CN204428203U - The anti-I type internal hemorrhage due to trauma support of attached sponge structure - Google Patents

Abstract

The utility model relates to an anti-type I endoleak bracket with a sponge structure, which is used for closing type I endoleaks, and is characterized in that it comprises: a metal mesh support layer matching the shape of an arterial vessel; covered by a metal mesh support The coating layer on the coating layer; and the sponge layer distributed at the proximal end of the outer side of the coating layer or at the proximal end and the distal end of the outer side of the coating layer at the same time, the sponge layer is filled under the effect of its own elasticity In the gap formed between the inner wall of the arterial vessel and the coating layer, the sponge layer does not exceed the edge of the end of the metal mesh support layer and the coating layer. The anti-I-type endoleak support with a sponge structure of the utility model can pre-seal the I-type endoleak.

Description

Anti-I type endoleak bracket with sponge structure

technical field

The utility model relates to an anti-I type endoleak bracket with a sponge structure, which belongs to the field of medical instruments.

Background technique

Aneurysms are among the most common disabling and fatal vascular diseases. It can be found in any artery in the whole body, and it is more common in the elderly. Aneurysms can have a variety of sizes, shapes, and distributions. The Ad Hoc Committee on Reporting Standards of the Society for Vascular Surgery defines an aneurysm as a permanent artery with a diameter greater than 50% of the normal arterial diameter. Classification and standardization for clinical decision-making.

The earliest record of an attempt to treat an aneurysm dates back to the 3rd century AD; until 1888, Matas et al. completed the first true aneurysm repair, that is, ligated branch arteries in the aneurysm cavity of the brachial aneurysm. In 1951, Dubost et al. completed the first case of aneurysm suturing repair. They resected the abdominal aortic aneurysm of a patient, and selected the thoracic aorta of a 20-year-old deceased donor as an allograft and transplanted it into the abdominal aorta. In a patient with an aortic aneurysm, the patient survived for 8 years after surgery. The open surgery for aneurysm repair has gradually been perfected and optimized in the following 40 years, but its perioperative mortality rate is still as high as 5%. In 1991, Parodi et al first reported the experience of repairing aortic aneurysm with artificial stent composite. After the Food and Drug Administration (FDA) approved the clinical application of endovascular grafts, aneurysms (including peripheral aneurysms and aortic aneurysms) underwent an evolution from open bypass repair to endovascular repair.

Compared with traditional open surgery, the use of covered stents for endovascular exclusion in the treatment of aneurysms, arterial dissection and other diseases has the advantages of less surgical trauma, faster postoperative recovery, and shorter hospital stay, but its unique complication—endoleak So far it cannot be completely avoided. Endoleak is one of the most important complications after endovascular exclusion, and its incidence rate is as high as 45%. Endoleaks can be divided into types I-V according to their mechanism of occurrence; among them, type I endoleak refers to the leakage of blood through the proximal or distal end of the stent graft due to poor adhesion between the stent graft and the inner wall of the artery in the anchoring area. into the aneurysm cavity; the incidence rate is about 10%, and it can often be found in intraoperative angiography. Because the existence of type I endoleak can lead to high pressure in the aneurysm cavity, the aneurysm continues to expand and even has the risk of rupture, it needs intraoperative Deal with it immediately. It is generally believed that the incidence of type I endoleak will be significantly increased when the proximal anchoring area is less than 10 mm, and/or the aneurysm neck angle is greater than 60°. At present, the general treatment methods for type I endoleaks found during surgery are: balloon expansion, addition of short-stent grafts, bare stents, or embolization techniques using cyanoacrylate, Onyx glue, coils, and fibrin glue . These techniques can handle most type I endoleaks; but in some cases will be very difficult, such as: abdominal aortic aneurysm with too short proximal anchoring zone, adding a short graft at the proximal end may affect the renal artery blood supply. Maldonado et al. summarized the current effects of the above methods in dealing with type I endoleaks: the success rate of cyanoacrylate embolic agents was 92.3%, that of proximal short-segment grafts was 80%, and that of coils was 75%. No matter which of the above-mentioned treatment methods is adopted, there is not only the problem of success rate, but also the problem of a large increase in operation time and medical expenses; the prolongation of operation time will increase the risk of patients during operation and the incidence of postoperative infection, and the high medical expenses will impose a huge burden on patients. Patients bring a high economic burden and take up more social resources.

