Balloon catheter capable of automatically adjusting expansion strength according to blood vessel stenosis degree

Abstract

The invention provides a balloon catheter capable of automatically adjusting dilatation strength according to the degree of vascular stenosis, and relates to the technical field of balloon catheters.The balloon catheter comprises an inner tube, a balloon component, an outer tube component, a pipeline type flow monitoring meter, a pressure-adjustable air supply source and a controller; the pressure-adjustable air supply source supplies air to the inflation expansion space through the pipeline type flow monitoring meter and the outer pipe component, the pipeline type flow monitoring meter can obtain passing flow data Q (t), and after data processing, the air volume Vx, namely the expansion size of the bag component, in the inflation expansion space at the current moment can be obtained; and then the inflation air pressure Px is properly controlled, so that the expansion force of the balloon catheter can be stably adjusted, and the safety of a vascular operation is ensured.

Description

Technical Field

[0001] The invention relates to the technical field of balloon catheters, in particular to a balloon catheter capable of automatically adjusting the expansion force according to the degree of blood vessel stenosis. Background Art

[0002] In cardiovascular catheterization surgery, balloon catheters are often used to expand narrow areas or create passages in blood vessels. When in use, the uninflated balloon is first placed and positioned, then inflated according to the purpose of the surgery to create an exit or passage in the lumen. The catheter can be removed after the balloon is deflated.

[0003] The expansion force of the balloon catheter has a great impact on the safety of the operation. For example, a high expansion force will cause vascular damage, while a low expansion force is not conducive to the surgical operation. In the process of implanting some vascular stents, if the expansion force is low, the vascular stent may not be positioned, which seriously affects the effect of the operation. For this reason, the present invention provides a balloon catheter that can automatically adjust the expansion force according to the degree of vascular stenosis. Summary of the invention

[0004] In view of the deficiencies of the prior art, the present invention provides a balloon catheter capable of automatically adjusting the expansion force according to the degree of vascular stenosis, thereby solving the problem that the expansion force of the prior balloon catheter is difficult to adjust.

[0005] To achieve the above objectives, the present invention is implemented through the following technical solutions: A balloon catheter capable of automatically adjusting the expansion force according to the degree of vascular stenosis, comprising: Inner tube; A sac component, wherein the sac component is fixedly connected to the outer side of the inner tube, and the sac component is close to the first end of the inner tube, and an inflatable expansion space is formed between the inner side of the sac component and the outer side of the inner tube; Outer tube components, controller, and adjustable pressure gas supply source; The outer tube component is arranged outside the inner tube, the first end of the outer tube component is communicated with the inflation expansion space, and the second end of the outer tube component is located between the middle part of the inner tube and the second end of the inner tube; The second end of the outer tube component is set as an air inlet, and the air inlet of the outer tube component is connected to a pipeline flow monitor; The adjustable pressure gas supply source supplies gas to the inflation expansion space through the pipeline flow monitoring meter and the outer pipe component; The pipeline flow monitor is communicatively connected to the controller, and the adjustable pressure gas supply source is communicatively connected to the controller.

[0006] Further preferably, the controller receives flow data Q(t) measured by a pipeline flow monitor, and controls the gas supply pressure of the adjustable pressure gas supply source after data processing; The controller internally stores a (Fn, Pn, Vn) database, wherein Fn represents the expansion force, Pn represents the gas supply pressure of the adjustable pressure gas supply source, and Vn represents the gas volume inside the inflation expansion space; The operator inputs the required expansion force Fx into the controller, and the data processing unit inside the controller integrates the flow data Q(t) measured by the pipeline flow monitor to obtain the gas volume Vx inside the inflation expansion space at the current moment, and consults the (Fn, Pn, Vn) database to obtain Px, and then the controller controls the gas supply pressure of the adjustable pressure gas supply source to Px; Among them, (Fx, Px, Vx) is one set of data in the (Fn, Pn, Vn) database.

[0007] More preferably, the controller is a computer.

