Conical gradually-changing high-compliance balloon

Abstract

The invention provides a conical gradually-changing high-compliance balloon, and relates to the field of interventional vascular surgery. The conical gradually-changing high-compliance balloon comprises a balloon body, one end of the balloon body is communicated with a tube head, the other end of the balloon body is communicated with a sleeve, a conical positioning head is installed at one end of the sleeve in a sliding mode, in the initial state, the tube head vacuumizes the balloon body, a plurality of folding areas distributed in the circumferential direction are formed in the balloon body, and the folding gaps are used for containing chemical agents. According to the conical gradually-changing high-compliance balloon, in the expansion process, when the folding gap and the balloon body are unfolded to achieve synchronous drug release and the folding area is unfolded, chemical agents originally sealed in the gap are gradually extruded out along with separation of the folding face, the release path is consistent with the expansion direction of the balloon, and the balloon expands to push the agents to directly make contact with the lesion blood vessel wall, so that the drug release effect is improved. The problems that a traditional balloon drug is prone to falling off in advance after being coated, and cavity filling and releasing are lagged are solved.

Description

Technical Field

[0001] This invention relates to the field of interventional vascular surgery, specifically to a tapered, highly compliant balloon. Background Technology

[0002] In interventional vascular surgery, a balloon is a foldable, inflatable, minimally invasive medical device, typically used in conjunction with a guidewire (for guidance) and a catheter. Its core design is that it is "slender and folded when undilated (adapting to the vascular access), and balloon-shaped when inflated (adhering to the vessel wall)." The balloon's core clinical functions include: physically opening the channel to clear narrowed lesions; adhering to the vessel wall; and assisting in the precise positioning and shaping of stents. The guidewire acts as a "guide rope," guiding the balloon to the narrowed segment of the vessel. The undilated balloon is like a "closed-up support," flexibly passing through the narrow "gap." The inflated balloon is like an "open support," pushing the "obstacles (plaques)" at the narrowed area to both sides while adhering to the vessel wall without damaging it. If a stent is needed, the balloon acts as a "stent shaping mold," precisely shaping the stent to fit the vessel.

[0003] In current interventional treatments, traditional balloons lack a dedicated structure for drug storage and simultaneous release. Drugs are often directly coated on the surface or filled into the cavity, which can easily detach and be lost during advancement. Alternatively, drug release may be delayed after balloon dilation, failing to precisely coordinate with the dilation action. This makes it difficult for drugs to form an effective concentration in the lesion area, affecting the treatment outcome. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides a tapered, highly compliant balloon that solves the problems mentioned in the background section.

[0005] To achieve the above objectives, the present invention is implemented through the following technical solution: a cone-shaped, gradually increasing high compliance balloon, comprising a balloon body, one end of which is connected to a tube head, and the other end of which is connected to a sleeve, wherein a cone-shaped positioning head is slidably mounted on one end of the sleeve; In the initial state, the tube head evacuates the balloon body, causing the balloon body to form several circumferentially distributed folded areas, and the gaps between the folds are used to fill chemical agents. The stent is compressed and tightly wrapped around the outer surface of the balloon body.

[0006] When gas is injected into the balloon through the tube tip, the folded area of ​​the balloon unfolds, its cross-section forms a circle, and the chemical agent is released. The expanded sac gradually decreases in thickness from both ends to the middle, causing its outer surface to form a concave shape.

[0007] Preferably, the positioning head includes a miniature piston, a connector, and several elastic connecting pieces distributed circumferentially along the miniature piston, with the elastic connecting pieces fixed between the piston and the connector.

[0008] Preferably, the elastic connecting piece begins to deform and store force when it is inside the sleeve, and is in a bent state when it is detached from the sleeve.

[0009] Preferably, the elastic connecting piece has an arc-shaped curved shape, with its length near the piston being greater than its length near the connector end, and the bending amplitude near the piston end being less than that near the connector end.

[0010] Preferably, a cone-shaped guide head is fixedly installed at the end of the connector away from the piston. A guide wire is fixedly connected inside the guide head, and the guide wire is fixedly connected to the piston. Both ends of the guide wire pass through the guide head and extend to the outside of the tube head.

