In-vivo flow transferring device for aortic stent arch windowing

Abstract

The utility model provides an in-vivo bypass device for an aortic stent arch windowing, and belongs to the technical field of medical instruments. The in-vivo bypass device for the aortic stent arch fenestration comprises a sheath seat and a sheath tube, the lower end of the sheath base is communicated with a sheath body, and the side wall of the sheath base is communicated with a flushing pipe; the sheath tube is connected with the sheath body through a connecting part, a first inclined hole is formed in the upper end of the sheath tube, a bent tip is arranged at the lower end of the sheath tube, a bottom hole is formed in the bent tip, a first side hole is formed in the side wall of the lower end of the sheath tube, and a second side hole is formed in the side wall of the upper section of the sheath tube; compared with in-vitro bypass adopted in the prior art, blood supply from the femoral artery is not needed, the problem that a bypass pipeline is long is solved, the operation effect is improved, the burden of medical care is relieved, blood in-vivo bypass is formed to supply blood to the brain, an operator has sufficient time to conduct in-vivo stent in-situ windowing, safety is greatly improved, and convenience and safety are provided for the operation.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and more particularly, to an in-vivo bypass device for fenestration of the aortic arch of an aortic stent. Background Art

[0002] Currently, percutaneous puncture technology is mainly used for various angiographies and transvascular interventional treatments that require percutaneous catheter insertion, and is also used for non-vascular interventional treatments. When a covered stent needs to be implanted for aortic arch lesions, the covered stent will cover the branch vessels of the aortic arch (brachiocephalic trunk, left common carotid artery, left subclavian artery), which will cause cerebral ischemia. This requires fenestration of the stent in vivo, and a temporary bypass device is needed to supply blood to the brain during the fenestration process. Otherwise, serious complications such as cerebral infarction will occur.

[0003] The existing technical solutions have the following defects: Using a traditional sheath device for femoral bypass, there is a lack of a finished bypass device, and it is often made by the operator himself. The bypass pipeline is long, the operation is cumbersome, the risk of cerebral infarction is high, the safety is low, and the burden on medical staff is increased. Summary of the Utility Model

[0004] To make up for the above deficiencies, the present application provides an in-vivo bypass device for fenestration of the aortic arch of an aortic stent, aiming to improve the problems of long extracorporeal bypass pipeline, heavy burden on medical staff, cumbersome operation, and low safety.

[0005] An embodiment of the present application provides an in-vivo bypass device for fenestration of the aortic arch of an aortic stent, including a sheath base and a sheath tube;

[0006] The lower end of the sheath base is communicated with a sheath body, the side wall of the sheath base is communicated with a flushing tube, a hemostatic valve is embedded at the upper end of the sheath base, and a three-way valve is installed at one end of the flushing tube; the sheath tube is connected to the sheath body through a connecting part, a first inclined hole is opened at the upper end of the sheath tube, a curved tip is provided at the lower end of the sheath tube, a bottom hole is opened at the curved tip, a first side hole is opened at the side wall of the lower end of the sheath tube, and a second side hole is opened at the side wall of the upper section of the sheath tube.

[0007] In a preferred embodiment of the present utility model, a dilator is further included, the dilator is slidably inserted into the sheath body in a matching manner, a tapered head is provided at the lower end of the dilator, the tapered head is disposed outside the lower end of the sheath body, and a through hole is opened along the length direction of the dilator.

[0008] In a preferred embodiment of the present utility model, the dilator includes a tube body and a clamping seat, the clamping seat is fixed at one end of the tube body, an annular protrusion is provided at the upper end edge of the sheath base, and the clamping seat is engaged with the annular protrusion in a matching manner.

[0009] In a preferred embodiment of the present utility model, the connection between the flushing tube and the sheath base is a first communication port, the connection between the upper end of the sheath body and the sheath base is a second communication port, and the hemostatic valve is disposed between the first communication port and the upper port of the sheath base.

