Pericardiocentesis guide wire kit
By designing a pericardiocentesis kit with deformable guidewires and tilting catheters, the operational difficulties and risks of dry pericardiocentesis have been resolved, achieving safe and efficient puncture results and reducing complications and radiation exposure time.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- FUWAI HOSPITAL CHINESE ACAD OF MEDICAL SCI & PEKING UNION MEDICAL COLLEGE
- Filing Date
- 2025-12-25
- Publication Date
- 2026-07-02
AI Technical Summary
Existing pericardiocentesis equipment is difficult and risky to operate during dry pericardiocentesis, which can easily lead to serious complications such as myocardial injury and coronary artery injury, and requires a lot of X-ray guidance and monitoring.
Design a pericardiocentesis guidewire kit, including a guidewire and catheter with a flexible and deformable head. The guidewire head can be deformed into delivery, breakthrough, and fully bent shapes. The needle tip deflects to avoid the inner pericardial wall. The distal end of the catheter is tilted to ensure close contact with the outer pericardial wall. Combined with a Y-type tee connector and a locking connector, the kit improves the accuracy and safety of the procedure.
This reduces surgical time and radiation exposure time, increases surgical success rate, reduces the occurrence of complications, and ensures the safety and accuracy of puncture.
Smart Images
Figure CN2025145759_02072026_PF_FP_ABST
Abstract
Description
A pericardial puncture guidewire kit
[0001] Related applications
[0002] This disclosure claims priority to Chinese Patent Application No. CN 202411958285.X, filed on December 27, 2024, entitled “A Pericardial Puncture Guidewire Kit”, the entire contents of which are incorporated herein by reference. Technical Field
[0003] This disclosure relates to the field of cardiac puncture medical device technology, and more particularly to a pericardial puncture guidewire kit. Background Technology
[0004] The pericardium is a connective tissue membrane that tightly surrounds the heart. During cardiac surgery, a passage must be artificially opened in the pericardium, which is close to the outer wall of the heart, to facilitate the drainage of pericardial effusion or the insertion of an ablation catheter. Surgical instruments are then inserted through this passage between the outer wall of the heart and the pericardium.
[0005] Currently available pericardiocentesis devices come in various shapes and sizes. For example, Chinese patent CN00257117.X discloses a non-invasive pericardiocentesis needle, including an outer cannula, a needle core, and an end cap. The outer cannula is a hollow, flexible tube that fits over the needle core, while the needle core is a solid puncture needle, fixed to the end of the outer cannula by the end cap. After the needle core is inserted into the pericardium, it is withdrawn, and the outer cannula continues to be advanced into the pericardial cavity to aspirate pericardial effusion, inject medication, or perform ablation. However, in clinical practice, this puncture needle often fails due to insufficient insertion depth or causes serious damage to organs or surrounding blood vessels due to excessive insertion depth, leading to serious complications.
[0006] Current pericardiocentesis techniques require the needle to be inserted gradually, using imaging equipment and contrast agents to help determine its location. After a successful puncture, blood pressure and other information need to be monitored to confirm its success. Existing techniques require significant ultrasound or X-ray time to guide the needle into the heart region. Because the needle tip is sharp, whether using the Sosa, NIN, or wire guide method, the needle tip must be carefully brought close to the pericardium, carefully positioned, and then carefully inserted. Finally, contrast agents are used to confirm the success of the puncture.
[0007] Current techniques are mostly used for pericardial effusion puncture, but are not suitable for dry pericardial puncture. Because of pericardial effusion, there is a large amount of fluid between the pericardium and myocardium, which widens the gap between them, making conventional pericardial puncture less dangerous. However, in radiofrequency ablation of epicardial ventricular arrhythmias, most cases involve dry pericardial puncture, where the distance between the pericardium and myocardium is very small. Current techniques are extremely difficult to perform and carry a very high puncture risk, often hindering the continuation of the procedure. Summary of the Invention
[0008] In view of this, embodiments of the present disclosure provide a pericardial puncture guidewire kit to eliminate or improve one or more defects present in the prior art.
[0009] In a first aspect, this disclosure provides a pericardial puncture guidewire, the pericardial puncture guidewire including an elastically deformable head, the head having a head body and a needle tip deflected relative to the head body, the needle tip and the adjacent portion of the head body combining to form an "S" shaped structure.
[0010] Depending on the degree of extension of the head within the catheter, the head can be deformed into a delivery mode, a breakthrough mode, and a fully bent mode. In the delivery mode, the head can be delivered through the catheter, with the head fully extended within the catheter or only the needle tip exposed at the distal end of the catheter, the distal end of which is used to abut against the outer wall of the pericardium. In the breakthrough mode, a portion of the head extends from the distal end of the catheter, allowing the needle tip to pierce from the outer wall of the pericardium into the inner wall of the pericardium, positioned between the inner wall of the pericardium and the myocardium. The needle tip is configured to deflect away from the inner wall of the pericardium relative to the head body. In the fully bent mode, the head extends completely from the distal end of the catheter and returns to its bent state. The shape of the head is configured to allow the needle tip to be surrounded by the head body.
