Head-mounted ultrasonic device for opening blood brain barrier

Abstract

A head-mounted ultrasonic device used for opening a blood brain barrier comprises an ultrasonic transmitting head and an ultrasonic receiving head which are connected with a power module used for supplying power and a control module used for controlling operation. The ultrasonic transmitting head and the ultrasonic receiving head are fixedly connected through a support attached to the head of a human body. When in use, a user wears the device on the head, the temporal bone seam alignment mark is aligned with the temporal bone seam, and an operator controls the ultrasonic device through the control module to open the blood brain barrier of the user; the device has the advantages of being noninvasive, high in safety, convenient to use and flexible to operate.

Description

Technical Field

[0001] The utility model relates to the technical field of medical ultrasonic equipment, in particular to a head-mounted ultrasonic device for opening a blood-brain barrier. Background Art

[0002] The blood-brain barrier (BBB) ​​refers to a special structure in the brain microvascular system, which is composed of tight junctions and basal membranes between brain microvascular endothelial cells, astrocyte foot ends, pericytes, and brain vascular endothelial cells. The BBB strictly controls the exchange of substances between blood and brain in the brain microvascular system, protects the central nervous system (CNS) from circulating toxins and infected cells, and maintains the homeostasis of the brain microenvironment. However, its poor permeability has also become a major obstacle to the brain-targeted delivery of CNS drugs. The existence of the blood-brain barrier makes it difficult for most drugs to enter the brain, which especially limits the choice of effective drugs for brain cancer patients.

[0003] Nowadays, "low-intensity pulsed ultrasound combined with intravenous microbubbles (LIPU-MB)" is expected to solve this problem. The oscillation of microbubbles under ultrasound causes an instantaneous increase in cell membrane permeability, that is, sonoporation, which opens the tight junctions in the BBB. Microbubbles oscillate in a stable motion under low ultrasound intensity (0.3~3W·cm-2), that is, stable cavitation. The results of a phase 1 clinical trial recently published in The Lancet Oncology (Repeated blood-brain barrier opening with an implantable ultrasound device for delivery of albumin-bound paclitaxel in patients with recurrent glioblastoma: a phase 1 trial. Lancet Oncol. 2023May; 24(5): 509-522.) show that LIPU-MB technology can open the blood-brain barrier for 30-60 minutes, allowing the concentration of chemotherapy drugs in key areas of the brain to safely reach 4-6 times that of non-ultrasound treatment, and the operation can be repeated many times. However, the equipment used As an intracranial implant, the device is implanted in a skull window just below the skin and is invisible, while the device is activated for at least 15 days after implantation, and for longer periods of time. Summary of the invention

[0004] In order to overcome the shortcomings of the above-mentioned prior art, the purpose of the utility model is to provide a head-mounted ultrasound device for opening the blood-brain barrier, including an ultrasound transmitter and an ultrasound receiver. The ultrasound transmitter and the ultrasound receiver are fixedly connected by a bracket that fits the human head. The blood-brain barrier is opened by the head-mounted ultrasound device, which is easy to use and flexible to operate.

[0005] In order to achieve the above purpose, the technical solution adopted by the utility model is:

[0006] A head-mounted ultrasound device for opening a blood-brain barrier comprises an ultrasound transmitter 1 and an ultrasound receiver 2, wherein power input ends of the ultrasound transmitter 1 and the ultrasound receiver 2 are connected to power output ends of a power module 3, signal input / output ends of the ultrasound transmitter 1 and the ultrasound receiver 2 are connected to signal output / input ends of a control module 4, and the ultrasound transmitter 1 and the ultrasound receiver 2 are fixedly connected via a bracket 5 that fits the human head.

[0007] The ultrasonic transmitter 1 or the ultrasonic receiver 2 is provided with a temporal suture alignment mark 6 for aligning the ultrasonic transmitter 1 and the ultrasonic receiver 2 with the temporal suture.

[0008] The bracket 5 is semicircular and is provided with an adjustment mechanism for adjusting the size of the bracket 5 .

[0009] The adjustment mechanism is preferably provided with three adjustment cards, including a first adjustment card 81 provided in the middle of the bracket 5 , a second adjustment card 82 provided at the connection between the bracket 5 and the ultrasonic transmitter 1 , and a third adjustment card 83 provided at the connection between the bracket 5 and the ultrasonic receiver 2 .

[0010] The first adjustment card 81 divides the bracket 5 into two sections, one section is fixedly connected to the first adjustment card 81 , and the other section is slidably connected to the first adjustment card 81 through the first sliding groove 71 .

[0011] One end of the second adjustment card 82 is fixedly connected to the ultrasonic transmitter 1 , and the other end is slidably connected to the bracket 5 via the second sliding groove 72 .

[0012] One end of the third adjustment card 83 is fixedly connected to the ultrasonic receiving head 2 , and the other end is slidably connected to the bracket 5 through the third sliding groove 73 .

