Self-powered thrombus monitoring wireless device and preparation method thereof

Abstract

The invention discloses a self-powered thrombus monitoring wireless device. The device at least comprises an artificial blood vessel, a first charge transfer layer, a second charge transfer layer, a rectifier and a wireless transmission module, the first charge transfer layer and the second charge transfer layer are not in direct contact and are located at the two ends of the artificial blood vessel respectively, the first charge transfer layer is located on the upstream of the blood flowing direction, and the second charge transfer layer is located on the downstream of the blood flowing direction and tightly attached to the outer wall of the artificial blood vessel or embedded into the wall of the artificial blood vessel; the first charge transmission layer, the second charge transmission layer, the rectifier and the wireless transmission module are connected through leads. The device generates electric charges through relative movement of blood and the blood vessel wall, the device is driven, an external power source is not needed, and high flexibility and convenience are achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of thrombosis risk monitoring, and in particular to a self-powered thrombosis monitoring wireless device and a preparation method thereof. Background Art

[0002] With the increasing trend of population growth and aging, the incidence of cardiovascular diseases continues to rise and has become the primary factor threatening human health. Among them, thrombosis is one of the most common pathological processes in cardiovascular diseases, which can occur in the human venous system or artificial blood vessels. According to the World Health Organization, as of 2022, the number of deaths caused by cardiovascular diseases accounts for about 40% of the total number of deaths worldwide, and up to 75% of surviving patients face varying degrees of disability. In fact, most cardiovascular and cerebrovascular diseases are caused by functional disorders caused by thrombosis, and thrombosis plays a key role in the death and disability of patients.

[0003] Therefore, early diagnosis, effective prevention and treatment of thrombosis have become an important direction of clinical research. At present, commonly used thrombosis detection methods include computed tomography (CT), nuclear magnetic resonance imaging (NMRI), thromboelastography (TEG) and near-infrared spectroscopy (NIRS). However, these technologies have many limitations in practical applications, such as bulky equipment, poor portability, insufficient real-time monitoring capabilities, complex operation, limited sensitivity and accuracy. In view of this, it is particularly urgent to develop technologies that can monitor newly implanted vascular grafts in real time, so as to detect potential complications in a timely manner and implement early intervention and preventive treatment. Summary of the invention

[0004] In view of the problems in the prior art, the present invention designs a self-powered artificial blood vessel thrombosis monitoring wireless device, which utilizes the different solid-liquid friction charges generated by blood at the two ends of the artificial blood vessel to form an electric potential difference and an alternating current signal, which is converted into a direct current output form that can be used for the operation of the wireless transmission module through an electric signal collection device, thereby achieving self-powering, and feedback of the electric potential difference signal strength through a remote wireless receiving device to monitor the thrombosis formation status in real time. When a large amount of protein deposition or thrombosis occurs on the inner wall of the artificial blood vessel, the contact between the blood and the artificial blood vessel is weakened, causing the solid-liquid friction charge at the two ends to decrease, and the electric potential difference to decrease. When the potential difference drops to a level that cannot drive the near-field communication device, the external terminal cannot obtain the signal feedback from the artificial blood vessel and is disconnected, thereby judging whether the artificial blood vessel can continue to serve or needs to be replaced.

[0005] To achieve the above technical objectives, the present invention provides a self-powered thrombus monitoring wireless device, the device comprising at least an artificial blood vessel, a first charge transfer layer, a second charge transfer layer, a rectifier and a wireless transmission module;

[0006] The artificial blood vessel material has biocompatibility and contains highly polar side chain groups;

[0007] The first charge transport layer and the second charge transport layer are not in direct contact, and are respectively located at two ends of the artificial blood vessel, the first charge transport layer is located upstream in the direction of blood flow, and the second charge transport layer is located downstream in the direction of blood flow, and are closely attached to the outer wall of the artificial blood vessel or embedded in the wall of the artificial blood vessel, and the first charge transport layer and the second charge transport layer are both made of conductive materials;

[0008] The first charge transport layer, the second charge transport layer, the rectifier and the wireless transmission module are connected via leads.

[0009] In some technical solutions of the present invention, the highly polar groups contained in the artificial blood vessel are selected from F and / or -CN. Preferably, the artificial blood vessel material is polytetrafluoroethylene. When blood flows relative to the blood vessel wall, polytetrafluoroethylene has a stronger polarity, and it can obtain more electrons from water per unit time and transfer them to the charge transfer layer, thereby increasing the amount of charge in the monitoring device and improving the signal strength of the wireless output module.

