Multi-modal sensor for intracranial monitoring of craniocerebral trauma

Abstract

The invention discloses a multi-modal sensor for intracranial monitoring of craniocerebral trauma, the multi-modal sensor comprises a main body part, an intracranial implantation part and an extracranial part, the intracranial implantation part and the extracranial part are respectively arranged at different positions of the main body part, the intracranial implantation part is connected with the extracranial implantation part, and the extracranial implantation part is connected with the extracranial part. Comprising an oxygen partial pressure sensor, a pressure and temperature sensor, a neural electrode site and a marker line, the oxygen partial pressure, the intracranial pressure, the intracranial temperature and the intracranial neural electrode site of local brain tissue are monitored respectively, and the extracranial part comprises a fixing structure, an electronic transmission module and a light source connector and is used for assisting the intracranial implantation part in operation and use. By means of the components, the multi-mode sensor is formed, synchronous and continuous real-time monitoring can be conducted on at least three physiological signals of intracranial pressure, intracranial temperature, local brain tissue oxygen partial pressure and intracranial electroencephalogram, and clinical diagnosis of a patient is facilitated.

Description

Technical Field

[0001] The present invention relates to the technical field of intracranial monitoring, and in particular to a multimodal sensor for intracranial monitoring of craniocerebral trauma. Background Art

[0002] Traumatic brain injury (TBI) has the highest incidence rate among all common neurological diseases. Patients with TBI need close clinical observation in many aspects such as clinical diagnosis, injury assessment, surgical indications, and treatment plans, and are supplemented by various brain monitoring technologies to monitor various physiological indicators. Among them, patients with severe TBI need intracranial monitoring in particular to monitor physiological indicators such as pressure, temperature, and oxygenation level in brain tissue. This has placed a serious burden on public health.

[0003] The existing TBI intracranial monitoring methods and sensor products can generally only monitor one or two of the following: increased intracranial pressure (ICP), increased intracranial temperature (ICT) and local brain tissue oxygen pressure (PbtO2). Single monitoring technology has the singleness and limitations of monitoring indicators. Currently, there is no equipment that can perform multi-dimensional monitoring of the above indicators. Summary of the invention

[0004] The present invention provides a multimodal sensor for intracranial monitoring of craniocerebral trauma, so as to solve the defect that multi-dimensional monitoring cannot be performed in the prior art.

[0005] The present invention provides a multimodal sensor for intracranial monitoring of craniocerebral trauma, the multimodal sensor comprising: a main body, the main body being used as a base for placing various components of the entire device, and having an intracranial implant part and an extracranial part thereon; the intracranial implant part comprising an oxygen partial pressure sensor, the oxygen partial pressure sensor being variably arranged on the main body located on the intracranial implant part, the intracranial implant part being provided with pressure and temperature sensors, neural electrode sites and marking lines in sequence from farthest from the extracranial part to closer to the extracranial part, the oxygen partial pressure sensor being used for monitoring the oxygen partial pressure of local brain tissue, the pressure and temperature sensors being arranged on the intracranial implant part in a manner similar to that of a pressure sensor. The sensor is used to monitor intracranial pressure and intracranial temperature, the neural electrode site is used to monitor intracranial neural electrodes, and the marking line is used to mark the intracranial implantation depth; the extracranial part includes a fixing structure, the fixing structure is located at the junction of the intracranial implant part and the extracranial part, the fixing structure is used to fix the skull or scalp, the extracranial part is provided with two ports, one of which is provided with an electronic transmission module, and the other port is provided with a light source connector, the electronic transmission module is used to supply power, control and collect signals for each sensor module of the intracranial implant part, and connect to the back-end control device.

[0006] Optionally, the longitudinal section diameter of the main body part is 0.5mm-5mm, the length of the intracranial implant part of the main body part is 10cm-30cm, and the length of the extracranial part of the main body part is 5cm-100cm.

[0007] Optionally, the outer surface of the main body is covered with a polymer insulating material and is made of a flexible and / or rigid material. When it is made of a flexible material, the main body is an elastomer and / or a non-elastic body.