[0013] The control module 4 is integrated with an adjustment unit 41 for adjusting the ultrasonic intensity and frequency, a safety protection unit 42 for automatically shutting down the ultrasonic transmitter 1 when the ultrasonic wave exceeds the preset safety parameters of the ultrasonic intensity and frequency, a feedback unit 43 for providing the user with the use status of the ultrasonic device, and a storage unit 44 for storing user usage data and status information.

[0014] The ultrasonic transmitter 1 emits a rated low-intensity ultrasound that can pass through the temporal bone suture and enter the brain tissue, and the ultrasonic receiver 2 receives the rated low-intensity ultrasonic signal to form an ultrasonic loop.

[0015] Compared with the prior art, the beneficial effects of the present invention are:

[0016] 1. The utility model adopts a bracket 5 that fits the human head to wear the ultrasonic transmitter 1 and the ultrasonic receiver 2 on the user's head. The blood-brain barrier is opened through the head-mounted device, which can be non-invasive, reduce harm to the user, and reduce the difficulty of operation.

[0017] 2. The head-mounted ultrasound device for opening the blood-brain barrier described in the utility model can be worn on the head and is ready for use, has a short activation cycle, and is easy and quick to operate.

[0018] 3. The utility model adopts an adjustment mechanism and a positioning module, and uses the temporal suture alignment mark 6 to facilitate ultrasound alignment with the temporal suture, thereby achieving a better effect of opening the blood-brain barrier.

[0019] 4. The control module 4 of the utility model integrates the adjustment unit 41, the safety protection unit 42, the feedback unit 43 and the storage unit 44, which can open the blood-brain barrier according to different situations. The operation is convenient and flexible, which can ensure the safety of the user and facilitate the operator to use.

[0020] In summary, the utility model adopts an adjustable bracket 5, a temporal suture alignment mark 6, an adjustment unit 41, a safety protection unit 42, a feedback unit 43 and a storage unit 44, which has the characteristics of reducing user injuries, improving user safety, short activation cycle, easy operation, and convenient and flexible use. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic diagram of the device structure of the utility model.

[0022] Figure 2 It is a cross-sectional view of the device of the utility model.

[0023] Figure 3 This is a diagram showing the relationship between power and signal output / input of the device of the present utility model.

[0024] In the figure, 1. ultrasonic transmitter; 2. ultrasonic receiver; 3. power module; 4. control module; 41. adjustment unit; 42. safety protection unit; 43. feedback unit; 44. storage unit; 5. bracket; 6. temporal suture alignment mark; 71. first slide slot; 72. second slide slot; 73. third slide slot; 81. first adjustment card; 82. second adjustment card; 83. third adjustment card. DETAILED DESCRIPTION

[0025] The structural principle and working principle of the utility model are described in detail below in conjunction with the accompanying drawings.

[0026] See also Figure 1 , Figure 3 A head-mounted ultrasound device for opening the blood-brain barrier includes an ultrasound transmitter 1 and an ultrasound receiver 2. The power input ends of the ultrasound transmitter 1 and the ultrasound receiver 2 are connected to the power output end of a power module 3. The signal input / output ends of the ultrasound transmitter 1 and the ultrasound receiver 2 are connected to the signal output / input end of a control module 4. The ultrasound transmitter 1 and the ultrasound receiver 2 are fixedly connected via a bracket 5 that fits the human head.

[0027] See also Figure 1 Since ultrasound passes through the human brain through the temporal suture, the ultrasound transmitter 1 or the ultrasound receiver 2 is provided with a temporal suture alignment mark 6 for aligning the ultrasound transmitter 1 and the ultrasound receiver 2 with the temporal suture.

[0028] The bracket 5 is semicircular and is provided with an adjustment mechanism for adjusting the size of the bracket 5 .

[0029] See also Figure 1 , Figure 2 The adjustment mechanism is preferably provided with three adjustment cards, including a first adjustment card 81 arranged in the middle of the bracket 5, a second adjustment card 82 arranged at the connection between the bracket 5 and the ultrasonic transmitter 1, and a third adjustment card 83 arranged at the connection between the bracket 5 and the ultrasonic receiver 2.

[0030] See also Figure 1 , Figure 2 The first adjustment card 81 divides the bracket 5 into two sections, one section is fixedly connected to the first adjustment card 81 , and the other section is slidably connected to the first adjustment card 81 through the first sliding groove 71 .

[0031] See also Figure 1 , Figure 2 One end of the second adjustment card 82 is fixedly connected to the ultrasonic transmitter 1 , and the other end is slidably connected to the bracket 5 through the second sliding groove 72 .

[0032] See also Figure 1 , Figure 2One end of the third adjustment card 83 is fixedly connected to the ultrasonic receiving head 2, and the other end is slidably connected to the bracket 5 through the third sliding groove 73.