[0011] In some embodiments, the pericardial puncture guidewire further includes a guidewire body, the head being located at the distal end of the guidewire body, the guidewire body including a first straight segment extending from the proximal end to the distal end of the pericardial puncture guidewire, and the head body including a first curved segment, a second straight segment, a second curved segment and a third straight segment connected in sequence.
[0012] Wherein, the first curved segment is connected to the first straight segment, and the third straight segment is connected to the needle tip;
[0013] In the fully bent shape of the head, the second straight segment is bent by the first bent segment into a shape that is parallel to or intersects the extension of the first straight segment. The third straight segment and the needle tip are bent by the second bent segment to the inside of the head. The extension of the third straight segment intersects the second straight segment, and the intersection point is close to the side of the first bent segment.
[0014] In some embodiments, the guidewire of the head is a flat wire, and the guidewire of the guidewire body is a round wire.
[0015] In some embodiments, the needle tip is a sharp point with both the vertical and horizontal angles of the tip being less than 25 degrees.
[0016] In some embodiments, the thickness of the second curved segment is less than the thickness of other parts of the head.
[0017] In some embodiments, the thickness of the needle tip is greater than the thickness of the third straight segment.
[0018] In some embodiments, the thickness of the third straight segment is greater than that of the second curved segment.
[0019] In some embodiments, the thickness of the second curved segment is less than the thickness of the second straight segment.
[0020] In some embodiments, the thickness of the needle tip is between 0.12 and 0.16 mm.
[0021] In some embodiments, the thickness of the third straight segment is between 0.10 and 0.14 mm.
[0022] In some embodiments, the thickness of the second curved segment is between 0.09 and 0.12 mm.
[0023] In some embodiments, the thickness of the second straight segment and the first curved segment is between 0.09 and 0.48 mm.
[0024] In some embodiments, the needle tip has a certain length, with an arc length between 0.8 and 1.5 mm.
[0025] In some embodiments, the distance between the second curved segments is between 1.5 and 3.5 mm.
[0026] In some embodiments, the diameter of the first bent segment is larger than the diameter of the second bend.
[0027] In some embodiments, the needle tip is configured to be located at or near the center of the first curved segment.
[0028] In some embodiments, the needle tip or the pericardial puncture guidewire is made of nickel-titanium alloy.
[0029] Secondly, this disclosure provides a pericardial puncture guidewire kit including the above-mentioned pericardial puncture guidewire, the pericardial puncture guidewire kit further including a catheter for inserting the pericardial puncture guidewire, the distal end of the catheter having an inclined portion for abutting against the outer wall of the pericardium.
[0030] In some embodiments, the orifice of the inclined portion of the catheter has a chamfer or a rounded corner, wherein the side length of the chamfer is less than the bending length of the needle tip, or the diameter of the rounded corner is less than the bending diameter of the needle tip.
[0031] In some embodiments, the tilt angle of the inclined portion is 130-170°.
[0032] In some embodiments, the outer wall of the catheter has an insulating coating, the length of which is configured to be greater than the length of the catheter extending into the human body and less than the overall length of the catheter; the catheter is made of metal, and its proximal outer wall is used to connect a wire clamp.
[0033] In some embodiments, the pericardial puncture guidewire kit further includes a Y-type three-way connector, which is installed at the proximal end of the catheter. The Y-type three-way connector has a side branch that is axially inclined to the catheter for the pericardial puncture guidewire to pass through. With the axial direction of the catheter as a reference, the side branch and the inclined portion of the catheter are located on the same side, such that the head of the distal end of the guidewire body, the axis of the catheter, and the axis of the side branch are coplanar.
[0034] In some embodiments, the Y-type tee connector is further provided with a guide plate, which is coplanar with the axis of the side support.
[0035] In some embodiments, the pericardial puncture guidewire kit further includes a locking connector mounted at the end of the lateral branch for securing the pericardial puncture guidewire.
[0036] In some embodiments, the Y-type tee connector further has a main branch arranged axially along the conduit, the end of which is used to connect an extension tube for injecting contrast agent, or to connect a tee valve plug to maintain a seal.
[0037] The beneficial effects that can be obtained from the technical solutions described in the pericardial puncture guidewire and pericardial puncture guidewire kit provided in the embodiments of this disclosure include at least the following:
[0038] This disclosure, by setting the needle tip of the pericardiocentesis guidewire to deflect in a specific direction and bend in a special shape, ensures that during puncture, the needle tip deflects away from the inner wall of the pericardium in the breakthrough position of the head, avoiding continuous puncture of the pericardium; in the fully bent position of the head, the needle tip is surrounded by the head body. This setting can minimize the probability of contact between the sharp needle tip structure and non-puncture sites of the pericardium and myocardium, thereby avoiding continuous puncture of the pericardium and scratching of myocardial cells, and minimizing complications.
