CN116549817A - a medical catheter - Google Patents

Abstract

The invention provides a medical catheter, which comprises a first expansion body, a second expansion body and a main body; the first expansion body is disposed at the distal end of the body, the second expansion body is disposed at the proximal end of the body, and the interior of the first expansion body is in fluid communication with the interior of the second expansion body. According to the scheme, an operator does not need to develop substances, and further does not need to observe the state of the internal expansion body by means of additional display equipment, and the state of the first internal expansion body can be known only by observing the state of the second external expansion body; meanwhile, various problems caused by misoperation of an in-vivo expansion body by operators in the prior art are solved, the use safety of the medical catheter is effectively improved, and the clinical medical efficiency is improved.

Description

a medical catheter

technical field

The invention relates to the technical field of medical instruments, in particular to a medical catheter.

Background technique

Medical catheters are a common tool used by clinicians to assess and manage critically ill patients, mainly for measuring hemodynamic parameters. In the related technology, the balloon of medical catheter is made of latex material. When contrast agents such as tungsten powder and barium sulfate are added to the latex, it will affect the physical properties of the balloon such as expansion ratio, contraction ratio, burst pressure, and burst volume. Injection of liquid developer will affect the floating function, thereby affecting its performance. Therefore, on the premise of ensuring normal use, the balloon has no choice but to not add developer. Due to the lack of contrast agent, the doctor cannot judge the state of the balloon in the body, such as whether the balloon is inflated or deflated, whether the balloon is leaking, whether the balloon is embolized in the small pulmonary artery, etc., and thus cannot accurately control the balloon . In addition, in clinical use, doctors may forget the state of the balloon and repeatedly inflate and deflate the balloon, thereby increasing the risk of balloon rupture and causing medical accidents. Therefore, there is an urgent need for a safe and reliable medical catheter so that doctors can understand the state of the balloon in the body outside the body and improve the safety and effectiveness of the medical process.

Contents of the invention

In order to overcome at least one of the problems in the related art, the present invention provides a medical catheter.

Wherein, the medical catheter includes a first expansion body, a second expansion body and a main body;

The first expansion body is disposed at the distal end of the main body, the second expansion body is disposed at the proximal end of the main body, and the interior of the first expansion body is in fluid communication with the interior of the second expansion body.

In an optional embodiment, when the first expansion body is inside the body and the second expansion body is outside the body, the volume change of the second expansion body reflects the working state of the first expansion body.

In an optional embodiment, when the first expansion body is in a non-compressed state, the outer diameters of the first expansion body and the second expansion body are equal.

In an optional embodiment, the first expansion body and the second expansion body are made of materials with the same expansion ratio.

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 the set pressure threshold, the second expansion The body switches from the primary expansion state to the secondary expansion state.

In an optional embodiment, the second inflatable body includes an unexpanded portion, wherein

When the internal pressure of the first inflatable body is greater than or equal to the set pressure threshold, the undeployed portion is opened to realize switching from the primary expansion state to the secondary expansion state.

In an optional embodiment, the unfolded part includes a folded part.

In an optional embodiment, the undeployed part is kept in an undeployed state by at least one of bonding, heat melting, heat shrinking or laser welding.

In an optional embodiment, the main body includes an air-filled cavity extending along the axis of the catheter, and the first inflation body and the second expansion body are respectively communicated with the inflation cavity.

In an optional embodiment, the catheter further includes a valve unit, and the valve unit communicates with the inflatable cavity.

In an optional embodiment, the main body further includes a thermistor cavity, and/or a distal cavity, and/or a proximal cavity.

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

(1) By setting the first expansion body at the far end and the second expansion body at the proximal end, and connecting the internal spaces of the two expansion bodies in series, the operator does not need to develop substances, and does not need to use additional display equipment to observe the expansion in the body The state of the body, the state of the first expansion body in the body can be understood only by observing the state of the second expansion body outside the body; the purpose of observing the state of the medical catheter is achieved; Various problems caused by misuse. Moreover, the device of the present disclosure enables the operator to deal with emergencies in time when observing abnormalities in the second expansion body outside the body, avoiding problems such as leakage and embolism of the expansion body in the body, and effectively improving the use safety of medical catheters and improve the efficiency of clinical care.