[0011] Preferably, the balloon body is provided with a catheter that is fixed relative to the tube head, the folded part of the balloon body abuts against the outer side of the catheter, and the length of the catheter is less than the length of the balloon body.

[0012] Preferably, a limit cap is fixedly connected to one end of the sleeve near the positioning head.

[0013] Preferably, the end of the tube head furthest from the balloon body is connected to the trachea, and gas is injected from one end of the trachea.

[0014] Preferably, the balloon body is made of a soft polymer material.

[0015] Compared with existing technologies, this invention has the following advantages: By setting a tapered guide head and guidewire, the advancement resistance at calcified and diffuse stenosis is significantly reduced, avoiding jamming. The folded gaps in the balloon body store drugs, achieving simultaneous expansion and drug release. The concave shape directionally constrains the drug, increasing the target concentration and reducing waste and stimulation of normal blood vessels. During expansion, the folded gaps and the balloon body's unfolding action achieve synchronous drug release. As the folded area expands, the chemical agent originally sealed in the gap is gradually squeezed out as the folded surface separates. The release path is consistent with the balloon expansion direction. The balloon expansion pushes the drug to directly contact the diseased blood vessel wall, solving the problems of traditional methods. To address the issues of premature drug detachment from balloons and delayed release due to chamber filling, this design achieves precise synergy of "drug release upon expansion." Simultaneously, after expansion, the balloon forms a concave shape with decreasing thickness from both ends to the middle, creating a constraint of "convergence in the middle and blocking at both ends." The thicker areas at both ends of the balloon adhere tightly to the vessel wall after expansion, forming a physical barrier that restricts drug leakage into normal vessel segments. Meanwhile, the concave area in the middle precisely corresponds to the lesion target area, allowing the drug to accumulate within the concave space, significantly increasing the drug concentration at the lesion site, reducing drug waste, and preventing drug irritation of the normal vascular endothelium, thus avoiding complications such as inflammation and thrombosis. Attached Figure Description

[0016] Figure 1 This is a schematic diagram of the balloon and stent structure after expansion according to the present invention; Figure 2 For the present invention Figure 1 An enlarged view of the structural schematic diagram at point A in the middle; Figure 3 This is a cross-sectional view of the front view of the balloon body of the present invention; Figure 4 For the present invention Figure 3 An enlarged view of the structural schematic diagram at point C; Figure 5 For the present invention Figure 3 An enlarged view of the structural schematic diagram at point B in the middle; Figure 6 This is a cross-sectional view of the folded region beginning to unfold during the initial expansion of the balloon body of the present invention; Figure 7 This is a partial schematic diagram of the concave cross-section of the outer periphery of the balloon of the present invention; Figure 8 This is a schematic diagram of the preoperative contraction of the balloon body of the present invention; Figure 9 For the present invention Figure 8 An enlarged view of the structural schematic diagram at point D; Figure 10 This is a partial sectional view of the sleeve of the present invention; Figure 11 This is a schematic diagram of the positioning head structure of the present invention.

[0017] In the diagram: 1. Balloon body; 101. Folding area; 102. Chemical agent; 2. Tube tip; 3. Sleeve; 4. Positioning head; 401. Miniature piston; 402. Connector; 403. Elastic connecting piece; 5. Guide head; 6. Guide wire; 7. Catheter; 8. Limiting cap; 9. Trachea; 10. Stent. Detailed Implementation

[0018] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0019] It should be noted that all directional indications in the embodiments of this application are only used to explain the relative positional relationship and movement of each component in a specific posture. If the specific posture changes, the directional indications will also change accordingly.

[0020] In this application, unless otherwise expressly specified and limited, the terms "connection," "fixed," etc., should be interpreted broadly. For example, "fixed" can mean a fixed connection, a detachable connection, or an integral part; it can mean a mechanical connection or an electrical connection; it can mean a direct connection or an indirect connection through an intermediate medium; it can mean the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0021] Furthermore, the use of terms such as "first" and "second" in this application is for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of those features. Additionally, the technical solutions of the various embodiments can be combined with each other, but only on the basis of being achievable by those skilled in the art. If the combination of technical solutions is contradictory or impossible to implement, such a combination of technical solutions should be considered non-existent and not within the scope of protection claimed in this application.

