WO2022252463A1

WO2022252463A1 - Implantable instrument having vertical double-concave structure

Info

Publication number: WO2022252463A1
Application number: PCT/CN2021/123174
Authority: WO
Inventors: 许贤春; 王云兵; 胡金鹏; 赵一甲; 钱卫东; 朱兴; 郭高阳; 陈宇; 王帆; 潘湘斌; 陈娟
Original assignee: 上海形状记忆合金材料有限公司
Priority date: 2021-06-03
Filing date: 2021-10-12
Publication date: 2022-12-08

Abstract

An implantable instrument having a vertical double-concave structure. The implantable instrument comprises an upper disc surface (1), a lower disc surface (2) and a connecting part (3). The connecting part (3) is disposed between the upper disc surface (1) and the lower disc surface (2). The upper disc surface (1) and the lower disc surface (2) are respectively provided with concave disc surface structures (4) recessed toward the middle connecting part (3). The vertical double-concave structure can enhance the support performance and the deformation resistance of the implantable instrument, and compensate for the poor mechanical support performance of a degradable wire material; moreover, after heat treatment shaping, the implantable instrument can have certain stress recovery capability and elastic deformation capability, so that the implantable instrument can be restored to the shape. The friction force between the implantable instrument and a contact tissue surface can be enhanced, the wire diameter of the implantable instrument is reduced, and the sheath passing performance of the instrument is enhanced.

Description

An implant instrument with a vertical double concave structure

technical field

The invention relates to an implant device with a vertical double concave structure, which belongs to the technical field of medical devices.

Background technique

At present, the main treatment method for congenital heart disease is the application of implanted devices for occlusion. Patients with non-valvular atrial fibrillation and stroke are increasingly choosing to occlude the left atrial appendage as a preventive measure. At present, the occluders that have been marketed at home and abroad are all made of nickel-titanium alloy. The congenital heart disease occluder made of nickel-titanium alloy has been used for decades at home and abroad. The left atrial appendage occlusion of nickel-titanium alloy The application of implants has been in use for four or five years, and has shown good short- and medium-term curative effects, but the complications caused by this metal material are still not negligible, including the wear of metal implants on surrounding tissue structures, galvanic corrosion, and metal implantation. Allergic reactions caused by ion precipitation, NMR restrictions, psychological impact factors caused by metal stents remaining in the body for life, etc., and metals remain in the body for life, there is still a lack of data support for the long-term safety of the human body. After the occluder is implanted in the body, it becomes a bridge for endothelial cells to climb. After a period of time after implantation, the surface of the occluder is covered by new endothelial tissue to achieve self-occlusion of the defect. At this point, the occluder has completed its mission and no longer needs to exist in the body. Therefore, the ideal occluder should provide a temporary "bridge" for the defect to achieve self-occlusion. After completing the "historical mission", the "bridge" will be degraded by the body, so that the defect can be completely repaired by its own tissue, avoiding metal retention in the body. future complications and safety hazards. Therefore, at present, degradable occluders have entered the research and development stage. Degradable implantable devices can avoid the problem of nickel ion precipitation in metal implanted devices, reduce the amount of metal implants, and achieve intervention without implantation. However, the skeleton or disk of the degradable occluder is made of degradable silk. The degradable silk is a polymer material, which is soft and has poor mechanical and mechanical properties, resulting in poor elastic recovery after the implanted device is released. , the support force at the defect site is not enough, which is the biggest difference or deficiency between the degradable occluder and the metal implant device, and it is also a problem that needs to be solved urgently in the technical field.

Contents of the invention

The purpose of the present invention is to solve the problem that the implanted device made of degradable silk is soft and has poor mechanical and mechanical properties, resulting in poor elastic recovery performance and insufficient support at the defect site after the implanted device is released. question.

In order to solve the above problems, the technical solution adopted by the present invention is to provide an implant device with a vertical double concave structure; it includes an upper disc surface, a lower disc surface and a connecting part; a connecting part is provided between the upper disc surface and the lower disc surface , the upper disk surface and the lower disk surface are respectively provided with a concave disk surface structure that is sunken toward the direction of the middle connection part.

Preferably, the upper and lower discs are parallel, and the upper and lower discs are provided with coincident imaginary central axes perpendicular to the upper and lower discs; the concave disc structure is provided with a disc perpendicular to the central axes of the upper and lower discs.

Preferably, the concave disc surface structure is recessed toward the middle connecting portion to a depth greater than or equal to 2mm.

