A medical device

Abstract

The present invention relates to a medical device, which comprises: an infusion catheter; a blocking mechanism, comprising a balloon and a catheter body; the balloon is arranged on the outer surface of the infusion catheter; the catheter body is connected to the balloon, and is used to infuse a filling agent into the balloon; and a supporting mechanism, comprising a supporting body and a driving body, the supporting body is arranged on the outer surface of the infusion catheter and is located at the proximal end of the balloon; the driving body is connected to the supporting body, and is used to drive the supporting body to expand outward or contract inward along its radial direction. When the medical device is used for surgical treatment of aortic dissection, it can provide a clean surgical field, facilitate the doctor's operation, and significantly reduce the circulatory arrest time and reduce the damage to the important organs of the patient's lower body.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a medical device used in total aortic arch replacement surgery + stent elephant trunk surgery. Background Art

[0002] Aortic dissection refers to the blood in the aorta cavity entering the aortic media from the tear in the aortic intima, causing the media to separate and expand along the long axis of the aorta to form a state of separation between the true and false cavities of the aortic wall. It is a critical, rapidly progressive, and high-mortality aortic disease. Dissection hematoma in the aortic media can cause serious cardiovascular emergencies, of which 65%-70% of patients die in the acute phase due to cardiac tamponade, arrhythmia, etc., so early treatment of aortic dissection is very necessary. At present, surgical treatment is mainly used for aortic dissection. Among them, Stanford B type dissection with the rupture in the descending aorta is generally treated with interventional treatment, and Stanford A type dissection with the rupture involving the ascending aorta and aortic arch is generally treated by a combination of total aortic arch replacement surgery and stent-elevator trunk surgery.

[0003] The elephant trunk surgery refers to the implantation of a free artificial blood vessel in the descending aorta during the replacement of the ascending aorta and the aortic arch, thereby eliminating the need for deep hypothermic circulatory arrest during the second-stage descending aortic surgery. The elephant trunk surgery shortens the aortic occlusion time and reduces the risk of ischemic complications. However, the traditional elephant trunk surgery is prone to aortic wall tears due to limited field of view and difficulty in inserting and removing the needle. At the same time, due to the long intraoperative circulatory arrest time, it is very easy to cause postoperative cerebral complications. The Sun's surgery in the prior art is a classic procedure for the treatment of Stanford type A dissection (i.e., total aortic arch replacement surgery + stent elephant trunk surgery), which further simplifies the surgical process, but the surgery also needs to be performed under conditions of deep hypothermic circulatory arrest.

[0004] In summary, the prior art has the following problems: it is difficult to expose the surgical field of view, the blood return of the descending aorta further affects the clarity of the field of view, the operation needs to be performed under extracorporeal circulation, and when performing anastomosis of the descending aorta, due to various reasons, the proximal end of the elephant trunk stent is not well fitted with the patient's autologous blood vessels, which is not conducive to the anastomosis and causes the anastomosis time to be too long, which leads to an extension of the deep hypothermic circulatory arrest time, thereby increasing the possibility of ischemic and hypoxic damage to organs such as the spinal cord, liver, and gastrointestinal tract, which is not conducive to the patient's postoperative recovery. Summary of the invention

[0005] The purpose of the present invention is to provide a medical device for providing a clear surgical field of view and performing descending aorta anastomosis under extracorporeal circulation conditions, thereby greatly shortening the time of deep hypothermic circulatory arrest, reducing ischemia and hypothermic damage to the patient's important organs in the lower body, and facilitating the patient's postoperative recovery. In particular, the medical device also improves the fit between the elephant trunk stent and the patient's own blood vessels, facilitates the anastomosis operation, and shortens the anastomosis time.

[0006] To achieve the above object, the present invention provides a medical device, comprising:

[0007] Irrigation catheter;

[0008] The blocking mechanism comprises a balloon and a catheter body; the balloon is arranged on the outer surface of the perfusion catheter; the catheter body is connected with the balloon and is used to perfuse a filling agent into the balloon; and,

[0009] The support mechanism comprises a support body and a driving body. The support body is arranged on the outer surface of the perfusion catheter and is located at the proximal side of the balloon. The driving body is connected to the support body and is used to drive the support body to expand outward or contract inward along its radial direction.