[0022] like Figures 1-11As shown, a tapered, highly compliant balloon includes a balloon body 1. One end of the balloon body 1 is connected to a tube head 2, and the other end is connected to a sleeve 3. A tapered positioning head 4 is slidably mounted on one end of the sleeve 3. The positioning head 4 includes a miniature piston 401, a connecting head 402, and several elastic connecting pieces 403 distributed circumferentially along the miniature piston 401. The elastic connecting pieces 403 are fixed between the piston and the connecting head 402. The elastic connecting pieces 403 are deformable and can be easily hidden inside the sleeve 3. When inside the sleeve 3, the elastic connecting piece 403 begins to deform and store energy. When it detaches from the sleeve 3, it is in a bent state. The deformation and energy storage within the sleeve 3 keep the connecting piece compact, facilitating the entire balloon's passage through the narrow channel. After detaching from the sleeve 3, it automatically bends to conform to the inner wall of the blood vessel, achieving an automatic positioning effect. The elastic connecting piece 403 has an arc-shaped bend, with its length near the piston greater than its length near the connector 402, and the bending amplitude near the piston less than that near the connector 402. During the bending process, as the positioning head 4 disengages from the sleeve 3, the radius of the positioning head 4 gradually increases under the elastic action of the elastic connecting piece 403, rather than increasing instantaneously. The contact pressure of the elastic connecting piece 403 on the blood vessel wall increases gradually (rather than instantaneously), avoiding traction and tearing of the blood vessel wall caused by instantaneous expansion. This is suitable for the fragile vascular intima around stenotic lesions, reducing the risk of vascular intima damage. A conical guide head 5 is fixedly installed at the end of the connecting head 402 away from the piston. A guide wire 6 is fixedly connected inside the guide head 5. The guide wire 6 is fixedly connected to the piston. Both ends of the guide wire 6 pass through the guide head 5 and extend to the outside of the tube head 2. The conical guide head 5 has the smallest contact area at its tip, which can penetrate the stenotic inlet, making it especially suitable for advancing blood vessels with severe stenosis. The end of the tube head 2 away from the balloon body 1 is connected to the trachea 9. Gas is injected from one end of the trachea 9. The balloon body 1 is made of a soft polymer material, such as polyamide elastomer (PAE), thermoplastic polyurethane (TPU), or silicone rubber, which can better adhere to irregular blood vessel walls and reduce the risk of damage.

[0023] In the initial state, the tube head 2 evacuates the balloon body 1, causing the balloon body 1 to form several circumferentially distributed folded areas 101. The gaps between the folds are used to store chemical agents 102. The stent 10 is compressed and tightly wrapped around the outer surface of the balloon body 1. The folded gaps are specifically for storing chemical agents 102. When the balloon is inflated and deployed, the folded areas 101 expand synchronously, and the drug is released immediately with the deployment, solving the problem of premature drug detachment or delayed release in traditional methods. After deployment, the concave shape with decreasing thickness from both ends to the middle forms a "converging in the middle and blocking at both ends" effect. The structure restricts drug leakage into normal blood vessel segments, increases drug concentration in the lesion target area, and reduces drug waste and stimulation of normal blood vessels. The balloon body 1 is equipped with a catheter 7 fixed relative to the tube head 2. The folded part of the balloon body 1 abuts against the outer surface of the catheter 7. The length of the catheter 7 is less than the length of the balloon body 1. The catheter 7 provides internal support for the balloon folding, making the circumferential folding area 101 uniform in shape and avoiding uneven unfolding caused by folding disorder. The sleeve 3 is fixedly connected to a limit cap 8 at one end near the positioning head 4. When the piston moves to the maximum stroke position, it abuts against the inner wall of one end of the limit cap 8, limiting the maximum stroke of the piston and preventing excessive air pressure from causing the positioning head 4 to extend excessively.

[0024] When the tube head 2 injects gas into the balloon body 1, the folded area 101 of the balloon body 1 unfolds, and its cross-section forms a circle, releasing the chemical agent 102.

[0025] After unfolding, the thickness of the spherical body 1 gradually decreases from both ends to the middle, causing its outer surface to form a concave shape.

