A medical interventional catheter

Abstract

This invention provides a medical interventional catheter, comprising a first expandable body, a second expandable body, and a main body. Both the first and second expandable bodies are disposed at the distal end of the main body, with the first expandable body located inside the second expandable body. A first space is formed between the outer surface of the first expandable body and the inner surface of the second expandable body. The contrast agent disclosed herein is filled within the double-layered nested expandable body, facilitating observation of the expandable bodies' state within the body via a display device. This floating catheter is effectively compatible with existing contrast agents, reducing the learning curve for operators. In the event of accidental rupture of the first expandable body, the gas inside can enter the second expandable body, preventing direct gas entry into the bloodstream and mitigating the risk of air embolism, thus improving catheter safety.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a medical interventional catheter. Background Technology

[0002] Floating catheters are commonly used tools by clinicians to assess and manage critically ill patients, primarily for measuring hemodynamic parameters. In related technologies, the balloon of the floating catheter is made of latex. Adding contrast agents to the latex can affect the balloon's expansion, contraction, and buoyancy, thus impacting its usability. Therefore, to ensure normal use, the balloon must be used without adding contrast agents. Due to the lack of contrast agents, doctors cannot determine the balloon's position within the body, such as whether it is inflated or deflated, whether it is leaking, or whether it is embolizing small vessels in the pulmonary artery, making accurate balloon control impossible. Furthermore, in clinical use, doctors may forget the balloon's position and repeatedly inflate and deflate it, increasing the risk of balloon rupture and potentially causing medical accidents. Therefore, there is an urgent need for a safe and reliable floating catheter that allows doctors to monitor the balloon's position outside the body, improving the safety and effectiveness of medical procedures. Summary of the Invention

[0003] In order to overcome at least one of the many problems in related technologies, the present invention provides a medical interventional catheter.

[0004] The medical interventional catheter includes a first expansion body, a third expansion body, and a main body;

[0005] The first expansion body and the second expansion body are both disposed at the far end of the main body, and the first expansion body is disposed inside the third expansion body;

[0006] A first space is formed between the outer surface of the first expansion body and the inner surface of the third expansion body.

[0007] In one alternative embodiment, the first space is filled with a developing substance.

[0008] In one optional embodiment, the interior of the first expansion body has a second space, and the volume of the second space is larger than the volume of the first space in the working state.

[0009] In one alternative embodiment, in the intervention state, the volume of the second space causes the first and third expansion bodies to float.

[0010] In one optional embodiment, the first expansion body is made of an elastic material, and / or the third expansion body is made of a semi-compliant material.

[0011] In one optional embodiment, the distal end of the main body is provided with a first vent and a second vent; wherein,

[0012] The first vent is connected to the interior of the first expansion body; the second vent is connected to the first space.

[0013] In one optional embodiment, the main body includes a first inflation chamber and a second inflation chamber extending along the axis of the catheter; wherein,

[0014] The first inflation chamber is connected to the first air hole, and the second inflation chamber is connected to the second air hole.

[0015] In one optional embodiment, the conduit further includes a first valve unit and a second valve unit; wherein,

[0016] The first valve unit is connected to the first inflation chamber, and the second valve unit is connected to the second inflation chamber.

[0017] In one optional embodiment, the catheter further includes a second expansion body disposed at the proximal end of the body, and the interiors of the first expansion body and the interiors of the second expansion body are in fluid communication.

[0018] In one optional embodiment, the second expansion body includes at least a primary expansion state and a secondary expansion state. When the internal pressure of the second expansion body is greater than or equal to a set pressure threshold, the second expansion body switches from the primary expansion state to the secondary expansion state.

[0019] In one optional embodiment, the main body further includes a thermistor cavity, and / or a distal cavity, and / or a proximal cavity.

[0020] The technical solution of the present invention has the following advantages or beneficial effects:

[0021] (1) The distal end of the floating catheter of this disclosure is provided with nested first and third expansion bodies. The contrast agent is filled in the double-nested expansion body interlayer, which constrains the distribution of the contrast agent. Compared with the scheme of directly filling the contrast agent inside a single-layer balloon, the contrast agent in this scheme is more evenly distributed in space, which is conducive to observing the state of the expansion body in the body through a display device. The floating catheter can be effectively compatible with existing contrast agents, reducing the learning cost for operators and enabling them to get started with the catheter device of this disclosure more quickly. In addition, the first expansion body is only filled with gas and not with contrast agent, so that the distal end of the floating catheter has sufficient buoyancy. Correspondingly, the first space between the first and third expansion bodies is filled with contrast agent and / or a small amount of gas, so that the pressure inside the third expansion body is lower than the pressure inside the first expansion body; thus, when the first expansion body ruptures accidentally, the gas inside it can enter the third expansion body, avoiding the risk of gas directly entering the blood and forming an air embolism, thereby improving the safety of the catheter.

