Balloon, balloon delivery system and application of balloon

Abstract

The invention relates to a balloon, a balloon delivery system and application of the balloon, the balloon is provided with a fillable inner cavity, the fillable inner cavity of the balloon is configured to be used for being filled with a filling substance, and the filling substance can be solidified from a liquid state to a solid state. According to the balloon conveying system, after the balloon in the contraction state is conveyed to the designated position in the body, the filling material in the liquid state can be solidified into the solid state in the inner cavity capable of being filled of the balloon, and the balloon can be shaped after solidification is completed, so that the balloon can adapt to the shape of the surrounding environment; the shape matched with the surrounding environment is automatically constructed, so that blood flow at the designated position can be fully and effectively blocked, and thrombosis in an interlayer false cavity, an intravascular stent peripheral internal leakage area or an aneurysm is promoted.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to balloons, balloon delivery systems, and the applications of balloons. Background Art

[0002] With the aging of the domestic population, the incidence of cardiovascular diseases is expected to gradually increase. Aneurysm and aortic dissection are two common and extremely high-risk cardiovascular diseases. Without intervention, the mortality rate of patients is close to 100%. Taking the aorta as an example, the aorta is the main blood vessel that transports blood from the heart to other parts of the body. The aortic blood vessel is divided into three layers from the inside to the outside. When a small tear appears in the inner layer, the blood in the aortic lumen can flow into the aortic wall through the vascular intima, and then due to the effect of blood pressure, the inner layer of the aorta will separate from the middle layer. This separation is called dissection. When the aortic wall is torn, the dissection will extend downward along the aorta, and the continuously expanding tear will cause the branch blood vessels connected to the aorta to be blocked, or the blood cannot flow into the aorta normally. At the same time, the outer wall of the blood vessel in the false lumen of the dissection is very fragile and has the risk of rupture. When the middle layer structure of the blood vessel wall is damaged and the elasticity gradually decreases, under the continuous scouring action of blood flow, the diameter of the blood vessel continues to expand and forms a permanent dilation, that is, an aneurysm. When it occurs, it will compress the surrounding tissue organs, and finally there is also the risk of rupture and death.

[0003] At present, the treatment methods for aortic dissection and aneurysm are mainly divided into open surgery and interventional surgery. Interventional surgery has been widely applied and promoted due to its relatively simple operation, minimally invasive, high safety, definite treatment effect, few complications, and rapid postoperative recovery. The main treatment method of interventional surgery is to place a vascular stent at the diseased site, use the vascular stent to cover the diseased site, block the blood supply in the dissection or aneurysm, so as to prevent the disease from deteriorating. However, the interventional treatment with vascular stents also has deficiencies, such as stent displacement, endoleakage in the stent, and obstruction of blood flow in branch blood vessels. Summary of the Invention

[0004] Based on this, it is necessary to provide a balloon, a balloon delivery system, and the applications of the balloon for at least one of the above-mentioned technical problems.

[0005] This application provides a balloon. The balloon has an inflatable lumen, and the inflatable lumen of the balloon is configured to be used for perfusing a filling substance, and the filling substance can be solidified from a liquid form to a solid form.

[0006] In one embodiment, the balloon is a compliant balloon, and the maximum deformation volume of the balloon is more than twice the nominal volume; and / or,

[0007] The filling substance can be solidified from a liquid form to a solid form at room temperature; and / or,

[0008] The solidification method of the filling substance includes at least one of covalent crosslinking and non-covalent crosslinking; and / or,

[0009] The filling substance can be solidified from a liquid form to a solid form within 1 minute to 60 minutes; and / or,

[0010] A developing element is provided on the balloon; and / or,

[0011] The wall thickness of the balloon body is between 0.01 mm and 1 mm.

[0012] In one embodiment, the filling substance is a hydrogel raw material solution.

[0013] In one embodiment, the hydrogel raw material solution contains a contrast agent.

[0014] The present application provides a balloon delivery system, and the balloon delivery system includes:

[0015] An outer sheath tube, and the outer sheath tube has a through sheath lumen;

[0016] An inner catheter, the inner catheter is movably assembled in the sheath lumen of the outer sheath tube, the inner catheter includes a detachable connected catheter main body and a split catheter, the catheter main body is provided with a first perfusion channel, the split catheter is provided with a second perfusion channel, and the first perfusion channel and the second perfusion channel are used to communicate with each other when the catheter main body and the split catheter are connected;

[0017] The balloon, the balloon is connected to the split catheter, and the perfusion outlet of the second perfusion channel is communicated with the inflatable lumen of the balloon.