[0008] Further preferably, the bladder component comprises: An elastic bladder layer, both ends of which are transition parts, one end of the elastic bladder layer is fixedly connected to the inner tube, and the other end of the elastic bladder layer is fixedly connected to the outer tube component; An elastic cushion layer, wherein the elastic cushion layer is fixedly connected to the inner side of the elastic bladder layer, and a plurality of elastic cushion layers are provided, and the plurality of elastic cushion layers are distributed in a ring array; The tensioning belt has two ends fixedly connected to the inner sides of the transition parts at the two ends of the elastic bag layer respectively. The tensioning belt is located on the inner side of the elastic cushion layer, and the number of the tensioning belts is equal to the number of the elastic cushion layers.

[0009] Further preferably, the outer tube component comprises: An outer tube body, the outer tube body is sleeved on the outer side of the inner tube, a first blocking ring member and a second blocking ring member are fixedly connected between the outer tube body and the inner tube and close to the two ends of the outer tube body, at least one channel tube is fixedly connected to the inner side of the outer tube body, and a first end of the channel tube is connected to the inflation expansion space; The first end of the outer tube body is fixedly connected to the transition part of the first end of the elastic bag layer, the second end of the outer tube body is fixedly connected to the expansion part, the end of the expansion part away from the outer tube body is fixedly connected to the annular end, the annular end is fixedly connected to the inner tube, a branch pipe is fixedly provided on the side of the annular end, and the second end of the channel tube is connected to the inner side of the expansion part.

[0010] Further preferably, the outer sides of the first blocking ring member and the second blocking ring member are both provided with recesses corresponding to the channel tube.

[0011] Further preferably, at least one marking member is fixedly connected to the outside of the inner tube and inside the bag component.

[0012] Further preferably, the adjustable pressure air supply source includes an air pump and an electromagnetic pressure regulating valve.

[0013] Further preferably, a convex ring portion is fixedly provided on the outer side of the first end of the inner tube, the transition portion of the elastic bladder layer is sleeved on the convex ring portion, and the transition portion of the elastic bladder layer is fixed to the convex ring portion via an inverted cover.

[0014] Further preferably, the transition portion of the elastic bag layer is fixedly connected to the outer tube body outside the second blocking ring component.

[0015] The present invention provides a balloon catheter that can automatically adjust the expansion force according to the degree of vascular stenosis. It has the following beneficial effects: 1. The present invention is a balloon catheter that automatically adjusts the expansion force by designing an inner tube, a sac component, an outer tube component, a pipeline flow monitor, an adjustable pressure gas supply source and a controller. The adjustable pressure gas supply source supplies gas to the inflation expansion space through the pipeline flow monitor and the outer tube component. The pipeline flow monitor can obtain the passing flow data Q (t). After data processing, the gas volume Vx inside the inflation expansion space at the current moment, that is, the expansion size of the sac component, can be obtained, and then the inflation pressure Px can be appropriately controlled, so that the expansion force of the balloon catheter can be stably adjusted to ensure the safety of vascular surgery.

[0016] 2. The present invention, through the specific design of the sac component, includes an elastic sac layer, and an elastic cushion layer and a tensioning belt are arranged on the inner side of the elastic sac layer. When the elastic sac layer expands, the transition parts at both ends of the elastic sac layer open outward, so that the tensioning belt is tensioned, and the tensioning belt is pushed outward in a linear structure. When the outer side of the sac component is partially obstructed, the tensioning belt can exert an expansion force well, and the elastic cushion layer disperses the force of the tensioning belt squeezing outward to avoid causing blood vessel damage. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 This is a schematic diagram of the principle of a balloon catheter proposed by the present invention that can automatically adjust the expansion force according to the degree of vascular stenosis; Figure 2 A top view of a balloon catheter proposed by the present invention that can automatically adjust the expansion force according to the degree of vascular stenosis; Figure 3 for Figure 2 Section view of the section line at AA; Figure 4 for Figure 3 The partial enlarged schematic diagram of point D in the middle; Figure 5 for Figure 3 The local enlarged schematic diagram of point E in the middle; Figure 6 for Figure 2 Section view of the section line at BB; Figure 7 for Figure 2 Section view of the section line at CC; Figure 8 for Figure 3 A partial enlarged schematic diagram of point F in the middle.