[0010] Optionally, the driving body is sleeved on the outer surface of the perfusion catheter and can move along the axial direction of the perfusion catheter; the distal end of the support body is fixedly connected to the perfusion catheter, and the proximal end of the support body is fixedly connected to the distal end of the driving body;

[0011] The support mechanism is configured as follows: when the driving body moves toward the distal end of the perfusion catheter, the driving body drives the proximal end of the support body to move toward the distal end of the perfusion catheter, so that the support body is deformed and expanded; when the driving body moves toward the proximal end of the perfusion catheter, the driving body drives the proximal end of the support body to move toward the proximal end of the perfusion catheter, so that the support body contracts.

[0012] Optionally, the support body is woven from a plurality of braided wires, and at least some of the braided wires are metal wires.

[0013] Optionally, the maximum diameter of the support body when expanded is 35mm-40mm.

[0014] Optionally, the support mechanism further includes a first handle, which is disposed on an outer surface of the perfusion catheter and is movable along the axial direction of the perfusion catheter, and is fixedly connected to the proximal end of the driving body.

[0015] Optionally, the support mechanism further comprises a locking assembly, which is disposed on the first handle and is used to selectively connect or disconnect with the irrigation catheter;

[0016] The support mechanism is configured to: when the locking assembly is connected to the perfusion catheter, prevent the first handle, the driving body and the proximal end of the support body from moving axially along the perfusion catheter; when the locking assembly is disconnected from the perfusion catheter, allow the first handle, the driving body and the proximal end of the support body to move axially along the perfusion catheter.

[0017] Optionally, the locking assembly includes a locking portion and a nut; the locking portion is arranged at the proximal end of the first handle and is a hollow tubular structure, the locking portion is provided with an external thread, and the proximal end of the locking portion is provided with a plurality of open grooves; the nut is used to be sleeved on the outer surface of the locking portion and is threadedly connected to the locking portion.

[0018] Optionally, the catheter body is disposed inside the perfusion catheter, and the distal end of the catheter body penetrates the distal wall of the perfusion catheter and is communicated with the balloon.

[0019] Optionally, the blocking mechanism further comprises an injection tube, the injection tube is spirally coiled inside the first handle, the distal end of the injection tube extends into the perfusion catheter and is connected to the proximal end of the catheter body, and the proximal end of the injection tube penetrates the first handle and extends to the outside of the first handle;

[0020] When the first handle moves toward the distal end of the perfusion catheter, the proximal end of the injection tube moves synchronously with the first handle to stretch and deform the injection tube.

[0021] Optionally, a second handle is further included, which is disposed on the outer surface of the irrigation catheter and is located at the proximal end of the first handle.

[0022] Optionally, the blocking mechanism further includes an injection tube, the distal end of which extends into the perfusion catheter and is connected to the proximal end of the catheter body, and the proximal end of the injection tube passes through the second handle and extends to the outside of the second handle.

[0023] Optionally, a one-way valve is provided at the proximal end of the injection tube.

[0024] Compared with the prior art, the medical device of the present invention has the following advantages:

[0025] The medical device includes an infusion catheter, a blocking mechanism and a supporting mechanism; wherein the blocking mechanism includes a balloon and a catheter body, and the balloon is arranged on the outer surface of the infusion catheter; the catheter body is connected to the balloon and is used to infuse the balloon with a filling agent; the supporting mechanism includes a supporting body and a driving body, and the supporting body is arranged on the outer surface of the infusion catheter and is located on the proximal side of the balloon; the driving body is connected to the supporting body and is used to drive the supporting body to expand outward or contract inward along its radial direction. When the medical device is used in surgical treatment of aortic dissection, the catheter body is used to perfuse the filling agent into the balloon so that the balloon is filled to fit the inner wall of the trunk stent, thereby dividing the interior of the trunk stent into two parts that are not connected to each other, blocking the return of blood from the descending aorta, so that the blood in the descending aorta will not flow back into the aortic arch and the ascending aorta, providing a clear field of vision for the operation; the perfusion catheter is connected to an external circulation machine to perform blood perfusion on the patient's lower body, thereby performing anastomosis without deep hypothermia circulatory arrest, significantly shortening the deep hypothermia and circulatory arrest time during the operation, and reducing the risk to the patient. The invention can prevent the damage of the important organs of the lower body of the patient, which is beneficial to the postoperative recovery of the patient; more particularly, by arranging a support body on the perfusion catheter and arranging the support body on the proximal side of the elephant trunk stent, after the balloon is inflated and before the extracorporeal circulation is restored, the driving body drives the support body to expand to support the proximal end of the elephant trunk stent, so that the proximal end of the elephant trunk stent expands again and fits with the inner wall of the patient's autologous blood vessel, on the one hand, blocking the blood return between the outer side of the elephant trunk stent and the autologous blood vessel, further providing a clean surgical field, and on the other hand, facilitating the doctor to perform anastomosis operation, shortening the anastomosis time, and thus shortening the operation time.