[0022] (2) In the working state, the volume of the second space inside the first expansion body is greater than the volume of the first space between the two expansion bodies, so that the second space can provide the buoyancy required for the distal end of the catheter to float in the blood.

[0023] (3) The first expansion body is made of elastic material. Compared with the existing technology of using natural latex to make balloons, the material disclosed herein is compatible with people who are intolerant to latex, thus improving the safety and applicable population of the floating catheter.

[0024] (4) By setting independent air holes and inflation cavities for the two nested expansion bodies, operators can easily control the cavity pressure of each expansion body and promptly control the amount of gas in the third expansion body in case of emergencies such as the rupture of the first expansion body, thus ensuring the safety of the device. Attached Figure Description

[0025] The accompanying drawings are provided to better understand the invention and are not intended to unduly limit the scope of the invention. Wherein:

[0026] Figure 1 This is a schematic diagram of the structure of the floating conduit according to an embodiment of the present invention;

[0027] Figure 2 This is a cross-sectional schematic diagram of the multi-cavity tube body according to an embodiment of the present invention;

[0028] Figure 3 This is a schematic diagram of the expansion state of each expansion body according to an embodiment of the present invention;

[0029] Figure 4 This is a schematic diagram of an inflatable body with a folded portion according to an embodiment of the present invention;

[0030] Figure 5 This is a schematic diagram of the folded portion in a folded state according to an embodiment of the present invention;

[0031] Figure 6 This is a schematic diagram of an expander in a second expansion state according to an embodiment of the present invention;

[0032] Figure 7 This is a schematic diagram of the expander in the third expansion state according to an embodiment of the present invention;

[0033] Figure 8 This is a schematic diagram of another folding method of the folding part according to an embodiment of the present invention;

[0034] Figure 9 This is a schematic diagram of the structure of a medical interventional catheter according to an embodiment of the present invention;

[0035] Figure 10 This is a partially enlarged schematic diagram of the distal end of a medical interventional catheter according to an embodiment of the present invention. Detailed Implementation

[0036] The following description, in conjunction with the accompanying drawings, illustrates exemplary embodiments of the present invention, including various details to aid understanding. These details should be considered merely exemplary. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the invention. Similarly, for clarity and brevity, descriptions of well-known functions and structures are omitted in the following description.

[0037] The terminology used in this application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The singular forms “a,” “the,” and “the” used in this application and the appended claims are also intended to include the plural forms unless the context clearly indicates otherwise. It should also be understood that the term “and / or” as used herein refers to and includes any and all possible combinations of one or more of the associated listed items.

[0038] It should be understood that although the terms first, second, third, etc., may be used in this application to describe various information, such information should not be limited to these terms. These terms are only used to distinguish information of the same type from one another. For example, without departing from the scope of this application, first information may also be referred to as second information, and similarly, second information may also be referred to as first information. Depending on the context, the word "if" as used herein may be interpreted as "when," "when," or "in response to determination."

[0039] Floating catheters are commonly used by clinicians to assess and manage critically ill patients. They are not an interventional tool, but rather an auxiliary diagnostic tool used to measure hemodynamic parameters such as cardiac output, central venous pressure, right atrial pressure, pulmonary artery pressure, and pulmonary artery wedge pressure. Existing floating catheters have at least the following problems: the balloon is made of latex, and adding contrast-enhancing substances to the balloon will affect its inflation, contraction, and buoyancy properties, ultimately impacting the catheter's usability. Therefore, to ensure the performance of the floating catheter, no contrast-enhancing substances are added to the balloon in related technologies. When a catheter without contrast-enhancing substances is inserted into the body, doctors cannot determine the balloon's position within the body, such as whether it is inflated or deflated, whether it is leaking, or whether it is embolizing small pulmonary vessels. Furthermore, in clinical use, doctors often cannot confirm the inflation status of the balloon inside the body and will repeatedly inflate and deflate the balloon. Such operations increase the risk of balloon rupture. More seriously, balloon leakage can cause gas to directly enter the blood, or the balloon may spontaneously move towards the small blood vessels of the pulmonary artery if it is inflated for a long time, leading to long-term embolism of the small blood vessels of the pulmonary artery and hematoma, or even pulmonary artery rupture.

