CN118453215A - Ascending aorta external support - Google Patents

Abstract

The present invention discloses an ascending aorta external stent, including an external stent diaphragm and a branch diaphragm. The external stent diaphragm can be rolled up to form an annular wrapping structure and wrapped around the outside of the ascending aorta. One end of the annular wrapping structure extends to the junction of the sinus and tube, and the other end of the annular wrapping structure extends to a position close to the branch artery. The end of the branch diaphragm is connected to the external stent diaphragm, and a suspension portion is provided on the branch diaphragm. The present invention wraps the dilated ascending aorta as a whole through the external stent diaphragm. On the one hand, through plasticity, the dilated ascending aorta is restored to a normal shape and good fluid mechanics characteristics; on the other hand, through wrapping, the risk of the ascending aortic aneurysm progressing to rupture, dissection and intramural hematoma is eliminated. In addition, the design of the branch diaphragm can prevent the external stent diaphragm from shifting on the ascending aorta, so that the external stent diaphragm can play a good protective and supporting role for the distal end of the ascending aorta.

Description

Ascending aorta external stent

Technical Field

The invention belongs to the technical field of medical devices, and in particular relates to an ascending aorta external stent.

Background Art

Ascending aortic aneurysm refers to the expansion or bulging of the local ascending aortic wall, and its diameter is significantly larger than the normal value. The dilated ascending aorta has the risk of dissection, intramural hematoma, rupture, etc., which seriously endangers life and health. The causes of ascending aortic aneurysm are: atherosclerosis, which is the most common cause; infection, with syphilis being the most prominent; cystic medial necrosis, which is mainly seen in ascending aortic aneurysm, and is more common in men. Genetic diseases such as Marfan syndrome can cause cystic medial necrosis, which is prone to dissecting aneurysms; congenital factors, including giant cell aortitis, Behcet's disease, and polyarteritis.

The current treatment options for ascending aortic aneurysms are as follows:

(1) Ascending aorta replacement, this technique removes the dilated ascending aorta and replaces it with a commercial artificial blood vessel. Its defects include: (a) Since the thickest artery in the human body needs to be removed and then the artificial blood vessel is sutured, and the extracorporeal circulation technology needs to be used during the operation to block the ascending aorta, the difficulty and trauma of the operation are relatively large, the risk of bleeding is high, and the postoperative recovery time is relatively long; (b) If the ascending aorta is still dilated from the distal end to the proximal end of the aortic arch, if a simple ascending aorta replacement method is adopted, it is easy to cause the diameter of the artificial blood vessel to be mismatched with the distal aorta, forming an extremely unnatural vascular morphology at the distal anastomosis, affecting fluid mechanics and causing subsequent progression; if the surgical method of removing and replacing the dilated distal ascending aorta and part of the aortic arch is adopted, complex techniques such as stopping extracorporeal circulation and brain protection are required, which further increases the difficulty and trauma of the operation.

(2) Ascending aorta plasty based on suture technology, this technology longitudinally cuts the dilated ascending aorta, removes part of the ascending aorta wall tissue longitudinally (or does not remove it), and then sutures it. The ascending aorta is narrowed to a certain extent by the position of the needle in and out and the suture method during suturing. Its defects are: (a) This technology also requires the use of extracorporeal circulation technology to block the ascending aorta, which is relatively difficult and traumatic, and has a high risk of bleeding; (b) The suture technology has a poor plastic effect on the ascending aorta. The shape of the ascending aorta after shaping is extremely unnatural. At the same time, it also destroys the aortic wall tissue, which has a negative impact on fluid mechanics and tissue physiology; (c) The suture technology cannot effectively prevent the further expansion of the ascending aorta in the later stage, there is a risk of late progression, and the long-term effect is not good.

