A lung edema patch type ultrasonic monitoring and early warning device for shoulder arthroscopy

Abstract

The application provides a lung edema patch type ultrasonic monitoring and early warning device for shoulder arthroscopy surgery. The lung edema patch type ultrasonic monitoring and early warning device for shoulder arthroscopy surgery comprises a patch type ultrasonic probe array, a body position self-adaptive fixing structure, a signal acquisition and control module, a B-line identification and trend analysis module and a grading early warning module. The lung edema patch type ultrasonic monitoring and early warning device for shoulder arthroscopy surgery has the advantages that the real-time monitoring and grading early warning of lung edema in shoulder arthroscopy can be realized through back patching and asymmetric analysis.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a patch-type ultrasound monitoring and early warning device for pulmonary edema in shoulder arthroscopic surgery. Background Technology

[0002] Shoulder arthroscopy is a standard surgical procedure for treating rotator cuff tears, Bankart tears, shoulder impingement syndrome, frozen shoulder, and other conditions. During the procedure, a continuous infusion of irrigation fluid (usually saline) is injected into the shoulder joint cavity to expand the joint space, provide clear visualization, irrigate the wound, and control bleeding. Due to the abundance of soft tissues surrounding the shoulder joint (rotator cuff muscles, deltoid muscle, fascia), the irrigation fluid, under high pressure, can extravasate along the intermuscular spaces and neurovascular bundles, entering the neck, chest wall, mediastinum, and even the pleural cavity, leading to pleural effusion and airway compression. Excessive irrigation fluid may also be absorbed by the body, causing excessive intravascular volume and pulmonary edema, seriously endangering the patient's life. Literature reports that the incidence of extravasation during shoulder arthroscopy can be as high as 30%, with extravasation volumes reaching 1000-2000 mL in procedures lasting >90 minutes, and an incidence of pulmonary edema of approximately 0.3%-1%.

[0003] Currently, the main methods for monitoring extravasation of perfusion fluid and early pulmonary edema during shoulder arthroscopy include:

[0004] Clinical observation: Observe the degree of swelling in the neck, chest wall, and axilla. However, this indicator is highly subjective and is only significant when there is a large amount of extravasation.

[0005] Inflow and outflow calculation: Record the difference between the total inflow and outflow of perfusion fluid. However, extravasation is not completely absorbed and some of it accumulates in the interstitial space, so it cannot directly reflect the state of pulmonary edema in the pleural cavity.

[0006] Chest X-ray: Postoperative bedside chest X-rays can detect pleural effusion or pulmonary edema, but cannot be used for real-time monitoring during surgery, and pose radiation hazards to both patients and medical staff.

[0007] Traditional lung ultrasound: Under normal physiological conditions, ultrasound waves reflect multiple times between the probe surface and the pleural line, creating reverberation artifacts and appearing as multiple horizontal hyperechoic lines parallel to the pleural line, i.e., A-lines. When pulmonary edema increases, the ultrasound beam undergoes deep reverberation between the fluid and gas particles filling the alveoli, appearing as hyperechoic lines emanating from the pleural line and extending vertically downwards to the edge of the screen without attenuation, i.e., B-lines. The number and intensity of B-lines are directly proportional to the degree of pulmonary ventilation loss; therefore, observing the generation and changes in the number of B-lines under lung ultrasound can effectively identify the occurrence of pulmonary edema. However, traditional ultrasound probes require professional handheld operation, and during shoulder arthroscopy, patients are positioned on a beach chair, making it easy for the ultrasound probe attached to the chest to slip off, and it also interferes with the surgical sterilization area.

[0008] Therefore, it is necessary to provide a new pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopy to solve the above-mentioned technical problems. Summary of the Invention

[0009] The technical problem solved by this invention is to provide a pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopy, which can realize real-time monitoring and graded early warning of pulmonary edema during shoulder arthroscopy through back patch and asymmetric analysis.

[0010] To address the aforementioned technical problems, the present invention provides a patch-type ultrasound monitoring and early warning device for pulmonary edema in shoulder arthroscopy, comprising: a patch-type ultrasound probe array, wherein the patch-type ultrasound probe array includes multiple flexible ultrasound patches, each of which embeds a piezoelectric transducer array, the piezoelectric transducer array being encapsulated using medical-grade silicone or TPU; the attachment positions of the multiple flexible ultrasound patches are all located in the posterior chest wall region of the patient's back, to avoid the surgical disinfection area of ​​the affected shoulder and anterior chest during shoulder arthroscopy;

[0011] The body position adaptive fixation structure is used in conjunction with the patch-type ultrasound probe array. The body position adaptive fixation structure is used to firmly attach each flexible ultrasound patch to the skin of the patient's back in the beach chair position, resisting gravity slippage and maintaining ultrasound coupling.

