CN108451570A - Assist molding device and method in Wholly-degradable plugging device body - Google Patents

Abstract

The invention provides a device for assisting the in vivo formation of a fully degradable occluder. The degradable occluder for congenital heart disease includes upper and lower disks and a waist. The upper and lower disks are connected through the waist to assist the fully degradable occluder. The device formed in the body is a safety rope, and the two free ends of the safety rope penetrate from two places on the upper disk surface from top to bottom, pass through the waist, and pass through the lower disk surface. The present invention also provides a method for assisting in vivo molding of a fully degradable occluder for congenital heart disease. The safety rope follows the occluder and is implanted into the defect site; If it protrudes outwards and cannot be recovered by itself, the two free ends of the safety rope are pulled to assist the forming of the upper and lower panels, so that both the upper and lower panels clamp the waist and are close to the gap between the defect. next door. The invention greatly improves the recovery performance in the human body after implantation of the degradable occluder for congenital heart disease.

Description

Device and method for assisting in vivo molding of fully degradable occluder

technical field

The invention relates to a device for assisting the in vivo formation of a fully degradable occluder for congenital heart disease, belonging to the technical field of medical devices.

Background technique

Congenital heart disease is the most common type of congenital malformation, accounting for about 28% of various congenital malformations. Congenital heart disease refers to the anatomical abnormality caused by the formation disorder or abnormal development of the heart and great blood vessels during the embryonic development period, or the failure of the channel that should be automatically closed after birth (it is normal in the fetus). It is generally believed that early pregnancy (5-8 weeks) is the most important period for fetal heart development. There are many causes of congenital heart disease, genetic factors account for only about 8%, and the vast majority of 92% are caused by environmental factors. For example, women taking drugs during pregnancy, infection with viruses, environmental pollution, radiation, etc. will all cause abnormal fetal heart development. In particular, infection with rubella virus in the first 3 months of pregnancy will sharply increase the risk of congenital heart disease in the child. Current data show that the incidence of congenital heart disease cannot be underestimated, accounting for 0.4% to 1% of live babies, which means that there are 150,000 to 200,000 new congenital heart disease patients in my country every year.

At present, the medical devices used to treat congenital heart disease are mainly occluders braided with nickel-titanium alloy wires, such as atrial septal defect occluders, ventricular septal defect occluders, patent ductus arteriosus occluders, Vascular plug occluders for the treatment of peripheral vascular diseases, etc. These occluders generally include nickel-titanium alloy wire stents, left and right disks, and flow-blocking membranes in the nickel-titanium alloy wire stents. The flow-blocking membranes are generally polyester polyester film PET, polytetrafluoroethylene film PTFE, polyurethane PU or polyvinyl alcohol. PVA. The material of each part of the currently used occluder is a non-degradable material, and they will remain in the body for a lifetime.

In China, occluders have been used for decades and have shown good curative effect, but the occurrence of complications still cannot be ignored, including occluder shedding, thrombosis, valve damage, residual shunt, hemolysis, arrhythmia , nickel allergies, etc., and metals remain in the body for life, there is still no data support for the long-term safety of the human body, especially for children, whose hearts are still developing, and the occluder in their bodies has no long-term impact on them. Follow-up data can prove it. The most important thing is that when the surface of the occluder is completely endothelialized and the defect is repaired by the body's own tissues, there is no need to keep the occluder in the body. Therefore, the ideal occluder should provide a temporary place for the heart to repair itself. The "bridge" is degraded by the body after the work is completed, so that the defect is completely repaired by its own tissue, avoiding long-term complications and safety hazards caused by metal retention in the body, so a degradable occluder is needed.

Since the degradable occluder needs to be made of polymer materials, and the elasticity of the polymer material wire is inferior to that of the ordinary NiTi alloy occluder, the in vivo formability of the degradable occluder is poor. How to assist the in vivo molding of the degradable occluder to improve the recovery performance of the degradable occluder in the human body after implantation is a difficult problem that those skilled in the art are committed to solving.

