Safe pericardiocentesis device and its usage

Abstract

The present invention discloses a puncture needle, which is composed of a needle body and a needle seat. The head end of the needle body is laterally bent, the needle opening is opened on the inner side of the bend and is perpendicular to the longitudinal axis of the needle body, and the needle tip is an arc-shaped cutting surface. Based on this, the inventor has also designed a matching guide wire ejector, and the two together constitute a safe pericardial puncture device. Among them, the puncture needle with a side opening can reduce the sharpness of the tip of the puncture needle, change the direction of the outlet, and reduce the risk of the puncture needle and the guide wire piercing the heart; the guide wire ejector is used in conjunction with the puncture needle, and the guide wire can be automatically ejected from the lateral needle opening into the pericardial cavity at the moment when the needle opening completely enters the pericardium, so as to avoid inadvertent shaking of the puncture needle so that the needle tip pierces the heart and the guide wire is directly ejected toward the heart to damage the heart, thereby playing an immediate role in protecting the heart. Therefore, the present invention can be used to conveniently and quickly implement pericardial puncture, and it is safe, stable and reliable.

Description

Technical Field

[0001] The invention belongs to the technical field of pericardiocentesis, and in particular relates to a safe pericardiocentesis device and a use method thereof. Background Art

[0002] Pericardiocentesis is an important method for clinical diagnosis and treatment of pericardial effusion and epicardial ablation of ventricular arrhythmias. The risk of pericardial puncture is high due to the small pericardial cavity, narrow puncture safety window, proximity to important organs, continuous heart beating, and dense coronary arteries and veins on the surface of the heart. Traditional pericardiocentesis can easily damage the heart and its blood vessels, adjacent organs, and can lead to complications such as acute cardiac tamponade, hemothorax, abdominal organ damage, and lung damage. In severe cases, pericardial drainage, blood transfusion, thoracotomy, abdominal exploration, and surgical repair of tissue organs are required, causing significant damage and economic burden to patients and great pressure on physicians. Studies have shown that the incidence of significant pericardial effusion caused by inadvertent puncture of myocardial tissue during pericardiocentesis is 3.7%-10% ([1] Chen Lian. Preliminary exploratory study of improved catheter ablation technology for refractory ventricular arrhythmias [D]. Peking Union Medical College, 2017.).

[0003] At present, the guidance methods for pericardiocentesis include blind puncture after ultrasound positioning, real-time ultrasound-guided puncture, CT-guided puncture, DSA-guided puncture, puncture under epicardial electrogram monitoring, and 3D electrophysiology-guided puncture. Commonly used puncture needles are reported in the following literature:

[0004] 1. Thoracentesis ([2] Liu Kequan, Li Shengjin, You Na, Xia Mingkai, Wu Jinghong. Methods, complications and treatment strategies of pericardial puncture and drainage [J]. Clinical Collection, 2002, 06: 365-367.)

[0005] 2. Central venous puncture needle ([3] Li Jie, Zhou Yi, Jia Yong, Gao Jing, Fei Dun. Clinical effect of central venous catheter in pericardial effusion puncture and drainage [J]. China Medical Guide, 2014, 24: 26-27.)

[0006] 3. Tuohy needle ([4] Huang Kechang, Li Guangzong. Morphological measurement of the tips of several Tuohy epidural puncture needles and their clinical significance [J]. Journal of Clinical Anesthesiology, 2003, 09: 580-581.)

[0007] 4. Pajunk needle ([5] Guo Min. Evaluation of the effect of Pajunk enhanced echogenic needle in brachial plexus block [D]. Wannan Medical College, 2018.)

[0008] The common characteristics of the above puncture needles are that the tip is sharp and lacks a protection mechanism, which can easily injure the heart and its blood vessels and cause a series of complications. Therefore, a safer and more effective medical device and puncture method are urgently needed clinically to avoid accidental injury to the heart and its blood vessels during pericardial puncture. Summary of the invention

[0009] The technical problem to be solved by the present invention is to provide a safe pericardiocentesis device and a method for using the same which is simple and reasonable in structure, convenient and quick to use, stable and reliable.

