Delivery device for an atrial shunt

Abstract

This invention discloses a delivery device for an atrial shunt, comprising a delivery structure, a venting structure, and a pushing structure. The delivery structure includes a guide catheter and a delivery catheter. Both the guide catheter and the delivery catheter have venting structures at their proximal ends. The guide catheter serves as the path for an external guidewire, and the delivery catheter has a path for delivering the atrial shunt. The pushing structure controls the movement of the external atrial shunt along the delivery path of the delivery catheter. The delivery structure for the atrial shunt provided by this invention integrates the delivery and loading processes in traditional atrial shunt implantation surgery, reducing surgical time and providing a new standard module for the design of atrial shunts or occluders.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, and more particularly to a delivery device for an atrial shunt. Background Technology

[0002] Heart failure (HF) is a syndrome caused by impaired systolic and / or diastolic function of the heart, which fails to adequately pump venous blood back to the heart, leading to blood pooling in the venous system and insufficient blood perfusion in the arterial system. This syndrome is characterized by pulmonary congestion and vena cava congestion.

[0003] According to the location of heart failure, it can be divided into: (1) left heart failure: refers to heart failure caused by the inability of the left ventricle to compensate. It is relatively common in clinical practice and is characterized by pulmonary congestion; (2) right heart failure: simple right heart failure is mainly seen in pulmonary heart disease and some congenital heart diseases, and is characterized by systemic congestion; (3) total heart failure: after left heart failure, the pulmonary artery pressure increases, which increases the load on the right heart. After a long time, right heart failure will also appear, which is total heart failure.

[0004] For chronic heart failure caused by persistent high pressure in the left atrium, one of the existing technical solutions is to implant a shunt device in the interatrial septum between the left and right atria to redistribute the pressure between the left and right atria and reduce the pressure imbalance between the two atria.

[0005] The common procedure for implanting atrial shunt devices involves first compressing the device onto a loader, then using a delivery system to transport the device to a pre-designated location in the atrial septum for positioning. The delivery system is then withdrawn to release the shunt until it is fully deployed. However, current atrial shunt implantation procedures are overly complex, increasing surgical time and posing significant risks to patients. Therefore, it is necessary to develop a functional, easy-to-operate, and time-saving implantable atrial shunt device to benefit patients and their families.

[0006] Therefore, it is necessary to redesign it to overcome the above-mentioned shortcomings. Summary of the Invention

[0007] The purpose of this invention is to address the shortcomings of existing technologies by providing a delivery device for an atrial shunt.

[0008] To achieve the above objectives, the present invention adopts the following technical solution:

[0009] A delivery device for an atrial shunt includes a delivery structure, a venting structure, and a pushing structure; the delivery structure is provided with a guide catheter and a delivery catheter; both the guide catheter and the delivery catheter have venting structures at their proximal ends; the guide catheter serves as the path for an external guidewire, and the delivery catheter has a path for the delivery of the atrial shunt; the pushing structure controls the movement of the external atrial shunt along the delivery path of the delivery catheter.

[0010] Furthermore, the pushing structure includes a pushing rod and a control component, the distal end of the pushing rod being connected to the proximal end of the connector, and the distal end of the connector being connected to the atrial shunt.

[0011] Furthermore, the distal end of the delivery conduit is provided with a bend, the angle of which is 15° to 90°.

[0012] Furthermore, the distal end of the curved portion is provided with a closable member, which is provided with triangular leaflets. The triangular leaflets form a hollow cone or hollow frustum structure with a circular proximal end and a smooth distal end.

[0013] Furthermore, the proximal end of the triangular leaflet is rigidly connected to the conveying structure, while the distal end of the triangular leaflet is in a free state.

[0014] Furthermore, the closable member is also provided with an outlet for a guide tube, the outlet of which is used for a guide wire to pass through, so that the guide wire guides the delivery direction of the delivery structure.

[0015] Furthermore, a connector is provided between the triangular leaflet and the curved portion. The connector is made of shape memory alloy, which causes the triangular leaflet to close up to a closed state.

