Pericardial puncture sheath needle

Abstract

This application discloses a pericardial puncture sheath needle, comprising an outer sheath needle, a puncture needle, a needle slide, and a negative pressure injector. The outer sheath needle is fitted onto the puncture needle, and the puncture needle slides inside the outer sheath needle via the needle slide. The negative pressure injector is connected to the outer sheath needle via a Luer interface. The outer sheath needle includes an upturned tip and a straight sheath needle, the straight sheath needle being connected to the upturned tip. A negative pressure hole is provided at the end of the straight sheath needle near the upturned tip. The puncture needle has a drainage hole. When the puncture needle slides to its outermost position, the tip of the puncture needle is located on the side of the negative pressure hole away from the upturned tip. When the puncture needle slides to its innermost position, the drainage hole corresponds to the negative pressure hole. By setting the upturned tip, the sheath needle can conform to the human body structure when entering the body. By setting the negative pressure hole, the puncture site can be drawn into the sheath needle by negative pressure, and then the puncture needle can be used to puncture the pericardial tissue.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a pericardial puncture sheath needle. Background Technology

[0002] Pericardiocentesis is an important technique for diagnosing and treating pericardial diseases. A needle is inserted into the pericardial cavity to aspirate fluid or inject medication. Traditional needles are mostly straight, which are poorly adapted to the anatomy of the human pericardium. During insertion, the needle tip can easily deviate from the pericardial cavity, leading to accidental puncture of the myocardium, coronary arteries, or lung tissue, causing serious complications such as pericardial hemorrhage and pneumothorax. Furthermore, the current method of using an external sheath needle and a puncture needle lacks a clear positioning mechanism, and the puncture depth relies entirely on the physician's experience. If the puncture is too shallow, it will not be able to enter the pericardial cavity; if it is too deep, it may penetrate the pericardial wall and damage the heart, especially with increased risk during respiratory movements or changes in body position. Summary of the Invention

[0003] In view of the aforementioned problems, this application is made in order to provide a pericardial puncture sheath needle that overcomes or at least partially solves the aforementioned problems.

[0004] This invention discloses a pericardial puncture sheath needle, comprising an outer sheath needle, a puncture needle, a needle slide plug, and a negative pressure syringe;

[0005] The outer sheath needle is fitted onto the puncture needle, the puncture needle slides inside the outer sheath needle through the needle plug, and the negative pressure injector is connected to the outer sheath needle through a Luer interface;

[0006] The outer sheath needle includes an upturned tip and a straight sheath needle, the straight sheath needle being connected to the upturned tip, and a negative pressure hole being provided at one end of the straight sheath needle near the upturned tip; the puncture needle is provided with a drainage hole;

[0007] When the puncture needle slides to its outermost position, the tip of the puncture needle is located on the side of the negative pressure hole away from the upward-curved head;

[0008] When the puncture needle slides to the innermost side, the drainage hole corresponds to the negative pressure hole.

[0009] Furthermore, the curvature of the upturned head is 15°.

[0010] Furthermore, the puncture needle is provided with an interface at its tail end, and the interface is equipped with a one-way airtight valve.

[0011] Furthermore, it also includes a "J"-shaped guide wire, which corresponds to the one-way airtight valve.

[0012] Furthermore, the cross-section of the outer sheath needle is elliptical.

[0013] Furthermore, it also includes a pusher, which is connected to the tail of the puncture needle.

[0014] Furthermore, the outer sheath needle is a blunt needle tip.

[0015] Furthermore, the negative pressure hole has the same diameter as the drainage hole.

[0016] Furthermore, the upward-curving tip of the outer sheath needle and the straight sheath needle are integrally formed.

[0017] Furthermore, the needle insertion plug is provided with a positioning buckle, and the puncture needle is provided with two positioning slots corresponding to the positioning buckle. When the puncture needle is at the outermost or innermost position, the positioning buckle and the positioning slots fix the position of the puncture needle.