[0026] The conical positioning head 4 reduces the contact area with the stenotic inlet, and the circumferentially regular folded area 101 formed by vacuuming avoids messy fold patterns, reducing friction with the blood vessel wall and lesion tissue during advancement. With the guidance of the guide wire 6, it ensures that the balloon can smoothly penetrate dense stenosis (such as calcification and diffuse stenosis).

[0027] Before use, the balloon needs to be pre-positioned to lay the foundation for interventional treatment. First, a vacuum is drawn into the balloon body 1 through the trachea 9. Using the negative pressure, the balloon body 1 forms several circumferentially evenly distributed folded areas 101 along the outer side of the internal catheter 7. The catheter 7 serves as an internal support structure, and its length is less than that of the balloon body 1. This provides a regular reference surface for folding and avoids excessive constraint on the deformation space in the middle of the balloon, ensuring that the folded areas 101 have a uniform shape, uniform gaps, and no messy patterns. At this time, the closed gaps formed by the folded areas 101 serve as dedicated drug storage chambers. The target chemical agent 102 (such as antiplatelet drugs or vasodilators) is loaded into them. The chemical agent 102 is sealed within the folded gaps to prevent pre-operative leakage.

[0028] Subsequently, the treatment stent 10 is compressed and tightly wrapped around the outer surface of the balloon body 1. The compressed shape of the stent 10 perfectly matches the contour of the folded balloon. With the help of the surface tension of the folded balloon and the elastic contraction force of the stent 10 itself, the stent 10 is stably pre-installed, avoiding displacement during transportation or intervention. At the same time, the positioning head 4 is in the initial storage state: the elastic connecting piece 403 is completely contained in the sleeve 3, and deforms and stores force under the constraint of the inner wall of the sleeve 3, maintaining a compact and closed state. The tapered guide head 5 is fixedly connected to the guide wire 6. The two ends of the guide wire 6 pass through the guide head 5 and extend to the outside of the tube head 2, forming a through-type guide structure. The doctor can precisely control the direction of the positioning head 4 by operating the guide wire 6 externally. In addition, the balloon body 1 is made of a soft polymer material such as polyamide elastomer (PAE), thermoplastic polyurethane (TPU) or silicone rubber. This type of material has no permanent creases in the initial folded state and can withstand repeated deformation, which is beneficial to subsequent expansion work.

[0029] In the initial state, the balloon body 1 has the smallest diameter (to match the size of the vascular intervention channel), the positioning head 4 has a conical and compact structure, the stent 10 fits tightly with the balloon body 1, and the drug is sealed in the fold gap. All the structures work together to ensure that the balloon has the intervention prerequisite of "small size and high stability".

[0030] During intervention, the physician guides the balloon along the vascular pathway using an externally operated guidewire 6. The core utilizes multiple structures to reduce resistance at the site of stenosis. First, the tapered guide tip 5 acts as a "barrier-breaking guide": its tip has the smallest contact area, allowing precise aiming at the entrance to the stenotic lesion (such as calcified plaque gaps or diffuse stenosis), concentrating the propulsion force at the tip for effective penetration of dense stenotic lesions. Simultaneously, the balloon body 1's circumferentially regular folded structure reduces propulsion resistance. Compared to the chaotic folds of traditional balloons, the evenly distributed folding areas 101 in this design allow for better balloon penetration. With no protruding edges or corners on the surface, the contact area with the blood vessel wall and lesion tissue is reduced, thus lowering the coefficient of friction. The compact design of the superimposed elastic connecting piece 403 housed within the sleeve 3 minimizes the overall radial space occupied by the positioning head 4, avoiding jamming caused by exposed connecting pieces. In addition, the surface of the soft polymer balloon body 1 is smooth and has a certain degree of flexibility, allowing it to deform slightly with the blood vessel wall during advancement, further reducing traction friction and avoiding pretreatment damage to the vascular intima. Through the synergy of the above structures, the balloon can smoothly penetrate complex stenosis lesions such as calcification and diffuse stenosis, solving the problems of traditional balloon advancement jamming and the need for external force to push it.