[0016] Furthermore, the venting structure includes a stress protection tube, a venting head, a venting tail, a silicone valve, a three-way stopcock, and a venting pipe. The venting tail is fixedly connected to the proximal end of the venting head, and the silicone valve is located inside the venting structure. The distal end of the venting head is provided with an insertion interface for inserting the stress protection tube, so that the stress protection tube can be inserted into the insertion interface. A through hole is opened on one side of the venting head for one end of the venting pipe to pass through, so that one end of the venting pipe is installed in the through hole, and the other end of the venting pipe is connected to the three-way stopcock.

[0017] Furthermore, it also includes a delivery handle, the distal end of which is connected to the proximal end of the delivery conduit; the delivery handle is provided with a control structure, which includes a control part and a transmission part connected to each other; the distal end of the transmission part is connected to the push rod, and rotating the control part drives the transmission part to move, thereby causing the transmission part to drive the push rod to move along the channel formed by the delivery conduit.

[0018] Furthermore, the control unit is a manual control unit or an electric control unit.

[0019] Compared with the prior art, the delivery structure of the atrial shunt provided by the present invention integrates the delivery and loading processes in the traditional atrial shunt implantation surgery procedure, reducing the operation time and providing a new standard module for the design of atrial shunts or occluders. Attached Figure Description

[0020] Figure 1 This is a structural diagram of the delivery device for an atrial shunt provided in Embodiment 1;

[0021] Figure 2 This is a cross-sectional view of the conveying structure provided in Embodiment 1;

[0022] Figure 3 This is a schematic diagram of the conical structure at the far end of the conveying structure provided in Embodiment 1 when it is opened;

[0023] Figure 4 This is a schematic diagram of the conical structure at the far end of the conveying structure provided in Embodiment 1 when it is opened.

[0024] Figure 5 This is a schematic diagram of the conical structure at the far end of the conveying structure provided in Embodiment 1 when it is closed;

[0025] Figure 6 This is a schematic diagram of the first empty section provided in Embodiment 1;

[0026] Figure 7 This is a schematic diagram of the second empty section provided in Embodiment 1;

[0027] Figure 8 This is a schematic diagram of the left disc release of the atrial shunt provided in Embodiment 1;

[0028] Figure 9 This is a schematic diagram of the right disc release of the atrial shunt provided in Embodiment 1;

[0029] Figure 10 This is a partial schematic diagram of the atrial shunt device installed on the interatrial septum according to Embodiment 1;

[0030] Figure 11 This is a schematic diagram of the conveying structure and conveying handle provided in Embodiment 5;

[0031] Figure 12 This is a schematic diagram of the manual control unit and transmission unit provided in Embodiment 5;

[0032] Figure 13 This is a schematic diagram of the conductive part provided in Embodiment 5;

[0033] Figure 14 This is a schematic diagram of the electric control unit and transmission unit provided in Embodiment Six;

[0034] The components include: 1. Delivery structure; 11. Delivery catheter; 12. Guiding catheter; 13. Triangular leaflet; 14. Guiding catheter outlet; 2. Drainage structure; 21. First drainage section; 211. First silicone valve; 212. First drainage tail section; 213. First drainage head section; 214. First drainage tube; 215. First three-way stopcock; 22. Second drainage section; 221. Second silicone valve; 222. Second drainage tail section; 223. Second drainage head section; 224. Second drainage tube; 225. Second three-way stopcock; 3. Pushing structure; 4. Guidewire; 5. Atrial shunt; 6. Atrial septum; 7. Delivery handle. 71. Conveying housing; 72. Control structure; 73. Control unit; 74. Transmission unit; 731. First knob / first gear; 732. First screw; 733. First threaded cylinder; 741. Second knob / second gear; 742. Second screw; 743. Second threaded cylinder; 751. Push rod connector; 752. First threaded cylinder connector; 753. First connecting rod; 754. Second threaded cylinder connector; 755. Second connecting rod; 756. Guide; 75. Electrical control structure; 761. First control motor; 762. Second control motor; 763. Battery; 764. Control circuit. Detailed Implementation

[0035] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that, unless otherwise specified, the following embodiments and features described therein can be combined with each other.