(3) Ascending aorta wrapping technology based on artificial blood vessel homemade materials, this technology cuts the artificial blood vessel longitudinally, cuts it to the appropriate size, makes an artificial blood vessel sheet, and wraps the artificial blood vessel sheet around the dilated ascending aorta to narrow and shape it, eliminating the risk of long-term progression of ascending aortic aneurysm. Compared with traditional open surgery, the ascending aorta wrapping technology avoids the need for resection and incision of the ascending aorta, completely preserves the ascending aorta, and greatly reduces the difficulty, trauma and risk of surgery. However, the existing ascending aorta wrapping technology is not very mature, and its defects include: (a) There is currently no product specifically used for wrapping the ascending aorta. When this method is used, the wrapping sheets used are all obtained by cutting artificial blood vessels; but artificial blood vessels themselves are used for arterial replacement surgery, not for wrapping, so their shape, material and size are not suitable for ascending aorta wrapping technology; artificial blood vessel sheets that are too hard may cause a certain degree of compression and damage to the aortic wall tissue of the body; when the body's ascending aorta is long, the largest existing artificial blood vessel may not meet the required size of the wrapping sheet after cutting; (b) The current wrapping technology only wraps the ascending aorta, and there is no special treatment for the proximal and distal ends of the wrapping segment. During postoperative follow-up, it was found that the native ascending aorta at the proximal and distal ends of the wrapping sheet was prone to expansion due to the lack of wrapping sheet restrictions, and the ascending aorta as a whole showed a "dumbbell-like" shape; in addition, such a wrapping sheet is prone to longitudinal displacement on the ascending aorta, affecting the wrapping effect.

Summary of the invention

The purpose of the present invention is to provide an ascending aorta external stent to solve the above-mentioned problems existing in the prior art.

In order to achieve the above-mentioned purpose, the present invention adopts the following technical scheme: an ascending aorta external stent, including an external stent membrane and a branch membrane, the external stent membrane can be rolled up to form an annular wrapping structure and wrapped around the outside of the ascending aorta, the annular wrapping structure fits the outer wall of the ascending aorta to shape the ascending aorta; one end of the annular wrapping structure extends to the junction of the sinus tube, and the other end of the annular wrapping structure extends to a position close to the aortic arch; the end of the branch membrane is connected to the external stent membrane, and a suspension part is provided on the branch membrane, and the suspension part is mounted on the branch artery and partially wraps the aortic arch.

As an optional implementation of the above technical solution, the external support membrane includes a first membrane body and a second membrane body, the first membrane body and the second membrane body are connected on one side close to each other, and an upper notch portion and a lower notch portion are provided between the first membrane body and the second membrane body, and the upper notch portion and the lower notch portion are both located on the inner side of the outer wall of the ascending aorta to avoid local wrinkles in the annular wrapping structure.

As an optional implementation of the above technical solution, the first membrane body and the second membrane body are both provided with arc edges on the sides away from each other, and the curvature of the arc edges matches the curvature of the outer side of the outer wall of the ascending aorta.

As an optional implementation of the above technical solution, the first film body and the second film body are integrally formed.

As an optional implementation of the above technical solution, the arc edge of the first membrane body is provided with a first suture belt, and the arc edge of the second membrane body is provided with a second suture belt. The first suture belt and the second suture belt are sutured to each other so that the first membrane body and the second membrane body form the annular wrapping structure.

As an optional implementation of the above technical solution, a plurality of gaskets are provided between the annular wrapping structure and the junction of the sinus tube.

As an optional implementation of the above technical solution, a plurality of gaskets are provided between the annular wrapping structure and the junction of the sinus tube, the plurality of gaskets are distributed in an annular shape, and the plurality of gaskets are fixed on the outer support membrane by suturing.

As an optional implementation of the above technical solution, a lower suture belt is provided at the bottom of the outer support membrane, and the gasket is connected to the lower suture belt.

As an optional implementation of the above technical solution, the outer support membrane and the branch membrane are both made of ultra-high molecular weight polyethylene material, and the surfaces of the outer support membrane and the branch membrane are both provided with mesh structures.

As an optional implementation of the above technical solution, both ends of the branch membrane are sutured and connected to the outer support membrane.

As an optional implementation of the above technical solution, an upper suture band is provided on the top of the outer support membrane, and both ends of the branch membrane are connected to the upper suture band.