[0010] In order to solve the above technical problems, the present invention adopts the following technical solutions:

[0011] The puncture needle is composed of a needle body and a needle seat. The head end of the needle body is laterally bent, the needle opening is opened on the inner side of the bend and is perpendicular to the longitudinal axis of the needle body, and the needle tip is an arc-shaped cutting surface.

[0012] A safe pericardiocentesis device, including a guidewire ejector and a puncture needle;

[0013] The guide wire ejector is mainly composed of a low-resistance syringe, which includes an outer sleeve, a guide wire tube and a core rod; the outer sleeve has a cone head at the front end, a curled edge at the opening at the rear end of the outer sleeve, and a bottom plate is tightly fastened outside the curled edge, and a hole is provided in the center of the bottom plate that is concentric with the opening of the outer sleeve; a spring is built into the rear section of the outer sleeve, and the rear end of the spring is supported on the inner wall of the bottom plate; a staple and a bayonet are provided in the middle of the outer sleeve, and the staple passes through the bayonet and is embedded in the outer sleeve; the cone head is tightly connected to the coaxial guide wire tube head end in the outer sleeve, and the cone head hole is smoothly connected with the inner cavity of the guide wire tube, and there are two side holes at the connection between the front section of the guide wire tube and the cone head hole that are connected to the inner cavity of the outer sleeve; the core rod includes a core tube, and the core tube is sleeved outside the coaxial guide wire tube. The central cavity of the core tube runs through both ends, and a valve is provided at the end of the core tube extending out of the bottom plate; a piston is provided at the head end of the core tube, and a sealing ring is provided on the piston sleeve; the outer wall of the core tube behind the piston is provided with four mutually perpendicular and four-way radially arranged support plates; the centripetal end of the support plate is connected to the core tube, and the edge end is close to the inner wall of the outer sleeve; two groups of fan-shaped cards in opposite directions are arranged at the edge ends of a pair of support plates on the same plane, and several fan-shaped cards are arranged along the longitudinal axis of the core tube, and a card slot is formed between two adjacent fan-shaped cards, and a notch that can pass the card pin is provided on the support plate in each card slot; a vertical partition is provided on the core tube after the card slot, and the partition is parallel to the piston, and the front end of the spring coil is against the partition;

[0014] The needle seat of the puncture needle is tightly connected to the cone head of the guide wire ejector through a screw joint. The guide wire passes through the core tube and the guide wire tube through the valve, and then passes through the needle seat from the cone head hole and penetrates the needle body.

[0015] The needle body or the guide wire tube is made of a medical stainless steel tube, and the tail end of the needle body is connected to the needle seat.

[0016] The specification of the medical stainless steel tube of the needle body is 16G-18G, and the effective length is 8-16cm; the specification of the medical stainless steel tube of the guide wire tube is 16G, and the length is equivalent to the outer sleeve; the guide wire is a J-shaped guide wire with a diameter of ≤0.035 inches.

[0017] The cone head is an external cone locking joint with an internal threaded collar with a center-head fixed connection.

[0018] Spring length ≥2.5-3.5cm.

[0019] Along the longitudinal axis of the core tube, a sector-shaped card is set every 0.5 cm, with a total of 4-6 sector-shaped cards.

[0020] The method of using the safe pericardiocentesis device is to tightly connect the needle seat of the puncture needle and the cone head of the guide wire ejector through a screw joint, and the guide wire is sent into the central cavity of the core rod, passes through the core tube and the guide wire tube through the valve, and then passes through the needle seat from the cone head hole and the needle body to reach the needle port; when the puncture needle is pushed to the target position, the guide wire is automatically ejected from the lateral needle port under the action of the guide wire ejector.