[0018] In one embodiment, the catheter main body is provided with a first catheter lumen, the split catheter is provided with a second catheter lumen, the first catheter lumen and the second catheter lumen are used to communicate with each other when the catheter main body and the split catheter are connected, and the first catheter lumen and the second catheter lumen are used to thread a guide wire.

[0019] In one embodiment, the balloon has a distal balloon port and a proximal balloon port, the balloon is sleeved outside the split catheter, both the distal balloon port and the proximal balloon port are hermetically connected to the outer wall of the split catheter, and the perfusion outlet of the second perfusion channel is located on the side wall of the split catheter;

[0020] Alternatively, the balloon has a proximal balloon port, and the proximal balloon port of the balloon is communicated with the perfusion outlet of the second perfusion channel.

[0021] In one embodiment, the first perfusion channel has at least one perfusion inlet; and / or,

[0022] The perfusion inlet of the first perfusion channel is connected to a perfusion catheter; and / or,

[0023] The second perfusion channel is an annular perfusion channel with an annular radial cross-section.

[0024] In one embodiment, a first connection part is provided on the catheter body, a second connection part is provided on the split catheter, and the first connection part and the second connection part are detachably connected; a first through hole is formed in the first connection part, a second through hole is formed in the second connection part, the first through hole communicates with the first perfusion channel, the second through hole communicates with the second perfusion channel, and the first through hole and the second through hole are used to communicate with each other when the first connection part and the second connection part are connected.

[0025] The present application provides an application of the balloon, or the balloon in the balloon delivery system, in the occlusion of arterial dissection and / or blood vessels.

[0026] In the above-mentioned balloon, balloon delivery system and application of the balloon, in the balloon delivery system, after the balloon in a contracted state is delivered to a designated position in the body, the liquid filling substance can be solidified into a solid state in the inflatable inner cavity of the balloon. After the solidification is completed, the balloon can be shaped accordingly, so that the balloon can adapt to the shape of the surrounding environment and automatically construct a shape adapted to the surrounding environment, thereby fully and effectively occluding the blood flow at the designated position and promoting thrombosis in the false lumen of the dissection, the endoleak area around the vascular stent or the aneurysm. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 It is a schematic structural diagram of a balloon delivery system provided by an embodiment of the present application.

[0028] Figure 2 As Figure 1 shown, it is an exploded structural diagram of the balloon delivery system.

[0029] Figures 3 to 5 As Figure 1 shown, it is a schematic diagram of the filling process of the balloon delivery system.

[0030] Figure 6 As Figure 1 shown, it is a partial cross-sectional view of the balloon delivery system.

[0031] Figure 7 As Figure 1 shown, it is a schematic diagram of the first filling method of the balloon delivery system.

[0032] Figure 8 Schematic diagram of the second inflation mode of the balloon delivery system as shown in Figure 1 Figure

[0033] Figure 9 Schematic diagram of the structure of the balloon delivery system provided by another embodiment of the present application.

[0034] Figure 10 Schematic diagram of the explosion structure of the balloon delivery system as shown in Figure 9 Figure

[0035] Figures 11 to 13 Schematic diagram of the inflation process of the balloon delivery system as shown in Figure 9 Figure

[0036] Figure 14 Schematic diagram of the partial cross-sectional view of the balloon delivery system as shown in Figure 9 Figure

[0037] Figure 15 Schematic diagram of the first inflation mode of the balloon delivery system as shown in Figure 9 Figure

[0038] Figure 16 Schematic diagram of the second inflation mode of the balloon delivery system as shown in Figure 9 Figure

[0039] Figures 17a to 17f Schematic diagram of the usage process of the balloon delivery system provided by an embodiment of the present application.

[0040] Figures 18a to 18c Schematic diagram of the blood flow change before and after treatment by the balloon delivery system provided by an embodiment of the present application.

[0041] Figure 19a And Figure 19b Schematic diagram of the balloon delivery system provided by an embodiment of the present application for treating aortic dissection alone.

