Nuclear magnetic compatible lead wire and physiological parameter monitoring equipment

Abstract

The invention provides a nuclear magnetic compatible lead wire and physiological parameter monitoring equipment, the nuclear magnetic compatible lead wire comprises a cable connector, at least four lead cables, at least four electrode connectors and a connection fixing piece, the connection fixing piece is made of a non-magnetic material, the connection fixing piece is located between the cable connector and the electrode connectors, and the connection fixing piece is made of a non-magnetic material. And the lead cables are used for limiting the parts, located in the first section, of any two lead cables to be parallel to each other, and the axes of the parts, located in the first section, of all the lead cables are not in the same plane. The lead wire production difficulty is reduced, and meanwhile cleaning and disinfection are facilitated.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a nuclear magnetic resonance (MR) compatible lead wire and a physiological parameter monitoring device. Background Art

[0002] Magnetic Resonance Imaging (MRI) is an important monitoring method, which has the advantages of being radiation-free and sensitive to soft tissues. Many critically ill patients, children, and neonatal patients can benefit from it. However, sedation, anesthesia, unstable conditions, and the closed and noisy physical environment pose challenges to the MR scanning of such patients. Therefore, strict physiological monitoring of patients (such as parameters like ECG, SPO2, Temp, NIBP, etc.) is required during the scanning process. However, the MRI environment has a static magnetic field, as well as high-frequency alternating magnetic fields such as radiofrequency magnetic fields and gradient magnetic fields, which prevent non-magnetic field compatible conventional monitors from accurately reflecting the patient's condition and timely identifying medical emergencies, resulting in MRI artifacts. Moreover, it may even cause the conventional monitor and its accessories to eject or heat up, endangering the safety of personnel and equipment. Therefore, ECG sensors and other sensors used in the MRI environment are mostly composed of MR inert materials to avoid scanning artifacts and equipment ejection. At the same time, the structural design reduces the loop area formed by the conductor of the sensor wire and the human body, reduces the alternating magnetic flux and the induced current generated by it, and prevents the electrodes and lead wires from heating up and harming the patient.

[0003] Currently in the industry, carbon fiber is usually used as the conductor material, and the lead wire is braided or wound to reduce the loop area formed by the conductor, thereby reducing the heat generation of the ECG sensor during the MRI scan. However, this processing method is cumbersome, time-consuming, labor-intensive, has a high cost and poor consistency, and there are cleaning dead corners on the ECG lead wire, which is not conducive to hospital cleaning and disinfection. Summary of the Invention

[0004] In view of the above problems, the present invention provides a nuclear magnetic resonance (MR) compatible lead wire and a physiological parameter monitoring device, which improve the processing convenience of the lead wire.

[0005] To achieve the above object, the present invention adopts the following technical solutions:

[0006] According to one aspect of the present invention, the present invention provides a nuclear magnetic resonance (MR) compatible lead wire, comprising:

[0007] A cable connector for electrically connecting to a physiological parameter monitoring host; at least four lead wires, the lead wires including a conductor and an insulating coating from the inside to the outside, the conductor being a non-magnetic material conductor, one end of at least four of the lead wires being electrically connected to the cable connector; at least four electrode connectors made of non-magnetic materials, each electrode connector being individually electrically connected to the other end of at least one of the lead wires for connecting to the human body and obtaining the physiological parameters of the human body, so as to transmit the obtained physiological parameter signals to the physiological parameter monitoring host through the lead wires and the cable connector; and a connection fixing member made of non-magnetic materials, the connection fixing member being located between the cable connector and the electrode connector for defining that the portions of any two lead wires within a first section are parallel to each other, and the axes of the portions of all the lead wires within the first section are not in the same plane.

[0008] In some embodiments, the connection fixing member is a sleeve and / or a support bar, the sleeve covering the outer periphery of the first section of all the lead wires; the support bar being fixedly connected to the first section of at least four of the lead wires.

[0009] In some embodiments, the sleeve is one or a combination of an extrusion sleeve, a fitting sleeve or a heat shrink sleeve.

[0010] In some embodiments, the sleeve is an annular sleeve, and the inner side wall of the annular sleeve contacts the outer peripheries of all the lead wires.

[0011] In some embodiments, the distances between the portions of any two adjacent lead wires within the first section are the same.

[0012] In some embodiments, at least one of all the lead wires contacts two other lead wires within the first section;

[0013] Or

[0014] Each of all the lead wires contacts at least two other lead wires within the first section.

[0015] In some embodiments, the number of the lead wires is four, and the central connection lines of the cross-sections of the four lead wires at the connection fixing member form a square or a rhombus.

[0016] In some embodiments, one of all the lead wires is placed at the center, and the rest are arranged around the outer periphery of the lead wire at the center.

[0017] In some embodiments, the distance between any two lead wires is less than or equal to 10 mm.

[0018] In some embodiments, the length of the connection fixing member is more than 10 cm shorter than the length of any one of the lead wires.

[0019] In some embodiments, the conductor is a non-magnetic conductive plastic material or the conductor is a non-magnetic metal.

[0020] In some embodiments, the insulating coating layer includes an insulating layer and an outer sheath layer from the inside to the outside.

[0021] In some embodiments, the insulating layer is a PP insulating layer, a PE insulating layer or a PTFE insulating layer; and / or, the outer sheath layer is a PU outer sheath layer, a TPR outer sheath layer or a silicone outer sheath layer.

[0022] In some embodiments, the electrode connector is a carbon fiber material electrode connector or a non-magnetic conductive plastic electrode connector.

[0023] In some embodiments, the electrode connector includes an ECG electrode connector.

[0024] In some embodiments, it further includes:

[0025] A heat insulation layer, provided outside all the lead wires.

[0026] In some embodiments, the heat insulation layer includes a foamed silicone heat insulation layer, a foamed TPU heat insulation layer, a foamed EVA heat insulation layer or a foam heat insulation layer.