(2) In the non-compressed state of the first expansion body, the outer diameters of the first expansion body and the second expansion body are equal; so that the operator can simply and clearly know the first expansion in the body through the outer diameter of the second expansion body outside the body The outer diameter of the first expansion body can be controlled safely and efficiently, and the inflation will be stopped when the outer diameter of the second expansion body reaches the target value.

(3) The first expansion body and the second expansion body are made of materials with the same expansion ratio; so that parameters such as the volume and outer diameter of one expansion body can be changed synchronously and stably following the change of the other expansion body. The material adopted in the invention enables the expansion body to be compatible with people who are latex intolerant, and improves the use safety of the medical catheter and the range of applicable people.

(4) The second expansion body at least includes a primary expansion state and a secondary expansion state. When the pressure on the outside of the first expansion body increases, resulting in an increase in internal pressure, when the pressure is greater than or equal to the set pressure threshold, The second expansion body is switched from a primary expansion state to a secondary expansion state; the operator can understand the pressure-bearing state of the first expansion body inside the body through the different expansion states of the second expansion body outside the body. More advantageously, when the second inflatable body jumps from the first inflated state to the second inflated state, the increase in its volume will reduce the internal pressure, thereby reducing the internal pressure of the first inflatable body to within a safe range, and the outer diameter Correspondingly shrink to avoid problems such as bursting, and at the same time avoid the rupture of blood vessels such as the pulmonary artery, and give the operator sufficient time to deal with the internal pressure of inflation, which further improves the safety of the device.

(5) By providing an undeployed structure such as a folded portion on the second inflatable body, and opening the undeployed structure when a predetermined pressure threshold is met, the operator can clearly detect the state change of the in vitro inflatable body.

Description of drawings

The accompanying drawings are used to better understand the present invention, and do not constitute improper limitations to the present invention. in:

Fig. 1 is a schematic structural view of a medical catheter according to an embodiment of the present invention;

2 is a schematic cross-sectional view of a multi-lumen tube body according to an embodiment of the present invention;

Fig. 3 is a schematic diagram of the expansion state of each expansion body according to an embodiment of the present invention;

Fig. 4 is a schematic diagram of an inflatable body with folds according to an embodiment of the present invention;

Fig. 5 is a schematic diagram of a folded part in a folded state according to an embodiment of the present invention;

Fig. 6 is a schematic diagram of an expansion body in a second expanded state according to an embodiment of the present invention;

Fig. 7 is a schematic diagram of an inflatable body in a third expanded state according to an embodiment of the present invention;

Fig. 8 is a schematic diagram of another folding method of the folding part according to an embodiment of the present invention;

Fig. 9 is a schematic structural view of a medical intervention catheter according to an embodiment of the present invention;

Fig. 10 is a partially enlarged schematic diagram of a distal end of a medical intervention catheter according to an embodiment of the present invention.

Detailed ways

Exemplary embodiments of the present invention are described below in conjunction with the accompanying drawings, which include various details of the embodiments of the present invention to facilitate understanding, and they should be regarded as exemplary only. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the invention. Also, descriptions of well-known functions and constructions are omitted in the following description for clarity and conciseness.

The terminology used in this application is for the purpose of describing particular embodiments only, and is not intended to limit the application. As used in this application and the appended claims, the singular forms "a", "the", and "the" are intended to include the plural forms as well, unless the context clearly dictates 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.

It should be understood that although the terms first, second, third, etc. may be used in this application to describe various information, the 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 the present application, first information may also be called second information, and similarly, second information may also be called first information. Depending on the context, the word "if" as used herein may be interpreted as "at" or "when" or "in response to a determination."

Medical catheter is a commonly used tool for clinicians to assess and manage critically ill patients. Medical catheter is not an intervention tool, but an auxiliary diagnostic tool for measuring hemodynamic parameters, such as cardiac output, central venous pressure, right Atrial pressure, pulmonary artery pressure, pulmonary wedge pressure, etc. The medical catheters in the prior art have at least the following problems: the balloon of the catheter is made of latex material, and when a developing substance is added to the balloon, it will affect the physical properties of the balloon, such as expansion performance, contraction performance and floating performance, and ultimately affect the medical performance. Catheter performance. Therefore, on the premise of ensuring the usability of the medical catheter, no imaging substance is added to the balloons in the related art. When a catheter with no imaging substance is inserted into the human body, the doctor cannot judge the state of the balloon in the body, such as whether the balloon is inflated or deflated, whether the balloon is leaking, or whether the balloon is embolizing small pulmonary arteries. In addition, in clinical use, doctors are often unable to confirm the inflation status of the balloon in the body, and will repeatedly inflate and deflate the balloon. Such operations increase the risk of balloon rupture, and more seriously, balloon leakage It will cause the gas to directly enter the blood, or the balloon will spontaneously move to the small pulmonary artery when it is inflated for a long time, resulting in long-term embolism of the small pulmonary artery and hematoma, and even rupture of the pulmonary artery.

