Plasma and negative pressure closed drainage coupled integrated device and use method

Abstract

The invention belongs to the technical field of negative pressure wound treatment, and relates to a plasma and negative pressure closed drainage coupled integrated device and a use method. The invention provides a plasma and negative pressure closed drainage coupled integrated device. The plasma and negative pressure closed drainage coupled integrated device comprises a drainage unit, a wound covering unit, a flushing unit and a plasma discharge unit, the plasma discharge unit is integrated in a drainage tube of the drainage unit and / or a flushing tube of the flushing unit, and generated plasmas carry active substances through the drainage tube and / or the flushing tube and are conveyed to the wound surface through the wound surface covering unit. The invention further provides a using method of the plasma and negative pressure sealing drainage coupling integrated set. The core of the using method is that in the cleaning process, plasma is used for carrying active substances to sterilize a wound surface and promote healing. Through the integrated design of the negative pressure wound treatment device and the plasma device, multi-mode wound treatment is achieved, and the problems of flow channel blockage and short circuit of the plasma device are solved.

Description

Technical Field

[0001] This invention relates to the field of negative pressure wound therapy technology, and in particular to an integrated device and method of using a plasma-negative pressure wound therapy device coupled with negative pressure wound therapy. Background Technology

[0002] Negative Pressure Wound Therapy (NPWT), introduced in Europe and America in the late 1980s, has become a commonly used clinical method for treating acute and chronic wounds. This technique creates a closed negative pressure environment at the wound site, using foam or sponge dressings to evenly distribute negative pressure across the entire wound surface. This effectively removes wound exudate, reduces edema, promotes local blood circulation and granulation tissue growth, and protects the wound from infection. However, NPWT still has significant limitations in clinical use: First, for wounds with incomplete removal of infected or necrotic tissue, negative pressure therapy cannot completely remove bacteria and purulent secretions, and may even cause anaerobic bacteria to multiply, potentially leading to sepsis; second, the mechanical negative pressure in this therapy increases the risk of wound bleeding, and if tumors are present in the wound, it can accelerate their proliferation; in addition, NPWT has limited efficacy for most chronic wounds such as diabetic foot ulcers and pressure sores, and cannot significantly shorten the healing period; furthermore, dressings need to be changed frequently, and the pain during the changing process is generally unbearable for patients, often requiring anesthesia, and the negative pressure device and consumables are expensive, increasing the treatment burden.

[0003] To overcome the limitations of NPWT in antibacterial, anti-inflammatory, and tissue repair-promoting effects, researchers attempted to introduce continuous saline irrigation (NPWTi) into the system to improve wound cleanliness and maintain a moist environment. However, saline only provides physical irrigation and does not have bactericidal, hemostatic, or healing-promoting effects, while the use of antibacterial drugs often inhibits the growth of normal cells, affecting wound healing, making it difficult to achieve a balance between bactericidal and tissue repair.

[0004] In recent years, cold atmospheric plasma (CAP) has shown great potential in the repair of chronic, refractory wounds due to its ability to generate reactive oxygen species (ROS / RNS) at low temperatures. Existing research has shown that CAP not only reduces bacterial load on wounds but also modulates inflammatory responses and promotes the proliferation and migration of fibroblasts and epithelial cells, thereby accelerating tissue regeneration. Therefore, the technological advantages of CAP are highly compatible with those of non-invasive wound healing (NPWT), and it has the potential to provide integrated functions of sterilization, anti-inflammation, hemostasis, healing promotion, and scar inhibition throughout the entire NPWT process, perfectly solving the challenges faced in its application.

[0005] However, current CAP devices and NPWT devices are mostly used independently, and there is a lack of mature products that can be organically combined with NPWT in clinical practice. This fails to address the key issues of NPWT in infection control, wound healing, and patient comfort. Therefore, how to introduce a multi-modal plasma therapy strategy into the NPWT system, taking into account debridement, sterilization, moisture maintenance, hemostasis, healing promotion, and scar inhibition, and constructing a novel synergistic wound repair technology, has become a key problem that urgently needs to be solved in this field.

[0006] Existing technologies provide a flexible plasma patch, but the through holes on the patch surface are not conducive to the flow of gas and liquid during drainage, making it difficult to control the negative pressure during NPWT operation, and there is a risk of blockage. Existing technologies also provide a negative pressure closure drainage dressing and wound treatment device, but the plasma discharge device in this device may come into contact with liquid during discharge, posing a risk of short circuit. The wound is always in a moist environment, and the plasma needs to pass through the through holes of the flexible plasma patch during drainage, making it difficult to achieve absolute sealing. Existing technologies also provide a wound repair system, but its plasma discharge device structure has been redesigned, differing greatly from the NPWT structure that is currently widely used in the market, making technological integration difficult and promotion costly.

[0007] In summary, the existing negative pressure wound therapy devices have the following problems: 1. Existing plasma discharge devices mostly use flexible plasma patches, which pose a risk of clogging the system flow channels; 2. Existing flexible plasma patches require direct contact with liquids, and plasma discharge devices in contact with liquids pose a risk of short circuits; 3. Existing flexible plasma patches have a through-hole structure, and drainage needs to pass through the through-hole, making it difficult to achieve absolute sealing; 4. Existing negative pressure wound cleaning systems require the use of external plasma discharge devices. Integrating the plasma discharge device with the negative pressure wound cleaning system is difficult, the equipment modules are scattered, the equipment is bulky, and it is inconvenient to use. Summary of the Invention

[0008] The purpose of this invention is to provide an integrated device coupling plasma and negative pressure closed drainage, comprising a drainage unit, a wound covering unit, an irrigation unit, and a plasma discharge unit. The plasma discharge unit is integrated into the drainage unit and / or irrigation tube, and the generated plasma can carry active substances through the drainage tube and / or the irrigation tube of the irrigation unit to the wound through the wound covering unit. This invention also provides a method of using the integrated device coupling plasma and negative pressure closed drainage, the core of which is to utilize plasma carrying active substances to sterilize the wound and promote healing during the cleaning process. By integrating the plasma discharge device into the drainage tube and / or irrigation tube, this invention achieves separation of the discharge device from the wound treatment device's flow channel, avoiding flow channel blockage and the risk of short circuit in the discharge device.