[0027] In some embodiments, it further includes:

[0028] A sleeve, provided at at least one end of the connection fixing member, one end of the sleeve wraps the connection fixing member, and the other end of the sleeve wraps all the lead wires.

[0029] In some embodiments, the size of the end of the sleeve that wraps the connection fixing member is larger than the size of the other end of the sleeve.

[0030] According to another aspect of the present invention, the present invention provides a physiological parameter monitoring device, including a physiological parameter monitoring host and the above-mentioned MRI-compatible lead wire, and the MRI-compatible lead wire is used for detachably electrically connecting with the physiological parameter monitoring host.

[0031] The present invention has at least the following advantages: By means of the connecting and fixing member, the portions of any two lead wires located within the first section are defined to be parallel to each other, that is, the connecting and fixing member fixes the lead wires together, so that all the lead wires form an integral body, which can effectively prevent the lead wires from forming loops. Under a high-frequency alternating magnetic field, the generation of induced current due to loop formation can be avoided, thereby preventing the situation of heat generation. And since the axes of the portions of all the lead wires located within the first section are not in the same plane, the cross-sectional thickness of the lead wires can be increased, further preventing the lead wires from forming loops. Through the parallel arrangement, the relative positions between the lead wires can be maintained, and the distance between the lead wires can be prevented from being easily changed and increased, thereby avoiding the increase in the loop area formed between the lead wires and the human body, and reducing the induced current. At the same time, since the lead wires are parallel to each other, there is no need for the lead wires to be wound and crossed, reducing the production difficulty. Since the lead wires are parallel to each other, the distance between any two parallel lead wires is the same at any position, making the influence of the nuclear magnetic resonance magnetic field on the lead wires tend to be consistent, with good consistency, thereby improving the common-mode rejection ratio. In addition, the parallel lead wires are not prone to form cleaning dead corners, and during cleaning, cleaning can be carried out along the parallel direction, which is convenient for cleaning and disinfection.

[0032] The above description of the invention content is only an overview of the technical solution of this application. In order to enable those of ordinary skill in the art to more clearly understand the technical solution of this application, and then to implement it according to the content described in the specification and the drawings, and in order to make the above objects, other objects, features and advantages of this application more easily understood, the following will be described in conjunction with the specific embodiments and drawings of this application. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The drawings are only used to illustrate the principles, implementation methods, applications, features and effects of the specific embodiments of the present invention and other related contents, and should not be considered as a limitation to this application.

[0034] In the accompanying drawings of the specification:

[0035] Figure 1 is a schematic structural diagram of an embodiment of the nuclear magnetic resonance compatible lead wire of the present invention.

[0036] Figure 2 is a schematic structural diagram of an embodiment of the connection between the nuclear magnetic resonance compatible lead wire of the present invention and the physiological parameter monitoring host.

[0037] Figure 3 is a schematic cross-sectional structural diagram of an embodiment of the lead wire of the present invention.

[0038] Figure 4 is a schematic loop structure diagram of an embodiment of the nuclear magnetic resonance compatible lead wire of the present invention.

[0039] Figure 5It is a schematic diagram of the middle cross-sectional structure of an embodiment of the nuclear magnetic resonance compatible lead wire of the present invention.

[0040] Figure 6 It is a schematic diagram of the cross-sectional structure of an embodiment of the lead wire cable and the connection fixing member of the present invention.

[0041] Figure 7 It is a schematic diagram of the structure of another embodiment of the nuclear magnetic resonance compatible lead wire of the present invention.

[0042] Figure 8 It is a schematic diagram of the cross-sectional structure of another embodiment of the lead wire cable and the connection fixing member of the present invention.

[0043] Figure 9 It is a schematic diagram of the cross-sectional structure of yet another embodiment of the lead wire cable and the connection fixing member of the present invention.

[0044] Figure 10 It is a schematic diagram of the cross-sectional structure of an embodiment of the nuclear magnetic ellipse layout of the lead wire cable and the connection fixing member of the present invention.

[0045] Figure 11 It is a schematic diagram of the cross-sectional structure of an embodiment of the lead wire cable and the connection fixing member with a central lead wire cable of the present invention.

[0046] Figure 12 It is a schematic diagram of the cross-sectional structure of another embodiment of the lead wire cable of the present invention.

[0047] Figure 13 It is a schematic diagram of the cross-sectional structure of an embodiment of the heat insulation layer, the lead wire cable and the connection fixing member of the present invention.

[0048] The descriptions of the reference numerals involved in the above-mentioned respective drawings are as follows:

[0049] 1. Cable connector; 10. Outer shell; 11. Conductive pin;

[0050] 2. Lead wire cable; 20. Conductor; 21. Insulating coating layer; 210. Insulation layer; 211. Outer sheath; 22. First section; 23. Second section; 24. Third section;

[0051] 3. Connection fixing member; 4. Electrode connector; 5. Physiological parameter monitoring host; 6. Loop; 7. Heat insulation layer; 8. Sleeve. Detailed implementation manners

[0052] To illustrate in detail the possible application scenarios, technical principles, implementable specific solutions, achievable purposes and effects, etc. of the present application, the following will be described in detail with reference to the specific embodiments listed and in conjunction with the drawings. The embodiments described herein are only used to more clearly illustrate the technical solutions of the present application, and therefore are only used as examples and cannot be used to limit the protection scope of the present application.

[0053] Reference to "embodiment" in this document means that the specific features, structures, or characteristics described in connection with the embodiment may be included in at least one embodiment of the present application. The term "embodiment" that appears in various positions in the specification does not necessarily refer to the same embodiment, nor does it particularly limit its independence or relevance to other embodiments. In principle, in the present application, as long as there is no technical contradiction or conflict, the technical features mentioned in each embodiment can be combined in any way to form corresponding implementable technical solutions.

[0054] Unless otherwise defined, the meanings of the technical terms used in this document are the same as those commonly understood by those skilled in the technical field to which this application belongs; the use of the relevant terms in this document is only for describing specific embodiments and is not intended to limit this application.

