CN216777296U - Degradable shunt suit - Google Patents

Abstract

The utility model relates to a degradable shunt set, which belongs to the technical field of medical equipment. Including an atrial shunt delivery device and an atrial shunt; the atrial shunt delivery device includes a knob, a handle, an outer sheath, a double-threaded connector and a mandrel; the outer sheath is provided with a mandrel, and the end of the mandrel away from the operator A double-threaded connection head is provided on which an atrial shunt made of degradable material is movably connected; the end of the outer sheath tube close to the operator is provided with a handle, and the handle is provided with a knob connected with the mandrel. The utility model can be used for treating heart failure. The atrial shunt made of bioimplantable materials has good biocompatibility, can be metabolized by the human body without leaving traces, and can reduce the adverse effects of heart failure patients after treatment. The device of the utility model has the advantages of simple structure, convenient operation and safe and reliable use.

Description

Degradable Diverter Kit

technical field

The utility model relates to a degradable shunt set, which belongs to the technical field of medical equipment.

Background technique

Heart failure is the final result of various cardiovascular events and the cumulative effect of various cardiac abnormalities, ultimately leading to a decrease in the pumping function of the heart. In heart failure patients, heart failure with preserved ejection fraction (HIPEF, LVEP) is a common type of heart failure, accounting for about 50% of heart failure cases, and is generally characterized by elevated left atrial pressure (LAP), causing pulmonary hypertension (especially during exercise), which can lead to pulmonary congestion and difficulty breathing. In addition, heart failure with reduced ejection fraction (HFrEF) can also exhibit elevated LAP. Current treatments for heart failure drugs do not halt the progression of heart failure. Medical practice and computer simulation results show that puncturing a hole in the atrial septum can effectively reduce left atrial hypertension in patients with HFpEF and HFrEF, thereby reducing pulmonary artery pressure and pulmonary capillary wedge pressure (PCWP), reducing pulmonary complications, Relieve dyspnea and fatigue in patients to relieve heart failure. There are now studies on the market to treat heart failure by implanting an atrial shunt device. Most of them are made of metal, which may cause certain damage to the heart tissue. Once the metal implant device is implanted, it is permanent, and various complications may occur in the follow-up, and the interatrial septal channel will be blocked, making other related interventions impossible. treat. Therefore, a degradable atrial shunt set is urgently needed in the technical field, and the degradable material will eventually be metabolized and absorbed by the human body, and eventually disappear, thereby avoiding various adverse effects that may be caused by the permanent implanted device.

SUMMARY OF THE INVENTION

The purpose of this utility model is to solve how to use degradable implanted devices to effectively reduce left atrial hypertension in patients with HFpEF and HFrEF, thereby reducing pulmonary artery pressure and pulmonary capillary wedge pressure (PCWP), reducing pulmonary complications and relieving patients' breathing Difficulty and fatigue to relieve technical problems in heart failure.

In order to achieve the purpose of solving the above problems, the technical solution adopted by the present utility model is to provide a degradable shunt set, including an atrial shunt delivery device and an atrial shunt; the atrial shunt delivery device includes a knob, a handle, an outer sheath tube , a double-threaded connector and a mandrel; the outer sheath is provided with a mandrel, the end of the mandrel away from the operator is provided with a double-threaded connector, and the double-threaded connector is provided with a movable connection of the atrium made of degradable materials A shunt; the end of the outer sheath tube close to the operator is provided with a handle, and the handle is provided with a knob connected with the mandrel.

Preferably, the double-threaded connector includes a hollow retractable thread head and a hollow flexible thread head; one end close to the operator is provided with a retractable thread head, and the other end away from the operator is provided with a flexible thread head; retraction The thread head is connected with the external thread provided on one side of the flexible thread head through the internal thread provided, and the other side of the flexible thread head away from the operator is provided with an internal thread for connecting with the atrial shunt; the flexible thread head is set to be variable Diameter-shaped, the side wall of the flexible screw head is set to be separable in the radial direction; the mandrel is connected with the flexible screw head.

Preferably, the side wall of the flexible screw head is set to be multi-lobed along the circumference; the outer shapes of the retracted screw head and the flexible screw head are set to be conical; The diameter of the operator's end.

Preferably, the handle is provided with a locking switch to prevent misoperation.