The beneficial effects of the present invention are:

The ascending aorta external stent provided by the present invention is used for surgical treatment of ascending aortic aneurysm. The expanded ascending aorta is wrapped as a whole by the external stent membrane. On the one hand, the expanded ascending aorta is restored to a normal shape and good fluid mechanics characteristics through plasticity; on the other hand, the risk of the ascending aortic aneurysm progressing to rupture, dissection and intramural hematoma is eliminated through wrapping. In addition, the design of the branch membrane can prevent the external stent membrane from shifting on the ascending aorta, so that the external stent membrane can play a good role in protecting and supporting the distal end of the ascending aorta.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a diagram showing a state of use of an ascending aorta external stent in one embodiment of the present invention;

FIG. 2 is a schematic diagram of the structure of an outer support membrane and a branch membrane in one embodiment of the present invention.

In the figure: 1-external stent membrane; 2-branch membrane; 3-ascending aorta; 4-branch artery; 5-first membrane body; 6-second membrane body; 7-upper notch; 8-lower notch; 9-first suture band; 10-second suture band; 11-gasket; 12-lower suture band; 13-upper suture band.

DETAILED DESCRIPTION

As shown in Figures 1 and 2, this embodiment provides an ascending aorta external stent, including an external stent membrane 1 and a branch membrane 2. The external stent membrane 1 is in the shape of a long sheet. The external stent membrane 1 can be rolled up to form an annular wrapping structure and wrapped around the outside of the ascending aorta 3. The annular wrapping structure fits the outer wall of the ascending aorta 3 to shape the ascending aorta 3, eliminating the risk of long-term progression of ascending aortic aneurysm. One end of the annular wrapping structure extends to the junction of the sinus tube, and the other end of the annular wrapping structure extends to a position close to the aortic arch. The external stent membrane 1 wraps the ascending aorta 3 as a whole, avoiding the problem of expansion at the proximal and distal ends of the ascending aorta 3 due to the lack of wrapping restrictions, and preventing the two ends of the ascending aorta 3 from further expanding and presenting a "dumbbell-like" shape as a whole.

As shown in FIG2 , the branch diaphragm 2 is in the shape of a long strip, and the end of the branch diaphragm 2 is connected to the external stent diaphragm 1. A suspension portion is provided on the branch diaphragm 2, and the suspension portion is sleeved on the branch artery 4 and partially wraps the aortic arch. The suspension portion is hung on the branch artery 4 to prevent the external stent diaphragm 1 from longitudinally shifting on the ascending aorta 3.

The ascending aorta external stent provided by the present invention is used for surgical treatment of ascending aortic aneurysms. The expanded ascending aorta 3 is wrapped as a whole by the external stent membrane 1. On the one hand, the expanded ascending aorta 3 is restored to a normal shape and good fluid mechanics characteristics through plasticity; on the other hand, the risk of the ascending aortic aneurysm progressing to rupture, dissection and intramural hematoma is eliminated through wrapping. In addition, the design of the branch membrane 2 can prevent the external stent membrane 1 from shifting on the ascending aorta 3, so that the external stent membrane 1 can play a good role in protecting and supporting the distal end of the ascending aorta 3.

The ascending aorta external stent of the present invention does not simply wrap the ascending aorta 3. The annular wrapping structure is reinforced and suspended upward by the branch membrane 2 and extends downward to the junction of the sinus and tubule. Such an overall wrapping concept can well optimize the long-term effect after wrapping and avoid the long-term disease progression at the upper and lower ends (the site where progression usually occurs); in addition, the lower end of the external stent membrane 1 at least reaches the position of the junction of the sinus and tubule, or even exceeds it. Such wrapping actually has a certain fixing and ring contraction effect on the aortic sinus and the aortic valve ring therein, and will have a mild to moderate molding effect on the aortic valve ring; and ascending aortic aneurysms are often combined with aortic root aneurysms and aortic valve regurgitation. Such an overall wrapping concept will actually reduce the degree of aortic valve regurgitation to a certain extent, thereby achieving the effect of reducing aortic valve regurgitation. The basis of this effect is holistic wrapping. The existing technology does not have the concept of holistic wrapping, and in actual wrapping it often does not reach down to the sinotubular junction. This is because the further downstream the surgery is, the more important tissue structures there are around it, and the more difficult the surgery becomes. Therefore, it can be considered that only with the concept of holistic wrapping can the ascending aortic stent have the potential to reduce aortic valve regurgitation.