[0012] The signal acquisition and control module is connected to the patch-type ultrasound probe array. The signal acquisition and control module is used to acquire the lung ultrasound echo signal obtained by each flexible ultrasound patch at a preset monitoring frequency, and output the number of B lines in the corresponding area of ​​each patch.

[0013] The B-line identification and trend analysis module is electrically connected to the signal acquisition and control module. The B-line identification and trend analysis module is used to identify the number of B-lines based on the ultrasound echo signals of the corresponding areas of each patch, and to perform asymmetric comparison of B-lines in the same side and contralateral lungs after surgery, as well as analysis of the trend of B-line changes.

[0014] A graded early warning module is electrically connected to the B-line identification and trend analysis module. The graded early warning module is used to output a graded early warning signal when preset early warning conditions are met.

[0015] Preferably, the number of flexible ultrasound patches is four, and the four flexible ultrasound patches are respectively attached to the posterior axillary line of the 4th intercostal space and the inferior scapular line of the 6th intercostal space on both sides of the posterior chest; and a fifth flexible ultrasound patch is added to the 4th intercostal space of the midaxillary line on the affected side.

[0016] Preferably, the body position adaptive fixation structure includes at least one of the following: a medical-grade hydrocolloid backing, an elastic nylon auxiliary fixation strap, and anti-slip protrusions or micro-suction cups provided on the contact surface of the patch.

[0017] Preferably, the signal acquisition and control module communicates with each of the flexible ultrasonic patches via a wireless connection, wherein the wireless connection method is selected from at least one of Bluetooth 5.2, Wi-Fi 6, UWB, or ZigBee.

[0018] Preferably, the preset monitoring frequency is once every 1 to 2 minutes; the B-line identification and trend analysis module is also used to dynamically increase the monitoring frequency to once every 30 seconds when an increase in the number of B-lines is detected.

[0019] Preferably, the B-line identification and trend analysis module performs the following specific B-line asymmetry comparison: calculates the difference ΔB in the number of B-lines in the corresponding areas on the same side and the opposite side of the surgery, and determines that extravasation has caused an increase in pulmonary edema on the same side when ΔB ≥ 3 lines; the B-line change trend analysis is specifically performed by monitoring the increase in B-lines ΔB(t) in the same area within 30 minutes, and triggering an early warning when ΔB(t) ≥ 5 lines.

[0020] Preferably, the graded early warning signal output by the graded early warning module includes:

[0021] Level 1 warning: The number of B lines in a single area on the same side as the surgery is ≥3, or the number of lines increases by ≥5 compared to the preoperative baseline, or ΔB is ≥3;

[0022] Level II warning: ≥8 B lines in any area, or a total B line score of ≥15 in both lungs, or ≥3 B lines in the contralateral lung;

[0023] Level 3 warning: The number of B lines in any area is ≥15, or there is a sign of fused B lines, or there is a sign of pleural effusion, i.e., the costophrenic angle disappears.

[0024] Preferably, it also includes a wireless handheld monitoring terminal, which is used to display a schematic diagram of the lung regions on the back and to indicate the B-line score of each region with color gradation or numbers, a bar chart comparing the B-line on the same side and the opposite side of the surgery, a B-line trend curve and the current warning level, and to issue an alarm through vibration, sound or screen flashing.

[0025] Preferably, it also includes an irrigation system interface module, which is used to communicate with the shoulder arthroscopy irrigation pump to obtain real-time irrigation pressure and / or flow data; the graded early warning module is further configured to: when the irrigation pressure or flow rate rises abnormally and the B-line data shows an upward trend synchronously, comprehensively judge the risk of extravasation and raise the early warning level.

[0026] Compared with related technologies, the pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopic surgery provided by the present invention has the following beneficial effects:

[0027] This invention provides a patch-type ultrasound monitoring and early warning device for pulmonary edema in shoulder arthroscopy. Through a position-adaptive fixation structure, the patch can be securely attached to the patient's back skin while maintaining ultrasound coupling, thus solving the problems of slippage and poor coupling of general-purpose patches in this position. By placing all patches in the posterior chest wall region of the back, the surgical disinfection areas of the affected shoulder and anterior chest during shoulder arthroscopy can be completely avoided, thus not interfering with the surgical procedure and aseptic requirements. Through a B-line recognition and trend analysis module, it performs asymmetric comparison of B-lines on the same side and the contralateral side of the surgery and analyzes the trend of B-line changes, enabling targeted monitoring of pulmonary edema in shoulder arthroscopy. The technology enables early identification of ipsilateral pulmonary edema caused by effusion, achieving earlier and more specific early warning than existing technologies. Wireless communication between the signal acquisition and control module and the patch avoids cables tangling under the beach chair, interfering with anesthesia tubing and surgical drapes, thus improving operating room safety and convenience. The system integration of the patch-type ultrasound probe array, signal acquisition and control module, B-line recognition and trend analysis module, and graded early warning module allows for continuous, non-invasive, and real-time monitoring of pulmonary edema, achieving closed-loop monitoring and early warning of pulmonary edema risk during shoulder arthroscopy. Attached Figure Description

[0028] Figure 1 This is a block diagram illustrating the principle of the pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopic surgery provided by the present invention.

[0029] Figure 2 A schematic diagram of an ultrasound image of a normal lung;

[0030] Figure 3 This is a schematic diagram of an ultrasound image of pulmonary edema.

[0031] Figure 4 Rear view of the flexible ultrasonic patch attachment location.

[0032] Figure 5 Side view of the attachment position of the flexible ultrasonic patch. Detailed Implementation

[0033] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0034] Please refer to the following: Figure 1 , Figure 2 and Figure 3 ,in, Figure 1 This is a block diagram illustrating the principle of the pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopic surgery provided by the present invention. Figure 2 A schematic diagram of an ultrasound image of a normal lung; Figure 3 This is a schematic diagram of an ultrasound image of pulmonary edema. A patch-type ultrasound monitoring and early warning device for pulmonary edema used in shoulder arthroscopy includes:

[0035] This patch-type ultrasound probe array comprises four flexible ultrasound patches encapsulated in medical-grade silicone. Each patch contains an embedded piezoelectric transducer array, operating at a frequency range of 2MHz to 10MHz. The patch layout is optimized for beach chair positioning and shoulder arthroscopy: bilaterally at the posterior axillary line of the 4th intercostal space (approximately at the level of the inferior angle of the scapula) and the inferior scapular line of the 6th intercostal space. All patches are located on the back and posterior chest wall, completely avoiding the surgical disinfection areas around the anterior chest and shoulder joint (acromion, clavicle, upper arm). An additional patch can be placed on the same side (affected side) at the 4th intercostal space along the mid-axillary line for more sensitive detection of areas initially affected by extravasation, such as... Figure 4 and Figure 5 .

[0036] The adaptive fixation structure is designed for beach chair positions (upper body elevated 45°-90°). It includes a high-adhesion hydrocolloid backing (medical-grade hydrocolloid, with strong adhesion and skin-friendly properties, maintaining its position for 4-6 hours) and auxiliary fixation straps (elastic nylon straps that wrap around the patient's chest or armpits to further tighten the patch; the straps have Velcro closures at both ends for adjustable tightness). Micro-suction cup structures or silicone bumps are added to the patch contact surface to increase friction. The patch and fixation structure can be designed as an integrated unit or as a detachable unit.

[0037] The signal acquisition and control module is integrated into a small control box, which can be placed beside the patient's bed or fixed to the bed rail. Wireless connection (Bluetooth 5.2 or Wi-Fi 6) is preferred for the connection with the patches to avoid cables getting tangled under the beach chair and interfering with anesthesia tubing and surgical drapes. A wired connection (ultra-fine shielded cable) is optional as a backup. The monitoring frequency is to acquire all patch data every 1-2 minutes. This can also be dynamically adjusted according to the risk of extravasation (e.g., initially every 2 minutes, increasing to every 30 seconds after an increase in B-line detection).

[0038] The B-line recognition and trend analysis module uses a B-line recognition algorithm to identify the number of B-lines in each region. Asymmetric analysis function: Automatically compares the number of B-lines in the ipsilateral and contralateral lungs after surgery. If the number of B-lines on the ipsilateral side is significantly higher than on the contralateral side (e.g., a difference of ≥3 lines), it indicates that extravasation has led to increased pulmonary edema on the ipsilateral side. Trend warning: Monitors the rate of change of B-lines in the same region over a short period. If the number of B-lines increases by ≥5 within 30 minutes, a warning is triggered even if the absolute value does not reach the high-risk threshold.

[0039] The graded early warning module has a Level 1 warning (early warning of extravasation): ≥3 B-lines in a single area on the same side as the surgery, or an increase of ≥5 lines (absolute value) compared to the baseline, or a difference of ≥3 lines between the B-lines in the same area on the contralateral side. Warning message: "Note: Increased pulmonary effusion on the same side as the surgery; investigation of extravasation is recommended."

