Balloon catheter for mild hypothermia treatment

Abstract

The utility model relates to the technical field of medical instruments, and discloses a balloon catheter for mild hypothermia treatment, which comprises a catheter and a balloon, the catheter is provided with a liquid inlet cavity, a liquid outlet cavity and a guide wire cavity which extend along the axial direction of the catheter, the liquid inlet cavity is arranged close to the outer wall of the catheter, the liquid outlet cavity is arranged close to the center of the catheter, and the liquid inlet cavity and the liquid outlet cavity are communicated at the far end of the catheter; the balloon is sleeved and fixed outside the catheter, a liquid spraying pipe is further arranged on the part, located in the balloon, of the catheter, the liquid spraying pipe is communicated with the liquid inlet cavity and the interior of the balloon, and the cross section area of the liquid spraying pipe is smaller than that of the liquid inlet cavity; a liquid outlet is further communicated between the balloon and the liquid inlet cavity so that circulation of cooling liquid in the balloon can be achieved. The liquid inlet cavity is arranged on the outer side of the liquid outlet cavity, so that the heat exchange efficiency of the guide pipe and external substances is improved; by arranging the balloon, the heat exchange surface area is increased, and the cooling rate is increased; by arranging the liquid spraying pipe, the fountain effect and the vortex phenomenon are formed in the balloon, and the heat exchange efficiency of the balloon and the blood is further improved.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, in particular to a balloon catheter for mild hypothermia treatment. Background Art

[0002] As an effective brain protection method, mild hypothermia therapy can minimize the damage to the nervous system caused by brain injury and improve neurological recovery after cardiac arrest without obvious adverse reactions. It is suitable for brain protection during extracorporeal circulation in cardiac surgery, craniocerebral injury related to decreased cerebral perfusion pressure, encephalopathy after cardiopulmonary resuscitation, neonatal hypoxic-ischemic encephalopathy, craniocerebral injury (traumatic craniocerebral injury, cerebral edema after extensive cerebral contusion and hemorrhage, etc.), ischemic stroke, various high fever conditions (central hyperpyrexia, febrile convulsions, encephalitis), etc.

[0003] At present, the methods of mild hypothermia brain protection mainly include cooling the whole body surface, intravascular cooling, etc. Intravascular heat exchange brain treatment is to place a balloon catheter with heat exchange function in the human inferior vena cava, and use an extracorporeal cryoprotection system to accurately control the temperature of the coolant in the intravascular temperature-controlled balloon, so as to reduce the core temperature of the human body to 33℃-36℃ (depending on the patient's condition) and maintain it for 48-72 hours.

[0004] The heat exchange efficiency of balloon catheters currently on the market is low. For example, patent CN115177431A provides a balloon for cooling in cryotherapy equipment. The balloon is provided with liquid passages responsible for the inflow and outflow of cooling liquid respectively. The cooling liquid circulates only in the circulation pipeline, which limits the cooling range to a certain extent, resulting in low heat exchange efficiency and slow cooling rate.

[0005] Therefore, there is an urgent need for a balloon catheter for mild hypothermia treatment to solve the above technical problems. Utility Model Content

[0006] Based on the above, the purpose of the utility model is to provide a balloon catheter for mild hypothermia treatment to accelerate the heat exchange efficiency with the human body and improve the cooling rate.

[0007] In order to achieve the above purpose, the utility model adopts the following technical solutions:

[0008] The utility model provides a balloon catheter for sub-hypothermia treatment, comprising a catheter and a balloon, wherein the catheter is provided with a liquid inlet cavity, a liquid outlet cavity and a guide wire cavity extending along the axial direction thereof, wherein the liquid inlet cavity is arranged close to the outer wall of the catheter, the liquid outlet cavity is arranged close to the center of the catheter, and the liquid inlet cavity is communicated with the liquid outlet cavity at the distal end of the catheter; the balloon is sleeved and fixed outside the catheter, a portion of the catheter located inside the balloon is further provided with a liquid spray pipe, the liquid spray pipe is connected with the liquid inlet cavity and the inside of the balloon, and the cross-sectional area of ​​the liquid spray pipe is smaller than the cross-sectional area of ​​the liquid inlet cavity; a liquid outlet is further communicated between the balloon and the liquid inlet cavity to realize the circulation of cooling liquid in the balloon.