[0031] Once the front end of the balloon 1 reaches the target lesion area, it needs to be stably anchored by the positioning head 4 to provide a reference for subsequent expansion and drug release. At this time, a small amount of gas is slowly injected through the trachea 9. The initial air pressure pushes the balloon 1 to expand slightly, while driving the micro piston 401 to move away from the balloon 1 along the sleeve 3. As the piston moves, the elastic connecting piece 403 gradually detaches from the constraint of the inner wall of the sleeve 3. During the detachment process, since the sleeve 3 no longer restricts the deformation of the connecting piece, its preoperative stored elastic potential energy is gradually released, transitioning from a retracted state to a bent state. The connecting piece has an arc-shaped bend, with the length near the piston being greater than that near the connector 402 and the bending amplitude being smaller. This structure allows the radius of the positioning head 4 to increase gradually, rather than expanding instantaneously. Specifically, in the initial stage of the connecting piece detaching from the sleeve 3, only the small-length, large-bending segment near the connector 402 unfolds first, and the radius of the positioning head 4 increases slightly and initially contacts the vessel wall. As the piston continues to move, the large-length, small-bending segment near the piston gradually unfolds, and the radius of the positioning head 4 continues to increase. The contact pressure gradually increases from the initial slight contact to a stable anchoring pressure. This gradual contact design avoids the impact of instantaneous expansion on the fragile vascular intima around the stenotic lesion, and the contact pressure is evenly transmitted, effectively reducing the risk of vascular traction and tearing.

[0032] When the miniature piston 401 moves to its maximum stroke, one end of it comes into close contact with the inner wall of the limiting cover 8. The limiting cover 8 restricts the piston from moving further by mechanically blocking it, preventing excessive air pressure from causing the positioning head 4 to extend excessively, and ensuring that the relative position of the balloon body 1 and the target lesion area is fixed. At this time, the flexible connecting piece 403 in a bent state fits against the inner wall of the blood vessel and forms a stable anchor with the blood vessel wall through friction, preventing the balloon from shifting axially during subsequent expansion, and providing a guarantee for precise expansion and drug release.

[0033] After positioning, gas is continuously injected through the trachea 9. The gas pressure is transmitted to the inside of the balloon body 1 along the trachea 9, initiating a coordinated process of dilation, drug release, and stent 10 deployment. The gas pressure acts on the inner wall of the balloon body 1, pushing the balloon body 1 to gradually unfold from a circumferential folded state. Since the catheter 7 provides internal support for the balloon body 1, the folded area 101 unfolds orderly along the outer side of the catheter 7, avoiding local sudden expansion or uneven unfolding caused by disordered folding of traditional balloons. As the gas pressure increases, the cross-section of the balloon body 1 gradually forms a regular circle. Its expansion process presents a gradual pattern of "expansion at both ends first, and then complete unfolding in the middle", which is adapted to the physiological morphology of blood vessels.

[0034] like Figure 6As shown, during expansion, the folded gap and the deployment of the balloon body 1 enable synchronous drug release: when the folded area 101 expands, the chemical agent 102 originally sealed in the gap is gradually squeezed out as the folded surface separates, and the release path is consistent with the balloon expansion direction. The balloon expansion pushes the agent to directly contact the diseased blood vessel wall, solving the problems of premature drug coating and delayed release when the chamber is filled in traditional balloons, and achieving precise synergy of "expansion and drug release". At the same time, after expansion, the balloon body 1 forms a "concave shape with decreasing thickness from both ends to the middle". This structure forms a constraint of "convergence in the middle and blocking at both ends". The thicker areas at both ends of the balloon adhere tightly to the blood vessel wall after expansion, forming a physical barrier to limit the leakage of drugs into normal blood vessel segments. The concave area in the middle corresponds exactly to the lesion target area, allowing the drug to accumulate in the concave space, significantly increasing the drug concentration at the lesion site, reducing drug waste, and avoiding drug stimulation of the normal blood vessel intima, which can cause complications such as inflammation and thrombosis.