[0008] Optionally, the intracranial implant part is partially and / or completely implanted into the skull, and each sensing part thereon can reach an intracranial range including any brain substance, cerebral ventricle, and the space between the skull and the dura mater.

[0009] Optionally, the oxygen partial pressure sensor is provided with a light source, including an external light source transmitted by optical fiber and / or a micro LED light source integrated on the sensor; when the light source is an external light source transmitted by optical fiber, the oxygen partial pressure sensor is located at the tip of the intracranial implant part; when the light source is a micro LED light source integrated on the sensor, the oxygen partial pressure sensor is located at any position of the intracranial implant part, and the light source connector can be replaced by an electronic transmission module to power and control the micro LED.

[0010] Optionally, the neural electrode sites are distributed on the intracranial implantation part of the main body, the number of the neural electrode sites is X, 1≤X≤1024, and the size of the neural electrode sites is Y, 1μm≤Y≤5mm.

[0011] Optionally, the neural electrode sites are implemented as single macro sites, single micro sites, or a combination of macro sites and micro sites.

[0012] Optionally, the neural electrode site is independently and / or integrally connected to the intracranial implant part. When the neural electrode site is in an independent form, the neural electrode is processed and prepared on an insulating polymer film substrate.

[0013] Optionally, when the neural electrode site is a single microsite or a combination of a macrosite and a microsite, the electronic transmission module includes an amplifier and an ADC element that can at least amplify and perform analog-to-digital conversion on the EEG signal collected by the microsite.

[0014] Optionally, the fixing structure is fixed to the attachment by at least adhesion, suturing or screw fixation.

[0015] The present invention provides a multimodal sensor for intracranial monitoring of craniocerebral trauma. By integrating an oxygen partial pressure sensor, a pressure and temperature sensor, and a neural electrode site, the sensor can synchronously and continuously monitor at least three physiological signals of intracranial pressure, intracranial temperature, local brain tissue oxygen partial pressure, and intracranial electroencephalogram in real time, thereby solving the limitation of single monitoring in the prior art and achieving the beneficial effect of clinical monitoring of the comprehensive indicators of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the present invention or the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0017] Figure 1 is a schematic structural diagram of a multimodal sensor for intracranial monitoring of craniocerebral trauma provided by one embodiment of the present invention;

[0018] Figure 2 It is a module schematic diagram of a control system of a multimodal sensor provided by the present invention.

[0019] Reference numerals:

[0020] 1. Main part; 2. Intracranial implant part; 3. Oxygen partial pressure sensor; 4. Pressure and temperature sensor; 5. Neural electrode site; 6. Marking line; 7. Extracranial part; 8. Fixing structure; 9. Electronic transmission module; 10. Light source connector. DETAILED DESCRIPTION

[0021] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the drawings of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0022] As mentioned above, intracranial monitoring sensors designed by the prior art can generally only monitor one or two of the intracranial pressure, intracranial temperature and local brain tissue oxygen partial pressure, lack multimodal monitoring capabilities, and are single and limited.

[0023] To address this issue, the present invention proposes a multimodal sensor for intracranial monitoring of craniocerebral trauma. The present invention solves the problem of the limitations of single monitoring in the prior art by performing synchronous, continuous and real-time monitoring of at least three physiological signals including intracranial pressure, intracerebral temperature, local brain tissue oxygen partial pressure and intracranial electroencephalogram.

[0024] Combine the following Figure 1 The present invention is described in detail.

[0025] Figure 1 It is a schematic diagram of the structure of a multimodal sensor for intracranial monitoring of craniocerebral trauma provided by one embodiment of the present invention.