Preferably, the implant device is made of degradable materials.

Preferably, the implant device is provided with an auxiliary shaping wire.

Preferably, the auxiliary molding thread is a surgical suture.

Preferably, the implant device is configured as an atrial septal defect (ASD) implant device, a ventricular septal defect (VSD) implant device, a patent ductus arteriosus (PDA) implant device, an atrial shunt, a degradable vascular plug and Degradable left atrial appendage implant device.

Compared with the prior art, the present invention has the following beneficial effects:

The implant device provided by the present invention is designed with a vertical double-concave structure, which has very unique advantages; the double-concave structure is equivalent to a double-layer structure, which greatly enhances the support performance of the implant device. When the implanted device is subjected to external stress, the reaction force of the implanted device is just perpendicular to the mass point of the implanted device. Such a reaction force is the largest, so it can enhance the support performance of the implanted device, resist deformation, and compensate for degradability. The problem of poor mechanical support performance of wire. After the concave structure design is heat-treated and finalized, the implanted device can have a certain stress recovery ability and elastic deformation ability, allowing the implanted device to recover its shape. The double-concave structure enhances the supporting force of the degradable implanted device and at the same time enhances the friction between the device and the contact tissue surface. Reduce the wire diameter of the device and enhance the performance of the device through the sheath (that is, it can pass through a smaller delivery sheath). The vertical depth of the indentation is above 2 mm (inclusive), and the greater the depth, the better the anti-deformation ability of the implanted device and the better the shape recovery performance.

The implant device provided by the present invention adopts degradable materials, and the materials are one or more of polydioxanone (PDO), polylactic acid (PLA) or their copolymers, and the use of degradable materials can realize Degradable purpose of the implanted device. In addition to biodegradable instruments, the vertical biconcave structure is also suitable for metal instrument structures.

Description of drawings

Fig. 1 is a schematic diagram of the structure of the present invention;

The figure shows a U-shaped + flat-bottomed structure.

Fig. 2 is a schematic diagram of the second structure of the present invention.

The figure shows a semi-vertical + U-shaped bottom concave structure.

Fig. 3 is a schematic diagram of the third structure of the present invention.

The figure shows a semi-vertical + V-shaped bottom concave structure.

Fig. 4 is a schematic diagram 4 of the structure of the present invention.

The picture shows a half V shape + flat bottom structure.

Fig. 5 is a schematic diagram of the structure and mechanical analysis of the present invention.

In the figure, F ₁ represents the external force applied to the implanted device, and F ₂ represents the reaction force of the implanted device. In this structure, F ₁ =F ₂ .

Fig. 6 is a schematic diagram of a mechanical analysis of a non-perpendicular biconcave structure.

In the figure, _F1 represents the external force applied to the implanted device, and _F2 represents the reaction force of the implanted device. In this structure, F ₂ has a component force on the X-axis and Y-axis respectively, and the reaction force of F ₁ is F ₁ '; F ₁ '=F ₂ cosα=F ₁ , at this time, F ₂ is on the Y-axis There is also a component force F ₃ , precisely because of the existence of F ₃ , the two disk surfaces of the instrument will have a force protruding outward, and the magnitude of the force is F ₃ =F ₂ sinα.

Fig. 7 is a schematic structural diagram of an ASD occluder applied to the present invention.

Fig. 8 is a schematic structural diagram of a VSD occluder applying the present invention.

Fig. 9 is a schematic structural diagram of a PDA occluder applying the present invention.

Fig. 10 is a schematic structural view of an atrial shunt applying the present invention.

Fig. 11 is a schematic diagram of the structure of a blood vessel plug applying the present invention.

Fig. 12 is a schematic structural view of the left atrial appendage occluder applied to the present invention.

Reference signs: 1. Upper panel surface; 2. Lower panel surface; 3. Connection portion; 4. Concave panel surface structure.