It should be noted that the external stent membrane 1 of the present invention is individually customized according to the size of the patient's ascending aorta 3, and based on the morphological characteristics of the ascending aorta 3 of different patients, the external stent membrane 1 can fit well with the outer wall of the ascending aorta 3 when wrapped, thereby achieving overall customized wrapping.

As shown in FIG2 , in this embodiment, the external support membrane 1 includes a first membrane body 5 and a second membrane body 6, the first membrane body 5 and the second membrane body 6 have the same structure, the first membrane body 5 and the second membrane body 6 are connected on one side close to each other, and an upper notch 7 and a lower notch 8 are provided between the first membrane body 5 and the second membrane body 6, and the upper notch 7 and the lower notch 8 are both located on the inner side of the outer wall of the ascending aorta 3 to avoid local wrinkles in the annular wrapping structure. Preferably, the first membrane body 5 and the second membrane body 6 are integrally formed by 3D printing. Because the ascending aorta 3 has a special shape, local wrinkles are prone to occur when the external support membrane 1 wraps the ascending aorta 3. If local wrinkles occur, the aortic wall will be compressed, affecting the aortic wall tissue, and easily causing physical damage, compression ischemia and other problems. The external stent membrane sheet 1 of the present invention is not a rectangular sheet, but is composed of a first membrane body 5 and a second membrane body 6 of the same structure, and an upper notch portion 7 and a lower notch portion 8 are provided between the first membrane body 5 and the second membrane body 6. The upper notch portion 7 and the lower notch portion 8 are both located on the inner side of the outer wall of the ascending aorta 3, so that the wrapping can well conform to the shape of the ascending aorta 3 and can fit well with the ascending aorta 3, avoiding the occurrence of local wrinkles in the annular wrapping structure.

The first membrane body 5 and the second membrane body 6 are both provided with an arc edge on the side away from each other, and the curvature of the arc edge matches the curvature of the outer wall of the ascending aorta 3, so that the annular wrapping structure can fit the ascending aorta 3 better without local wrinkles. In order to facilitate the rolling of the external stent membrane 1 to form an annular wrapping structure, the arc edge of the first membrane body 5 is provided with a first suture belt 9, and the arc edge of the second membrane body 6 is provided with a second suture belt 10. The first suture belt 9 and the second suture belt 10 are sutured to each other, so that the first membrane body 5 and the second membrane body 6 form the annular wrapping structure.

As shown in FIG1 , in a specific embodiment, a plurality of gaskets 11 are provided between the annular wrapping structure and the junction of the sinus and tube. Preferably, a plurality of gaskets 11 are provided between the annular wrapping structure and the junction of the sinus and tube, the plurality of gaskets 11 are distributed in an annular shape, and the plurality of gaskets 11 are fixed on the outer support membrane 1 by suturing. Among them, a lower suture belt 12 is provided at the bottom of the outer support membrane 1, and the gasket 11 is connected to the lower suture belt 12. The bottom of the first membrane body 5 and the second membrane body 6 are both provided with a lower suture belt 12 to fix the gasket 11. The ascending aorta outer stent of the present invention wraps the ascending aorta 3 as a whole. Since the lower end of the annular wrapping structure at least reaches the level of the junction of the sinus and tube, or even exceeds the junction of the sinus and tube, and a gasket 11 is provided between the annular wrapping structure and the junction of the sinus and tube, such wrapping strengthens the fixation and ring contraction of the aortic sinus and the aortic valve ring therein, increases the mild to moderate molding effect on the aortic valve ring, and effectively reduces the degree of aortic valve regurgitation.

In a specific embodiment, the external stent diaphragm 1 and the branch diaphragm 2 are both made of ultra-high molecular weight polyethylene material, and the surface of the external stent diaphragm 1 and the branch diaphragm 2 are provided with a mesh structure. The external stent diaphragm 1 and the branch diaphragm 2 are both made of ultra-high molecular weight polyethylene material, which has a high strength and can achieve a certain degree of softness, and has a strong protective effect on the aortic wall; the mesh structure design of the external stent diaphragm 1 further reduces the pressure of the external stent diaphragm 1 on the ascending aorta 3, and the mesh structure design of the branch diaphragm 2 further reduces the pressure of the branch diaphragm 2 on the branch artery 4, reducing damage.