[0026] like Figure 1 As shown, the multimodal sensor for intracranial monitoring of craniocerebral trauma provided by the embodiment of the present invention mainly includes a main body 1, an intracranial implant part 2 and an extracranial part 7. Among them, the intracranial implant part 2 and the extracranial part 7 are arranged at different positions of the main body 1. And the main body 1 is used as a base for placing various components of the entire device. The intracranial implant part 2 includes an oxygen partial pressure sensor 3, a pressure and temperature sensor 4, a neural electrode site 5 and a marking line 6. The oxygen partial pressure sensor 3 is used to monitor the local brain tissue oxygen partial pressure (brain tissue oxygen pressure, PbtO2), the pressure and temperature sensor 4 is used to monitor the intracranial pressure and intracranial temperature, the neural electrode site 5 is used to perform physiological monitoring of the intracranial neural electrode, and the marking line 6 is used to mark the intracranial implant depth. The extracranial part 7 includes a fixing structure 8, an electronic transmission module 9 and a light source connector 10. The fixing structure 8 is used for fixing the skull or scalp, and the electronic transmission module 9 is used to power, control and collect signals for each sensor module on the intracranial implant part 2 and connect to the back-end control device.

[0027] Through the above-mentioned design, the present invention integrates components such as the oxygen partial pressure sensor 3, the pressure and temperature sensor 4, and the neural electrode site 5 on the intracranial implant part 2, thereby realizing the above-mentioned synchronous continuous real-time monitoring of at least three physiological signals of intracranial pressure, intracranial temperature, local brain tissue oxygen partial pressure, and intracranial EEG, solving the problem of the limitation of single monitoring in the prior art, thereby facilitating medical staff to conduct clinical monitoring of the patient's comprehensive indicators.

[0028] In order to explain the operating principle of the above-mentioned embodiment of the present invention more clearly and in detail, in another preferred embodiment of the present invention, the longitudinal section of the main body 1 can be circular, and the overall shape can be a linear or cylindrical slender structure; except for each sensor part and the non-connection interface part, the whole can be covered with a flexible or rigid polymer insulating material, and when it is a flexible material, it can be an elastomer or a non-elastic body; in terms of the overall length, the diameter can be 0.5mm-5mm, the length of the intracranial implant part 2 can be 10cm-30cm, and the length of the extracranial part 7 can be 5cm-100cm.

[0029] In another preferred embodiment of the present invention, the intracranial implant part 2 can be partially or completely implanted into the skull, and the sensing parts thereon can reach the intracranial range including any brain substance, cerebral ventricle, and the space between the skull and the dura mater.

[0030] In another preferred embodiment of the present invention, the oxygen partial pressure sensor 3 continuously monitors PbtO2 in real time, and the realization principle is photoluminescence quenching. When excited by a light source (i.e., generally violet light with a wavelength below 400nm), the phosphorescent dye on the sensor surface exhibits oxygen concentration-dependent photoluminescence (generally manifested as red light with a wavelength greater than 600nm). This photoluminescence can be captured by the detection element on the oxygen partial pressure sensor 3 and converted into an electrical signal output.

[0031] At the same time, the light source of the oxygen partial pressure sensor 3 can be in two forms, one is an external light source transmitted by optical fiber, and the other is a micro LED light source integrated on the sensor. When an external light source is used, the light source connector 10 is a necessary component of the multimodal intracranial monitoring sensor device as a whole. At this time, the oxygen partial pressure sensor 3 is located at the tip of the main body 1 (i.e., away from the extracranial part 7); when a micro LED light source is used, the light source connector 10 may not be a necessary component of the device body. Alternatively, the electronic transmission module 9 may be used to power and control the micro LED. At this time, the oxygen partial pressure sensor 3 may be located at any position of the main body 1.

[0032] In another preferred embodiment of the present invention, the pressure and temperature sensor 4 is arranged at the tip and / or near the tip of the main body 1, and the distance from the tip is no more than 1 cm, and the pressure and temperature sensor 4 is divided into two parts, namely the pressure sensor and the temperature sensor, which are used to monitor the intracranial pressure and temperature in the skull, and can be a micro pressure sensor and a micro temperature sensor that are independent or integrated into one. The pressure sensor can be a micro strain gauge sensor, which can be a resistive and / or capacitive sensor, and the temperature sensor can be any type of non-optical micro temperature sensor, for example, a thermocouple type, a thermal resistor type or a semiconductor type.

