Ice cap and brain protection device

Abstract

The invention discloses an ice cap and a brain protection device, and relates to the technical field of medical instruments. The ice cap is used for the extracorporeal circulation operation and comprises an inner cap body and an outer cap body, the outer cap body is arranged on the inner cap body, a fluid filling cavity used for being filled with a cooling medium is defined by the outer cap body and the inner cap body, and the fluid filling cavity is suitable for being communicated with an external cooling machine. According to the ice cap, the fluid filling cavity is formed in the ice cap to contain the cooling medium, compared with a conventional manual ice water adding scheme, medical workers do not need to replace ice water when the ice cap is used, the using convenience of the ice cap is greatly improved, the cooling effect is improved, and therefore the brain protection effect is improved. In addition, the ice cap convenient to disassemble is provided, by arranging a zipper or a hook-and-loop fastener and the like, medical staff can conveniently open the ice cap and adjust the position of a monitoring device of the brain, operation is more convenient and faster, the monitoring device can be located at a proper examination position, and the medical monitoring accuracy is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an ice cap and brain protection device. Background Technology

[0002] Cardiopulmonary bypass (CPB), often referred to as an "artificial heart-lung machine," is a landmark technique in cardiac surgery. Its core principle is to temporarily replace the functions of the heart and lungs, draining venous blood from the patient's body, oxygenating it outside the body (i.e., converting venous blood into arterial blood), and then pumping it back into the body. This creates a bloodless, still, and clear surgical field for surgeons to perform delicate procedures on the heart.

[0003] In clinical practice, to meet the organ protection needs of different surgeries, doctors will choose different body temperature management strategies according to the type of surgery. Among them, deep hypothermia circulation and moderate hypothermia are the two most core modes.

[0004] Deep hypothermia circulation typically refers to lowering a patient's body temperature to 18°C-20°C or even lower. At this temperature, it is often used in conjunction with deep hypothermia (DHCA) techniques. Hypothermia is a powerful organ protectant. For every 1°C decrease in body temperature, the basal metabolic rate decreases by approximately 5%-7%. In deep hypothermia, cellular metabolic demands are extremely low, with oxygen consumption only about 10% of that at room temperature. This allows surgeons to perform the most complex surgical procedures within the safe timeframe of "circulatory arrest" (i.e., completely stopping extracorporeal circulation, resulting in a bloodless and stagnant state).

[0005] Moderate hypothermia typically refers to maintaining a patient's body temperature between 28°C and 34°C. This is currently the most commonly used temperature management strategy in routine cardiac surgery. Unlike deep hypothermia, moderate hypothermia does not aim to create a bloodless field of vision by circulatory arrest. Instead, it moderately reduces the metabolic rate to minimize ischemia-reperfusion injury while ensuring sufficient blood flow to vital organs (especially the brain, kidneys, and spinal cord).

[0006] With the continuous development of extracorporeal circulation surgery techniques, deep hypothermic circulation or moderate hypothermic extracorporeal circulation surgery has become routine. However, the quality of surgery needs to be further improved, especially brain protection, which is related to the recovery of the patient's nervous system after surgery and has a significant impact on the patient's postoperative quality of life.

[0007] Currently, most hospitals still use traditional ice caps for head cooling during deep hypothermic extracorporeal circulation surgery. However, existing ice caps consist of a cap body with a cavity inside to hold ice water or ice cubes. The ice caps are unpowered and rely on water and ice for cooling. Over time, the ice melts and needs to be replaced, making the operation cumbersome. Furthermore, the temperature of the ice water or ice cubes is constantly changing, and the brain protection effect gradually deteriorates. Summary of the Invention

[0008] The main objective of this invention is to provide an ice cap and brain protection device, which aims to improve the convenience of using the ice cap and enhance the brain protection effect.

