

the adjusting mechanism is connected with the near end of the adjusting wire and can drive the far end of the adjusting wire to axially move so as to further drive the grabbing rods to open and close.

10. The atrial shunt device of claim 9, wherein said adjustment wire comprises a main body segment and a plurality of elongate segments extending divergently from a distal end of said main body segment; the far end of each extension section is respectively connected with each grabbing rod.

11. The atrial shunt instrument of claim 10, wherein said adjustment wire further comprises a looped segment; the surrounding section is arranged in a surrounding manner and is connected with the plurality of extension sections; the surrounding sections are wound on the grabbing rods.

12. The atrial shunt device according to claim 9, wherein said adjustment mechanism includes a reel that rotates about a radial axis and a drive unit that rotates said reel;

the adjustment cord is connected to and wound around the reel.

13. The atrial shunt apparatus of claim 12, wherein the driving unit comprises a rack extending in the axial direction and capable of moving in the axial direction, a slider fixedly connected to the rack, and an adjustment key screwed to the slider for moving the slider in the axial direction;

the reel is provided with meshing teeth meshed with the rack, so that the reel is driven by the rack to rotate.

14. The atrial shunt apparatus according to claim 13, wherein the reel has a meshing portion and a winding portion arranged in a direction in which a rotational axis thereof extends, the meshing portion being provided at an outer periphery thereof with the meshing teeth, the winding portion being around which the adjustment wire is wound, the meshing portion having a diameter larger than a diameter of the winding portion.

15. The atrial shunt apparatus according to claim 12, wherein a winding groove is concavely provided on an outer periphery of the reel; the adjusting wire is wound in the wire winding groove.

16. The atrial shunt apparatus of claim 1, wherein said sheath assembly comprises a sheath core and a sheath axially movable about said sheath core; the proximal end of the sheath is connected with the conveying component and driven by the conveying component to move; the grabbing component is fixedly connected to the sheath core.

17. The atrial shunt apparatus of claim 16, wherein said delivery assembly includes a rotatable operating knob and a connector axially movable by said operating rotation, said connector being connected to said sheath.

18. The atrial shunt device of any one of claims 1-17, wherein the retrieval portion and the grasping portion each have visualization indicia thereon.

19. The atrial shunt apparatus of any one of claims 1-17, wherein the recovery portion comprises a plurality of connection units distributed circumferentially; a slot with an opening facing to the far end is formed on each connecting unit; the grabbing part can extend into the slot to be combined with the connecting unit.

20. The atrial shunt device of claim 19, wherein the connection unit has two axially extending connecting rods, proximal ends of the two connecting rods being connected and distal ends of the two connecting rods being spaced apart, the slot being formed between the two connecting rods.

21. The atrial shunt device of any one of claims 1 to 17, wherein the recovery portion has a cylindrical shape, and a plurality of connection holes are formed in a side wall of the recovery portion along a circumferential direction; the grabbing part can extend into the connecting hole to be combined with the recycling part.

22. The atrial shunt apparatus of any one of claims 1-17, wherein the stent body comprises an axially extending channel portion, a left atrial positioning portion connected to a distal end of the channel portion, and a right atrial positioning portion connected to a proximal end of the channel portion; an interatrial septum channel which is axially communicated is arranged in the channel part to construct the stoma; the left room positioning part and the right room positioning part are used for respectively abutting against two sides of the room partition; the recovery part extends from the right house positioning part to the near end.

23. The atrial shunt device of claim 22, wherein the surfaces of said left atrial positioning portion and said right atrial positioning portion are further provided with a coating, said coating being a parylene coating or a polyurethane coating.

Technical Field

The invention relates to the field of medical devices, in particular to an atrium shunt device.

Background

Heart failure (abbreviated as heart failure) is a complex clinical syndrome caused by abnormal changes of heart structure and/or function due to various reasons, and dysfunction of contraction and/or relaxation of ventricles, and mainly manifested as dyspnea, fatigue, fluid retention (pulmonary congestion, systemic congestion, peripheral edema) and the like. According to the left ventricular ejection fraction, the heart failure with reduced ejection fraction, the heart failure with preserved ejection fraction and the heart failure with the intermediate value of ejection fraction are divided. According to the time and speed of heart failure, it is classified into chronic heart failure and acute heart failure. After hospitalization, most acute heart failure patients partially relieve symptoms and turn into chronic heart failure; patients with chronic heart failure often need hospitalization due to acute exacerbation of various causes.

The aging of the population of China is aggravated, the incidence of chronic diseases such as coronary heart disease, hypertension, diabetes, obesity and the like is on the rise, and the improvement of the medical level prolongs the life cycle of heart disease patients, so that the heart failure morbidity of China is on the continuous rise. The domestic 10714 inpatient heart failure patients were investigated and shown: 1980. the fatality rates during hospitalization of heart failure patients in 1990 and 2000 were 15.4%, 12.3% and 6.2%, respectively, with the main causes of death being left heart failure (59%), arrhythmia (13%) and sudden cardiac death (13%). The China-HF study showed that the mortality rate of hospitalized heart failure patients was 4.1%.

HFpEF (preserved ejection fraction heart failure) patients are clinically characterized by labored dyspnea, and among HFpEF patients, there are many mechanisms that may lead to impaired exercise tolerance. HFpEF patients have increased left ventricular relaxation disorder and stiffness, which prevents end-diastolic volume increase in the left ventricle during exercise, resulting in increased Pulmonary Capillary Wedge Pressure (PCWP) and Left Atrial Pressure (LAP), leading to increased pulmonary congestion with poorer prognosis.

