Drug injection laser locator

Abstract

The invention discloses a medicine injection laser locator, and belongs to the technical field of medical instruments. The positioning instrument comprises a main control unit, an identity recognition module, a distance sensing module, a multi-mode sensing module, a penetration imaging module and a display and interaction module. Wherein the multi-mode sensing module is integrated with a miniature ultrasonic probe and an impedance sensor array; and the penetration imaging module adopts visible light and a near-infrared laser source to be matched with a photoelectric detector, and reconstructs a subcutaneous tissue depth image by analyzing a reflected signal, so that non-intrusive evaluation on the fat layer thickness and the tissue interface is realized. After the equipment enters a preset working distance, the main control unit synchronously starts sensing and imaging scanning and recommends an injection point in combination with a historical injection record of a patient and an injection part rotation algorithm. According to the method, multi-source data fusion analysis is carried out on the ultrasonic image, the impedance value and the near-infrared reflection signal, and diagnosis reliability rise caused by perception dimension complementation is reflected.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an auxiliary positioning device for subcutaneous drug injection. BACKGROUND

[0002] Subcutaneous injection is a common drug administration method in clinical practice, which is widely used in insulin therapy for diabetic patients, postoperative use of anticoagulant drugs (such as low molecular weight heparin), and management of immunomodulators for chronic diseases. In order to ensure stable drug absorption and reduce local tissue damage, clinical guidelines generally require systematic rotation of injection sites to avoid repeated injection in the same area in a short period of time. Currently, the selection of injection sites mainly relies on the judgment of medical staff or patients through visual observation and experience, for example, dividing the abdomen into a "nine-square grid" or using the "quadrant method" for rotation. However, this method is highly subjective and lacks objective basis, and the standards vary between different operators, especially when patients self-inject at home, it is difficult to ensure standardization and accuracy.

[0003] To improve the above problems, existing technologies have attempted to introduce auxiliary positioning tools. For example, Chinese patent CN205307522U discloses an insulin abdominal injection positioning system, which includes at least two insulin abdominal injection positioning cards. Each insulin abdominal injection positioning card includes a panel, a navel positioning hole in the center of the panel, and a plurality of injection holes on the panel. The distance between each injection hole on the insulin abdominal injection positioning card is more than 3 cm. Each injection hole on the insulin abdominal injection positioning card is provided with a label or mark of injection time to facilitate the patient to inject according to the set injection time. However, this solution lacks the ability to perceive the physiological state of subcutaneous tissue and cannot identify whether there are abnormal tissues such as subcutaneous induration, hematoma, inflammation, or fat hyperplasia at the injection site, which may increase the risk of injecting drugs into unsuitable areas and may affect drug absorption or exacerbate tissue damage. Therefore, the current technology still remains at the "surface marking + experience rotation" stage, and lacks a comprehensive injection assistance solution that integrates identity recognition, real-time perception of subcutaneous tissue, intelligent decision-making, and information interconnection, which is difficult to meet the comprehensive needs of modern precision nursing and smart medical care for safety, standardization, and traceability.

[0004] Any discussion of background art throughout the specification should in no way be considered as an admission that such art is widely known or forms part of common general knowledge in the field. SUMMARY

[0005] The present application aims to provide a drug injection laser positioning instrument that comprehensively evaluates the patient's condition before injection to achieve better injection treatment effect.

