An intelligent probe patch for micro free skin flap blood supply monitoring

Abstract

This invention relates to the field of medical device technology, and more particularly to an intelligent probe patch for monitoring blood circulation in microscopic free flaps, comprising: a disposable probe patch configured to be attached to the surface or edge of the free flap; a biocompatible adhesive layer is provided on the bottom surface of the flexible base of the disposable probe patch, and an auxiliary structure is provided on the top of the flexible base to resist postoperative tissue activity or secretions; the disposable probe patch integrates an optical sensing unit and a temperature sensing unit for collecting local blood oxygen saturation, pulse rate, and surface temperature of the flap, respectively; a repeater, establishing non-contact near-field coupling with the disposable probe patch, the repeater being configured to provide working power to the disposable probe patch through near-field coupling, enabling it to operate without a built-in battery; and synchronously receiving physiological parameter data reflecting the local microcirculation status of the flap collected by the disposable probe patch; and a terminal device, wirelessly connected to the repeater, receiving and processing the physiological parameter data.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an intelligent probe patch for monitoring blood supply in microscopic free flaps. Background Technology

[0002] Microsurgical flap transplantation is a core technique for surgical repair of tissue defects, widely used in postoperative repair of oral tumors, repair of complex maxillofacial defects, soft tissue reconstruction after limb trauma, breast reconstruction after breast cancer surgery, and repair of burn scars. However, postoperative flap blood supply disorder is a major complication, occurring in 5%-15% of cases. It needs to be detected and treated within the golden intervention period of 6-8 hours; otherwise, it can lead to flap ischemia and necrosis, increasing medical costs and affecting patient prognosis.

[0003] Current clinical methods for monitoring blood supply to skin flaps have significant limitations: Doppler flowmeters are bulky, require specialized operation, can only perform intermittent monitoring, cannot be adapted to special environments, and have limited monitoring range; percutaneous oxygenation probes have poor adaptability, are not securely fixed, are easily interfered with, and lack biocompatibility, failing to meet the monitoring needs of multiple sites; infrared thermal imagers indirectly reflect blood supply through temperature, which can easily lead to delays in the monitoring window and thus delay treatment. Furthermore, monitoring skin flaps at different surgical sites presents individual challenges, such as the narrow space and abundant secretions within the oral cavity, frequent limb movements, and significant wound exudation. Large-area skin flaps require extensive monitoring and are easily affected by body position, making it impossible for existing technologies to achieve accurate and continuous blood supply monitoring of skin flaps in multiple scenarios. Summary of the Invention

[0004] The purpose of this invention is to overcome the shortcomings of existing technologies and provide an intelligent probe patch for monitoring blood supply in microsurgical free flaps, comprising: A disposable probe patch is configured to be directly attached to the surface or edge of a free flap. The bottom surface of the flexible base of the disposable probe patch is provided with a biocompatible adhesive layer to provide initial adhesion force, and the top of the flexible base is also provided with an auxiliary structure to resist postoperative tissue activity or secretions. The disposable probe patch integrates an optical sensing unit and a temperature sensing unit for collecting local blood oxygen saturation, pulse rate, and surface temperature of the flap, respectively. A repeater establishes a non-contact near-field coupling with the disposable probe patch. The repeater is configured to provide working power to the disposable probe patch through near-field coupling, enabling it to operate without a built-in battery. It also synchronously receives physiological parameter data reflecting the local microcirculation status of the flap collected by the disposable probe patch. The terminal device is wirelessly connected to the repeater to receive and process the physiological parameter data.

[0005] Furthermore, the auxiliary structure includes a protective surface layer coated on the outer layer of the flexible substrate and stitching holes disposed on the flexible substrate.

[0006] Furthermore, the protective surface layer is a hydrophobic or superhydrophobic coating with a thickness ≤0.05mm.

[0007] Furthermore, the biocompatible adhesive layer is a medical-grade hydrocolloid dressing with a thickness ≤0.3mm, an adhesion strength ≥5N / 25mm, and an adhesion decay of ≤10% over 24 hours.

[0008] Furthermore, it also includes multiple disposable probe patches, and the repeater simultaneously establishes non-contact near-field coupling with multiple disposable probe patches; the multiple disposable probe patches are respectively attached to different spatial positions of the same free flap.

[0009] Furthermore, the substrate material of the disposable probe patch is medical-grade flexible PI material, and the thickness of the flexible substrate is ≤0.1mm and the bending radius is ≤3mm.