[0021] In view of the existing problems of pericardial puncture, the inventor has designed and manufactured a puncture needle, which consists of a needle body and a needle seat. The head end of the needle body is bent laterally, the needle opening is opened on the inner side of the bend and is perpendicular to the longitudinal axis of the needle body, and the needle tip is an arc-shaped cutting surface. Based on this, the inventor has also designed a matching guide wire ejector, and the two together constitute a safe pericardial puncture device. Among them, the puncture needle with a side opening can reduce the sharpness of the puncture needle tip, change the direction of the exit, and reduce the risk of the puncture needle and guide wire puncturing the heart; at the same time, it can also prevent tissue debris from being embedded in the needle hole during puncture, causing the guide wire to be stuck and the ejection failure; the guide wire ejector is used in conjunction with the puncture needle, and the guide wire can be automatically ejected from the lateral needle hole into the pericardial cavity at the moment the needle hole completely enters the pericardium, avoiding inadvertent shaking of the puncture needle to cause the needle tip to puncture the heart and the guide wire directly bouncing toward the heart and damaging the heart, thereby immediately protecting the heart; triggering the guide wire ejection indicates that the needle hole has entered the pericardial cavity, which is conducive to judging the position of the needle tip; in addition, the ejector also has a negative pressure suction function, and the outflow of pericardial effusion can be observed at the moment the needle hole completely enters the pericardium, which is conducive to judging that the needle hole has entered the pericardial cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a schematic diagram of the structure of the puncture needle.

[0023] Figure 2 The invention is a schematic diagram of the use state and structure of the guide wire ejection device, wherein: the core rod is pulled open, the core rod is rotated, the pin is inserted into the groove, and the spring is compressed.

[0024] Figure 3 The invention is a schematic diagram of the use state and structure of the guide wire ejection device, wherein: the core rod is rotated, the staple is ejected from the groove, the spring is released, and the core rod moves forward.

[0025] Figure 4 This is the core rod sliding position indication Figure 1 , wherein: the staple is located outside the slot, and the core rod can slide longitudinally.

[0026] Figure 5 Rotating core rod Figure 1 Wherein: the core rod is rotated, the staple enters the slot, and the core rod is locked (that is, the core rod cannot slide longitudinally).

[0027] Figure 6 Rotating core rod Figure 2 , wherein: the core rod is rotated, the staple passes over the notch of the support plate and escapes from the slot.

[0028] Figure 7 This is the core rod sliding position indication Figure 2 , wherein: the core rod can slide longitudinally.

[0029] Figure 8 Schematic diagram of assembling the safe pericardiocentesis device of the present invention Figure 1 , wherein: the safety puncture needle seat is tightly connected with the screw cone head, the J-shaped guide wire passes through the core tube of the core rod, the guide wire tube, the cone hole and the puncture needle, reaches the needle port, and the staple is placed in the sliding position.

[0030] Fig. 9 Schematic diagram of assembling the safe pericardiocentesis device of the present invention Figure 2 , wherein: keep the guide wire in place, pull out the core rod 0.5-3.0cm, and compress the spring; rotate the core rod so that the staple passes through the notch on the support plate, enters the card slot, and is stuck on the card, that is, the core rod is placed in the locking position; tighten the valve at the tail of the core rod to fix the guide wire on the core rod, and the guide wire and the core rod are connected as one.

[0031] Fig.10 The present invention is a schematic diagram of the operation process of performing pericardiocentesis using the safe pericardiocentesis device of the present invention, wherein:

[0032] aAfter local anesthesia, make a 2 mm skin incision and insert the safety puncture needle into the subcutaneous tissue. Stop inserting the needle when it approaches the pericardial wall.

[0033] b Rotate the core rod, the staple moves out of the slot through the notch of the support plate to the other smooth side of the support plate, and the core rod is placed in the sliding position. Due to the elastic force of the spring, the head end of the J-type guide wire tightly presses against the subcutaneous tissue outside the needle port, and the ejector is ready to go.

[0034] c Push the puncture needle to break through the pericardial wall layer, and the needle port completely enters the pericardial cavity. The resistance at the tip of the J-type guide wire suddenly disappears. Under the action of the spring force, the core rod drives the J-type guide wire forward, and the J-type guide wire is immediately sent into the pericardial cavity.