[0055] In the description of this application, the term "and / or" is an expression used to describe the logical relationship between objects, indicating that there can be three relationships. For example, A and / or B means: the existence of A, the existence of B, and the simultaneous existence of both A and B. In addition, the character " / " in this document generally represents an "or" logical relationship between the associated objects before and after.

[0056] In this application, terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual quantitative, primary-secondary, or sequential relationships between these entities or operations.

[0057] Without further limitation, in this application, the open-ended expressions such as "include", "comprise", "have", or other similar ones used in the statement are intended to cover non-exclusive inclusion. These expressions do not exclude the possibility that there may be additional elements in the process, method, or product that includes the said elements. Thus, a process, method, or product that includes a series of elements may not only include those defined elements, but also include other elements that are not explicitly listed, or elements that are inherent to this process, method, or product.

[0058] Similar to the understanding in the "Examination Guidelines", in this application, expressions such as "greater than", "less than", "exceeding", etc. are understood not to include the number itself; expressions such as "above", "below", "within", etc. are understood to include the number itself. In addition, in the description of the embodiments of this application, the meaning of "multiple" is two or more (including two). Similar expressions related to "many", such as "multiple groups", "multiple times", etc., are also understood in this way, unless otherwise specifically defined.

[0059] In the description of the embodiments of the present application, the spatially related expressions used, such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "perpendicular", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the specific embodiment or the drawings, and is only for the convenience of describing the specific embodiments of the present application or for the reader to understand, rather than indicating or implying that the device or component referred to must have a specific position, a specific orientation, or be constructed or operated in a specific orientation. Therefore, it should not be construed as a limitation to the embodiments of the present application.

[0060] Unless otherwise clearly specified or limited, in the description of the embodiments of the present application, the terms such as "installed", "connected", "connected to", "fixed", "set", etc. should be understood in a broad sense. For example, the "connection" can be a fixed connection, a detachable connection, or an integral setting; it can be a mechanical connection, an electrical connection, or a communication connection; it can be directly connected, or indirectly connected through an intermediate medium; it can be the communication inside two components or the interaction relationship between two components. For those skilled in the art to which the present application pertains, the specific meanings of the above terms in the embodiments of the present application can be understood according to specific circumstances.

[0061] Referring to Figures 1 to 13 , according to some embodiments of the present invention, the present invention provides a nuclear magnetic resonance (NMR) compatible lead wire. Specifically, in the structure shown in Figure 1 , it includes a cable connector 1, a lead wire cable 2, a connection fixing member 3, and an electrode connector 4. The usage scenario of the NMR compatible lead wire in this embodiment is as follows: When a patient needs to undergo an NMR examination, the patient's body is placed inside the NMR examination equipment. In order to monitor the physiological parameters of the patient's body, it is necessary to use the NMR compatible lead wire of the present invention to connect the patient's body and the physiological parameter monitoring host (or called the monitor host). Then, the physiological parameter monitoring host detects the human physiological parameters through the lead wire cable of the NMR compatible lead wire and displays them in real time on the physiological parameter monitoring host. Medical staff can obtain the physical condition of the patient undergoing the NMR examination through the physiological parameter monitoring host. Actually, when in use, the length of the NMR compatible lead wire is very long. In the figure, the lead wire cable 2 is drawn in a simplified way, so it looks relatively short.

[0062] In this embodiment, as shown in Figure 2As shown, the cable connector 1 is used for electrically connecting with the physiological parameter monitoring host 5. Inside the physiological parameter monitoring host 5, there is an interface adapted to the cable connector 1, and the cable connector 1 is inserted into this interface to achieve electrical connection with the physiological parameter monitoring host 5. The basic structure of the cable connector 1 includes a housing 10 for fixing and conductive pins 11 for electrical connection. Among them, the housing 10 is used to fix the conductive pins 11 and the lead wire cable 2. The housing is generally made of insulating materials, such as plastics. In some embodiments, in order to improve the wear resistance of the housing, a wear-resistant material, such as metal, can be coated on the outside of the housing. Since the physiological parameter monitoring host 5 and the connected cable connector 1 are generally far away from the nuclear magnetic resonance detection equipment, generally there is no need to use non-magnetic materials. Here, the non-magnetic materials refer to materials that do not have magnetism and materials that will not be induced to have magnetism by a magnetic field. One end of the conductive pin 11 is connected to the lead wire cable 2 inside the housing 10, and the other end of the conductive pin 11 is used to be electrically connected to the pins inside the interface of the physiological parameter monitoring host 5 when the cable connector 1 is inserted into the physiological parameter monitoring host 5. The other end of the conductive pin 11 can protrude from the housing 10 or be arranged inside the housing 10. When it is placed inside the housing 10, the housing 10 should be provided with corresponding openings at the positions of the conductive pins 11 to facilitate the pins inside the interface of the physiological parameter monitoring host 5 to be electrically connected to the conductive pins 11 inside the housing 10 through the openings. When the cable connector 1 is inserted into the physiological parameter monitoring host 5, the housing 10 also plays a role in mechanically connecting with the interface of the physiological parameter monitoring host 5. In this way, the housing 10 can be firmly placed in the interface of the physiological parameter monitoring host 5, so as to ensure good electrical connection between the conductive pins 11 and the pins inside the interface of the physiological parameter monitoring host 5, and also prevent the cable connector 1 from easily falling off from the interface of the physiological parameter monitoring host 5.