[0018] This application has the following advantages:

[0019] In the embodiments of this application, addressing the shortcomings of existing technologies where puncture needles are not adapted to human anatomical structures and the insertion process is difficult to determine and position, this application proposes a pericardial puncture sheath needle, comprising an outer sheath needle, a puncture needle, a needle slide plug, and a negative pressure injector; the outer sheath needle is sleeved on the puncture needle, and the puncture needle slides inside the outer sheath needle via the needle slide plug; the negative pressure injector is connected to the outer sheath needle via a Luer interface; the outer sheath needle includes an upturned tip and a straight sheath needle, the straight sheath needle being connected to the upturned tip, and a negative pressure hole being provided at one end of the straight sheath needle near the upturned tip; the puncture needle is provided with a drainage hole; when the puncture needle slides to the outermost side, the needle tip of the puncture needle is located on the side of the negative pressure hole away from the upturned tip; when the puncture needle slides to the innermost side, the drainage hole corresponds to the negative pressure hole. By setting an upward-curving tip, the sheath needle can conform to the human body structure when entering the body, rather than being inserted vertically into the pericardium, thus ensuring the safety of the operation; by setting a negative pressure port, the puncture site can be drawn into the sheath needle through negative pressure, and then the puncture needle can be used to puncture the pericardial tissue, achieving a precise puncture method. Attached Figure Description

[0020] To more clearly illustrate the technical solution of this application, the drawings used in the description of this application will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This is a schematic diagram of the structure of a pericardial puncture sheath needle provided in one embodiment of this application;

[0022] Figure 2This is a schematic diagram of the structure of a pericardial puncture sheath needle provided in an embodiment of this application when the puncture needle slides to the innermost side.

[0023] Explanation of reference numerals in the attached diagram: 101, upturned tip; 102, straight sheath needle; 103, puncture needle; 104, negative pressure hole; 105, drainage hole; 106, needle plug; 107, one-way airtight valve; 108, Luer connector. Detailed Implementation

[0024] To make the objectives, features, and advantages of this application more apparent and understandable, the application will be further described in detail below with reference to the accompanying drawings and specific embodiments. Obviously, the described embodiments are only some, not all, of the embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0025] The inventors, through analysis of existing technologies, discovered that traditional puncture needles are mostly straight in design, resulting in poor compatibility with the anatomical structure of the human pericardium. During insertion, the needle tip is prone to deviating from the pericardial cavity, leading to accidental puncture of the myocardium, coronary arteries, or lung tissue, causing serious complications such as pericardial hemorrhage and pneumothorax. Furthermore, the existing coordination between the external sheath needle and the puncture needle lacks a clear positioning mechanism, relying entirely on the physician's experience to determine the puncture depth. If the puncture is too shallow, it will fail to enter the pericardial cavity; if it is too deep, it may penetrate the pericardial wall and damage the heart, with the risk significantly increasing, especially during patient breathing movements or changes in body position.

[0026] In the embodiments of this application, addressing the shortcomings of existing puncture needles that are not adapted to human anatomy and whose insertion process is difficult to determine and position, this application proposes a pericardial puncture sheath needle, comprising an outer sheath needle, a puncture needle, a needle slide plug, and a negative pressure injector; the outer sheath needle is sleeved on the puncture needle, and the puncture needle slides inside the outer sheath needle via the needle slide plug; the negative pressure injector is connected to the outer sheath needle via a Luer interface; the outer sheath needle includes an upturned tip and a straight sheath needle, the straight sheath needle being connected to the upturned tip, and a negative pressure hole being provided at one end of the straight sheath needle near the upturned tip; the puncture needle is provided with a drainage hole; when the puncture needle slides to the outermost side, the needle tip of the puncture needle is located on the side of the negative pressure hole away from the upturned tip; when the puncture needle slides to the innermost side, the drainage hole corresponds to the negative pressure hole. By setting an upward-curving tip, the sheath needle can conform to the human body structure when entering the body, rather than being inserted vertically into the pericardium, thus ensuring the safety of the operation; by setting a negative pressure port, the puncture site can be drawn into the sheath needle through negative pressure, and then the puncture needle can be used to puncture the pericardial tissue, achieving a precise puncture method.

[0027] Reference Figure 1-2The image shows a pericardial puncture sheath needle, including an outer sheath needle, a puncture needle 103, a needle slide 106, and a negative pressure syringe;

[0028] The outer sheath needle is fitted onto the puncture needle 103, and the puncture needle 103 slides inside the outer sheath needle through the needle slide plug 106. The negative pressure injector is connected to the outer sheath needle through the Luer interface 108.