[0010] In a preferred embodiment of the present utility model, the inclination angle of the first inclined hole is 30° - 45°, the first side holes are arrayed on the surface of the sheath tube, and the second side holes are arrayed on the outer wall of the sheath tube.

[0011] In a preferred embodiment of the present utility model, a plurality of the first side holes are equally spaced, and a plurality of the second side holes are equally spaced.

[0012] In a preferred embodiment of the present utility model, the length of the sheath body is 13 cm, and the length of the sheath tube is 5 - 8 cm.

[0013] In a preferred embodiment of the present utility model, a holding part is fixed on the outer surface of the upper end of the sheath body, and a hanging ring is fixed on the outer wall of the holding part.

[0014] Beneficial effects: The present application provides an in-vivo bypass device for aortic arch fenestration. The sheath base communicates with the sheath body through the lower end, and the sheath body is connected to the distal sheath tube. ； The side wall of the sheath base is also communicated with a flushing tube, which is convenient for infusion flushing operations and for operation during the surgical process. The hemostatic valve embedded in the upper end of the sheath base can prevent bleeding and ensure the safety of the operation. After the aortic arch stent is released, the blood in the ascending aorta is introduced through the curved tip hole of the sheath tube and the first side hole array, and then exported from the first inclined hole and the second side hole array to supply blood to the brain. Compared with the extracorporeal bypass used in the prior art, there is no need to supply blood from the femoral artery, solving the problem of long bypass pipelines, improving the surgical effect, reducing the burden on medical staff, forming an in-vivo blood bypass to supply blood to the brain, enabling the surgeon to have sufficient time for in-situ fenestration of the in-vivo stent, greatly improving the safety, and providing convenience and safety for the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings required for the embodiments. It should be understood that the following drawings only show some embodiments of the present application, and thus should not be regarded as limiting the scope. For those of ordinary skill in the art, other related drawings can be obtained based on these drawings without creative efforts.

[0016] Figure 1 It is a schematic front view of the connection between the sheath body and the sheath tube provided by the embodiment of the present application;

[0017] Figure 2 It is a schematic three-dimensional structure of the connection between the sheath body and the sheath tube provided by the embodiment of the present application;

[0018] Figure 3 Schematic three-dimensional structure diagram of the dilator provided by the embodiment of the present application;

[0019] Figure 4 Schematic three-dimensional structure diagram of the dissected dilator provided by the embodiment of the present application.

[0020] In the figure: 100, sheath base; 101, hemostatic valve; 103, annular protrusion; 110, sheath body; 130, flushing tube; 131, three-way valve; 150, handheld part; 151, hanging ring; 300, sheath tube; 301, curved tip; 310, first inclined hole; 320, connecting part; 330, first side hole; 340, second side hole; 350, metal coating layer; 500, dilator; 501, cone head; 503, through hole; 510, tube body; 530, card seat. Specific embodiments

[0021] In the present utility model, unless otherwise clearly defined and limited, terms such as "installation", "connection", "connection", "fixation" and other terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the internal communication of two components or the interaction relationship between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances.

[0022] Next, the technical solutions in the embodiments of the present application will be described with reference to the accompanying drawings in the embodiments of the present application.

[0023] Please refer to Figures 1 - 4 , the present utility model provides an in-vivo bypass device for aortic arch fenestration, including a sheath base 100 and a sheath tube 300;

[0024] The lower end of the sheath base 100 is communicated with a sheath body 110, the side wall of the sheath base 100 is communicated with a flushing tube 130, the upper end of the sheath base 100 is embedded with a hemostatic valve 101, and a three-way valve 131 is installed at one end of the flushing tube 130;

[0025] The sheath tube 300 is connected to the sheath body 110 through a connecting part 320. The upper end of the sheath tube 300 is provided with a first inclined hole 310. The lower end of the sheath tube 300 is provided with a curved tip 301. The curved tip 301 is provided with a bottom hole. The side wall of the lower end of the sheath tube 300 is provided with a first side hole 330. The side wall of the upper section of the sheath tube 300 is provided with a second side hole 340.