[0033] In another preferred embodiment of the present invention, the neural electrode site 5 is a multi-site neural electrode distributed on the surface of the intracranial implant part 2. The number of sites can be multiple (for example: 1-1024); the site distribution range is uniform or uneven distribution from the tip to the end of the intracranial implant part 2. The types of neural electrode sites 5 include two categories, one is a millimeter-level macro site, which can achieve a relatively low electrochemical impedance and is mainly used to record the local field potential (LFP) signal of neural tissue below 200Hz; the other is a micron-level micro site, which can achieve a spatial resolution of a single nerve cell scale, and can record full-frequency LFP, multi-neuron discharges, and single neuron spikes (single unitspikes). Therefore, the size of a single neural electrode site in any direction is 1μm-5mm. The neural electrode site can be realized by a single macro site, a single micro site, or a combination of a macro site and a micro site, and its material is any conductive material with good bio-tissue compatibility, for example, such as gold, platinum, platinum-iridium alloy, iridium oxide, titanium nitride, etc.

[0034] Meanwhile, the neural electrode site 5 and the intracranial implant part 2 can be integrated or independent. When in an independent form, the neural electrode is processed and prepared on an insulating polymer film substrate. The neural electrode film on the neural electrode site 5 is assembled to the surface of the intracranial implant part 2 on the main body 1 by any method such as gluing, bonding or winding.

[0035] In another preferred embodiment of the present invention, the marking line 6 for marking the intracranial implantation depth is a physical mark on the intracranial implantation part 2 for quantifying the intracranial implantation depth.

[0036] In another preferred embodiment of the present invention, the fixing structure 8 is a fixing device on the surface of the skull or scalp, which can be fixed by adhesion, suturing or screw fixation, and can achieve the fixed limiting effect on the front end intracranial implant part 2 and the extracranial part 7. The non-implanted part of the extracranial part 7 and the intracranial implant part 2 at the front end of the fixing structure during actual implantation can reach the fixed position of the fixing structure 8 through the subcutaneous tissue or the scalp surface.

[0037] In another preferred embodiment of the present invention, the electronic transmission module 9 is used to supply power, control and collect signals for each sensor module of the intracranial implant part 2, and to connect to the functional module of the back-end control device. When the neural electrode site 5 is a single macro site, the electronic transmission module 9 may or may not include an amplifier and ADC element for amplifying and converting EEG signals into analog and digital signals; when the neural electrode site 5 is a single micro site or a combination of a macro site and a micro site, it must include an amplifier and ADC element that can at least amplify and convert EEG signals collected by the micro site into analog and digital signals.

[0038] In another preferred embodiment of the present invention, the light source connector 10 is a functional module for connecting an external light source that provides an excitation light source for the oxygen partial pressure sensor 3. The light source connector 10 is a necessary component only when the oxygen partial pressure sensor 3 uses an external light source transmitted by an optical fiber.

[0039] Therefore, in summary, another preferred embodiment provided by the present invention, in view of the defect of lack of multimodal intracranial monitoring in the prior art, combines the oxygen partial pressure sensor 3, the pressure and temperature sensor 4, and the neural electrode site 5, and can synchronously and continuously monitor at least three physiological signals of intracranial pressure, intracranial temperature, local brain tissue oxygen partial pressure, and EEG in real time, solving the problem of the limitation of single monitoring in the prior art. This will be beneficial to the multi-indicator clinical monitoring of TBI patients, especially severe TBI patients, in terms of clinical diagnosis, injury assessment, surgical indications, treatment plans, etc.

[0040] Based on the same general inventive concept, the present invention also protects a control system of a multi-modal sensor, such as Figure 2 As shown, the system includes a multimodal intracranial sensor unit, a control unit, a light source module and a host computer software. The multimodal intracranial sensor unit is used to synchronously monitor intracranial pressure, intracranial oxygen partial pressure, intracranial temperature and intracranial neuroelectrophysiological monitoring. The control unit is used for controlling the sensor unit, receiving signals, preprocessing signals and connecting to the host computer software. The host computer software is used for editing and sending control commands of the control unit, collecting and storing signals, analyzing signals and presenting results, so as to realize the driving and control of the multimodal sensor used for intracranial monitoring of craniocerebral trauma.