Contents of the invention

The technical problem to be solved by the present invention is how to assist the in vivo molding of the fully degradable occluder for the treatment of congenital heart disease, so as to improve the recovery of the degradable occluder in the human body after implantation performance.

In order to solve the above technical problems, the technical solution of the present invention is to provide a device for assisting the in vivo formation of a fully degradable occluder. The degradable occluder for congenital heart disease includes an upper disc surface, a lower disc surface and a waist, and the upper and lower parts of the waist The two ends are respectively connected to the upper disk surface and the lower disk surface. It is characterized in that: the device formed in the auxiliary fully degradable occluder is a safety rope, and the two free ends of the safety rope are connected from two places on the upper disk surface. Passes down, through the waist, and out the lower panel.

Preferably, the two free ends of the safety rope penetrate from top to bottom from two places on the upper panel, pass through the waist, and pass out from two places on the lower panel.

More preferably, the two places on the upper disk surface are arranged symmetrically on the upper disk surface.

More preferably, the two places on the lower disk surface are arranged symmetrically on the lower disk surface.

Preferably, the shuttle path of the safety rope on the degradable occluder for congenital heart disease may also be as follows: one end of the safety rope penetrates through the lower panel, passes through the waist, and then passes through the side of the upper panel. out; then penetrate from the other side of the upper disk, and pass through the waist and then out from the lower disk.

Preferably, the safety rope is provided with an upper reserved section on the top of the upper plate for ensuring that the upper plate can be smoothly received into the loader.

More preferably, the length of the upper reserved section is 3-5 cm.

Preferably, the safety rope is provided with a reserved lower part at the lower part of the lower disc surface to ensure that the lower disc surface is received in the loader and passed through the delivery sheath, and there is still a sufficient length for the operator to operate.

More preferably, for the degradable occluder for congenital heart disease used in minimally invasive surgery, the length of the reserved lower part is 15-30 cm.

More preferably, for the degradable occluder for congenital heart disease used in medical interventional operations, the length of the reserved lower part is 130-150 cm.

Preferably, the safety cord is a biocompatible silk thread conforming to three types of short-term contact.

More preferably, the safety rope is a surgical suture, either non-absorbable or absorbable, such as catgut, chemically synthesized PGA, pure natural collagen suture or degradable suture.

Further, the material of the degradable suture includes polydioxanone PDO, polylactic acid PLA, PLLA, PDLLA, PLGA, PGA, PCL, PHB series, etc.

Preferably, the fully degradable occluder is an atrial septal defect occluder, a ventricular septal defect occluder, a patent ductus arteriosus occluder or a patent foramen ovale occluder.

The present invention also provides a method for assisting in vivo molding of a fully degradable occluder for congenital heart disease, which is characterized in that, using the above-mentioned device for assisting in vivo molding of a fully degradable occluder, the steps are as follows: During the process, the safety rope followed the degradable occluder of congenital heart disease and was implanted into the defect site; the degradable occluder of congenital heart disease was released, and the molding effect of the upper and lower plates of the degradable occluder of congenital heart disease was not good. In the case of good, protruding outward, and unable to recover by itself, the method of pulling the two free ends of the safety rope can assist in the formation of the upper and lower discs of the fully degradable occluder, so that both the upper and lower discs can clamp the waist , close to the partition wall of the defect; finally pull out the safety rope. This avoids the occupancy and thrombus formation in the heart after the protruding upper and lower discs of the degradable congenital heart disease occluder, and at the same time enables endothelial cells to better adhere and climb during the endothelialization stage, promoting process.

The device provided by the present invention to assist the in vivo formation of a fully degradable occluder can be used in surgical minimally invasive small incision surgery to implant a degradable occluder for congenital heart disease, and also supports medical interventional surgery for implanting a congenital heart disease Formation of biodegradable occluder.