[0040] To address at least one of the aforementioned problems, a first aspect of the present invention provides a floating conduit.

[0041] The floating conduit includes a first expansion body, a second expansion body, and a main body; the first expansion body is located at the distal end of the main body, and the second expansion body is located at the proximal end of the main body, with fluid communication between the interior of the first expansion body and the interior of the second expansion body.

[0042] like Figure 1 and Figure 3The diagram shows the overall structure of a medical catheter. The medical catheter mainly includes a main body, a first expansion body 112, and a second expansion body 105. In one embodiment, the expansion body can be made into a balloon shape. From a user's perspective, the medical catheter includes a distal end and a proximal end, where the distal end is the end furthest from the operator, and the proximal end is the end closest to the operator. In actual use, the operator controls the medical catheter at the proximal end, for example, controlling the inflation and deflation of each expansion body. The first expansion body is located at the distal end, is inside the body during use, and expands in volume when inflated. The inflated first expansion body floats in the blood and moves towards the target location with the flow of blood. The main body includes a multi-lumen tube body 109, a main body connector 107, and a connecting tubing, etc. The main body connector 107 serves as a connecting structure for connecting the multi-lumen tube body and the connecting tubing. Specifically, the multi-lumen tube body 109 is a tubular structure, with its proximal end connected to the distal end of the main connector; correspondingly, the proximal end of the main connector is connected to the distal end of the transfer tubing. The transfer tubing may include multiple tubes, each with a different connector connected to its proximal end, such as Luer connectors 101, 102, etc.

[0043] Preferably, the first expansion body 112 is located at the distal end of the main body, and the second expansion body 105 is located at the proximal end of the main body, with fluid communication between the interior of the first expansion body and the interior of the second expansion body. It should be noted that in this embodiment, the first expansion body located at the distal end is not filled with any contrast agent, and no contrast agent is added to its manufacturing material. Therefore, the operator cannot observe the state of the first expansion body located inside the body using common contrast agents. Accordingly, to facilitate real-time monitoring of the state of the first expansion body within the body, one embodiment of this disclosure employs a dual expansion body design, with the second expansion body located at the distal end of the main body. In use, the first expansion body is inserted into the body along a blood vessel, while the second expansion body is placed outside the body. Due to the fluid communication between the interior spaces of the first and second expansion bodies, the internal pressures of the two balloons are equal in real time. Any change in the pressure, volume, or other state parameters of either expansion body will cause a corresponding change in the state parameters of the other expansion body. That is, through the structural design of this embodiment of the disclosure, when the first expansion body is located inside the body and the second expansion body is located outside the body, the volume change of the second expansion body can reflect the working state of the first expansion body. Therefore, the operator can monitor the status of the first expansion body in real time by observing the state of the second expansion body outside the body. Specifically, when the operator performs inflation or deflation, the volumes of the first and second expansion bodies will expand or contract synchronously. In practice, the first expansion body can move in the heart or blood vessels after inflation. If the first expansion body is inflated for a long time, it will spontaneously move towards the small blood vessels of the pulmonary artery, causing pulmonary embolism. If inflation continues, the first expansion body will be compressed by the blood vessels, resulting in increased pressure within the first expansion body. Conversely, when the first expansion body is not compressed by blood vessels, it will be in a non-compressed state. When the first expansion body inside the body embolisms the pulmonary artery, the internal pressure of the first expansion body increases, causing the second expansion body outside the body to expand under pressure. In practice, the first and second expansion bodies need to be securely installed to avoid blocking the corresponding inflation holes. For this reason, in one embodiment, heat shrinking, bonding, laser welding, or hot melting are used to connect the expansion bodies. In summary, by connecting the internal spaces of the two expansion tubes in series, operators do not need contrast agents or additional display equipment to observe the state of the expansion tubes inside the body. They can understand the state of the first expansion tube inside the body simply by observing the state of the second expansion tube outside the body. This achieves the goal of conveniently observing the state of medical catheters. At the same time, it also solves various problems caused by operator misoperation of the expansion tubes inside the body in the existing technology. For example, repeated inflation and deflation confirmation will prolong the operation time and increase the risk of balloon rupture. Balloon leakage will cause the injected air to directly enter the blood and blood vessels. Prolonged embolism will lead to hematoma or even pulmonary artery rupture. These are all adverse events that have occurred in clinical practice.Furthermore, the device disclosed herein enables operators to promptly handle emergencies when abnormalities are observed in the external second expansion body, avoiding problems such as leakage or vascular embolism in the internal expansion body, effectively improving the safety of medical catheter use and increasing the efficiency of clinical medicine.