[0035] d When the J-shaped guide wire pops out of the puncture needle and enters the pericardial cavity, the tip of the J-shaped guide wire curls naturally and returns to a round and blunt J shape to avoid damaging the heart.

[0036] In the figure: 1 needle port, 2 needle body, 3 guide wire, 4 needle seat, 5 cone head, 6 side hole, 7 notch, 8 slot, 9 staple, 10 card, 11 spring, 12 curling edge, 13 bottom plate, 14 valve, 15 screw joint, 16 guide wire tube, 17 piston, 18 support plate, 19 partition, 20 outer sleeve, 21 central cavity, 22 core tube, 23 heart, 24 pericardial cavity, 25 pericardial wall, 26 subcutaneous tissue. DETAILED DESCRIPTION

[0037] 1. Basic structure

[0038] A safe pericardiocentesis device comprises a guide wire ejector and a puncture needle.

[0039] The puncture needle is composed of a needle body and a needle seat. The head end of the needle body is bent laterally, the needle mouth is opened on the inner side of the curve and is approximately perpendicular to the longitudinal axis of the needle body. The needle tip is an arc-shaped cutting surface, which is sufficient for piercing the pericardium, but not as sharp as an ordinary pen-tip puncture needle to avoid accidental injury to the heart.

[0040] The guide wire ejector is mainly composed of the YY / T 0909-2013 disposable low-resistance syringe as the basis, and the low-resistance syringe includes an outer sleeve, a guide wire tube and a core rod; the outer sleeve has a cone head at the front end, and the cone head is a 6% (Luer) external cone locking joint (GB / T1962.2) of the internal threaded clamp ring with a fixed connection of the middle head type. There is a curling edge at the opening of the rear end of the outer sleeve, and a bottom plate is tightly attached outside the curling edge. The outer contour of the bottom plate is consistent with the curling edge. There is a hole in the center of the bottom plate that is concentric with the opening of the outer sleeve. The hole is 2mm smaller than the radius of the opening of the outer sleeve, which plays the role of blocking the built-in spring of the outer sleeve; the rear section of the outer sleeve has a built-in spring with a length of ≥2.5-3.5cm (the length of the spring is equivalent to the distance of the card (i.e. the ejection distance), and the longer the spring, the longer the ejection distance), and the outer diameter of the spring is smaller than the inner diameter of the outer sleeve and larger than the central hole of the bottom plate. The diameter of the hole enables the rear end of the spring to be supported on the inner wall of the bottom plate and cannot fall out; a staple and a bayonet are provided in the middle of the outer sleeve, and the staple passes through the bayonet and is embedded in the outer sleeve to prevent the core rod from sliding back and forth; the cone head is tightly connected to the head end of the coaxial wire guide tube in the outer sleeve, and the cone head hole is smoothly connected with the inner cavity of the wire guide tube. There are two side holes at the connection between the front section of the wire guide tube and the cone head hole that are connected to the inner cavity of the outer sleeve, and the tail is close to the tail end of the outer sleeve; the core rod includes a tubular core tube, and its central cavity runs through both ends. The diameter of the core tube is slightly larger than 16G, so that it can be sleeved outside the coaxial wire guide tube, the gap between the core tube and the wire guide tube is minimized, and it can slide freely forward and backward. The central cavity of the core tube runs through both ends, and the end of the core tube extending out of the bottom plate is provided with a valve that can be opened and closed, which can control the opening and closing of the tail opening of the central cavity of the core tube, and can also lock the wire guide; a piston is provided 0.5 cm from the head end of the core tube, and the piston sleeve is provided with a sealing ring; the outer wall of the core tube behind the piston is provided with four mutually perpendicular and four-way radially arranged (cross arrangement); the centripetal end of the support plate is connected to the core tube, and the edge end is close to the inner wall of the outer sleeve; in the same plane Two groups of fan-shaped cards in opposite directions are arranged on the edge ends of a pair of support plates. Along the longitudinal axis of the core tube, a fan-shaped card is set every 0.5cm, with a total of 4-6 fan-shaped cards. A slot is formed between two adjacent fan-shaped cards. Rotating the core rod can make the pins on the outer sleeve enter / exit the slot, which plays a role in limiting / not limiting the longitudinal movement of the core rod; there is a notch on the support plate in each slot that can pass the pins. Rotating the core rod can make the pins on the outer sleeve move from one side of the support plate to the other side through the notch; there is a vertical partition on the core tube after the slot, which divides the core tube into two sections, front and back. The partition is parallel to the piston, and the support plate at the rear section of the core tube is radially reduced by 2mm, so that the spring coil built into the rear section of the outer sleeve presses against the partition and becomes the fulcrum of the front end of the spring coil, and the fulcrum of the rear end of the spring coil is the bottom plate.