In order to solve at least one of the above problems, the first aspect of the present invention provides a medical catheter.

The medical catheter includes a first expansion body, a second expansion body and a main body; the first expansion body is arranged at the distal end of the main body, the second expansion body is arranged at the proximal end of the main body, and the first expansion body The interior of the body is in fluid communication with the interior of the second expansion body.

As shown in FIG. 1 and FIG. 3 , it discloses a schematic diagram of 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. Viewed from the perspective of use, the medical catheter includes a distal end and a proximal end, wherein the distal end is the end away from the operator, and the proximal end is the end close to the operator. In actual use, the operator controls the medical catheter at the proximal end, such as controlling the inflation and deflation of each expansion body. The first expansion body is arranged at the distal end, it is located in the human body when in use, and its volume expands when it is inflated. The inflated first swelling body will float in the blood and move to the target location with the blood flow. The main body part includes a multi-lumen tube main body 109, a main body connector 107, a transfer line and the like. Wherein, the main body joint 107 is used as a connecting structure for connecting the main body of the multi-lumen tube and the transfer line. Specifically, the multi-lumen tube main body 109 is a tubular structure, and its proximal end is connected to the distal end of the main body joint; correspondingly, the proximal end of the main body joint is connected to the distal end of the transfer line. The transfer pipeline may include multiple tubes, and their proximal ends are respectively connected with various connectors, such as Luer connectors 101, 102 and so on.

Preferably, the first expansion body 112 is disposed at the distal end of the main body, the second expansion body 105 is disposed at the proximal end of the main body, and the interior of the first expansion body is in fluid communication with the interior of the second expansion body. It should be noted that, in this embodiment, the first expansion body disposed at the distal end is not filled with a developing substance, and no developer is added to its production material, so the operator cannot observe the first expansion body located in the body through a common developing device. The state of the expander. Correspondingly, in order to facilitate the operator to know the state of the first expansion body in the body in real time, a design scheme of double expansion bodies is adopted in one embodiment of the present disclosure, and the second expansion body is arranged at the distal end of the main body. When in use, the first expansion body is inserted into the human body along the blood vessel, while the second expansion body is placed outside the body. Due to the fluid communication of the inner spaces of the first inflation body and the second inflation body, the inner pressures of the two balloons are equal in real time. When the state parameters such as pressure and volume of any expansion body change, the state parameters of the other expansion body will change accordingly. That is, through the structural design of this embodiment of the present 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 that of the first expansion body. The working state of the expander. Therefore, the operator can know the state 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 an inflation or deflation operation, the volumes of the first expansion body and the second expansion body will expand or contract synchronously. In practice, the first inflatable body can move in the heart or blood vessels after being inflated. If the first inflatable body is inflated for a long time, it will spontaneously move to the small blood vessels of the pulmonary artery, causing the pulmonary artery to be embolized. If the inflation is continued, the first inflatable body will be compressed by the blood vessel and will be in a compressed state, so that the pressure in the first inflatable body will increase. In contrast, 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 embolizes 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 inflatable body and the second inflatable body need to be installed securely and avoid blocking the corresponding air holes. To this end, in one embodiment, heat shrinkage, bonding, laser welding or heat fusion are used to connect the expansion body. To sum up, by connecting the internal spaces of the two expansion bodies in series, the operator does not need to develop substances, and does not need to use additional display equipment to observe the state of the expansion body in the body. Only by observing the state of the second expansion body outside the body can It can understand the state of the first expansion body in the body; achieve the purpose of simply observing the state of the medical catheter; at the same time, it also solves various problems caused by the operator's misoperation of the expansion body in the prior art, such as repeated inflation and deflation confirmation It will prolong the operation time and increase the risk of balloon rupture. If the balloon leaks, the gas injection will directly enter the blood and blood vessels. If it is embolized for a long time, it will cause hematoma or even rupture of the pulmonary artery. These are all adverse events in clinical practice. Moreover, the device of the present disclosure enables the operator to deal with emergencies in time when observing abnormalities in the second expansion body outside the body, avoiding problems such as leakage and embolism of the expansion body in the body, and effectively improving the use safety of medical catheters and improve the efficiency of clinical care.