[0044] In one optional embodiment, the outer diameters of the first and second inflatable bodies are equal in the uncompressed state. Since the diameter of blood vessels in the human body is small, the outer diameters of the first and second inflatable bodies are also small. Under these conditions, when the volume difference between the two inflatable bodies in their normal inflated state is large, especially the difference in outer diameter, and the volume or pressure change of the internal balloon is slow, the operator will find it difficult to detect the volume change of the external inflatable body in a timely manner. Especially when the volume of the external inflator is significantly larger than the volume of the internal inflator, the minute diameter change of the external inflator is even less visually noticeable. Furthermore, when the outer diameters of the two inflatable bodies are different, the operator will also find it difficult to understand the real-time volume change of the internal inflator during inflation. Therefore, in one embodiment of this disclosure, the external dimensions of the two inflatable bodies are set to be the same, so that the dimensions of the two inflatable bodies are the same in both the uninflated and normally inflated states, especially the outer diameter. When the first inflatable body is working normally in the body, that is, when the first inflatable body is in the uncompressed state, the outer diameter of the first inflatable body is equal to the outer diameter of the second inflatable body. The above design allows operators to determine the outer diameter of the first expansion body inside the body by observing the outer diameter of the second expansion body outside the body when inflating or deflating the expansion body. Inflation can be stopped when the outer diameter of the second expansion body reaches the target value, thus safely and efficiently controlling the outer diameter of the first expansion body inside the body.

[0045] In one optional embodiment, the first and second expandable bodies are made of materials with the same expansion ratio. To ensure that the volume and outer diameter of one expandable body can synchronously and stably follow the changes of the other expandable body, especially to ensure that their outer diameters are the same during inflation or deflation, one embodiment of this disclosure uses two expandable bodies made of materials with the same expansion ratio to solve this problem. Preferably, the two expandable bodies are made of the same material. Exemplarily, highly elastic materials such as synthetic latex, silicone, rubber, TPE, TPX, TPU, and WPU can be used to make the expandable bodies. Advantageously, compared to natural latex, expandable bodies made of the above materials are compatible with people who are intolerant to latex, improving the safety and applicability of medical catheters.

[0046] In one optional embodiment, the second expansion body includes at least a primary expansion state and a secondary expansion state. When the internal pressure of the first expansion body is greater than or equal to a set pressure threshold, the second expansion body switches from the primary expansion state to the secondary expansion state. Figures 5 to 7In the embodiment shown, the second expansion body includes three stages of expansion, namely... Figure 5 The first-order expansion state shown Figure 6 The second-order expansion state shown and Figure 7 The diagram illustrates three levels of expansion. In each of these expansion states, the outer diameter of the expanding body is discontinuous and discretely distributed; that is... Figure 5 The diameter OD1 shown will only step up when a preset pressure is met. Figure 6 The OD2 shown; similarly, Figure 6 The diameter OD2 shown will only step up when another preset pressure is met. Figure 7 The OD3 shown is an example. It should be noted that the number of expansion states described above is merely an example; in practice, it can be reasonably set according to usage needs. In practice, different expansion states are set to reflect the working state of the first expansion body within the body. For example, using a safe pressure threshold as the set pressure threshold, since the first expansion body is located inside a blood vessel, its volume expansion is constrained by the blood vessel. When air is continuously pumped into the first expansion body, the blood vessel will compress the first expansion body, preventing it from expanding in volume. At this time, the external pressure on the first expansion body increases, and the internal pressure also gradually increases. When the internal pressure of the first expansion body is greater than or equal to the safe pressure threshold, the second expansion body will... Figure 5 The first-order expansion state shown is stepped to Figure 6 The diagram illustrates a secondary expansion state. The outer diameter of the secondary expansion state is significantly larger than that of the primary expansion state. Operators can clearly observe the change in the outer diameter of the second expansion body outside the body and confirm that the internal pressure of the first expansion body inside the body has reached a safe threshold. More advantageously, when the second expansion body transitions to the second expansion state, its large volume change reduces internal pressure, thereby lowering the internal pressure of the first expansion body to within a safe range. The outer diameter decreases accordingly, preventing rupture and other problems, including the rupture of blood vessels such as the pulmonary artery. This provides operators with ample time to manage the internal pressure of the expansion body, further improving the safety of instrument use. Of course, when the pressure of the expansion body is within the safe threshold, the maximum outer diameter of the expansion body is... Figure 5 OD1 is shown. Furthermore, by setting multiple pressure thresholds and corresponding expansion states, the operator can understand the various working states of the first expansion body within the body. For example, by further setting a preset pressure threshold slightly lower than the pressure that would cause pulmonary artery rupture, when the second expansion body outside the body expands due to the increased internal pressure of the first expansion body inside the body... Figure 6 The second expansion state shown is stepped to Figure 7 In the third expansion state shown, the operator can clearly see that the pressure of the first expansion body in the body is too high, and there is a risk of pulmonary artery rupture. It is necessary to release the pressure of the expansion body in time to ensure safety.