[0039] Additional advantages, objects, and features of this disclosure will be set forth in part in the description which follows, and will in part become apparent to those skilled in the art upon studying the following text, or may be learned by practice of this disclosure. The objects and other advantages of this disclosure may be realized and obtained by means of the structures specifically pointed out in the specification and the accompanying drawings.
[0040] Those skilled in the art will understand that the purposes and advantages achievable with this disclosure are not limited to those specifically described above, and that the above and other purposes achievable with this disclosure will become clearer from the following detailed description. Attached Figure Description
[0041] The accompanying drawings, which are included to provide a further understanding of this disclosure and form part of this application, do not constitute a limitation thereof. The components in the drawings are not drawn to scale but are merely for illustrating the principles of this disclosure. For ease of illustration and description of certain parts of this disclosure, corresponding portions in the drawings may be enlarged, i.e., may appear larger relative to other components in an exemplary device actually manufactured according to this disclosure. In the drawings:
[0042] Figure 1 is a schematic diagram of the pericardial puncture guidewire kit in one embodiment of the present disclosure.
[0043] Figure 2 is a schematic diagram of the pericardial puncture guidewire in one embodiment of this disclosure.
[0044] Figure 3 is a schematic diagram of the pericardial puncture guidewire kit in an embodiment of the present disclosure, with the kit abutting against the outer wall of the pericardium.
[0045] Figure 4 is a schematic diagram of the state of the pericardial puncture guidewire exiting the catheter in one embodiment of the present disclosure.
[0046] Figure 5 is a schematic diagram showing the state of the pericardial puncture guidewire tip breaking through the pericardium in one embodiment of this disclosure.
[0047] Figure 6 is a schematic diagram of the state of the pericardial puncture guidewire after it passes through the pericardium in one embodiment of this disclosure.
[0048] Reference numerals: 1. Pericardial puncture guidewire; 2. Catheter; 3. Y-type three-way connector; 4. Locking connector; 5. Three-way valve cap; 11. Guidewire body; 111. First straight segment; 12. Head; 121. First curved segment; 122. Second straight segment; 123. Second curved segment; 124. Third straight segment; 125. Needle tip; 21. Inclined portion; 211. Chamfer; 31. Lateral branch; 32. Main branch; 33. Pointer plate. Detailed Implementation
[0049] To make the objectives, technical solutions, and advantages of this disclosure clearer, the following detailed description is provided in conjunction with the embodiments and accompanying drawings. Here, the illustrative embodiments and descriptions of this disclosure are used to explain this disclosure, but are not intended to limit it.
[0050] It should also be noted that, in order to avoid obscuring this disclosure with unnecessary details, only the structures and / or processing steps closely related to the scheme according to this disclosure are shown in the accompanying drawings, while other details that are not closely related to this disclosure are omitted.
[0051] It should be emphasized that the term "including / comprises" as used herein refers to the presence of a feature, element, step, or suite, but does not exclude the presence or addition of one or more other features, elements, steps, or suites.
[0052] It should also be noted that, unless otherwise specified, the term "connection" in this article can refer not only to a direct connection, but also to an indirect connection involving an intermediary.
[0053] In the following description, embodiments of the present disclosure will be illustrated with reference to the accompanying drawings. In the drawings, the same reference numerals represent the same or similar parts, or the same or similar steps.
[0054] This disclosure improves the shape of the pericardial puncture guidewire and catheter, ensuring safety and high efficiency when pericardial puncture is required clinically. The technical solution provided by this disclosure offers advantages such as significantly reducing operation time and radiation exposure, increasing surgical success rate, and reducing surgical complications.
[0055] In a first aspect, this disclosure provides a pericardial puncture guidewire 1, as shown in Figure 2. The pericardial puncture guidewire 1 has an elastically deformable head 12, the head 12 having a head body and a needle tip 125 deflected relative to the head body. The needle tip 125 can be used to puncture the pericardium during pericardial puncture surgery, while the head 12 can be used to fully enter the area between the pericardium and the myocardium.
[0056] As shown in Figures 4-6, depending on the extent to which the head 12 extends within the conduit 2, the head 12, due to its elasticity, toughness, and strength, can be deformed into a transmission form, a breakthrough form, and a fully bent form, respectively.
[0057] In the delivery mode, the pericardial puncture guidewire 1 and its head 12 are inserted into the catheter and can be delivered under the guidance and shape restriction of the catheter 2. The head 12 is fully extended inside the catheter or only the needle tip 125 is exposed at the distal end of the catheter 2 (see the position shown in Figure 4). The distal end of the catheter 2 (away from the instrument operator) is used to abut or abut against the outer wall of the pericardium in preparation for the puncture operation of the needle tip 125.