[0041] The needle seat of the puncture needle is tightly connected to the cone head of the guide wire ejector through a screw joint. The guide wire passes through the core tube and the guide wire tube through the valve, and then passes through the needle seat from the cone head hole and penetrates the needle body.

[0042] The needle body or guide wire tube is made of medical stainless steel tube, and the tail end of the needle body is connected to the needle seat. The specifications of the medical stainless steel tube of the needle body are 16G-18G (outer diameter 1.26-1.61mm, inner diameter 0.90-1.25mm, tube wall thickness about 0.1mm), and the effective length is 8-16cm; the specifications of the medical stainless steel tube of the guide wire tube are 16G (outer diameter 1.61mm, inner diameter 1.25mm, tube wall thickness about 0.1mm), and the length is equivalent to the outer sleeve; the guide wire is a J-shaped guide wire with a diameter of ≤0.035 inches, which can freely pass through the inner cavity of the medical stainless steel tube.

[0043] 2. Usage

[0044] 1. Tightly connect the needle seat of the puncture needle and the cone head of the guide wire ejector through the screw joint, unscrew the valve at the tail of the core rod of the guide wire ejector, and send the J-type guide wire with a diameter of ≤0.035 inches into the central cavity of the core rod, through the guide wire tube, cone head hole, needle seat, and needle body to the needle port of the safe pericardial puncture device.

[0045] 2. Locally anesthetize the puncture site, use a surgical blade to incise the skin 2mm, and insert the puncture needle into the subcutaneous tissue through the incision.

[0046] 3. Rotate the core rod to the sliding position, keep the guide wire tip at the needle mouth, pull out the core rod 0.5-3cm, and rotate the core rod at the same time so that the pin fixed on the outer sleeve enters the slot on the core rod to fix the core rod in the locked position; tighten the valve at the tail of the core rod, close the tail opening of the central cavity of the core rod, and lock the guide wire at the same time to connect the core rod and the guide wire as one.

[0047] 4. Determine the distance between the safe pericardiocentesis device and the pericardium based on preoperative and / or intraoperative medical images such as ultrasound, X-ray, DSA, CT, etc. When the safe pericardiocentesis device is pushed so that the needle tip approaches the pericardial wall, rotate the core rod to make the staple leave the slot, and the core rod is in the sliding position. The tip of the guide wire is tightly against the subcutaneous tissue outside the needle port, and the spring is ready to go.

[0048] 5. Continue to push the safety puncture needle. When the needle tip breaks through the pericardial wall and completely enters the pericardial cavity, the resistance of the guide wire head disappears, and the guide wire automatically bounces into the pericardial cavity from the side needle port under the action of the spring, which plays an immediate role in protecting the heart. In the narrow pericardial cavity, the blunt J-shaped head of the guide wire isolates the heart and the needle tip to avoid heart damage; the guide wire automatically bounces into the pericardial cavity, which helps the physician to judge that the puncture needle has entered the pericardial cavity and avoids continuing blind operations; the guide wire bounces into the pericardial cavity from the side needle port to avoid the guide wire directly stimulating the heart, damaging the heart or triggering unexpected complications such as arrhythmia; the needle tip design with a side opening prevents tissue debris from being embedded in the needle port during the puncture process, causing the guide wire to be stuck and unable to pop out.