[0026] The sheath tube 300, the connecting part 320, and the sheath body 110 are an integral structure; the connecting part 320 and the sheath body 110 and the sheath tube 300 are made of the same material, and the structure stability is increased by internally pressing steel wires.

[0027] In a specific embodiment of the present utility model, there is also an expander 500, the expander 500 is slidably inserted and fitted in the sheath body 110 and the sheath tube 300, a tapered head 501 is provided at the lower end of the expander 500, a through hole 503 is provided along the length direction of the expander 500, and a 0.035 guide wire for general interventional therapy can pass through the through hole 503.

[0028] The bending tip 301 and the sheath tube 300 are in a tapered structure starting from the bending part, and the bottom hole of the bending tip 301 is inserted and fitted with a 0.035 guide wire.

[0029] The expander 500 can be slidably inserted and fitted in the sheath body 110 and the sheath tube 300, and a tapered head 501 is provided at its lower end. In addition, a through hole 503 is provided along the length direction of the expander 500, and a 0.035” guide wire can pass through the through hole 503, so that the instrument can enter the ascending aorta along the guide wire and be positioned when inserted into the blood vessel. The instrument has a simple structure and convenient operation, providing an effective solution for the medical field.

[0030] In a specific embodiment of the present utility model, the expander 500 includes a tube body 510 and a card seat 530, the card seat 530 is fixed at one end of the tube body 510, and an annular protrusion 103 is provided at the upper end edge of the sheath seat 100, and the card seat 530 is engaged and connected with the annular protrusion 103.

[0031] The expander 500 is composed of a tube body 510 and a card seat 530 fixed at one end of the tube body 510. An annular protrusion 103 is particularly provided at the upper end edge of the sheath seat 100. The card seat 530 and the annular protrusion 103 are connected by a mating and clamping method, so as to ensure the stable connection between the expander 500 and the sheath seat 100, providing a stable support for subsequent operations.

[0032] In a specific embodiment of the present utility model, the communication part between the flushing tube 130 and the sheath seat 100 is a first communication port, the communication part between the upper end of the sheath body 110 and the sheath seat 100 is a second communication port, and the hemostatic valve 101 is arranged between the first communication port and the upper port of the sheath seat 100.

[0033] The connection between the flushing tube 130 and the sheath base 100 is designed as the first communication port to achieve effective transmission of flushing. The connection between the upper end of the sheath body 110 and the sheath base 100 is the second communication port, and the hemostatic valve 101 is arranged at the upper end of the second communication port. Moreover, the hemostatic valve 101 is between the first communication port and the upper port of the sheath base 100, ensuring that interventional devices such as guide wires, catheters, balloons, and stents can smoothly enter and exit during the operation, and effectively controlling the outflow of blood, thereby improving the safety and efficiency of the operation.

[0034] In a specific embodiment of the present utility model, a metal coating layer 350 is wrapped around the periphery of the first inclined hole 310 of the sheath tube 300 to increase the visibility under X-ray.

[0035] A metal coating layer 350 is wrapped around the periphery of the first inclined hole 310. With the metal coating setting, it plays a role in image tracking and positioning during interventional treatment, can locate and mark at any time during use, and has good detectability. Such a design can significantly improve the operation accuracy of medical staff when using this medical device, reduce the medical risks caused by inaccurate positioning, and thus improve the overall medical quality and efficiency.

[0036] The hemostatic valve 101 conducts downward and closes upward. The characteristic of the hemostatic valve 101 is that it can ensure the smooth entry and exit of interventional devices such as guide wires, catheters, balloons, and stents when conducting downward, while effectively preventing blood from leaking when closing upward.