[0006] The drug injection laser positioning instrument comprises a main control unit and the following modules: An identity recognition module is configured to read patient identity information and communicate with a hospital information system to obtain current medical orders; A distance sensing module is configured to detect the distance between the device and the surface of the patient's skin and trigger a positioning preparation state when the distance is within a preset range; A multi-modal sensing module comprises a miniature ultrasonic probe and an impedance sensor array, which are configured to image and measure the electrical impedance of the subcutaneous tissue of the target injection area, and send the collected information to the main control unit to assess whether there is a pathological state that is not suitable for injection; A penetrating imaging module comprises a visible light laser source, a near-infrared laser source, and a photodetector, wherein the near-infrared laser is used to penetrate the epidermis and receive reflected signals from the subcutaneous tissue, and the main control unit reconstructs a depth image of the subcutaneous tissue based on the reflected signals, thereby achieving non-invasive evaluation of the thickness of the fat layer and the state of the tissue interface; A display and interaction module is configured to display patient information, injection area illustrations, tissue state evaluation results, historical injection records, and recommended injection points; The main control unit is configured to: Access the patient's historical injection records based on the patient ID obtained by the identity recognition module; Identify and mark forbidden areas based on the fusion data of the multi-modal sensing module and the penetrating imaging module; In combination with an injection site rotation algorithm, recommend injection points while avoiding forbidden areas and areas that have been injected within a preset time period; After the distance sensing module detects that the device enters the preset distance range, control the multi-modal sensing module and the penetrating imaging module to perform synchronous scanning on the target area; After the injection is completed, automatically record the execution information and upload it to the hospital information system.

[0007] The main control unit of the present patent performs multi-source data fusion analysis on ultrasonic images, impedance values, and near-infrared reflected signals, and cross- validates the tissue state. The accuracy of this fusion judgment is much higher than that of any single modality, effectively avoiding misjudgment, and reflecting the jump in diagnostic reliability brought about by the complementary perception dimensions. Other specific beneficial effects include the following points: Achieve a leap from "surface experience judgment" to "subcutaneous objective perception": By integrating a miniature ultrasonic probe, an impedance sensor array, and a near-infrared laser penetrating imaging module, the present invention can non-invasively obtain the structure and electrophysiological information of the subcutaneous tissue of the injection area, accurately identify hardening, fat hyperplasia, hematoma, or inflammation, and other invisible contraindicated areas, thereby fundamentally avoiding repeated injections on pathological tissue and significantly reducing the incidence of injection-related complications such as abnormal drug absorption, local necrosis, and infection risk.

[0008] Intelligence and individualization of injection site recommendation: The master control unit integrates multi-modal sensing data and patient's historical injection records, combines with the preset injection site rotation algorithm, intelligently recommends the current optimal injection site based on dynamically avoiding forbidden areas and recently injected areas (such as within 72 hours), effectively preventing local tissue overstimulation and drug accumulation, optimizing drug efficacy stability, especially suitable for chronic disease patients (such as diabetes and multiple sclerosis) who need regular long-term injections.

[0009] Ensure precise synchronization of evaluation timing and operation actions: Trigger the scanning mechanism through the distance sensing module, only when the device is close to the skin to the effective working distance, start the subcutaneous tissue evaluation, avoid invalid energy consumption, and ensure the spatial accuracy of imaging and measurement data, improve system response efficiency and clinical operation fluency.

[0010] Strengthen medical closed-loop management and data traceability: Injection execution information (including time, location, tissue state evaluation results, etc.) is automatically uploaded to the hospital information system after operation is completed, realizing digital recording and full-process tracing of injection behavior, providing reliable data support for clinical quality control, medication compliance analysis and individualized treatment plan adjustment.

[0011] Further, the visible light laser source is a green laser with a wavelength of 532 nm, and the near-infrared laser source has a wavelength of 650 nm or 850 nm. Limiting specific wavelengths and safety levels echoes the dual requirements of visibility and safety in clinical practice.

[0012] Further, when reconstructing the subcutaneous tissue depth image, the master control unit uses time-of-flight method or optical coherence tomography algorithm to process the reflected signal received by the photodetector, and combines with the ultrasound image for spatial registration to generate a fused three-dimensional tissue state map. The introduction of "spatial registration" reflects the depth of multi-modal data fusion.

[0013] Further, the injection site rotation algorithm dynamically adjusts the priority weight of each candidate area according to the patient's body type, the type of injected drug, and the recommended injection depth, and excludes areas with a fat layer thickness less than a preset threshold as injection sites.

[0014] Further, the display and interaction module includes a touch screen and a voice prompt unit, which gives an avoidance reminder through visual highlighting warning and / or voice broadcast when detecting that the user moves the device towards an area marked as forbidden.