[0009] To achieve the above objectives, the present invention proposes an ice cap for extracorporeal circulation surgery, the ice cap comprising: Inner cap body; and An outer cap body is disposed on the inner cap body, and the outer cap body and the inner cap body surround to form a fluid filling cavity for filling a cooling medium, the fluid filling cavity being adapted to communicate with an external cooling unit.

[0010] Optionally, the outer cap body is provided with a medium inlet and a medium outlet. The medium inlet is connected to the fluid filling cavity and is adapted to be connected to the output end of an external chiller. The medium outlet is connected to the fluid filling cavity and is adapted to be connected to the input end of an external chiller, so as to circulate and supply cooling medium to the fluid filling cavity.

[0011] Optionally, the cooling medium is cold air or ice water.

[0012] Optionally, the ice cap further includes a temperature sensor disposed within the fluid-filled cavity and used to detect the temperature of the cooling medium within the fluid-filled cavity.

[0013] Optionally, the inner cap and the outer cap constitute an ice cap body. The ice cap body has a first side and a second side that are arranged opposite to each other. The first side and the second side are detachably connected so that the ice cap body can be switched between a wearing state and an unfolded state. When worn, the first side is connected to the second side, and the ice cap body surrounds and forms the shape of a human head; In the unfolded state, the first side and the second side are separated, and the ice cap body is opened to allow the ice cap to be put on or taken off, or to adjust the position of the monitoring device on the human head.

[0014] Optionally, the first side and the second side are bonded together by hook and loop fasteners.

[0015] Optionally, the first side and the second side are connected by a zipper.

[0016] Optionally, the ice cap further includes a NIRS sensor, which is detachably mounted on the side of the inner cap near the human brain and adapted to be electrically connected to a monitoring unit. The NIRS sensor is used to monitor tissue oxygenation; and / or The ice cap also includes a BIS electrode patch, which is detachably disposed on the side of the inner cap body near the human brain and is adapted to be electrically connected to the monitoring host. The BIS electrode patch is used to detect electroencephalogram (EEG) signals.

[0017] Optionally, the ice cap body is provided with a wire-passing hole for allowing the signal line of the monitoring device to pass through.

[0018] To achieve the above objectives, the present invention also proposes a brain protection device, comprising: An ice cap, the ice cap as described above; the ice cap includes an inner cap body and an outer cap body, the outer cap body being disposed on the inner cap body, the outer cap body and the inner cap body surrounding to form a fluid filling cavity for filling a cooling medium, the fluid filling cavity being adapted to communicate with an external chiller; and A cooling unit is connected to the ice cap via a connecting pipe. The cooling unit is used to supply cooling medium to the fluid-filled cavity of the ice cap.

[0019] In the technical solution of this invention, the ice cap is used in extracorporeal circulation surgery. The ice cap includes an inner cap body and an outer cap body, with the outer cap body disposed on the inner cap body. The outer cap body and the inner cap body enclose a fluid-filled cavity for filling with a cooling medium, and the fluid-filled cavity is adapted to communicate with an external cooling unit. It can be understood that this invention, by setting a fluid-filled cavity inside the ice cap to contain the cooling medium, compared to the conventional method of manually adding ice water, eliminates the need for medical personnel to change the ice water during use, greatly improving the convenience of using the ice cap, enhancing the cooling effect, and thus improving the brain protection effect.

[0020] In addition, the present invention provides an ice cap that is easy to disassemble. By setting zippers or hook and loop fasteners, the ice cap can not only be easily put on or taken off, but also make it easy for medical staff to open the ice cap and adjust the position of the monitoring device attached to the brain. The operation is more convenient and helps to place the monitoring device in the appropriate examination position, thereby improving the accuracy of medical monitoring. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the structures shown in these drawings without creative effort.

[0022] Figure 1 This is a schematic diagram of the structure and application of an embodiment of the brain protection device and its ice cap of the present invention; Figure 2 This is a schematic diagram showing the arrangement of monitoring devices in one embodiment of the brain protection device and its ice cap of the present invention.