[0047] In one optional embodiment, the second expansion body includes an unexpanded portion, wherein when the internal pressure of the first expansion body is greater than or equal to the set pressure threshold, the unexpanded portion opens to achieve a switch from a first-level expansion state to a second-level expansion state. In another optional embodiment, the unexpanded portion includes a folded portion. To achieve the step change in the outer diameter of the expansion body between different expansion states as described above, one embodiment of this disclosure uses an unexpanded portion on the expansion body to solve this problem. The unexpanded portion can be set at multiple locations on the expansion body, and the number can also be multiple. By reasonably controlling the connection strength of the unexpanded portion, it can be matched with the corresponding pressure threshold to achieve expansion under different pressure thresholds. Preferably, the unexpanded portion is located in the radial direction of the second expansion body, and its expansion can cause a significant change in the outer diameter. Figures 5 to 7 The second expansion body is folded in the diameter direction with a first fold 401 and a second fold 402, and the unfolding pressures of the two folds are unequal. When the internal pressure of the first expansion body reaches a first pressure threshold, the first fold 401 unfolds, while the second fold 402 does not unfold, and the outer diameter of the second expansion body jumps from OD1 to OD2. When the internal pressure of the first expansion body further increases and reaches a second pressure threshold, the second fold 402 unfolds, and the outer diameter of the second expansion body jumps from OD2 to OD3. The folds can be made as follows: Figure 5 The single-sided folding method described above can, of course, also be adopted. Figure 8 The illustration shows a double-sided folding method. The folding methods described above are merely examples and are not intended to limit the scope of this disclosure. It is understood that the folded portion or the unfolded portion may take other forms than those described in the embodiments of this disclosure, and only needs to meet the requirement of unfolding under a predetermined pressure.

[0048] In one optional embodiment, the unexpanded portion is maintained in an unexpanded state by at least one of the following methods: bonding, hot melting, heat shrinking, or welding. Figure 5 Taking the folded state shown as an example, in practice, the connection strength of the folded part needs to be designed according to the predetermined unfolding pressure. Sufficient connection strength can be obtained at the folding location through bonding, hot melting, heat shrinking, or welding. Laser welding can be one such welding method. The specific connection location and connection area of ​​the folded part can be flexibly adjusted as needed.

[0049] In one optional embodiment, the main body includes an inflation chamber extending along the axis of the conduit, and the first expansion body and the second expansion body are respectively connected to the inflation chamber. In another optional embodiment, the conduit further includes a valve unit connected to the inflation chamber, the valve unit being used to control the on / off state of the external air source and the inflation chamber. Figure 1As shown, the medical catheter includes a multi-lumen tube body 109, a body connector 107, and a connecting pipe connected to a valve unit 106. The multi-lumen tube body, body connector, and connecting pipe all have internally arranged inflatable cavities extending along the catheter axis. Specifically, as shown... Figure 2 As shown, it displays a cross-sectional view of the multi-cavity tube body, which includes an inflatable cavity 202. The distal end of the inflatable cavity communicates with the interior of the first expansion body through a first inflation port 111; the proximal end of the inflatable cavity communicates with the interior of the second expansion body through a second inflation port 104. Figure 1 As shown, the first expansion body and the first inflation port are both located at the distal end of the multi-lumen tube body; the second expansion body and the second inflation port are both located on the transfer pipe connected to the valve unit 106. The operator inflates or deflates the two expansion bodies through the inflation unit. The valve unit 106 can be a common medical valve such as a two-way valve, a three-way valve, a spring-loaded valve, or a silicone valve.