Wherein, both ends of the branch diaphragm 2 are sutured and connected to the external support diaphragm 1. Preferably, an upper suture belt 13 is provided on the top of the external support diaphragm 1, and both ends of the branch diaphragm 2 are connected to the upper suture belt 13. The upper suture belt 13 is provided on the top of the first membrane body 5 and the second membrane body 6, one end of the branch diaphragm 2 is fixed to the upper suture belt 13 of the first membrane body 5, and the other end of the branch diaphragm 2 extends upward and then bends downward to form a suspension part, so that the other end of the branch diaphragm 2 is fixed to the upper suture belt 13 of the second membrane body 6, and the suspension part is hung on the branch artery 4 to prevent the external support diaphragm 1 from displacement.

The present invention provides an ascending aorta external stent, the main innovative features of which include:

(1) Wrapping and shaping of the ascending aorta 3: The structural morphology of the ascending aorta external stent enables it to shape and wrap the ascending aorta 3 well, which is consistent with its function; the morphology of the external stent membrane 1 takes into account the morphological characteristics of the ascending aorta 3 itself, so that the external stent membrane 1 and the blood vessel can fit well when wrapping; the design of the branch membrane 2 enables the external stent membrane 1 to also play a good protective and supporting role for the distal end of the ascending aorta 3; the design of the first suture band 9 and the second suture band 10 provides space for surgical suture, simplifies the surgical process, and increases suture safety; the lower suture band 12 at the lower edge of the external stent membrane 1 provides a suture area for fixing the proximal end of the external stent membrane 1 to the aortic root.

(2) Material and mesh structure design of the external stent membrane 1: The external stent membrane 1 is made of ultra-high molecular weight polyethylene, which has high strength and a certain degree of softness, and has a strong protective effect on the aortic wall; the mesh structure design further reduces the pressure on the aortic wall and reduces the damage to the ascending aorta 3.

(3) Holistic wrapping concept of the ascending aorta 3: Different from the traditional method of simply wrapping the ascending aorta 3, the holistic wrapping includes: (a) wrapping the ascending aorta 3 from the sinotubular junction to the arterial branch; (b) at the sinotubular junction, the external stent membrane 1 is fixed to the aortic wall by the gasket 11; (c) at the distal end of the ascending aorta 3 and the proximal end of the aortic arch, the branch membrane 2 partially wraps the branch artery 4, thereby playing a supporting and suspending role; the holistic wrapping strategy of the ascending aorta 3 can enable the ascending aorta 3 to obtain a better morphology and better long-term effect after surgery, and the design of the aortic external stent complements this concept.

(4) Anti-local wrinkle design: The external stent membrane 1 is not a rectangular sheet, but is composed of a first membrane body 5 and a second membrane body 6 of the same structure, and an upper notch 7 and a lower notch 8 are provided between the first membrane body 5 and the second membrane body 6. The upper notch 7 and the lower notch 8 are both located on the inner side of the outer wall of the ascending aorta 3. In this way, the wrapping can well conform to the shape of the ascending aorta 3 and can fit well with the ascending aorta 3, thereby avoiding the occurrence of local wrinkles in the annular wrapping structure.

Compared with the existing technology, the present invention has the following advantages:

(1) The present invention eliminates the need for operations such as resection and incision of the ascending aorta 3, and completely preserves the ascending aorta 3, thereby greatly reducing the difficulty, trauma and risk of surgery.

(2) The present invention does not require blocking of the ascending aorta 3, and the related risks and trauma are greatly reduced.

(3) By completely wrapping the ascending aorta 3 from the junction of the sinus tube to the proximal part of the aortic arch, and wrapping and suspending the upper end with the branch membrane 2, the risk of long-term progression of the ascending aortic aneurysm is eliminated, and the possibility of further expansion of the two ends of the ascending aorta 3 to form a "dumbbell shape" is avoided; at the same time, this treatment method can effectively prevent the displacement of the annular wrapping structure and improve the wrapping effect of the ascending aorta 3.