[0042] Figure 20a And Figure 20b Schematic diagram of the balloon delivery system provided by an embodiment of the present application for treating aortic aneurysm in cooperation with a covered stent.

[0043] Figure 21 Schematic diagram of the balloon delivery system provided by an embodiment of the present application for occluding the body lumen alone.

[0044] Reference numerals in the drawings:

[0045] 100. Balloon delivery system; 200. Covered stent; 300. Aneurysm;

[0046] 1000, outer sheath tube; 2000, inner catheter; 3000, balloon; 4000, first connection part; 5000, second connection part;

[0047] 2100, catheter main body; 2200, split catheter;

[0048] 2100a, first perfusion channel; 2200a, second perfusion channel;

[0049] 2200b, second catheter lumen;

[0050] 2100a1, perfusion inlet; 2100a2, perfusion catheter;

[0051] 3000a, inflatable lumen; 3000b, distal balloon port; 3000c, proximal balloon port;

[0052] 4000a, first through hole; 5000a, second through hole. Detailed implementation manners

[0053] To make the above objects, features, and advantages of the present application more obvious and understandable, the following will describe the detailed implementation manners of the present application with reference to the accompanying drawings. Many specific details are set forth in the following description to fully understand the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present application. Therefore, the present application is not limited by the specific embodiments disclosed below.

[0054] In the description of the present application, it should be understood that if terms such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or positional relationship indicated by these terms is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present application.

[0055] In addition, if terms such as "first" and "second" appear, these terms are only for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise specifically defined.

[0056] In this application, unless otherwise clearly specified and defined, if terms such as "installed", "connected", "linked", "fixed", etc. appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; 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 the communication inside two components or the interaction relationship between two components, unless otherwise clearly defined. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0057] In this application, unless otherwise clearly specified and defined, if there is a description such as a first feature being "on" or "under" a second feature, its meaning can be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature can mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is at a higher horizontal level than the second feature. The first feature being "under", "beneath" and "underneath" the second feature can be that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is at a lower horizontal level than the second feature.

[0058] It should be noted that if an element is referred to as "fixed to" or "disposed on" another element, it can be directly on the other element or there can also be an intermediate element. If an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. If so, the terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used in this application are only for the purpose of illustration and do not represent the only implementation.

[0059] To more clearly describe the structure of the balloon delivery system 100, the term "distal end" is hereby defined as the end far from the operator during the surgical operation, and the "proximal end" is defined as the end close to the operator during the surgical operation. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as those commonly understood by those skilled in the technical field to which this application belongs. The terms used in the description of this application are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0060] An embodiment of this application provides a balloon delivery system. Refer to Figure 1 、 Figure 2 and Figure 6 As shown, the balloon delivery system includes an outer sheath tube 1000, an inner catheter 2000 and a balloon 3000.

[0061] The balloon 3000 has an inflatable inner lumen 3000a for perfusing an inflating substance, and the inflating substance can solidify from a liquid state to a solid state. The balloon 3000 is applied to the occlusion of arterial dissection. The outer sheath 1000 has a through sheath lumen, and the inner catheter 2000 is movably assembled in the sheath lumen of the outer sheath 1000. The inner catheter 2000 includes a detachable connected catheter body 2100 and a split catheter 2200. The catheter body 2100 is provided with a first perfusion channel 2100a, and the split catheter 2200 is provided with a second perfusion channel 2200a. When the catheter body 2100 and the split catheter 2200 are connected, the first perfusion channel 2100a and the second perfusion channel 2200a communicate with each other. The balloon 3000 is connected to the split catheter 2200, and the perfusion outlet of the second perfusion channel 2200a communicates with the inflatable inner lumen 3000a of the balloon 3000.

[0062] The catheter body 2100 and the split catheter 2200 can be made of a polymer material and have good flexibility. The catheter body 2100 can be provided with a first catheter lumen, and the split catheter 2200 is provided with a second catheter lumen 2200b. The first catheter lumen and the catheter lumen are used to communicate with each other when the catheter body 2100 and the split catheter 2200 are connected. When the catheter body 2100 and the split catheter 2200 are connected, the guide wire can pass through the second catheter lumen 2200b and the first catheter lumen and exit distally to help the balloon delivery system be delivered into the body along a specified trajectory.

