An integrated thoracentesis assembly

Abstract

This invention relates to the field of medical device technology and discloses an integrated thoracentesis assembly, including a drainage tube and a display. A puncture needle is disposed within the drainage tube, and the front end of the puncture needle has a puncture needle expansion section. The expansion section includes a self-puncture tip, a tapered expansion segment, and a main body segment. The puncture needle enters the pleural cavity through the expansion section, eliminating the need for guidewire insertion and dilation, eliminating the window period, preventing air from entering the pleural cavity, and reducing the risk of repeated punctures and infection. This invention achieves one-step puncture and catheter placement by overlapping the puncture needle and drainage tube, inserting them simultaneously during puncture, removing the inner core after successful insertion, and leaving the outer tube in place. This eliminates the need for guidewire insertion and dilation, significantly simplifying the operation. The drainage tube is equipped with a valve-type one-way valve to maintain a seal during puncture, solving the problem of tissue debris blockage in the absence of a needle core.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an integrated thoracentesis assembly. Background Technology

[0002] Closed thoracic drainage is a routine procedure used in respiratory and critical care medicine, thoracic surgery, and emergency departments to treat diseases such as pneumothorax, pleural effusion, and hemothorax. The core steps of this procedure are: using a puncture needle to enter the thoracic cavity through the intercostal space, inserting a drainage tube, and draining the gas or fluid from the thoracic cavity out of the body.

[0003] Currently, the thoracentesis kits widely used in clinical practice mainly consist of components such as a puncture needle, guide wire, dilator, drainage tube, syringe, and dressing. During the procedure, doctors rely on touch and anatomical landmarks to determine whether the puncture needle has entered the pleural cavity, and they determine the needle tip position solely by feeling the "loose feeling" when the puncture needle breaks through the pleura.

[0004] Inaccurate pleural breakthrough assessment: In obese patients, with thickened pleura, pleural adhesions, or small pleural effusion, the "empty feeling" is often not obvious or even completely disappears, making it difficult for doctors to accurately determine whether the needle tip has entered the pleural cavity. This can lead to repeated punctures or excessively deep punctures, increasing the risk of complications such as worsening pneumothorax, lung tissue damage, and intercostal vascular injury. Summary of the Invention

[0005] The purpose of this invention is to provide an integrated thoracentesis assembly to solve the problems mentioned in the background art. Technical solution

[0006] This invention provides the following technical solution: an integrated thoracentesis assembly, including a drainage tube and a display, wherein a puncture needle is disposed in the drainage tube, and a puncture needle expansion section is disposed at the front end of the puncture needle. The puncture needle expansion section includes a self-puncture tip, a conical expansion section and a main body section. The puncture needle is inserted into the pleural cavity through the puncture needle expansion section, thereby eliminating the need for guidewire placement, reducing repeated punctures, and lowering the risk of infection and pneumothorax.

[0007] Preferably, the drainage tube is provided with an outer wall sensor, an inner wall sensor, a one-way valve, a wireless module, and a side wall hole. Neither the outer wall sensor nor the inner wall sensor covers the side wall hole, and the side wall hole is in contact with the outer diameter of the puncture needle.

[0008] Preferably, the one-way valve is located at the front end of the inner wall of the drainage tube and adopts a valve-type structure.

[0009] Preferably, the sidewall hole drains gas or liquid from inside the pleural cavity.

[0010] Preferably, the inner diameter of the drainage tube is adapted to the outer diameter of the puncture needle and is movably sleeved outside the inner core of the puncture needle.

[0011] Preferably, a puncture needle sensor and a puncture needle wireless module are also provided on the outside of the puncture needle, and both the puncture needle sensor and the puncture needle wireless module are connected to the display via signals.

[0012] Preferably, the drainage tube is connected to a T-connector at its tail end, and the T-connector is provided with a specimen collection channel, an air and fluid drainage channel, and a pleural infusion channel.

[0013] Beneficial effects: Compared with the prior art, the present invention provides an integrated thoracentesis assembly, which has the following beneficial effects: 1. In this invention, the puncture needle and drainage tube are stacked and inserted simultaneously during puncture. After the puncture is completed, the inner core is pulled out and the outer tube is left in place, realizing a "one-step" puncture and catheter placement, eliminating the steps of guide wire insertion, guide wire removal, and dilation with a dilator, greatly simplifying the operation steps.