[0009] To achieve the above objectives, the present invention adopts the following technical solution: In a first aspect, the present invention provides an integrated device coupling plasma and negative pressure closed drainage, comprising: a drainage unit, a wound covering unit, a flushing unit, and a plasma discharge unit; The drainage port included in the drainage unit is connected to the wound covering unit; The irrigation unit includes an irrigation port that is connected to the wound covering unit. The irrigation fluid is applied to the wound through the irrigation unit and the wound covering unit. After use, the irrigation fluid and wound exudate are drained out through the drainage unit via the wound covering unit. The discharge electrodes of the plasma discharge unit are integrated into the drainage tube of the drainage unit and / or the irrigation tube of the irrigation unit, generating plasma and carrying active substances to the wound through the wound covering unit.

[0010] As one possible approach, the drainage port is located above the wound. There is at least one irrigation port; when there is one irrigation port, the irrigation port is located on the front coverage surface of the wound covering unit and on any side of the wound; when there are multiple irrigation ports, the irrigation ports are located on the side of the wound covering unit and are spaced apart, or the irrigation ports are located on the front coverage surface of the wound covering unit and are spaced apart around the drainage port.

[0011] As one possible implementation, the discharge electrode includes a high-voltage electrode and a ground electrode, and the arrangement of the drainage tube and / or flushing tube is as follows: Both the drainage tube and the flushing tube are single-tube structures. The high-voltage electrode and the ground electrode are embedded in the tube wall, and both the high-voltage electrode and the ground electrode extend spirally around the axis of the tube; or, Both the drainage tube and the flushing tube are single-tube structures. The high-voltage electrode and the ground electrode are embedded in the tube wall. There are one or more pairs of high-voltage electrodes and ground electrodes, and each pair of high-voltage electrodes and ground electrodes is parallel to the axis of the tube.

[0012] As one possible implementation, the discharge electrode includes a high-voltage electrode and a ground electrode, and the arrangement of the drainage tube and / or flushing tube is as follows: Both the drainage tube and the flushing tube are double-tube structures, consisting of a coaxial inner tube and an outer tube with a space between them; the high-voltage electrode and the ground electrode are located within the space. Both the high-voltage electrode and the ground electrode extend helically around the axis of the tube; or, the high-voltage electrode and the ground electrode are one or more pairs, each pair of high-voltage electrode and ground electrode being parallel to the axis of the tube; or, The high-voltage electrode is attached to one side of the inner wall of the outer tube, and the ground electrode is attached to the other side of the inner wall of the outer tube.

[0013] As one possible implementation, both the drainage tube and the flushing tube are single-tube structures, with the high-voltage electrode embedded in the tube wall. The high-voltage electrode extends spirally around the axis of the tube, with one end connected to a high-voltage power supply and the other end grounded.

[0014] As one possible implementation, both the drainage tube and the flushing tube are single-tube structures, with a high-voltage electrode surrounding the outer wall of the tube and a floating electrode installed inside; or, Both the drainage tube and the flushing tube are single-tube structures. The high-voltage electrode and the ground electrode are both encircled on the outer wall of the tube, and the high-voltage electrode and the ground electrode are spaced a predetermined distance apart axially; or, The flushing tube is a single-tube structure. The high-voltage electrode is located inside the tube, and the ground electrode is surrounded on the outer wall of the tube. When flushing fluid is flowing through the flushing tube, the high-voltage electrode is de-energized. When process gas is flowing through the flushing tube, the high-voltage electrode is energized.

[0015] As one possible implementation, the high-voltage power supply included in the plasma discharge unit is an AC power supply with a peak voltage of 2–12 kV and a discharge frequency of 5–100 kHz; or, The high-voltage power supply included in the plasma discharge unit is a pulsed power supply with a voltage of 3–12 kV, a frequency of 1–30 kHz, and a pulse width of 0.1–3 µs; or, The high-voltage power supply included in the plasma discharge unit is a DC power supply with a voltage of 2–12 kV and a current of 0.3–12 mA; or, The high-voltage power supply included in the plasma discharge unit is a radio frequency source with an output power of 10–80 W and a radio frequency voltage of 200–1200 Vpp.

[0016] As one possible implementation, one end of the irrigation tube near the irrigation port is inserted into the dressing layer of the wound covering unit; or, the end of the irrigation tube near the irrigation port is designed as a probe structure to penetrate deep into the wound layer; and / or, A diversion hole is opened at one end of the flushing pipe near the flushing port.

[0017] As one possible implementation, the integrated device coupling plasma and negative pressure closed drainage is a single-piece structure; or, The high-voltage power supply included in the drainage unit, wound covering unit, irrigation unit, and plasma discharge unit is a separate structure. When in use, they are assembled to form a complete integrated device that couples plasma with negative pressure closed drainage.

[0018] Secondly, the present invention provides a method for using an integrated device coupling plasma and negative pressure closed drainage, the method comprising the following steps: Cover and secure the wound covering unit to the wound surface; The drainage unit includes a drainage port that is inserted into the wound covering unit, and the drainage unit is controlled to keep the wound under the wound covering unit in a negative pressure state. The irrigation port of the irrigation unit is inserted into the wound covering unit. In the irrigation mode, the irrigation fluid is controlled to cover the wound through the wound covering unit. The used irrigation fluid and wound exudate are drained out through the drainage unit via the wound covering unit. In plasma mode, the plasma discharge unit is activated to generate plasma by integrating the plasma discharge unit in the irrigation tube and / or drainage tube, and the plasma active substances are used to sterilize the wound and promote healing.

[0019] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. The integrated device for coupling plasma and negative pressure sealing provided by the present invention does not have a plasma discharge device in the negative pressure sealing area, thus avoiding the risk of plasma patch affecting negative pressure and blockage; the discharge device is far away from the wound location, is not affected by liquid, and has no risk of short circuit.

[0020] 2. The integrated device for plasma and negative pressure closed drainage coupling provided by the present invention has a simple structure. Compared with the traditional NPWT-CAP treatment device, it does not introduce additional devices and operating steps. The device is lightweight and portable and can be designed as a backpack or waist hanging structure for carrying. It is suitable for field or battlefield environments.