[0049] 6. Unscrew the valve at the end of the core rod, and the pericardial effusion will flow out. Confirm again that the needle port has entered the pericardial cavity. Operate the guide wire to continue to penetrate the pericardial cavity and fix the guide wire; close the valve, pull back the core rod, and the pericardial effusion can be drawn out. Confirm again that the guide wire is stably located in the pericardial cavity.

[0050] 7. Keep the guide wire in the pericardial cavity, withdraw the puncture needle and guide wire ejector, and then complete the pericardial cavity catheterization operation along the guide wire.

[0051] In addition, the safe pericardiocentesis device of the present invention can also be used for medical punctures such as thoracentesis and abdominal puncture. Among them, the guide wire ejector is suitable for various types of guide wires with a diameter of ≤0.035 inches commonly used in clinical practice, and the guide wire is easy to exchange.

Claims

1. A safe pericardiocentesis device, characterized in that Including a guide wire ejector and a puncture needle; The puncture needle is composed of a needle body and a needle seat, and is characterized in that: the head end of the needle body is laterally bent, the needle opening is opened on the inner side of the bend and is perpendicular to the longitudinal axis of the needle body, and the needle tip is an arc-shaped cutting surface; The guide wire ejector is mainly composed of a low-resistance syringe, which includes an outer sleeve, a guide wire tube and a core rod; the outer sleeve has a cone head at the front end, a curling edge at the opening of the rear end of the outer sleeve, and a bottom plate is tightly fastened outside the curling edge, and a hole is provided in the center of the bottom plate that is concentric with the opening of the outer sleeve; a spring is built into the rear section of the outer sleeve, and the rear end of the spring is supported on the inner wall of the bottom plate; a staple and a bayonet are provided in the middle of the outer sleeve, and the staple passes through the bayonet and is embedded in the outer sleeve; the cone head is tightly connected to the coaxial guide wire tube head end in the outer sleeve, and the cone head hole is smoothly connected with the inner cavity of the guide wire tube, and the front section of the guide wire tube and the cone head hole are connected at the connection with the inner cavity of the outer sleeve. The core rod includes a core tube, and the core tube is sleeved outside the coaxial guide wire tube, The central cavity of the core tube runs through both ends, and a valve is provided at the end of the core tube extending out of the bottom plate; a piston is provided at the head end of the core tube, and a sealing ring is provided on the piston sleeve; the outer wall of the core tube behind the piston is provided with four mutually perpendicular and four-way radially arranged support plates; the centripetal end of the support plate is connected to the core tube, and the edge end is close to the inner wall of the outer sleeve; two groups of fan-shaped cards in opposite directions are arranged at the edge ends of a pair of support plates on the same plane, and several fan-shaped cards are arranged along the longitudinal axis of the core tube, and a card slot is formed between two adjacent fan-shaped cards, and a notch that can pass the card pin is provided on the support plate in each card slot; a vertical partition is provided on the core tube after the card slot, and the partition is parallel to the piston, and the front end of the spring coil is against the partition; The needle seat of the puncture needle is tightly connected to the cone head of the guide wire ejector through a screw joint. The guide wire passes through the core tube and the guide wire tube through the valve, and then passes through the needle seat from the cone head hole to the needle body; the cone head is an outer cone locking joint of an internal threaded collar with a fixed connection of a middle head type; The needle body or the guide wire tube is made of a medical stainless steel tube, and the tail end of the needle body is connected to the needle seat.

2. The safe pericardiocentesis device according to claim 1, characterized in that: The specification of the medical stainless steel tube of the needle body is 16G-18G, and the effective length is 8-16cm; the specification of the medical stainless steel tube of the guide wire tube is 16G, and the length is equivalent to the outer sleeve; the guide wire is a J-shaped guide wire with a diameter of ≤0.035 inches.

3. The safe pericardiocentesis device according to claim 1, characterized in that: The spring is 2.5-3.5 cm long.

4. The safe pericardiocentesis device according to claim 1, characterized in that Along the longitudinal axis of the core tube, a sector-shaped card is set every 0.5 cm, with a total of 4-6 sector-shaped cards.

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