The method for assisting in vivo molding of a fully degradable occluder provided by the present invention does not require a special delivery sheath, and both general medical interventional delivery sheaths and conventional surgical interventional delivery sheaths can be used.

The device provided by the present invention to assist the in vivo formation of fully degradable occluders is suitable for atrial septal defect occluders, ventricular septal defect occluders, patent foramen ovale occluders, and patent ductus arteriosus occluders , left atrial appendage occluder, etc. after implantation recovery molding.

The device provided by the invention overcomes the deficiencies of the prior art, can assist the in vivo molding of a fully degradable occluder, and greatly improves the recovery performance of the degradable occluder in the human body after implantation of congenital heart disease; The degradable occluder for heart disease does not require a special delivery sheath, and can be used for both general medical interventional delivery sheaths and conventional surgical interventional delivery sheaths. It is easy to operate and low in cost, and is suitable for wide-scale promotion and use.

Description of drawings

Figure 1 is the rendering of the biodegradable occluder for congenital heart disease after the safety rope is inserted before the operation;

Figure 2 is the rendering of the degradable occluder for congenital heart disease after it is inserted into the safety rope and received in the delivery sheath;

Figure 3 is a schematic diagram of the natural state of the degradable occluder for congenital heart disease after it is released. The upper and lower plates protrude outwards and cannot be fully restored to the finalized state of the degradable occluder;

Fig. 4 is an effect diagram of assisting the recovery of the upper and lower discs of the degradable occluder by pulling the safety rope after the release of the degradable occluder for congenital heart disease.

Detailed ways

Below in conjunction with specific embodiment, further illustrate the present invention.

The fully degradable occluder for congenital heart disease is generally made of polymer materials, including the upper disc, the lower disc and the waist, and the upper and lower ends of the waist are respectively connected to the upper disc and the lower disc.

The invention provides a device for assisting in vivo molding of a fully degradable occluder, which is a safety rope. The two free ends of the safety rope pass through from two places on the upper panel from top to bottom, pass through the waist, and pass out from two places on the lower panel. The shuttle path of the safety rope on the degradable occluder can also be as follows: one end of the safety rope penetrates upwards from the side of the lower plate, passes through the side of the waist, and passes upwards from the side of the upper plate, and then passes through the side of the upper plate. The other side of the plate passes down, past the other side of the waist, and out the other side of the lower plate. The final structures obtained by the two methods are consistent.

The safety rope needs to reserve a certain length on the upper surface of the degradable occluder to ensure that the upper surface of the degradable occluder can be smoothly received into the loader, and the reserved length is 3-5cm. This length refers to the distance between the top of the safety rope and the upper plate surface after straightening.

The safety rope also needs to reserve a certain length on the lower surface of the degradable occluder to ensure that the degradable occluder is received into the loader, and after passing through the delivery sheath, there is still enough length for the operator to operate.

The device provided in this embodiment to assist in the formation of a fully degradable occluder in vivo can be used in surgical minimally invasive small incision surgery to implant a degradable occluder, and also supports medical interventional surgery to implant a degradable occluder. forming. The reserved length of the safety rope on the lower panel of the biodegradable occluder for minimally invasive surgery is 15-30 cm; the reserved length of the lower panel safety rope of the degradable occluder for medical interventional surgery is 130-150 cm.

With reference to Figures 1 to 4, when the device provided by this embodiment assists in the in vivo formation of a fully degradable occluder, during the surgical implantation process, the safety rope always follows the degradable occluder for congenital heart disease into the delivery sheath Tube, the safety rope leaves enough operable margin outside the delivery sheath. The biodegradable occluder for congenital heart disease is delivered to the lesion and released. With the help of ultrasonic imaging technology, when the upper and lower discs are poorly formed, protruding outward, and cannot recover by themselves, the operator controls the delivery rod and the safety rope. , specifically: pull the tail end of the safety rope backwards (that is, in the direction opposite to the protruding direction of the upper disk surface), so that the upper and lower disk surfaces return to the preset shape; shrink the disk surface of the degradable occluder, and clamp the defect Partial septal tissue. Finally, the safety rope is withdrawn, and the delivery sheath, push rod, etc. are withdrawn. This avoids the occupancy and thrombus formation in the heart after the protruding upper and lower discs of the degradable congenital heart disease occluder, and at the same time enables endothelial cells to better adhere and climb during the endothelialization stage, promoting process.