[0014] 2. In this invention, a valve-type one-way valve is installed inside the drainage tube to maintain a seal during puncture, thus solving the problem of tissue debris blockage in the absence of a needle core.

[0015] 3. In this invention, the puncture needle uses a tapered progressive expansion structure instead of a blunt dilator, which reduces tissue tearing and compression and alleviates postoperative pain.

[0016] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative only, and are not intended to limit this disclosure.

[0017] This application provides an overview of various implementations or examples of the technology described in this disclosure, and is not a full disclosure of the entire scope or all features of the disclosed technology. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this invention. For those skilled in the art, other drawings can be obtained based on these drawings.

[0019] Figure 1 This is a front view of the overall structure of the present invention; Figure 2 This is a cross-sectional view of the puncture assembly of the present invention; Figure 3 This is a front view of the drainage tube in this invention.

[0020] Explanation of reference numerals in the attached figures: In the diagram: 1. Drainage tube; 2. Sensor on the outer wall of the drainage tube; 3. Puncture needle; 4. Puncture needle sensor; 5. Puncture needle expansion section; 6. Puncture needle wireless module; 7. Display; 8. Sensor on the inner wall of the drainage tube; 9. One-way valve; 10. Wireless module of the drainage tube; 11. Side wall hole; 12. T-connector; 13. Specimen collection channel; 14. Air and fluid drainage channel; 15. Thoracic cavity perfusion channel. Detailed Implementation

[0021] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] Example: Please refer to Figures 1-3 The present invention provides a technical solution: an integrated thoracentesis assembly, including a drainage tube 1 and a display 7. A puncture needle 3 is movably connected through the drainage tube 1. The front end of the puncture needle 3 is provided with a puncture needle expansion section 5. The puncture needle expansion section 5 includes a self-puncture tip, a conical expansion section and a main body section. The puncture needle 3 is punctured into the pleural cavity through the puncture needle expansion section 5, thereby eliminating the need for guide wire insertion and skin dilation with a dilator, reducing repeated punctures, and lowering the risk of infection and pneumothorax.

[0023] From the puncture tip, the front end of the puncture needle 3 is a sharp three-sided beveled needle tip, which can independently puncture the skin and tissue without the need for a separate puncture needle core.

[0024] The conical dilation section is located behind the puncture tip, and its outer diameter gradually increases from the tip diameter to the main body diameter, so that puncture and dilation are completed simultaneously.

[0025] The main section, located behind the conical expansion section, is a tubular structure of equal diameter, used to form a puncture channel and guide the insertion of the drainage tube.

[0026] The puncture needle wireless module 6 at the end of the puncture needle 3 includes a magnetic induction coil, a power management unit, and a Bluetooth module. The connection between the magnetic induction coil, the power management unit, and the Bluetooth module all adopt existing mature technologies.

[0027] In this embodiment, the drainage tube 1 is equipped with an outer wall sensor 2, an inner wall sensor 8, a one-way valve 9, a wireless module 10, and a side wall hole 11. Neither the outer wall sensor 2 nor the inner wall sensor 8 covers the side wall hole 11, and the side wall hole 11 is in contact with the outer diameter of the puncture needle 3.

[0028] Inside the drainage tube outer wall sensor 2 and the drainage tube inner wall sensor 8, there is an impedance sensor: consisting of a first electrode and a second electrode set on the outer wall of the puncture needle tip, with a spacing of 0.5-2mm between the first electrode and the second electrode, forming an impedance measurement circuit. It is used to measure the impedance value of the tissue around the needle tip, and the type of tissue (skin, subcutaneous fat, muscle, pleura, pleural effusion, lung tissue, etc.) is determined by the magnitude of the impedance value. A micro-electro-mechanical system (MEMS) pressure sensor is set at the tip of the puncture needle 3 to measure the pressure value borne by the needle tip in real time, to sense the mechanical changes during the puncture process, and to help judge the "feeling of emptiness" at the moment of pleural breakthrough.

[0029] The outer wall sensor 2 and the inner wall sensor 8 of the drainage tube are used for real-time monitoring during the tube placement stage.

[0030] The drainage tube 1 has a flexible tubular structure and is made of medical-grade silicone or polyurethane. Its inner diameter is compatible with the outer diameter of the puncture needle 3.

[0031] In this embodiment, the one-way valve 9 is located at the front end of the inner wall of the drainage tube 1 and adopts a valve-type structure.

[0032] In this embodiment, the side wall hole 11 drains gas or liquid from the pleural cavity.