In an optional embodiment, when the first expansion body is in a non-compressed state, the outer diameters of the first expansion body and the second expansion body are equal. Since the diameter of blood vessels in the human body is small, the outer diameters of the first expansion body and the second expansion body are also small. Under such conditions, when the two inflatable bodies have a large difference in volume under normal inflated state, especially when the difference in outer diameter is large, and the volume or pressure of the balloon in the body changes slowly, it will be difficult for the operator to find out in time. Volume change of in vitro swollen bodies. Especially when the volume expanded in vitro is significantly larger than the volume of the expanded body in vivo, the small diameter change of the expanded body in vitro is less obvious visually. In addition, when the outer diameters of the two expansion bodies are different, it is also difficult for the operator to know the real-time volume change of the expansion body in the body during the inflation process. For this reason, in one embodiment of the present disclosure, the outer dimensions of the two expansion bodies are set to be the same, so that the dimensions, especially the outer diameters, of the two expansion bodies are the same in the non-inflated state and the normal inflated state. When the first expansion body works normally in the body, that is, when the first expansion body is in a non-compressed state, the outer diameter of the first expansion body is equal to the outer diameter of the second expansion body. The above-mentioned design allows the operator to know the outer diameter of the first inflatable body in the body by observing the outer diameter of the second inflatable body outside the body when inflating or deflating the inflatable body, and the outer diameter of the second inflatable body reaches the target Stop inflation when the value is reached, so as to safely and efficiently control the outer diameter of the first expansion body in the body.

In an optional embodiment, the first expansion body and the second expansion body are made of materials with the same expansion ratio. In order to make parameters such as the volume and outer diameter of one expansion body change synchronously and stably following the change of the other expansion body, especially to ensure that the outer diameters of the two are the same during inflation or deflation, an embodiment of the present disclosure In this paper, two expansion bodies are made of materials with the same expansion ratio to solve this problem. Preferably, the same material is used to make the two expansion bodies. Exemplarily, the expansion body can be made of synthetic latex, silica gel, rubber, TPE, TPX, TPU, WPU and other high elastic materials. Advantageously, compared with natural latex, the expansion body made of the above material is compatible with latex-intolerant people, which improves the safety of medical catheters and the range of applicable people.

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 first expansion body is greater than or equal to a set pressure threshold, the second expansion The body switches from the primary expansion state to the secondary expansion state. In the implementation shown in Figures 5 to 7, the second expansion body includes three expansion states, that is, the primary expansion state shown in Figure 5, the secondary expansion state shown in Figure 6 and the expansion state shown in Figure 7. tertiary expansion state. In each of the expansion states, the outer diameter of the expansion body is discontinuous and discrete; that is, the diameter OD1 shown in Figure 5 needs to meet a preset pressure before stepping to the OD2 shown in Figure 6 ; Similarly, the diameter OD2 shown in FIG. 6 needs to meet another preset pressure before stepping to OD3 shown in FIG. 7 . It should be noted that the above-mentioned number of expansion states is only an example, and can be reasonably set according to practical needs in practice. In practice, the working state of the first expansion body in the body is reflected by setting different expansion states. For example, if the safe pressure threshold is used as the set pressure threshold, since the first expansion body is located in the blood vessel, the expansion of its volume is restricted by the blood vessel. When continuing to inflate the first inflatable body, the blood vessel will press the first inflatable body so that its volume cannot be increased. At this time, the external pressure on the first inflatable body increases, and the internal pressure also gradually increases. When the first inflatable body When the internal pressure is greater than or equal to the safety pressure threshold, the second expansion body will step from the primary expansion state shown in FIG. 5 to the secondary expansion state shown in FIG. 6 . The outer diameter of the secondary expansion state is obviously larger than that of the primary expansion state, and the operator can obviously find the change of the outer diameter of the second expansion body outside the body, and confirm that the internal pressure of the first expansion body in the body has reached the safety threshold. More advantageously, when the second expansion body steps to the second expansion state, its large volume change will reduce the internal pressure, thereby reducing the internal pressure of the first expansion body to within a safe range, and the outer diameter will be correspondingly reduced , to avoid problems such as bursting, and at the same time avoid the rupture of blood vessels such as the pulmonary artery, and give the operator sufficient time to deal with the internal pressure of inflation, further improving the safety of the device. Of course, when the pressure of the expansion body is within the safety threshold, the maximum outer diameter of the expansion body is OD1 shown in FIG. 5 . In addition, when setting various pressure thresholds and correspondingly setting the expansion state, the operator can know various working states of the first expansion body in the body. For example, when the preset pressure threshold is slightly lower than the pressure that causes pulmonary artery rupture, when the second inflatable body outside the body steps from the second inflated state shown in Fig. 6 to the state shown in Fig. In the third expansion state shown in 7, the operator can clearly understand that the pressure of the first expansion body in the body is too high, and there is a risk of rupture of the pulmonary artery, and it is necessary to release the pressure of the expansion body in time to ensure safety.