[0063] The inventive concept of this application is to combine the inflating substance with the balloon 3000 for use in a diseased site in the body to achieve the occlusion of the false lumen or a specific site and block blood supply. The balloon 3000 used in this application needs to be made of a polymer material with good elasticity, flexibility and biocompatibility, so that the balloon 3000 can fit the inner wall of the aneurysm 300, the false lumen of the dissection or other body cavities. The balloon 3000 can have a contracted state and an expanded state, and its contracted state and expanded state can be changed according to the filling of the inflating substance, and the volume of the balloon 3000 can be actively regulated as the filling amount of the inflating substance increases.

[0064] The inflating substance used in this application is not a simple ordinary solution. The inflating substance needs to have the function of solidifying from a liquid state to a solid state, which is reflected in that the inflating substance can solidify from a liquid state to a solid state at room temperature. Based on the material property that the inflating substance solidifies from a liquid state to a solid state at room temperature, the balloon 3000 can be first delivered to a specified position in the body, and then the inflating substance is perfused into the balloon 3000. At this time, the inflating substance is in a liquid state. When the balloon 3000 is in the specified position, with the morphological change property of the inflating substance, the inflating substance can gradually become a solid state.

[0065] After the balloon delivery system 100 delivers the contracted balloon 3000 to a designated position in the body, a liquid filling substance can be introduced into the inflatable lumen 3000a of the balloon 3000, such as Figure 3 and Figure 4 As shown, as the amount of the liquid filling substance introduced increases, the balloon 3000 begins to gradually expand and gradually transforms from the contracted state to the expanded state. The liquid filling substance can solidify into a solid state in the inflatable lumen 3000a of the balloon 3000, and after the solidification is completed, the balloon 3000 can be shaped accordingly. During the process of the filling substance solidifying and the balloon 3000 being shaped, the balloon 3000 can adapt to the shape of the surrounding environment and automatically construct into a shape adapted to the surrounding environment, so as to fully and effectively block the blood flow at the designated position, promote thrombosis in the false lumen of the dissection or aneurysm 300, or block the blood flow at other required sites. As Figure 5 As shown, after the operation is completed, the balloon 3000 can be left in the body to complete the treatment, and other parts of the balloon delivery system 100 are separated from the balloon 3000 and withdrawn.

[0066] As Figure 6 As shown, the balloon 3000 can have a distal balloon port 3000b and a proximal balloon port 3000c. Among them, the distal balloon port 3000b and the proximal balloon port 3000c are the openings located at the distal and proximal ends of the balloon 3000, and are respectively called the distal balloon port 3000b and the proximal balloon port 3000c. Both the distal balloon port 3000b and the proximal balloon port 3000c are in communication with the inflatable lumen 3000a. The balloon 3000 is sleeved outside the split catheter 2200, and both the distal balloon port 3000b and the proximal balloon port 3000c are hermetically connected to the outer wall of the split catheter 2200, so that the perfusion outlet of the second perfusion channel 2200a on the side wall of the split catheter 2200 is in the inflatable lumen 3000a to introduce the filling substance into the inflatable lumen 3000a. Continuing to refer to Figure 6 As shown, the second perfusion channel 2200a can be an annular perfusion channel with a radially annular cross-section. When the second catheter lumen 2200b on the split catheter 2200 is in the center, the annular perfusion channel can surround the second catheter lumen 2200b, so that the split catheter 2200 can not only pass a guide wire through the second catheter lumen 2200b, but also be used to introduce the filling substance through the annular perfusion channel. The wall thickness of the balloon body of the balloon 3000 is between 0.01 mm and 1 mm. For example, the wall thickness of the balloon body of the balloon 3000 is 0.01 mm, 0.02 mm, 0.03 mm, 0.04 mm, 0.05 mm, 0.06 mm, 0.07 mm, 0.08 mm, 0.09 mm, 0.1 mm, etc., which are not limited here.

[0067] This application uses the combined use of a filling substance and balloon 3000, which has lower cost and better compliance compared to coil embolization devices made of precious metals. It has higher safety compared to sponges, simple hydrogels, and particulate embolization materials. The filling substance is wrapped by the balloon 3000, which can effectively prevent leakage into other parts and avoid causing the risk of embolization to normal blood vessels. In addition, the combined use of the filling substance and balloon 3000 can not only be used for the treatment of dissections or aneurysms 300, but also as an auxiliary device for other surgical treatments that require blood flow interruption, which is not limited here.