[0009] In some possible embodiments, at least two liquid inlet cavities are provided, and at least two of the liquid inlet cavities are evenly arranged along a concentric circle of the catheter; at least two liquid outlet cavities are provided, and at least two of the liquid outlet cavities are evenly arranged along another concentric circle of the catheter, and at least two of the liquid inlet cavities are connected to at least two of the liquid outlet cavities in a one-to-one correspondence.

[0010] In some possible implementations, the cross-sectional shape of the liquid inlet cavity is circular, and / or the cross-sectional shape of the liquid outlet cavity is circular.

[0011] In some possible implementations, at least two balloons are axially spaced apart from each other on the catheter, each balloon has a corresponding liquid spraying tube inside, and each balloon is connected to the liquid inlet cavity through at least one liquid outlet.

[0012] In some possible implementations, each of the balloons has at least two corresponding liquid spray tubes, and the at least two liquid spray tubes are evenly spaced and distributed along the same circumference on the side wall of the catheter.

[0013] In some possible implementations, there are two corresponding liquid spraying tubes in each of the balloons, and the two liquid spraying tubes are symmetrically arranged along the radial direction of the catheter.

[0014] In some possible embodiments, the spray pipe is a straight pipe perpendicular to the side wall of the catheter; or, the spray pipe has a U-shaped structure, including two longitudinal pipelines perpendicular to the side wall of the catheter and a transverse pipeline parallel to the side wall of the catheter, the two longitudinal pipelines are respectively connected to the liquid inlet cavity, the transverse pipeline is connected to the two longitudinal pipelines, and the transverse pipeline is provided with a spray outlet connected to the interior of the balloon.

[0015] In some possible implementations, the surface of the balloon and the distal end of the catheter are further provided with an anticoagulant coating.

[0016] In some possible implementations, a bottom layer is provided between the anticoagulant coating and the surface of the balloon, and between the anticoagulant coating and the surface of the catheter.

[0017] In some possible embodiments, the anticoagulant coating includes a heparin coating, and the bottom layer includes a hydrophilic coating.

[0018] In some possible implementations, the guidewire cavity is located at the center of the catheter.

[0019] In some possible implementations, the distal end and the proximal end of the balloon are fixed to the catheter by heat shrinking or welding.

[0020] The beneficial effects of the utility model are:

[0021] The utility model provides a balloon catheter for hypothermia treatment, which forms a circulation channel for cooling liquid by arranging a connected liquid inlet cavity and a liquid outlet cavity on the catheter, wherein the liquid inlet cavity is arranged close to the outer wall of the catheter, and the liquid outlet cavity is arranged close to the center of the catheter, thereby enhancing the heat exchange efficiency between the catheter and the outside; by arranging a balloon outside the catheter, the liquid inlet cavity is connected with the inside of the balloon through a liquid spray pipe, and the inside of the balloon is connected with the liquid inlet cavity through a liquid outlet, thereby realizing the circulation of cooling liquid in the balloon, and since the surface of the entire balloon is a heat exchange surface, the heat exchange surface area is greatly increased, and the cooling rate for the human body is improved; in addition, the cross-sectional area of ​​the liquid spray pipe is smaller than the cross-sectional area of ​​the liquid inlet cavity, so that the flow rate of the cooling liquid increases when it enters the liquid spray pipe, and a fountain effect is formed when it is sprayed out from the liquid spray pipe, at this time, the cooling liquid will preferentially flow along the inner wall of the balloon, and can quickly exchange heat with the blood flowing through the outer wall of the balloon, and the cooling liquid will form a vortex between the inner wall of the balloon and the liquid spray pipe, further accelerating the heat exchange efficiency and ensuring the cooling rate. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a schematic structural diagram of a balloon catheter for mild hypothermia treatment provided by an embodiment of the utility model;

[0023] Figure 2 yes Figure 1 A partial enlarged view of the middle balloon and the liquid spraying tube;

[0024] Figure 3 is a cross-sectional view of a catheter provided by an embodiment of the utility model;

[0025] Figure 4 It is a structural schematic diagram of another liquid spray pipe provided in an embodiment of the utility model.