[0033] See also Figure 3 The control module 4 is integrated with a regulating unit 41, a safety protection unit 42, a feedback unit 43 and a storage unit 44:

[0034] The regulating unit 41 adopts an MCU chip, controls the voltage duty cycle through a PWM wave, and adjusts the ultrasonic intensity and frequency;

[0035] The safety protection unit 42 determines whether the ultrasonic wave exceeds the preset safety parameters of ultrasonic wave intensity and frequency by detecting the working current of the ultrasonic device;

[0036] The feedback unit 43 provides the user with the use status of the ultrasonic device by detecting the feedback signal;

[0037] The storage unit 44 uses an SSD hard disk to store user usage data and status information.

[0038] The ultrasonic transmitter 1 emits a rated low-intensity ultrasound that can pass through the temporal bone suture and enter the brain tissue, and the ultrasonic receiver 2 receives the rated low-intensity ultrasonic signal to form an ultrasonic loop.

[0039] The working principle of the utility model is:

[0040] When low-frequency focused ultrasound and microbubble ultrasound are combined with chemotherapy drugs to treat brain tumors, first, micro-lipid bubbles mixed with chemotherapy drugs are injected into the blood vessels, and then the patient is asked to wear the head-mounted ultrasound device for opening the blood-brain barrier described in the utility model, and the ultrasound transmitter 1 and the ultrasound receiver 2 are adjusted to align with the temporal suture through the temporal suture alignment mark 6 and the adjustment mechanism. The ultrasound intensity and frequency are adjusted through the adjustment unit 41, and the safety parameters are set. The operator obtains the use status in real time through the feedback unit 43, and the user's use data and status information are stored in the storage unit 44. When the ultrasound intensity and frequency exceed the set safety parameters, the safety protection unit 42 automatically turns off the ultrasound transmitter 1. When the ultrasound beam irradiates a specific area, the volume of the micro-lipid bubbles is small enough to attach to the blood-brain barrier. When encountering ultrasound, the micro-lipid bubbles will expand or shrink, and the bubbles in the area will shake slightly, making the blood vessel wall less firm. This ultrasound technology combined with the force generated by microbubbles can temporarily separate the cells of the blood-brain barrier and allow targeted drugs to enter the brain.

Claims

1. A head-mounted ultrasound device for opening the blood-brain barrier, characterized in that: The ultrasonic transmitter (1) and the ultrasonic receiver (2) are provided. The power input ends of the ultrasonic transmitter (1) and the ultrasonic receiver (2) are connected to the power output end of the power module (3). The signal input / output ends of the ultrasonic transmitter (1) and the ultrasonic receiver (2) are connected to the signal output / input end of the control module (4). The ultrasonic transmitter (1) and the ultrasonic receiver (2) are fixedly connected via a bracket (5) that fits the human head.

2. A head-mounted ultrasound device for opening the blood-brain barrier according to claim 1, characterized in that: The ultrasonic transmitter (1) or the ultrasonic receiver (2) is provided with a temporal suture alignment mark (6) for aligning the ultrasonic transmitter (1) and the ultrasonic receiver (2) with the temporal suture.

3. A head-mounted ultrasound device for opening the blood-brain barrier according to claim 1, characterized in that: The support (5) is semicircular and is provided with an adjustment mechanism for adjusting the size of the support (5).

4. A head-mounted ultrasound device for opening the blood-brain barrier according to claim 3, characterized in that: The adjustment mechanism is preferably provided with three adjustment cards, including a first adjustment card (81) provided in the middle of the bracket (5), a second adjustment card (82) provided at the connection between the bracket (5) and the ultrasonic transmitter (1), and a third adjustment card (83) provided at the connection between the bracket (5) and the ultrasonic receiver (2); The first adjustment card (81) divides the bracket (5) into two sections, one section is fixedly connected to the first adjustment card (81), and the other section is slidably connected to the first adjustment card (81) through the first sliding groove (71); One end of the second adjustment card (82) is fixedly connected to the ultrasonic transmitter (1), and the other end is slidably connected to the bracket (5) via a second sliding groove (72); One end of the third adjustment card (83) is fixedly connected to the ultrasonic receiving head (2), and the other end is slidably connected to the bracket (5) through the third sliding groove (73).

5. A head-mounted ultrasound device for opening the blood-brain barrier according to claim 1, characterized in that: The control module (4) is integrated with an adjustment unit (41) for adjusting the ultrasonic intensity and frequency, a safety protection unit (42) for automatically shutting down the ultrasonic transmitter (1) when the ultrasonic wave exceeds preset safety parameters of the ultrasonic intensity and frequency, a feedback unit (43) for providing the user with the use status of the ultrasonic device, and a storage unit (44) for storing user use data and status information.

6. A head-mounted ultrasound device for opening the blood-brain barrier according to claim 1, characterized in that: The ultrasonic transmitter (1) emits a rated low-intensity ultrasound wave that can pass through the temporal bone suture and enter the brain tissue, and the ultrasonic receiver (2) receives the rated low-intensity ultrasonic wave signal to form an ultrasonic loop.

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