[0068] The curing method of the filling substance can include at least one of covalent cross-linking and non-covalent cross-linking, and the filling substance can be defined to solidify from a liquid form to a solid form within 1 minute to 60 minutes. For example, the filling substance can be defined to solidify from a liquid form to a solid form within 1 minute, 5 minutes, 10 minutes, 20 minutes, 25 minutes, 30 minutes, 45 minutes, 50 minutes, 60 minutes, etc. After the liquid filling substance solidifies into a solid state, it needs to have good mechanical properties so that its solid form can not only fix the shape of the balloon 3000, but also withstand the movement of surrounding biological tissues without breaking or permanent deformation in the body. Moreover, the filling substance also needs to have good biocompatibility, including blood compatibility, cell compatibility, and tissue compatibility, etc.

[0069] In one embodiment, the filling substance can use a hydrogel raw material solution, which can present as a liquid form before the balloon 3000 is delivered to a designated position in the body. After the balloon 3000 is delivered to the designated position in the body, the hydrogel raw material solution can gradually gelate within 1 minute to 60 minutes through covalent cross-linking or non-covalent cross-linking, etc., and then gradually solidify from a liquid form to a solid form. The hydrogel raw material solution can be gelated by mixing multiple components and injecting them into the inflatable lumen 3000a of the balloon 3000 at the same time, or can be mixed evenly in vitro and then delivered into the inflatable lumen 3000a of the balloon 3000 together and then gelate. For example Figure 7 and Figure 8 As shown, the proximal end of the first perfusion channel 2100a can have one or more perfusion inlets 2100a1, and the perfusion inlet 2100a1 of the first perfusion channel 2100a can also be connected with a perfusion catheter 2100a2 according to requirements. The input of the filling substance can be directly communicated with the perfusion inlet 2100a1 through a syringe to input the filling substance into the inflatable lumen 3000a of the balloon 3000. Alternatively, the input of the filling substance can also be communicated with the perfusion catheter 2100a2 through a syringe, and the filling substance can be input into the inflatable lumen 3000a of the balloon 3000 through the perfusion catheter 2100a2.

[0070] A developing function can be incorporated into the balloon delivery system 100. For example, in one embodiment, the hydrogel raw material solution contains a contrast agent that can be uniformly dispersed in water, and the developing function is achieved through the contrast agent. After the hydrogel raw material solution is mixed with a clinically used water-soluble contrast agent, a homogeneous solution can be formed without phase separation and without significantly affecting the gelation of the hydrogel raw material solution and the properties of the gel after gelation. Alternatively, a developing element can be provided on the balloon 3000 to achieve the developing function for indicating the position of the balloon 3000. The developing element can be made of materials such as tantalum, platinum, gold, iridium, and their alloys, which are not limited herein.

[0071] In one embodiment, the balloon 3000 can be made of a polyurethane film material, the developing element is made of a platinum-gold alloy, and the hydrogel raw material solution filled in the inflatable lumen 3000a of the balloon 3000 is a mixed solution of glutaraldehyde and gelatin. A certain concentration of iohexol contrast agent is added to the gelatin solution, and by adjusting the concentration and volume ratio, the time for it to solidify into a hydrogel is 10 minutes.

[0072] Continue to refer to Figures 9 to 16 As shown, the balloon 3000 in another balloon delivery system 100 can be connected to the split catheter 2200 using a different scheme. Refer to Figure 14 As shown, at this time, the balloon 3000 may only have a proximal balloon port 3000c, and the proximal balloon port 3000c of the balloon 3000 communicates with the perfusion outlet of the second perfusion channel 2200a, so that the perfusion outlet of the second perfusion channel 2200a can communicate with the inflatable lumen 3000a through the proximal balloon port 3000c for inputting a filling substance into the inflatable lumen 3000a. The rest of the balloon delivery system 100 in this embodiment can refer to the balloon delivery system 100 in Figures 1 to 8 which is not limited herein. Comparing the two embodiments, in the balloon delivery system 100 in Figures 1 to 8 , the perfusion outlet of the second perfusion channel 2200a can be located inside the inflatable lumen 3000a of the balloon and can release the filling substance from the center to the periphery, which is more suitable for relatively tortuous lumens and has stronger delivery ability. In the balloon delivery system 100 in Figures 9 to 16 , the perfusion outlet of the second perfusion channel 2200a can be located at the proximal end of the balloon, and the filling substance is released from the proximal balloon port 3000c. The inflated volume of the balloon 3000 is easier to adjust, and the shape and size of the balloon 3000 are not restricted by the split catheter 2200 present in its inflatable lumen 3000a.