Utility model content

In order to solve the above problems, the utility model adopts the following technical solutions:

An anti-type I endoleak bracket with a sponge structure, which is used to close type I endoleak, is characterized in that it includes:

Metal mesh support layer matching the shape of arteries;

a coating layer covering the metal mesh support layer; and

The spongy layer distributed at the proximal end outside the covering layer or at the proximal end and distal end outside the covering layer at the same time, the sponge layer fills the inner wall of the arterial vessel and the covering film under the action of its own elasticity. In the gap formed between the layers, the sponge layer does not exceed the edge of the ends of the metal mesh support layer and the film layer.

In addition, the anti-I-type endoleak bracket with sponge structure of the present invention can also have such a feature: wherein, the thickness range of the sponge layer is 1mm-5mm.

In addition, the anti-I-type endoleak stent with sponge structure of the present invention can also have the following feature: wherein, the material of the sponge layer is poly(ethylene lactide) PGLA.

In addition, the anti-type I endoleak stent with sponge structure of the present invention can also have the following feature: wherein, the sponge layer is made of materials capable of absorbing coagulation factors and blood cells such as platelets in blood.

In addition, the anti-I type endoleak stent with sponge structure of the present invention can also have the following features: wherein, the sponge layer has evenly distributed diamond-shaped depressions, and the longer diagonal line of the rhombus is aligned with the direction of blood flow. unanimous.

Functions and Effects of Utility Models

According to the anti-type I endoleak stent with sponge structure of the present invention, when it is used to seal the aneurysm cavity formed by aortic aneurysm, since the sponge layer is also used outside the covering layer, and the sponge layer has the effect of its own elasticity The bottom is filled in the gap formed between the inner wall and the covering layer, so that the blood flow cannot directly rush into the tumor cavity, and the blood in the sponge gap will coagulate after a period of time, thereby completely sealing the tumor cavity, making The tumor cavity enters a stable state.

Description of drawings

Fig. 1 is the overall structure schematic diagram of the anti-I type endoleak support with sponge structure of the utility model;

Fig. 2 is the internal structure schematic diagram of the anti-I type endoleak support with sponge structure of the utility model;

Fig. 3 is the cross-sectional view of the anti-I type endoleak support with sponge structure of the utility model;

Fig. 4 is the schematic diagram of the anti-I type endoleak stent with sponge structure of the present invention implanted into the blood vessel;

Fig. 5 is a schematic cross-sectional view at BB' in Fig. 4;

Fig. 6 is a schematic diagram of the two ends of the anti-I-type endoleak bracket with a sponge structure covered by a sponge layer of the present invention; and

Fig. 7 is a schematic diagram of the anti-I-type endoleak bracket with sponge structure of the present invention, in which the sponge layer is a rhombus grid.

Detailed ways

Due to the formation of type I endoleak, that is, due to poor adhesion between the stent covering and the inner wall of the artery in the anchoring area, there are many reasons for the blood to leak into the aneurysm cavity through the proximal end or the distal end of the covering stent. The anti-endoleak bracket with sponge structure can prevent type I endoleak caused by various reasons. In the specific embodiment, the description will be made only by taking the poor adherence between the stent covering and the inner wall of the artery in the anchoring area caused by the arteriosclerotic plaque as an example.

The specific embodiment of the utility model is described below in conjunction with accompanying drawing.

<Example 1>

Fig. 1 is a schematic diagram of the overall structure of the anti-I-type endoleak bracket with a sponge structure of the present invention, and Fig. 2 is a schematic diagram of the internal structure of the anti-I-type endoleak bracket with a sponge structure of the present invention. As shown in FIG. 1 and FIG. 2 , the anti-type I endoleak stent 10 with a sponge structure has a metal mesh support layer 11 , a coating layer 12 and a sponge layer 13 . The metal mesh support layer 11 is located in the innermost layer, the coating layer 12 covers the outer layer, and the sponge layer 13 is located in the outer layer of the proximal end of the coating layer 12 . The reason is that on the side facing the blood flow, the impact force of the blood flow is very strong, and facing the gap supported by the arteriosclerotic block, the blood flow is particularly easy to rush into the gap in this direction, while at the far end, Since the opening of the gap is along the direction of blood flow, it is difficult for blood to rush into the gap. Even if there is a gap, the blood flow in it is very slow. After a period of time, the blood in it will naturally coagulate, which is dangerous. Sex is very small. Therefore, no sponge layer may be provided at the distal end of the anti-I-type endoleak stent 20 with a sponge structure, so that the manufacturing cost can be reduced.