[0018] Among them, 1. inner tube; 1a, convex ring part; 2. sac component; 201, elastic sac layer; 202, elastic cushion layer; 203, tension belt; 204, inverted cover; 3. outer tube component; 301, outer tube body; 302, first blocking ring component; 303, expansion part; 304, annular end; 305, second blocking ring component; 306, branch pipe component; 307, channel pipe; 4. controller; 5. pipeline flow monitoring meter; 6. adjustable pressure gas supply source. DETAILED DESCRIPTION

[0019] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Example

[0020] like Figure 1 - Figure 8 As shown, an embodiment of the present invention provides a balloon catheter capable of automatically adjusting the expansion force according to the degree of blood vessel stenosis, comprising: an inner tube 1, a balloon component 2, an outer tube component 3, a controller 4, and an adjustable pressure air supply source 6.

[0021] The inner tube 1 is a central tube, which is designed with different structures according to different surgical requirements, for example, a whole exchange balloon, a quick exchange balloon, a balloon with a fixed guidewire, an infusion balloon, etc. The balloon component 2 is fixedly connected to the outside of the inner tube 1. The balloon component 2 is made of elastic material. The balloon component 2 is close to the first end of the inner tube 1. An inflation expansion space is formed between the inner side of the balloon component 2 and the outer side of the inner tube 1. When gas (or liquid) is filled into the inflation expansion space, the balloon component 2 expands elastically, and the balloon component 2 presses against the inner wall of the blood vessel to the outside, and the balloon component 2 exerts an expansion force on the inner wall of the blood vessel.

[0022] The degree of stenosis of blood vessels of different users / different parts of the same user is different, and the size of the expansion required by the balloon component 2 is different; it is obviously impossible to accurately control the expansion force exerted by the balloon component 2 on the inner wall of the blood vessel by only relying on the set standard air supply pressure. The gas filled in the balloon component 2 needs to overcome the contraction elasticity of the balloon component 2 itself. The size of the contraction elasticity of the balloon component 2 itself is related to the size of the expansion of the balloon component 2 itself, and the inner wall of the blood vessel exerts a squeezing force on the balloon component 2, so it is very difficult for the surgeon to stabilize the expansion force of the balloon component 2 on the blood vessel, and it takes a long time of experience to barely control it.

[0023] Preferably, the required expansion size of the bladder component can be determined by the following process: S11. Obtain basic characteristics of multiple historical patients, characteristics of diseased blood vessels (e.g., location, diameter, degree of stenosis, etc.), characteristics of vascular stents (e.g., material characteristics, structural characteristics (e.g., diameter, length, etc.), etc.), and optimal expansion size, wherein the basic characteristics may include the age, gender, medical history (e.g., previous surgical history, medication history, etc.), vital signs (e.g., body temperature, pulse, respiratory rate, blood pressure, etc.), and blood tests (e.g., blood routine, blood sugar, blood lipids, liver and kidney function, etc.) of the historical patients, and the characteristics of diseased blood vessels may be determined by imaging examinations such as X-ray, CT (Computed Tomography), and MRI (Magnetic Resonance Imaging); S12, obtaining the basic characteristics of the current patient, the characteristics of the diseased blood vessels, and the characteristics of the vascular stent; S13. For each historical patient, based on the basic characteristics, diseased vessel characteristics, and vascular stent characteristics of the historical patient and the basic characteristics, diseased vessel characteristics, and vascular stent characteristics of the current patient, calculate the feature similarity between the historical patient and the current patient; S14, when the feature similarity is greater than the feature similarity threshold, the historical patient is regarded as a similar historical patient; S15. Determine the optimal expansion size for the current patient based on the optimal expansion sizes corresponding to similar historical patients.