[0015] Further, the master control unit is also configured to: while uploading the execution information to the hospital information system, synchronously encrypt and store in the local non-volatile memory, and automatically cache data when communication is interrupted, and re-upload after network recovery. BRIEF DESCRIPTION OF DRAWINGS

[0016] Figure 1 A schematic diagram of the module structure of an embodiment of the application. DETAILED DESCRIPTION

[0017] The application will be further described in detail below through specific embodiments: The module structure of the embodiment is substantially as shown in the accompanying Figure 1 I. Overall structure and hardware configuration The application can be a portable handheld device, with a size similar to the PDA (Personal Digital Assistant) widely used in clinics, and can be operated with one hand. The device integrates the following functional modules, which are all uniformly scheduled and controlled by the main control unit: Main control unit: adopts an embedded system architecture, carries an ARM Cortex-A55 processor, runs a Linux real-time operating system, has an internal storage capacity ≥ 32 GB, and supports encrypted storage of patient operation records.

[0018] Identity recognition module: integrates a high-precision two-dimensional code scanner, located at the top front end of the device, used for scanning the identity information on the patient's wristband.

[0019] HIS communication module: supports Wi-Fi 6 and Bluetooth 5.2, can safely access the hospital intranet, and realize bidirectional data interaction with HIS (Hospital Information System) and EMR (Electronic Medical Record System).

[0020] Display and interaction module: equipped with a 5.5-inch LCD touch screen, used for displaying patient information, injection diagram, recommended area, tissue state image and operation prompt.

[0021] Distance sensing module: uses a ToF (Time-of-Flight) time-of-flight sensor to measure the distance between the device and the skin surface, with a measurement range of 5-30 cm and an accuracy of ±1 mm.

[0022] Multi-modal sensing module: Miniature ultrasonic probe: frequency 10 MHz, bandwidth 7-12 MHz, number of elements 32, used for subcutaneous tissue imaging, with a maximum penetration depth of about 15 mm; Impedance sensor array: composed of 4 miniature electrodes, working frequency 50 kHz, measuring local tissue impedance values, used to distinguish fat, muscle and abnormal tissues (such as induration).

[0023] Penetrating imaging module: Dual-wavelength laser source: contains 532 nm green visible light laser (Class II safety level) and 650 nm red near-infrared laser; at the same time, equipped with a high-sensitivity photodetector array (such as APD or SiPM) for receiving the reflected near-infrared laser signal. ​

[0024] Injection Guidance Module Visible light emitter: integrates high-brightness LEDs to generate clear cross-shaped light spots, circular dots, or ring marks for clearly indicating recommended injection sites; Omnidirectional gimbal: As the base of the visible light emitter, it supports horizontal (±30°) and vertical (±20°) angle adjustment; Power module: Built-in rechargeable lithium battery, supports automatic low battery reminder.

[0025] Audio module: Built-in speaker and microphone for voice prompts and voice interaction functions.

[0026] II. Software System and Functional Flow 1. System startup and patient identification The nurse turns on the device, and the system performs a self-check of the status of each module (such as laser, ultrasound, and communication). The nurse then scans the patient's wristband using a QR code scanner. The system automatically parses the patient's ID and requests the patient's current medical order from the hospital server via the HIS communication module. The server returns the medical order information to be executed (e.g., "Insulin 12U, subcutaneous injection, abdomen", execution time: 08:00). The system then automatically redirects to the "Medical Order Execution Interface," which displays the patient's name, medication name, dosage, recommended injection site, and other information.

[0027] 2. Injection site selection The interface provides multiple preset injection area diagrams: abdomen (nine-square grid), outer upper arm (three-zone division), front thigh (five-zone grid), and buttocks (four quadrants). The nurse selects "abdomen" as the injection site according to the doctor's order, and the system prompts to start the next information collection procedure.

[0028] 3. Distance sensing and positioning preparation Point the device at the patient's abdomen (avoiding the area more than 5cm above the navel). ToF sensor detects the distance between the device and the skin in real time; When the distance enters the optimal projection range of 10-15cm, the screen will display "Entered the positioning area" and proceed to the next step. If the distance is too close or too far, the system will prompt "Please adjust the distance".