[0058] Referring to Figure 5, in the breakthrough configuration, a portion of the head 12 extends from the distal end of the catheter 2, allowing the needle tip 125 to puncture from the outer pericardial wall into the inner pericardial wall, positioned between the inner pericardial wall and the myocardium. The configuration of the needle tip 125, deflected relative to the head body, allows it to deflect away from the inner pericardial wall. As shown in Figure 5, the portion of the head 12 refers to both the needle tip 125 and a portion of the head body. The deflection of the needle tip 125 relative to the head body means that the adjacent segment of the needle tip 125 and its head body does not extend in a straight line; that is, in this configuration, the needle tip 125 deflects in a direction away from the inner pericardial wall, avoiding continuous punctures of the pericardium.
[0059] Referring to Figure 6, in the fully bent configuration, the head 12 extends completely from the distal end of the catheter 2. Without the constraint of the catheter 2, the head returns to its fully bent shape. The shape of the head 12 is configured so that the needle tip 125 is surrounded by the head body. It can be understood that the fully bent configuration is also the original configuration of the head 12. The phrase "the needle tip 125 is surrounded by the head body" means that within the plane of the fully bent configuration, the needle tip 125 is surrounded by the head body structure; in other words, the needle tip 125 is curled up inside the head 12. This configuration minimizes the probability of contact between the sharp needle tip 125 structure and non-puncture sites of the pericardium and myocardium, thus avoiding continuous punctures of the pericardium and scratching of myocardial cells, and minimizing complications.
[0060] In the above embodiments, this disclosure, through a reasonable head design and the application of elastic materials, ensures that the guidewire is more flexible during operation and can be smoothly guided to the target site (the pericardial site requiring puncture), reducing the difficulty and risk of the operation. The length of the needle tip is designed to be appropriate to ensure that it can penetrate the target tissue without being too long, causing unnecessary tissue damage or affecting the accuracy of the puncture.
[0061] This disclosure, by setting the needle tip to deflect in a specific direction and adopting a special bending shape, ensures that the guidewire, under the bending stress of the head 12, advances away from the myocardium during puncture, helping to reduce or avoid damage to other cardiac tissues. Due to the improved shape of the head 12 and the needle tip 125, using this guidewire allows for faster and more precise surgical procedures, significantly shortening the operation time and reducing the time patients and medical personnel are exposed to radiation. Precise puncture and guidance reduce mispuncture, tissue damage, and operational errors, thereby lowering the probability of complications and improving the success rate of the procedure.
[0062] To further explain the shape of the head 12 of the pericardial puncture guidewire 1, as at least one possible implementation, as shown in Figure 2, the pericardial puncture guidewire 1 also includes a guidewire body 11, with the head 12 located at the distal end of the guidewire body 11. The guidewire body 11 includes a first straight segment 111, which has good rigidity and linear force transmission, facilitating the transmission of pressure applied to the needle tip 125.
[0063] As shown in Figure 2, extending from the proximal to the distal end of the pericardial puncture guidewire 1, the head body of the head 12 includes a first curved segment 121, a second straight segment 122, a second curved segment 123, and a third straight segment 124 connected in sequence. The head body is designed to consist of four continuous parts, roughly forming an unclosed elongated waist-shaped structure. The needle tip 125 is located inside the elongated waist-shaped structure, that is, the needle tip 125 is surrounded by the structure of the guidewire (specifically the guidewire body and the head body), preventing the needle tip from scratching myocardial cells or other parts of the pericardium after puncture, thus minimizing complications.
[0064] Wherein, the first curved segment 121 is connected to the first straight segment 111, and the third straight segment 124 is connected to the needle tip 125; in the fully curved form of the head 12, the second straight segment 122 is bent by the first curved segment 121 to be parallel to or intersect the extension of the first straight segment 111 (but the lengths of the two straight segments are designed so that they will not cross or interfere), the third straight segment 124 and the needle tip 125 are bent by the second curved segment 123 to the inside of the head 12, and the extension of the third straight segment 124 intersects the second straight segment 122, and the intersection position is close to the side of the first curved segment 121.
[0065] The first curved segment 121, as the starting point for the guidewire's transition from a straight to a curved shape, determines the initial direction of the head 12. The bending angle of the first curved segment 121 can be configured to 180 degrees, allowing the guidewire to turn around. The second straight segment 122, guided by the first curved segment 121, forms a straight section parallel to the first straight segment 111. This straight segment maintains a certain stability and directionality through the guidance of the curved segment, ensuring precise targeting of the target site during subsequent puncture procedures. The second curved segment 123 connects the second straight segment 122 to the third straight segment 124, further bending the third straight segment 124 and the needle tip 125 to the inside of the head 12, ensuring precise positioning of the needle towards the target location. The bending angle of the second curved segment 123 can be configured to be greater than 180 degrees, allowing the guidewire to turn around again and extend inward. The other side of the second curved segment 123 can serve as a soft segment, meaning its support or strength is less than other parts, acting as a safety structure to avoid puncturing myocardial cells. The angle between the third straight segment 124 and the needle tip is obtuse, or the angle of its arc transition causes the needle tip to deviate to one side of the first straight segment 111, so that the direction of the needle tip is inconsistent with the curling direction of the guidewire head 12, thus avoiding continuous puncture of the myocardium or other parts of the pericardium.