[0026] In the figure:

[0027] 1. Catheter; 11. Liquid inlet cavity; 12. Liquid outlet cavity; 13. Guidewire cavity; 14. Liquid spray tube; 15. Liquid outlet; 2. Balloon; 3. Guidewire. DETAILED DESCRIPTION

[0028] The present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the present invention, rather than to limit the present invention. It should also be noted that, for ease of description, only the parts related to the present invention, rather than all structures, are shown in the accompanying drawings.

[0029] In the description of the present invention, unless otherwise clearly specified and limited, the terms "connected", "connected", and "fixed" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0030] In the present utility model, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being "above", "above" and "above" a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being "below", "below" and "below" a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0031] In the description of this embodiment, the terms "upper", "lower", "left", "right", etc., and the orientation or position relationship are based on the orientation or position relationship shown in the drawings, and are only for the convenience of description and simplified operation, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as a limitation of the present invention. In addition, the terms "first" and "second" are only used to distinguish in the description and have no special meaning.

[0032] like Figure 1-Figure 4As shown, this embodiment provides a balloon catheter for sub-hypothermia treatment, including a catheter 1 and a balloon 2. The catheter 1 is provided with a liquid inlet cavity 11, a liquid outlet cavity 12 and a guidewire cavity 13 extending along its axial direction respectively. The liquid inlet cavity 11 is arranged near the outer wall of the catheter 1, and the liquid outlet cavity 12 is arranged near the center of the catheter 1. The liquid inlet cavity 11 and the liquid outlet cavity 12 are connected at the distal end of the catheter 1, thereby forming a circulating flow channel for the coolant. The coolant is transported to the liquid inlet cavity 11 through an extracorporeal transport device, and after heat exchange with the human body, it flows out of the human body through the liquid outlet cavity 12. Specifically, the coolant can be a liquid such as physiological saline, and the transport device can be a circulating water tank and a circulating water pump arranged outside the body. In this embodiment, since the liquid inlet cavity 11 is arranged near the outer wall of the catheter 1 and the liquid outlet cavity 12 is arranged near the center of the catheter 1, the heat exchange efficiency between the catheter 1 and the outside is enhanced. The guidewire cavity 13 of this embodiment is used for the guidewire 3 or other instruments to push the cavity. Preferably, the guidewire cavity 13 is arranged at the center of the catheter 1 to improve the guiding property of the balloon catheter when it intervenes in the human body.