[0033] In this embodiment, the inner diameter of the drainage tube 1 is adapted to the outer diameter of the puncture needle 3, and is movably sleeved on the outside of the inner core of the puncture needle.

[0034] The drainage tube 1 has a side wall hole 11 at the front end, which is used to drain gas or fluid from the pleural cavity.

[0035] The drainage tube wireless module 10 is located at the tail of the drainage tube and has the same structure as the puncture needle wireless module 6 at the tail of the puncture needle 3. It is also connected to the display 7 via signal to transmit sensor data during tube placement.

[0036] In this embodiment, a puncture needle sensor 4 and a puncture needle wireless module 6 are also provided on the outside of the puncture needle 3. Both the puncture needle sensor 4 and the puncture needle wireless module 6 are connected to the display 7 via signals.

[0037] In this embodiment, the end of the drainage tube 1 is connected to a three-way connector 12, and the three-way connector 12 is provided with a specimen collection channel 13, an air and fluid drainage channel 14, and a pleural perfusion channel 15.

[0038] The outer diameter of the inner core of the puncture needle is a tapered expansion section with a gradually increasing outer diameter, ranging from 1.2 mm to 2.0 mm; the length of the puncture needle 3 is 15-25 mm, and the taper is 1:8 to 1:12, achieving gradual and uniform expansion; the surface hydrophilic coating reduces friction and tissue damage.

[0039] The puncture needle sensor 4 installed at the front end of the puncture needle 3 is used for tissue identification and pleural breakthrough judgment during the puncture stage; the drainage tube outer wall sensor 2 at the front end of the drainage tube 1 is used for real-time position monitoring during the tube placement stage; the impedance sensor and MEMS pressure sensor are integrated at the front end of the puncture needle to realize the dual functions of tissue type identification and mechanical change sensing. The electrode is arranged on the outer wall and the pressure sensor is arranged on the inner wall, realizing real-time tissue identification and pleural breakthrough judgment in the absence of a needle core, providing objective data support for pleural breakthrough judgment.

[0040] The display 7 is a reusable control unit that integrates a signal processing module, a power module, and a human-machine interaction module. It is equipped with a contactless wireless connection interface, including: a magnetic induction transmitting coil, a Bluetooth main module, a depth detection unit, an angle detection unit, a signal processing module, and an output module.

[0041] Magnetic induction transmitting coil: used to provide wireless power to the puncture assembly, operating at a frequency of 13.56MHz or 125kHz.

[0042] Bluetooth main module: Built-in BLE5.3 chip, which serves as the main device for wireless data communication with the puncture component.

[0043] Depth detection unit: Located inside the display, it consists of a Hall sensor and a magnetic scale (attached to the tail of the puncture needle 3) for real-time measurement of puncture depth with a resolution of 0.1 mm. Due to the wireless connection, depth detection can be performed non-contactly through the magnetic scale and the Hall sensor.

[0044] Angle detection unit: Located inside the display, it is a six-axis inertial measurement unit (IMU) that measures the angle between the puncture needle and the chest wall in real time with an accuracy of ±1°.

[0045] Signal processing module: Receives sensor data sent by the puncture component via Bluetooth, and simultaneously receives signals from the depth detection unit and angle detection unit. It executes algorithms such as tissue recognition, pleural breakthrough judgment, depth monitoring, and angle monitoring. The signal processing module also controls the power supply start and stop of the magnetic induction transmitting coil.

[0046] The signal processing module is configured to receive and process signals acquired by each unit, and performs the following operations: It receives sensor data (impedance value, pressure value) from the puncture component via Bluetooth, and simultaneously collects depth and angle values.

[0047] The electrical impedance value is compared with a preset tissue impedance threshold to identify the current tissue type. Pleural breakthrough is determined by calculating the rate of change of electrical impedance value dZ / dt and the rate of change of pressure value dP / dt. When the absolute value of dZ / dt exceeds the preset threshold (e.g., 30% / 0.1s) and dP / dt is negative (sudden pressure drop), it is determined to be a pleural breakthrough event.

[0048] Depth monitoring: Compares the current depth value with a preset safe depth threshold (e.g., 8cm, adjustable according to patient size). When the depth exceeds the safe threshold and no pleural breakthrough event is detected, a depth over-limit alarm signal is output.

[0049] Angle monitoring: Compares the current angle value with a preset safe angle range (e.g., 60°-90°). When the angle exceeds the safe range, an angle deviation warning signal is output.