[0037] In a specific embodiment of the present utility model, the first inclined hole 310 is opened at the lower end of the sheath body 110. The inclination angle of the first inclined hole 310 is 30° - 45°. The first side holes 330 are arrayed on the surface of the sheath tube 300, and the second side holes 340 are arrayed on the outer wall of the sheath tube 300. The first inclined hole 310, the first side holes 330, the second side holes 340, and the curved tip 301 communicate with each other.

[0038] The length of the connecting portion 320 is 1 cm, and the distance between the lower port of the sheath body 110 and the first inclined hole 310 is 1 cm. This distance helps to ensure that the sheath tube 300 bends along the aortic arch when placed in the aortic arch, and can ensure that the puncture needle, catheter, and guide wire can smoothly pass through the sheath body 110 to create a window for the aortic endovascular stent in the aortic arch. Specifically, the first inclined hole 310 on the outer surface of the sheath tube 300 is opened at an inclination angle of 30° at the proximal end of the sheath tube 300. Such a design enables the first inclined hole 310 to effectively drain blood. At the same time, it can ensure that when retrieving the sheath tube 300, the guide wire can smoothly enter the sheath tube 300 and the curved tip 301 can be straightened under the support of the guide wire and can be smoothly withdrawn from the body.

[0039] In the specific embodiment of the present utility model, a plurality of first side holes 330 are equidistantly arranged, and the length of the first side holes 330 extending along the surface of the sheath 300 is 1.5 cm. A plurality of second side holes 340 are equidistantly arranged, and the length of the second side holes 340 extending along the surface of the sheath 300 is 1.5 cm.

[0040] A plurality of first side holes 330 are equidistantly arranged. These first side holes 330 are closely arranged, and the number can be increased or decreased according to requirements. Moreover, these first side holes 330 extend a length of 1.5 cm; a plurality of second side holes 340 are equidistantly arranged. These second side holes 340 are closely arranged, and the number can be increased or decreased according to requirements. And these second side holes 340 extend a length of 1.5 cm. These side holes can increase the flow rate of the catheter, ensuring the stable circulation of blood in its actual application; thus ensuring the safety of the operation.

[0041] In the specific embodiment of the present utility model, the outer diameter of the sheath body 110 is 8F (0.264 cm), and the distance between the first inclined hole 310 and the curved tip 301 is 5 - 8 cm.

[0042] During specific implementation, according to the selection of the insertion point, when the brachiocephalic artery is selected as the insertion point, the distance between the first inclined hole 310 and the distal end of the first side hole 330 (i.e., the lower end of the first side hole 330) is set within the range of 5 cm; when the left common carotid artery is selected as the insertion point, the distance between the first inclined hole 310 and the distal end of the first side hole 330 (i.e., the lower end of the first side hole 330) is set within the range of 8 cm; such a distance setting is beneficial to the flexibility of operation and can ensure the effectiveness of blood flow diversion. The overall design not only reflects scientificity but also ensures the medical effect and the safety of patients.

[0043] During specific implementation, a holding part 150 is fixed on the outer surface of the upper end of the sheath body 110, and a hanging ring 151 is fixed on the outer wall of the holding part 150, which is convenient for holding and placing, and convenient for operation and use.

[0044] The working principle of the intracorporeal flow diversion device with a window opening in the arch of the aortic stent is as follows: when in use, the sheath seat 100 is connected to the sheath body 110 through the lower end to achieve connection with the surgical site. The side wall of the sheath seat 100 is also connected to a flushing tube 130, which is convenient for infusion flushing operations and convenient for operation during surgery. The hemostatic valve 101 embedded at the upper end of the sheath seat 100 can prevent bleeding and ensure the safety of the operation. At the same time, one end of the flushing tube 130 is fixed by a three-way valve 131 for easy control. The sheath body 110 and the sheath tube 300 are an integral structure. The sheath tube 300 bends naturally after being placed in the aortic arch, and the curved tip 301 set at its end can avoid damage to the ascending aorta and the aortic valve. After the aortic arch covered stent is placed, the blood in the ascending aorta is introduced through the bottom hole of the curved tip 301 and the first side hole 330, and then guided out from the first oblique hole 310 and the second side hole 340 array to supply blood to the brain. Compared with the extracorporeal bypass used in the prior art, it does not need to supply blood from the femoral artery, solving the problems of long bypass pipes, complicated connection procedures, and high incidence of cerebral infarction. It improves the surgical effect, reduces the burden on medical staff, forms effective blood bypass in the body, supplies blood to the brain, greatly improves safety, and provides convenience and safety for surgery.