Detailed ways

In order to make the present invention more obvious and understandable, the preferred embodiments are described in detail as follows in conjunction with the accompanying drawings:

As shown in Figures 1-12, the present invention provides an implant device with a vertical double concave structure; it includes an upper disk surface 1, a lower disk surface 2 and a connecting part 3; a connecting part is provided between the upper disk surface 1 and the lower disk surface 2 3. The upper disk surface 1 and the lower disk surface 2 are respectively provided with concave disk surface structures 4 that are recessed in the direction of the intermediate connection part 3 . The upper disk surface 1 and the lower disk surface 2 are parallel, and the upper disk surface 1 and the lower disk surface 2 are provided with coincident central axes; the concave disk surface structure 4 is provided with a disk surface perpendicular to the central axes of the upper and lower disk surfaces. The depth of the recessed disc structure 4 towards the middle connection part is greater than or equal to 2mm. Implantable devices are manufactured using materials including degradable ones. The implant device is provided with an auxiliary shaping wire. Surgical sutures are used for the auxiliary molding line; the implanted devices are set as atrial septal defect implanted devices, ventricular septal defect implanted devices, patent ductus arteriosus implanted devices, atrial shunts, degradable vascular plugs and degradable left atrial appendage implants. into the device.

In order to solve the problems of poor mechanical properties and mechanical properties of biodegradable braided devices, resulting in poor elastic recovery performance after device release, insufficient support force, and poor deformation resistance, the present invention provides a biodegradable implant with a vertical double concave structure. Inserting devices can solve the problems of poor surface forming and insufficient support performance of degradable implant devices.

The specific design of the implanted device with vertical double concave structure is as follows:

1. The degradable implantable device is characterized by having upper and lower disc surfaces and (or) the connecting part in the middle, and adopts a vertical double-concave structural design (see Figures 1-4).

2. The vertical depth of the concave is ≥2mm.

3. Degradable implantable devices have an auxiliary molding line.

4. The material of the implanted device can be synthetic degradable polymer polydioxanone PDO, polylactic acid PLA, PLLA, PDLLA, PLGA, PGA, PCL, PHB, PVA, natural degradable polymer silk fibroin , Collagen fiber, chitosan, etc., one or more or their copolymers; it can also be nickel-titanium metal materials.

5. The degradable implant device may be an atrial septal defect (ASD) implant device (as shown in Figure 7), and the two disc surfaces of the left atrium and the right atrium are concave to enhance radial support. At the same time, the edges of the two disks are buckled inside to ensure that the disks can closely fit the atrial septal tissue, which is conducive to the process of endometrialization. The diameter of the waist can be 4mm-50mm, and the two disks of the left atrium and the right atrium are 4mm-20mm larger than the diameter of the waist.

6. The degradable implant device can be a ventricular septal defect (VSD) implant device (as shown in Figure 8). The two disks of the left ventricle and the right ventricle are concave to enhance radial support. The waist height can be 3mm-14mm. To adapt to the different thickness of the interventricular septum at different locations, the two discs of the left ventricle and the right ventricle are 4mm-10mm larger than the diameter of the waist.

7. The degradable implant device can be a patent ductus arteriosus (PDA) implant device (as shown in Figure 9). The double concave structure at the aortic end and pulmonary artery end enhances the support of the waist and ensures the stability of the implant device. The diameter of the waist can be 4mm-30mm, and the diameter of the aortic end disc is 4mm-14mm larger than the diameter of the waist.

8. The degradable implantable device can be an atrial shunt (as shown in Figure 10). The two discs of the left atrium and right atrium are concave to enhance the radial support force and avoid the "fish mouth effect" after release, that is, the shunt port is outward Throwing, resulting in smaller shunt aperture, device deformation and failure. The size (D1) of the middle shunt hole can be 4mm-22mm, and the size (D2) of the two disks of the left atrium and the right atrium can be 4mm-20mm larger than the shunt hole.

9. Others include degradable vascular plugs (as shown in Figure 11), degradable left atrial appendage implant devices (as shown in Figure 12), etc., all of which can have unexpected effects.

10. The material of the auxiliary forming thread is surgical suture, such as polyester, nylon and other surgical sutures with good tensile strength.

The effect that the present invention reaches:

1. The effect of the vertical double concave structure: the vertical double concave structure has very unique advantages in the application of degradable implant devices:

1.1 The vertical double-concave structure is equivalent to a double-layer structure, which greatly enhances the support performance of implanted devices.

1.2 On the other hand, when the implanted device is subjected to external stress, the reaction force of the implanted device is just perpendicular to the mass point of the implanted device. Such a reaction force is the largest, so it can also enhance the support performance of the implanted device , anti-deformation ability, to compensate for the poor mechanical support performance of the degradable wire, see the force analysis diagram of the particle in Figure 5 and Figure 6 for details.

1.3 After the concave structure design is heat-treated and shaped, the implanted device can have a certain stress recovery ability and elastic deformation ability, so that the implanted device can be restored to shape.