In an optional embodiment, the second inflatable body includes an undeployed portion, wherein when the internal pressure of the first inflatable body is greater than or equal to the set pressure threshold, the undeployed portion opens to realize a The first-stage expansion state is switched to the second-stage expansion state. In an optional embodiment, the unfolded part includes a folded part. In order to realize the above-mentioned step change of the outer diameter of the expander between different expanded states, one embodiment of the present disclosure adopts an undeployed portion on the expander to solve this problem. The undeployed part can be arranged in multiple positions of the expansion body, and the number can also be multiple. By reasonably controlling the connection strength of the undeployed part, it can be matched with the corresponding pressure threshold to realize the expansion under different pressure thresholds. Expand. Preferably, the unexpanded portion is arranged in the radial direction of the second inflatable body, and its outer diameter can change significantly when expanded. As shown in FIG. 5 to FIG. 7 , the second inflatable body is folded with a first folded portion 401 and a second folded portion 402 in the diameter direction, and the unfolding pressures of the two folded portions are unequal. When the internal pressure of the first expansion body reaches the first pressure threshold, the first folded part 401 is unfolded, but the second folded part 402 is not unfolded, and the outer diameter of the second expansion body is stepped from OD1 to OD2 ; When the internal pressure of the first expansion body further increases and reaches the second pressure threshold, the second folded portion 402 unfolds, and the outer diameter of the second expansion body steps from OD2 to OD3. The folding part can be folded on one side as shown in FIG. 5 , or folded on two sides as shown in FIG. 8 . The above-mentioned folding methods are all examples, and are not enough to limit the protection scope of the present disclosure. It can be understood that, the folded portion or the undeployed portion may adopt other forms than those described in the embodiments of the present disclosure, and it only needs to be unfolded under a predetermined pressure.

In an optional embodiment, the undeployed part is kept in an undeployed state by at least one of bonding, heat melting, heat shrinking or welding. Taking the folded state shown in FIG. 5 as an example, in practice, the connection strength of the folded portion needs to be designed according to a predetermined unfolding pressure. Adhesive, thermal fusion, thermal shrinkage or welding can be used at the folded position to obtain sufficient connection strength. Wherein, the welding method may be laser welding. Parameters such as the specific connection position and connection area of the folding portion can be flexibly adjusted as required.

In an optional embodiment, the main body includes an air-filled cavity extending along the axis of the catheter, and the first inflation body and the second expansion body are respectively communicated with the inflation cavity. In an optional embodiment, the conduit further includes a valve unit, the valve unit communicates with the inflatable cavity, and the valve unit is used to control the on-off state of the external air source and the inflatable cavity. As shown in FIG. 1 , the medical catheter includes a multi-lumen tube main body 109 , a main body joint 107 and a transfer line connected with a valve unit 106 . An air-filled cavity extending along the axis of the catheter is arranged inside the multi-lumen tube main body, the main body joint and the transfer pipeline. Specifically, as shown in FIG. 2 , it shows a cross-sectional view of the main body of the multi-lumen tube, which includes the gas-filled cavity 202 . The distal end of the inflatable cavity communicates with the interior of the first inflatable body through the first inflatable hole 111 ; the proximal end of the inflatable cavity communicates with the interior of the second inflatable body through the second inflatable hole 104 . As shown in Figure 1, the first expansion body and the first inflation hole are both arranged at the distal end of the multi-lumen tube body; the second expansion body and the second inflation hole are both arranged at the valve unit 106 connected on the transfer line. The operator inflates or deflates the inside of the two expansion bodies through the inflation unit. The valve unit 106 may be a common medical valve such as a two-way valve, a three-way valve, a spring-type air valve, and a silicone-type air valve.