[0024] Preferably, the feature similarity between the historical patient and the current patient can be calculated based on the following formula: in, is the feature similarity between the i-th historical patient and the current patient, is the cosine similarity between the basic features of the i-th historical patient and the current patient, is the preset parameter, greater than 0, is the g-th diseased vessel feature of the i-th historical patient, is the g-th diseased vessel feature of the current patient, is the total number of diseased vascular features, is the hth feature of the vascular stent of the i-th historical patient, is the hth feature of the current patient’s vascular stent, is the preset parameter, greater than 0, , and is the preset weight, , and are greater than 0, .

[0025] The optimal expansion size discrete parameters can be calculated based on the optimal expansion size corresponding to similar historical patients: in, is the optimal expansion size discrete parameter, is the optimal expansion size corresponding to the kth similar history patient, The total number of historical patients similar to the current patient.

[0026] When the optimal expansion size discrete parameter is less than the optimal expansion size discrete parameter threshold, the optimal expansion size of the current patient can be calculated based on the following formula: in, The optimal expansion size for the current patient.

[0027] When the optimal expansion size discrete parameter is greater than or equal to the optimal expansion size discrete parameter threshold, the optimal expansion size of the current patient can be calculated based on the following formula: in, , , , , and All are multivariate nonlinear regression coefficients.

[0028] The elasticity of the current patient's blood vessels can be predicted through the squeeze force prediction model based on the current patient's basic characteristics and diseased blood vessel characteristics, wherein the parameter determination model can be a convolutional neural network (CNN) model. The better the elasticity of the blood vessel wall, the more it can deform under a smaller expansion force. The elasticity of the blood vessel wall may vary from patient to patient, and needs to be adjusted according to actual conditions. Lesions of the blood vessel wall (such as arteriosclerosis, calcification, etc.) will change its mechanical properties, causing the expansion force to be different in different patients or in different vascular sites of the same patient.

[0029] After determining the optimal expansion size and vascular elasticity of the current patient, the optimal expansion speed and optimal expansion duration of the current patient can be calculated through a parameter determination model based on the diseased vascular characteristics of the current patient, the elasticity of the blood vessels, the optimal expansion size and the characteristics of the balloon catheter (for example, material characteristics, size characteristics, etc.), wherein the parameter determination model can be a convolutional neural network model.

[0030] The optimal expansion force of the current patient is determined by the expansion force determination model based on the optimal expansion size, vascular elasticity, optimal expansion speed and optimal expansion duration of the current patient, wherein the expansion force determination model can be a convolutional neural network model. The magnitude of the optimal expansion force of the current patient depends on multiple factors, including but not limited to: the expansion degree of the balloon component: the larger the balloon component expands, the greater the expansion force it exerts on the vascular wall; the material and design of the balloon component: balloon components of different materials and designs may exhibit different mechanical properties when expanded, such as hardness, elasticity, etc., which directly affect the magnitude of the expansion force; the elasticity of the vascular wall: the better the elasticity of the vascular wall, the easier it is to deform under a smaller expansion force; on the contrary, a vascular wall with poor elasticity requires a larger expansion force to produce the same deformation; the pathological condition of the vascular wall: the pathological condition of the vascular wall (such as arteriosclerosis, calcification, etc.) will change its mechanical properties, so that the expansion force is different in different patients or different vascular sites of the same patient; the expansion speed and duration: a faster expansion speed may cause greater impact and damage to the vascular wall, while a longer period of continuous expansion may gradually adapt the vascular wall and reduce the required expansion force.