[0063] It should be further noted that the number of conductive pins 11 is generally the same as the number of lead wires 2, that is, they play a role in one-to-one connection. In some embodiments, the number of conductive pins 11 can be less than the number of lead wires 2. This situation is generally due to the different interfaces of different physiological parameter monitoring hosts 5, and there are cable connectors 1 with different numbers of conductive pins 11. Considering the manufacturing cost, a wire of the same type with a larger number of lead wires 2 may be used. In this case, the number of lead wires 2 is greater than the number of conductive pins 11, that is, some of the lead wires 2 are not connected to the conductive pins 11. In some embodiments, the number of conductive pins 11 can be greater than the number of lead wires 2. At this time, the extra conductive pins 11 can be used for other functions, such as for grounding shielding or as detection pins. For example, a sensor is provided inside the cable connector 1, and the sensor is connected to the interface of the physiological parameter monitoring host 5 through the conductive pins 11 that are not electrically connected to the lead wires 2. The physiological parameter monitoring host 5 can obtain the data of the sensor through these conductive pins 11 to realize the detection of the cable connector 1. The sensor can be an access detection sensor or a temperature sensor, etc., and can obtain the state of whether the cable connector 1 is inserted or the temperature of the cable connector 1.

[0064] The present invention does not limit the arrangement of the conductive pins 11 in the cable connector 1 and the cross-sectional shape of the housing 10. The conductive pins 11 can be arranged in parallel or arranged in a circle. The cross-section of the housing 10 can be square or circular, as long as it can form an electrical connection with the corresponding interface of the physiological parameter monitoring host 5.

[0065] Please refer to Figure 3 , among the lead wires 2 connected to the above-mentioned cable connector 1, the lead wire 2 includes a conductor 20 and an insulating coating 21 from the inside to the outside. The conductor 20 is the main component of the lead wire 2 and is made of a non-magnetic conductor material. It is used to transmit current, voltage, and electromagnetic waves. These electrical-related parameters can be physiological parameters generated by the human body, and the conductor 20 can play a role in transmitting physiological parameters. The conductor 20 can be one (i.e., single-core), and the single conductor 20 is placed in an insulating coating 21. The cross-section of the single conductor can be circular or other shapes; or the conductor 20 can also be multiple (i.e., multi-core), and the multiple conductors 20 are placed in an insulating coating 21. The multiple conductors 20 can be wound around each other and then placed in an insulating coating 21 or can also be arranged in parallel and then placed in an insulating coating 21. The type of the conductor 20 is not limited. Exemplarily, it can be a composite stranded wire, such as a silver-plated copper composite stranded wire.

[0066] The insulating coating layer 21 is used to coat and insulate the conductor 20 to prevent the conductor 20 from contacting the outside. The insulating coating layer 21 is made of a non-magnetic insulating material, such as plastic. Since the insulating coating layer 21 may also come into contact with human skin, it is preferably made of a material with good skin affinity and biocompatibility, such as a material that is not likely to cause skin allergies in humans. At the same time, the surface of the insulating coating layer 21 is also as smooth as possible. The insulating coating layers 21 of different lead wires 2 can have the same color, which is convenient for using the same production materials and saving costs; the insulating coating layers 21 of different lead wires 2 can also have different colors, which makes it convenient to distinguish different lead wires 2 by color. The cross-sectional shape of the insulating coating layer 21 is preferably circular, and in some embodiments, it can also be oval or the like.

[0067] The insulating coating layer 21 generally covers the entire outer side of the conductor 20. Only at both ends of the conductor 20, in order to form a fixed electrical connection with the conductive pins 11 in the cable connector 1 and the electrode plates in the electrode connector 4 respectively, the insulating coating layer 21 at the fixed electrical connection points at both ends of the conductor 20 is removed. That is, except for the fixed electrical connection points at both ends, the rest of the conductor 20 is coated with the insulating coating layer 21, and the insulating coating layer 21 extends into the cable connector 1 and the electrode connector 4. That is, one end of the lead wire 2 is connected to the cable connector 1, and the other end of the lead wire 2 is connected to the electrode connector 4.

[0068] The number of lead wires 2 in the present invention is at least four. Of course, the number of lead wires can also be any number greater than four, such as 5 - 13. The lead wires 2 are used to transmit the detected physiological parameters. The more types of physiological parameters transmitted, the more the number of lead wires 2. The types of physiological parameters include, but are not limited to, electrocardiogram, blood oxygen, blood pressure, respiration, body temperature, etc. It should be noted that the above physiological parameters are only for example, rather than indicating that the nuclear magnetic resonance compatible lead wire of the present invention must be able to transmit these parameters. This depends on whether the electrode connector 4 connected to the lead wire 2 meets the nuclear magnetic resonance compatibility requirements. If it meets the nuclear magnetic resonance compatibility requirements, it can be used to transmit the physiological parameters collected by the electrode connector. In this embodiment, taking the electrocardiogram parameter as an example, four lead wires 2 can be used to transmit the three - lead electrocardiogram signal (ECG signal), where three are used to transmit the electrocardiogram signal and one is the reference signal. Common electrocardiogram leads include three - lead (I, II, III), five - lead (I, II, III, aVR, aVL, aVF), twelve - lead (I, II, III, aVR, aVL, aVF, V1 - V6), etc., which can be transmitted by three lead wires 2, five lead wires 2, and twelve lead wires 2 respectively. Adding one lead wire 2 for the reference signal, the final number of lead wires 2 can be four, seven, or thirteen. On this basis, other physiological parameters can be additionally transmitted, such as blood oxygen, blood pressure, respiration, and body temperature. Different lead wires 2 can be of the same type or different types, such as different diameters, different materials, etc. For different physiological parameters, different types of lead wires 2 can be used according to actual needs. For example, different types of lead wires 2 can be used to transmit blood oxygen and electrocardiogram separately. And for one type of physiological parameter, the same type of lead wires 2 is used. For example, the four lead wires 2 of the three - lead electrocardiogram can be of the same type. The lengths of the lead wires 2 are generally selected to be the same, which is convenient for setting. Different lengths can also be selected. For example, different lengths enable the electrode connectors 4 to be staggered, and when storing, the electrode connectors 4 can be prevented from stacking together, thereby reducing the height during storage and facilitating storage.