[0040] Level II Warning (Confirmed Pulmonary Edema): ≥8 B-lines in any region, or a total B-line score of ≥15 in both lungs, or ≥3 B-lines in the contralateral lung. Warning Message: "Warning: Pulmonary edema has formed. It is recommended to limit perfusion fluid pressure / flow and prepare diuretics."

[0041] Level 3 Warning (Severe Pulmonary Edema): ≥15 B-lines in any area, or fused B-lines ("white lung" appearance), or signs of pleural effusion (disappearance of the costophrenic angle). Warning message: "Danger: Severe pulmonary edema / pleural effusion, surgery to be terminated and emergency treatment recommended."

[0042] The wireless handheld monitoring terminal is a 5-7 inch handheld touchscreen device that can be placed on the anesthesiologist's workbench or held by the anesthesiologist. Displayed content includes: a diagram of the lung regions on the back, with B-line scores for each region displayed using color gradations or numbers; a comparative bar chart of the ipsilateral and contralateral sides; a B-line trend curve (timeline for the most recent 2 hours); and text prompts indicating the current warning level and recommended measures. Alarm methods include vibration, sound, and screen flashing; optional Bluetooth notifications can be sent to the smartwatches of all surgical team members.

[0043] The perfusion system interface module connects to the shoulder arthroscopy perfusion pump to obtain real-time perfusion pressure (normal <60mmHg) and flow rate (normal <1L / min). When the pressure or flow rate abnormally increases, the risk of extravasation is assessed in conjunction with B-line data.

[0044] The working principle of the pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopic surgery provided by this invention is as follows:

[0045] After anesthesia, the patient's back is cleaned and disinfected in a beach chair position. Four patches are applied to the predetermined locations on both sides of the posterior chest, with a fifth patch potentially added to the affected side. A hydrocolloid backing and / or auxiliary fixation straps are used for reinforcement. The control box is connected, and the device undergoes a self-test, acquiring baseline B-line values ​​1-2 times to record the patient's preoperative baseline. Ultrasound echo signals from all patches are automatically acquired every 1-2 minutes. The B-line recognition module outputs the number of B-lines in each region in real time, and the display terminal dynamically updates the bilateral lung contrast map and trend curve. If ≥3 B-lines appear on the ipsilateral posterior chest (Level 1 warning), the surgeon should check for shoulder joint swelling, reduce the perfusion pump pressure, or pause perfusion for 30 seconds. If the number of B-lines continues to increase to Level 2 warning, the anesthesiologist may administer furosemide 5-10 mg and monitor airway management. If Level 3 warning occurs (≥15 B-lines or bilateral involvement), it is recommended to terminate the surgery, perform bedside ultrasound to confirm pleural effusion, and drain pleural effusion if necessary. The surgery is then completed, and the patches are removed.

[0046] Compared with related technologies, the pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopic surgery provided by the present invention has the following beneficial effects:

[0047] This invention provides a patch-type ultrasound monitoring and early warning device for pulmonary edema in shoulder arthroscopy. Through a position-adaptive fixation structure, the patch can be securely attached to the patient's back skin while maintaining ultrasound coupling, thus solving the problems of slippage and poor coupling of general-purpose patches in this position. By placing all patches in the posterior chest wall region of the back, the surgical disinfection areas of the affected shoulder and anterior chest during shoulder arthroscopy can be completely avoided, thus not interfering with the surgical procedure and aseptic requirements. Through a B-line recognition and trend analysis module, it performs asymmetric comparison of B-lines on the same side and the contralateral side of the surgery and analyzes the trend of B-line changes, enabling targeted monitoring of pulmonary edema in shoulder arthroscopy. The technology enables early identification of ipsilateral pulmonary edema caused by effusion, achieving earlier and more specific early warning than existing technologies. Wireless communication between the signal acquisition and control module and the patch avoids cables tangling under the beach chair, interfering with anesthesia tubing and surgical drapes, thus improving operating room safety and convenience. The system integration of the patch-type ultrasound probe array, signal acquisition and control module, B-line recognition and trend analysis module, and graded early warning module allows for continuous, non-invasive, and real-time monitoring of pulmonary edema, achieving closed-loop monitoring and early warning of pulmonary edema risk during shoulder arthroscopy.

[0048] The above description is merely an embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural or procedural transformations made based on the content of the present invention specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of the present invention.