[0033] The balloon 2 is fixedly sleeved on the outside of the catheter 1, and there is a space inside the balloon 2 that can be filled with cooling liquid. Specifically, the distal end and the proximal end of the balloon 2 can be fixed to the outer surface of the catheter 1 by heat shrinkage or welding, which is easy to process and firmly fixed. The part of the catheter 1 located inside the balloon 2 is also provided with a liquid spray pipe 14, and the liquid spray pipe 14 connects the liquid inlet cavity 11 and the internal space of the balloon 2. The balloon 2 and the liquid inlet cavity 11 are also connected with a liquid outlet 15. The cooling liquid in the liquid inlet cavity 11 can enter the balloon 2 through the liquid spray pipe 14, and flow back to the liquid inlet cavity 11 through the liquid outlet 15, thereby realizing the circulation of the cooling liquid in the balloon 2. Preferably, the liquid outlet 15 is an opening provided on the liquid inlet cavity 11, and is located at one end of the balloon 2 downstream along the flow direction of the cooling liquid. In this embodiment, by arranging the balloon 2 outside the catheter 1, the cooling liquid in the liquid inlet cavity 11 can flow through the balloon 2, and heat exchange with the blood through the balloon 2. Since the entire surface of the balloon 2 is a heat exchange surface, the heat exchange area is greatly increased, and the cooling rate of the balloon catheter on the human body is improved. Furthermore, the cross-sectional area of ​​the liquid spraying pipe 14 is smaller than the cross-sectional area of ​​the liquid inlet cavity 11. Such an arrangement increases the flow rate of the cooling liquid when it enters the liquid spraying pipe 14, and forms a fountain effect when it is sprayed out from the liquid spraying pipe 14. At this time, the cooling liquid will flow along the inner wall of the balloon 2 first, and can quickly exchange heat with the blood flowing through the outer wall of the balloon 2. In addition, the cooling liquid will form a vortex between the inner wall of the balloon 2 and the liquid spraying pipe 14, further accelerating the heat exchange efficiency and effectively ensuring the cooling rate.

[0034] like Figure 1-Figure 3As shown, in an optional embodiment, at least two liquid inlet chambers 11 are provided in the conduit 1, and at least two liquid inlet chambers 11 are evenly arranged along a concentric circle of the conduit 1; at the same time, at least two liquid outlet chambers 12 are provided in the conduit 1, and at least two liquid outlet chambers 12 are evenly arranged along another concentric circle of the conduit 1, and the liquid outlet chamber 12 is located on the inner side of the liquid inlet chamber 11; the number of liquid outlet chambers 12 is the same as that of the liquid inlet chamber 11, and each liquid inlet chamber 11 is connected to the corresponding liquid outlet chamber 12 in a one-to-one correspondence. In this embodiment, by providing at least two liquid inlet chambers 11 and at least two liquid outlet chambers 12, the heat exchange efficiency between the conduit 1 and its external substances is further accelerated. It should be noted that the cross-sectional shapes of the liquid inlet chamber 11 and the liquid outlet chamber 12 can be set to circular, square, elliptical or other shapes according to requirements. Preferably, in this embodiment, there are two liquid inlet chambers 11 and two liquid outlet chambers 12, and the cross-sectional shapes of the liquid inlet chamber 11 and the liquid outlet chamber 12 are both set to circular, and the circular cavity is easy to process and is conducive to the flow of the coolant.

[0035] Preferably, at least two balloons 2 are arranged at intervals along the axial direction on the catheter 1 of this embodiment, and each balloon 2 has a corresponding spray tube 14, and each balloon 2 is connected to the liquid inlet cavity 11 through at least one liquid outlet 15 to realize the circulation of the coolant in each balloon 2. Specifically, according to the requirements of the cooling range, two, three, four, five or other balloons 2 can be arranged on the catheter 1. By arranging at least two balloons 2, the dog bone phenomenon can be effectively prevented during use, and the supporting performance of the balloon catheter can be improved. Moreover, when multiple balloons 2 are filled with coolant at the same time, the position displacement of the device during the treatment process can be prevented to a certain extent. Specifically, the outer diameter of the catheter 1 in this embodiment is 1.98mm, and the length is about 100cm; the diameter of the balloon 2 is about 5mm, and the total cooling length of multiple balloons 2 along the axial direction of the catheter 1 is about 20-40mm.

[0036] Since the balloon catheter in the prior art can generally only be used for systemic cooling treatment in the inferior vena cava, there are side effects such as vasospasm, HCT abnormality, pneumonia, coagulation abnormality, infection, etc., the risk is relatively high and requires close monitoring, and the requirements for doctors and nurses in the intensive care unit are high, so it is difficult to promote it in clinical practice. However, the balloon catheter provided in this embodiment has a suitable size of balloon 2, which will not block blood flow, and can selectively perform cooling treatment in the carotid artery, and realize accurate cooling treatment of local brain tissue, which can achieve the purpose of cooling the target tissue and has less impact on the whole body temperature, which can greatly reduce the side effects of systemic cooling and facilitate clinical promotion.