[0069] To obtain physiological parameters, it is necessary to connect the human body with an electrode connector 4. A lead wire cable 2 is connected to one electrode connector 4. At least four lead wire cables 2 can be connected to at least four electrode connectors 4. The electrode connector 4 contains electrodes, and the electrodes form a fixed electrical connection with the conductors of the lead wire cable 2 inside the electrode connector 4. The electrodes in the electrode connector 4 have exposed surfaces that can contact the human body to obtain the physiological parameters of the human body. The electrodes transmit the obtained physiological parameter signals to the physiological parameter monitoring host 5 through the lead wire cable 2 and the cable connector 1. Since during nuclear magnetic resonance (NMR) detection, the patient's body is placed inside the NMR detection device, at this time the electrode connector 4 is also inside the NMR detection device. To avoid the interaction between the electrode connector 4 and the magnetic field of the NMR detection device, the electrode connector 4 and the internal electrodes are made of non-magnetic materials. The electrode connector 4 can be fixed to the human body by means of clamping or adsorption.

[0070] When performing NMR detection and physiological parameter acquisition simultaneously, a loop 6 will be formed between the lead cable for physiological parameter acquisition and the human body, as Figure 4 shown. The magnetic field of the NMR detection will pass through this loop 6. The loop 6 has a loop area in physical space, and the larger the area, the stronger the interaction between the loop and the magnetic field. To reduce this loop area, in the present invention, all the lead wire cables 2 are fixed together by connecting a fixing member 3. Specifically, please refer to Figure 5, the connecting and fixing member 3 is made of non-magnetic material. The connecting and fixing member 3 is located between the cable connector 1 and the electrode connector 4 and is used to limit the parts of any two lead wires 2 within the first section 22 to be parallel to each other. The first section 22 is the section where the lead wires 2 are at the position of the connecting and fixing member 3. The parts of all the lead wires 2 at the position of the connecting and fixing member 3 are parallel to each other. By "parallel to each other", it means that the axes of the lead wires 2 are parallel to each other. It can be understood that the so-called axis of the lead wire is the axis of the lead wire, that is, the center of the cylindrical lead wire, which is a virtual line. Since the whole nuclear magnetic resonance compatible lead wire may be bent and placed, in the current placement state, the axes of the lead wires 2 are not in a parallel state. At this time, one end of the nuclear magnetic resonance compatible lead wire can be lifted, such as lifting the cable connector 1 or the electrode connector 4, so that the lead wire 2 is in a state of only being affected by gravity and sagging. If the lead wire 2 has undergone a certain deformation, it can be left still for a period of time to allow the nuclear magnetic resonance compatible lead wire to recover. Then the lead wire 2 is in a straight state, and the axes of the lead wires 2 can be restored to a parallel state. It is also possible to straighten both ends of the lead wire. It can be understood that the "parallel" mentioned in this solution refers to the parallelism of the lead wires within the first section when the wires are straightened. In this embodiment, the connecting and fixing member 3 restricts the lead wires 2 to be in a parallel state, which can maintain the relative positions between the lead wires 2, prevent the distance between the lead wires 2 from being easily changed and increased, and thus avoid the increase of the loop area formed by the lead wires 2. At the same time, since the lead wires 2 are parallel to each other, there is no need for the lead wires 2 to be wound and crossed, reducing the production difficulty. Since the lead wires 2 are parallel to each other, the distance between two parallel lead wires 2 is the same at any position, making the influence of the nuclear magnetic resonance magnetic field on the lead wires tend to be consistent, with good consistency, thereby improving the common mode rejection ratio. In addition, the parallel lead wires 2 are not likely to produce cleaning dead corners. When cleaning, it can be cleaned along the parallel direction, which is convenient for cleaning and disinfection.

[0071] Since the first section 22 is the section where the lead wires 2 are at the position of the connecting and fixing member 3, the length of the first section 22 is the same as the length of the connecting and fixing member 3. The lead wire 2 further includes a second section 23 and a third section 24. The section of the lead wire 2 between the cable connector 1 and the connecting and fixing member 3 is the second section 23. The length of the second section 23 can be set to be shorter so that as much of the lead wire 2 as possible is fixed by the connecting and fixing member 3. The second section 23 can also be absent. In this case, one end of the connecting and fixing member 3 is directly connected to the position of the cable connector 1. The section of the lead wire 2 between the connecting and fixing member 3 and the electrode connector 4 is the third section 24. The length of the third section 24 should meet the requirement that the connected electrode connector 4 can be connected to the part of the human body where physiological parameters need to be collected, and at the same time, it should be as short as possible on the premise of meeting the requirements for collecting physiological parameters of different body types of people, such as a length of more than 10 cm.

[0072] The axes of the portions of all the lead wires 2 of the present invention located within the first section 22 are not in the same plane, that is, the axes of the lead wires 2 within the first section 22 are not in the same plane. As shown in Figure 6 shown. Or it can be said that within the first section 22, there is at least one lead wire 2 (such as the lead wire 2 on the right side in Figure 6 ), whose axis is on the side of the plane formed by the axes of the other two lead wires 2 and not in this plane. Or it can be said that within the first section 22, there is at least one lead wire 2, whose axis is on the side of the plane formed by the axes of the other two lead wires 2 and not in this plane. Or rather, there are at least three lead wires 2, and the centers of the cross-sectional axes thereof can form a triangle (such as the lead wire 2 on the right side in Figure 6 and any other two lead wires 2 can form a triangle). Since the axes of the portions of all the lead wires 2 located within the first section 22 are not in the same plane, the cross-sectional thickness of the lead wires can be increased, further preventing the lead wires from forming loops. As shown in Figure 6 , the horizontal thickness therein is the thickness of two lead wires 2, so the horizontal bending resistance becomes higher and it is not easy to form loops. And because the axes of the portions of all the lead wires 2 located within the first section 22 are not in the same plane, that is, there are three lead wires 2, and the centers of the cross-sectional axes thereof can form a triangle. A triangle has the following property that the difference between its two sides must be less than the third side. Compared with the situation where the centers of the cross-sectional axes of the three lead wires 2 are on the same straight line, since the difference between its two sides is equal to the third side on the same straight line, when the two smaller sides of the triangle are the same, its largest side is shorter, that is, the lead wires 2 can be closer, which not only reduces the loop area of the lead wires 2 but also improves the common-mode rejection ratio of the lead wires 2.