[0010] Furthermore, the optical sensing unit is a dual-wavelength micro LED, which emits 660nm red light and 940nm near-infrared light, and uses an intermittent lighting mode of 2 seconds once and 50ms each time. The temperature sensing unit is a micro temperature sensor with an accuracy of ±0.1℃.

[0011] Furthermore, the outer wall of the biocompatible adhesive layer is provided with release paper.

[0012] Furthermore, the repeater is fixed to clothing or bedside with a distance of ≤20cm from the probe using medical tape.

[0013] This invention also provides a monitoring method for the above-mentioned intelligent probe patch for monitoring blood supply in microscopic free flaps: At least one disposable probe is attached to the target monitoring point of the free flap through the biocompatible adhesive layer and then reinforced by suturing through the suture hole; The repeater is activated, establishing a non-contact near-field coupling between the repeater and the disposable probe patch. The disposable probe patch receives electrical energy and begins collecting blood oxygen, pulse rate, and temperature data. Clinical parameters, including flap area, number of anastomosed vessels, and postoperative time, are entered on the terminal device. The terminal device receives physiological parameter data from the repeater, substitutes the clinical parameters and the physiological parameter data into the quantitative evaluation function, and generates a quantitative index. The terminal device compares the quantification index with a preset threshold range and issues a graded warning signal based on the comparison result.

[0014] Compared with the prior art, the beneficial effects of the present invention are: This invention provides an intelligent probe patch for monitoring blood supply to microsurgical free flaps, achieving universal adaptability to multiple environments. The single probe structure, through a flexible substrate, hydrophobic coating, and adhesive-suture fixation method, can be applied to flaps in different surgical sites such as oral mucosa, limb joints, and chest wall curves, eliminating the need for customized probes for specific scenarios and simplifying clinical use and production processes.

[0015] This invention provides an intelligent probe patch for monitoring blood supply in microscopic free flaps. It is a wire-free, disposable device that uses NFC near-field power supply and data transmission, eliminating the need for a built-in battery, reducing the size of the probe patch, avoiding the risk of battery leakage, and allowing for 7 days of single use. It can be replaced after each use, making it hygienic and convenient.

[0016] This invention provides an intelligent probe patch for monitoring blood supply in microscopic free flaps. It enables real-time continuous monitoring with multiple probes combined. Two to four probe patches can work simultaneously, accurately collecting blood oxygen saturation, pulse rate, and temperature data at different locations on the flap. The data is transmitted without interruption, covering the overall blood supply status of the flap, and has high monitoring accuracy.

[0017] This invention provides an intelligent probe patch for monitoring blood supply in microsurgical free flaps, enabling formulaic and precise early warning. Based on the FSI calculation formula of clinical information and monitoring data, it objectively assesses the blood supply status of the flap, avoiding the subjectivity of manual monitoring. The graded early warning can promptly detect blood supply abnormalities, providing a basis for treatment during the golden intervention period.

[0018] This invention provides an intelligent probe patch for monitoring blood supply in microscopic free flaps. It has good biocompatibility, all parts that come into contact with the human body meet national standards, are non-cytotoxic and non-sensitizing, can be directly attached to mucous membranes or skin without causing a foreign body sensation, and are firmly fixed. The dual fixation method of adhesive bonding and suturing reduces the displacement rate, has strong anti-interference ability, and the hydrophobic coating avoids the influence of liquids on the monitoring signal. Attached Figure Description

[0019] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used together with the embodiments of the invention to explain the invention and do not constitute a limitation thereof. In the drawings: Figure 1 This is a schematic diagram of the structure of an intelligent probe patch for monitoring blood supply in a microscopic free flap according to the present invention, wherein (a) is a front view and (b) is a cross-sectional view; Figure 2This is a schematic diagram of the application of an intelligent probe patch for monitoring blood supply in microscopic free flaps according to the present invention; Figure 3 This is a schematic diagram of the workflow of an intelligent probe patch for monitoring blood supply in microscopic free flaps according to the present invention.

[0020] Figure Labels 1: Disposable probe adhesive; 11: Flexible substrate; 12: Biocompatible adhesive layer; 13: Protective surface layer; 14: Seam opening; 15: Release paper; 16: Optical sensing unit; 17: Temperature sensing unit; 2: Repeater; 3: Terminal equipment. Detailed Implementation

[0021] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0022] To keep the drawings concise, only the parts relevant to the invention are shown schematically in each figure, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some figures, only one of components with the same structure or function is shown schematically, or only one is labeled. In this document, "one" can mean not only "only one" but also "more than one".