[0036] The purpose of this invention is to address the shortcomings of existing technologies by providing a delivery device for an atrial shunt.

[0037] Example 1

[0038] This embodiment provides a delivery device for an atrial shunt, such as... Figure 1-10 As shown, it includes a delivery structure 1 and a draining structure 2. The delivery structure 1 has two cavities, namely a guide catheter 12 and a delivery catheter 11. Both the guide catheter 12 and the delivery catheter 11 have a draining structure 2 at their proximal ends. A guide wire 4 is installed in the guide catheter 12, and a pushing structure 3 is installed in the delivery catheter 11. An atrial shunt 5 is connected to the pushing structure 3, thereby enabling the pushing structure 3 to control the movement of the external atrial shunt 5 along the delivery path of the delivery catheter 11.

[0039] It should be noted that in this embodiment, the atrial shunt is stored in the delivery catheter before delivery. After reaching the target position, the atrial shunt is pushed out of the delivery catheter and placed in the target position.

[0040] like Figure 2 The diagram shows a cross-sectional view of the conveying structure 1. The conveying structure 1, the conveying conduit 11, and the guiding conduit 12 all have circular cross-sections. The diameter of the conveying conduit 11 is larger than the diameter of the guiding conduit 12, which is slightly larger than the diameter of commercially available hardened guide wires by 0.1-2 mm, preferably 1 mm. The conveying structure 1, the conveying conduit 11, and the guiding conduit 12 are all made of polymer materials, springs, or stainless steel braided wire. The polymer material is one of PTFE, HDPE, LDPE, Pebax, or nylon.

[0041] The delivery conduit 11 and the guiding conduit 12 consist of two layers: an inner layer and a middle layer. The inner layer is made of a smooth material such as PTFE or nylon, while the middle layer is made of stainless steel braided wire or springs. The outermost layer of the delivery structure 1 is made of one or more polymer materials such as Pebax, HDPE, and LDPE.

[0042] like Figure 3-5 As shown, the distal end of the conveying structure 1 is provided with a bend, which controls the angle between the distal end of the conveying conduit 11 and the axis of the conveying structure 1. The angle between the distal end of the conveying conduit 11 and the conveying structure 1 is 15°~90°. The distal end of the bend is also provided with a closable member, which is located at the distal end of the conveying conduit 11, and the proximal end of the closable member is connected to the bend.

[0043] The closable component is provided with triangular leaflets 13, which can be arranged into a hollow cone or hollow frustum structure with a circular proximal end and a smooth, non-sharp distal end. The proximal end of the triangular leaflet 13 is rigidly connected to the conveying structure 1, while the distal end of the triangular leaflet 13 is in a free state. In this embodiment, there are several triangular leaflets 13, preferably 3-6 pieces; the several triangular leaflets 13 are pre-jointed together by means of heat fusion, pressurization, etc., in order to facilitate initial entry with relative sealing and ensure the effectiveness of operation before releasing the atrial shunt, minimizing contact with the interior of the ventricle.

[0044] In the initial state, the state of triangular leaflet 13 is as follows: Figure 4 The shunt is in a retracted state; when the atrial shunt needs to be pushed, the applied force acts on the interior of the conical structure, breaking through the conical structure, causing the triangular leaflets to separate from each other, opening the atrial release channel, as shown. Figure 3 As shown.

[0045] In this embodiment, the triangular leaflet 13 has the ability to maintain pre-plasticity. This plasticity ensures that after the push structure 3 is retracted into the delivery catheter 11, the triangular leaflet can retract in time, avoiding damage to blood vessels by the delivery structure.

[0046] One of the triangular leaflets 13 also has a circular opening outlet 14 of the guide tube 12. The outlet 14 of the guide tube 12 is used to allow the guide wire 4 to pass through, so that the guide wire 4 placed in the guide tube 12 can be punctured first, and the guide wire 4 guides the delivery direction of the delivery structure 1.