[0066] In the above embodiment, after the guidewire head 12 is fully inserted into the punctured pericardium, its curved structure is fully released and can be restored to its original curved shape. The needle tip is surrounded inside, which can protect the adjacent myocardial tissue or other pericardial tissue.
[0067] In the above embodiment, the second straight line segment 122 is parallel to the first straight line segment 111, but is not limited thereto, and can also be configured as a non-parallel structure; similarly, the second straight line segment 122 intersects the extension line of the third straight line segment 124, but is not limited thereto, and can also be configured as a parallel structure, but the needle tip needs to be configured as being inside the head and in a shape that bends toward the first straight line segment 111.
[0068] In some embodiments, the guidewire of the head 12 is flat, meaning its cross-section is flat, making it more flexible in curved sections and avoiding tissue damage in complex vascular or organ structures, while providing better control and adaptability. The flat-wire design also facilitates smoother passage through curved, narrow, or irregular anatomical structures. The guidewire body 11 is round, meaning its main trunk is circular, providing better rigidity compared to a flat wire for stable transmission of pressure or thrust.
[0069] In some embodiments, the needle tip is a sharp point, specially designed or processed to provide sharp cutting capability. A sharp needle tip allows for easier penetration of skin, tissue, or other media, reducing pain and damage during insertion. The vertical and horizontal angles of the needle tip are both less than 25 degrees. This design results in a very shallow cutting angle, allowing the needle tip to contact the surface at a small angle and avoiding excessive deviation, thus enabling easier, smoother, and more precise insertion into the target location within the pericardium.
[0070] In some embodiments, the thickness of the second curved segment 123 is less than the thickness of other parts of the head 12, and the rigidity or support of the second curved segment 123 is less than that of its adjacent parts, thus serving as a soft segment. This ensures that even if the needle tip accidentally punctures the myocardium, the presence of the soft segment, which lacks support, will prevent the needle tip from penetrating further; instead, it will be pulled out by the soft segment, avoiding serious complications.
[0071] In some embodiments, the thickness of the needle tip 125 is greater than the thickness of the third straight segment 124; for example, the thickness of the needle tip 125 is between 0.12 and 0.16 mm, and the thickness of the third straight segment 124 is between 0.10 and 0.14 mm. During the puncture procedure, the needle tip 125 needs sufficient support to maintain its shape and stability. During the puncture, the needle will face certain external forces (such as the reaction force and resistance of the pericardium). Its greater thickness ensures that the needle tip is sufficiently robust and rigid to withstand the pressure required during the puncture and to facilitate successful penetration of the pericardium.
[0072] In some embodiments, the thickness of the third straight segment 124 is greater than the thickness of the second curved segment 123; the thickness of the second curved segment 123 is less than the thickness of the second straight segment 122. For example, the thickness of the second curved segment 123 is between 0.09 and 0.12 mm; the thickness of the second straight segment 122 and the first curved segment 121 is between 0.09 and 0.48 mm. The design of the second curved segment 123 (soft segment) is used to increase safety; specifically, the lack of support in the soft segment prevents the needle tip from penetrating further into the tissue due to excessive rigidity, but instead guides it out through the soft curved segment, reducing the risk of complications. In this embodiment, the change in hardness is achieved by reducing the wall thickness, but it is not limited to this and can also be achieved by other means, such as heat treatment processes, coatings, or designs using different materials.
[0073] Furthermore, extending from the second straight segment 122 or the first curved segment 121 towards the proximal end of the guide wire, the wall thickness gradually increases, and the cross-sectional shape gradually transitions from a flat wire to a round wire, until the proximal end of the head 12, where the wall thickness gradually increases from 0.09 to 0.48 mm. The wall thickness of the head 12 (first curved segment 121 and second straight segment 122) gradually decreases from the proximal end to the distal end, ensuring both flexibility and providing greater structural support when necessary.
[0074] In some embodiments, the needle tip 125 has a certain length and is curved, with an arc length between 0.8 and 1.5 mm. Considering the size of the needle tip, a channel of predetermined size needs to be punctured through the pericardium to facilitate the aspiration of pericardial effusion or the implantation of an ablation catheter. If the needle tip is set too long, the contact length will be too large, requiring greater pressure and potentially causing unnecessary damage to the pericardium. In this embodiment, the curved needle tip is set within a certain length range, which helps to reduce damage to the pericardium during puncture, provides better control, and facilitates smooth puncture.
[0075] In some embodiments, the diameter of the second curved segment 123 is between 1.5 and 3.5 mm. Maintaining the diameter of the second curved segment 123 within the range of 1.5-3.5 mm is to achieve an optimal balance during insertion and puncture: avoiding the risk of the guidewire becoming entangled with tissues such as the pericardium due to an excessively small diameter, while also avoiding excessively high insertion resistance due to an excessively large diameter.