No drug or device has been available to date that can significantly reduce mortality or hospitalization risk in HFpEF patients. Clinically, by creating an artificial defect (stoma) at the interatrial septum, a shunt can be created in the left and right atrium, shunting the left atrium to the right atrium, thereby reducing left atrial pressure. After the pressure of the left atrium is reduced, the pressure of the pulmonary artery and the pressure of the pulmonary capillary wedge are reduced, so that the symptoms of dyspnea, fatigue and the like of a patient are relieved.

The above-mentioned stoma is generally formed by implanting an atrial shunt device into the interatrial space, but when a thrombus or stoma closure or the like occurs and the atrial shunt device needs to be removed, it needs to be removed by a thoracic operation, which results in poor prognosis and high treatment cost for the patient.

Disclosure of Invention

It is an object of the present invention to provide an atrial shunt device that is easy to retrieve.

In order to solve the technical problems, the invention adopts the following technical scheme: an atrial shunt device comprising a stent and a transporter; the stent is a structure which can be radially contracted and expanded as a whole and comprises a stent main body which can be implanted and positioned in the interatrial septum to construct a stoma and a recovery part connected to the stent main body; the conveyor comprises a sheath tube component, a grabbing component and a handle; the distal end of the sheath tube component is used for detachably connecting the bracket and can accommodate the bracket in a contraction state; the grasping component can be folded or unfolded along the radial direction, the proximal end of the grasping component is fixedly connected with the distal end of the sheath component, the distal end of the grasping component is a free end and is provided with a grasping part extending inwards along the radial direction so as to be combined with or separated from the recovering part of the bracket; the handle is connected to the near end of the sheath assembly, and comprises an adjusting assembly and a conveying assembly, wherein the adjusting assembly is connected with the grabbing assembly to control the grabbing part to open and close, and the conveying assembly is used for driving the sheath assembly to axially move to release or accommodate the stent.

In some embodiments, the grasping assembly comprises a plurality of grasping rods distributed circumferentially about the sheath assembly; the proximal end of each grabbing rod is fixedly connected with the sheath tube assembly, and the distal end of each grabbing rod is provided with the grabbing part; each grabbing rod can be elastically opened and closed relative to the sheath tube assembly along the radial direction, and the opening and the closing are controlled by the adjusting assembly.

In some embodiments, the grasping rod further comprises a caudal portion, a lumbar portion, and a anterior portion that are joined in sequence from a proximal end to a distal end; the near end of the tail collecting part is fixedly connected with the sheath tube assembly, the waist part is connected with the adjusting assembly, and the far end of the front part extends out of the grabbing part.

In some embodiments, the strength of the grasping portion and the anterior portion is greater than the strength of the caudal portion.

In some embodiments, the tail portion extends in a straight or arc shape and the head portion extends in a straight or arc shape.

In some embodiments, the waist is recessed toward the sheath assembly for connection of the adjustment assembly.

In some embodiments, a plurality of the grasping rods are evenly circumferentially arranged around the sheath assembly.

In some embodiments, the number of the grabbing bars is even, and the grabbing bars are arranged in pairs in radial direction.

In some embodiments, the adjustment assembly comprises: the adjusting wire penetrates through the sheath tube assembly, and the far ends of the adjusting wire are respectively connected with the plurality of grabbing rods so as to drive the grabbing rods to synchronously open and close along the radial direction; the adjusting mechanism is connected with the near end of the adjusting wire and can drive the far end of the adjusting wire to axially move so as to further drive the grabbing rods to open and close.

In some embodiments, the accommodating wire comprises a main body segment and a plurality of elongate segments divergently extending from a distal end of the main body segment; the far end of each extension section is respectively connected with each grabbing rod.

In some embodiments, the conditioning line further comprises a looped segment; the surrounding section is arranged in a surrounding manner and is connected with the plurality of extension sections; the surrounding sections are wound on the grabbing rods.

In some embodiments, the adjustment mechanism includes a reel that rotates about a radial axis and a drive unit that rotates the reel; the adjustment cord is connected to and wound around the reel.

In some embodiments, the driving unit includes a rack extending along the axial direction and capable of moving axially, a slider fixedly connected with the rack, and an adjusting key in threaded connection with the slider to drive the slider to move axially; the reel is provided with meshing teeth meshed with the rack, so that the reel is driven by the rack to rotate.

In some embodiments, the reel has a meshing portion arranged in a direction in which a rotation axis thereof extends, the meshing portion being provided at an outer periphery thereof with the meshing teeth, and a winding portion around which the adjustment wire is wound, the meshing portion having a diameter larger than a diameter of the winding portion.

In some embodiments, the reel has a winding groove recessed in its outer circumference; the adjusting wire is wound in the wire winding groove.

In some embodiments, the sheath assembly comprises a sheath core and a sheath axially movable around the sheath core; the proximal end of the sheath is connected with the conveying component and driven by the conveying component to move; the grabbing component is fixedly connected to the sheath core.

In some embodiments, the delivery assembly includes a rotatable operating knob and a connector axially movable by the operating knob, the connector being connected to the sheath.

In some embodiments, the recovery portion and the grasping portion are provided with development marks, respectively.

In some embodiments, the recovery portion comprises a plurality of connection units distributed circumferentially; a slot with an opening facing to the far end is formed on each connecting unit; the grabbing part can extend into the slot to be combined with the connecting unit.

In some embodiments, the connecting unit has two axially extending connecting rods, the proximal ends of the two connecting rods being connected, the distal ends of the two connecting rods being spaced apart, the slot being formed between the two connecting rods.

In some embodiments, the recovery part is cylindrical, and a side wall of the recovery part is provided with a plurality of connecting holes along the circumferential direction; the grabbing part can extend into the connecting hole to be combined with the recycling part.