[0047] In this embodiment, a connector is provided between the triangular leaflet 13 and the curved portion. The material of the connector is a shape memory alloy, such as a nickel-titanium alloy. The shape memory alloy is sufficient to provide the triangular leaflet 13 with a timely force to retract, so that the triangular leaflet retracts to the retracted state.

[0048] like Figure 1 , 3 As shown, the push structure 3 consists of three layers: an inner layer, a middle layer, and an outer layer. The inner layer is made of smooth materials such as PTFE and nylon, the middle layer is made of stainless steel braided wire or springs, and the outer layer is made of one or more polymer materials such as Pebax, HDPE, and LDPE.

[0049] The pushing structure 3 includes a pushing rod and a connector. The distal end of the pushing rod is connected to the proximal end of the connector, and the distal end of the connector is connected to the atrial shunt 5. In this embodiment, the pushing structure 3 is a catheter with the function of loading an atrial shunt, but it is not limited to this. The pushing structure 3 connected with a similar catheter can also enter the delivery structure 1 through the delivery catheter.

[0050] like Figure 6-7 As shown, the venting structure 2 includes a first venting section 21 and a second venting section 22. The first venting section 21 is connected to the proximal end of the delivery conduit 11, and the second venting section 22 is connected to the guide conduit 12.

[0051] The first venting section 21 includes a first stress protection tube, a first silicone valve 211, a first venting tail section 212, a first venting head section 213, a first venting pipe 214, and a first three-way stopcock 215.

[0052] The first emptying head 213 is hollow funnel-shaped. A stepped hole is located on the inner side of the proximal end of the first emptying head 213. The thickness of the first silicone valve 211 is not less than the height of the stepped hole, to seal the space between the first emptying head 213 and the first emptying tail 212. An opening adapted to the first stress protection tube is provided at the distal end of the first emptying head 213, and an opening is also provided at the proximal end of the first emptying head 213, allowing the first stress protection tube, the delivery conduit 11, and the push rod to be inserted into the first emptying head 213. The first stress protection tube is sleeved on the proximal end of the delivery conduit 11. The first emptying tail 212 is located at the proximal end of the first emptying head 213 and is fixedly connected to the first emptying head 213 by means of threaded connection, snap-fit ​​connection, or sleeve connection.

[0053] The first silicone valve 211 is housed inside the first venting section 21, preferably positioned between the first venting tail and the first venting head. A small hole, compatible with a push rod, is provided at a corresponding position between the first venting tail 212 and the first silicone valve 211 to facilitate the passage of the push rod. An opening, compatible with one end of the first venting tube 214, is provided on one side of the first venting head 213, allowing one end of the first venting tube 214 to be inserted into the opening. The other end of the first venting tube 214 is connected to the first three-way stopcock 215. In this embodiment, the function of the first venting section 21 is to vent internal air.

[0054] The second venting section 22 includes a second stress protection tube, a second silicone valve 221, a second venting tail section 222, a second venting head section 223, a second venting pipe 224, and a second three-way stopcock 225.

[0055] The second-row head 223 is a stepped column, and the second-row tail 222 is a near-right-angled funnel shape. The distal end of the second-row head 223 has an opening adapted to the second stress protection tube, and the proximal end of the second-row head 223 also has an opening, allowing the second stress protection tube, guide tube, and guide wire 4 to be inserted into the second-row head 223. The second stress protection tube is fitted onto the proximal end of the guide tube 11. The second-row tail 222 is located at the proximal end of the second-row head 223 and is fixedly connected to the second-row head 223 by means of threaded connection, snap-fit ​​connection, or loop fastening.

[0056] The second silicone valve 221 is housed inside the second venting section 22, preferably positioned between the second venting tail and the second venting head. A small hole, compatible with the guide wire 4, is provided at a corresponding position between the second venting tail 222 and the second silicone valve 221 to facilitate the passage of the guide wire. An opening, compatible with one end of the second venting tube 224, is provided on one side of the second venting head 223, allowing one end of the second venting tube 224 to be inserted into the opening. The other end of the second venting tube 224 is connected to the second three-way valve 225. In this embodiment, the function of the second venting section 22 is to vent internal air.