[0023] Explanation of icon numbers: 100. Ice cap; 200. Cooling unit; 10. Outer cap body; 20. Hook and loop fastener; 100a. Fluid filling chamber; 10a. Medium inlet; 10b. Medium outlet; 30. NIRS sensor; 40. BIS electrode patch; 31. Signal line.

[0024] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0025] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0026] It should be noted that all directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of the present invention are only used to explain the relative positional relationship and movement of each component in a certain specific posture (as shown in the figure). If the specific posture changes, the directional indication will also change accordingly.

[0027] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0028] Furthermore, the use of terms such as "first" and "second" in this invention is for descriptive purposes only and should not be construed as indicating or implying their relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. The word "and / or" throughout the text means including three parallel solutions; for example, "A and / or B" includes solution A, solution B, or a solution that simultaneously satisfies A and B. The technical solutions of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. When the combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

[0029] Cardiopulmonary bypass (CPB), often referred to as an "artificial heart-lung machine," is a landmark technique in cardiac surgery. Its core principle is to temporarily replace the functions of the heart and lungs, draining venous blood from the patient's body, oxygenating it outside the body (i.e., converting venous blood into arterial blood), and then pumping it back into the body. This creates a bloodless, still, and clear surgical field for surgeons to perform delicate procedures on the heart.

[0030] In clinical practice, to meet the organ protection needs of different surgeries, doctors will choose different body temperature management strategies according to the type of surgery. Among them, deep hypothermia circulation and moderate hypothermia are the two most core modes.

[0031] Deep hypothermia circulation typically refers to lowering a patient's body temperature to 18°C-20°C or even lower. At this temperature, it is often used in conjunction with deep hypothermia (DHCA) techniques. Hypothermia is a powerful organ protectant. For every 1°C decrease in body temperature, the basal metabolic rate decreases by approximately 5%-7%. In deep hypothermia, cellular metabolic demands are extremely low, with oxygen consumption only about 10% of that at room temperature. This allows surgeons to perform the most complex surgical procedures within the safe timeframe of "circulatory arrest" (i.e., completely stopping extracorporeal circulation, resulting in a bloodless and stagnant state).

[0032] Moderate hypothermia typically refers to maintaining a patient's body temperature between 28°C and 34°C. This is currently the most commonly used temperature management strategy in routine cardiac surgery. Unlike deep hypothermia, moderate hypothermia does not aim to create a bloodless field of vision by circulatory arrest. Instead, it moderately reduces the metabolic rate to minimize ischemia-reperfusion injury while ensuring sufficient blood flow to vital organs (especially the brain, kidneys, and spinal cord).

[0033] With the continuous development of extracorporeal circulation surgery techniques, deep hypothermic circulation or moderate hypothermic extracorporeal circulation surgery has become routine. However, the quality of surgery needs to be further improved, especially brain protection, which is related to the recovery of the patient's nervous system after surgery and has a significant impact on the patient's postoperative quality of life.

[0034] Currently, most hospitals still use traditional ice caps for head cooling during deep hypothermic extracorporeal circulation surgery. However, existing ice caps consist of a cap body with a cavity inside to hold ice water or ice cubes. The ice caps are unpowered and rely on water and ice for cooling. Over time, the ice melts and needs to be replaced, making the operation cumbersome. Furthermore, the temperature of the ice water or ice cubes is constantly changing, and the brain protection effect gradually deteriorates.

[0035] In response, this invention proposes an ice cap.

[0036] Reference Figure 1 In one embodiment of the present invention, the ice cap 100 is used for extracorporeal circulation surgery. The ice cap 100 includes an inner cap body and an outer cap body 10. The outer cap body 10 is disposed on the inner cap body. The outer cap body 10 and the inner cap body surround to form a fluid filling cavity 100a for filling with cooling medium. The fluid filling cavity 100a is adapted to communicate with an external cooling machine 200.