In an optional embodiment, the main body further includes a thermistor cavity, and/or a distal cavity, and/or a proximal cavity. FIG. 2 shows a schematic diagram of a multi-lumen tube body provided with multiple lumens, which includes a thermistor lumen 201 , a distal lumen 203 and a proximal lumen 204 . Wherein, the number of cavities is just an example, and those skilled in the art can increase or decrease the number of cavities as required. The main body of the multi-lumen tube is made of polymer materials, such as PEBAX, PVC, PU, PE, PP and other materials; and it is made by extrusion technology and post-processing technology. The four cavities described in FIG. 2 are independent of each other and extend to the main body joint. A corresponding number of channels are provided in the main body joint corresponding to the cavities one by one. Each cavity in the main body of the multi-lumen tube is separated through the main body joint and then connected to the corresponding transfer pipeline. The main body joint can be made by bonding, injection molding and other methods. As shown in Figure 1, the distal end of the multi-lumen tube main body is also provided with a distal cavity outlet 113, and the distal cavity outlet 113 communicates with the distal cavity body 203, and the distal cavity The body passes through the multi-lumen tube main body 109, the main body joint 107 and the interior of the transfer line connected with the distal lumen Luer joint 101 in sequence along the axial direction of the medical catheter. The distal cavity is used for guiding wire, withdrawing blood, infusion, pressure measurement and so on. The transfer line connected with the luer connector 101 of the distal cavity and the main body connector 107 are fixed by bonding or injection molding. The position near the distal end of the multi-lumen tube body is also provided with a proximal cavity outlet 108, and the proximal cavity outlet 108 communicates with the proximal cavity 204, and the proximal cavity is along the medical The axial direction of the catheter runs through the multi-lumen tube main body 109 , the main body connector 107 and the interior of the transfer line connected with the proximal luer Luer connector 102 in sequence. The proximal cavity is used for blood withdrawal, infusion, pressure measurement and so on. The adapter pipe connected with the luer connector 102 of the proximal cavity and the main body connector are fixed by bonding or injection molding. In one embodiment, the outlet of the proximal lumen is set at a position about 30 cm away from the distal end surface of the main body of the multi-lumen tube. The position near the distal end of the multi-lumen tube main body is also provided with a thermistor 110, the lead wire of the thermistor 110 is installed in the thermistor cavity 201, and the thermistor cavity 201 is along the medical catheter The axial direction of the multi-lumen tube runs through the interior of the multi-lumen tube main body 109, the main body joint 107 and the transfer line connected with the thermistor joint 103 in sequence. The thermistor connector is connected with an adapter wire or equipment for data transmission. Exemplarily, the thermistor connector can be a commonly used aviation plug or the like. Optionally, the thermistor 110 is placed at a position about 4 cm away from the distal end surface of the multi-lumen tube main body, and is used to measure the blood temperature in the body, and measure or calculate the cardiac output through the change of the blood temperature.

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.

The medical intervention catheter includes a first expansion body, a third expansion body and a main body; the first expansion body and the third expansion body are arranged at the distal end of the main body, and the first expansion body is arranged at the third The interior of the 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 nested arrangement of the two expansion bodies ensures that when the inner first expansion body ruptures and leaks air due to excessive filling of gas, the outer third expansion body can accommodate the gas and prevent it from entering blood vessels.

In an optional embodiment, the first space is filled with a developing substance. At this time, the medical intervention catheter can be effectively compatible with the digital subtraction angiography (DAS) commonly used in the prior art, and the operator can observe the medical intervention catheter in the human body through the digital subtraction angiography device. working status.