[0041] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A multimodal sensor for intracranial monitoring of craniocerebral trauma, characterized in that: The multimodal sensor comprises: A main body part (1), the main body part (1) is used as a base for placing various components of the entire device, and is provided with an intracranial implant part (2) and an extracranial part (7); The intracranial implant part (2) comprises an oxygen partial pressure sensor (3), the oxygen partial pressure sensor (3) is variably arranged on the main body part (1) located on the intracranial implant part (2), and the intracranial implant part (2) is provided with a pressure and temperature sensor (4), a neural electrode site (5) and a marking line (6) in sequence from far away from the extracranial part (7) to close to the extracranial part (7), the oxygen partial pressure sensor (3) is used to monitor the local brain tissue oxygen partial pressure, the pressure and temperature sensor (4) is used to monitor the intracranial pressure and intracranial temperature, the neural electrode site (5) is used to monitor the intracranial neural electrode, and the marking line (6) is used to mark the intracranial implant depth; The extracranial part (7) comprises a fixing structure (8), wherein the fixing structure (8) is located at the junction of the intracranial implant part (2) and the extracranial part (7), and the fixing structure (8) is used to fix the skull or scalp. The extracranial part (7) is provided with two ports, one of which is provided with an electronic transmission module (9), and the other port is provided with a light source connector (10). The electronic transmission module (9) is used to supply power, control and collect signals for each sensor module of the intracranial implant part (2), and to connect to a back-end control device.

2. The multimodal sensor according to claim 1, characterized in that: The longitudinal section diameter of the main body (1) is 0.5mm-5mm, the length of the intracranial implant part (2) of the main body (1) is 10cm-30cm, and the length of the extracranial part (7) of the main body (1) is 5cm-100cm.

3. The multimodal sensor according to claim 1, characterized in that: The outer surface of the main body part (1) is covered with a polymer insulating material and is made of a flexible and / or rigid material. When it is made of a flexible material, the main body part (1) is an elastomer and / or a non-elastic body.

4. The multimodal sensor according to claim 1, characterized in that: The intracranial implant part (2) is partially and / or completely implanted into the skull, and the intracranial range accessible to each sensing part thereof includes any brain substance, cerebral ventricle, and the space between the skull and the dura mater.

5. The multimodal sensor according to claim 1, characterized in that: The oxygen partial pressure sensor (3) is provided with a light source, including an external light source transmitted by an optical fiber and / or a micro LED light source integrated on the sensor; When the light source is an external light source transmitted by an optical fiber, the oxygen partial pressure sensor (3) is located at the tip of the intracranial implant part (2); When the light source is a micro LED light source integrated on the sensor, the oxygen partial pressure sensor (3) is located at any position of the intracranial implant part (2), and the light source connector (10) can be replaced by an electronic transmission module (9) to power and control the micro LED.

6. The multimodal sensor according to claim 1, characterized in that: The neural electrode sites (5) are distributed on the intracranial implantation part (2) of the main body (1), the number of the neural electrode sites (5) is X, 1≤X≤1024, and the size of the neural electrode sites (5) is Y, 1μm≤Y≤5mm.

7. The multimodal sensor according to claim 6, characterized in that: The neural electrode site (5) is implemented in the form of a single macro site, a single micro site, or a combination of a macro site and a micro site.

8. The multimodal sensor according to claim 1, characterized in that: The neural electrode site (5) is independently and / or integrally connected to the intracranial implant part (2). When the neural electrode site (5) is in an independent form, the neural electrode is processed and prepared on an insulating polymer film substrate.

9. The multimodal sensor according to claim 7, characterized in that: When the neural electrode site (5) is a single microsite or a combination of a macrosite and a microsite, the electronic transmission module (9) comprises an amplifier and an ADC element capable of at least amplifying and performing analog-to-digital conversion on the brain electrical signal collected by the microsite.

10. The multimodal sensor according to claim 1, characterized in that: The fixing structure (8) is fixed to the attachment by at least adhesion, suturing or screw fixing.

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