[0031] By comprehensively considering the similarities between the data of historical patients (including basic characteristics, lesion vessel characteristics and vascular stent characteristics) and the current patient, the optimal expansion size of the current patient can be predicted and determined more accurately. This personalized treatment strategy can significantly improve the success rate of surgery and the treatment effect of patients. Based on the analysis and comparison of relevant data of historical patients, excessive or insufficient expansion can be avoided, thereby reducing the risk of surgical complications. For example, excessive expansion may cause vascular rupture, while insufficient expansion may not effectively relieve vascular stenosis. After determining the optimal expansion size, the parameter determination model is further used to calculate the optimal expansion speed and duration, as well as the optimal expansion force. The optimization of these parameters can ensure that the surgical process is smoother and more controllable, reducing trauma and discomfort to patients. Through automated and intelligent prediction and calculation, doctors can obtain more comprehensive information before surgery, so as to make decisions faster, shorten the operation time and improve the efficiency of surgery. Traditionally, doctors need to rely on experience and intuition to determine surgical parameters, which often involves great subjectivity and uncertainty. By introducing data analysis and machine learning models, this process can reduce human errors and improve the objectivity and accuracy of decision-making. Through accurate prediction and personalized treatment, unnecessary waste of medical resources can be reduced, such as reducing the need for secondary surgery or long-term treatment due to surgical failure.

[0032] The outer tube component 3 is arranged on the outside of the inner tube 1, and the first end of the outer tube component 3 is connected to the inflation expansion space. The second end of the outer tube component 3 is located between the middle of the inner tube 1 and the second end of the inner tube 1, so as not to hinder the positioning of one end of the balloon catheter into the blood vessel. The second end of the outer tube component 3 is set as an air inlet, and air is taken in from the air inlet at the second end of the outer tube component 3. The gas passes through the airway in the outer tube component 3 and enters the inflation expansion space formed between the inner side of the sac component 2 and the outer side of the inner tube 1. The air inlet of the outer tube component 3 is connected to a pipeline flow monitor 5, and the pipeline flow monitor 5 is used to measure the flow data Q (t) entering the inflation expansion space formed between the inner side of the sac component 2 and the outer side of the inner tube 1.

[0033] The adjustable pressure gas supply source 6 supplies gas to the inflation expansion space through the pipeline flow monitor 5 and the outer tube component 3. The pipeline flow monitor 5 is connected to the controller 4 for communication. The pipeline flow monitor 5 transmits the detected data to the controller 4. The adjustable pressure gas supply source 6 is connected to the controller 4 for communication. The controller 4 controls the adjustable pressure gas supply source 6 to adjust the gas supply pressure.

[0034] The adjustable pressure gas supply source 6 supplies gas to the inflation expansion space through the pipeline flow monitor 5 and the outer tube component 3. The pipeline flow monitor 5 can obtain the flow data Q (t). After data processing, the gas volume Vx inside the inflation expansion space at the current moment, that is, the expansion size of the balloon component, can be obtained, and then the inflation pressure Px can be appropriately controlled, so as to stably adjust the expansion force of the balloon catheter and ensure the safety of vascular surgery.

[0035] Specifically, the controller 4 receives the flow data Q(t) measured by the pipeline flow monitor 5 , and controls the gas supply pressure of the adjustable pressure gas supply source 6 after data processing.

[0036] The controller 4 internally stores a (Fn, Pn, Vn) database, wherein Fn represents the expansion force, Pn represents the gas supply pressure of the adjustable pressure gas supply source 6, and Vn represents the gas volume inside the inflation expansion space.

[0037] The (Fn, Pn, Vn) database is obtained from laboratory experiments: for example, in an experiment within a simulated blood vessel with an adjustable inner diameter, a pressure sensor is designed within the simulated blood vessel with an adjustable inner diameter, the expansion force Fa measured by the pressure sensor is kept unchanged, and then a group of (Fa, P1, V1) is measured, and then the inner diameter of the simulated blood vessel is adjusted, and another group of (Fa, P2, V2) is measured, thereby obtaining several groups of data, and then another expansion force Fb is determined to be unchanged, and then a group of (Fb, P1, V1) is measured, and then the inner diameter of the simulated blood vessel is adjusted, and another group of (Fb, P2, V2) is measured, thereby obtaining several groups of data, thereby obtaining the (Fn, Pn, Vn) database. The operator inputs the required expansion force Fx into the controller 4 (Fx should be an expansion force existing in the database). The data processing unit inside the controller 4 integrates the flow data Q(t) measured by the pipeline flow monitor 5 to obtain the gas volume Vx inside the inflation expansion space at the current moment, and consults the (Fn, Pn, Vn) database to obtain Px. Then, the controller 4 controls the gas supply pressure of the adjustable pressure gas supply source 6 to Px.