[0050] In one optional embodiment, the main body further includes a thermistor cavity, and / or a distal cavity, and / or a proximal cavity. Figure 2 A schematic diagram of a multi-cavity tube body with multiple chambers is shown, including a thermistor chamber 201, a distal chamber 203, and a proximal chamber 204. The number of chambers described is merely an example; those skilled in the art can increase or decrease the number of chambers as needed. The multi-cavity tube body is made of polymer materials, such as PEBAX, PVC, PU, ​​PE, PP, etc., and is manufactured through extrusion and post-processing techniques. Figure 2 The four cavities described herein are independent of each other and extend to the main connector. The main connector contains a corresponding number of channels that correspond one-to-one with each cavity. The main connector separates each cavity within the multi-cavity tube body and connects it to the corresponding transfer pipeline. The main connector can be manufactured by bonding, injection molding, or other methods. Figure 1As shown, the distal end of the multi-lumen tube body is provided with a distal lumen outlet 113, which communicates with the distal lumen 203. The distal lumen sequentially passes through the interior of the multi-lumen tube body 109, the main connector 107, and the adapter tubing connected to the distal lumen Luer connector 101 along the axis of the medical catheter. The distal lumen is used for guidewire routing, blood aspiration, infusion, pressure measurement, etc. The adapter tubing connected to the distal lumen Luer connector 101 is fixed to the main connector 107 by bonding or injection molding. Near the distal end of the multi-lumen tube body, a proximal lumen outlet 108 is also provided, which communicates with the proximal lumen 204. The proximal lumen sequentially passes through the interior of the multi-lumen tube body 109, the main connector 107, and the adapter tubing connected to the proximal lumen Luer connector 102 along the axis of the medical catheter. The proximal lumen is used for blood aspiration, infusion, pressure measurement, etc. The adapter tube connected to the proximal lumen Luer connector 102 is fixed to the main connector by bonding or injection molding. In one embodiment, the proximal lumen outlet is located approximately 30 cm from the distal end face of the multi-lumen tube body. A thermistor 110 is also located near the distal end of the multi-lumen tube body. The wires of the thermistor 110 are installed within a thermistor cavity 201, which sequentially passes through the multi-lumen tube body 109, the main connector 107, and the adapter tube connected to the thermistor connector 103 along the axis of the medical catheter. The thermistor connector is connected to the adapter wire or device for data transmission. For example, the thermistor connector can be a common aviation connector. Optionally, the thermistor 110 is placed approximately 4 cm from the distal end face of the multi-lumen tube body to measure blood temperature and measure or calculate cardiac output based on changes in blood temperature.

[0051] In order to solve at least one of the problems described in the background section, a second aspect of the present invention provides a medical interventional catheter.

[0052] The medical interventional catheter includes a first expansion body, a third expansion body, and a body; both the first and third expansion bodies are disposed at the distal end of the body, and the first expansion body is disposed inside the third expansion body; a first space is formed between the outer surface of the first expansion body and the inner surface of the third expansion body.

[0053] Preferably, the first space is filled with a contrast-enhancing material. In this case, the medical interventional catheter is effectively compatible with commonly used digital subtraction angiography (DAS) equipment, allowing operators to observe the working status of the medical interventional catheter within the human body using the DAS equipment.

[0054] See Figure 9 and Figure 10 , Figure 9 The main structure of medical interventional catheters is shown. Figure 10 This image shows a magnified view of the distal end of a medical interventional device. (For example...) Figure 9 and 10 As shown, the medical interventional catheter mainly includes a first expansion body 1001, a third expansion body 1002, and a main body. In one embodiment, the two expansion bodies can be made into a balloon shape. The main body is similar to the main body of the medical catheter described in the first aspect, and it also includes a multi-lumen tube main body, a main body connector, and a connecting tubing, etc.; the connecting tubing can be multiple, and its proximal end is provided with a connector with corresponding functions, such as a Luer connector, a thermistor connector, or a valve unit, etc. Herein, the proximal or distal end refers to the end of the medical catheter closer to the operator, which is the proximal end, and the end farther away from the operator is the distal end. Since the structural form of the main body is the same as or similar to that of the main body of the catheter described in the first aspect, the only difference lies in the structure connecting the two expansion bodies and inflating or deflating the expansion bodies. Therefore, the parts of the medical catheter with the same structure on the main body described in the second aspect will not be described again; only the differences will be described later.

[0055] Preferably, both the first expansion body 1001 and the third expansion body 1002 are disposed at the distal end of the main body, and the first expansion body is nested inside the third expansion body; a first space 1003 is formed between the outer surface of the first expansion body and the inner surface of the third expansion body. The nested arrangement of the two expansion bodies ensures that when the inner first expansion body ruptures and leaks due to excessive gas filling, the outer third expansion body can contain the gas and prevent it from entering the blood vessels.