[0037] Furthermore, in this embodiment, each balloon 2 has at least two corresponding spray tubes 14, and at least two spray tubes 14 are evenly spaced along the same circumference on the side wall of the catheter 1. Such an arrangement enables the balloon 2 to be evenly expanded, improves its position stability and cooling uniformity, and ensures more accurate and safe treatment. Preferably, each balloon 2 may have two corresponding spray tubes 14, and the two spray tubes 14 are symmetrically arranged along the radial direction of the catheter 1, so that the coolant enters the balloon 2 from the two spray tubes 14 in opposite directions, respectively, to ensure that the balloon 2 is balanced in force, and to prevent uneven filling of the balloon 2, that is, one side of the balloon 2 is under-expanded and the other side is over-expanded, which causes the position of the device to shift.

[0038] like Figure 1-Figure 2 As shown, the liquid spraying tube 14 can be a straight tube vertically arranged on the side wall of the catheter 1, and the two ends of the straight tube are connected to the liquid inlet cavity 11 and the internal space of the balloon 2 respectively. Figure 4 As shown, the liquid spray pipe 14 may also be in a U-shaped structure, including two longitudinal pipelines perpendicular to the catheter 1 and a transverse pipeline parallel to the catheter 1, wherein the two longitudinal pipelines are respectively connected to the liquid inlet cavity 11, and the two ends of the transverse pipeline are respectively connected to the two longitudinal pipelines, and a spray port connected to the internal space of the balloon 2 is provided on the transverse pipeline for injecting coolant into the balloon 2. Preferably, the cross-sectional areas of the longitudinal pipeline, the transverse pipeline and the spray port are all smaller than the cross-sectional area of ​​the liquid inlet cavity 11. Of course, in other embodiments, the liquid spray pipe 14 may also be set in other forms, and is not limited to this embodiment.

[0039] In this embodiment, the surface of the balloon 2 and the distal end of the catheter 1 are also provided with an anticoagulant coating to avoid adverse conditions such as thrombosis during long-term cooling. At the same time, an antibacterial coating can also be provided on the surface of the balloon 2 and the catheter 1 to provide antibacterial protection for the human body and prevent infection. Optionally, the anticoagulant coating of this embodiment is a heparin coating, which is used as an anticoagulant layer to effectively prevent the formation of attached emboli. In this embodiment, the thickness of the anticoagulant coating is about 10-300 nm.

[0040] Furthermore, a bottom layer is provided between the anticoagulant coating and the surface of the balloon 2, and between the anticoagulant coating and the surface of the catheter 1. Optionally, the bottom layer is a hydrophilic coating. The hydrophilic coating improves the lubricity of the outer surfaces of the catheter 1 and the balloon 2, reduces the resistance when the balloon catheter is inserted into and removed from the blood vessel, and facilitates operation; and the hydrophilic coating can also firmly bond the anticoagulant coating to the catheter 1 and the balloon 2. Exemplarily, the hydrophilic coating of this embodiment can be a polyvinyl pyrrolidone coating, which has a good lubricating effect.

[0041] Note that the above are only preferred embodiments of the present invention and the technical principles used. Those skilled in the art will understand that the present invention is not limited to the specific embodiments described herein, and that various obvious changes, readjustments and substitutions can be made by those skilled in the art without departing from the scope of protection of the present invention. Therefore, although the present invention is described in more detail through the above embodiments, the present invention is not limited to the above embodiments, and may include more other equivalent embodiments without departing from the concept of the present invention, and the scope of the present invention is determined by the scope of the appended claims.