[0038] Among them, (Fx, Px, Vx) is one set of data in the (Fn, Pn, Vn) database.

[0039] Since Px is obtained by querying the (Fn, Pn, Vn) database, the gas volume Vx inside the inflation expansion space at the current moment is an arbitrary value. Here, a set of data closest to Vx in the (Fx, Pn, Vn) database can be selected.

[0040] As a preferred method, a multivariate nonlinear model corresponding to the balloon catheter required for the current patient can also be established based on the (Fn, Pn, Vn) database, wherein the dependent variable of the multivariate nonlinear model corresponding to the balloon catheter required for the current patient is the air supply pressure, and the independent variables of the multivariate nonlinear model corresponding to the balloon catheter required for the current patient include the expansion force and the gas volume inside the inflated expansion space. The expansion force and the gas volume inside the inflated expansion space are brought into the multivariate nonlinear model corresponding to the balloon catheter required for the current patient to obtain the air supply pressure, and then the controller 4 controls the air supply pressure of the adjustable pressure air supply source 6 to be Px.

[0041] The controller 4 is a computer, and the corresponding database and reference program are imported into the computer to realize the above control function.

[0042] In one embodiment, the bladder component 2 includes: an elastic bladder layer 201 , an elastic cushion layer 202 , and a tensioning belt 203 .

[0043] Both ends of the elastic sac layer 201 are transition parts. When the elastic sac layer 201 is inflated, the transition parts at both ends of the elastic sac layer 201 are conical. One end of the elastic sac layer 201 is fixedly connected to the inner tube 1, and the other end of the elastic sac layer 201 is fixedly connected to the outer tube component 3, so that the two ends of the elastic sac layer 201 are sealed. The elastic pad layer 202 is fixedly connected to the inner side of the elastic sac layer 201, and a plurality of elastic pad layers 202 are provided, and the plurality of elastic pad layers 202 are distributed in a ring array. The two ends of the tensioning belt 203 are respectively fixedly connected to the inner sides of the transition parts at both ends of the elastic sac layer 201. The tensioning belt 203 is located on the inner side of the elastic pad layer 202, and the number of the tensioning belts 203 is equal to the number of the elastic pad layers 202.

[0044] When the elastic sac layer 201 expands, the transition parts at both ends of the elastic sac layer 201 open outward, so that the tensioning belt 203 is tightened, and the tensioning belt 203 is pushed outward in a linear structure. When the outer side of the sac component 2 is partially obstructed, the tensioning belt 203 can exert an expansion force well, and the elastic cushion layer 202 disperses the force of the tensioning belt 203 squeezing outward to avoid causing vascular damage.

[0045] In one embodiment, the outer tube component 3 includes: an outer tube body 301 , a first blocking ring component 302 , a second blocking ring component 305 , a channel tube 307 , a tube expansion portion 303 , an annular end portion 304 , and a branch tube component 306 .

[0046] The outer tube body 301 is sleeved on the outside of the inner tube 1, and a first blocking ring member 302 and a second blocking ring member 305 are fixedly connected between the outer tube body 301 and the inner tube 1 and near the two ends of the outer tube body 301, and at least one channel tube 307 is fixedly connected to the inner side of the outer tube body 301. The first end of the channel tube 307 is connected to the inflation expansion space, and the first end of the outer tube body 301 is fixedly connected to the transition part of the first end of the elastic bladder layer 201. The second end of the outer tube body 301 is fixedly connected to the expansion part 303, and the end of the expansion part 303 away from the outer tube body 301 is fixedly connected to the annular end 304, and the annular end 304 is fixedly connected to the inner tube 1. A branch pipe member 306 is fixedly arranged on the side of the annular end 304, and the second end of the channel tube 307 is connected to the inner side of the expansion part 303.