[0056] Preferably, the first space is filled with a contrast agent. The contrast agent can be a contrast agent or other substances with equivalent functions. In practice, to ensure that the expansion body of the medical catheter has both contrast-enhancing function and can float in the blood, it is necessary to reasonably control the inner volume of the first expansion body and the volume of the first space. Since the contrast agent is filled in the double-nested expansion body interlayer, the first space constrains the distribution of the contrast agent. Compared to directly filling the contrast agent inside a single-layer balloon, the contrast agent in this embodiment is more evenly distributed in the space, making it easier to observe the state of the expansion body in the body through a display device. Furthermore, the first expansion body is only filled with gas and not with contrast agent, thus providing sufficient buoyancy at the distal end of the medical catheter. Correspondingly, the first space between the first and third expansion bodies is filled with a contrast agent and / or a small amount of gas, resulting in a lower pressure inside the third expansion body compared to the first expansion body. Therefore, when the first expansion body ruptures unexpectedly, the gas inside it can enter the third expansion body. The smaller pressure conditions of the third expansion body can effectively contain the gas leaking from the first expansion body, thereby avoiding the risk of gas directly entering the blood and forming an air embolism, and ultimately improving the safety of the catheter.

[0057] In one optional embodiment, the first expansion body has a second space 1004 inside, and the volume of the second space 1004 is larger than the volume of the first space in the working state. In the intervention state, the volume of the second space causes the first expansion body 1001 and the third expansion body 1002 to be in a floating state. Figure 10 In the described embodiment, the first expansion body 1001 has a second space 1004 inside, the volume of which needs to be large enough to provide the buoyancy required for the distal end of the catheter to float in the blood. Preferably, the volume of the second space 1004 is designed to be much larger than the volume of the first space 1003.

[0058] In one optional embodiment, the first expansion body is made of an elastic material, and / or the third expansion body is made of a semi-compliant material. The elastic material includes highly elastic materials such as synthetic latex, silicone, rubber, TPE, TPX, TPU, and WPU. In practice, the first expansion body preferably uses highly elastic materials such as synthetic latex, thermoplastic elastomer (TPE), and thermoplastic polyurethane elastomer (TPU). Compared to the existing technology that uses natural latex to make balloons, this method is compatible with people who are intolerant to latex, improving the safety and applicability of medical catheters. Furthermore, the semi-compliant material can be PEBAX, etc. Materials with an expansion ratio of 110-130% are considered semi-compliant materials.

[0059] In one optional embodiment, the distal end of the main body is provided with a first vent 1006 and a second vent 1005; wherein the first vent 1006 communicates with the interior of the first expansion body 1004; and the second vent communicates with the first space. Figure 10 As shown, in order to facilitate the separate filling of gas into the first space and the second space, and to control the amount of gas filled, corresponding gas filling channels need to be provided for the first space and the second space respectively. Specifically, the second space of the first expansion body is connected to the first air hole 1006 located at the distal end of the multi-cavity tube body; correspondingly, the first space is connected to the second air hole 1005 located at the distal end of the multi-cavity tube body.

[0060] In one optional embodiment, the main body includes a first inflation chamber and a second inflation chamber extending along the axis of the conduit; wherein the first inflation chamber communicates with a first air hole, and the second inflation chamber communicates with a second air hole. Figure 9 As shown, the catheter further includes a first valve unit 901 and a second valve unit 902; wherein the first valve unit communicates with the first inflation chamber, and the second valve unit communicates with the second inflation chamber. The first inflation chamber sequentially penetrates the interior of the multi-lumen tube body, the main body connector, and the transfer pipe connected to the first valve unit 901; correspondingly, the second inflation chamber sequentially penetrates the interior of the multi-lumen tube body, the main body connector, and the transfer pipe connected to the second valve unit 902. In use, the operator injects or expels gas into the corresponding spaces at the proximal end through the first and second valve units, respectively. The valve units can be common medical valves such as two-way valves, three-way valves, spring-loaded valves, and silicone valves.

[0061] In one optional embodiment, the first and third expansion bodies are disposed at the distal end of the body by at least one of the following methods: bonding, hot melting, heat shrinking, or laser welding. Figure 9 As shown, the first and third expansion bodies are respectively located at the distal end of the multi-cavity tube body. The two expansion bodies need to be securely installed to avoid blocking the corresponding inflation holes. Therefore, in one embodiment, bonding, laser welding, heat shrinking, or heat fusion are used to connect the expansion bodies and the multi-cavity tube body.