[0057] like Figure 8-10 The diagram shows the usage of the atrial shunt delivery device in this embodiment. When needed, the atrial shunt 5 is pre-installed in the push structure 2, and then the push structure 2 is placed in the delivery catheter 11. After preparation, the guide wire 4 placed in the guide catheter 12 of the delivery structure 1 is punctured and enlarged, and the delivery structure 1 is pushed into the target position of the interatrial septum 6 along the guide wire 4. Then, the atrial shunt 5 is gradually released by controlling the push structure 2 placed in the delivery catheter 11 so that the atrial shunt 5 reaches the target position, completing the implantation of the atrial shunt. Finally, the delivery device is withdrawn.

[0058] The atrial shunt delivery device provided in this embodiment has a dual-chamber structure, rich functions, and simple operation. It integrates the delivery and loading processes in the traditional atrial shunt implantation surgery procedure, reducing the operation time. It also provides a new standard module for the design of atrial shunt or occluder delivery devices.

[0059] Example 2

[0060] The difference between the atrial shunt delivery device provided in this embodiment and that in Embodiment 1 is:

[0061] In this embodiment, the diameter of the guiding catheter is slightly larger than that of commercially available guidewires. It can be used with a balloon, meaning that the stoma requiring balloon dilation can also be achieved in one step through the delivery structure, further shortening the surgical steps and time.

[0062] Example 3

[0063] The difference between the atrial shunt delivery device provided in this embodiment and that in Embodiment 1 is:

[0064] The inner and outer layers of the conveying structure 1 are made of one or more polymer materials such as Pebax, HDPE, and LDPE, the middle layer is made of stainless steel braided wire or spring, and the conveying conduit 11 and the guiding conduit 12 are covered with smooth materials such as PTFE and nylon.

[0065] Example 4

[0066] The difference between the atrial shunt delivery device provided in this embodiment and that in Embodiment 1 is:

[0067] The loading catheter has been eliminated in the delivery structure, meaning that the loading of the atrial shunt is completed at the distal or proximal end of the delivery catheter, further reducing the complexity of the device.

[0068] Example 5

[0069] The difference between the atrial shunt delivery device provided in this embodiment and that in Embodiment 1 is:

[0070] like Figure 11-13 As shown, the delivery device of an atrial shunt in this embodiment further includes a delivery handle 7, the distal end of which is connected to the proximal end of the delivery catheter 11; the delivery handle 11 includes a delivery housing 71 and a control structure 72, the control structure 72 includes a control part 73 and a conduction part 74 connected to each other; the distal end of the conduction part 74 is connected to a push rod, and rotating the control part 73 drives the conduction part 74 to move, thereby causing the conduction part 74 to drive the push rod to move along the channel formed by the delivery catheter 11.

[0071] In this embodiment, the control unit 73 is a manual control unit.

[0072] The conveying housing 71 includes a handle head and a housing. The handle head is shaped like a hollow cone with a semi-cylindrical shape added to the bottom of the cone. The housing body is shaped like a hollow cylinder.

[0073] The first empty part 21 is disposed inside the handle head, and the handle head and the first empty part head 213 are also provided with a hole that matches the first empty tube 214 so that the first empty tube 214 can pass through the handle head.

[0074] Both the upper and lower ends of the handle head are provided with openings. The opening at the far end of the handle head is adapted to the diameter of the push structure 3; the opening at the near end of the handle head is adapted to the diameter of the housing, so that the push structure 3, the handle head, and the housing are connected.