1.4 In addition, this structure increases the frictional force between the implanted device and the contact tissue surface while enhancing the supporting force of the degradable implanted device.

1.5 It can also reduce the wire diameter of the device and enhance the performance of the device through the sheath (that is, it can pass through a smaller delivery sheath).

2. The vertical depth of the concave is above 2mm (inclusive), because the greater the depth, the better the deformation resistance of the implanted device and the better the shape recovery performance.

3. The material for manufacturing degradable implant devices is one or more of polydioxanone (PDO), polylactic acid (PLA) or their copolymers, and the use of degradable materials can realize the degradable implant devices. purpose of degradation.

In addition to biodegradable instruments, the vertical biconcave structure is also suitable for metallic instrument structures.

4. The vertical biconcave structure can be applied to biodegradable or metal atrial septal defect (ASD) occluders, ventricular septal defect (VSD) occluders, patent ductus arteriosus (PDA) occluders, vascular plugs , atrial shunt, left atrial appendage occluder, etc. (as shown in Figures 7 to 12).

Because the vertical biconcave structure can:

4.1 Enhance the clamping force and stability between the two disks of the atrial septal defect occluder to avoid throwing the disks outward;

4.2 Enhance the adhesion of the upper and lower discs of the ventricular septal defect occluder, so that the discs can be formed better and the discs will not be thrown out;

4.3 Enhance the fit of the disk surface of the aortic end and the pulmonary artery end of the patent ductus arteriosus occluder, the disk surface will not be thrown out, and at the same time enhance the support performance of the occluder waist to avoid residual shunt;

4.4 Enhance the radial support force of the waist of the vascular plug, improve the fit between the device and the vessel wall, and reduce the possibility of residual shunt.

4.5 The maximum performance requirement of the atrial shunt is that the radial support force must be sufficient to prop up the created defect and realize effective shunt. This vertical double-concave structure can enhance the radial support force of the instrument and help the disc surface not to protrude.

4.6 Enhance the radial support force of the left atrial appendage occluder, and present adaptive deformation with the shape of the atrial appendage, which can adapt to the adjustment of the axial direction and avoid residual shunt.

According to the characteristics and advantages of the vertical double concave structure, combined with U-shaped concave and V-shaped concave, there are several ways to realize it. As shown in Figures 1 to 4, A1, A2, A3, and A4 in the figure represent the structure of one disk, and B1, B2, B3, and B4 represent the structure of another disk. Between the upper and lower disks (that is, A1, A2, A3, A4 disk surface and B1, B2, B3, B4 disk surface) can be combined in any way.

The foregoing is only a preferred embodiment of the present invention, and is not intended to limit the present invention in any form and in essence. Several improvements and supplements are made, and these improvements and supplements should also be regarded as the protection scope of the present invention. Those who are familiar with this profession, without departing from the spirit and scope of the present invention, when they can use the technical content disclosed above to make some changes, modifications and equivalent changes of evolution, are all included in the present invention. Equivalent embodiments; at the same time, all changes, modifications and evolutions of any equivalent changes made to the above-mentioned embodiments according to the substantive technology of the present invention still belong to the scope of the technical solution of the present invention.

Claims

An implant instrument with a vertical double-concave structure; it is characterized in that it includes an upper disc surface, a lower disc surface and a connecting part; A concave disk surface structure that is concave in the external direction.
An implant device with a vertical double-concave structure according to claim 1, characterized in that: the upper and lower discs are parallel, and the upper and lower discs are provided with overlapping virtual central axes perpendicular to the upper and lower discs; The concave disk surface structure is provided with a disk surface perpendicular to the central axis of the upper and lower disk surfaces.
An implant instrument with a vertical double concave structure according to claim 2, characterized in that: the depth of the depression of the concave disc surface structure towards the middle connection part is greater than or equal to 2mm.
An implant device with vertical double concave structure according to claim 3, characterized in that: said implant device is made of degradable materials.
An implant device with vertical double concave structure according to claim 4, characterized in that: said implant device is provided with an auxiliary molding line.
An implant instrument with a vertical double-concave structure according to claim 5, wherein the auxiliary molding line is a surgical suture.
Any implant device with a vertical double concave structure according to claims 1 to 6, wherein the implant device is configured as an implant device for atrial septal defect, a device for ventricular septal defect, or an arterial catheter. Closure implants, atrial shunts, degradable vascular plugs and degradable left atrial appendage implants.