The commonly used material for the coating layer 12 is polyester, also known as ethylene terephthalate. The material used for the sponge layer 13 is polyglycolide, English abbreviation PGLA. The PGLA material has the function of adsorbing blood cells such as coagulation factors and platelets. The sponge layer 13 is pasted on the coating layer.

Fig. 3 is a cross-sectional view of the anti-I-type endoleak bracket with a sponge structure of the present invention, as shown in Fig. 3 , the elastic sponge layer 13 is on the periphery of the coating layer 12.

Fig. 4 is a schematic diagram of the anti-I type endoleak stent with a sponge structure of the present invention implanted into a blood vessel, and Fig. 5 is a schematic cross-sectional view of BB' in Fig. 4 . As shown in Fig. 4 and Fig. 5, when the anti-type I endoleak stent 10 with a spongy structure is implanted in the blood vessel where the aneurysm occurs, there is atherosclerotic block on the blood vessel wall of the arterial vessel 14 near the aneurysm cavity 16 15. The arteriosclerotic block 15 protrudes into the blood vessel wall, and lifts up the metal mesh support layer 11 and the coating layer 12 of the anti-type I endoleak stent 10 with a sponge structure, forming a gap between the coating layer 12 and the inner wall of the blood vessel. Gap, because sponge layer 13 has elasticity, therefore can be filled in the gap, and because sponge layer itself has many pores. The flow rate of blood in the gap filled by the sponge layer is greatly reduced, and at the same time due to the effect of coagulation factors in the blood, the residual blood in the gap filled by the sponge layer will coagulate after a period of time, thereby sealing the gap.

In the case of gaps, there is another adverse effect, that is, because the gaps are always under the impact of blood flow, the endothelial cells in the inner wall of the blood vessels cannot grow into the inside of the stent, so that the edges of the stent cannot be covered by endothelial cells and thus communicate with the blood vessels. The inner skin is connected into one piece. After the anti-type I endoleak stent 10 with spongy structure of this embodiment is implanted, because the blood flow velocity at the gap drops, the epithelial cells on the blood vessel wall near the gap of the stent have sufficient time to gradually grow into the spongy structure. The inner surface of the anti-type I endoleak stent 10 finally completely covers the inner surface of the stent and connects with the vascular endothelium at both ends. As a result, the stent enters a stable state, the tumor cavity will not be filled with blood, and the tumor cavity will enter a stable state after the blood remaining in the tumor cavity coagulates, and then endothelial cells proliferate and grow into the tumor cavity, making the tumor cavity less likely to rupture .

The direction A in Figure 1 and Figure 5 both refers to the direction of arterial blood flow, the end close to the direction A is the proximal end, and the end far away from the direction A is the distal end. The length of the sponge layer 13 does not exceed the edges of the upper and lower ends of the metal mesh support layer and the coating layer. The reason for this setting is to prevent the sponge layer from protruding from the edge of the anti-type I endoleak stent 10 with the sponge structure, causing the blood flow here to coagulate and form a thrombus, which enters the blood vessel under the impact of the blood flow and embolizes the blood vessel.

Implantation method of anti-type I endoleak stent with sponge structure:

The anti-type I endoleak stent 10 with sponge structure is installed on the balloon catheter, delivered to the vascular lesion through the balloon catheter, and the liquid is injected by the pressure pump to expand the balloon, and then the anti-type I endoleak stent with sponge structure is stretched apart. Leaking the stent 10 to close the blood vessels on both sides of the tumor cavity, and then withdrawing the balloon catheter, so that the stent is permanently placed in the lesion, so as to achieve the purpose of sealing the tumor cavity. The orientation of the stent in the balloon catheter should be such that the end with the spongy layer is located proximally in the vessel when installation is complete.

During the operation, X-ray contrast video is used to monitor the whole process of the catheter entering the aorta from the small artery in the human body and finally reaching the tumor cavity.

Function and effect of embodiment one

According to the anti-I-type endoleak bracket with a sponge structure in Example 1, according to the anti-I-type endoleak bracket with a sponge structure of the present utility model, since a sponge layer is also used outside the coating layer, and the sponge layer is on its own Under the action of elasticity, it fills in the gap formed between the inner wall and the covering layer. When there is an arteriosclerotic block on the blood vessel wall, the elastic sponge layer will support the metal mesh support layer supported by the arteriosclerotic block and the covering layer. The gap formed between the membrane layer and the inner wall of the blood vessel is filled so that the blood flow cannot directly rush into the tumor cavity. state.