[0026] Second, the support body is woven from a plurality of braided wires, and at least some of the braided wires are metal wires. That is, the support body is mainly made of metal material, ensuring that the support body has sufficient strength to effectively support the proximal end of the elephant trunk stent, so that the proximal end of the elephant trunk stent can expand again to fit with the inner wall of the autologous blood vessel.

[0027] Third, the support mechanism includes a first handle, which is arranged on the outer surface of the perfusion catheter and can move along the axial direction of the perfusion catheter, and the first handle is fixedly connected to the proximal end of the driving body, so that the operator can hold it to push the driving body to move along the axial direction of the perfusion catheter. Further, the support mechanism also includes a locking assembly, which is arranged on the first handle and is used to selectively connect or disconnect with the perfusion catheter. When the locking assembly is disconnected from the perfusion catheter, the first handle, the driving body and the proximal end of the support body are allowed to move along the axial direction of the perfusion catheter so that the support body can expand; when the support body expands to a suitable degree to support the proximal end of the elephant trunk stent to fit closely with the inner wall of the autologous blood vessel, the locking assembly is connected to the perfusion catheter to prevent the first handle, the driving body and the proximal end of the support body from moving along the axial direction of the perfusion catheter, so as to achieve the purpose of locking the support body in the expanded state, which is convenient for the operator to perform anastomosis operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a schematic structural diagram of a medical device provided according to an embodiment of the present invention;

[0029] Figure 2 yes Figure 1 A schematic diagram of a medical device in use is shown;

[0030] Figure 3 is a schematic structural diagram of a support body of a medical device provided by an embodiment of the present invention when expanded;

[0031] Figure 4 is a schematic structural diagram of a driving body of a supporting mechanism of a medical device provided according to an embodiment of the present invention;

[0032] Figure 5 1 is a schematic structural diagram of a locking assembly of a supporting mechanism of a medical device according to an embodiment of the present invention, in which the locking portion is separated from the nut;

[0033] Figure 6 is a schematic structural diagram of a medical device provided according to another embodiment of the present invention;

[0034] Figure 7 yes Figure 6 An enlarged schematic diagram of point A of the medical device shown;

[0035] Figure 8 yes Figure 6 Schematic diagram of the medical device in use.

[0036] [Description of reference numerals is as follows]:

[0037] 10- Medical devices;

[0038] 100-irrigation catheter;

[0039] 200-blocking mechanism;

[0040] 210-balloon, 220-catheter body, 230-injection tube, 240-check valve;

[0041] 300-support mechanism;

[0042] 310-support body;

[0043] 320- driving body;

[0044] 321-inner tube, 322-supporting wire, 323-outer tube;

[0045] 330- first handle;

[0046] 340-locking assembly;

[0047] 341-locking portion, 341a-opening slot, 341b-buckle;

[0048] 342-nut;

[0049] 400-Second handle;

[0050] 20-Trunk support. DETAILED DESCRIPTION

[0051] The following is an explanation of the embodiments of the present invention by specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in the present embodiment only illustrate the basic concept of the present invention in a schematic manner, and only the components related to the present invention are shown in the figure instead of being drawn according to the number, shape and size of the components in the actual implementation. The type, quantity and proportion of each component in the actual implementation can be a random change, and the component layout type may also be more complicated.

[0052] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise that implementation is possible, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0053] As used in this specification, the singular forms "a", "an", and "the" include plural objects, and the plural form "a plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense including "and / or", unless the content clearly indicates otherwise, and the terms "install", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be a connection between the internal parts of two elements or an interaction relationship between two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0054] In this article, the terms "proximal end" and "distal end" refer to the relative orientation, relative position, and direction of components or actions relative to each other from the perspective of a doctor using the medical device. Although "proximal end" and "distal end" are not restrictive, "proximal end" generally refers to the end of the medical device that is close to the doctor during normal operation, and "distal end" generally refers to the end that first enters the patient's body. Unless otherwise clearly stated in the content.

[0055] The object of the present invention is to provide a medical device, comprising an infusion catheter, a blocking mechanism and a supporting mechanism. The blocking mechanism comprises a balloon and a catheter body, wherein the balloon is arranged on the outer surface of the infusion catheter, the catheter body is connected to the balloon and is used to infuse a filling agent into the balloon. The supporting mechanism comprises a supporting body and a driving body, wherein the supporting body is arranged on the outer surface of the infusion catheter and is located proximal to the balloon. The driving body is connected to the supporting body and is used to drive the supporting body to expand outward or contract inward along its radial direction.