[0073] The present invention does not limit the specific form of the connecting fixture 3. It can be a fixed connection formed between the lead wires 2 or a fixed connection formed on the outer periphery of the lead wires 2. In order to keep the lead wires 2 in a parallel state, the shape of the connecting fixture 3 should be uniform, that is, the cross-sectional shape at any position is the same and in a straight line state. The connection between the connecting fixture 3 and the lead wires 2 can be achieved by mechanical coating, mechanical clamping, glue sticking, hot pressing and fitting, etc., as long as the connecting fixture 3 can limit the position of the lead wires 2. When the connecting fixture 3 forms a fixed connection between the lead wires 2, the connecting fixture 3 can be a support bar, as shown in Figure 6 shown, and the outer periphery of the support bar is fixedly connected to the first section 22 of at least four lead wires 2. The structure of the NMR-compatible lead wire formed at this time is as shown in Figure 7 shown.

[0074] When the connecting fixture 3 forms a fixed connection on the outer periphery of the lead wires 2, the connecting fixture 3 can be a sleeve, asFigure 8 As shown. The sleeve covers the outer periphery of the first section of all the lead wires. That is, a fixed connection is formed between the inner wall of the sleeve and the outer periphery of the lead wire 2. In some embodiments, the connecting and fixing member 3 may also include a sleeve and a support bar, such as Figure 9 As shown, the inner and outer supports are provided by the sleeve and the support bar, which can better keep the lead wire 2 in a parallel state.

[0075] In specific implementation, the support bar can be first extruded or injection molded and then fixedly connected to the lead wire 2. The sleeve can be one or a combination of an extruded sleeve, a fitted sleeve or a heat shrink sleeve. The extruded sleeve can extrude plastic on the outer periphery of the lead wire 2 to fix the lead wire 2. The fitted sleeve means that the side of the sleeve can be opened, and then the lead wire 2 is placed inside the fitted sleeve, and then the sleeve is closed, so as to assemble the lead wire 2 inside the fitted sleeve. The heat shrink sleeve can be a heat shrink tube, and then the lead wire 2 is assembled inside the heat shrink tube, and the heat shrink tube is shrunk by hot air to fix the lead wire 2. The sleeve can be one kind or a combination of multiple kinds. For example, a fitted sleeve or a heat shrink sleeve can be sleeved outside the extruded sleeve.

[0076] In a preferred embodiment, the sleeve is an annular sleeve, and the inner side wall of the annular sleeve contacts the outer periphery of all the lead wires. The annular sleeve means that the thickness at any position of the cross section of the sleeve is the same, which is convenient for processing and has good consistency. Of course, in some embodiments, the thickness of some positions of the cross section of the sleeve can be thicker. For example, the thickness of the position between the lead wires 2 can be thicker, so as to compensate for the gap between the lead wires 2, so that the bending resistance strength of the MRI-compatible lead wire in all directions is relatively close, and the situation of bending into a ring can be avoided.

[0077] As mentioned above, the spacing of the lead wires 2 determines the loop area formed with the human body. In order to make the loop areas similar to each other, that is, to ensure the consistency of the loop areas, preferably, the spacing of the portions of any two adjacent lead wires 2 located in the first section 22 is the same. Of course, in some embodiments, it can also be different, such as Figure 6As shown. The spacing here refers to the distance between intervals, that is, the width of the interval at the closest position of two lead wires. When the two lead wires are in contact with each other, the spacing is zero. For the lead wire 2 with a circular cross-section, the spacing can also be regarded as the center-to-center spacing of the axes minus the radii of the two lead wires 2. Since the radius is fixed, the same spacing can also be regarded as the same axis spacing. Then for the lead wire 2 with a circular cross-section, it can also be said that the axis spacings of the parts of any two adjacent lead wires 2 located in the first section 22 are the same. It should be noted that this embodiment is a further description of the lead wire 2. The above embodiment regarding the connection fixing member 3 can be combined with this embodiment so that the MRI-compatible lead wire has the beneficial effects of both this embodiment and the above embodiment.

[0078] In the above embodiment, only the spacings between each other are the same, and the size of the spacing is not limited. Preferably, in order to reduce the loop area formed by the lead wire 2 and the human body, the spacing is preferably zero. At this time, the two lead wires are in contact with each other. In order to make more lead wires 2 in contact with each other, at least one of all the lead wires 2 is in contact with the other two lead wires in the first section. At this time, at least three lead wires are in contact with each other, as Figures 8 - 10 shown. The remaining lead wires 2 can also be in contact with these three lead wires.

[0079] Preferably, the remaining lead wires 2 are also in contact with at least two other lead wires in the first section 22. At this time, each of all the lead wires is in contact with at least two other lead wires 2 in the first section 22. As Figure 8 shown, each of all the lead wires is in contact with two other lead wires 2 in the first section 22. At this time, from the cross-section view, the lead wires 2 are in contact with each other and are connected end to end to form a closed figure. The closed figure can be a circle. At this time, its axis is on a circle, and the sleeve can also be a circle. For a larger number of lead wires 2, this method can also be used for setting to form an MRI-compatible lead wire. In this way, the spacing between adjacent lead wires 2 is small, so the formed loop area is small, and the loop areas formed by adjacent lead wires 2 are similar, which is beneficial to the consistency of signal transmission. When forming a circle, the bending resistance strengths of the MRI-compatible lead wire in all directions are similar, and it can better avoid bending into a loop.