In some embodiments, the stent body comprises an axially extending channel portion, a left atrial positioning portion connected to a distal end of the channel portion, and a right atrial positioning portion connected to a proximal end of the channel portion; an interatrial septum channel which is axially communicated is arranged in the channel part to construct the stoma; the left room positioning part and the right room positioning part are used for respectively abutting against two sides of the room partition; the recovery part extends from the right house positioning part to the near end.

In some embodiments, the stent is laser cut or braided from nitinol.

In some embodiments, the surfaces of the left room-positioning portion and the right room-positioning portion are both further provided with a coating, and the coating is a parylene coating or a polyurethane coating.

According to the technical scheme, the invention has at least the following advantages and positive effects: the atrial shunt device of the present invention includes a stent with which the atrial septum may be implanted to create a stoma, and a transporter for transporting and retrieving the stent. The support and the conveyor can be connected or separated through the recovery part arranged on the support and the grabbing part arranged on the grabbing component of the conveyor. The bracket is grabbed or released by grabbing the radial opening of the assembly, and the bracket can be conveniently conveyed and recovered by matching the axial movement realized by the sheath assembly and the conveying assembly.

Drawings

FIG. 1 is a schematic structural view of a first embodiment of an atrial shunt device of the present invention.

Fig. 2 is a perspective view of the stent of fig. 1.

Fig. 3 is a front view of fig. 2.

Fig. 4 is a top view of fig. 3.

Fig. 5 is a schematic view of the structure of the conveyor of fig. 1.

Fig. 6 is a perspective view of the grasping assembly of fig. 5.

Fig. 7 is a schematic view of the internal structure at a in fig. 5.

Fig. 8 is a side view of the reel of fig. 7.

Fig. 9 is a schematic view of the internal structure at B in fig. 5.

Fig. 10 is a schematic view of a first state of fig. 1 in use.

Fig. 11 is a schematic view of a second state of fig. 1 in use.

FIG. 12 is a schematic view of the delivery apparatus of the second embodiment of the atrial shunt apparatus of the present invention showing, primarily, the structure of the grasping assembly.

FIG. 13 is a schematic illustration of the delivery apparatus of the third embodiment of the atrial shunt device of the present invention showing, primarily, the structure of the grasping assembly.

FIG. 14 is a perspective view of a stent of a fourth embodiment of an atrial shunt device of the present invention.

Fig. 15 is a front view of fig. 14.

Fig. 16 is a top view of fig. 15.

The reference numerals are explained below:

1. a support; 11. a channel portion; 111. an atrial septal pathway; 112. a channel ring; 113. a support unit;

12. a left room positioning section; 121. a positioning unit; 122. a developing well;

13. a right room positioning section; 131. an elastic bending rod;

14. a recovery unit; 141. a connection unit; 1411. a connecting rod; 1412. grooving; 142. a developing well;

2. a conveyor; 201. a sheath assembly; 203. a grasping assembly; 205. a handle;

21. a sheath core; 211. a sheath-core head; 22. a sheath tube;

23. a grabbing rod; 231. collecting the tail part; 232. a waist part; 233. a front portion; 234. a grasping section;

24. a housing; 241. a rotating shaft;

25. an adjustment assembly; 251. an adjustment line; 2511. a main body section; 2512. an extension section; 2513. a surrounding section; 252. an adjustment mechanism; 2521. a reel; 2521a, a rotating shaft hole; 2521b, an engagement portion; 2521c, a winding portion; 2521d, meshing teeth; 2521e, a winding slot; 2522. a rack; 2523. a slider; 2524. an adjustment key;

26. a delivery assembly; 261. an operation knob; 262. a joint;

3. a support; 31. a channel portion; 311. an atrial septal pathway; 32. a left room positioning section; 33. a right room positioning section; 34. a recovery unit; 341. connecting holes; 342. and developing the mark.

Detailed Description

Exemplary embodiments that embody features and advantages of the invention are described in detail below in the specification. It is to be understood that the invention is capable of other embodiments and that various changes in form and details may be made therein without departing from the scope of the invention and the description and drawings are to be regarded as illustrative in nature and not as restrictive.

The invention provides an atrium shunting device, which comprises a bracket and a matched conveyor, wherein when in use, the bracket is sent into the interatrial septum of the heart by a percutaneous intervention operation through the conveyor, and the bracket is implanted and positioned at the interatrial septum to form a construction opening, so that the left atrium shunts to the right atrium, thereby reducing the left atrial pressure. When the stent is implanted incorrectly, generates thrombus or other adverse reactions in the operation process, the transporter is used for grabbing the stent, withdrawing the stent, and then performing the replacement or terminating the implantation. In addition, when the stent is implanted into a human body for a period of time to cause problems such as thrombus or stoma closure, the conveyor is also used for grabbing the stent to take out, thereby avoiding the application of a thoracic surgery.

For ease of reference, the term "distal" is defined herein as the end of the surgical procedure distal to the operator, and the term "proximal" is the end of the surgical procedure proximal to the operator. In addition, the support and the conveyor according to the present invention are generally tubular or cylindrical structures having a rotation center axis, and a direction along the rotation center axis is defined as an axial direction, a direction perpendicular to the axial direction is defined as a radial direction, and a direction around the rotation center axis is defined as a circumferential direction. It is to be understood that these definitions are primarily for convenience and are not to be construed as limiting the scope of the present application.

The first embodiment is specifically as shown in the structural schematic diagrams of fig. 1 to 11.