[0029] The outer sheath needle includes an upturned head 101 and a straight sheath needle 102. The straight sheath needle 102 is connected to the upturned head 101. A negative pressure hole 104 is provided at one end of the straight sheath needle 102 near the upturned head 101. The puncture needle 103 is provided with a drainage hole 105.

[0030] When the puncture needle 103 slides to the outermost position, the tip of the puncture needle 103 is located on the side of the negative pressure hole 104 away from the upturned head 101;

[0031] When the puncture needle 103 slides to the innermost side, the drainage hole 105 corresponds to the negative pressure hole 104.

[0032] It should be noted that the outer sheath needle, as the outer channel, is fitted over the puncture needle 103, forming a concentric nested structure. The outer sheath needle consists of an upturned tip 101 and a straight sheath needle 102, and their connection forms a puncture path that conforms to human anatomy. A negative pressure hole 104 is provided near the upturned end 101 of the straight sheath needle 102. The negative pressure hole 104 corresponds to the puncture position. When the negative pressure hole 104 moves to the puncture position, a negative pressure is generated inside the outer sheath needle by a negative pressure injector, so that the pericardial tissue at the puncture site is adsorbed into the negative pressure hole 104. Then, the puncture needle 103 punctures the adsorbed tissue to achieve pericardial puncture. After the puncture, the puncture needle 103 moves to the innermost side of the outer sheath needle. At this time, the drainage hole 105 coincides with the negative pressure hole 104, that is, the drainage hole 105 corresponds to the puncture position. Fluid aspiration or drug injection is performed inside the pericardium through the drainage hole 105. The puncture needle 103 is made of a high-toughness material. When it is extended to the upturned end 102, it automatically bends with the bending of the sheath tube and automatically returns to its original position when it is extended. The puncture needle 103 allows for simultaneous drainage and puncture procedures, eliminating the need for instrument changes and shortening the operation time.

[0033] The following will further describe a pericardial puncture sheath needle in this exemplary embodiment.

[0034] In one embodiment of this application, the curvature of the upturned head 101 is 15°.

[0035] It should be noted that the 15° curvature of the upward-curving tip 101 allows for close insertion into the thoracic cavity. The pericardium is located within the thoracic cavity, adjacent anteriorly to the sternal body and the 2nd-6th costal cartilages, and inferiorly to the central tendon of the diaphragm; its anatomical position has a certain angle of inclination. Subxiphoid pericardiocentesis is a commonly used clinical approach, requiring the needle to be inserted upwards, backwards, and slightly to the left to avoid organs such as the sternum, ribs, and liver. The 15° curvature of the upward-curving tip 101 perfectly matches the physiological angle of this puncture path, guiding the outer sheath needle and puncture needle 103 along the safest trajectory into the pericardial cavity, minimizing accidental contact with surrounding tissues.

[0036] In one embodiment of this application, the puncture needle 103 is provided with an interface at its tail, and the interface is provided with a one-way airtight valve 107.

[0037] It should be noted that the interface at the tail of the puncture needle 103 is the key hub for connecting external instruments, and the one-way airtight valve 107 is the core control component at the interface. The one-way airtight valve 103 is made of medical-grade elastic material and has an internal valve structure that can open in one direction. When an external instrument is inserted, the valve opens under external force, allowing the instrument to pass through; when the instrument is withdrawn, the valve automatically closes due to its own elasticity, achieving an airtight seal at the interface. This prevents air leakage during the negative pressure puncture process, which could prevent the pericardial tissue from being adsorbed into the negative pressure port 104, and also prevents air and fluid leakage problems caused by open interfaces.

[0038] In one embodiment of this application, a "J"-shaped guide wire is also included, which corresponds to the one-way airtight valve 107.

[0039] It should be noted that the "J"-shaped guidewire corresponds to the one-way airtight valve 107. The valve diameter and elastic coefficient of the one-way airtight valve 107 allow the "J"-shaped guidewire to pass through smoothly. When the guidewire is inserted, the valve can adapt to the shape of the guidewire, ensuring that the guidewire enters the puncture needle 103 without obstruction. The smoothness of the guidewire surface and the rounded curvature of the "J"-shaped head can avoid damage to the valve. At the same time, when the guidewire is in place, the valve and the outer wall of the guidewire fit tightly, maintaining the airtightness of the interface and preventing fluid leakage or air entry.