[0080] As Figure 10As shown, each of the left and right lead cables 2 is in contact with the two middle lead cables 2 respectively within the first section 22, and each of the middle lead cables 2 is in contact with the other three (i.e., more than two) lead cables 2 within the first section 22. At this time, when viewed from the cross-section, the lead cables 2 are in contact with each other and are connected end to end to form a closed figure. This closed figure can be an ellipse. At this time, its axis is on an ellipse, and at this time, the sleeve can also be an ellipse. For a larger number of lead cables 2, this method can also be used for setting, so that the lead cables 2 are in contact as much as possible to form a nuclear magnetic compatible lead wire. In this way, the distance between all the lead cables 2 is as small as possible, so that the total area of the formed loop is relatively small.

[0081] For the electrocardiogram physiological parameters of three leads, the number of lead cables 2 is four, and the central connection lines of the cross-sections of the four lead cables 2 at the connection fixture 3 form a square or a rhombus. As Figure 8 shown, the central connection lines of the cross-sections of the four lead cables 2 form a square, as Figure 10 shown, the central connection lines of the cross-sections of the four lead cables 2 form a rhombus. In some embodiments, it can also form a rectangle, a parallelogram or a trapezoid, etc. These figures can be achieved by increasing the distance between the lead cables 2.

[0082] For a larger number of lead cables 2, one of all the lead cables 2 can be placed at the center, and the rest are arranged around the periphery of the lead cable 2 at the center. As Figure 11 shown, one lead cable 2 is placed at the center, and there are 6 lead cables 2 surrounding it on the outside. In this way, all the lead cables 2 can be closer as a whole, so that the total area of the formed loop is relatively small. Preferably, the lead cable 2 at the center can be a reference signal line, and the reference signal line can have the shortest distance from other signal lines, improving the common-mode rejection ratio.

[0083] In one embodiment, the distance between any two lead cables 2 is less than or equal to 10 mm. That is, the distance between the two lead cables 2 can be a little closer to reduce the formed loop area.

[0084] In one embodiment, the length of the connection fixture 3 is more than 10 cm shorter than the length of any one of the lead cables 2. That is, the length of the lead cable 2 outside the connection fixture 3 is more than 10 cm. That is, the lengths of the second section 23 and the third section 24 are more than 10 cm. Preferably, the length of the third section 24 is more than 10 cm, which is convenient for the electrode connector 4 connected to the third section 24 to be connected to the part of the human body where the physiological parameters need to be collected.

[0085] In one embodiment, the conductor is a non-magnetic conductive plastic material or the conductor is a non-magnetic metal. The non-magnetic conductive plastic material is more suitable for the magnetic resonance imaging environment than the metal material because of its high resistance, non-magnetism, and the fact that no surface treatment or other operations introducing other elements are required. Non-magnetic metals such as copper and aluminum can also be selected.

[0086] In one embodiment, as Figure 12 shown, the insulation coating layer 21 includes an inner insulation layer 210 and an outer jacket layer 211 from the inside to the outside. Different materials can be selected for the insulation layer 210 and the outer jacket layer 211. For example, the insulation layer 210 can be selected to have good insulation properties, while the outer jacket layer 211 can be selected to be relatively soft to improve the comfort of human contact. The insulation layer 132 is made of an insulating material to play an insulating role. For example, a PP (Polypropylene) insulation layer, a PE (Polyethylene) insulation layer, or a PTFE (Polytetrafluoroethylene) insulation layer can be selected. The outer jacket layer 211 plays the role of contacting the human body and can be selected to have better elasticity, such as a PU (Polyurethane) outer jacket layer, a TPR (Thermoplastic Rubber) outer jacket layer, or a silicone outer jacket layer.

[0087] In one embodiment, the electrode connector 4 is a carbon fiber material electrode connector or a non-magnetic conductive plastic electrode connector. This can enable the electrode connector 4 to have good electrical conductivity with the lead wire cable 2 while not generating magnetism.

[0088] When the physiological parameter collected is an electrocardiogram parameter, the electrode connector 4 includes an ECG electrode connector. By connecting the ECG electrode connector to the human electrocardiogram site, an electrocardiogram signal can be collected, and then transmitted to the physiological parameter monitoring host 5 through the lead wire cable 2 and the cable connector 1 to realize the monitoring of the electrocardiogram signal.

[0089] To avoid the lead wire cable 2 from possibly getting hot and scalding the patient, a heat insulation layer 7 can also be provided on the outside of all lead wire cables 2, as Figure 13 shown. The heat insulation layer 7 is used to isolate the heat of the lead wire cable 2 and can be directly sleeved on the outside of all lead wire cables 2. In the embodiment where the connection fixing member 3 is a sleeve, the heat insulation layer 7 is preferably sleeved on the outside of the sleeve. Since the outer heat insulation layer 7 may contact the human body, it also needs to meet the biocompatibility requirements. The material of the heat insulation layer can be selected as a foamed silicone heat insulation layer, a foamed TPU (Thermoplastic Polyurethane Rubber) heat insulation layer, a foamed EVA (Ethylene-Vinyl Acetate Copolymer) heat insulation layer, or a foam heat insulation layer. And it should be noted that the heat insulation layer 7 is an additional structure and can be combined with any of the above embodiments for implementation.

[0090] AsFigure 1 As shown, in order to wrap and connect the lead wires 2 at both ends of the connecting fixture 3, the MRI-compatible lead wire of this embodiment may further include a sleeve 8, which is provided at at least one end of the connecting fixture 3, or may be provided at both ends of the connecting fixture 3. One end of the sleeve 8 wraps the connecting fixture 3, and the other end of the sleeve wraps all the lead wires 2. It should be noted that when the connecting fixture 3 is a support bar between the lead wires 2, at this time, one end of the sleeve 8 wrapping the connecting fixture 3 does not mean that one end of the sleeve 8 has to contact the connecting fixture 3 (i.e., the support bar), but wraps the position where the connecting fixture 3 is located, that is, wraps to one end of the connecting fixture 3 through the lead wires 2, so as to achieve wrapped connection and prevent the lead wires 2 from spreading due to tension. For the embodiment where the connecting fixture 3 is a sleeve, the sleeve 8 can make both ends of the sleeve smoother and avoid hurting the human skin due to being too sharp. And it should be noted that the sleeve 8 is an additional component and can be combined with any of the above embodiments for implementation.