Preferably, the atrial shunt is made by weaving, melting and shaping; the weaving methods include cross-shaped weaving and well-shaped weaving, and the cross-shaped weaving is set as one wire and one wire interlaced to form a dense mesh The well-shaped weaving is set as two wires in parallel, and the four wires are interlaced to form a dense mesh; the melting method is set as one end of the wire is melted at a high temperature into a cylinder with an external thread and an internal hole; so The shaping method is set as high temperature processing and shaping with a mold.

Preferably, the atrial shunt is set as an equal disk surface shunt, and the equal disk surface shunt includes an upper disk surface, a waist, a lower disk surface, a shunt hole and a closing end; the size of the upper disk surface and the lower disk surface are the same; between the upper disk surface and the lower disk surface A waist is provided, the upper and lower disc surfaces are provided with communicating shunt holes, and the outer side of the lower disc surface is provided with a closing end;

Preferably, the atrial shunt is set as a large and small disk surface shunt, and the large and small disk surface shunt includes a large disk surface, a waist, a small disk surface, a shunt hole and a closing end; the diameter of the large disk surface is greater than the diameter of the small disk surface; the difference between the large disk surface and the small disk surface There is a waist between the large and small disk surfaces, and the same shunt holes are arranged on the disk surfaces of the large disk surface and the small disk surface, and the outer side of the small disk surface is provided with a closing end;

Preferably, the atrial shunt is set as a flip-up shunt, and the flip-up shunt includes an upper disk surface, a waist, a lower disk surface, a shunt hole and a closing end; a waist is provided between the upper disk surface and the lower disk surface, and the upper disk surface and the lower disk surface There are communicating shunt holes on the disc surface, and the outer side of the lower disc surface is provided with a closing end; the external thread provided at the closing end is connected with the live thread head; Make a tic-tac-toe braid and a criss-cross braid at the waist.

Compared with the prior art, the utility model has the following beneficial effects:

The utility model designs a degradable shunt set for treating heart failure. Made of biological implantable materials, it has good biocompatibility and can be metabolized by the human body without leaving traces, which can reduce the adverse effects of heart failure patients after treatment. The utility model selects degradable materials that meet the standards of medical equipment, and the optional materials include polydioxanone PDO, polylactic acid PLA, PLLA, PDLLA, PLGA, PGA, PCL, PHB series, etc. Into filament, to weave a degradable atrial shunt. According to the requirement of atrial shunt, the utility model provides a shunt device set, which can shunt the blood of the heart to achieve the purpose of treating heart failure. The device of the utility model has the advantages of simple structure, convenient operation and safe and reliable use.

Description of drawings

Figure 1 is a schematic structural diagram of the atrial shunt delivery device of the present invention.

FIG. 2 is a schematic structural diagram of the double-threaded connecting head structure of the present invention when the live screw head is not opened.

FIG. 3 is a side view of the structure of the double-threaded connector of the present invention.

FIG. 4 is a schematic structural diagram of the open-ended screw head of the double-threaded connecting head structure of the present invention.

FIG. 5 is a schematic structural diagram of an iso-disk flow divider of the present invention.

FIG. 6 is a schematic structural diagram of a large and small disc surface shunt of the present invention.

FIG. 7 is a schematic structural diagram of the flip-pan type diverter of the present invention.

8 is a schematic diagram of the cross-shaped braided structure of the atrial shunt of the present invention.

FIG. 9 is a schematic diagram of a well-shaped braided structure of the atrial shunt of the present invention.

Reference numerals: 1. Knob; 2. Locking switch; 3. Handle; 4. Outer sheath; 5. Double threaded connector; 6. Mandrel; . Movable mouth; 10. Upper plate surface; 11. Waist; 12. Lower plate surface; 13. Diverter hole; 14. Closing end.

Detailed ways

In order to make the utility model more obvious and easy to understand, the preferred embodiments are hereby described in detail with the accompanying drawings as follows:

As shown in Figures 1-9, a degradable shunt set is provided for the utility model, including an atrial shunt delivery device and an atrial shunt; the atrial shunt delivery device includes a knob 1, a handle 3, an outer sheath 4, a double The threaded connector 5 and the mandrel 6; the outer sheath tube 4 is provided with a mandrel 6, and the end of the mandrel 6 away from the operator is provided with a double-threaded connector 5, and the double-threaded connector 5 is provided with a movable connecting An atrial shunt made of degradable material; a handle 3 is provided at one end of the outer sheath tube 4 close to the operator, and a knob 1 connected to the mandrel 6 is provided on the handle 3 . The double-threaded connector 5 includes a hollow retractable thread head 7 and a hollow flexible thread head 8; one end close to the operator is provided with a retractable thread head 7, and the other end away from the operator is provided with a flexible thread head 8; retraction The thread head 7 is connected with the external thread provided on one side of the flexible thread head 8 through the internal thread provided, and the other side of the flexible thread head 8 away from the operator is provided with an internal thread for connecting with the atrial shunt; the flexible thread head 8 It is set as a variable diameter shape, and the side wall of the flexible screw head 8 is set to be separable in the radial direction; the mandrel 6 is connected with the flexible screw head 8 . The side wall of the flexible screw head 8 is set to be multi-lobed along the circumference; the outer shape of the retracted screw head 7 and the flexible screw head 8 is set to be conical; The diameter of the operator's end. The handle 3 is provided with a locking switch 2 to prevent misoperation. The atrial shunt is made by weaving, melting and shaping; the weaving methods include cross-shaped weaving and well-shaped weaving. The wires are parallel, and the four wires are interlaced to form a dense net; the melting method is set to melt one end of the wire at high temperature into a cylinder with external threads and inner holes;

The atrial shunt is set as an equal disc surface shunt, and the equal disc surface shunt includes an upper disc surface 10, a waist 11, a lower disc surface 12, a shunt hole 13 and a closing end 14; the upper disc surface 10 and the lower disc surface 12 have the same size; the upper disc surface 10 and the lower disc surface A waist portion 11 is provided between the disc surfaces 12, a shunt hole 13 is provided on the disc surfaces of the upper disc surface 10 and the lower disc surface 12, and a closing end 14 is provided on the outer side of the lower disc surface 12; 8 connections.

The atrial shunt is set as a large and small disk surface shunt, and the large and small disk surface shunt includes a large disk surface, a waist 11, a small disk surface, a shunt hole 13 and a closing end 14; the diameter of the large disk surface is larger than the diameter of the small disk surface; There is a waist 11, the large disk surface and the small disk surface are provided with communicating shunt holes 13, and the outer side of the small disk surface is provided with a closing end 14;

The atrial shunt is set as a flip-up shunt, and the flip-up shunt includes an upper disk surface 10, a waist 11, a lower disk surface 12, a shunt hole 13 and a closing end 14; 10 and the disk surface of the lower disk surface 12 are provided with a shunt hole 13 that communicates with each other, and the outer side of the lower disk surface 12 is provided with a closing end 14; The disc surfaces are set to be turned outwards at both ends; the upper and lower disc surfaces are set to be knitted in a zigzag shape, and the waist 11 is set to be a cross-shaped weave.

Example:

1. Delivery device for degradable atrial shunt:

The device is used to transport a degradable atrial shunt into the human body, and the main components include: knob 1, locking switch 2, handle 3, outer sheath 4, double-threaded connector 5, and mandrel 6. The knob 1 can be rotated to drive the mandrel 6 to control the loosening and locking of the double-threaded connector 5, and the locking switch 2 plays a protective role. The handle 3 is used to hold and operate the conveying device. The outer sheath 4 is used for intervening delivery and loading the degradable atrial shunt, the double threaded connector 5 is used for loading the degradable atrial shunt, and the mandrel 6 is connected with the knob 1, which can transmit rotational force remotely.

1.1 Double threaded connector 5:

The double-threaded connector 5 is the main part used to connect the atrial shunt. This connector is different from the previous connection method. Today, there are only metal atrial shunts on the market. The connection method is a snap-on design. Not as hard as metal, so the snap-on designs on the market are not suitable for degradable materials.

The connecting head of the utility model is designed with double threads, and the main components include a mandrel 6 , a retracting thread head 7 , an active thread head 8 , and an active port 9 . The retracting thread head 7 and the flexible opening thread head 8 are threaded connections. The front end of the flexible thread head 8 is an internal thread, and the tail end is an external thread, and the front end of the flexible thread head 8 is provided with a movable port 9, which can be opened and closed up and down. The closed end 14 of the degradable atrial shunt is matched with the flexible thread head 8. When in use, the flexible thread head 8 is unscrewed to open the movable port 9, and the closed end 14 of the shunt is installed into the front end of the movable thread head 8 (not here. The closing end 14 is rotated into the movable port 9, but the movable port 9 is directly opened, and the closing end 14 of the shunt is installed), where the inner thread plays a frictional role and can firmly fix the atrial shunt. Then, the flexible threaded head 8 loaded with the atrial shunt is rotated into the retracted threaded head 7, and the atrial shunt can be fixed.