[0047] The filled gas enters the inner side of the expansion tube portion 303 through the branch pipe 306 , and then enters the inflation expansion space formed between the inner side of the bag component 2 and the outer side of the inner tube 1 through the channel tube 307 .

[0048] In one embodiment, the outer sides of the first blocking ring 302 and the second blocking ring 305 are both provided with recesses corresponding to the channel tube 307. The first blocking ring 302 and the second blocking ring 305 can stabilize the outer tube body 301 and prevent the outer tube body 301 and the inner tube 1 from rotating relative to each other.

[0049] In one embodiment, at least one marking member is fixedly connected to the outside of the inner tube 1 and inside the bladder component 2. The marking member may be a metal ring, and the existing image detection equipment may be used to detect the location of the bladder component 2 in the human body.

[0050] In one embodiment, the adjustable pressure gas supply source 6 includes an air pump and an electromagnetic pressure regulating valve, which can adjust the air pressure generated by the air pump, and then supply the gas with adjusted pressure to the inflation expansion space formed between the inner side of the bag component 2 and the outer side of the inner tube 1.

[0051] In one embodiment, a convex ring portion 1a is fixedly provided on the outer side of the first end of the inner tube 1, and the transition portion of the elastic sac layer 201 is sleeved on the convex ring portion 1a, and the transition portion of the elastic sac layer 201 is fixed to the convex ring portion 1a through an inverted cover 204. The inverted cover 204 is annular, and one end of the inverted cover 204 is contracted inward to ensure that the transition portion of the elastic sac layer 201 is stably fixed to the convex ring portion 1a.

[0052] In one embodiment, the transition portion of the elastic bag layer 201 is fixedly connected to the outer tube body 301 outside the second blocking ring 305, and the connection can be made by heating welding to ensure the sealing effect.

[0053] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A balloon catheter capable of automatically adjusting the dilation force according to the degree of vascular stenosis, comprising: Inner tube (1); A sac component (2), the sac component (2) being fixedly connected to the outer side of the inner tube (1), and the sac component (2) being close to the first end of the inner tube (1), and an inflatable expansion space being formed between the inner side of the sac component (2) and the outer side of the inner tube (1); It is characterized by further comprising: an outer tube component (3), a controller (4), and an adjustable pressure gas supply source (6); The outer tube component (3) is arranged outside the inner tube (1), the first end of the outer tube component (3) is in communication with the inflation expansion space, and the second end of the outer tube component (3) is located between the middle of the inner tube (1) and the second end of the inner tube (1); The second end of the outer tube component (3) is arranged as an air inlet, and the air inlet of the outer tube component (3) is connected to a pipeline flow monitor (5); The adjustable pressure air supply source (6) supplies air to the inflation expansion space through the pipeline flow monitoring meter (5) and the outer tube component (3); The pipeline flow monitor (5) is communicatively connected to the controller (4), and the adjustable pressure gas supply source (6) is communicatively connected to the controller (4).

2. A balloon catheter capable of automatically adjusting the expansion force according to the degree of vascular stenosis according to claim 1, characterized in that: The controller (4) receives flow data Q(t) measured by the pipeline flow monitor (5), and controls the gas supply pressure of the adjustable pressure gas supply source (6) after data processing; The controller (4) internally stores a database (Fn, Pn, Vn), wherein Fn represents the expansion force, Pn represents the gas supply pressure of the adjustable pressure gas supply source (6), and Vn represents the gas volume inside the inflation expansion space; The operator inputs the required expansion force Fx into the controller (4), and the data processing unit in the controller (4) integrates the flow data Q(t) measured by the pipeline flow monitor (5) to obtain the gas volume Vx in the inflation expansion space at the current moment, and consults the (Fn, Pn, Vn) database to obtain Px, and then the controller (4) controls the gas supply pressure of the adjustable pressure gas supply source (6) to be Px; Among them, (Fx, Px, Vx) is one set of data in the (Fn, Pn, Vn) database.