[0021] 3. The integrated device for coupling plasma and negative pressure closed drainage provided by the present invention has a drainage tube and a flushing tube forming a circulation system, which drives the plasma or flushing fluid containing plasma activation liquid to circulate in the wound site. The active substances in the plasma that play a key role can act on the wound site efficiently, increasing the therapeutic effect of the plasma. Attached Figure Description

[0022] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this invention, illustrate exemplary embodiments of the invention and are used to explain the invention, but do not constitute an undue limitation of the invention. In the drawings: Figure 1 This is a cross-sectional view of the integrated device for coupling plasma and negative pressure closed drainage in this embodiment; Figure 2 This is a schematic diagram showing the arrangement of paired electrodes parallel to the tube axis in the single tube wall of the plasma discharge unit in this embodiment. Figure 3 This is a schematic diagram showing the arrangement of the high-voltage electrode and the grounding electrode in the single tube wall of the plasma discharge unit in this embodiment; Figure 4 This is a schematic diagram of the arrangement of high-voltage electrodes and floating electrodes in the single tube wall of the plasma discharge unit in this embodiment; Figure 5 This is a schematic diagram showing the arrangement of paired electrodes parallel to the axis in the dual-tube structure of the plasma discharge unit in this embodiment; Figure 6 This is a schematic diagram showing the arrangement of paired electrodes against the inner wall in the dual-tube structure of the plasma discharge unit in this embodiment. Figure 7 This is a schematic diagram showing the layout of the high-voltage electrode and ground electrode on a single tube in a traditional plasma discharge unit. Figure 8 This is a schematic diagram showing the arrangement of the high-voltage electrode and the ground electrode on the chuck of a traditional plasma discharge unit. Figure 9 This is a schematic diagram of the integrated device for coupling plasma with negative pressure closed flow and the waist-mounted drive unit in this embodiment.

[0023] Figure Labels 1-Drainage unit, 2-Wound covering unit, 3-Irrigation unit, 4-Plasma discharge unit, 5-Waist-mounted drive unit; 10-Suction cup, 11-Drainage tube, 12-Drainage port; 20 - Sealing patch; 21 - Dressing layer; 30 - Flushing port; 31 - Single-tube structure; 32 - Double-tube structure; 40-High voltage electrode, 41-Ground electrode, 42-Grounding device, 43-Floating electrode; 320 - outer tube, 321 - inner tube. Detailed Implementation

[0024] To facilitate a clear description of the technical solutions in the embodiments of the present invention, the terms "first" and "second" are used to distinguish identical or similar items with essentially the same function and effect. For example, the first threshold and the second threshold are merely used to distinguish different thresholds and do not limit their order. Those skilled in the art will understand that the terms "first" and "second" do not limit the quantity or execution order, and that the terms "first" and "second" are not necessarily different.

[0025] It should be noted that in this invention, the terms "exemplary" or "for example" are used to indicate examples, illustrations, or descriptions. Any embodiment or design described as "exemplary" or "for example" in this invention should not be construed as being more preferred or advantageous than other embodiments or designs. Specifically, the use of terms such as "exemplary" or "for example" is intended to present the relevant concepts in a concrete manner.

[0026] In this invention, "at least one" refers to one or more, and "more than one" refers to two or more. "And / or" describes the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A alone, A and B simultaneously, or B alone, where A and B can be singular or plural. The character " / " generally indicates that the preceding and following related objects are in an "or" relationship. "At least one" or similar expressions refer to any combination of these items, including any combination of singular or plural items. For example, "at least one of a, b, or c" can represent: a, b, c, a combination of a and b, a combination of a and c, a combination of b and c, or a, b, and c, where a, b, and c can be single or multiple.

[0027] The present invention aims to provide an integrated device and method for coupling plasma and negative pressure closed drainage, which can solve the technical problems existing in the prior art, such as easy blockage of the flow channel in negative pressure wound therapy devices, short circuit risk of plasma discharge devices, difficulty in combining negative pressure wound therapy devices and plasma discharge devices, and inconvenience in use.

[0028] In a first aspect, the present invention provides an integrated device coupling plasma and negative pressure closed drainage, comprising: a drainage unit 1, a wound covering unit 2, a flushing unit 3, and a plasma discharge unit 4; The drainage port 12 included in the drainage unit 1 is connected to the wound covering unit 2; The irrigation port 30 included in the irrigation unit 3 is connected to the wound covering unit 2. The irrigation fluid covers the wound through the irrigation unit 3 and the wound covering unit 2. The used irrigation fluid and wound exudate are drained out through the drainage unit 1 via the wound covering unit 2. The plasma discharge unit 4 is integrated into the drainage tube 11 included in the drainage unit 1, and / or the irrigation tube included in the irrigation unit 3, to generate plasma and carry active substances to the wound through the wound covering unit 2.

[0029] The drainage unit refers to a device that uses a certain negative pressure to accelerate blood circulation in the wound area, stimulate tissue growth, fully drain, and promote wound healing; it mainly includes a suction cup 10, a drainage tube 11, and a drainage port 12.

[0030] The wound covering unit is a technical module used to repair skin defects and promote tissue regeneration. It mainly includes a sealing patch 20 and a dressing layer 21. The suction cup 10, sealing patch 20, and dressing layer 21 create a negative pressure environment. Used in conjunction with the dressing, they ensure complete isolation of the wound from the outside world, maintaining a stable negative pressure environment. Through continuous or intermittent suction from the negative pressure source, wound exudate and necrotic tissue are drawn out, reducing the risk of interference. As an example, the dressing can use porous materials such as artificial dermis, medical foam, medical sponge, and hydrogel.

[0031] The irrigation unit refers to a module that actively delivers irrigation fluid to rinse and remove wound exudate, necrotic tissue, and bacteria. It works in conjunction with the drainage unit to optimize the wound microenvironment. The irrigation unit includes an irrigation tube and an irrigation port.

[0032] Among them, the plasma discharge unit refers to the device that generates plasma by ionizing gas.

[0033] Specifically, the integrated device coupling plasma and negative pressure closed drainage provided in this embodiment assists in removing wound exudate and used cleaning fluid through negative pressure suction. Its drainage port is directly connected to the wound covering unit. Through pressure sensor and spiral structure design, it can achieve precise control and management of negative pressure value and drainage volume. The dressing, sealing patch, etc. provided by the wound covering unit are used to close the wound and provide a stable environment for negative pressure drainage and plasma therapy. The irrigation unit has an independent irrigation port, which can deliver irrigation fluid to the wound or dressing to complete wound cleaning.