[0037] In this embodiment, both the inner cap and the outer cap 10 can be made of materials such as PVC, TPU or nylon, and there is no limitation here.

[0038] The portion of the cavity that forms the fluid filling cavity 100a, consisting of the inner cap and the outer cap 10, may be provided with a sealing layer to prevent air or water leakage. The sealing layer may be made of a waterproof or air-proof material, and the specific material is not limited.

[0039] In this embodiment, the cooling medium can be a gas, a liquid, a gas-liquid mixture, or a solid-liquid mixture, specifically such as cold air or ice water, and is not limited here.

[0040] It should be noted that the external cooling unit 200 can be a fan cooler, refrigeration equipment, or other device or equipment capable of lowering the temperature of the medium. Figure 1 The image shows two air coolers.

[0041] It is understood that the present invention uses a fluid-filled cavity 100a inside the ice cap 100 to contain the cooling medium. Compared with the conventional method of manually adding ice water, the ice cap 100 of the present invention does not require medical staff to change the ice water during use, which greatly improves the convenience of using the ice cap 100, enhances the cooling effect, and thus enhances the brain protection effect.

[0042] To facilitate connection to the external chiller 200, in one embodiment, the outer cap 10 may be provided with a medium inlet 10a and a medium outlet 10b. The medium inlet 10a is connected to the fluid filling chamber 100a and is adapted to be connected to the output end of the external chiller 200. The medium outlet 10b is connected to the fluid filling chamber 100a and is adapted to be connected to the input end of the external chiller 200, so as to circulate and supply cooling medium to the fluid filling chamber 100a.

[0043] In this embodiment, universal medical tubing interfaces can be installed at both the media inlet 10a and the media outlet 10b to adapt to existing conventional medical connection tubes, which helps reduce the cost of designing new catheter interfaces.

[0044] In one embodiment, reference is made to Figure 1 The ice cap 100 may also include a temperature sensor, which is located inside the fluid filling chamber 100a and used to detect the temperature of the cooling medium inside the fluid filling chamber 100a. This allows medical personnel to monitor the temperature of the cooling medium in the ice cap 100 in real time, and to adjust the temperature or troubleshoot malfunctions promptly in case of abnormal temperatures, greatly improving the safety of the ice cap 100.

[0045] Currently, most institutions still use the traditional ice cap 100 for head cooling in deep hypothermic extracorporeal circulation surgery. Because this type of surgery has many monitoring devices to protect brain function, such as NIRS and BIS, and because the head space is small and there are many electrodes and probes, it is difficult to smoothly place these devices with the ice cap 100, and it is difficult to make further adjustments after they are fixed.

[0046] The present invention has made further improvements to this, as follows: Based on the foregoing embodiments, referring to Figure 1 The inner cap body and outer cap body 10 of the ice cap 100 constitute the ice cap body. The ice cap body has a first side and a second side that are arranged opposite to each other. The first side and the second side are detachably connected so that the ice cap body can be switched between a worn state and an unfolded state. Figure 1 As shown, when worn, the first side and the second side are connected, and the ice cap body is closed to form the shape of a human head. When unfolded (i.e., when the hook and loop fastener 20 is open), the first side and the second side are separated, and the ice cap body is opened to allow the ice cap 100 to be put on or taken off, or to adjust the position of the monitoring device on the human head.

[0047] In this embodiment, the first side and the second side can be bonded together by hook and loop fastener 20; or, the first side and the second side can be connected by a zipper.

[0048] It is understood that the present invention provides an easily detachable ice cap 100. By setting zippers or hook and loop fasteners 20, the ice cap 100 can not only be easily put on or taken off, but also make it easy for medical staff to open the ice cap 100 and adjust the position of the monitoring device attached to the brain. The operation is more convenient and helps to place the monitoring device in a suitable examination position, thereby improving the accuracy of medical monitoring.