3. A balloon catheter capable of automatically adjusting the expansion force according to the degree of vascular stenosis according to claim 2, characterized in that: The controller (4) is a computer.

4. A balloon catheter capable of automatically adjusting the expansion force according to the degree of vascular stenosis according to claim 1, characterized in that: The sac component (2) comprises: An elastic bladder layer (201), both ends of the elastic bladder layer (201) being transition portions, one end of the elastic bladder layer (201) being fixedly connected to the inner tube (1), and the other end of the elastic bladder layer (201) being fixedly connected to the outer tube component (3); An elastic cushion layer (202), the elastic cushion layer (202) being fixedly connected to the inner side of the elastic bladder layer (201), and a plurality of elastic cushion layers (202) are provided, and the plurality of elastic cushion layers (202) are distributed in a ring array; A tensioning belt (203), wherein two ends of the tensioning belt (203) are respectively fixedly connected to the inner sides of transition portions at two ends of the elastic bag layer (201), the tensioning belt (203) is located on the inner side of the elastic cushion layer (202), and the number of the tensioning belts (203) is equal to the number of the elastic cushion layers (202).

5. A balloon catheter capable of automatically adjusting the expansion force according to the degree of vascular stenosis according to claim 4, characterized in that: The outer tube component (3) comprises: An outer tube body (301), the outer tube body (301) being sleeved on the outer side of the inner tube (1), a first blocking ring member (302) and a second blocking ring member (305) being fixedly connected between the outer tube body (301) and the inner tube (1) and close to the two ends of the outer tube body (301), and at least one channel tube (307) being fixedly connected to the inner side of the outer tube body (301), a first end of the channel tube (307) being in communication with the inflation expansion space; The first end of the outer tube body (301) is fixedly connected to the transition portion of the first end of the elastic bag layer (201); the second end of the outer tube body (301) is fixedly connected to a tube expansion portion (303); the end of the tube expansion portion (303) away from the outer tube body (301) is fixedly connected to an annular end portion (304); the annular end portion (304) is fixedly connected to the inner tube (1); a branch pipe member (306) is fixedly provided on the side of the annular end portion (304); and the second end of the channel tube (307) is connected to the inner side of the tube expansion portion (303).

6. A balloon catheter capable of automatically adjusting the expansion force according to the degree of vascular stenosis according to claim 5, characterized in that: The outer sides of the first blocking ring member (302) and the second blocking ring member (305) are both provided with notches corresponding to the channel tube (307).

7. A balloon catheter capable of automatically adjusting the expansion force according to the degree of vascular stenosis according to claim 1, characterized in that: At least one marking component is fixedly connected to the outside of the inner tube (1) and located inside the bag component (2).

8. The balloon catheter capable of automatically adjusting the expansion force according to the degree of vascular stenosis according to claim 1, characterized in that: The adjustable pressure air supply source (6) comprises an air pump and an electromagnetic pressure regulating valve.

9. The balloon catheter capable of automatically adjusting the expansion force according to the degree of vascular stenosis according to claim 4, characterized in that: A convex ring portion (1a) is fixedly provided on the outer side of the first end of the inner tube (1), a transition portion of the elastic bladder layer (201) is sleeved on the convex ring portion (1a), and the transition portion of the elastic bladder layer (201) is fixed to the convex ring portion (1a) via an inverted cover (204).

10. The balloon catheter capable of automatically adjusting the expansion force according to the degree of vascular stenosis according to claim 5, characterized in that: The transition portion of the elastic bag layer (201) is fixedly connected to the outer tube body (301) outside the second blocking ring (305).

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