[0034] In addition, the device also integrates or is equipped with a negative pressure pump unit to generate negative pressure for the drainage unit, so that the wound is in a negative pressure environment; a power supply unit to supply liquid to the negative pressure pump and the irrigation unit and to the plasma discharge unit; and an irrigation fluid container unit to provide physiological saline, antibiotic solution, hydrogen peroxide solution, chlorhexidine solution and plasma activation solution for wound cleaning.

[0035] The key innovation of this invention lies in the integration of the electrodes and drainage / irrigation tubes of the plasma discharge unit. The discharge electrodes are directly integrated into the wall of the single-tube drainage tube and / or irrigation tube or the space formed by the inner and outer tubes of the double-tube drainage tube and / or irrigation tube. This design provides an independent space for the plasma discharge unit, avoiding blockage of the flow channel or short circuit caused by liquid erosion. It also ensures that the plasma and its carried active substances can directly act on the wound through the wound covering unit.

[0036] This device combines multiple functions such as negative pressure drainage, irrigation and cleaning, and plasma therapy. Doctors can flexibly choose single or combined treatment modes according to the specific condition of the wound. Furthermore, by integrating the plasma discharge device into the existing tubing, the system structure is greatly simplified, avoiding the complexity of setting up a separate channel for plasma therapy. This integrated design not only gives negative pressure wound therapy a one-stop function of sterilization, anti-inflammation, hemostasis, and healing promotion, but it can also be designed as a pocket or waist-hanging structure, expanding its application scenarios and potentially leading to its application in the treatment of wounds in the field or even on the battlefield.

[0037] Compared to existing technologies, the plasma discharge device provided by current methods is integrated into a flexible patch, which is tightly attached to the wound. During drainage, this can easily lead to blockage of the drainage channel, and direct contact between the drainage fluid and the plasma discharge device can cause a short circuit. This solution, by separating the plasma discharge device from the flexible patch, keeps the plasma discharge device away from the wound and provides it with an independent containment space, completely avoiding the risks of channel blockage and short circuits.

[0038] Through the above technical solution, the present invention integrates a plasma discharge device into the drainage tube / irrigation tube, utilizes plasma sterilization and healing promotion, and uses negative pressure treatment for irrigation and debridement. This achieves a combination of the two in terms of function and structure, while avoiding the adverse effects between them. Furthermore, this combination method greatly simplifies the structure of the negative pressure wound treatment-plasma sterilization combined treatment device, making it possible for the sterilization and debridement treatment device to be developed into a miniaturized and portable device, making it possible to apply it to wound treatment in the field or even on the battlefield.

[0039] As one possible approach, the drainage port is located above the wound. There is at least one irrigation port 30; when there is one irrigation port 30, the irrigation port 30 is located on the front covering surface of the wound covering unit 2 and on any side of the wound; when there are multiple irrigation ports 30, the irrigation ports 30 are located on the side of the wound covering unit 2 and are distributed at intervals, or the irrigation ports 30 are located on the front covering surface of the wound covering unit 2 and are distributed at intervals around the drainage port 12.

[0040] The irrigation port refers to the outlet of the irrigation tube. The irrigation port delivers irrigation fluid to the wound to remove necrotic tissue, bacteria, and residual fluid, keeping the wound clean.

[0041] Specifically, different settings are made according to the layout requirements of the drainage and irrigation ports of the integrated device that couples plasma with negative pressure closed drainage. The negative pressure drainage port is set above the wound surface, so it does not act directly on the wound surface and avoids the drainage tube compressing the wound surface; the negative pressure drainage port is located at a high position, which can effectively collect and drain exudate from multiple directions and reduce the probability of drainage fluid flowing back to the wound surface.

[0042] When there is only one irrigation port, the irrigation port is located on the front of the wound covering unit and can be on either side of the wound. By rinsing the side of the wound, the wound can be cleaned evenly. This avoids the irrigation port being too close to the drainage port, so that the irrigation fluid is not completely covered by the drainage tube and is sucked away. As an example, in the treatment of lower extremity ulcers, the irrigation port can be placed on one side of the wound and the drainage port can be centered and above, forming a lateral irrigation-vertical drainage pattern.

[0043] When multiple irrigation ports are required, the irrigation ports are located on the sides of the wound covering unit and are spaced apart, such as symmetrically or equidistantly. As an example, in an infected chest wall wound, two irrigation ports are provided on each side, and the drainage port is located in the upper middle, forming a ring-shaped irrigation flow field.

[0044] Alternatively, multiple irrigation ports can be arranged in a ring shape, with intervals between them on the front coverage surface, forming a ring-shaped irrigation flow field to improve cleaning coverage. The multi-irrigation port design can reduce irrigation dead corners, which is especially suitable for complex wounds. As an example, in the cleaning of diabetic foot wounds, three irrigation ports are arranged at a 120° angle around the drainage port to ensure that the irrigation fluid covers the dead corners of the wound.

[0045] Through the above-mentioned technical methods, the present invention rationally sets up the irrigation port, making the spatial relationship between the drainage port and the irrigation port reasonable. According to fluid dynamics, the irrigation port and the drainage port need to maintain a reasonable distance to avoid short circuit of the electrodes caused by the liquid, and also to ensure that the irrigation fluid fully contacts the wound before being attracted by negative pressure. This layout achieves a balance between drainage efficiency and cleaning effect through physical position optimization, which meets the clinical needs for wound relief management.

[0046] As one possible implementation, the discharge electrode includes a high-voltage electrode 40 and a ground electrode 41, and the arrangement of the drainage tube 11 and / or flushing tube is as follows: Both the drainage tube 11 and the flushing tube are single-tube structures. The high-voltage electrode 40 and the ground electrode 41 are integrally embedded in the tube wall, and both the high-voltage electrode 40 and the ground electrode 41 extend spirally around the axis of the tube; or, The drainage tube 11 and the flushing tube are both single tube structures. The high-voltage electrode 40 and the ground electrode 41 are embedded in the tube wall. The high-voltage electrode 40 and the ground electrode 41 are one or more pairs. Each pair of high-voltage electrode 40 and ground electrode 41 is parallel to the axis of the tube.

[0047] The high-voltage electrode creates a strong electric field in the gas or liquid medium by applying voltage, triggering electron avalanche and generating plasma; the ground electrode, as the current return path, is usually designed as a large-area grounding structure to ensure the asymmetry of the voltage between the plasma and the electrode.