[0045] The above description is only an embodiment of the present application and is not intended to limit the scope of protection of the present application. For those skilled in the art, the present application may have various changes and variations. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present application should be included in the scope of protection of the present application. It should be noted that similar reference numerals and letters represent similar items in the following drawings, so once an item is defined in one drawing, it does not need to be further defined and explained in the subsequent drawings.

Claims

1. An in-vivo bypass device with fenestration in the aortic arch part of an aortic stent, characterized in that including a sheath base (100), a sheath body (110) is connected to the lower end of the sheath base (100), a flushing tube (130) is connected to the side wall of the sheath base (100), a hemostatic valve (101) is embedded in the upper end of the sheath base (100), and a three-way valve (131) is installed at one end of the flushing tube (130); a sheath tube (300), the sheath tube (300) is connected to the sheath body (110) through a connecting portion (320), a first inclined hole (310) is formed in the upper end of the sheath tube (300), a curved tip (301) is arranged at the lower end of the sheath tube (300), a bottom hole is formed in the curved tip (301), a first side hole (330) is formed in the side wall of the lower end of the sheath tube (300), and a second side hole (340) is formed in the side wall of the upper section of the sheath tube (300).

2. The in-vivo bypass device with fenestration at the aortic arch part according to claim 1, characterized in that, further comprising a dilator (500), the dilator (500) is slidably inserted into the sheath body (110) in a matching manner, a cone head (501) is arranged at the lower end of the dilator (500), the cone head (501) is arranged outside the lower end of the sheath body (110), and a through hole (503) is formed in the dilator (500) along the length direction.

3. The in-vivo bypass device with an aortic arch fenestration according to claim 2, characterized in that, the dilator (500) comprises a tube body (510) and a clamping seat (530), the clamping seat (530) is fixed at one end of the tube body (510), an annular protrusion (103) is arranged at the edge of the upper end of the sheath base (100), and the clamping seat (530) is clamped with the annular protrusion (103) in a matching manner.

4. The in-vivo bypass device with fenestration in the aortic arch part according to claim 1, characterized in that, the connection between the flushing tube (130) and the sheath base (100) is a first connection port, the connection between the upper end of the sheath body (110) and the sheath base (100) is a second connection port, and the hemostatic valve (101) is arranged between the first connection port and the upper port of the sheath base (100).

5. The in-vivo bypass device with fenestration in the aortic arch part according to claim 1, characterized in that, the inclination angle of the first inclined hole (310) is 30°-45°, the first side holes (330) are distributed in an array on the surface of the sheath tube (300), and the second side holes (340) are distributed in an array on the outer wall of the sheath tube (300).

6. The in-vivo bypass device with aortic arch fenestration according to claim 1, characterized in that, a plurality of the first side holes (330) are arranged at equal intervals, and a plurality of the second side holes (340) are arranged at equal intervals.

7. The in-vivo bypass device with fenestration at the aortic arch part according to claim 1, characterized in that the length of the sheath body (110) is 13 cm, and the length of the sheath tube (300) is 5-8 cm.

8. The in-vivo bypass device with fenestration in the aortic arch part according to claim 1, wherein, a holding portion (150) is fixed on the outer surface of the upper end of the sheath body (110), and a hanging ring (151) is fixed on the outer wall of the holding portion (150).

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