[0010] In some technical solutions of the present invention, the materials of the first charge transport layer and the second charge transport layer may be the same or different, and each is independently selected from at least one of gold, silver, aluminum, copper, indium tin oxide, graphene, carbon nanotubes, conductive carbon black, and Mxene. The charge transport layer can transfer the charge captured in the artificial blood vessel to the circuit of the monitoring device. Preferably, the materials of the first charge transport layer and the second charge transport layer are independently selected from gold, silver, aluminum, and copper. Further, the materials of the first charge transport layer and the second charge transport layer are selected from copper.

[0011] In some technical solutions of the present invention, the area of ​​the first charge transport layer is not less than that of the second charge transport layer. Furthermore, the area of ​​the first charge transport layer is not less than 5 cm 2 , the area of ​​the second charge layer is not less than 1cm 2 .

[0012] In some technical solutions of the present invention, the rectifier is connected in parallel with a capacitor filter. The rectifier converts the alternating current generated by the device into pulsating direct current, and the capacitor filter is used to filter and smooth the voltage fluctuation after rectification to drive the wireless transmission module.

[0013] In some technical solutions of the present invention, the wireless transmission module is thin and light, and is specifically selected from short-distance signal transmission devices such as Bluetooth and near field communication (NFC). The signal transmitted by the wireless transmission module can be received by a remote signal receiving device such as a mobile phone, a computer, or a watch.

[0014] In some technical solutions of the present invention, the device further comprises an outer packaging layer. The outer packaging layer has biocompatibility and insulation properties, and can isolate the device from the external tissue environment to prevent tissue invasion from affecting device detection.

[0015] In some technical solutions of the present invention, the material of the outer packaging layer is selected from at least one of polyparaxylene, polyimide, polydimethylsiloxane, polybutylene adipate-terephthalate copolymer, and polytetrafluoroethylene.

[0016] The present invention also provides a method for preparing the self-powered thrombus monitoring wireless device, the method comprising at least the following steps:

[0017] Step 1: ultrasonically clean the artificial blood vessel in anhydrous ethanol and deionized water for 25-35 minutes, and then dry it at 78-82°C for 1.5-2.5 hours to obtain a dry and clean artificial blood vessel;

[0018] Step 2: Install the first charge transfer layer and the second charge transfer layer at both ends of the artificial blood vessel, connect the AC input and output ends of the rectifier to the first charge transfer layer and the second charge transfer layer respectively, and connect the wireless transmission module to the positive output and negative output of the rectifier to obtain the self-powered thrombus monitoring wireless device.

[0019] In some technical solutions of the present invention, the wireless transmission module is connected to the positive and negative terminals of the rectifier after being connected in parallel with the capacitor filter.

[0020] In some technical solutions of the present invention, the preparation method further comprises packaging the device. Specifically, the device obtained in step 2 is placed in a hollow mold, a packaging material is injected and cured, and then the cured device is demoulded.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] 1. The self-powered thrombosis monitoring wireless device provided by the present invention has relatively consistent blood flow rates between the two charge transfer layers when the artificial blood vessel is not blocked, and when thrombosis occurs in the artificial blood vessel, there is a significant difference in blood flow rates at the upstream and downstream charge transfer layers, which reduces the potential difference between the upstream and downstream charge transfer layers. Furthermore, by connecting a rectifier, the generated AC signal is converted into a DC output form that can be used for the operation of the wireless transmission module through an electrical signal collection device, driving the wireless transmission module to transmit a potential difference signal. The device can monitor the thrombosis of the implanted artificial blood vessel in real time, and dynamically feedback the blood vessel blockage status according to the strength of the electrical signal. The device generates electric charge and drives the device through the relative movement of blood and the blood vessel wall. No external power supply is required, and it has high flexibility and convenience.

[0023] 2. The self-powered thrombus monitoring wireless device provided by the present invention, the charge transfer layer, the rectifier and the wireless transmission module can be used as detachable devices independent of the artificial blood vessel. When the artificial blood vessel is detected to be blocked, only the artificial blood vessel can be replaced. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0025] Figure 1 A schematic diagram of the operation of the self-powered thrombus monitoring wireless device of the present invention;

[0026] Figure 2 A schematic diagram of the structure of a self-powered thrombus monitoring wireless device provided by the present invention;

[0027] Figure 3 An embodiment of the present invention provides a potential difference signal diagram monitored before and after simulating protein deposition in an artificial blood vessel;

[0028] Figure 4 An embodiment provided by the present invention simulates a potential difference signal diagram monitored by different coagulation amounts in an artificial blood vessel.