[0076] In some embodiments, the combination of the needle tip 125, the third straight segment 124, and the second curved segment 123 is approximately "S"-shaped. This S-shaped structure, in conjunction with the needle tip 125, the third straight segment 124, and the second curved segment 123, ensures precise control and direction of movement of the needle tip during puncture. By ensuring that the needle tip moves away from the pericardium after puncture, this design greatly improves puncture safety, especially during pericardiocentesis, reducing the risk of accidentally injuring the pericardium or other vital tissues. Simultaneously, this design also provides better guidewire guidance, ensuring the success rate and safety of the surgical procedure.
[0077] In some embodiments, the diameter of the first curved segment 121 is larger than the diameter of the second bend. This design allows the needle tip 125 to be contained within the head 12. In some embodiments, the needle tip is configured to be located at or near the center of the first curved segment 121. Because the needle tip is located near the center of the curved segment, its position can be more easily controlled during or after puncture, reducing the risk of puncturing surrounding tissue and effectively avoiding unnecessary damage.
[0078] In some embodiments, the needle tip 125 or the pericardial puncture guidewire 1 is made of nickel-titanium alloy. Due to the unique physical properties of nickel-titanium alloy, especially its shape memory effect and superelasticity, it has significant advantages in the field of medical devices, particularly in pericardial puncture and other precision procedures. Nickel-titanium alloy possesses a shape memory effect, allowing it to retain its shape during use. Its superelasticity enables it to withstand significant forces and return to its original shape when bent or compressed, which is particularly important for guidewires that need to be flexible and pass through narrow channels, such as during pericardial puncture where the guidewire needs to flexibly enter the complex pericardial structure. Nickel-titanium alloy does not produce significant toxicity or immune responses to tissues in the body, reducing invasiveness and discomfort for patients. Using nickel-titanium alloy allows for thin, flexible guidewires or needles, resulting in less invasiveness and faster patient recovery. The flexibility and shape memory effect enable the device to enter the target area more precisely, thereby reducing unnecessary tissue damage and complications.
[0079] In the above embodiments, in addition to nickel-titanium alloy, the needle tip 125 or the pericardial puncture guide wire 1 can also be made of a variety of materials such as cobalt-chromium alloy, nickel-cobalt alloy, and polymer materials. The specific choice depends on the needs of the surgery, the precision requirements of the operation, and the biocompatibility, corrosion resistance and mechanical properties of the material.
[0080] Current techniques are mostly used for puncturing the pericardium after myocarditis or cardiac tamponade, where the pericardium is not completely attached to the heart, with a significant gap between them. Therefore, clinical data is much better than for dry pericardium. Even so, there is still at least a 4% puncture injury rate. This is because contacting the heart with a sharp point during a heartbeat is a very dangerous procedure. Current techniques have a high risk of complications, ranging from mild cases like hemopericardium requiring emergency treatment to severe cases like myocardial and coronary artery damage, often requiring emergency open-heart surgery and threatening life.
[0081] Secondly, this disclosure provides a pericardial puncture guidewire kit including the aforementioned pericardial puncture guidewire 1, as shown in Figures 1, 3, and 4. The kit further includes a catheter 2 for inserting the pericardial puncture guidewire 1. The distal end of the catheter 2 has an inclined portion 21 for abutting against the outer wall of the pericardium. The angle of the inclined portion 21 allows the distal end of the catheter 2 to better conform to the outer wall of the pericardium. Due to the complex shape and location of the pericardium, the catheter 2 needs to accurately and stably contact the outer wall of the pericardium during puncture. The angle of the inclined portion 21 ensures that the catheter contacts the outer wall of the pericardium more smoothly, thereby avoiding deviation or slippage and maintaining stable positioning.
[0082] Furthermore, the tilt angle of the inclined portion 21 is 130-170°. This angle provides good pericardial apposition and also allows the catheter 2 to easily pass through the pericardium after the guidewire has passed through. This tilt angle serves as a physical guide, making it easier for the catheter 2 to enter the pericardial cavity during puncture. A suitable tilt angle reduces the difficulty of entry, allowing the catheter 2 to remain stable when passing through the pericardium, preventing deviation or damage to surrounding tissues.
[0083] In some embodiments, as shown in FIG4, the orifice of the inclined portion 21 of the catheter 2 has a chamfer 211 or a rounded corner. The side length of the chamfer 211 is less than the bending length of the needle tip, or the diameter of the rounded corner is less than the bending diameter of the needle tip. The bending diameter of the needle tip is slightly larger than the side length of the corresponding chamfer 211 / rounded corner diameter of the catheter 2. This ensures that the orifice of the catheter 2 can smoothly mate with the needle tip during puncture, allowing the catheter 2 to maintain appropriate support and shape stability. This not only ensures guidance and accuracy during puncture but also prevents the catheter 2 from becoming stuck or damaging pericardial tissue during operation.