(4) Both the external stent membrane 1 and the branch membrane 2 are made of ultra-high molecular weight polyethylene material and are designed with a mesh structure. While ensuring the shaping strength, they have a certain degree of softness and elasticity, and do not compress the aortic wall as a whole, thus protecting the aortic wall tissue to a great extent and reducing problems such as physical damage, compression and ischemia.

(5) The lower end of the external stent membrane 1 reaches the position of the sinus-tubular junction. Such wrapping actually plays a certain role in fixing and shrinking the aortic sinus and the aortic valve ring therein, and will have a light to moderate shaping effect on the aortic valve ring, which has a potential effect on improving the structure and function of the aortic valve.

In the description of the present invention, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, and may be fixedly connected, detachably connected, or integrated; may be mechanically connected or electrically connected; may be directly connected or indirectly connected through an intermediate medium, may be the internal connection of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood. In addition, the specific features, structures, etc. described in the embodiments are included in at least one embodiment. Under the condition that there is no contradiction, those skilled in the art may combine the features of different embodiments. The protection scope of the present invention is not limited to the above-mentioned specific embodiments. According to the basic technical concept of the present invention, the embodiments that can be associated with by ordinary technicians in this field without creative work all belong to the protection scope of the present invention.

Claims (10)

1. An ascending aorta external stent, characterized in that it comprises an external stent membrane (1) and a branch membrane (2), wherein the external stent membrane (1) can be rolled up to form an annular wrapping structure and wrapped around the outer side of the ascending aorta (3), wherein the annular wrapping structure fits the outer wall of the ascending aorta (3) to shape the ascending aorta (3); one end of the annular wrapping structure extends to the junction of the sinus tube, and the other end of the annular wrapping structure extends to a position close to the aortic arch; the end of the branch membrane (2) is connected to the external stent membrane (1), and a suspension portion is provided on the branch membrane (2), wherein the suspension portion is sleeved on the branch artery (4) and partially wraps the aortic arch. 2. The ascending aorta external stent according to claim 1 is characterized in that the external stent membrane (1) includes a first membrane body (5) and a second membrane body (6), the first membrane body (5) and the second membrane body (6) are connected on one side close to each other, and an upper notch portion (7) and a lower notch portion (8) are provided between the first membrane body (5) and the second membrane body (6), and the upper notch portion (7) and the lower notch portion (8) are both located on the inner side of the outer wall of the ascending aorta (3) to avoid local wrinkles in the annular wrapping structure. 3. The ascending aorta external stent according to claim 2 is characterized in that the first film body (5) and the second film body (6) are both provided with an arc edge on the side away from each other, and the curvature of the arc edge matches the curvature of the outer side of the outer wall of the ascending aorta (3); the first film body (5) and the second film body (6) are integrally formed. 4. The ascending aorta external stent according to claim 3 is characterized in that the arc edge of the first film body (5) is provided with a first suture tape (9), and the arc edge of the second film body (6) is provided with a second suture tape (10), and the first suture tape (9) and the second suture tape (10) are sutured to each other so that the first film body (5) and the second film body (6) form the annular wrapping structure. 5. The ascending aorta external stent according to claim 1, characterized in that a plurality of gaskets (11) are provided between the annular wrapping structure and the junction of the sinus tube. 6. The ascending aorta external stent according to claim 5 is characterized in that a plurality of gaskets (11) are provided between the annular wrapping structure and the junction of the sinus tube, the plurality of gaskets (11) are distributed in an annular shape, and the plurality of gaskets (11) are fixed on the external stent membrane (1) by suturing. 7. The ascending aorta external stent according to claim 5, characterized in that a lower suture band (12) is provided at the bottom of the external stent membrane (1), and the gasket (11) is connected to the lower suture band (12). 8. The ascending aorta external stent according to claim 1 is characterized in that the external stent membrane (1) and the branch membrane (2) are both made of ultra-high molecular weight polyethylene material, and the surfaces of the external stent membrane (1) and the branch membrane (2) are both provided with a mesh structure. 9. The ascending aorta external stent according to claim 1, characterized in that both ends of the branch membrane (2) are sutured and connected to the external stent membrane (1). 10. The ascending aorta external stent according to claim 9, characterized in that an upper suture band (13) is provided on the top of the external stent membrane (1), and both ends of the branch membrane (2) are connected to the upper suture band (13).