[0029] Reference numerals:

[0030] 1. First charge transfer layer; 2. Second charge transfer layer; 3. Rectifier; 4. Capacitor filter; 5. Wireless transmission module; 6. Remote wireless receiving device; 7. Packaging layer; 8. Artificial blood vessel; 9. Lead wire. DETAILED DESCRIPTION

[0031] The following is a clear and complete description of the technical solutions in the present invention in conjunction with the embodiments of the present invention. The described embodiments are part of the embodiments of the present invention, but not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] like Figure 2 As shown, a self-powered thrombus monitoring wireless device includes an artificial blood vessel 8, a first charge transfer layer 1, a second charge transfer layer 2, a rectifier 3, a capacitor filter 4, a wireless transmission module 5, and a packaging layer 7.

[0033] The artificial blood vessel uses polytetrafluoroethylene (PTFE). In some other embodiments, the artificial blood vessel can also use other materials containing strongly polar side chain groups, such as F and / or -CN.

[0034] The first charge transport layer and the second charge transport layer use copper tape. In some other embodiments, other conductive materials may also be used, such as at least one of gold, silver, aluminum, copper, indium tin oxide, graphene, carbon nanotubes, conductive carbon black, and Mxene.

[0035] The encapsulation layer uses polybutylene adipate-terephthalate copolymer. In some other embodiments, the encapsulation layer can also be selected from at least one of polyparaxylene, polyimide, polydimethylsiloxane, polysuccinic acid-terephthalic acid-terephthalate copolymer, and polytetrafluoroethylene.

[0036] The wireless transmission module is a thin-sheet Bluetooth module. In some other implementations, the wireless transmission module may also be a near field communication (NFC).

[0037] The connecting lead is a copper wire.

[0038] The device preparation method comprises the following steps: ultrasonically cleaning an artificial blood vessel in anhydrous ethanol and deionized water for 30 minutes in sequence, and then drying it at 80°C for 2 hours to obtain a dry and clean artificial blood vessel; connecting the first charge transfer layer and the second charge transfer layer to the AC input and output ends of the rectifier respectively, and connecting the wireless transmission module and the capacitor filter module in parallel, and then connecting the positive and negative electrodes of the rectifier to the two ends respectively; placing the prepared device in a hollow mold, injecting polybutylene adipate-terephthalate copolymer, curing, and then demolding to obtain the device.

[0039] The self-powered thrombus detection artificial blood vessel can send the state of the blood vessel to the terminal by wireless transmission, which has the advantage of wireless measurement; the signal transmitting device adopts a near-field communication device, and its driving energy is directly provided by the solid-liquid friction between the artificial blood vessel and the blood, without the need to install an external power supply. The energy supply principle is to use the different solid-liquid friction charges generated by the blood at the two end electrodes of the artificial blood vessel to form a potential difference. After the generated alternating current is converted into direct current by a rectifier, it can be directly used to drive the connected near-field communication device and output signals to the external terminal; when a large amount of protein deposition or thrombus blockage appears on the inner wall of the artificial blood vessel, the contact between the blood and the artificial blood vessel is weakened, so that the solid-liquid friction charge at both ends is reduced, and the potential difference decreases. When it drops to the point where the near-field communication device cannot be driven, the external terminal cannot obtain signal feedback from the artificial blood vessel. At this time, the terminal sends a reminder to the user, and the user can choose to go to the doctor to replace the artificial blood vessel; the artificial blood vessel and the communication module in this device are detachably connected, that is, the original communication module can be connected to the replaced artificial blood vessel, and the transplantation operation can be performed directly after packaging.

[0040] 1. Simulated coagulation test:

[0041] 1) Wash the artificial blood vessel with ethanol and deionized water, dry it and set it aside for use;

[0042] 2) Mix mouse blood and CaCl2 solution (0.2 mol / L) at a volume ratio of 5:1, draw with a syringe and inject a certain volume of solution into the artificial blood vessel at a distance of 5 cm, then incubate at 37°C for 30 min; after constant temperature oscillation for 1 h, add deionized water to 40 mL, and let the resulting blood solution stand for 5 min before use;

[0043] 3) Gently wash the artificial blood vessel with deionized water and dry it for later use;

[0044] 4) Attach charge transfer materials to both ends of the artificial blood vessel and connect them to an electrometer to measure the voltage and current curves at different flow rates.

[0045] 2. Test of artificial blood vessels simulating protein deposition:

[0046] 1) Wash the artificial blood vessel with ethanol and deionized water, dry it and set it aside for use;

[0047] 2) Adding bovine serum albumin to phosphate buffer solution to prepare a solution with a concentration of 2 mg / mL;

[0048] 3) After sealing one end of the artificial blood vessel, the bovine serum albumin solution is perfused into the interior thereof, and the other end is sealed after the artificial blood vessel is filled. After standing for 2 hours, the sealed end is opened and the internal solution is released, and the artificial blood vessel is dried for later use;

[0049] 4) Attach charge transfer materials to both ends of the artificial blood vessel and connect them to an electrometer to measure the voltage and current curves at different flow rates.