[0056] The medical device is used in conjunction with an elephant trunk stent to perform surgical treatment on aortic dissection, for example, in Sun's surgery. Specifically, during surgery, the perfusion catheter is first connected to the elephant trunk stent so that the medical device is fixed in the aorta, wherein the balloon is located in the middle of the inner cavity of the elephant trunk stent, and the support body is located in the proximal inner cavity of the elephant trunk stent. The catheter body is used to perfuse a filling agent into the balloon, so that the balloon is filled to fit the inner wall of the elephant trunk stent, so as to separate the interior of the elephant trunk stent into two unconnected parts, that is, the balloon is expanded to block the return of blood to the descending aorta, prevent the blood in the descending aorta from flowing back into the aortic arch and the ascending aorta, and provide a clear field of view for surgery. Afterwards, the operator manipulates the driving body to drive the support body to expand and support the proximal end of the trunk stent, so that the proximal end of the trunk stent expands again until the proximal end of the trunk stent is tightly fitted with the inner wall of the autologous blood vessel. On the one hand, it can block the blood return between the outer wall of the trunk stent and the proximal end of the descending aorta, further providing a clean surgical field of view, and on the other hand, it is convenient for the doctor to perform subsequent anastomosis operations and shorten the anastomosis time. Then, the perfusion catheter is connected to the extracorporeal circulation machine for extracorporeal circulation. Finally, the doctor performs anastomosis and other surgical operations. That is to say, the medical device provided by the present invention provides a clean surgical field of view through the joint action of the balloon and the support body, uses the perfusion catheter to establish extracorporeal circulation, reduces the time of deep hypothermic circulatory arrest, and can also facilitate the anastomosis operation through the action of the support body, providing convenience for the operation.

[0057] Therefore, the surgical treatment of aortic dissection can be carried out according to the following process: when the temperature of the extracorporeal circulation reaches about 28°C, the selective antegrade perfusion of the brain is maintained; then the circulation can be stopped, the aortic arch is opened, and the elephant trunk stent and the medical device are implanted; then the balloon of the blocking mechanism is used to block the aortic blood flow; then the circulation is restored, and finally the anastomosis operation and other operations are performed. That is, when the medical device is used for the surgical treatment of aortic dissection, on the one hand, it is not necessary to reduce the patient's body temperature to too low, thereby effectively protecting the patient's visceral function and coagulation function, avoiding the patient's related organs from being damaged due to long-term ischemia and hypoxia, and reducing complications caused by postoperative coagulation dysfunction. On the other hand, blood circulation can be carried out during the anastomosis process during the operation, reducing the pressure on the operator caused by the long anastomosis time. In particular, in the present invention, a supporting mechanism is also provided on the perfusion catheter, and the proximal end of the elephant trunk stent is supported by the supporting mechanism, so that the proximal end of the elephant trunk stent is closely attached to the inner wall of the patient's own blood vessel, which is convenient for anastomosis and further shortens the operation time.

[0058] Preferably, the support body is mainly made of metal material, so that the support body can provide sufficiently large radial support force when supporting the proximal end of the elephant trunk stent, ensuring that the proximal end of the elephant trunk stent expands again and fits tightly against the inner wall of the autologous blood vessel.

[0059] In order to make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings. It should be noted that the drawings are all in a very simplified or schematic form and are not in precise proportions, which are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention. The same or similar figure numbers in the drawings represent the same or similar parts. It should also be understood that the following only describes the preferred structure of each component of the medical device, but it is not the only implementation method and should not limit the present invention.

[0060] Figure 1 FIG. 1 shows a schematic diagram of the structure of a medical device provided by a preferred embodiment of the present invention. Figure 2 A schematic diagram of the medical device in use is shown.

[0061] Please refer to Figure 1 The medical device 10 includes an irrigation catheter 100, a blocking mechanism 200 and a supporting mechanism 300. The irrigation catheter 100 is a hollow structure. The blocking mechanism 200 includes a balloon 210 and a catheter body 220. The balloon 210 is sleeved on the outer surface of the irrigation catheter 100. The catheter body 220 is connected to the balloon 210 and is used to inject a filling agent into the balloon 210. The supporting mechanism 300 includes a supporting body 310 and a driving body 320. The supporting body 310 is sleeved on the outer surface of the irrigation catheter 100 and is located at the proximal end of the balloon 210. The driving body 320 is connected to the supporting body 310 and is used to drive the supporting body 310 to expand outward or contract inward along its radial direction.