Referring to FIG. 1, FIG. 1 illustrates the atrial shunt device of this embodiment in a use configuration in which the stent 1 is attached to the delivery device 2 in an expanded configuration. The transporter 2 has a sheath assembly 201, a grasping assembly 203 attached to the distal end of the sheath assembly 201, and a handle 205 attached to the proximal end of the sheath assembly 201. The bracket 1 is sleeved on the sheath tube component 201 and is positioned in the grabbing range of the grabbing component 203. The stent 1 may be combined with the grasping member 203 according to a principle which will be described in detail later, and then the stent 1 may be accommodated in the sheath member 201 in a contracted state or released from the sheath member 201 to be expanded by the operation of the handle 205. When the stent 1 is implanted in the interatrial septum in the expanded state, the grasping element 203 may be separated from the stent 1 so that the stent 1 may be separated from the conveyor 2 and the stent 1 may be positioned in the interatrial septum to construct a stoma.

The specific structure of the frame 1 and conveyor 2 will first be described.

Referring to fig. 2 to 4, the stent 1 of the present embodiment is a cut-type stent, preferably formed by laser cutting a nitinol alloy, having super-elasticity and self-expandability, and integrally formed in a radially contractible and expandable structure. The specific manufacturing process can refer to the prior related art.

The stent 1 comprises a channel portion 11 extending in the axial direction, a left room-positioning portion 12 connecting the distal ends of the channel portion 11, a right room-positioning portion 13 connecting the proximal ends of the channel portion 11 and extending in the distal direction, and a recovery portion 14 extending proximally from the right room-positioning portion 13.

The left and right atrial positioning portions 12 and 13 have spaces in the axial direction for positioning on the left and right atrial sides of the interatrial septum, respectively, and the channel portion 11 forms an interatrial septum channel 111 that passes through in the axial direction to form a stoma at the interatrial septum.

Specifically, in the present embodiment, the channel portion 11 includes a channel ring 112 at the distal end and four supporting units 113 uniformly distributed along the circumference of the channel ring 112. The four support units 113 extend in the axial direction and are connected by two bars to form an X-shape. The four supporting units 113 are enclosed to form the interatrial septum passage 111 inside.

The left room-positioning portion 12 is substantially in a plane and may be integrally in contact with the atrial septum. The left room positioning section 12 of the present embodiment has four positioning units 121 circumferentially distributed, and the four positioning units 121 are dispersedly connected to the outer periphery of the passage ring 112. Each positioning unit 121 is formed by two rods connected to form a V-shape, the vertex of the V-shape faces outward, and the vertex is provided with a developing hole 122.

The right atrium positioning portion 13 comprises a plurality of elastic bending rods 131, each elastic bending rod 131 extends from the proximal end of the channel portion 11 to the distal end in a bending manner, and then extends outwards in a radial direction to form a positioning surface capable of abutting against the atrial septum.

The duct portion 11, the left atrium positioning portion 12, and the right atrium positioning portion 13 are integrally formed as a stent body, and are positioned on both sides of the interatrial septum, so that the interatrial septum duct 111 forms a stoma penetrating the left atrium and the right atrium, and maintains the size of the stoma.

Further, the surfaces of the left and right atrial positioning portions 12 and 13 are provided with coatings, and the coating material is a material having insulating property, inhibiting thrombus formation, or both, such as parylene coating or polyurethane coating.

It will be appreciated that the construction of the stent body is not limited to that shown. The number of the supporting units 113, the number of the positioning units 121, and the number of the elastic bending rods 131 can be flexibly set. The support units 113 may have other shapes, such as a V shape or a grid shape, and two adjacent support units 113 may be connected or spaced apart from each other. The positioning unit 121 may have other shapes, and the positioning unit 121 is not limited to be on a plane. The shape of the resilient bending rod 131 can also be designed flexibly.

The recovery part 14 includes a plurality of connection units 141 circumferentially spaced around the passage part 11, and each connection unit 141 protrudes and extends from the distal end of the right atrium positioning part 13 toward the proximal end. In this embodiment, the connection unit 141 includes two connection rods 1411 extending along the axial direction, the proximal ends of the two connection rods 1411 are connected, and the distal ends of the two connection rods 1411 are separated to form a substantially V-shaped structure. A slot 1412 with an opening facing the distal end is formed between the two connecting rods 1411. The end of the two connecting rods 1411 where they are connected is also provided with a developing hole 142.

The developing holes 122 of the left room positioning portion 12 and the developing holes 142 of the collecting portion 14 are used for providing developing marks, which can be formed by filling the developing holes 122, 142 with a developing material. A developing material such as at least one of platinum, gold, palladium, or an alloy thereof.

The position of the left room positioning section 12 can be easily indicated by the development mark on the left room positioning section 12 to confirm whether the correct position is implanted, and the position of the recovery section 14 can be easily indicated by the development mark on the recovery section 14 to facilitate grasping by the grasping assembly 203 of the conveyor 2.

Next, referring to fig. 5 to 9, the structure of the conveyor 2 in the present embodiment will be described in detail.

Referring first to fig. 5, the sheath assembly 201 of the conveyor 2 includes a sheath core 21 and a sheath 22 axially movable around the sheath core 21. In a configuration not shown, the distal end of the sheath assembly 201 may be pre-bent to allow the sheath assembly 201 to be easily aligned with the atrial septum.

The distal end of sheath core 21 extends beyond the distal end of sheath 22 for connection of grasping assembly 203 to stent 1, and the distal end of sheath core 21 is provided with a sheath core head 211, and sheath core head 211 enables sheath assembly 201 to pass more smoothly through the atrial septum. The proximal end of sheath core 21 is secured to handle 205.