[0073] Regarding the above two embodiments, see Figures 12 to 14, the catheter body 2100 and the separable catheter 2200 can be detachably connected in various ways such as snap connection, threaded connection, magnetic connection, etc. A first connection portion 4000 is provided on the catheter body 2100, and a second connection portion 5000 is provided on the separable catheter 2200. The first connection portion 4000 and the second connection portion 5000 can be detachably connected by means of snap connection, threaded connection, magnetic connection, etc. In one embodiment, a first through hole 4000a is formed in the first connection portion 4000, and a second through hole 5000a is formed in the second connection portion 5000. The first through hole 4000a communicates with the first perfusion channel 2100a, and the second through hole 5000a communicates with the second perfusion channel 2200a. The first through hole 4000a and the second through hole 5000a are used to communicate with each other when the first connection portion 4000 and the second connection portion 5000 are connected. After the balloon delivery system 100 delivers the deflated balloon 3000 to a designated position in the body, a liquid filling substance can be input into the inflatable lumen 3000a of the balloon 3000 through the second perfusion channel 2200a, the second through hole 5000a, the first through hole 4000a, and the first perfusion channel 2100a. After the operation is completed, the first connection portion 4000 and the second connection portion 5000 can be separated, the balloon 3000 is left in the body to complete the treatment, and the other parts of the balloon delivery system 100 are separated from the balloon 3000 and withdrawn.

[0074] Refer to Figures 17a to 17f The treatment scenario shown is to assist the aortic stent-graft 200 in treating aortic dissection, and its purpose is to fill the distal tear. Due to reasons such as endoleak, new tears may appear at the distal end of the aorta. If another stent-graft 200 is placed, it may cause the relevant branch arteries to be blocked. Therefore, such tears need to be separately occluded. The balloon delivery system 100 of the present application can first use a guide wire to extend into the dissection through the tear, and then push the inner catheter 2000 and the outer sheath 1000 to the designated position along the guide wire. Subsequently, the balloon 3000 is introduced along the guide wire to the designated position. After the outer sheath 1000 is withdrawn, a part of the balloon 3000 is exposed in the false lumen. At this time, the outer sheath 1000 does not expose the first connection portion 4000 and the second connection portion 5000, ensuring that the first connection portion 4000 and the second connection portion 5000 are in a clamped state, so that the catheter body 2100 and the separable catheter 2200 are not separated. A filling substance is filled into the inflatable lumen 3000a of the balloon 3000 to expand the balloon 3000 to the required size. After the filling substance is cured after a period of time, the outer sheath 1000 is further withdrawn to expose the first connection portion 4000 and the second connection portion 5000, and the catheter body 2100 is swung or rotated to release the clamping between the first connection portion 4000 and the second connection portion 5000. Subsequently, the balloon delivery system 100 and other consumables are withdrawn. Among them, Figures 18a to 18cThis is a schematic diagram comparing the blood flow directions before and after the treatment of the balloon delivery system 100 of the present application. It can be clearly seen that the arterial dissection is blocked and the blood flow is normal.

[0075] The balloon 3000 is a compliant balloon. The maximum deformed volume of the balloon 3000 is more than twice the nominal volume. Among them, the maximum deformed volume of the balloon 3000 refers to when the balloon 3000 is filled with a filling substance, the balloon 3000 will expand. Since the balloon 3000 is a compliant balloon, the volume of the balloon 3000 can change, and the maximum deformed volume refers to the maximum volume that the balloon 3000 can stably expand and not rupture in the extreme state. Correspondingly, the nominal volume refers to the maximum volume of the balloon 3000 before elastic deformation.