[0048] Among them, the single-tube structure refers to the guide tube / flushing tube with a single-layer tubular design, which integrates high-voltage electrodes and ground electrodes inside the tube wall, and achieves plasma discharge function through a specific arrangement.

[0049] Specifically, in this embodiment, the plasma discharge unit is set in a single-tube structure drainage / flushing tube in a highly integrated manner. It optimizes the generation and delivery of plasma through a specific electrode arrangement. At the same time, by embedding it in the tube wall, the plasma discharge unit can be isolated from the liquid, effectively avoiding short circuits that may occur after the electrodes come into contact with the liquid.

[0050] The electrodes extend spirally around the pipe axis, a design that causes the high-voltage and ground electrodes to spirally wind within the pipe wall. Its advantage lies in generating a continuous and uniform electric field distribution along the pipe. When the working gas flows through the pipe, this electric field can more effectively ionize it, thereby generating plasma with a wider distribution and more uniform concentration of active substances, which helps improve the effectiveness on wounds or treatment media.

[0051] In this design, the electrodes are parallel to the pipe axis. High-voltage and ground electrodes are embedded in the pipe wall in one or more pairs, parallel to the pipe axis. Parallel arrangement of electrode pairs with the pipe axis reduces processing difficulty; when multiple pairs of electrodes are arranged parallel to the pipe axis, the spacing between the electrode pairs is easily adjusted, helping to reduce edge effects and forming multiple stable discharge regions inside the pipe, thus enhancing discharge intensity and increasing the yield of active materials.

[0052] Compared with existing technologies, this technical solution adopts an integrated embedded electrode design. Compared with the external or inserted plasma discharge devices of existing technologies, it not only has the advantage of simplifying the system structure, but also protects the electrode device from displacement or damage, while ensuring the safety of electrode discharge and reducing the risk of short circuit.

[0053] Through the above technical solutions, this invention achieves efficient, stable, and safe plasma output: the spiral extension of the electrodes ensures a wide and uniform plasma distribution; the parallel arrangement of the electrodes facilitates adjustment of the electrode spacing to achieve regional electric field control and reduce edge effects. Both electrode distribution methods optimize the treatment effect of the plasma and its active materials on the target. Furthermore, the embedded electrodes avoid the risk of short circuits caused by contact with liquids.

[0054] As one possible implementation, the discharge electrode includes a high-voltage electrode 40 and a ground electrode 41, and the arrangement of the drainage tube 11 and / or flushing tube is as follows: Both the drainage tube 11 and the flushing tube are dual-tube structures, namely, they include a coaxial inner tube 320 and an outer tube 321, with a receiving space between the inner tube 320 and the outer tube 321; the high-voltage electrode 40 and the ground electrode 41 are arranged in the receiving space. Both the high-voltage electrode 40 and the ground electrode 41 extend helically around the axis of the tube; or, the high-voltage electrode 40 and the ground electrode 41 are one or more pairs, and each pair of high-voltage electrode 40 and ground electrode 41 is parallel to the axis of the tube; or, The high-voltage electrode 40 is attached to one side of the inner wall of the outer tube 321, and the ground electrode 41 is attached to the other side of the inner wall of the outer tube 321.

[0055] The dual-tube structure refers to the annular cavity formed between the inner and outer tubes of the flow tube / flushing tube, in which a high-voltage electrode and a ground electrode are installed, and the plasma discharge function is achieved through a specific arrangement.

[0056] Specifically, in this embodiment, the plasma discharge unit is set in the dual-tube structure drainage / flushing tube in a highly integrated manner. It optimizes the generation and delivery of plasma through a specific electrode arrangement. At the same time, by setting the electrodes in the annular cavity formed by the dual-tube structure, the plasma discharge unit can be isolated from the liquid, effectively avoiding short circuits after the electrodes come into contact with the liquid.

[0057] The electrodes extend spirally around the pipe axis, a design that causes the high-voltage and ground electrodes to spirally wind within the pipe wall. Its advantage lies in generating a continuous and uniform electric field distribution along the pipe. When the working gas flows through the pipe, this electric field can more effectively ionize it, thereby generating plasma with a wider distribution and more uniform concentration of active substances, which helps improve the effectiveness on wounds or treatment media.

[0058] In this design, the electrodes are parallel to the pipe axis, and the high-voltage and ground electrodes are embedded in the pipe wall in one or more pairs, parallel to the pipe axis. This structure helps to form multiple stable discharge regions inside the pipe. The design of multiple electrode pairs can enhance the discharge intensity and potentially increase the yield of active materials.

[0059] The high-voltage electrode and the ground electrode are set on separate sides. This design can provide sufficient cooling space for the electrodes, avoid local overheating that could lead to electrode erosion, and extend the service life of the electrodes. At the same time, setting the electrodes on two separate sides helps to observe the electrode discharge status and can also prevent breakdown by adding a dielectric layer.

[0060] Compared with existing technologies, this technical solution adopts a ring cavity to accommodate the electrode design. Compared with the external or inserted plasma discharge devices of existing technologies, it not only has the advantage of simplifying the system structure, but also protects the electrode device from displacement or damage, while ensuring the safety of electrode discharge and reducing the risk of short circuit.

[0061] Through the above technical solutions, this invention achieves efficient, stable, and safe plasma output: the spiral extension of the electrodes ensures a wide and uniform plasma distribution; the parallel arrangement of the electrodes facilitates adjustment of the electrode pair spacing to achieve regional electric field modulation and reduce edge effects; and the side-mounted electrode arrangement significantly extends the lifespan of the plasma electrodes and the treatment device. All three electrode distribution methods optimize the treatment effect of the plasma and its active substances on the target.

[0062] As one possible implementation, both the drainage tube 11 and the flushing tube are single-tube structures, with the high-voltage electrode 40 embedded in the tube wall. The axis of the high-voltage electrode 40 tube extends spirally, with one end of the high-voltage electrode 40 connected to a high-voltage power supply and the other end grounded.

[0063] Specifically, this design simplifies the fluid path with a single-tube structure, while the helical electrode enhances gas-liquid mixing efficiency. The high-pressure electrode is embedded in the tube wall in a helical form, with the other end directly connected to the ground via grounding device 42. As an example, the helical electrode can be embedded with an electrode spacing of 0.5-2 mm and a helix angle of 30°. o -60 o .