[0035] Simultaneously, the stent 10 pre-installed on the outside of the balloon body 1 expands synchronously with the balloon expansion. The regular expansion of the balloon body 1 causes the stent 10 to be uniformly stressed, gradually expanding from a compressed state to a shape that fits the blood vessel wall. The soft polymer balloon body 1 described in claim 9 can undergo micron-level deformation with irregular blood vessel walls (such as plaque depressions or vascular undulations), ensuring that the stent 10 adheres tightly to the blood vessel wall during expansion. The concave shape of the balloon further optimizes the fit of the stent 10, preventing the stent 10 from being suspended or displaced due to irregular blood vessel walls. Throughout the expansion process, the pressure transmission of the gas medium is instantaneous and uniform, with no risk of liquid leakage. Doctors can adjust the expansion rhythm in real time through an external pressure monitoring device to ensure that the expansion force and drug release rate match the needs of the lesion.

[0036] After treatment, a vacuum is drawn in reverse through the trachea 9, reducing the air pressure inside the balloon 1. Under negative pressure, the balloon 1 folds back along the internal catheter 7, restoring its initial compact shape. At this time, the elastic connecting piece 403 loses the radial support force brought by the balloon expansion and gradually shrinks under its own elastic recovery force, re-fitting the main body of the positioning head 4, restoring its compact state, and reducing the radial space occupied during retrieval.

[0037] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. In addition, those skilled in the art can combine and integrate the different embodiments or examples described in this specification.

[0038] Furthermore, the technical solutions of the various embodiments can be combined with each other, but only if they are based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such combination of technical solutions does not exist and is not within the scope of protection claimed in this application.

[0039] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A tapered, gradually changing high compliance balloon comprising a balloon body (1), characterized in that: One end of the balloon body (1) is communicated with a pipe head (2), and the other end is communicated with a sleeve (3), and one end of the sleeve (3) is slidably provided with a tapered positioning head (4). In the initial state, the pipe head (2) is used to vacuum the balloon body (1), so that the balloon body (1) forms a plurality of circumferentially distributed folding areas (101), and the folding gap is used to load chemical agents (102), and the stent (10) is compressed and tightly wrapped on the outer surface of the balloon body (1). When the pipe head (2) injects gas into the balloon body (1), the folding area (101) of the balloon body (1) is unfolded, the cross section forms a circle, and the chemical agent (102) is released; The unfolded balloon body (1) gradually reduces the thickness from both ends to the middle, so that the outer surface forms a concave shape.

2. The tapered, progressive high compliance balloon of claim 1, wherein: The positioning head (4) includes a micro-piston (401), a connecting head (402) and a plurality of elastic connecting pieces (403) circumferentially distributed along the micro-piston (401), and the elastic connecting pieces (403) are fixed between the piston and the connecting head (402).

3. The tapered, progressive high compliance balloon of claim 2, wherein: When the elastic connecting piece (403) is in the sleeve (3), it starts to deform and store power, and when the elastic connecting piece (403) is separated from the sleeve (3), it is in a bent state.

4. The tapered high compliance balloon of claim 2, wherein: The elastic connecting piece (403) has an arc-shaped bending shape, the length of the end close to the piston is greater than the length of the end close to the connecting head (402), and the bending amplitude of the end close to the piston is less than the bending amplitude of the end close to the connecting head (402).

5. The tapered high compliance balloon of claim 2, wherein: The connecting head (402) is fixedly provided with a tapered guide head (5) away from the piston, the guide head (5) is fixedly connected with a guide wire (6), the guide wire (6) is fixedly connected with the piston, and both ends of the guide wire (6) penetrate the guide head (5) and extend to the outside of the pipe head (2).

6. The tapered high compliance balloon of claim 1, wherein: The balloon body (1) is provided with a catheter (7) fixed relative to the pipe head (2), the folded part of the balloon body (1) abuts against the outer side of the catheter (7), and the length of the catheter (7) is less than the length of the balloon body (1).

7. The tapered high compliance balloon of claim 1, wherein: The sleeve (3) is fixedly connected with a limiting cover (8) close to the positioning head (4).

8. The tapered high compliance balloon of claim 1, wherein: The pipe head (2) is communicated with an air pipe (9) away from the balloon body (1), and the gas is injected from one end of the air pipe (9).

9. The tapered high compliance balloon of claim 1, wherein: The balloon body (1) is made of soft polymer material.

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