Claims

1. A patch-type ultrasound monitoring and early warning device for pulmonary edema in shoulder arthroscopic surgery, characterized in that, include: A patch-type ultrasound probe array, comprising multiple flexible ultrasound patches, each of which embeds a piezoelectric transducer array, the piezoelectric transducer array being encapsulated in medical-grade silicone or TPU; the multiple flexible ultrasound patches are attached to the posterior chest wall region of the patient's back, to avoid the surgical disinfection area of ​​the affected shoulder and anterior chest during shoulder arthroscopy. The body position adaptive fixation structure is used in conjunction with the patch-type ultrasound probe array. The body position adaptive fixation structure is used to firmly attach each flexible ultrasound patch to the skin of the patient's back in the beach chair position, resisting gravity slippage and maintaining ultrasound coupling. The signal acquisition and control module is connected to the patch-type ultrasound probe array. The signal acquisition and control module is used to acquire the lung ultrasound echo signal obtained by each flexible ultrasound patch at a preset monitoring frequency, and output the number of B lines in the corresponding area of ​​each patch. The B-line identification and trend analysis module is electrically connected to the signal acquisition and control module. The B-line identification and trend analysis module is used to identify the number of B-lines based on the ultrasound echo signals of the corresponding areas of each patch, and to perform asymmetric comparison of B-lines in the same side and contralateral lungs after surgery, as well as analysis of the trend of B-line changes. A graded early warning module is electrically connected to the B-line identification and trend analysis module. The graded early warning module is used to output a graded early warning signal when preset early warning conditions are met.

2. The pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopy as described in claim 1, characterized in that, The number of flexible ultrasound patches is four, and the four flexible ultrasound patches are respectively attached to the posterior axillary line of the 4th intercostal space and the inferior scapular line of the 6th intercostal space on both sides of the posterior chest; and a fifth flexible ultrasound patch is added to the 4th intercostal space of the mid-axillary line on the affected side.

3. The pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopy as described in claim 1, characterized in that, The body position adaptive fixation structure includes at least one of the following: medical-grade hydrocolloid backing, elastic nylon auxiliary fixation strap, anti-slip protrusions or micro-suction cups provided on the contact surface of the patch.

4. The pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopy as described in claim 1, characterized in that, The signal acquisition and control module communicates with each of the flexible ultrasonic patches via a wireless connection, wherein the wireless connection method is selected from at least one of Bluetooth 5.2, Wi-Fi 6, UWB, or ZigBee.

5. The pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopy as described in claim 1, characterized in that, The preset monitoring frequency is once every 1 to 2 minutes; the B-line identification and trend analysis module is also used to dynamically increase the monitoring frequency to once every 30 seconds when the number of detected B-lines increases.

6. The pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopy as described in claim 1, characterized in that, The B-line identification and trend analysis module performs the following specific actions: Calculate the difference in the number of B-lines ΔB between the corresponding areas on the same side and the opposite side of the surgery. When ΔB ≥ 3 lines, it is determined that extravasation has led to an increase in pulmonary edema on the same side. The B-line trend analysis module monitors the increase in B-lines ΔB(t) in the same area within 30 minutes. When ΔB(t) ≥ 5 lines, an early warning is triggered.

7. The pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopy as described in claim 1, characterized in that, The graded early warning signals output by the graded early warning module include: Level 1 warning: The number of B lines in a single area on the same side as the surgery is ≥3, or the number of lines increases by ≥5 compared to the preoperative baseline, or ΔB is ≥3; Level II warning: ≥8 B lines in any area, or a total B line score of ≥15 in both lungs, or ≥3 B lines in the contralateral lung; Level 3 warning: The number of B lines in any area is ≥15, or there is a sign of fused B lines, or there is a sign of pleural effusion, i.e., the costophrenic angle disappears.

8. The pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopy as described in claim 1, characterized in that, It also includes a wireless handheld monitoring terminal, which is used to display a schematic diagram of the lung regions on the back and to indicate the B-line score of each region with color gradation or numbers, a bar chart comparing the B-line on the same side and the opposite side of the surgery, the B-line trend curve and the current warning level, and to issue an alarm through vibration, sound or screen flashing.

9. The pulmonary edema patch-type ultrasound monitoring and early warning device for shoulder arthroscopy as described in claim 1, characterized in that, It also includes an irrigation system interface module, which is used to communicate with the shoulder arthroscopy irrigation pump to obtain real-time irrigation pressure and / or flow data; the graded early warning module is also configured to: when the irrigation pressure or flow rate rises abnormally and the B-line data shows an upward trend, comprehensively judge the risk of extravasation and raise the early warning level.

Images