[0064] Through the above technical solution, the present invention achieves compact plasma generation by embedding a spiral electrode in the tube wall, and focuses on solving the problems of electrode-tube wall interface stress and long-term discharge stability. In addition, the compact layout is achieved by embedding the electrode in a single tube wall, and the fluid channel diameter can be reduced to 1-3 mm, which is suitable for space-constrained scenarios such as minimally invasive medical catheters.

[0065] As one possible implementation, both the drainage tube 11 and the flushing tube are single-tube structures, with the high-voltage electrode 40 surrounding the outer wall of the tube and a floating electrode 43 installed inside the tube; or, Both the drainage tube 11 and the flushing tube are single-tube structures. The high-voltage electrode 40 and the ground electrode 41 are both encircled on the outer wall of the tube, and the high-voltage electrode 40 and the ground electrode 41 are axially spaced at a predetermined distance; or, The flushing tube is a single-tube structure. The high-voltage electrode 40 is installed inside the tube, and the ground electrode 41 is surrounded on the outer wall of the tube. When flushing fluid is flowing through the flushing tube, the high-voltage electrode 40 is de-energized. When process gas is flowing through the flushing tube, the high-voltage electrode 40 is energized.

[0066] Among them, a floating electrode is an electrode structure that is not directly connected to the positive and negative terminals of a power source. Its potential is determined by the bipolar diffusion dynamics in the plasma environment, ultimately reaching a floating potential in equilibrium between electron and ion currents.

[0067] Specifically, a floating electrode design is employed. High-voltage electrodes surround the outer wall to form the main electric field. The floating electrodes obtain a dynamic potential through capacitive coupling, with a voltage value approximately 30%-70% of that of the outer wall electrodes. This potential adjusts in real time according to changes in the electric field strength of the outer wall, forming an asymmetric electric field distribution. The floating electrodes are not directly connected to a power source; their potential is determined by the induced charges in the surrounding electric field. The axially spaced design of high-voltage and ground electrodes surrounding the outer wall of the pipe creates a directional electric field gradient, suitable for electroosmotic drainage during liquid drainage or plasma disinfection in gaseous environments. This design completely isolates the liquid from contact with the electrodes, ensuring no short-circuit risk.

[0068] For the flushing tube, since the flushing tube transports flushing fluid, the electrode will inevitably come into contact with the liquid medium in the flushing tube. A structure can be adopted in which the high-voltage electrode is placed inside the tube and the ground electrode is placed on the outer wall of the tube. This structure effectively avoids short circuits caused by the high-voltage electrode and the ground electrode being in the liquid medium at the same time. When the flushing tube transports flushing fluid, the high-voltage electrode is de-energized to avoid liquid electrolytic corrosion. When gas passes through, the high-voltage electrode is energized to generate plasma active material.

[0069] Through the above technical solutions, this invention provides multiple electrode setting methods, allowing for the selection of different electrode setting methods according to actual needs. By integrating electrodes into a single tube, the volume of external components is reduced; time-sharing control of internal and external electrodes enables multiple uses from a single tube, reducing device complexity; and the use of floating electrode layout optimizes space utilization, making it suitable for portable medical devices.

[0070] As one possible implementation, the high-voltage power supply included in the plasma discharge unit is an AC power supply with a peak voltage of 2–12 kV and a discharge frequency of 5–100 kHz; or, The high-voltage power supply included in the plasma discharge unit is a pulsed power supply with a voltage of 3–12 kV, a frequency of 1–30 kHz, and a pulse width of 0.1–3 µs; or, The high-voltage power supply included in the plasma discharge unit is a DC power supply with a voltage of 2–12 kV and a current of 0.3–12 mA; or, The high-voltage power supply included in the plasma discharge unit is a radio frequency source with an output power of 10–80 W and a radio frequency voltage of 200–1200 Vpp.

[0071] Specifically, the appropriate power supply should be selected according to actual needs. Different power supplies generate plasma in different ways, have different requirements for equipment, and have different common applications.

[0072] As an example, when treating superficial wounds, an AC power supply should be selected, with the voltage controlled at 2-5 kV to avoid thermal damage to the tissue. As an example, when it is necessary to kill drug-resistant bacteria in diabetic foot ulcers, a pulse power supply should be selected, and the power supply should be controlled at 8-12 kV. As an example, when plasma penetration debridement is required for deep wounds or high-resistivity media (such as bone tissue), a DC power supply should be selected and the voltage controlled at 8-12 kV. As an example, when a high-density ion flow is needed for physical debridement, a radio frequency source should be selected with a voltage of 200-600 Vpp; when it is necessary to increase the content of bactericidal and healing-promoting active substances, a radio frequency source should be selected with a voltage of 800-1200 Vpp.

[0073] Through the above technical solutions, the present invention provides different power supply options to adapt to different treatment purposes or applicable to different treatment scenarios. By selecting power supplies with different characteristics, the power supply parameters can be precisely adjusted to dynamically control plasma density, active substance concentration and ion energy, thereby meeting the needs of different application scenarios.

[0074] As one possible implementation, the end of the irrigation tube near the irrigation port is inserted into the dressing layer 21 of the wound covering unit 2, or the end of the irrigation tube near the irrigation port is designed as a probe structure to penetrate into the wound layer; A diversion hole is opened at one end of the flushing pipe near the flushing port.

[0075] Among them, the probe-type structure refers to a structure in which one end of the irrigation tube is a slender probe that can be inserted into the dressing layer, and the irrigation fluid is evenly distributed to the wound through a diversion channel. As an example, the diameter of the slender probe is 1-3 mm.

[0076] In this context, a diversion orifice refers to a tiny hole made in the side wall of the flushing pipe, used to achieve uniform distribution or directional discharge of the flushing fluid. As an example, the orifice diameter is 0.2-0.5 mm.

[0077] Specifically, the end of the irrigation tube is a slender probe that can penetrate the dressing to reach the deep layers of the wound for precise irrigation of deep wound cavities; the diversion holes can be distributed on the sidewall of the probe in a spiral or array arrangement to ensure uniform coverage of the irrigation fluid.