[0049] To achieve non-invasive monitoring of blood oxygenation and blood flow in the brain and further improve the safety of cardiopulmonary bypass surgery, in one embodiment, referring to... Figure 1 and Figure 2 The ice cap 100 may also include a NIRS (Near-Infrared Spectroscopy) sensor 30, which is detachably mounted on the side of the inner cap body near the human brain and is adapted to be electrically connected to a monitoring host. The NIRS sensor 30 is used to monitor tissue oxygenation.

[0050] In this embodiment, the NIRS sensor 30 can be detachably mounted on the surface of the inner cap by means of snap-fit ​​or double-sided adhesive.

[0051] The full name of NIRS sensor 30 is near-infrared spectroscopy sensor, which is mainly used for non-invasive and continuous monitoring of oxygen saturation in organs and tissues such as the brain or kidneys.

[0052] During deep hypothermic circulatory arrest or cardiopulmonary bypass, the NIRS sensor 30 placed in the head can monitor this value in real time. If the cerebral oxygen saturation drops sharply when the blood flow is insufficient, the system will indicate a risk of cerebral ischemia. It should be noted that when the intraoperative cerebral oxygen saturation drops by more than 22% (unilateral) or the cumulative value drops by 32% (bilateral), the risk of postoperative hyperlactatemia (a marker of tissue hypoxia) is significantly increased.

[0053] In addition, non-pulsatile blood flow during extracorporeal circulation can easily lead to insufficient renal perfusion. By placing an NIRS sensor 30 in the renal area, renal hypoxia can be detected in real time, and the occurrence of acute kidney injury can be warned.

[0054] In one embodiment, reference is made to Figure 1 and Figure 2 The ice cap 100 may also include a BIS (Bispectral Index) electrode patch 40, which is detachably mounted on the side of the inner cap body near the human brain and is adapted to be electrically connected to a monitoring host. The BIS electrode patch 40 is used to detect electroencephalogram (EEG) signals. This can further improve the safety of extracorporeal circulation.

[0055] In this embodiment, the BIS electrode patch 40 can be detachably mounted on the surface of the inner cap body by means of snap-fit ​​or double-sided adhesive.

[0056] The BIS electrode patch 40, also known as the bifrequency index sensor, is a disposable, non-invasive sensor used in conjunction with a BIS monitor. In cardiopulmonary bypass surgery, it is primarily used to monitor the depth of anesthesia in real time, helping doctors determine the patient's level of sedation and ensuring that the patient remains conscious during surgery without experiencing delayed postoperative recovery or nerve damage due to excessive anesthesia.

[0057] In one embodiment, reference is made to Figure 1 and Figure 2 The ice cap body may be provided with several wire holes for allowing the signal line 31 of the monitoring device to pass through, so as to facilitate the wiring and avoid the signal line 31 being laid between the head and the ice cap 100, which would affect the cooling effect.

[0058] In this embodiment, the monitoring device can be the NIRS sensor 30, BIS electrode patch 40, or other monitoring devices inherent to the ice cap 100 itself, or it can be a device independent of the ice cap 100. That is, the NIRS sensor 30, BIS electrode patch 40, and other monitoring devices can be mounted on the ice cap 100 and are part of the ice cap 100, or they can be mounted independently of the ice cap 100 and are not part of the ice cap 100. Both types of ice caps 100 fall within the scope of the technical solution of this invention.

[0059] In summary, this invention, by providing a fluid-filled cavity 100a within the ice cap 100 to accommodate the cooling medium, eliminates the need for medical personnel to replace the ice water during use, significantly improving the convenience of use and enhancing the cooling effect, thereby improving brain protection. This invention also provides an easily detachable ice cap 100. By incorporating zippers or hook and loop fasteners 20, the ice cap 100 can be easily put on or taken off, and medical personnel can easily open it to adjust the position of the monitoring device attached to the brain. This more convenient operation helps to place the monitoring device in the appropriate examination position, improving the accuracy of medical monitoring.