The sheath 22 is spaced from the sheath core 21 to accommodate the grasping assembly 203 and the stent 1. The proximal end of the sheath 22 extends into the handle 205 and is axially moved relative to the sheath core 21 by the handle 205.

The grasping elements 203 are radially movable toward and away from each other, and in their closed state, they are accommodated in the sheath 22. The proximal end of grasping element 203 is fixedly attached to the distal end of sheath core 21 and is spaced from sheath core head 211 to allow stent 1 to be removably nested over sheath core 21. The distal end of the grasping element 203 is free and has a radially inwardly extending grasping portion 234. The grasping portion 234 may be combined with or separated from the recovering portion 14 of the stand 1, and particularly, in combination with the structure of the stand 1, the grasping portion 234 may extend into the slot 1412 of the recovering portion 14 to be combined with the connecting unit 141.

Referring to fig. 6, the grasping assembly 203 includes a plurality of grasping rods 23 distributed circumferentially around the sheath assembly 201. The proximal end of each grabbing rod 23 is fixedly connected with the sheath core 21 of the sheath tube assembly 201, and the distal end of each grabbing rod 23 is a free end separated from the sheath core 21. The grasping rods 23 are elastically openable and closable in the radial direction with respect to the sheath core 21, and thus opened or closed in the radial direction as a whole.

The grab bar 23 further comprises a tail 231, a waist 232 and a front 233, which are connected in sequence from the proximal end to the distal end.

The proximal end of the ending part 231 is fixedly connected with the sheath core 21, and in the embodiment, the ending part 231 extends linearly, is connected with the sheath core 21 at a certain angle, and is opened and closed relative to the sheath core 21 by the elasticity of the structure. The grasping rod 23 is opened and closed radially mainly by the elasticity of the ending part 231, and preferably, the ending part 231 is made of a material with better elasticity, such as a super-elastic nickel-titanium alloy.

The front portion 233 extends linearly in the axial direction of the sheath core 21, and the distal end thereof extends radially inward beyond the catching portion 234. The grasping portion 234 and the front portion 233 substantially constitute an L-shaped hook structure so as to grasp the recovery portion 14 of the rack 1. Preferably, the grasping portions 234 and the front portions 233 have a strength greater than that of the tail portions 231, so that the grasping portions 234 and the front portions 233 can grasp the stent 1 and apply pressure to the stent 1 more reliably. As a preferred example, the grasping portion 234 and the front portion 233 may be made of stainless steel.

Preferably, the grasping portion 234 is further provided with a developing mark (not shown) to facilitate positioning of the grasping portion 234.

The waist 232 is connected between the tail 231 and the front 233 for transition, and the waist 232 is controlled by the handle 205 to drive the grabbing rod 23 to open and close radially. The waist 232 may be made of stainless steel or nitinol.

Waist 232 is recessed toward sheath core 21 to form a groove having a substantially U-shaped cross section, the opening of which faces outward. Namely: the waist 232 extends radially inward from the distal end of the tail 231 and then radially outward to the proximal end of the front 233.

In the present embodiment, the number of the grasping rods 23 is four, corresponding to the four collecting sections 14 of the rack 1, respectively. The four grabbing rods 23 are uniformly arranged around the circumferential direction of the sheath core 21, and meanwhile, the four grabbing rods 23 are arranged in pairs along the radial direction. Based on this arrangement, the engagement of the grab bar 23 with the recovery part 14 can be more reliable.

In other embodiments, not shown, the number of gripping bars 23 can also be flexibly adjusted and is preferably adapted to the recovery section 14. However, it should be noted that the plurality of gripping rods 23 are uniformly arranged along the circumferential direction, which is a preferred mode, and can grip the stent 1 uniformly along the circumferential direction, and the force is uniformly applied. The grabbing rods 23 are arranged oppositely in pairs along the radial direction, so that two sides of the support 1 can be grabbed oppositely in the radial direction, and the support 1 is convenient to clamp. In the actual structure, can rationally set up according to actual conditions.

Referring to fig. 5-7 and 9, a handle 205 is attached to the proximal end of the sheath assembly 201 for use by an operator for controlling the motion of the grasping assembly 203 and the sheath assembly 201.

The handle 205 generally includes a housing 24, an adjustment assembly 25, and a delivery assembly 26. The housing 24 serves as a carrier for the adjustment assembly 25 and the delivery assembly 26 to be mounted, and at the same time, the housing 24 is fixedly connected with the sheath core 21 of the sheath assembly 201.

Referring to fig. 6 and 7, the adjusting assembly 25 is connected to the grasping assembly 203 to control the opening and closing of the grasping portion 234.

Specifically, the adjustment assembly 25 includes an adjustment wire 251 and an adjustment mechanism 252. The adjusting wire 251 is arranged in the sheath assembly 201 in a penetrating manner, and the distal end of the adjusting wire 251 is respectively connected with the plurality of grabbing rods 23 of the grabbing assembly 203 so as to drive each grabbing rod 23 to open and close synchronously along the radial direction. The adjusting mechanism 252 is located at the proximal end of the housing 24, connected to the proximal end of the adjusting wire 251, and can drive the distal end of the adjusting wire 251 to move axially to further drive the plurality of grabbing bars 23 to open and close.

Referring to fig. 6, the adjustment wire 251 includes a main body section 2511, a plurality of extension sections 2512 extending from a distal end of the main body section 2511, and a surrounding section 2513 disposed around and connected to the plurality of extension sections 2512.

The surrounding portion 2513 is wound around the waist portion 232 of each of the catching bars 23, wherein, since the waist portion 232 is recessed toward the sheath assembly 201, the surrounding portion 2513 wound around the waist portion 232 can conveniently maintain its position without easily slipping off.