[0062] Please refer to Figure 2 The process of surgical treatment of aortic dissection using the medical device and the elephant trunk stent is as follows:

[0063] First, extracorporeal circulation is established to maintain selective antegrade perfusion of the brain, followed by circulatory arrest.

[0064] Next, the patient's aortic arch is opened, and the elephant trunk stent 20 is implanted in the descending aorta region of the patient's aorta. The elephant trunk stent 20 is expanded to support the descending aorta wall.

[0065] Next, the medical device 10 is placed in the aorta, and the distal end of the perfusion catheter 100 is connected to the trunk stent 20, while the balloon 210 is arranged in the middle lumen of the trunk stent 20, and the support body 310 is arranged in the proximal lumen of the trunk stent 20. It is well known to those skilled in the art that the distal end of the perfusion catheter 100 can extend from the distal end of the balloon 210 to facilitate the connection between the two.

[0066] Next, the catheter body 220 is used to inject a filling agent into the balloon 210, so that the balloon 210 is filled to fit the inner wall of the trunk stent 20. After the balloon 210 is filled, the inner cavity of the trunk stent 20 is divided into two parts that are not connected to each other, thereby blocking the blood circulation in the aorta, so that the blood in the descending aorta cannot flow back into the aortic arch and the aorta.

[0067] Next, the driving body 320 is used to drive the support body 310 to expand. The expanded support body 310 supports the proximal end of the elephant trunk stent 20, so that the proximal end of the elephant trunk stent 20 is tightly fitted with the inner wall of the patient's own blood vessel, blocking the blood return between the outer side of the elephant trunk stent 20 and the proximal end of the descending aorta.

[0068] Next, the perfusion catheter 100 is connected to an extracorporeal circulation machine to resume extracorporeal circulation.

[0069] Finally, anastomosis and other surgical operations are performed.

[0070] That is to say, in the medical device provided by the embodiment of the present invention, the balloon 210 is used to block the aortic blood flow to prevent aortic blood return, and the support body 310 is used to support the proximal end of the trunk stent 20 to block the blood return between the trunk stent 20 and the proximal end of the descending aorta, thereby providing a clean and clear surgical field of view at the aortic arch and the ascending aorta. Afterwards, the perfusion catheter 100 can be used to restore extracorporeal circulation, which reduces the time of circulatory arrest, so there is no need to reduce the patient's body temperature to too low, effectively protect the patient's visceral function and coagulation function, and greatly reduce complications caused by coagulation dysfunction after surgery. In addition, the support body 310 is used to support the proximal end of the trunk stent 20 so that the trunk stent 20 fits the inner wall of the autologous blood vessel, which is also convenient for doctors to perform anastomosis operations, provide convenience for surgery, shorten the anastomosis time, and thus shorten the operation time.

[0071] In this embodiment, the perfusion catheter 100 is used to perform blood perfusion on the lower body of the patient. Therefore, the perfusion catheter 100 is made of a medical polymer tubing that is resistant to bending and relatively soft, so that the perfusion catheter 100 can enter any angle of the descending aorta and provide blood circulation. In this embodiment, the diameter of the perfusion catheter 100 is 8mm-12mm. The balloon 210 can be a compliant balloon, which can expand according to the size of the trunk stent 20 until it fits tightly with the inner wall of the trunk stent 20 to block the blood return of the descending aorta.

[0072] The support body 310 has an expansion state and a contraction state. The operator drives the proximal end of the support body 310 to move along the axial direction of the perfusion catheter 100 through the driver 320 to achieve the switching of the support body 310 between the expansion state and the contraction state. Specifically, the driver 320 is sleeved on the outer surface of the perfusion catheter 100 and can move along the axial direction of the perfusion catheter 100. The distal end of the support body 310 is fixedly connected to the perfusion catheter 100, so that the distal end of the support body 310 and the perfusion catheter 100 remain relatively stationary, and the proximal end of the support body 310 is fixedly connected to the distal end of the driver 320, so that the proximal end of the support body 310 can move synchronously with the driver 320. The support mechanism 300 is configured such that when the driving body 320 moves toward the distal end of the perfusion catheter 100, the proximal end of the support body 310 moves synchronously with the driving body 320 toward the distal end of the perfusion catheter 100, so that the support body 310 is deformed to the expanded state. When the driving body 320 moves toward the proximal end of the perfusion catheter 100, the proximal end of the support body 310 moves synchronously with the driving body 320 toward the proximal end of the perfusion catheter 100, so that the shape of the support body 310 is restored and returned to the contracted state.