[0023] First Embodiment Please see Figure 1-3 The technical solution of the intelligent probe patch for monitoring blood supply in microscopic free flaps provided in this embodiment includes the following: like Figure 2 As shown, the present invention includes a disposable probe patch 1, a repeater 2, and a terminal device 3. The disposable probe patch 1 and the repeater 2 are connected via NFC near-field coupling, and the repeater 2 and the terminal device 3 are connected wirelessly via Bluetooth.

[0024] As attached Figure 1As shown, for ease of understanding, this embodiment uses one of the dimensions within the numerical range as an example, but is not limited to this specific dimension. The flexible substrate 11 of the disposable probe patch 1 is made of polyimide (PI) material, with a thickness of 0.08 mm and a bending radius of 2.5 mm. A biocompatible adhesive layer 12 is provided on the bottom surface, which is a medical-grade hydrocolloid dressing with a thickness of 0.25 mm and an adhesion strength of 6 N / 25 mm. A protective surface layer 13 is provided on the top surface, which is a mixed coating of PTFE and nano-hydrophobic materials with a thickness of 0.04 mm. Four suture holes 14 with a diameter of 0.3 mm are provided at the four corners of the flexible substrate 11. An optical sensing unit 16 is integrated inside, including a 660 nm and 940 nm dual-wavelength LED, which adopts an intermittent lighting mode of 2 seconds once, 50 ms each time; and a temperature sensing unit 17 with an accuracy of ±0.1℃. Release paper 15 is provided on the outer wall of the biocompatible adhesive layer 12, which is peeled off before use.

[0025] In specific implementation, as shown in the appendix Figure 2 As shown, a repeater 2 with dimensions of 50mm×30mm×5mm can be fixed to the patient's clothing or bedside area using medical tape, with a working distance of ≤20cm between it and the probe patch. The repeater 2 powers the probe patch via NFC and receives blood oxygen saturation (SpO2), pulse rate (PR), and temperature (T) data.

[0026] Terminal device 3 is a medical tablet or other device. Terminal device 3 has a built-in evaluation model and uses a quantitative evaluation function: FSI= (SpO2×0.4)+(PR×0.2)+(T×5)-(A×0.5)-(B×0.3)+(C×2), Where A is the flap area, B is the postoperative time, and C is the number of anastomosed vessels.

[0027] Medical staff entered the following clinical parameters: flap area A = 20cm² 2 The number of anastomosed vessels was C=1 (1 arterial and 1 venous), and the postoperative time was B=12 hours. Real-time monitoring data showed SpO2=95%, PR=80 bpm, T=36℃, and the calculated FSI=222.4. Terminal device 3 compared the FSI with the preset threshold range and determined that the blood supply was normal, with no warning.

[0028] Second Embodiment This embodiment employs multiple disposable probe patches 1 from Embodiment 1. Three disposable probe patches 1 are respectively attached to the central area, edge area, and surface projection area of ​​the anastomosing vascular pedicle of the flap. The repeater 2 simultaneously establishes an NFC connection with the three probe patches to receive three sets of physiological parameter data. The terminal device 3 calculates the quantification index at each point and compares the differences in the indices at each point. When the difference in the indices between the central area and the edge area exceeds a set threshold, a prompt signal is issued.

[0029] Third Embodiment The working principle or process of the intelligent probe patch for monitoring blood supply in microscopic free flaps provided by this invention is as follows: At least one disposable probe patch 1 is attached to the target monitoring point of the free flap through the biocompatible adhesive layer 12 and then sutured and reinforced through the suture hole 14; Activate repeater 2 to establish non-contact near-field coupling between repeater 2 and disposable probe patch 1. Disposable probe patch 1 receives electrical energy and begins to collect blood oxygen, pulse rate and temperature data. Clinical parameters are entered on terminal device 3, including flap area, number of anastomosed vessels and postoperative time. The terminal device 3 receives physiological parameter data from the repeater 2, and substitutes the clinical parameters and the physiological parameter data into the quantitative evaluation function to generate a quantitative index; The terminal device 3 compares the quantification index with a preset threshold range and issues a graded warning signal based on the comparison result.