[0084] This disclosure involves using a catheter without a sharp tip to align with the outer wall of the pericardium, then employing a pericardial puncture guidewire that follows the catheter's curve to lift and puncture the pericardium. Because the needle tip is always directed away from the heart, accidental puncture and organ damage are prevented. Furthermore, due to the small diameter of the pericardial puncture guidewire, even if accidental puncture occurs, serious complications are unlikely.
[0085] In some embodiments, the outer wall of the catheter 2 has an insulating coating. The length of the insulating coating is configured to be greater than the length of the catheter 2 extending into the human body, but less than the total length of the catheter. This coating can reduce frictional resistance and isolate electrical signals. Optionally, for catheters with a total length in the range of 150mm-210mm, the length of the coating required is in the range of 120mm-190mm. This length ensures that when the catheter passes through the human body, it will not cause incorrect judgments due to electromyographic signals.
[0086] Furthermore, the catheter 2 is made of metal, with its proximal outer wall used to connect to the guide wire clamp. During the puncture, a tail wire can be connected to the needle body for real-time electrical signal detection to determine whether the puncture was successful. By ensuring that the length of the insulating coating does not cover the entire catheter 2, it is possible to ensure that the metal part of the catheter 2 can connect to the guide wire clamp for real-time electrical signal detection and transmission. In this way, the guide wire clamp can contact the metal part of the catheter 2 at its proximal end, achieving accurate transmission and monitoring of electrical signals. This method of electrical signal detection is very useful, especially during cardiac surgery or punctures, as it allows for real-time monitoring of the puncture accuracy based on the morphology of the electrical signal and helps determine the position of the guide wire, ensuring that the operator can promptly determine whether the puncture was successful.
[0087] In some embodiments, as shown in FIG1, the pericardial puncture guidewire kit further includes a Y-type three-way connector 3, which is installed at the proximal end of the catheter 2. The Y-type three-way connector 3 has a side branch 31 that is axially inclined to the catheter 2 for the pericardial puncture guidewire 1 to pass through. With the axial direction of the catheter 2 as a reference, the side branch 31 and the inclined portion 21 of the catheter 2 are located on the same side, such that the head 12 of the guidewire body 11 at the distal end, the axis of the catheter 2, and the axis of the side branch 31 are coplanar.
[0088] The Y-shaped three-way connector 3 not only serves as an extension of catheter 2 but also acts as a guide, helping the guidewire to smoothly exit catheter 2 in a specific direction and angle. The side branch 31 of the Y-shaped three-way connector is aligned with the direction of the guidewire head 12, making the guidewire's movement trajectory more stable and preventing guidewire deviation. This coplanar design reduces instability during guidewire puncture. The curved design of the guidewire tip ensures that the guidewire tip always faces the direction of operation during the procedure, ensuring that the guidewire can be accurately punctured towards the predetermined target. Especially during high-precision procedures such as pericardiocentesis, directional accuracy is crucial.
[0089] Furthermore, the Y-type tee connector 3 is also provided with a guide plate 33, which is coplanar with the axis of the side support 31. The design of the guide plate 33 provides the operator with a clear visual reference, helping them to determine the precise direction of the guidewire based on the layout of the Y-type tee. By observing the guide plate 33, the operator can determine the direction and position of the guidewire tip without directly viewing the guidewire or X-ray images, greatly improving the convenience and safety of operation.
[0090] In some embodiments, the pericardial puncture guidewire kit further includes a locking connector 4, which is installed at the end of the side support 31 for securing the pericardial puncture guidewire 1. The locking connector 4 may be a locking nut to ensure that the guidewire does not shift, making the operation more stable.
[0091] In some embodiments, the Y-type three-way connector 3 also has a main branch 32 arranged axially along the catheter 2. The end of the main branch 32 is used to connect an extension tube for injecting contrast agent, or to connect a three-way valve cap 5 to maintain a seal. This design allows the Y-type three-way connector 3 to not only provide guidewire support and guidance, but also to add the additional functions of injecting contrast agent and maintaining a seal. The end of the main branch 32 can be connected to an extension tube. The connection between the main branch 32 and the extension tube allows the operator to inject contrast agent through this interface, ensuring smooth flow of the contrast agent into the pericardial cavity or target area, thereby providing real-time imaging support. When using contrast agent during puncture or interventional procedures, the puncture path and the specific location of the pericardial cavity can be more clearly seen, avoiding mispuncture or inaccurate operation, thus ensuring safety and effectiveness. Another function is that the end of the main branch 32 can also be connected to a three-way valve cap 5 to maintain a seal. Ensuring the system's airtightness is crucial to preventing infection or leakage, especially in procedures such as pericardiocentesis, where even a small leak can have serious consequences. By simply attaching or removing the cap, operators can flexibly control the system's sealing and opening states, facilitating adjustments at different stages of the procedure. For example, in some steps, the guidewire path needs to be sealed, while in others it needs to be open to inject contrast agent.
[0092] To further explain the working principle and puncture process of the pericardiocentesis guidewire kit in the embodiments of this disclosure, the following detailed description is provided in conjunction with Figures 3, 5 and 6.