[0073] The diameter of the support body 310 in the contracted state is 9mm-13mm, and when the support body 310 is in the expanded state, the maximum diameter of the support body 310 can reach 35mm-40mm, and the support body 310 of this diameter is sufficient to support the proximal end of the trunk stent 20 so that it fits with the inner wall of the patient's own blood vessel. Further, the support body 310 is mainly made of metal material, which ensures that when the support body 310 is in the expanded state, it can provide sufficient support force for the proximal end of the trunk stent 20 so that the proximal end of the trunk stent 20 fits with the inner wall of the patient's own blood vessel.

[0074] To achieve the above object, in an optional implementation manner, Figure 3As shown, the support body 310 is formed by braiding a plurality of braided wires, and at least some of the braided wires are metal wires, and preferably all of the braided wires are metal wires. The metal wires are made of shape memory alloys such as nickel-titanium alloys, and the high elasticity of the shape memory alloys can be used to achieve deformation and recovery of the support body 310, so that the support body 310 can switch between the expanded state and the contracted state. Figure 3 As shown, when the support body 310 is in the expanded state, the support body 310 has a cage-like structure, as shown in FIG. Figure 1 As shown in , when the support body 310 is in the contracted state, the support body 310 is in a tube network structure. In this embodiment, the distal end of the support body 310 can be fixedly connected to the perfusion catheter 100 through a clamp ring, and the proximal end of the support body 310 can be fixedly connected to the distal end of the driver 320 through a clamp ring.

[0075] The driving body 320 moves along the axial direction of the perfusion catheter 100, and it needs to have good flexibility and good supporting force, so that the driving body 320 can follow the bending of the perfusion catheter 100 and also push the proximal end of the support body 310 to move, so that the support body 310 switches from the contracted state to the expanded state. Figure 4 As shown, the driving body 320 preferably includes an inner tube body 321, a supporting wire 322 and an outer tube body 323. The inner tube body 321 and the outer tube body 323 are both polymer tubes, the supporting wire 322 is spirally wound on the outer surface of the inner tube body 321, and the outer tube body 323 is sleeved on the inner tube body 321 to cover the supporting wire 322. The inner and outer layers of polymer tubes are used to improve the flexibility of the driving body 320, and the supporting wire 322 is used to improve the supporting force, so as to achieve a balanced effect between the two.

[0076] Further, please refer back to Figure 1 The support mechanism 300 further includes a first handle 330, which has an inner cavity that penetrates axially, and the irrigation catheter 100 can movably penetrate the inner cavity of the first handle 330, so that the first handle 330 is sleeved on the outer surface of the irrigation catheter 100 and can move along the axial direction of the irrigation catheter 100. The first handle 330 is fixedly connected to the proximal end of the driving body 320. The operator holds the first handle 330 and pushes the first handle 330 to move along the axial direction of the irrigation catheter 100 to move the driving body 320, which is convenient for operation.

[0077] For further information, please refer to Figure 1The support mechanism 300 further includes a locking assembly 340, which is disposed on the first handle 330 and is used to selectively connect or disconnect with the irrigation catheter 100. When the locking assembly 340 is connected to the irrigation catheter 100, the first handle 330, the driving body 320, and the proximal end of the support body 310 are prevented from moving along the axial direction of the irrigation catheter 100. When the locking assembly 340 is disconnected from the irrigation catheter 100, the first handle 330, the driving body 320, and the proximal end of the support body 310 are allowed to move along the axial direction of the irrigation catheter 100. That is, the locking assembly 340 can be used to lock the state of the support body 310, so that when the support body 310 is in the expanded state and the proximal end of the elephant trunk stent 20 is tightly fitted with the inner wall of the patient's own blood vessel, the locking assembly 340 is connected to the perfusion catheter 100 to keep the support body 310 in the expanded state, thereby continuously blocking the blood return between the elephant trunk stent 20 and the proximal end of the descending aorta during the operation, and facilitating the operator to perform the anastomosis operation conveniently and quickly.