The porous sponge structure has three functions. On the one hand, it is a physical barrier, which greatly slows down the flow of blood here, thereby promoting coagulation. On the other hand, it is a chemical effect. PGLA can absorb blood cells such as coagulation factors and platelets, and further promote coagulation; At the same time, the grid structure also acts as a matrix for the formation of fibrosis.

In addition, because the length of the sponge layer 13 does not exceed the edges of the upper and lower ends of the metal mesh support layer and the coating layer, it can prevent the sponge layer from stretching out from the edge of the anti-I-type endoleak stent 10 with a sponge structure, causing here The blood flow coagulates and forms a thrombus, which enters the blood vessel under the impact of the blood flow and embolizes the blood vessel.

The implantation method of the anti-I type endoleak stent 10 with sponge structure:

The anti-type I endoleak stent 10 with sponge structure is installed on the balloon catheter, delivered to the vascular lesion through the balloon catheter, and the liquid is injected by the pressure pump to expand the balloon, and then the anti-type I endoleak stent with sponge structure is stretched apart. Leaking the stent 10 to close the blood vessels on both sides of the tumor cavity, and then withdrawing the balloon catheter, so that the stent is permanently placed in the lesion, so as to achieve the purpose of sealing the tumor cavity.

During the operation, X-ray contrast video is used to monitor the whole process of the catheter entering the aorta from the small artery in the human body and finally reaching the tumor cavity.

<Example 2>

In this second embodiment, for the same structures as those of the above-mentioned embodiment, this modified example assigns the same numbers, and the same descriptions are omitted.

Fig. 6 is a schematic diagram of the two ends of the anti-I-type endoleak bracket with a sponge structure covered by a sponge layer of the present invention. The two ends of the anti-I type endoleak bracket 20 of the structure. The advantage of setting the fluff layer at the proximal end and the distal end at the same time is that it can further prevent type I endoleak at the distal end. Although the probability of this happening is very low, such setting can further enhance the safety of the stent.

<Example Three>

In the third embodiment, for the same structures as those in the above embodiment, the modification is assigned the same numbers and the same descriptions are omitted.

Fig. 7 is the schematic diagram that the sponge layer of the anti-I-type endoleak bracket with sponge structure of the present invention is a rhombus grid, as shown in Figure 7, the sponge layer of the anti-I-type endoleak bracket 30 with sponge structure has a uniform arrangement The rhombus groove 33. On the one hand, the diamond-shaped groove 33 can save the material used in the sponge. On the other hand, because the diamond-shaped groove 33 itself has a certain space, these spaces may just accommodate the arteriosclerosis after implantation. When the protruding edges between the diamond-shaped grooves 33 corresponded, the force used by the arteriosclerotic mass to prop up the sponge was also very small. There is less pressure on the blood vessel wall and less irritation to the blood vessel.

In addition, the coating layer of the present invention can also be covered on the inner side of the metal mesh support layer, so that the sponge layer is directly connected to the metal mesh support layer. This lamination sequence can also achieve the technical effect of the present invention.

Claims (5)

1. An anti-type I endoleak bracket with a sponge structure, used for sealing type I endoleak, is characterized in that, comprising: Metal mesh support layer matching the shape of arteries; a coating layer covering the metal mesh support layer; and The spongy layer distributed at the proximal end outside the covering layer or at the proximal end and the distal end outside the covering layer at the same time, the sponge layer fills in the arterial vessel under the action of its own elasticity In the gap formed between the inner wall and the coating layer, the sponge layer does not exceed the edges of the ends of the metal mesh support layer and the coating layer. 2. the anti-I type endoleak support with sponge structure according to claim 1, is characterized in that: Wherein, the thickness range of the sponge layer is 1mm-5mm. 3. the anti-I type endoleak support with sponge structure according to claim 1, is characterized in that: Wherein, the material of the sponge layer is polyglycolide PGLA. 4. the anti-I type endoleak support with sponge structure according to claim 1, is characterized in that: Wherein, the sponge layer is made of materials capable of absorbing blood cells such as coagulation factors and platelets in blood. 5. the anti-I type endoleak support with sponge structure according to claim 1, is characterized in that: Wherein, the sponge layer has evenly distributed diamond-shaped depressions, and the longer diagonal line of the rhombus is consistent with the direction of blood flow.