[0050] Output module: includes an OLED display, RGB indicator lights, and a buzzer, used to provide real-time feedback to the operator.

[0051] Output module: The output module is electrically connected to the signal processing module and is used to provide the operator with feedback signals corresponding to the current state. The output module includes: a display unit: used to display tissue type, electrical impedance value, pressure value, depth value, and angle value in real time.

[0052] Indicator unit: Located on the display panel, it indicates the current status through different colors (e.g., yellow - needle insertion, orange - approaching the pleura, green - safe, red - danger).

[0053] Sound unit: Located on the display panel, it alerts the operator through different beeping modes (intermittent beep - approaching the pleura, continuous beep - high risk warning, short beep - breakthrough confirmation).

[0054] The display is equipped with a magnetic induction transmitting coil, and the puncture component is equipped with a receiving coil. The disposable consumables are powered by electromagnetic coupling, eliminating the need for a built-in battery. The Bluetooth Low Energy (BLE) 5.3 protocol is used to achieve real-time transmission of sensor data with a latency of <10ms, meeting the millisecond-level event capture requirements of pleural breakthrough. The puncture component features a fully sealed, contactless design, achieving IPX8 waterproof rating. This completely solves problems such as difficulty in disinfecting electrical contacts, poor contact, and poor sealing, while also improving the degree of freedom of operation.

[0055] The working principle of this embodiment is as follows: In use, first take out the various components for puncture from the sterile package. The puncture needle 3 passes through the drainage tube 1 and is pre-placed in the drainage tube 1. At the same time, the tip of the puncture needle 3 protrudes about 2-5mm from the front end of the drainage tube. Bring the assembled puncture assembly close to the front end of the display 7, at a distance of about 1-3cm. The display 7 automatically detects the puncture assembly and starts magnetic induction power supply: the display transmitting coil generates a 13.56MHz high-frequency electromagnetic field, and the puncture assembly receiving coil couples to generate an induced voltage. After rectification and voltage regulation by the power management unit, it powers the Bluetooth slave module and the sensor. After the Bluetooth slave module is powered on, it automatically broadcasts. The display Bluetooth master module scans and establishes a connection. The whole process takes less than 2 seconds. After the system self-test passes, the display shows the initial interface, and the indicator light shows a yellow standby state. The operator can preset the safe depth (such as 6cm, 8cm, 10cm) and angle range (such as 60°-90°) in the system according to the patient's body shape.

[0056] The operator inserts the puncture needle 3 from the puncture assembly, aligning the tip with the predetermined puncture point. The needle pierces the skin from the puncture tip, and the sensor unit begins operation, displaying an impedance value of 300-600Ω (skin). The display shows "skin." As the needle advances, the impedance value gradually decreases to 100-300Ω (subcutaneous tissue). The depth detection unit begins recording the depth, and the angle detection unit displays the angle in real time. The tapered expansion section on the puncture needle 3 enters the tissue along with the needle tip. Because its outer diameter gradually increases from 1.2mm to 2.0mm, channel expansion is completed simultaneously during the puncture process. The operator experiences no significant additional resistance. The expansion process is completed synchronously with the puncture, and the system continuously monitors it. The indicator light remains constantly yellow. When the impedance value drops to the 50-150Ω range near the pleura, the system... When the system detects that the needle tip is close to the pleura, the indicator light flashes orange, the buzzer emits an intermittent beep (0.5Hz), and the display shows "Approximately 2mm from the pleura, please advance the needle slowly." The operator slows down the needle advance speed according to the prompt. When the needle tip passes through the pleura and enters the pleural cavity, the impedance value drops sharply from 80-150Ω to 10-50Ω (effusion) or 50-100Ω (pneumothorax) within 0.1 seconds. At the same time, the MEMS pressure sensor detects the sudden drop in pressure (typical "feeling of falling back"). The signal processing module detects that dZ / dt exceeds 30% / 0.1s and dP / dt is negative, which is determined to be a pleural breakthrough event. The indicator light flashes green, the buzzer emits a short beep, and the display shows "Entered the pleural cavity, please stop advancing the needle." The operator stops advancing the needle according to the prompt.

[0057] Throughout the puncture process, the system continuously monitors the depth and angle. If the depth exceeds the preset safety threshold (e.g., 8cm) and no pleural breakthrough is detected, the indicator light will flash red, the buzzer will sound continuously, and the display will show "Depth exceeded! Stop immediately". If the angle exceeds the preset safety range (e.g., 60°-90°), the system will issue an angle deviation prompt to guide the operator to adjust the needle insertion direction.