[0050] Test result description: Figure 3 As shown in the figure, after protein deposition, the potential difference signal of Example 1 is higher than that of Comparative Example 1 at the same flow rate, indicating that the potential difference change of the solid-liquid friction device of the present invention can feedback the potential difference signal change according to the liquid phase deposition, and then feedback the thrombus formation status in real time; Figure 4 As shown, after depositing different amounts of coagulated blood, the potential difference signals showed obvious differences, indicating that the degree of change in the potential difference can be compared with the degree of thrombus blockage, and the greater the degree of thrombus blockage, the greater the degree of potential difference change.

[0051] Finally, a few points should be explained: Although the present invention has been described in detail above with general descriptions and specific embodiments, on the basis of the present invention, the above embodiments are only used to illustrate the technical solution of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the aforementioned embodiments, ordinary technicians in this field should understand that: it is still possible to modify the technical solutions recorded in the aforementioned embodiments, or to replace part or all of the technical features therein with equivalents; and these modifications or replacements do not make the essence of the corresponding technical solution deviate from the scope of the technical solution of the embodiments of the present invention.

Claims

1. A self-powered thrombus monitoring wireless device, characterized in that: The device at least comprises an artificial blood vessel, a first charge transport layer, a second charge transport layer, a rectifier and a wireless transmission module; The artificial blood vessel material has biocompatibility and contains highly polar side chain groups; The first charge transport layer and the second charge transport layer are not in direct contact, and are respectively located at two ends of the artificial blood vessel, the first charge transport layer is located upstream in the direction of blood flow, and the second charge transport layer is located downstream in the direction of blood flow, and are closely attached to the outer wall of the artificial blood vessel or embedded in the wall of the artificial blood vessel, and the first charge transport layer and the second charge transport layer are both made of conductive materials; The first charge transport layer, the second charge transport layer, the rectifier and the wireless transmission module are connected via leads.

2. The wireless device for monitoring thrombus according to claim 1, characterized in that: The artificial blood vessel comprises a highly polar group selected from F and / or -CN.

3. The wireless device for monitoring thrombus according to claim 1, characterized in that: The materials of the first charge transport layer and the second charge transport layer may be the same or different, and each is independently selected from at least one of gold, silver, aluminum, copper, indium tin oxide, graphene, carbon nanotubes, conductive carbon black, and Mxene.

4. The wireless device for monitoring thrombus according to claim 1, characterized in that: The area of ​​the first charge transport layer is not less than that of the second charge transport layer, and the area of ​​the first charge transport layer is not less than 5 cm 2 , the area of ​​the second charge layer is not less than 1cm 2 .

5. The wireless device for monitoring thrombus according to claim 1, characterized in that: The rectifier is connected in parallel with a capacitor filter.

6. The wireless device for monitoring thrombus according to claim 1, characterized in that: The wireless transmission module is thin and light, and is selected from short-distance signal transmission devices such as Bluetooth and near field communication (NFC).

7. The wireless device for monitoring thrombus according to claim 1, characterized in that: The device further comprises an outer packaging layer, and the material of the outer packaging layer is selected from at least one of polyparaxylene, polyimide, polydimethylsiloxane, polybutylene adipate-terephthalate copolymer, and polytetrafluoroethylene.

8. A method for preparing the self-powered thrombus monitoring wireless device as claimed in claim 1, characterized in that: The method comprises at least the following steps: Step 1: ultrasonically clean the artificial blood vessel in anhydrous ethanol and deionized water for 25-35 minutes, and then dry it at 78-82°C for 1.5-2.5 hours to obtain a dry and clean artificial blood vessel; Step 2: Install the first charge transfer layer and the second charge transfer layer at both ends of the artificial blood vessel, connect the AC input and output ends of the rectifier to the first charge transfer layer and the second charge transfer layer respectively, and connect the wireless transmission module to the positive output and negative output of the rectifier to obtain the self-powered thrombus monitoring wireless device.

9. The preparation method according to claim 8, characterized in that: The wireless transmission module is connected to the positive and negative terminals of the rectifier after being connected in parallel with the capacitor filter.

10. The preparation method according to claim 8, characterized in that: The preparation method further comprises packaging the device obtained in step 2, placing the device obtained in step 2 in a hollow mold, injecting packaging material and curing it, and then demolding the cured device.

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