When releasing, rotate the knob 1 on the handle 3 and turn the mandrel 6, the flexible thread head 8 can be unscrewed from the retracted thread head 7, the flexible thread head 8 is opened, and the atrial shunt can be released remotely.

The design of the double-threaded head will not rub against the degradable material nor hook the degradable material, which can effectively avoid the damage of the degradable material, and is easy to load, and the release of the shunt can be controlled remotely.

2. Degradable atrial shunt:

The degradable atrial shunt is made by weaving, shaping and melting. The main body of the instrument is woven by a special weaving method, and its shape is made by the corresponding mold. The wire of the degradable atrial shunt will be melted at the closing end 14 and processed into a cylinder with external threads, which is convenient for connecting with the connector. connected. The melting properties of the material correspond to the corresponding temperature to process and shape, to ensure the elastic recovery of the degradable material, and to restore the previous shape quickly after being pushed out of the sheath.

2.1 Equal disk shunt

The utility model provides an equal disk surface shunt, which has two upper and lower disk surfaces and is woven from degradable wire materials. It includes an upper plate surface 10 , a waist portion 11 , a lower plate surface 12 , a shunt hole 13 , and a closing end 14 .

The size of the upper and lower disk surfaces of the device is the same, and the weaving method is a cross-shaped encircling weaving (see Figure 8), which can make the net structure denser and more stable. Since the hardness of the degradable material is slightly lower than that of metal, the diameter of the shunt hole 13 will shrink to a certain extent after being squeezed by the tissue. Combined with the mechanical model analysis, it is an important indicator that the shunt hole 13 can resist extrusion. The size design of the shunt hole 13 of the equal disk surface shunt is larger than that of the metal, and the cross-shaped dense mesh weaving makes the mesh surface more flexible, and the shunt port can better support the extrusion.

The iso-disc atrial shunt has a regular shape and is suitable for most patients with a uniform atrial septal hole. This design makes the device more evenly stressed, easier for doctors to operate, and less difficult to use, and can be suitable for most patients with heart failure.

2.2 Large and small disk shunt:

This design is a large and small disc surface shunt, with upper and lower disc surfaces, woven from degradable silk. It includes an upper plate surface 10 , a waist portion 11 , a lower plate surface 12 , a shunt hole 13 , and a closing end 14 . Its weaving method is also cross-shaped wrapping weaving (see Figure 8). The upper disk surface is larger and the lower disk surface is smaller. It is suitable for patients with the large disk surface located in the left atrium, which can resist the erosion of greater blood flow and has better stability.

Large and small disc shunts are different from equal disc shunts. This design is suitable for people with severe left atrial hypertension, thick atrial septal tissue, or thick at the proximal end of the hole but thin at the distal end of the hole; the larger upper disc can resist the left atrium. Greater blood flow scouring, and the unique internal buckle design can improve the clamping force to make the shunt clamp more firmly and adhere better to the wall.

2.3 Flip disc diverter

The flip-up diverter includes an upper disc surface 10 , a waist portion 11 , a lower disc surface 12 , a diverter hole 13 , and a closing end 14 . Different from the above two diverters, the design of the disk surface is turned out, the weaving method is a cross and a cross weave (see Figures 8 and 9), the upper and lower disks are a well-shaped weave (Figure 9), and the well-shaped weaving method is The weaving method of 2 threads in parallel and 4 threads interlaced with each other, this knitting method makes the mesh surface more sparse than the cross knitting method, the pressure between the wires is not so tight, and the movement margin is large, so the flexibility is better. The compression on the tissue is small and the symptoms of nerve conduction block are avoided. The waist is woven in a cross shape. This knitting method is denser than the well-shaped knitting method, and the movement margin between the wires is smaller, so the mesh surface has better toughness. , Not easy to deform, can better resist waist extrusion, so that the atrial septum can be better stretched, not easy to deform, and maintain its shunt effect. The disc surface of the device is everted to become a part of the waist, and it becomes a double layer at the end of the shunt, which can resist extrusion twice and play a buffering role. , more effectively maintain its diversion effect. The characteristics of this design are stronger stability and smaller waist deformation, which can better resist the compression of the atrial septal hole tissue.