Claims

1. A balloon catheter for mild hypothermia treatment, characterized in that: include: A catheter (1), the catheter (1) being provided with a liquid inlet cavity (11), a liquid outlet cavity (12) and a guide wire cavity (13) extending along its axial direction, the liquid inlet cavity (11) being arranged close to the outer wall of the catheter (1), the liquid outlet cavity (12) being arranged close to the center of the catheter (1), and the liquid inlet cavity (11) and the liquid outlet cavity (12) being connected at the distal end of the catheter (1); The balloon (2) is sleeved and fixed on the outside of the catheter (1); the part of the catheter (1) located inside the balloon (2) is also provided with a liquid spraying pipe (14); the liquid spraying pipe (14) connects the liquid inlet cavity (11) and the inside of the balloon (2); the cross-sectional area of ​​the liquid spraying pipe (14) is smaller than the cross-sectional area of ​​the liquid inlet cavity (11); a liquid outlet (15) is also connected between the balloon (2) and the liquid inlet cavity (11) to realize the circulation of the cooling liquid in the balloon (2).

2. The balloon catheter for mild hypothermia treatment according to claim 1, characterized in that: At least two liquid inlet chambers (11) are provided, and at least two of the liquid inlet chambers (11) are evenly arranged along a concentric circle of the conduit (1); at least two liquid outlet chambers (12) are provided, and at least two of the liquid outlet chambers (12) are evenly arranged along another concentric circle of the conduit (1), and at least two of the liquid inlet chambers (11) are connected to at least two of the liquid outlet chambers (12) in a one-to-one correspondence.

3. The balloon catheter for mild hypothermia treatment according to claim 2, characterized in that: The cross-sectional shape of the liquid inlet cavity (11) is circular, and / or the cross-sectional shape of the liquid outlet cavity (12) is circular.

4. The balloon catheter for mild hypothermia treatment according to claim 1, characterized in that: At least two balloons (2) are arranged on the catheter (1) at intervals along the axial direction, each balloon (2) has a corresponding liquid spraying tube (14), and each balloon (2) is connected to the liquid inlet chamber (11) through at least one liquid outlet (15).

5. The balloon catheter for mild hypothermia treatment according to claim 4, characterized in that: At least two of the liquid spraying tubes (14) are correspondingly arranged in each of the balloons (2), and the at least two liquid spraying tubes (14) are evenly spaced and distributed along the same circumference on the side wall of the catheter (1).

6. The balloon catheter for mild hypothermia treatment according to claim 5, characterized in that: There are two corresponding liquid spraying tubes (14) in each of the balloons (2), and the two liquid spraying tubes (14) are symmetrically arranged along the radial direction of the catheter (1).

7. The balloon catheter for mild hypothermia treatment according to claim 1, characterized in that: The liquid spray pipe (14) is a straight pipe perpendicular to the side wall of the catheter (1); or, the liquid spray pipe (14) is a U-shaped structure, including two longitudinal pipelines perpendicular to the side wall of the catheter (1) and a transverse pipeline parallel to the side wall of the catheter (1), the two longitudinal pipelines are respectively connected to the liquid inlet cavity (11), the transverse pipeline is connected to the two longitudinal pipelines, and a spray outlet connected to the interior of the balloon (2) is provided on the transverse pipeline.

8. The balloon catheter for mild hypothermia treatment according to any one of claims 1 to 7, characterized in that: The surface of the balloon (2) and the distal end of the catheter (1) are also provided with an anticoagulant coating.

9. The balloon catheter for mild hypothermia treatment according to claim 8, characterized in that: A bottom layer is provided between the anticoagulant coating and the surface of the balloon (2), and between the anticoagulant coating and the surface of the catheter (1).

10. The balloon catheter for mild hypothermia treatment according to claim 9, characterized in that: The anticoagulant coating comprises a heparin coating, and the base layer comprises a hydrophilic coating.

11. The balloon catheter for mild hypothermia treatment according to any one of claims 1 to 7, characterized in that: The guidewire cavity (13) is located at the center of the catheter (1).

12. The balloon catheter for mild hypothermia treatment according to any one of claims 1 to 7, characterized in that: The distal end and the proximal end of the balloon (2) are fixed to the catheter (1) by heat shrinking or welding.

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