[0078] Through the above technical solutions, the present invention avoids direct impact on the wound surface and reduces the risk of mechanical damage by setting a probe-type irrigation tube. It can also be used in conjunction with a moist healing environment to keep the base moist but not soaked. The diversion holes disperse the single-channel fluid into multiple fine streams to cover a larger wound or cavity area. The fluid pressure gradient is also controlled by the orifice size and number to avoid local high pressure damage to tissue.

[0079] As one possible implementation, the integrated device coupling plasma and negative pressure closed drainage is a single-piece structure; or, The high-voltage power supply included in the drainage unit 1, wound covering unit 2, irrigation unit 3, and plasma discharge unit 4 is a separate structure. When in use, they are assembled to form a complete integrated device that couples plasma with negative pressure closed drainage.

[0080] Among them, the integrated structure refers to the integrated design of the plasma and negative pressure closed drainage coupling device, that is, the plasma discharge unit, drainage unit and wound covering unit are integrated into a single device, and the functions are linked through the internal pipeline system.

[0081] Specifically, the integrated device coupling plasma and negative pressure closed drainage can be designed as an integrated structure, which can increase the portability of the device and make it suitable for mobile medical scenarios; the integrated device coupling plasma and negative pressure closed drainage can also be modularly designed, and the combination of components can be adjusted according to the size of the wound, which facilitates equipment maintenance and upgrades.

[0082] Compared to existing technologies, traditional negative pressure drainage devices only provide negative pressure drainage and require an external plasma generator or close contact with the wound surface, resulting in complex structures or easy blockage of the drainage channels. This solution provides an integrated device with plasma-assisted therapy capabilities, featuring a single-piece or modular design. This allows for the structural separation and functional integration of the plasma module and wound treatment module, facilitating integrated and portable applications or simplifying maintenance and upgrades.

[0083] Through the above technical solutions, the present invention provides two design forms of wound treatment device that couples plasma with negative pressure closed drainage. The integrated design gives the device portability for use in mobile medical scenarios; the modular design enables the device to be flexibly adapted and easy to maintain and upgrade.

[0084] Secondly, the present invention provides a method for using an integrated device coupling plasma and negative pressure closed drainage, the method comprising the following steps: Cover and secure the wound covering unit to the wound surface; The drainage unit includes a drainage port that is inserted into the wound covering unit, and the drainage unit is controlled to keep the wound under the wound covering unit in a negative pressure state. The irrigation port of the irrigation unit is inserted into the wound covering unit. In the irrigation mode, the irrigation fluid is controlled to cover the wound through the wound covering unit. The used irrigation fluid and wound exudate are drained out through the drainage unit via the wound covering unit. In plasma mode, the plasma discharge unit is activated to generate plasma by integrating the plasma discharge unit in the irrigation tube and / or drainage tube, and the plasma active substances are used to sterilize the wound and promote healing.

[0085] Specifically, during plasma-negative pressure wound therapy, the wound covering unit (such as polyurethane foam) is first tightly fitted to the wound, and the surrounding skin is pressed together with a sealing patch (such as a transparent film) to ensure no air bubbles leak. A drainage tube is inserted into the wound covering unit, connected to a negative pressure source, and the negative pressure range is set. The drainage status is continuously monitored throughout the process to ensure stable negative pressure. An irrigation tube is then inserted into the wound covering unit, and a cleaning solution (such as physiological saline or antibacterial solution) is injected. The irrigation solution and wound exudate are drained through the drainage tube to prevent exudate accumulation. When plasma-assisted therapy is required, the plasma discharge unit integrated into the irrigation / drainage tube is activated. Low-temperature plasma releases active particles to sterilize the wound and promote tissue regeneration. During the process, negative pressure and plasma can operate alternately or synchronously, with the timing adjusted according to the wound type.

[0086] Through the above technical solution, the present invention provides a method for using an integrated device that couples plasma with negative pressure closed drainage. This method actively cleans the wound and drains exudate through negative pressure drainage, and works synergistically with plasma sterilization and healing promotion to significantly improve the healing rate of refractory wounds.

[0087] To facilitate understanding of the technical solution of this application, further explanation is provided below with reference to specific embodiments.

[0088] Example 1 This embodiment demonstrates the use of a plasma-negative pressure closed drainage coupling device to treat burn wounds. Based on the characteristics of the burn wound, it is cleaned and sterilized to prevent wound infection. The power supply is AC power with a peak voltage of 5 kV and a discharge frequency of 80 kHz.

[0089] After initial wound cleaning, use the irrigation mode to perform negative pressure drainage on the wound: First, place the irrigation tube on the appropriate part of the wound. Then, gently cover the wound with a porous sponge as a dressing layer. Press the irrigation tube firmly against the wound surface to ensure that the entire injured area is completely covered by the dressing layer without any gaps. Use a medical film as a sealing sheet and stick it to the outer surface of the dressing layer and the skin around the wound. Cut a round hole in the medical film at the position corresponding to the wound. Completely cover the round hole of the medical film with a suction cup and fix the suction cup in place.

[0090] When the power is turned on and the device is activated, the flushing mode is used. The flushing fluid is delivered to the wound surface through the flushing tube to deeply clean the wound and remove damaged tissue. One end of the drainage tube is sealed and connected to the suction cup, and the other end is connected to the negative pressure source to establish a continuous negative pressure environment, which helps to drain wound exudate, promote blood circulation and tissue regeneration.

[0091] Then, turn on the power supply of the plasma discharge unit, set the power parameters, and generate plasma in the flushing tube. Driven by the gas in the flushing tube, the plasma active substances are delivered to the wound surface through the dressing, and the plasma sterilization and healing promotion effects begin.

[0092] Although the invention has been described herein in conjunction with various embodiments, those skilled in the art will understand and implement other variations of the disclosed embodiments by reviewing the accompanying drawings, disclosure, and other materials. In this specification, the word "comprising" does not exclude other components or steps, and "a" or "an" does not exclude multiple components. A single processor or other unit can implement several functions listed in the specification. While certain measures are described in different embodiments, this does not mean that these measures cannot be combined to produce good results.

[0093] Although the invention has been described in conjunction with specific features and embodiments, it is obvious that various modifications and combinations can be made therein without departing from the spirit and scope of the invention. Accordingly, this specification and drawings are merely illustrative of the invention and are considered to cover any and all modifications, variations, combinations, or equivalents within the scope of the invention. Clearly, those skilled in the art can make various alterations and modifications to the invention without departing from its spirit and scope. Thus, if such modifications and modifications fall within the scope of the invention and its equivalents, the invention is also intended to include such modifications and modifications.