[0040] Once the puncture needle 103 has been confirmed to have entered the pericardial cavity, a J-shaped guidewire is introduced through a one-way airtight valve. The guidewire can then extend deep into the pericardial cavity along the path of the puncture needle, and its J-shaped head can unfold and be fixed in position within the cavity. At this point, the sheath needle and other systems can be withdrawn, while the guidewire remains in the body. A standard drainage tube is then inserted, locally fixed, and drainage is performed.

[0041] In one embodiment of this application, the cross-section of the outer sheath needle is elliptical.

[0042] It should be noted that the elliptical cross-section ensures that the sheath needle will not rotate inside the body. The frictional force between the elliptical cross-section and the tissue has a directional difference, with a larger contact area along the long axis, which can form anti-rotation damping. During the sliding adjustment of the puncture needle or the indwelling of the outer sheath needle, it can effectively prevent the outer sheath needle from rotating circumferentially due to slight hand rotation or patient movement, ensuring the relative position of the negative pressure port and the drainage port 105 of the puncture needle 103 is stable, and preventing misalignment of the drainage channel due to rotation.

[0043] In one embodiment of this application, a pusher is also included, which is connected to the tail of the puncture needle 103.

[0044] It should be noted that the plunger typically consists of a push rod and a handle. The handle is ergonomically designed for easy gripping and force application by the doctor's fingers. Its connection to the puncture needle's tail employs a robust fitting structure, achieved through snap-fit, threaded, or plug-in methods, ensuring that the plunger and puncture needle 103 will not slip or detach during operation. When puncture is required, the doctor grips the plunger's handle and pushes the push rod to slide the puncture needle 103 to its outermost position. The stable thrust provided by the plunger helps the puncture needle penetrate the tissue smoothly. Because the force is transmitted smoothly, it reduces sudden impact on surrounding tissues during puncture, lowering the risk of tissue damage. Simultaneously, the doctor can better sense the resistance encountered by the puncture needle 103 through the plunger, thereby determining whether the puncture has reached the target location and improving puncture accuracy.

[0045] In one embodiment of this application, the outer sheath needle is a blunt needle tip.

[0046] It should be noted that the blunt tip of the needle is used to advance layer by layer into the pleural cavity and reach the pericardial surface. When the blunt needle touches or slightly touches the tissue, it will not easily cut or penetrate the tissue like a sharp needle. Instead, it will use blunt force to allow the tissue to separate naturally. This provides a physical buffer for surrounding vital organs in case of operational errors or positional deviations, reducing the probability of damage.

[0047] In one embodiment of this application, the negative pressure hole 104 and the drainage hole 105 have the same diameter.

[0048] It should be noted that the negative pressure port 104 and the drainage port 105 are the key channels for the effusion to enter the negative pressure syringe from the pericardial cavity. The fact that both ports have the same diameter ensures a smooth, equal-diameter channel. When the puncture needle slides to the innermost side, and the drainage port 105 corresponds to the negative pressure port 104, if their diameters are different, the drainage port 105 will restrict the flow of effusion, causing effusion to accumulate at the negative pressure port 104.

[0049] In one embodiment of this application, the upturned tip 101 of the outer sheath needle and the straight sheath needle 102 are integrally formed.

[0050] It should be noted that the upward-curved tip 101 and the straight sheath needle 102 are integrated as a single continuous unit, without any welded or bonded seams, eliminating weak points in the connection area and significantly improving the overall strength and toughness of the outer sheath needle. The one-piece molded structure also offers superior fatigue resistance. Unlike separate structures, it will not crack or break due to stress concentration at seams when subjected to repeated sterilization, use, or bending stress. This is especially beneficial in scenarios requiring rapid procedures, such as emergency cardiac tamponade, avoiding the fatal risk of instrument breakage and residue within the body. Furthermore, the curvature of the upward-curved tip 101 is a key parameter for precise puncture; the one-piece molded structure ensures that this curvature remains constant during production and use. Loosening or deformation of the seams in a separate structure can cause the angle of the upward-curved tip 101 to shift, causing the puncture path to deviate from the pericardial cavity, increasing the difficulty and risk of the procedure. The rigid connection of the one-piece molded structure keeps the angle error within an acceptable range, ensuring the accuracy of the puncture direction.