[0078] Figure 5 FIG. 3 shows a schematic diagram of the structure of an optional locking assembly 340. Figure 5 As shown, the locking assembly 340 includes a locking portion 341 and a nut 342, and the locking portion 341 can be fixedly arranged at the proximal end of the first handle 330. The locking portion 341 is a hollow tubular structure, and is sleeved on the outer surface of the perfusion catheter 100. An external thread is provided on the outer surface of the locking portion 341, and a plurality of open grooves 341a are provided at the proximal end of the locking portion 341 to divide the proximal side wall of the locking portion 341 into a plurality of buckles 341b. The nut 342 is sleeved on the outer surface of the locking portion 341 and is threadedly connected with the locking portion 341. By tightening the nut 342, the nut 342 radially presses the buckle 341b, and then the buckle 341b presses the outer surface of the perfusion catheter 100 to achieve connection with the perfusion catheter 100.

[0079] Generally, before the medical device 10 is used, the support body 310 is in the contracted state. Therefore, when performing surgery using the medical device 10, the operator pushes the first handle 330 toward the distal end of the irrigation catheter 100 to drive the driving body 320 to move, so as to drive the proximal end of the support body 310 to move toward the distal end of the irrigation catheter 100, so that the support body 310 is deformed to the expanded state to support the proximal end of the trunk support 20. After that, the operator rotates the nut 342 to connect the locking assembly 340 with the irrigation catheter 100 to lock the support body 310, and then the operator can perform anastomosis.

[0080] Please refer back to Figure 1 In this embodiment, the outer diameter of the catheter body 220 is smaller than the inner diameter of the perfusion catheter 100, and the catheter body 220 is preferably disposed in the perfusion catheter 100, and the distal end of the catheter body 220 penetrates the distal side wall of the perfusion catheter 100 and is communicated with the balloon 210. In other words, in this embodiment, the catheter body 220, the perfusion catheter 100 and the driving body 320 are nested, so that the structure of the medical device 10 is compact and entanglement is avoided.

[0081] Please continue to refer to Figure 1 The medical device 10 further includes a second handle 400, which is fixedly arranged on the perfusion catheter 100 and is located at the proximal end of the first handle 330. The blocking mechanism 200 further includes an injection tube 230, the distal end of which penetrates through the side wall of the perfusion catheter 100 and extends into the perfusion catheter 100, and is connected to the proximal end of the catheter body 220, and the proximal end of the injection tube 230 passes through the second handle 400 and extends to the outside of the second handle 400. The injection tube 230 is connected to a syringe to perfuse the filling agent into the balloon 210 so that the balloon 210 is filled. The second handle 400 is arranged to facilitate the injection operation. Further, a one-way valve 240 is arranged at the proximal end of the injection tube 230, and when the balloon 210 is filled to a suitable size, the one-way valve 240 is used to prevent the filling agent from being discharged from the balloon 210. The one-way valve 240 may be bonded to the proximal end of the injection tube 230 by UV adhesive.

[0082] In other embodiments, the injection tube 230 is a spiral structure. Figures 6 to 8The first handle 330 is a hollow structure, the injection tube 230 is spirally coiled inside the first handle 330, and the distal end of the injection tube 230 penetrates the side wall of the perfusion catheter 100 and then extends into the perfusion catheter 100, and is connected to the proximal end of the catheter body 220. The proximal end of the injection tube 230 passes through the first handle 330 and extends to the outside of the first handle 330. A one-way valve 240 is arranged on the proximal end of the injection tube 230. In this embodiment, the injection tube 230 is made of medical-grade PVC material, which can be stretched and deformed. In this way, when the operator drives the first handle 330 to move toward the distal end of the perfusion catheter 100, the proximal end of the injection tube 230 moves synchronously with the first handle 330 and stretches and deforms. At this time, the connection between the distal end of the injection tube 230 and the catheter body 220 remains relatively still, and when the operator drives the first handle 330 to move toward the proximal end of the perfusion catheter 100, the injection tube 230 can rebound. In addition, it should be known that, for the injection tube 230 , the distal end refers to the end connected to the catheter body 220 , and the proximal end refers to the end away from the catheter body 220 .