The distal end of each extension 2512 corresponds to each grasping rod 23, and is indirectly connected to the grasping rod 23 through the connection of the surrounding 2513 to the grasping rod 23. In this embodiment, the extension 2512 controls the diameter of the surrounding 2513, so as to control the opening and closing of the grabbing rods 23, thereby facilitating the synchronous operation of the grabbing rods 23. In this embodiment, the number of extension 2512 may or may not be the same as the number of gripping bars 23. In some embodiments, not shown, the surrounding portion 2513 may be eliminated, and the distal end of each extension 2512 is directly connected to the waist portion 232 of each grabbing bar 23, so that the grabbing bars 23 are directly opened and closed through the extension 2512.

The main body section 2511 extends in the axial direction and is inserted into the sheath assembly 201. Referring to FIG. 7, the proximal end of body segment 2511 extends into housing 24 to connect with adjustment mechanism 252.

Referring specifically to fig. 7, the adjustment mechanism 252 includes a reel 2521 rotatable about a radial axis, a rack 2522 extending in an axial direction and being axially movable, a slider 2523 fixedly connected to the rack 2522, and an adjustment key 2524 threadedly connected to the slider 2523 for axially moving the slider 2523.

The reel 2521 is provided with a through-hole 2521a for rotatably mounting in the housing 24. illustratively, a shaft 241 is provided protruding in the housing 24, and the reel 2521 is rotatably fitted to the shaft 241 through the shaft hole 2521 a.

With reference to fig. 7 and 8, the reel 2521 has a substantially stepped structure, and includes a meshing portion 2521b and a winding portion 2521c extending along the axis L of the spindle hole 2521a, the diameter of the meshing portion 2521b being larger than the diameter of the winding portion 2521 c.

The engaging portion 2521b has engaging teeth 2521d on the outer periphery thereof, and the engaging teeth 2521d are engaged with the rack 2522 so as to be rotated by the rack 2522. In this embodiment, the engagement portion 2521b is provided with engagement teeth 2521d over the entire circumference thereof, and in some other embodiments not shown, the engagement teeth 2521d may be disposed on only a part of the outer circumference of the engagement portion 2521 b.

The outer circumference of the winding portion 2521c is preferably recessed with a winding groove 2521e, so that the main body 2511 of the adjustment wire 251 is wound in the winding groove 2521 e. Through the arrangement of the winding slots 2521e, the adjusting wire 251 can be limited, so that the movement of the adjusting wire 251 is more accurate. In some embodiments, the winding groove 2521e may be omitted, and the adjustment wire 251 may be directly wound around the outer circumference of the winding portion 2521 c.

The rack 2522, slider 2523, and adjustment key 2524 integrally form a drive unit for rotating the reel 2521. Specifically, an adjustment key 2524 is sleeved on the proximal end of the housing 24 for operator operation. An internal thread is provided in the adjustment key 2524, and is engaged with an external thread provided on the outer periphery of the slider 2523. When the operator rotates the adjustment key 2524, the slider 2523 is moved in the axial direction by screw engagement, and the rack 2522 is moved in the axial direction along with the slider 2523 to rotate the reel 2521 by meshing engagement, thereby further winding the main body segment 2511 of the adjustment wire 251 on the reel 2521 or releasing it from the reel 2521.

As the proximal end of the body section 2511 winds up the reel 2521, the distal end of the body section 2511 will move axially proximally, driving the extension 2512 proximally, the diameter of the surrounding section 2513 decreases, and the waist 232 of each gripping rod 23 moves radially inwardly, driving the gripping rods 23 radially inwardly together.

When the proximal end of the body section 2511 is released from the reel 2521, the distal end of the body section 2511 will move axially distally, the extension section 2512 and the encircling section 2513 relax, the restraining force on the catch lever 23 decreases, and the catch lever 23 resiliently expands outwardly.

The adjusting wire 251 is structurally integrated into a wire, and the main body 2511, the extension 2512 and the surrounding 2513 are divided mainly according to the connection and matching relationship with other components. In fact, as the diameter of the surrounding section 2513 decreases, the reduced portion thereof will become the extension section 2512, and the proximal ends of the plurality of extension sections 2512 may also be considered to become the body section 2511 after they are gathered, and the same may be said to change from one another when moving in the opposite direction.

The material of the adjusting wire 251 can be selected according to the actual situation, for example, a metal wire, a polymer suture, etc. can be used.

It is particularly noted that in the present embodiment, the proximal end of the adjustment wire 251 is wound around the reel 2521, and the reel 2521 can apply a large tightening force to the adjustment wire 251, so that the adjustment wire 251 can be maintained in a tightened state, which is particularly advantageous when the grasping portion 234 is controlled to apply pressure to the stent 1 while closing the grasping rod 23.

Further, when the diameter of the engaging portion 2521b of the reel 2521 is larger than that of the winding portion 2521c and the engaging portion 2521b is rotated by the rack 2522 by a predetermined angle, the length of the adjustment wire 251 that can be wound around the winding portion 2521c is larger than the arc length of rotation of the engaging portion 2521b, and the adjustment wire 251 can be tightened in a similar manner. At the same time, the handle 205 is made more compact in its internal structure.

Referring again to fig. 9, the delivery assembly 26 basically includes a rotatable operating knob 261 and a connector 262 driven by the operating knob 261 to move axially, the connector 262 being connected to the proximal end of the sheath 22.

The operation knob 261 is used by an operator, and is in threaded fit with the joint 262 to drive the joint 262 to move axially, so as to further drive the sheath 22 of the sheath assembly 201 to move axially.