[0091] In a preferred embodiment, the size of the sleeve 8 wrapping one end of the connecting fixture is larger than the size of the other end of the sleeve. This can form a smooth transition and avoid hurting the human skin due to being too sharp.

[0092] On the other hand, the present invention also provides a physiological parameter monitoring device, and the specific form can refer to Figure 2 , which includes a physiological parameter monitoring host 5 and the MRI-compatible lead wire according to any one of the embodiments, and the MRI-compatible lead wire is used for detachably electrically connecting with the physiological parameter monitoring host. The physiological parameter monitoring device using the MRI-compatible lead wire of the present invention has all the beneficial effects mentioned in the above embodiments.

[0093] Finally, it should be noted that although the above embodiments have been described in the text of the specification and the drawings of the present application, the patent protection scope of the present application cannot be limited thereby. Any technical solutions generated by equivalent structure or equivalent process substitution or modification using the content recorded in the text of the specification and the drawings of the present application based on the essential concept of the present application, as well as those directly or indirectly implementing the technical solutions of the above embodiments in other related technical fields, are all included in the patent protection scope of the present application.

Claims

1. A nuclear magnetic resonance compatible lead wire, characterized in that, Comprising: A cable connector for electrically connecting with a physiological parameter monitoring host; At least four lead wires, the lead wires including a conductor and an insulating coating layer from the inside to the outside, the conductor being a non-magnetic material conductor, and one ends of at least four of the lead wires being electrically connected to the cable connector; At least four electrode connectors made of non-magnetic materials, each electrode connector being individually electrically connected to the other ends of at least one of the lead wires, for connecting with a human body and acquiring physiological parameters of the human body, so as to transmit the acquired physiological parameter signals to the physiological parameter monitoring host through the lead wires and the cable connector; And A connection fixing member made of non-magnetic material, the connection fixing member being located between the cable connector and the electrode connector, for defining that the portions of any two lead wires located in a first section are parallel to each other, and the axes of the portions of all the lead wires located in the first section are not in the same plane.

2. The nuclear magnetic compatible lead wire according to claim 1, characterized in that, The connection fixing member is a sleeve and / or a support bar, the sleeve covering the outer periphery of the first section of all the lead wires; the support bar being fixedly connected to the first section of at least four of the lead wires.

3. The nuclear magnetic compatibility lead wire according to claim 2, characterized in that, The sleeve is one or a combination of an extruded sleeve, a fitted sleeve or a heat-shrinkable sleeve.

4. The NMR-compatible lead wire according to claim 2, wherein The sleeve is an annular sleeve, and the inner side wall of the annular sleeve contacts the outer peripheries of all the lead wires.

5. The nuclear magnetic resonance compatible lead wire according to claim 1, wherein In the first section, the distance between the axes of any two adjacent lead wires is the same.

6. The NMR-compatible lead wire according to claim 1, characterized in that, At least one of all the lead wires contacts with at least two other lead wires in the first section; Or Each of all the lead wires contacts with at least two other lead wires in the first section respectively.

7. The nuclear magnetic resonance compatible lead wire according to claim 1, wherein The number of the lead wires is four, and the central connection lines of the cross-sections of the four lead wires at the connection fixing member form a square or a rhombus.

8. The NMR-compatible lead wire according to claim 1, wherein One of all the lead wires is placed at the center, and the rest are arranged around the periphery of the lead wire at the center.

9. The nuclear magnetic resonance compatible lead wire according to claim 1, wherein The interval distance between any two lead wires is less than or equal to 10 mm.

10. The nuclear magnetic resonance compatible lead wire according to claim 1, characterized in that, The length of the connection fixing member is more than 10 cm shorter than the length of any one of the lead wires.

11. The nuclear magnetic resonance compatible lead wire according to claim 1, wherein The conductor is a non-magnetic conductive plastic material or the conductor is a non-magnetic metal.

12. The nuclear magnetic resonance compatible lead wire according to claim 1, characterized in that, The insulating coating layer includes an insulating layer and an outer jacket layer from the inside to the outside.

13. The nuclear magnetic resonance compatible lead wire according to claim 12, wherein, The insulating layer is a PP insulating layer, a PE insulating layer or a PTFE insulating layer; and / or, the outer jacket layer is a PU outer jacket layer, a TPR outer jacket layer or a silicone outer jacket layer.

14. The NMR-compatible lead wire according to claim 1, wherein The electrode connector is a carbon fiber material electrode connector or a non-magnetic conductive plastic electrode connector.

15. The nuclear magnetic resonance compatible lead wire according to claim 1, wherein, The electrode connector includes an ECG electrode connector.

16. The nuclear magnetic compatibility lead wire according to claim 1, wherein Further comprising: A heat insulation layer provided outside all the lead wires.

17. The nuclear magnetic compatible lead wire according to claim 16, wherein The heat insulation layer includes a foamed silicone heat insulation layer, a foamed TPU heat insulation layer, a foamed EVA heat insulation layer or a foam heat insulation layer.

18. The nuclear magnetic resonance compatible lead wire according to claim 1, characterized in that, Further comprising: A head sleeve provided at at least one end of the connection fixing member, one end of the head sleeve covering the connection fixing member, and the other end of the head sleeve covering all the lead wires.

19. The NMR-compatible lead wire according to claim 18, wherein The size of the end of the head sleeve covering the connection fixing member is larger than the size of the other end of the head sleeve.

20. A physiological parameter monitoring device, comprising a physiological parameter monitoring main unit and a nuclear magnetic resonance compatible lead wire as described in any one of claims 1 to 19, wherein the nuclear magnetic resonance compatible lead wire is used for detachably electrically connecting with the physiological parameter monitoring main unit.

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