[0029] 4. Penetration imaging and tissue condition assessment Start the penetration imaging module, the system controls the 532 nm visible light laser and the 650 nm near-infrared laser to be emitted alternately, part of the laser penetrates the epidermis and enters the subcutaneous tissue and then reflects, the high-sensitivity photodetector array built-in the module receives the reflected laser signal, collects the light intensity, phase and time of flight data; the main control unit reconstructs the depth direction (A-line) or two-dimensional cross-sectional image of the subcutaneous tissue based on the time of flight method (ToF) or optical coherence tomography algorithm; The system analyzes the image features: High reflection area: determined as subcutaneous induration or fibrotic tissue; Low reflection area: may exist hematoma or liquid accumulation; Fat-muscle interface clarity: assesses the fat layer thickness and the appropriate needle insertion depth; Combine the tissue electrical impedance value collected synchronously by the impedance sensor to perform multi-modal data fusion judgment; If there is a pathological feature in the current area that is not suitable for injection, the system marks the "forbidden area" in red on the display screen, and after the system completes the subcutaneous tissue state evaluation of the current area and determines that it is "suitable for injection", the injection point recommendation process is started.

[0030] The main control unit calls the historical injection records of this patient (stored in the cloud server) and marks the areas injected in the past 72 hours (displayed in gray or semitransparent). Combined with the rotation algorithm, the system preferentially recommends the area farthest from the last injection point and not in the recovery period, avoiding repeated stimulation of local tissues. In the current scanning area, if there are multiple safe and unused candidate points, the system further sorts them according to the following priority: First, the fat layer thickness is moderate (≥8mm, ensuring sufficient drug absorption); Second, the tissue impedance value is normal (80-150 Ω·cm), without inflammation or fibrosis tendency; Third, away from anatomical contraindicated areas such as navel, prominent bones or skin folds (default to avoid the navel by more than 5 cm); The system selects the optimal position as the recommended injection site and highlights it with a green flashing icon in the positioning diagram on the display screen; At the same time, the screen prompts "recommended injection point generated, please confirm the position"; The operator can choose to accept the recommendation and need guidance service: click the "guide" button to enter the guidance phase; or manually adjust: reselect the point in the safe area through the touch screen, and the system updates the guidance information in real time; 5. Irradiation guidance This step is suitable for patients who inject themselves, especially for patients with diabetes who need long-term home self-injection, to improve their operation standardization and independence. If the injection is performed by a nurse, this irradiation guidance step can be skipped.

[0031] First, fix the device body to the bracket. The connection can be strengthened with clips or other tools. Then, align the camera and guide head with the injection area such as the abdomen. The guidance can be started by voice control. The system recognizes the patient's body through the camera and automatically controls the rotation of the visible light emitting head to accurately project the cross-shaped light spot to the recommended injection position.

[0032] The patient aligns the injection with the light spot, and after clicking confirm, the system records the execution information and uploads it to the cloud or hospital platform.

[0033] 6. Injection Execution and Record Upload After the injection is complete, tap "Complete Injection" on the touchscreen; The system automatically records the following information: execution time; injection site coordinates; operator ID; and subcutaneous tissue condition. All data is encrypted and uploaded to the hospital server via the HIS communication module to update the electronic medical order execution status. The local database is also updated with injection history for future rotation recommendations.

[0034] 7. Automatic memory and rotation management The system has a built-in "injection history database" that stores injection records for the past 30 days by patient ID. After each new injection, the old records are automatically grayed out (within 72 hours) or faded out (after 72 hours). The rotation algorithm prioritizes avoiding two consecutive injections in adjacent areas to ensure tissue recovery time. It supports exporting a PDF "Injection Site Rotation Report" for patient education or physician evaluation.