[0058] Monitoring during catheter placement: After successful puncture, the puncture assembly is located in the thoracic cavity. The one-way valve 9 at the front end of the drainage tube 1 remains closed during the puncture to prevent tissue debris from entering the drainage tube. The operator slowly pulls the puncture needle 3 out of the drainage tube 1. Since the conical expansion section of the puncture needle 3 has been pre-expanded, the drainage tube 1 can be smoothly left in place. After the puncture needle 3 is pulled out, the drainage tube 1 is located in the thoracic cavity, and the three-way connector 12 at the rear end is exposed outside the body. A drainage bag or drainage bottle can be connected as needed.

[0059] The drainage tube sheath is equipped with a front-end sensor and an independent wireless module. During insertion, the sensor continuously monitors the impedance and pressure values ​​of the front tissue. Real-time guidance: ① When the front end of the drainage tube is in the pleural cavity, the impedance value is stable at 10-50Ω (effusion) or 50-100Ω (pneumothorax), and the indicator light is solid green, indicating a "safe zone". If the tube is inserted too deeply and the front end touches the lung tissue, the impedance value suddenly rises to 100-300Ω, and the system immediately identifies and triggers a red alarm. The indicator light flashes red, the sound unit emits a continuous beep, and the display shows "High risk! Lung tissue may be in contact, please stop insertion immediately". The operator stops insertion according to the alarm and withdraws the drainage tube to a safe position.

[0060] Postoperative positioning confirmation: After catheter placement, rotate and pull out the inner core of the puncture needle, leaving the drainage tube in place and secured. The inner core of the puncture needle is disposed of as medical waste; the monitor is reusable. During chest tube placement, the operator can measure the impedance value at the tip of the drainage tube in real time. If the impedance value is within the normal range for pleural effusion (10-50Ω), it indicates that the drainage tube is in good position. If the impedance value is abnormally high (>100Ω), it indicates that the tube may be blocked, displaced, or dislodged.

[0061] The foregoing has only described certain exemplary embodiments of the present invention by way of illustration. Undoubtedly, those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the foregoing drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.

Claims

1. An integrated thoracentesis assembly, comprising a drainage tube (1) and a display (7), characterized in that: The drainage tube (1) is provided with a puncture needle (3), and the front end of the puncture needle (3) is provided with a puncture needle expansion section (5). The puncture needle expansion section (5) includes a self-puncture tip, a conical expansion section and a main body section. The puncture needle (3) is punctured into the pleural cavity through the puncture needle expansion section (5), thereby eliminating the need for guide wire insertion and dilator skin expansion, reducing repeated punctures, and lowering the risk of infection and pneumothorax.

2. The integrated thoracentesis assembly according to claim 1, characterized in that: The drainage tube (1) is equipped with a drainage tube outer wall sensor (2), a drainage tube inner wall sensor (8), a one-way valve (9), a drainage tube wireless module (10), and a side wall hole (11). Neither the drainage tube outer wall sensor (2) nor the drainage tube inner wall sensor (8) covers the side wall hole (11). The side wall hole (11) is in contact with the outer diameter of the puncture needle (3).

3. The integrated thoracentesis assembly according to claim 2, characterized in that: The one-way valve (9) is located at the front end of the inner wall of the drainage tube (1) and adopts a valve structure.

4. The integrated thoracentesis assembly according to claim 2, characterized in that: The side wall hole (11) drains gas or liquid from the pleural cavity.

5. The integrated thoracentesis assembly according to claim 1, characterized in that: The inner diameter of the drainage tube (1) is adapted to the outer diameter of the puncture needle (3) and can be movably sleeved on the outside of the inner core of the puncture needle.

6. The integrated thoracentesis assembly according to claim 1, characterized in that: The puncture needle (3) is also provided with a puncture needle sensor (4) and a puncture needle wireless module (6) on its outer side. Both the puncture needle sensor (4) and the puncture needle wireless module (6) are connected to the display (7) via signals.

7. The integrated thoracentesis assembly according to claim 1, characterized in that: The drainage tube (1) is connected to a three-way connector (12) at its tail end. The three-way connector (12) is provided with a specimen collection channel (13), an air and fluid drainage channel (14), and a pleural perfusion channel (15).

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