The above description 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 can be 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 (10)

1. molding device in a kind of auxiliary Wholly-degradable plugging device body, the degradable plugging device of congenital heart disease include upper disk The upper/lower terminal of face, lower disk and waist, waist is separately connected upper disk surface, lower disk, it is characterised in that：The auxiliary is complete Molding device is a safety rope in degradable plugging device body, two free ends of safety rope from two on the upper disk surface by It is penetrated under, passes through the waist, and be pierced by from the lower disk.

2. molding device in a kind of auxiliary Wholly-degradable plugging device body as described in claim 1, it is characterised in that：It is described Two free ends of safety rope from top to bottom penetrate from two on the upper disk surface, pass through the waist, and from the lower wall On face two at be pierced by.

3. molding device in a kind of auxiliary Wholly-degradable plugging device body as claimed in claim 2, it is characterised in that：It is described Two on upper disk surface be on upper disk surface be symmetrical arranged；Two in the lower disk be in lower disk be symmetrical arranged.

4. molding device in a kind of auxiliary Wholly-degradable plugging device body as described in claim 1, it is characterised in that：It is described Safety rope is equipped on the upper disk surface top for ensureing that the upper disk surface can successfully take in the reserved section in top of loader； The safety rope is equipped in the lower disk lower part for ensureing that the lower disk is incorporated into loader and after the delivery sheath, Still there is the lower part that enough length facilitates patient to operate to reserve section.

5. molding device in a kind of auxiliary Wholly-degradable plugging device body as claimed in claim 4, it is characterised in that：It is described It is 3~5cm that segment length is reserved on top.

6. molding device in a kind of auxiliary Wholly-degradable plugging device body as claimed in claim 4, it is characterised in that：For The degradable plugging device of congenital heart disease of needle holder being applied to surgery Minimally, it is 15~30cm that segment length is reserved in the lower part；For interior Section intervenes the degradable plugging device of congenital heart disease of operation, and it is 130~150cm that segment length is reserved in the lower part.

7. molding device in a kind of auxiliary Wholly-degradable plugging device body as described in claim 1, it is characterised in that：It is described Safety rope is the biocompatibility silk thread for meeting three classes short term contact.

8. molding device in a kind of auxiliary Wholly-degradable plugging device body as claimed in claim 1 or 7, it is characterised in that： The safety rope is catgut, chemical synthesis line PGA, pure-natural collagen suture or degradable suture.

9. molding device in a kind of auxiliary Wholly-degradable plugging device body as described in claim 1, it is characterised in that：It is described Wholly-degradable plugging device is atrial septal defect plugging device, ventricular septal defect, patend ductus arteriosus occluder or oval Hole arteriosus occluder.

10. a kind of molding method in auxiliary Wholly-degradable plugging device body, which is characterized in that using such as claim 1~9 times Molding device in auxiliary Wholly-degradable plugging device body described in one, step are：During performing the operation implantation, safety rope The degradable plugging device of congenital heart disease is followed to be implanted to defect always；The degradable plugging device release of congenital heart disease, The upper and lower disk molding effect of the degradable plugging device of congenital heart disease it is bad, outwardly protrude and the case where cannot voluntarily restore Under, the method by pulling safety rope two free ends assists the molding of the upper and lower disk of Wholly-degradable plugging device, make thereon, Lower disk clamps waist, is tightly attached in the spaced walls of defect；Finally extract safety rope out.