[0035] III. Typical Application Scenarios Scenario: Insulin injection for a diabetic patient (hospital environment) The nurse brought the equipment into the ward and turned on the power; Scan the patient's wristband, and the system will automatically retrieve the medical order: "Insulin 12U, abdominal injection". Select the "Abdominal Nine-Square Grid" icon and aim the device at the patient's lower left abdomen; The Time-of-Flight (ToF) indicator says "Distance is suitable," and the scan begins. The ultrasound image showed a 1.5cm nodule in the right upper abdomen with an impedance value of 220Ω·cm, which was marked as a red restricted area by the system. The system recommends the C3 area in the lower left abdomen as the injection site for this procedure. After the nurse completes the injection, she clicks "confirm," and the data is uploaded in real time. The C3 area will automatically turn gray during the next injection, and the system will recommend a new injection site.

[0036] The above are only embodiments of the present application, and for those skilled in the art, the prior art can be introduced to support the implementation of the present application, and under the premise of not departing from the scheme of the present application, a number of modifications and improvements can also be made, which should also be considered as the protection scope of the present application, and these will not affect the effect and practicality of the implementation of the present application. The scope of protection claimed by the present application shall be subject to the content of its claims, and the specific implementation mode and the like recorded in the specification can be used to explain the content of the claims.

Claims

1. A drug injection laser positioning device, characterized in that: Includes the main control unit and the following modules: The identity recognition module is used to read patient identity information and communicate with the hospital information system to obtain current medical orders; The distance sensing module is used to detect the distance between the device and the patient's skin surface, and triggers the positioning preparation state when it enters the preset distance range; The multimodal sensing module, including a miniature ultrasound probe and an impedance sensor array, is used to image and measure the electrical impedance of the subcutaneous tissue in the target injection area, and to send the collected information to the main control unit to assess whether there is a pathological condition that is unsuitable for injection. The penetrating imaging module includes a visible light laser source, a near-infrared laser source, and a photodetector. The near-infrared laser is used to penetrate the epidermis and receive reflected signals from the subcutaneous tissue. The main control unit reconstructs a subcutaneous tissue depth image based on the reflected signals, thereby achieving a non-invasive assessment of the fat layer thickness and tissue interface state. The display and interaction module is used to display patient information, injection area diagram, tissue status assessment results, historical injection records and recommended injection points; The main control unit is configured as follows: Retrieve the patient's historical injection records based on the patient ID obtained from the identity recognition module; Based on the fusion data from the multimodal sensing module and the penetration imaging module, prohibited areas are identified and marked. Combining the injection site rotation algorithm, injection points are recommended while avoiding prohibited areas and areas already injected within a preset time period; After the distance sensing module detects that the device has entered the preset distance range, it controls the multimodal sensing module and the penetration imaging module to scan the target area synchronously. After the injection is completed, the execution information is automatically recorded and uploaded to the hospital information system.

2. The drug injection laser positioning device according to claim 1, characterized in that: The visible light laser source is a green laser with a wavelength of 532nm, and the near-infrared laser source has a wavelength of 650nm or 850nm.

3. The drug injection laser positioning device according to claim 2, characterized in that: When reconstructing the subcutaneous tissue depth image, the main control unit uses the time-of-flight method or optical coherence tomography algorithm to process the reflected signal received by the photodetector, and combines it with the ultrasound image for spatial registration to generate a fused three-dimensional tissue state map.

4. The drug injection laser positioning device according to claim 3, characterized in that: The injection site rotation algorithm dynamically adjusts the priority weight of each candidate region based on the patient's body type, the type of injected drug, and the recommended injection depth, and excludes regions with a fat layer thickness less than a preset threshold as injection points.

5. A drug injection laser positioning device according to claim 4, characterized in that: The display and interaction module includes a touch screen and a voice prompt unit. When it detects that the user has moved the device toward a marked prohibited area, it issues an avoidance reminder through visual highlighting and / or voice broadcast.

6. A drug injection laser positioning device according to claim 5, characterized in that: The main control unit is also configured to: simultaneously encrypt and store the execution information in local non-volatile memory while uploading it to the hospital information system, and automatically cache the data when communication is interrupted, and re-upload it after the network is restored.

Images