The conveying assembly 26 may also be provided with a position control module for controlling the axial moving position, and the like, which can be referred to in the related art.

In addition, the handle 205 may also be provided with means for delivering a fluid, such as a contrast agent, through the sheath 22 to the heart of the patient, as is known in the art.

In the atrial shunt device of this embodiment, the stent 1 and the delivery device 2 are separately fabricated and used in combination. In the initial state before use, the stent 1 is in a free expansion state, that is, the state illustrated in fig. 2 to 4, and the grasping elements 203 of the transporter 2 are housed in the sheath 22 in a closed state. Based on the foregoing structural description, and with further reference to FIGS. 10 and 11, the atrial shunt device of this embodiment may be used in a manner generally as follows.

1. Rotating the operating knob 261 moves the sheath 22 proximally, causing the grasping assembly 203 to be released from the sheath 22. The adjustment knob 2524 is rotated again to rotate the reel 2521 to release the adjustment wire 251, and the grip levers 23 of the grip assembly 203 are radially expanded, at which time the conveyor 2 is in the condition shown in fig. 5. The stent 1 is then put in place on the sheath core 21 in the state shown in fig. 1 and 10. Then, the adjustment key 2524 is rotated to tighten the adjustment wire 251, so that the grasping rods 23 of the grasping assembly 203 are closed, and the grasping portion 234 extends into the slot 1412 of the recovering portion 14 of the holder 1 to be combined with the holder 1, and the state is shown in fig. 11. The operation knob 261 is rotated again to move the sheath 22 distally, thereby retracting the grasping assembly 203 and the stent 1 into the sheath 22.

2. Advancing transporter 2 along the guidewire to the right atrium and aligning the distal radial cross-section with the interatrial septum applies a stress to force sheath-core head 211 through the interatrial septum and continues to advance sheath assembly 201 a short distance forward.

3. The sheath tube 22 is slowly retracted proximally by rotating the operation knob 261, and the left atrium positioning portion 12 of the stent 1 is released into the left atrium. The position of the left atrium positioning portion 12 in the left atrium is observed through the development hole 122 of the left atrium positioning portion 12, and the left atrium positioning portion 12 is adjusted to be in contact with the atrial septum. Then, the operation knob 261 is continuously rotated to continue slow withdrawal of the sheath tube 22 and release the right room-positioning section 13 and the recovery section 14. When the stent 1 is completely released, continuing to rotate the operation knob 261 releases the grasping assembly 203. At this time, the grasping assembly 203 still firmly grasps the recovery portion 14 of the stent 1.

4. The adjustment key 2524 is rotated to gradually radially expand the grasping rods 23 until the grasping portion 234 is separated from the collecting portion 14 of the stent 1. The handle 205 is withdrawn slightly to allow the grasping assembly 203 to also be completely axially disengaged from the holder 1. The adjustment key 2524 is then rotated to bring the gripper assemblies 203 together until they are at a minimum. At this time, the operation knob 261 is rotated again to advance the sheath 22 slowly toward the distal end until the grasping assembly 203 is completely received in the sheath 22.

5. At this time, the stent 1 is implanted into the interatrial septum and creates a shunt hole using its interatrial septum passage 111. If there are no other anomalies, conveyor 2 may be withdrawn.

6. When the stent 1 needs to be retrieved, the sheath assembly 201 is delivered over the guide wire to the right atrium. Rotating the operating knob 261 retracts the sheath 22 slowly until the grasping assembly 203 is fully released, and then rotating the adjustment key 2524 causes the grasping assembly 203 to expand radially. The gripper assembly 203 is positioned in place by the development marks on the gripper portion 234 and the development marks formed by the development holes 142 of the recovery portion 14. At this time, the grasping unit 203 is controlled to close by the adjustment key 2524, so that the grasping portion 234 grasps the stent 1. The operating knob 261 is then rotated again to advance the sheath 22 slowly and retract the grasping assembly 203 and the stent 1 completely within the sheath 22. After the above steps are completed, the instrument is withdrawn, and the stent 1 is taken out.

In a second embodiment, please refer to the structure shown in FIG. 12.

The atrial shunt apparatus of this embodiment differs from the first embodiment in the structure of the grasping assembly 203.

In the present embodiment, as shown in fig. 12, the grabbing bar 23 of the grabbing component 203 extends in a curved line. The closing portion 231 of the catching rod 23 extends in an arc shape, and the extending shape of the closing portion 231 is generally composed of a section of an inner concave arc and a section of an outer convex arc. The front portion 233 of the grab bar 23 is also curved, and in this embodiment, the front portion 233 extends in an outward arc having a diameter larger than the arc diameter of the rear portion 231. The distal end of the front portion 233 is substantially parallel to the axial direction of the sheath assembly 201, and the grasping portion 234 extends radially inward from the front portion 233. The waist 232 is concave toward the sheath assembly 201 and extends in a shape of a generally concave arc.

The adjustment wire 251 is connected to the waist 232 of the grab bar 23 to control the opening and closing of the grab bar 23.

Other features of this embodiment are described in reference to the first embodiment and will not be described in detail.

In a third embodiment, please refer to the structure shown in FIG. 13.

The atrial shunt apparatus of this embodiment differs from the first embodiment in the structure of the grasping assembly 203.

As shown in fig. 13, in the present embodiment, the end 231 of the grab bar 23 extends linearly. The front portion 233 of the grab bar 23 extends in an arc, and in this embodiment, the front portion 233 extends in an outwardly convex arc. A grasping portion 234 extends radially inward from the distal end of the front portion 233. The waist 232 is concave toward the sheath assembly 201 and extends in a shape of a generally concave arc.