[0075] The housing is a hollow structure, including an upper housing and a lower housing. The distal end of the lower housing is connected to the semi-cylindrical bottom of the handle head. The upper housing and the lower housing are connected by snap-fit, thread, or other means. A first guide groove is provided at the distal end of the side where the upper and lower housings are connected. The length of the first guide groove is slightly greater than the length of the atrial shunt ballast in the push structure 3. The distal end of the upper housing is not connected to the conical bottom of the handle head, and a radial second guide groove is provided near the distal end of the upper housing.

[0076] The control structure 72 includes a control unit 73 and a transmission unit 74, with the control unit 73 connected to the transmission unit 74.

[0077] The control unit 73 includes a first control element and a second control element.

[0078] The first control component includes a first knob 731, a first screw 732, and a first threaded cylinder 733. The first knob 731 is located on the near-outer side of the housing and can be a round knob, a star-shaped knob, etc. The first knob 731 is connected to the inner sidewall of the near-outer side of the first screw 732 via a nested connecting rod. The first screw 732 and the first threaded cylinder 733 are connected by a threaded rotation, and the distal end of the first threaded cylinder 733 is connected to the transmission part 74. The outer side of the first screw 732 is threaded, and the first screw 732 has a hollow structure with open ends. The first threaded cylinder 733 is hollow inside and has a nut that matches the first screw 732 inside. The first threaded cylinder 733 moves axially under the action of the rotation of the first screw 732, so that the transmission part 74 drives the push rod to move.

[0079] The second control component includes a second knob 741, a second screw 742, and a second threaded cylinder 743. The second knob 741 is located on the near-end exterior of the housing, specifically on the near-end side of the first knob 731. The second knob 741 can be a round knob, a swivel knob, etc. The second screw 742 and the second threaded cylinder 743 are connected by a threaded rotation. The distal end of the second threaded cylinder 743 is connected to the transmission part 74. The outer side of the second screw 742 is provided with a thread, and the second threaded cylinder 743 is provided with a nut that matches the second screw 742. The second threaded cylinder 743 moves axially under the action of the rotation of the second screw 742, so that the transmission part 74 drives the push rod to move.

[0080] The second control component is nested within the first control component, that is, from the inside out, it consists of the second screw 742, the second threaded cylinder 743, the first screw 732, and the first threaded cylinder 733.

[0081] The pitch of the second screw 742 is smaller than that of the first screw 732, so that the second control component can precisely and accurately adjust the push component, while the first control component can quickly and coarsely (over a wide range) adjust the push component.

[0082] An annular boss is provided near the end of the second screw 742, close to the position where it connects to the first knob 731. A first annular groove is provided on the inner side of the first knob 731 to match the annular boss, so that the annular boss is set in the first annular groove, but not stuck, that is, the first knob 731 will not drive the second screw 3742 to rotate when it is rotated. The function of the annular boss in this embodiment is to make the second screw 742 rotate in the radial direction and restrict the movement of the second screw 742 in the axial direction.

[0083] A second annular groove is provided on the outer peripheral surface of the first knob 731 to match the near end of the housing, so that the near end of the housing is located in the second annular groove. The cooperation between the second annular groove and the near end of the housing facilitates the rotational movement of the first knob 731 in the radial direction and restricts the movement of the first knob 731 in the axial direction.

[0084] The transmission part 74 includes a push rod connector 751, a first threaded cylinder connector 752, and a first connecting rod 753. The push rod connector 751 has a through hole for clamping the push rod, so that the push rod passes through the push rod connector 751. The proximal end of the push rod connector 751 is connected to the distal end of the first connecting rod 753, and the proximal end of the first connecting rod 753 is connected to the proximal end of the first threaded cylinder connector 752. The connection can be made by means of threads, snaps, etc. The proximal end of the first connecting rod 753 is threadedly connected to the first threaded cylinder connector 752. The first threaded cylinder connector 752 is located in the first threaded cylinder 733 near the distal end. The distal end of the first threaded cylinder 733 has an opening, and the diameter of the opening is larger than the diameter of the first connecting rod 753 but smaller than the diameters of the push rod connector 751 and the first threaded cylinder connector 752. The distal end of the first threaded cylinder 733 is fitted on the outer circumferential surface of the first connecting rod 753, which can drive the push rod connector 751 and the first threaded cylinder connector 753 to move axially.