This design is suitable for: some patients who are not suitable for puncturing large holes in the atrial septum due to small atrial septum or other reasons; because the hardness of the degradable material is slightly lower than that of metal, the diameter of the shunt hole will be reduced after implantation. Certain shrinkage, but the smaller the hole is, the shunt hole will easily be overgrown and blocked by its own tissue after shrinking, so the small deformation of the shunt port becomes an important performance. Atrial shunts are smaller and are suitable for people who need smaller holes in the interatrial septum.

The above are only preferred embodiments of the present utility model, and are not intended to limit the present utility model in any form or substance. It should be pointed out that for those of ordinary skill in the art, without departing from the present utility model, Several improvements and additions can also be made, and these improvements and additions should also be regarded as the protection scope of the present invention. All those skilled in the art, without departing from the spirit and scope of the present utility model, can utilize the above-disclosed technical content to make some changes, modifications and equivalent changes of evolution, all are the present utility model. At the same time, any modification, modification and evolution of any equivalent changes made to the above-mentioned embodiments according to the essential technology of the present invention still belong to the scope of the technical solution of the present invention.

Claims (7)

1. A degradable shunt kit comprising an atrial shunt delivery device and an atrial shunt; the method is characterized in that: the atrium shunt conveying device comprises a knob, a handle, an outer sheath tube, a double-thread connector and a mandrel; a core shaft is arranged in the outer sheath tube in a penetrating manner, a double-thread connector is arranged at one end of the core shaft away from an operator, and an atrium shunt which is made of degradable materials and movably connected with the double-thread connector is arranged on the double-thread connector; one end of the outer sheath tube close to the operator is provided with a handle, and the handle is provided with a knob connected with the mandrel.

2. The degradable shunt kit of claim 1, wherein: the double-thread connector comprises a hollow retraction thread head and a hollow movable-port thread head; a retraction thread head is arranged at one end close to the operator, and a movable opening thread head is arranged at the other end far away from the operator; the retraction threaded head is connected with an external thread arranged on one side of the looper threaded head through an internal thread arranged on the retraction threaded head, and the other side of the looper threaded head, which is far away from an operator, is provided with an internal thread used for being connected with the atrium shunt; the movable opening threaded head is in a variable diameter shape, and the side wall of the movable opening threaded head is separable along the radial direction; the mandrel is connected with the movable threaded head.

3. The degradable shunt kit of claim 2, wherein: the side wall of the looper thread head is provided with a plurality of petals along the circumference; the retraction thread head and the movable opening thread head are conical in shape; the diameter of the end of the retraction thread head and the looper thread head far away from the operator is larger than that of the end close to the operator.

4. The degradable shunt kit of claim 3, wherein: and a locking switch for preventing misoperation is arranged on the handle.

5. The degradable shunt kit of claim 1, wherein: the atrium shunt is set as an isoplanar shunt, and the isoplanar shunt comprises an upper discoid surface, a waist part, a lower discoid surface, a shunt hole and a closing end; the upper disc surface and the lower disc surface have the same size; a waist part is arranged between the upper disc surface and the lower disc surface, the disc surfaces of the upper disc surface and the lower disc surface are provided with communicated shunting holes, and the outer side of the lower disc surface is provided with a closing end; the external thread arranged at the closing end is connected with the threaded head of the movable opening.

6. The degradable shunt kit of claim 1, wherein: the atrium shunt is set as a large and small disk shunt, and the large and small disk shunt comprises a large disk, a waist, a small disk, a shunt hole and a receiving end; the diameter of the large disc surface is larger than that of the small disc surface; a waist part is arranged between the large disc surface and the small disc surface, the disc surfaces of the large disc surface and the small disc surface are provided with communicated shunting holes, and the outer side of the small disc surface is provided with a closing end; the external thread arranged at the closing end is connected with the threaded head of the movable opening.

7. The degradable shunt kit of claim 1, wherein: the atrium splitter is a tilting disk type splitter, and the tilting disk type splitter comprises an upper disk surface, a waist part, a lower disk surface, a splitting hole and a closing end; a waist part is arranged between the upper disc surface and the lower disc surface, the disc surfaces of the upper disc surface and the lower disc surface are provided with communicated shunting holes, and the outer side of the lower disc surface is provided with a closing end; the external thread arranged at the closing end is connected with the threaded head of the movable opening; the disk surfaces of the upper disk surface and the lower disk surface are outwards turned towards the outer sides of the two ends; the upper and lower disc surfaces are woven in a shape like a Chinese character 'jing', and the waist part is woven in a shape like a cross.

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