The adjustment wire 251 is connected to the waist 232 of the grab bar 23 to control the opening and closing of the grab bar 23.

Other features of this embodiment are described in reference to the first embodiment and will not be described in detail.

In a fourth embodiment, please refer to the structure shown in fig. 14-16.

The atrial shunt apparatus of this embodiment differs from the first embodiment in the structure of the frame 3, and the transporter can still adopt the structure of the first embodiment.

Referring to fig. 14 to 16, in the present embodiment, the stent 3 is a woven stent woven from nitinol and has superelasticity and self-expansion properties.

The stent 3 also comprises a stent main body and a retrieval portion 34, wherein the stent main body also comprises an axially extending channel portion 31, a left atrium positioning portion 32 connected to the distal end of the channel portion 31, and a right atrium positioning portion 33 connected to the proximal end of the channel portion 31. An axial through atrial septum channel 311 is provided in the channel portion 31 to create a stoma.

The tunnel portion 31, the left room-positioning portion 32 and the right room-positioning portion 33 are each in a woven lattice structure, and the function of each portion is the same as that of the corresponding portion of the bracket 1 in the first embodiment.

In this embodiment, a development mark may be provided on the stent main body such as the channel part 31 to facilitate positioning of the stent 3 when it is implanted, and the development mark may be formed by weaving a development material together with nitinol.

The collecting section 34 is cylindrical and extends proximally from the right atrium positioning section 33. The side wall of the recovery portion 34 is provided with a plurality of connection holes 341 in the circumferential direction. The connection hole 341 allows the gripping portion 234 of the conveyor 2 to be inserted so that the rack 3 is gripped by the gripping member 203 of the conveyor 2.

The inner wall of the connection hole 341 is preferably provided with a developing mark 342 to facilitate positioning when the grasping portion 234 is combined with the recovery portion 34. The development mark 342 is made of a development material.

The manner in which the carrier 3 of this embodiment is used in conjunction with the conveyor 2 is substantially the same as in the first embodiment, as follows.

1. Rotating the operating knob 261 moves the sheath 22 proximally, causing the grasping assembly 203 to be released from the sheath 22. The adjustment knob 2524 is rotated again to rotate the reel 2521 to release the adjustment wire 251, and the grip lever 23 of the grip assembly 203 is radially expanded. Then, the stent 3 is put in place in the sheath core 21, and then the adjustment key 2524 is rotated to tighten the adjustment wire 251, so that the grasping rod 23 of the grasping member 203 is closed, and the grasping portion 234 is inserted into the connecting hole 341 of the recovering portion 34 of the stent 3 to be combined with the stent 3. The operation knob 261 is rotated again to move the sheath 22 distally, thereby retracting the grasping unit 203 and the stent 3 into the sheath 22.

2. Advancing transporter 2 along the guidewire to the right atrium and aligning the distal radial cross-section with the interatrial septum applies a stress to force sheath-core head 211 through the interatrial septum and continues to advance sheath assembly 201 a short distance forward.

3. The sheath tube 22 is slowly retracted proximally by rotating the operation knob 261, and the left atrium positioning portion 32 of the stent 3 is released into the left atrium. The positions of the left atrium positioning portion 32 and the channel portion 31 in the left atrium are observed and adjusted by the development marks on the stent main body. Then, the operation knob 261 is continuously rotated to continue slow withdrawal of the sheath tube 22 and release the right room-positioning portion 33 and the recovery portion 34. When the holder 3 is completely released, continuing to rotate the operation knob 261 releases the grasping assembly 203. At this time, the grasping member 203 still firmly grasps the recovery portion 34 of the holder 3.

4. The adjustment key 2524 is rotated to gradually radially expand the grasping rod 23 until the grasping portion 234 is separated from the connecting hole 341 of the recovery portion 34. The handle 205 is withdrawn slightly to allow the grasping assembly 203 to also be completely axially disengaged from the holder 3. The adjustment key 2524 is then rotated to bring the gripper assemblies 203 together until they are at a minimum. At this time, the operation knob 261 is rotated again to advance the sheath 22 slowly toward the distal end until the grasping assembly 203 is completely received in the sheath 22.

5. At this time, the stent 3 is implanted into the interatrial septum and creates a shunt hole using its interatrial septum passage 311. If there are no other anomalies, conveyor 2 may be withdrawn.

6. When the stent 3 needs to be retrieved, the sheath assembly 201 is delivered over the guide wire to the right atrium. Rotating the operating knob 261 retracts the sheath 22 slowly until the grasping assembly 203 is fully released, and then rotating the adjustment key 2524 causes the grasping assembly 203 to expand radially. The gripper assembly 203 is positioned in place by the development marks on the gripper 234 and the development marks 342 of the recovery section 34. At this time, the grasping unit 203 is controlled to close by the adjustment key 2524, so that the grasping portion 234 grasps the holder 3. The operating knob 261 is then rotated again to advance the sheath 22 slowly and retract the grasping assembly 203 and the stent 3 completely within the sheath 22. After the above steps are completed, the instrument is withdrawn, and the stent 3 is taken out.

While the present invention has been described with reference to several exemplary embodiments, it is understood that the terminology used is intended to be in the nature of words of description and illustration, rather than of limitation. As the present invention may be embodied in several forms without departing from the spirit or essential characteristics thereof, it should also be understood that the above-described embodiments are not limited by any of the details of the foregoing description, but rather should be construed broadly within its spirit and scope as defined in the appended claims, and therefore all changes and modifications that fall within the meets and bounds of the claims, or equivalences of such meets and bounds are therefore intended to be embraced by the appended claims.