[0051] In one embodiment of this application, the needle slide plug is provided with a positioning buckle, and the puncture needle is provided with two positioning slots corresponding to the positioning buckle. When the puncture needle 103 is at the outermost or innermost position, the positioning buckle and the positioning slots fix the position of the puncture needle 103.

[0052] It should be noted that the positioning buckle is usually made of elastic medical plastic or metal and is located on the inner wall of the needle slide, with its end forming an arc-shaped protrusion. Two positioning grooves are located on the corresponding position on the outer wall of the puncture needle, the shape of which matches the buckle protrusion. When the puncture needle 103 slides to its outermost or innermost position, the buckle protrusion will engage with the corresponding groove under elastic action, forming a mechanical lock. If the position of the puncture needle needs to be changed at this point, a certain external force must be applied to overcome the elastic resistance of the buckle in order to separate the two.

[0053] This combination of elastic embedding and mechanical locking ensures both positioning stability and operational flexibility, solving the problem of traditional sliding plugs being prone to slippage due to lack of positioning.

[0054] When the puncture needle 103 slides to its outermost position, the positioning latch engages in the first slot, securing the puncture needle 103 in that position. This locking ensures that the needle tip always maintains sufficient depth, preventing the puncture needle 103 from dislodging. During puncture, when the puncture needle 103 slides to its innermost position, the positioning latch engages in the second slot. This locking prevents accidental slippage of the puncture needle 103 during drainage, ensuring that the drainage hole and negative pressure hole are always aligned, preventing problems with the drainage device due to positional misalignment.

[0055] Although preferred embodiments of the present application have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments as well as all changes and modifications falling within the scope of the embodiments of the present application.

[0056] Finally, it should be noted that in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or terminal device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or terminal device. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or terminal device that includes said element.

[0057] The above provides a detailed description of a pericardial puncture sheath needle provided in this application. Specific examples have been used to illustrate the principles and implementation methods of this application. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this application. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the ideas of this application. Therefore, the content of this specification should not be construed as a limitation of this application.

Claims

1. A pericardial puncture sheath needle, characterized in that, Includes outer sheath needles, puncture needles, needle slide plugs, and negative pressure syringes; The outer sheath needle is fitted onto the puncture needle, the puncture needle slides inside the outer sheath needle through the needle plug, and the negative pressure injector is connected to the outer sheath needle through a Luer interface; The outer sheath needle includes an upturned tip and a straight sheath needle, the straight sheath needle being connected to the upturned tip, and a negative pressure hole being provided at one end of the straight sheath needle near the upturned tip; the puncture needle is provided with a drainage hole; the cross-section of the outer sheath needle is elliptical; the needle slide plug is provided with a positioning buckle, and the puncture needle is provided with two positioning slots corresponding to the positioning buckle. When the puncture needle is at the outermost or innermost position, the positioning buckle and the positioning slots fix the position of the puncture needle. When the puncture needle slides to its outermost position, the tip of the puncture needle is located on the side of the negative pressure hole away from the upward-curved head; When the puncture needle slides to the innermost side, the drainage hole corresponds to the negative pressure hole.

2. The pericardial puncture sheath needle according to claim 1, characterized in that, The curvature of the upturned end is 15°.

3. The pericardial puncture sheath needle according to claim 1, characterized in that, The puncture needle has an interface at its tail end, and the interface is equipped with a one-way airtight valve.

4. The pericardial puncture sheath needle according to claim 3, characterized in that, It also includes a "J"-shaped guide wire, which corresponds to the one-way airtight valve.

5. The pericardial puncture sheath needle according to claim 1, characterized in that, It also includes a pusher, which is connected to the tail of the puncture needle.

6. The pericardial puncture sheath needle according to claim 1, characterized in that, The outer sheath needle has a blunt tip.

7. The pericardial puncture sheath needle according to claim 1, characterized in that, The negative pressure hole has the same diameter as the drainage hole.

8. The pericardial puncture sheath needle according to claim 1, characterized in that, The upward-curving tip of the outer sheath needle and the straight sheath needle are integrally formed.

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