[0060] The present invention also proposes a brain protection device, which includes an ice cap 100. The specific structure of the ice cap 100 is as described in the above embodiments. Since the brain protection device proposed in this invention includes all schemes of all embodiments of the ice cap 100, it has at least the same technical effects as the ice cap 100, which will not be described in detail here.

[0061] Reference Figure 1 In one embodiment, the brain protection device further includes a cooler 200, which is connected to the ice cap 100 via a connecting pipe. The cooler 200 is used to deliver a cooling medium to the fluid filling chamber 100a of the ice cap 100.

[0062] In this embodiment, the chiller 200 can be a device or equipment that can reduce the temperature of the medium, such as a cold air blower, refrigeration equipment, or intelligent water tank. It can be one, two, or more units, and there is no limitation here.

[0063] The above description is merely an optional embodiment of the present invention and does not limit the patent scope of the present invention. All equivalent structural transformations made using the contents of the present invention's specification and drawings under the inventive concept of the present invention, or direct / indirect applications in other related technical fields, are included within the patent protection scope of the present invention.

Claims

1. An ice cap for use in extracorporeal circulation surgery, characterized in that, The ice cap includes: Inner cap body; and An outer cap body is disposed on the inner cap body, and the outer cap body and the inner cap body surround to form a fluid filling cavity for filling a cooling medium, the fluid filling cavity being adapted to communicate with an external cooling unit.

2. The ice cap as described in claim 1, characterized in that, The outer cap is provided with a medium inlet and a medium outlet. The medium inlet is connected to the fluid filling cavity and is adapted to be connected to the output end of an external chiller. The medium outlet is connected to the fluid filling cavity and is adapted to be connected to the input end of an external chiller, so as to circulate and supply cooling medium to the fluid filling cavity.

3. The ice cap as described in claim 1, characterized in that, The cooling medium is cold air or ice water.

4. The ice cap as described in claim 1, characterized in that, The ice cap also includes a temperature sensor, which is located inside the fluid-filled cavity and is used to detect the temperature of the cooling medium inside the fluid-filled cavity.

5. The ice cap as described in claim 1, characterized in that, The inner cap and the outer cap together constitute the ice cap body. The ice cap body has a first side and a second side that are arranged opposite to each other. The first side and the second side are detachably connected so that the ice cap body can be switched between a wearing state and an unfolded state. When worn, the first side is connected to the second side, and the ice cap body surrounds and forms the shape of a human head; In the unfolded state, the first side and the second side are separated, and the ice cap body is opened to allow the ice cap to be put on or taken off, or to adjust the position of the monitoring device on the human head.

6. The ice cap as described in claim 5, characterized in that, The first side and the second side are bonded together by hook and loop fasteners.

7. The ice cap as described in claim 5, characterized in that, The first side and the second side are connected by a zipper.

8. The ice cap as described in any one of claims 5-7, characterized in that, The ice cap also includes a NIRS sensor, which is detachably mounted on the side of the inner cap near the human brain and is adapted to be electrically connected to a monitoring unit. The NIRS sensor is used to monitor tissue oxygenation; and / or The ice cap also includes a BIS electrode patch, which is detachably disposed on the side of the inner cap body near the human brain and is adapted to be electrically connected to the monitoring host. The BIS electrode patch is used to detect electroencephalogram (EEG) signals.

9. The ice cap as described in claim 8, characterized in that, The ice cap body is provided with a through hole for allowing signal lines of monitoring devices to pass through.

10. A brain protection device, characterized in that, include: Ice cap, wherein the ice cap is the ice cap as described in any one of claims 1-9; as well as A cooling unit is connected to the ice cap via a connecting pipe. The cooling unit is used to supply cooling medium to the fluid-filled cavity of the ice cap.

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