[0076] In addition, as Figure 19a and Figure 19b shown, the balloon 3000 in the balloon delivery system 100 of the present application can also be used alone for blood flow occlusion of aortic dissection, expanding to several times the nominal volume to achieve one-time occlusion of multiple ruptures. As Figure 20a and Figure 20b shown, the balloon delivery system 100 of the present application can also cooperate with an aortic covered stent 200 to treat an aortic aneurysm 300. At this time, the stent can be placed first to isolate the blood flow from the aneurysm 300 cavity, and then the balloon 3000 is placed and a filling substance is input to completely occlude the aneurysm cavity. As Figure 21 shown, the balloon delivery system 100 of the present application can also be used alone to block the body lumen. At this time, the balloon 3000 can be placed in a lumen such as a blood vessel and a filling substance is input to block the subsequent branch pipelines, and can be used in treatment scenarios such as tumor blood vessel occlusion. Those skilled in the art can refer to the above methods to apply the balloon delivery system 100 of the present application in other suitable scenarios, such as delivering the balloon 3000 to the aortic aneurysm 300, the body lumen, etc. mentioned above, which are not limited herein. The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as the combinations of these technical features do not conflict, they should all be considered as within the scope described in this specification.

[0077] The above-described embodiments only express several implementation manners of the present application, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. A balloon, characterized in that, The balloon has an inflatable lumen, and the inflatable lumen of the balloon is configured to be perfused with a filling substance, and the filling substance can be solidified from a liquid form to a solid form.

2. The balloon according to claim 1, characterized in that, The balloon is a compliant balloon, and the maximum deformation volume of the balloon is more than twice the nominal volume; and / or, The filling substance can be solidified from a liquid form to a solid form at room temperature; and / or, The solidification method of the filling substance includes at least one of covalent crosslinking and non-covalent crosslinking; and / or, The filling substance can be solidified from a liquid form to a solid form within 1 minute to 60 minutes; and / or, A visualization element is provided on the balloon; and / or, The wall thickness of the balloon body is between 0.01 mm and 1 mm.

3. The balloon according to claim 2, characterized in that, The filling substance is a hydrogel raw material solution.

4. The balloon according to claim 3, characterized in that, The hydrogel raw material solution contains a contrast agent.

5. A balloon delivery system, characterized in that, The balloon delivery system includes: An outer sheath tube, and the outer sheath tube has a through sheath lumen; An inner catheter, and the inner catheter is movably assembled in the sheath lumen of the outer sheath tube. The inner catheter includes a detachable catheter main body and a split catheter. The catheter main body is provided with a first perfusion channel, and the split catheter is provided with a second perfusion channel. The first perfusion channel and the second perfusion channel are used to communicate with each other when the catheter main body and the split catheter are connected; The balloon according to any one of claims 1 to 4, the balloon is connected to the split catheter, and the perfusion outlet of the second perfusion channel is communicated with the inflatable lumen of the balloon.

6. The balloon delivery system according to claim 5, characterized in that, The catheter main body is provided with a first catheter lumen, and the split catheter is provided with a second catheter lumen. The first catheter lumen and the second catheter lumen are used to communicate with each other when the catheter main body and the split catheter are connected. The first catheter lumen and the second catheter lumen are used to thread a guide wire.

7. The balloon delivery system according to claim 6, characterized in that, The balloon has a distal balloon port and a proximal balloon port. The balloon is sleeved outside the split catheter, and both the distal balloon port and the proximal balloon port are hermetically connected to the outer wall of the split catheter. The perfusion outlet of the second perfusion channel is located on the side wall of the split catheter; or, The balloon has a proximal balloon port, and the proximal balloon port of the balloon is communicated with the perfusion outlet of the second perfusion channel.

8. The balloon delivery system according to claim 5, characterized in that, The first perfusion channel has at least one perfusion inlet; and / or, A perfusion catheter is connected to the perfusion inlet of the first perfusion channel; and / or, The second perfusion channel is a ring-shaped perfusion channel with an annular radial cross-section.

9. The balloon delivery system according to claim 5, characterized in that, A first connection part is provided on the catheter main body, and a second connection part is provided on the split catheter. The first connection part and the second connection part are detachably connected; a first through hole is provided in the first connection part, and a second through hole is provided in the second connection part. The first through hole is communicated with the first perfusion channel, and the second through hole is communicated with the second perfusion channel. The first through hole and the second through hole are used to communicate with each other when the first connection part and the second connection part are connected.

10. Use of a balloon as claimed in any one of claims 1 to 4, or a balloon in a balloon delivery system as claimed in any one of claims 5 to 9, in the occlusion of arterial dissection and / or blood vessels.

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