[0083] The medical device provided in the embodiment of the present invention comprises an infusion catheter, a blocking mechanism and a supporting mechanism. The blocking mechanism comprises a balloon and a catheter body, wherein the balloon is sleeved on the outer surface of the infusion catheter, and the catheter body is connected to the balloon, and is used to infuse the balloon with a filling agent. The supporting mechanism comprises a supporting body and a driving body, wherein the supporting body is sleeved on the outer surface of the infusion catheter and is located at the proximal end of the balloon, and the driving body is connected to the supporting body and is used to drive the supporting body to expand outward or contract inward along its radial direction. When performing surgical treatment of aortic dissection, the medical device uses the balloon to block the blood return of the descending aorta, and uses the supporting body to re-expand the proximal end of the elephant trunk stent to block the blood return between the outer wall of the elephant trunk stent and the rupture at the proximal end of the descending aorta, providing a clean and clear surgical field of view. The perfusion catheter is used for extracorporeal circulation, shortening the deep hypothermic circulatory arrest time, reducing the possibility of damage to the important organs of the lower body of the patient due to hypothermia and ischemia, and facilitating the patient's postoperative recovery. In addition, under the action of the support body, the proximal end of the elephant trunk stent is closely attached to the inner wall of the patient's own blood vessel, which is convenient for doctors to perform anastomosis operations and can shorten the operation time. That is, when the medical device is used in the surgical treatment of aortic dissection, it can reduce the damage to the patient's organs, facilitate the operation of the surgeon, and reduce the surgeon's pressure.

[0084] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A medical device, characterized in that: include: Irrigation catheter; The blocking mechanism comprises a balloon and a catheter body; the balloon is arranged on the outer surface of the perfusion catheter; The catheter body is in communication with the balloon and is used for infusing a filling agent into the balloon; and, The support mechanism comprises a support body and a driving body, wherein the driving body comprises an inner tube body, a supporting wire, and an outer tube body which are sequentially arranged from the inside to the outside; the driving body is sleeved on the outer surface of the perfusion catheter and can move along the axial direction of the perfusion catheter; the support body is arranged on the outer surface of the perfusion catheter and is located at the proximal end side of the balloon; the distal end of the support body is fixedly connected to the perfusion catheter, and the proximal end of the support body is fixedly connected to the distal end of the driving body; The support mechanism is configured as follows: when the driving body moves toward the distal end of the perfusion catheter, the driving body drives the proximal end of the support body to move toward the distal end of the perfusion catheter, so that the support body is deformed and expands radially outward; when the driving body moves toward the proximal end of the perfusion catheter, the driving body drives the proximal end of the support body to move toward the proximal end of the perfusion catheter, so that the support body contracts radially inward.

2. The medical device according to claim 1, characterized in that: The support body is woven from a plurality of braided wires, and at least part of the braided wires are metal wires.

3. The medical device according to claim 1 or 2, characterized in that: The maximum diameter of the support body when expanded is 35mm-40mm.

4. The medical device according to claim 1, characterized in that: The supporting mechanism further includes a first handle, which is disposed on the outer surface of the irrigation catheter and can move axially along the irrigation catheter, and the first handle is fixedly connected to the proximal end of the driving body.

5. The medical device according to claim 4, characterized in that: The support mechanism further comprises a locking assembly, which is disposed on the first handle and is used to selectively connect or disconnect with the irrigation catheter; The support mechanism is configured to: when the locking assembly is connected to the perfusion catheter, prevent the first handle, the driving body and the proximal end of the support body from moving axially along the perfusion catheter; when the locking assembly is disconnected from the perfusion catheter, allow the first handle, the driving body and the proximal end of the support body to move axially along the perfusion catheter.

6. The medical device according to claim 5, characterized in that: The locking assembly includes a locking part and a nut; the locking part is arranged at the proximal end of the first handle and is a hollow tubular structure, the locking part is provided with an external thread, and the proximal end of the locking part is provided with a plurality of open grooves; the nut is used to be sleeved on the outer surface of the locking part and is threadedly connected to the locking part.

7. The medical device according to claim 4, characterized in that: The catheter body is arranged inside the perfusion catheter, and the distal end of the catheter body penetrates the distal end wall of the perfusion catheter and is communicated with the balloon.

8. The medical device according to claim 7, characterized in that: The blocking mechanism further includes an injection tube, which is spirally coiled inside the first handle, and the distal end of the injection tube extends into the perfusion catheter and is connected to the proximal end of the catheter body, and the proximal end of the injection tube passes through the first handle and extends to the outside of the first handle; When the first handle moves toward the distal end of the perfusion catheter, the proximal end of the injection tube moves synchronously with the first handle to stretch and deform the injection tube.

9. The medical device according to claim 7, characterized in that: Also included is a second handle, which is disposed on the outer surface of the irrigation catheter and is located at the proximal end of the first handle.

10. The medical device according to claim 9, characterized in that: The blocking mechanism further includes an injection tube, the distal end of which extends into the perfusion catheter and is connected to the proximal end of the catheter body, and the proximal end of the injection tube passes through the second handle and extends to the outside of the second handle.

11. The medical device according to claim 8 or 10, characterized in that: A one-way valve is arranged at the proximal end of the injection tube.

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