[0062] In one optional embodiment, the main body further includes a thermistor cavity, and / or a distal cavity, and / or a proximal cavity. In practice, depending on the measurement needs, the main body can be equipped with multiple cavities to allow the corresponding measuring elements to extend from the proximal end to the distal end. The medical interventional catheter provided in the second aspect can also be provided with structures such as a thermistor cavity, a distal cavity, and a proximal cavity. The structure and purpose of the corresponding cavities are the same as those described in the first aspect, as detailed above, and will not be repeated here.

[0063] In one optional embodiment, the catheter further includes a second expansion body disposed at the proximal end of the body, and the interiors of the first and second expansion bodies are in fluid communication. Figure 9 Based on the illustrated scheme, this embodiment further includes a second expansion body (not shown in the figure). The second expansion body is located near the proximal end of the main body and is in fluid communication with the interior of the first expansion body. During use, the pressure, volume, and other parameters inside both the first and second expansion bodies change synchronously, allowing the operator to confirm the working state of the first expansion body within the body by observing the state changes of the second expansion body outside the body. In an optional embodiment, the second expansion body includes at least a primary expansion state and a secondary expansion state. When the internal pressure of the second expansion body is greater than or equal to a set pressure threshold, the second expansion body switches from the primary expansion state to the secondary expansion state. It should be noted that the construction, installation method, and working principle of the second expansion body here are the same as those described in the first aspect. Details of the second expansion body will not be elaborated here; please refer to the detailed description of the second expansion body in the first aspect for further details.

[0064] The specific embodiments described above do not constitute a limitation on the scope of protection of this invention. Those skilled in the art, after considering the specification and practicing the technical solutions disclosed in this application, will readily conceive of other embodiments of this disclosure. This application is intended to cover any variations, uses, or adaptations of this disclosure that follow the general principles of this disclosure and include common knowledge or customary technical means in the art not disclosed in this disclosure. The specification and embodiments are considered exemplary only, and the true scope and spirit of this disclosure are indicated by the following claims.

[0065] It should be understood that this disclosure is not limited to the precise structures described above and shown in the accompanying drawings, and various modifications and changes can be made without departing from its scope. The scope of this disclosure is limited only by the appended claims.

Claims

1. A medical interventional catheter, characterized in that: The catheter includes a first expansion body, a second expansion body, a third expansion body, and a main body; Both the first expansion body and the third expansion body are disposed at the far end of the main body, and the first expansion body is disposed inside the third expansion body; A first space is formed between the outer surface of the first expansion body and the inner surface of the third expansion body; The second expansion body is disposed at the proximal end of the main body, and the interior of the first expansion body and the interior of the second expansion body are in fluid communication. In the non-compression state of the first expansion body, the outer diameters of the first expansion body and the second expansion body are equal; When the first expansion body is located inside the body and the second expansion body is located outside the body, the volume change of the second expansion body can reflect the working state of the first expansion body.

2. The medical intervention catheter of claim 1, wherein, The first space is filled with a developing substance.

3. The medical interventional catheter according to claim 1, characterized in that, The first expansion body has a second space inside, and the volume of the second space is larger than the volume of the first space when it is in operation.

4. The medical interventional catheter according to claim 3, characterized in that, In the intervention state, the volume of the second space causes the first and third expansion bodies to float.

5. The medical interventional catheter according to claim 1, characterized in that, The first expansion body is made of an elastic material, and / or the third expansion body is made of a semi-compliant material.

6. The medical interventional catheter according to any one of claims 1 to 5, characterized in that, The main body has a first vent and a second vent at its distal end; wherein the first vent is connected to the interior of the first expansion body; and the second vent is connected to the first space.

7. The medical interventional catheter according to claim 6, characterized in that, The main body includes a first inflation chamber and a second inflation chamber extending along the axis of the conduit; wherein the first inflation chamber is connected to a first air hole, and the second inflation chamber is connected to a second air hole.

8. The medical interventional catheter according to claim 7, characterized in that, The conduit further includes a first valve unit and a second valve unit; wherein the first valve unit is connected to the first inflation chamber, and the second valve unit is connected to the second inflation chamber.

9. The medical interventional catheter according to claim 1, characterized in that, The second expansion body includes at least a primary expansion state and a secondary expansion state. When the internal pressure of the second expansion body is greater than or equal to a set pressure threshold, the second expansion body switches from the primary expansion state to the secondary expansion state.

10. The medical interventional catheter according to claim 1, characterized in that, The main body also includes a thermistor cavity, and / or a distal cavity, and / or a proximal cavity.

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