[0085] The transmission part 74 also includes a second threaded cylinder connector 754 and a second connecting rod 755. The distal end of the second connecting rod 755 is connected to the proximal end of the first threaded cylinder 733, and the proximal end of the second connecting rod 755 is connected to the distal end of the second threaded cylinder connector 754. The connection can be made by means of threads, snaps, etc. The distal end of the second threaded cylinder 743 has an opening, and the diameter of the opening is larger than the diameter of the second connecting rod 755 and smaller than the diameter of the second threaded cylinder connector 754. The diameter of the second threaded cylinder connector 754 is smaller than the diameter of the first threaded cylinder connector 752. The distal end of the second threaded cylinder 743 is fitted on the outer circumferential surface of the second connecting rod 755, which can drive the push rod connector 751 and the second threaded cylinder connector 754 to move axially.

[0086] In this embodiment, the travel distance of the first control member is the length of the second connecting rod 755, and the travel distance of the second control member is the length of the first connecting rod 753.

[0087] The outer circumferential surface of the push rod connector 751 is also provided with a guide 756, and the first threaded cylinder 733 and / or the second threaded cylinder 743 move without rotating along the first guide groove under the guidance of the guide 756.

[0088] The distal end of the housing is also provided with a second guide groove, and the guide member 756 can move circumferentially along the second guide groove to disengage the distal end of the push rod from the atrial shunt.

[0089] The method of using the delivery device of an atrial shunt in this embodiment is as follows:

[0090] First, connect the atrial shunt 5 to the connector outside the body. By rotating the first or second knob, load the atrial shunt 5 onto the distal end of the push structure 3. The pre-compressed atrial shunt 5 and the delivery device pass through the femoral vein and superior vena cava to the right atrium, pass through the interatrial septum, enter the left atrium, and then stop pushing the delivery device.

[0091] After adjusting the distal position of the delivery device, rotate the second or first knob to advance the control unit halfway to release the left disc of the atrial shunt. Continue advancing the control system to fully release the right disc of the atrial shunt 5. Radially rotate the guide to release the atrial shunt 5, retract the delivery device, and remove the pushing structure 3 from the patient's body. The atrial shunt 5 is now fully released and fixed to the atrial septum between the left and right atria. During the procedure, the atrial shunt can be released quickly or slowly depending on the patient's condition and the surgeon's skill level.

[0092] The atrial shunt is delivered to the interatrial septum by the delivery device provided in this embodiment. The atrial shunt then redistributes the interatrial pressure and reduces the interatrial pressure between the left and right atria. The device is first roughly controlled by a second control element and then precisely controlled by a first control element, so that the atrial shunt can stably reach the target position.

[0093] Example 6

[0094] The difference between the atrial shunt delivery device provided in this embodiment and that in Embodiment 5 is:

[0095] like Figure 14 As shown, the control unit 73 in this embodiment is an electric control unit. The first knob and the second knob are removed, and the first knob and the second knob are replaced by the first gear 731 and the second gear 741, so that the first gear 731 is connected to the first screw 732 and the second gear 741 is connected to the second screw 742.

[0096] An electronic control structure 75 is installed near the first gear and the second gear.

[0097] The electronic control structure 75 is located at the near end of the housing and is connected to the control unit 73. The electronic control structure 75 is used to cause the control unit 73 to drive the transmission unit 74 to move, thereby causing the pusher to move.

[0098] The electronic control structure 75 includes a first control motor 761, a second control motor 762, a battery 763, and a control circuit 764. The first control motor 761 is connected to a first gear 731, the second control motor 762 is connected to a second gear 742, the battery 763 is connected to the first control motor 761, the second control motor 762, and the control circuit 764, and the control circuit 764 is connected to the first control motor 761 and the second control motor 762.