Referring to Fig. 9 and Fig. 10, Fig. 9 shows the main structure of the medical intervention catheter, and Fig. 10 shows a partial enlarged view of the distal end of the medical intervention device. As shown in FIGS. 9 and 10 , the medical intervention catheter mainly includes a first expansion body 1001 , a third expansion body 1002 and a main body. In one embodiment, the two inflatable bodies can be made in the shape of a balloon. The main body is similar to the main body of the medical catheter described in the first aspect, and it also includes structures such as a multi-lumen tube main body, a main body joint, and a transfer line; the transfer line may be multiple, and its proximal end is provided with Connectors for the corresponding function, such as Luer connectors, thermistor connectors or valve units, etc. Wherein, the proximal end or the distal end are both relative to the operator, the end of the medical catheter close to the operator is the proximal end, and the first end away from the operator is the distal end. Since the structure of the main body is the same or similar to the main body of the catheter described in the first aspect, there are only differences in the structure of connecting the two expansion bodies and inflating or deflating the expansion body. Therefore, the medical use described in the second aspect The parts with the same structure on the main body of the catheter will not be repeated; only the differences will be described later. In addition, in one embodiment, a second expansion body (not shown in the figure) is further provided in the scheme shown in FIG. On the one hand, the second expansion body described is the same, and the second expansion body will not be repeated here.

Preferably, both the first expansion body 1001 and the third expansion body 1002 are arranged 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 and the inner surface of the third expansion body, and the first space is filled with a developing substance. The imaging substance can be a contrast agent, or other substances with equivalent functions. In practice, in order to make the expansion body of the medical catheter not only have a developing function but also be able to float in the blood, it is necessary to reasonably control the lumen volume of the first expansion body and the volume of the first space. Since the developing substance is filled in the double-layer nested expansion body interlayer, the first space constrains the distribution of the developing substance. Compared with the solution of directly filling the developing substance inside the single-layer balloon, the developing agent in this embodiment is more evenly distributed in the space, which is more conducive to observing the state of the inflatable body in the body through the display device. In addition, the first expansion body is only filled with gas without injecting developing substances, so that the distal end of the medical catheter has sufficient buoyancy. Correspondingly, the first space between the first inflatable body and the third inflatable body is filled with developer and/or a small amount of gas, so that the pressure inside the third inflatable body is lower than that of the first inflatable body Less stress. Therefore, when the first inflatable body breaks accidentally, the gas inside it can enter the third inflatable body, and the lower pressure condition of the third inflatable body can effectively contain the gas leaked from the first inflatable body, thereby preventing the gas from directly entering In the blood, there is a risk of air embolism forming, which ultimately improves the safety of the catheter.

In an optional embodiment, the inside of the first expansion body has a second space 1004, and the volume of the second space 1004 is greater than that of the first space in a working state. In the intervention state, the volume of the second space makes the first expansion body 1001 and the third expansion body 1002 in a floating state. As in the embodiment shown in Figure 10, the inside of the first expansion body 1001 has a second space 1004, and the volume of the second space 1004 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 .

In an optional embodiment, the first expansion body is made of elastic material, and/or the third expansion body is made of semi-compliant material. The elastic material includes synthetic latex, silica gel, rubber, TPE, TPX, TPU, WPU and other high elastic materials. In practice, the first expansion body is preferably made of high-elastic materials such as synthetic latex, thermoplastic elastomer (TPE), thermoplastic polyurethane elastomer (TPU), compared with the natural latex used in the prior art to make the balloon , can be compatible with latex intolerant people, improving the safety of medical catheters and the scope of applicable people. In addition, the semi-compliant material can be PEBAX and the like. Among them, materials with an expansion ratio of 110-130% are semi-compliant materials.

In an optional embodiment, the distal end of the main body is provided with a first air hole 1006 and a second air hole 1005; wherein, the first air hole 1006 communicates with the interior of the first expansion body 1004; The two air holes communicate with the first space. As shown in FIG. 10 , in order to inflate gas into the first space and the second space and control the amount of gas to be inflated respectively, it is necessary to provide corresponding inflating channels for the first space and the second space respectively. Wherein, the second space of the first expansion body communicates with the first air hole 1006 at the distal end of the multi-lumen tube main body; correspondingly, the first space communicates with the second air hole 1005 at the distal end of the multi-lumen tube main body.