Claims

1. An integrated device for coupling plasma with negative pressure closed-loop drainage, characterized in that, include: Drainage unit, wound covering unit, irrigation unit, and plasma discharge unit; The drainage port included in the drainage unit is connected to the wound covering unit; The irrigation unit includes an irrigation port that is connected to the wound covering unit. The irrigation fluid is applied to the wound through the irrigation unit and the wound covering unit. After use, the irrigation fluid and wound exudate are drained out through the drainage unit via the wound covering unit. The discharge electrodes of the plasma discharge unit are integrated into the drainage tube of the drainage unit and / or the irrigation tube of the irrigation unit, generating plasma and carrying active substances to the wound through the wound covering unit.

2. The integrated device for coupling plasma and negative pressure closed-loop drainage according to claim 1, characterized in that, The drainage port is located above the wound; There is at least one irrigation port; when there is one irrigation port, the irrigation port is located on the front coverage surface of the wound covering unit and on any side of the wound; when there are multiple irrigation ports, the irrigation ports are located on the side of the wound covering unit and are spaced apart, or the irrigation ports are located on the front coverage surface of the wound covering unit and are spaced apart around the drainage port.

3. The integrated device for coupling plasma and negative pressure closed-loop drainage according to claim 1, characterized in that, The discharge electrodes include a high-voltage electrode and a ground electrode, and are arranged in the drainage tube and / or flushing tube as follows: Both the drainage tube and the flushing tube are single-tube structures. The high-voltage electrode and the ground electrode are embedded in the tube wall, and both the high-voltage electrode and the ground electrode extend spirally around the axis of the tube; or, Both the drainage tube and the flushing tube are single-tube structures. The high-voltage electrode and the ground electrode are embedded in the tube wall. There are one or more pairs of high-voltage electrodes and ground electrodes, and each pair of high-voltage electrodes and ground electrodes is parallel to the axis of the tube.

4. The integrated device for coupling plasma and negative pressure closed-loop drainage according to claim 1, characterized in that, The discharge electrodes include a high-voltage electrode and a ground electrode, and are arranged in the drainage tube and / or flushing tube as follows: Both the drainage tube and the flushing tube are double-tube structures, consisting of a coaxial inner tube and an outer tube with a space between them; the high-voltage electrode and the ground electrode are located within the space. Both the high-voltage electrode and the ground electrode extend helically around the axis of the tube; or, the high-voltage electrode and the ground electrode are one or more pairs, each pair of high-voltage electrode and ground electrode being parallel to the axis of the tube; or, The high-voltage electrode is attached to one side of the inner wall of the outer tube, and the ground electrode is attached to the other side of the inner wall of the outer tube.

5. The integrated device for coupling plasma and negative pressure closed drainage according to claim 1, characterized in that, Both the drainage tube and the flushing tube are single-tube structures. The high-voltage electrode is embedded in the tube wall and extends spirally around the axis of the tube. One end of the high-voltage electrode is connected to a high-voltage power supply, and the other end is grounded.

6. The integrated device for coupling plasma and negative pressure closed drainage according to claim 1, characterized in that, Both the drainage tube and the flushing tube are single-tube structures, with a high-voltage electrode surrounding the outer wall of the tube and a floating electrode installed inside; or, Both the drainage tube and the flushing tube are single-tube structures. The high-voltage electrode and the ground electrode are both encircled on the outer wall of the tube, and the high-voltage electrode and the ground electrode are spaced a predetermined distance apart axially; or, The flushing tube is a single-tube structure. The high-voltage electrode is located inside the tube, and the ground electrode is surrounded on the outer wall of the tube. When flushing fluid is flowing through the flushing tube, the high-voltage electrode is de-energized. When process gas is flowing through the flushing tube, the high-voltage electrode is energized.

7. The integrated device for coupling plasma and negative pressure closed-loop drainage according to claim 1, characterized in that, The high-voltage power supply included in the plasma discharge unit is an AC power supply with a peak voltage of 2–12 kV and a discharge frequency of 5–100 kHz; or, The high-voltage power supply included in the plasma discharge unit is a pulsed power supply with a voltage of 3–12 kV, a frequency of 1–30 kHz, and a pulse width of 0.1–3 µs; or, The high-voltage power supply included in the plasma discharge unit is a DC power supply with a voltage of 2–12 kV and a current of 0.3–12 mA; or, The high-voltage power supply included in the plasma discharge unit is a radio frequency source with an output power of 10–80 W and a radio frequency voltage of 200–1200 Vpp.

8. The integrated device for coupling plasma and negative pressure closed drainage according to claim 1, characterized in that, The end of the irrigation tube near the irrigation port is inserted into the dressing layer of the wound covering unit, or the end of the irrigation tube near the irrigation port is designed as a probe structure to penetrate deep into the wound layer; and / or, A diversion hole is opened at one end of the flushing pipe near the flushing port.

9. The integrated device for coupling plasma and negative pressure closed drainage according to claim 1, characterized in that, The integrated device coupling plasma and negative pressure closed-loop drainage is a single-unit structure; or, The high-voltage power supply included in the drainage unit, wound covering unit, irrigation unit, and plasma discharge unit is a separate structure, but when in use, they are assembled to form a complete integrated device.

10. A method of using an integrated device coupling plasma and negative pressure closed-loop drainage, characterized in that, The integrated device for coupling plasma and negative pressure closed drainage is the integrated device for coupling plasma and negative pressure closed drainage as described in any one of claims 1 to 9, and its usage method includes the following steps: Cover and secure the wound covering unit to the wound surface; The drainage unit includes a drainage port that is inserted into the wound covering unit, and the drainage unit is controlled to keep the wound under the wound covering unit in a negative pressure state. The irrigation port of the irrigation unit is inserted into the wound covering unit. In the irrigation mode, the irrigation fluid is controlled to cover the wound through the wound covering unit. The used irrigation fluid and wound exudate are drained out through the drainage unit via the wound covering unit. In plasma mode, the plasma discharge unit is activated to generate plasma by integrating the plasma discharge unit in the irrigation tube and / or drainage tube, and the plasma active substances are used to sterilize the wound and promote healing.

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