[0099] The method of using the atrial shunt delivery device in this embodiment is as follows:

[0100] First, connect the atrial shunt to the connector externally. Start the second or first control motor of the electronic control structure to make the second control motor drive the second gear to rotate or the first control motor drive the first gear to rotate. Load the atrial shunt at the distal end of the delivery sheath. Pass the pre-compressed atrial shunt and delivery device through the femoral vein and superior vena cava to the right atrium, pass through the interatrial septum, enter the left atrium, and stop pushing the delivery device.

[0101] After adjusting the distal position of the delivery device, the second or first gear rotates, advancing the control system halfway to release the left disc of the atrial shunt. Continuing to advance the control system fully releases the right disc of the atrial shunt. Radial rotation of the release mechanism releases the atrial shunt, retracting the delivery device and removing the pushing structure from the patient's body. The atrial shunt is then fully released and secured to the atrial septum between the left and right atria. During the procedure, the atrial shunt can be released quickly or slowly depending on the patient's condition and the surgeon's skill level.

[0102] The atrial shunt is delivered to the interatrial septum by the delivery device provided in this embodiment. The atrial shunt then redistributes the interatrial pressure and reduces the interatrial pressure between the left and right atria. The device is first roughly controlled by a second control element and then precisely controlled by a first control element, so that the atrial shunt can stably reach the target position.

[0103] The specific embodiments described herein are merely illustrative of the spirit of the invention. Those skilled in the art to which this invention pertains may make various modifications or additions to the described specific embodiments or use similar methods to substitute them, without departing from the spirit of the invention or exceeding the scope defined by the appended claims.

Claims

1. A delivery device for an atrial shunt, characterized in that, It includes a delivery structure, a draining structure, and a pushing structure; the delivery structure is provided with a guide catheter and a delivery catheter; both the guide catheter and the delivery catheter have a draining structure at their proximal ends; the guide catheter serves as the path for an external guidewire, and the delivery catheter has a path for the delivery of an atrial shunt; the pushing structure controls the movement of the external atrial shunt along the delivery path of the delivery catheter; The distal end of the delivery conduit is provided with a curved section, and the distal end of the curved section is provided with a closable member. The closable member is provided with triangular leaflets, which form a hollow cone or hollow frustum structure with a circular proximal end and a smooth distal end. The proximal end of the triangular leaflet is rigidly connected to the conveying structure, while the distal end of the triangular leaflet is in a free state. The closable component is also provided with an outlet for a guide tube, the outlet of which is used for a guide wire to pass through, so that the guide wire guides the delivery direction of the delivery structure; The triangular leaflet and the curved part are also connected by a connector made of shape memory alloy, which allows the triangular leaflet to fold into a folded state. The venting structure includes a stress protection tube, a venting head, a venting tail, a silicone valve, a three-way stopcock, and a venting pipe. The venting tail is fixedly connected to the proximal end of the venting head, and the silicone valve is located inside the venting structure. The distal end of the venting head is provided with an insertion interface for inserting the stress protection tube, so that the stress protection tube can be inserted into the insertion interface. One side of the venting head is provided with a through hole for one end of the venting pipe to pass through, so that one end of the venting pipe can be installed in the through hole, and the other end of the venting pipe is connected to the three-way stopcock.

2. The delivery device for an atrial shunt according to claim 1, characterized in that, The pushing structure includes a pushing rod and a control component. The distal end of the pushing rod is connected to the proximal end of the connector, and the distal end of the connector is connected to the atrial shunt.

3. The delivery device for an atrial shunt according to claim 1, characterized in that, The angle of the curved portion is 15° to 90°.

4. The delivery device for an atrial shunt according to claim 2, characterized in that, It also includes a delivery handle, the distal end of which is connected to the proximal end of the delivery conduit; the delivery handle is provided with a control structure, which includes a control part and a transmission part connected to each other; the distal end of the transmission part is connected to the push rod, and rotating the control part drives the transmission part to move, thereby causing the transmission part to drive the push rod to move along the channel formed by the delivery conduit.

5. The delivery device for an atrial shunt according to claim 4, characterized in that, The control unit is either a manual control unit or an electric control unit.

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