In an optional embodiment, the main body includes a first gas-filled cavity and a second gas-filled cavity extending along the catheter axis; wherein, the first gas-filled cavity communicates with the first air hole, and the second gas-filled cavity communicates with the first air hole. The second inflatable cavity communicates with the second air hole. As shown in Figure 9, the catheter also includes a first valve unit 901 and a second valve unit 902; wherein, the first valve unit communicates with the first inflatable cavity, and the second valve unit The unit communicates with the second gas-filled cavity. The first inflatable cavity sequentially runs through the main body of the multi-lumen tube, the main body joint, and the interior of the transfer pipeline connected with the first valve unit 901; correspondingly, the second inflatable cavity runs through the multi-lumen tube in sequence The inside of the main body, the main body joint and the transfer pipeline connected with the second valve unit 902 . When in use, the operator fills or discharges gas into the corresponding space through the first valve unit and the second valve unit at the proximal end. The valve unit can be common medical valves such as two-way valves, three-way valves, spring-type air valves, and silicone-type air valves.

In an optional embodiment, the first expansion body and the third expansion body are arranged at the distal end of the main body by at least one of bonding, heat melting, heat shrinking or laser welding. As shown in FIG. 9 , the first expansion body and the third expansion body are respectively arranged at the distal end of the main body of the multi-lumen tube, and the two expansion bodies need to be installed firmly and avoid blocking the corresponding inflation holes. To this end, in one embodiment, the expansion body and the multi-lumen tube main body are connected by means of adhesion, laser welding, heat shrinkage or heat fusion.

In an optional embodiment, the main body further includes a thermistor cavity, and/or a distal cavity, and/or a proximal cavity. In practice, according to measurement requirements, multiple cavities can be provided inside the main body as required for the corresponding measuring elements to extend from the proximal end to the distal end. The medical interventional catheter provided in the second aspect may also be provided with structures such as a thermistor cavity, a distal cavity, and a proximal cavity. The structure and purpose of the corresponding cavity are the same as those described in the first aspect, please refer to the previous description for details, and details will not be repeated here.

The above specific implementation methods do not constitute a limitation to the protection scope of the present invention. Other implementations of the present disclosure will be easily conceived by those skilled in the art after considering the specification and practicing the technical solutions disclosed in the present application. This application is intended to cover any modification, use or adaptation of the present disclosure, and these modifications, uses or adaptations follow the general principles of the present disclosure and include common knowledge or conventional technical means in the technical field not disclosed in the present disclosure . The specification and examples are to be considered exemplary only, with a true scope and spirit of the disclosure being indicated by the following claims.

It should be understood that the present disclosure is not limited to the precise constructions which have been described above and shown in the drawings, and various modifications and changes may be made without departing from the scope thereof. The scope of the present disclosure is limited only by the appended claims.

Claims (11)

1. A medical catheter which is used for the treatment of the skin,

the method is characterized in that:

the catheter comprises a first expansion body, a second expansion body and a main body;

the first expansion body is disposed at the distal end of the body, the second expansion body is disposed at the proximal end of the body, and the interior of the first expansion body is in fluid communication with the interior of the second expansion body.

2. The medical catheter according to claim 1, wherein,

when the first expansion body is positioned in the body and the second expansion body is positioned outside the body, the volume change of the second expansion body reflects the working state of the first expansion body.

3. The medical catheter according to claim 2, wherein,

in the non-compressed state of the first expansion body, the outer diameters of the first expansion body and the second expansion body are equal.

4. The medical catheter according to claim 1, wherein,

the first expansion body and the second expansion body are made of materials with the same expansion proportion.

5. The medical catheter according to any one of claim 1 to 4, wherein,

the second expansion body at least comprises a first expansion state and a second expansion state, and when the internal pressure of the second expansion body is larger than or equal to a set pressure threshold value, the second expansion body is switched from the first expansion state to the second expansion state.

6. The medical catheter according to claim 5, wherein,

the second inflatable body comprises an undeployed section, wherein

When the internal pressure of the first expansion body is greater than or equal to the set pressure threshold, the undeployed section is opened to realize the switching from the primary expansion state to the secondary expansion state.

7. The medical catheter according to claim 6, wherein,

the unexpanded section includes a fold.

8. The medical catheter according to claim 7, wherein,

the undeployed part is kept in an undeployed state by at least one mode of bonding, hot melting, thermal shrinkage or laser welding.

9. The medical catheter according to claim 1, wherein,

the main body comprises an inflation cavity extending along the axis of the catheter, and the first inflation body and the second inflation body are respectively communicated with the inflation cavity.

10. The medical catheter according to claim 8, wherein,

the conduit also includes a valve unit in communication with the inflation lumen.

11. The medical catheter according to claim 1, wherein,

the body further includes a thermistor cavity, and/or a distal cavity, and/or a proximal cavity.