[0030] Fourth embodiment This embodiment is a fixed alternative solution. The difference from the first embodiment is that the suture hole 14 of the disposable probe patch 1 is removed, and the skin and mucous membrane adhesive layer is replaced with a medical-grade double-sided tape with a thickness of 0.09mm and an adhesion strength of 4.5N / 25mm. A 5mm wide medical spandex elastic band is used to fix the disposable probe patch 1 around the patient's wrist.

[0031] The disposable probe patch 1 in this embodiment is used for monitoring the dorsum of the foot flap in the repair of avulsion injuries of children's hands, avoiding secondary damage to children caused by suturing. The fixation method of double-sided adhesive and elastic bandage is firm and easy to disassemble, and is adapted to the characteristics of children's limb movement.

[0032] Finally, it should be noted that the above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An intelligent probe patch for monitoring blood supply in microscopic free flaps, characterized in that, include: A disposable probe patch is configured to be directly attached to the surface or edge of a free flap. The bottom surface of the flexible base of the disposable probe patch is provided with a biocompatible adhesive layer to provide initial adhesion force, and the top of the flexible base is also provided with an auxiliary structure to resist postoperative tissue activity or secretions. The disposable probe patch integrates an optical sensing unit and a temperature sensing unit for collecting local blood oxygen saturation, pulse rate, and surface temperature of the flap, respectively. A repeater establishes a non-contact near-field coupling with the disposable probe patch. The repeater is configured to provide working power to the disposable probe patch through near-field coupling, enabling it to operate without a built-in battery. It also synchronously receives physiological parameter data reflecting the local microcirculation status of the flap collected by the disposable probe patch. The terminal device is wirelessly connected to the repeater to receive and process the physiological parameter data.

2. The intelligent probe patch for monitoring blood supply in microscopic free flaps according to claim 1, characterized in that, The auxiliary structure includes a protective surface layer coated on the outer layer of the flexible substrate and stitching holes disposed on the flexible substrate.

3. The intelligent probe patch for monitoring blood supply in microscopic free flaps according to claim 2, characterized in that, The protective surface layer is a hydrophobic or superhydrophobic coating with a thickness ≤0.05mm.

4. The intelligent probe patch for monitoring blood supply in microscopic free flaps according to claim 1, characterized in that, The biocompatible adhesive layer is a medical-grade hydrocolloid dressing with a thickness ≤0.3mm, an adhesion strength ≥5N / 25mm, and an adhesion decay of ≤10% over 24 hours.

5. The intelligent probe patch for monitoring blood supply in microscopic free flaps according to claim 1, characterized in that, It also includes multiple disposable probe patches, and the repeater simultaneously establishes non-contact near-field coupling with multiple disposable probe patches; the multiple disposable probe patches are respectively attached to different spatial positions of the same free flap.

6. The intelligent probe patch for monitoring blood supply in microscopic free flaps according to claim 1, characterized in that, The substrate material of the disposable probe patch is medical-grade flexible PI material, and the thickness of the flexible substrate is ≤0.1mm and the bending radius is ≤3mm.

7. The intelligent probe patch for monitoring blood supply in microscopic free flaps according to claim 1, characterized in that, The optical sensing unit is a dual-wavelength micro LED, which uses 660nm red light + 940nm near-infrared light and adopts an intermittent lighting mode of 2 seconds once and 50ms each time. The temperature sensing unit is a micro temperature sensor with an accuracy of ±0.1℃.

8. The intelligent probe patch for monitoring blood supply in microscopic free flaps according to claim 1, characterized in that, The outer wall of the biocompatible adhesive layer is provided with release paper.

9. The intelligent probe patch for monitoring blood supply in microscopic free flaps according to claim 1, characterized in that, The repeater is fixed to clothing or bedside with a distance of ≤20cm from the probe using medical tape.

10. A monitoring method for an intelligent probe patch for monitoring blood supply in microscopic free flaps according to any one of claims 1-9, characterized in that, include: At least one disposable probe is attached to the target monitoring point of the free flap through the biocompatible adhesive layer and then reinforced by suturing through the suture hole; The repeater is activated, establishing a non-contact near-field coupling between the repeater and the disposable probe patch. The disposable probe patch receives electrical energy and begins collecting blood oxygen, pulse rate, and temperature data. Clinical parameters, including flap area, number of anastomosed vessels, and postoperative time, are entered on the terminal device. The terminal device receives physiological parameter data from the repeater, and substitutes the clinical parameters and the physiological parameter data into a quantitative evaluation function to generate a quantitative index. The terminal device compares the quantification index with a preset threshold range and issues a graded warning signal based on the comparison result.

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