[0093] Figure 3 is a schematic diagram of the pericardial puncture guidewire kit in an embodiment of this disclosure, with the kit resting against the outer wall of the pericardium. As shown in Figure 3, during the procedure, the catheter 2 needs to be positioned with its back to the pericardium, and the outlet portion of the tube (the end of the inclined portion 21) tangent to the arc surface of the heart. This ensures that the guidewire is inserted upwards. Because the Y-type tee has a directional function, it ensures that the needle tip 125 of the pericardial puncture guidewire 1 always points upwards towards the opening. Simultaneously, based on the guidewire shape and the fixing effect of the locking nut, the orientation of the needle tip of the pericardial puncture guidewire 1 can be determined by the pointing plate 33 of the Y-type tee connector 3. After confirming the direction of the catheter 2 through cardiac pulsation and imaging, the catheter 2 is moved back and forth to ensure that the pericardium exhibits the folds shown in Figure 3, which cover a portion of the opening of the catheter 2.
[0094] Figure 4 is a schematic diagram of the state of the needle tip 125 of the pericardial puncture guidewire 1 exiting the catheter 2 in one embodiment of this disclosure. As shown in Figure 4, when the pericardial puncture guidewire 1 is pushed, the needle tip will briefly puncture downwards along the chamfer 211 or rounded corner of the tip of the catheter 2. This is the first puncture window. Since the arc length of the needle tip is very small, even if part of the myocardium is punctured at this time, its impact can be ignored. If the pericardium is slightly far from the catheter 2, the guidewire will continue to be pushed forward and upward (Figure 5). Once the guidewire contacts the pericardium, the needle tip 125 of the guidewire can easily pass through the pericardium by relying on the supporting force of the third straight segment 124, completing the puncture.
[0095] After a successful puncture, the head 12, made of nickel-titanium alloy wire, has excellent resilience and will return to its original shape (Figure 6). This shape can remain within the pericardial cavity. Furthermore, the head 12 of the pericardial puncture guidewire 1 is designed with a curved shape around the needle tip, thus ensuring that the needle tip does not scratch myocardial cells and the pericardium after puncture.
[0096] In some embodiments, the guidewires described above can be used as disposable consumables. Disposable guidewires are discarded after each surgery or procedure, effectively preventing cross-contamination between multiple patients. Using disposable instruments avoids problems such as material fatigue, wear, or incomplete cleaning caused by reuse. Disposable guidewires do not require cumbersome sterilization and cleaning procedures. This not only reduces the hospital's sterilization burden but also eliminates potential problems during the cleaning process. Disposable guidewires are made of high-quality materials and undergo rigorous quality control. Each guidewire is brand new and conforms to design specifications before use, ensuring its performance and reliability. Disposable instruments do not require pre-use inspection and preparation, saving pre-operative time.
[0097] The pericardial puncture guidewire kit in this embodiment is suitable not only for pericardial effusion puncture but also for dry pericardial puncture, and is simple to operate with low puncture risk.
[0098] The beneficial effects that can be obtained from the technical solutions described in the pericardial puncture guidewire and pericardial puncture guidewire kit provided in the embodiments of this disclosure include at least the following:
[0099] (1) Traditional pericardiocentesis guidewires typically require a sharp tip close to the heart for positioning and puncture, which may lead to accidental injury or damage to cardiac structures. In contrast, the pericardiocentesis guidewire kit disclosed herein eliminates the need for a sharp tip close to the heart. The guidewire kit design allows the pericardiocentesis guidewire to smoothly adhere to the pericardial surface and puncture smoothly, advancing away from the myocardium after puncture, reducing damage to cardiac tissue and avoiding the potential dangers of traditional sharp punctures. Because direct contact between the sharp part and the heart is reduced, the probability of bleeding and other complications is also decreased.
[0100] (2) Due to the optimized structure and materials of the pericardiocentesis guidewire and catheter, they can quickly approach the target area, reducing the time required for frequent adjustments to the guide and confirmation of position in traditional procedures. Especially in complex or emergency situations, reducing operation time is crucial for patient safety.
[0101] (3) Traditional pericardiocentesis usually requires the injection of contrast agent and confirmation of successful puncture through imaging examinations. However, the guidewire kit in this disclosure uses electrocardiogram (ECG) signals to monitor the puncture effect in real time. This method does not rely on the injection of contrast agent, thus saving on the use of contrast agent and reducing the patient's exposure time to radiation. The ECG can confirm the correctness of the puncture immediately, avoiding delays that may be caused by imaging examinations.
[0102] (4) In traditional pericardiocentesis, improper handling of the guide wire can lead to significant cardiac perforation, which may result in cardiac tamponade, an acute and serious complication that can be life-threatening. Guide wires effectively prevent the needle from entering deep cardiac structures or causing over-puncture. Due to their flexibility and guiding function, guide wires help the operator control the direction and depth of the puncture, reducing the risk of accidental injury. The design of the guide wire's head and curved tip allows for precise control of the puncture path, reducing unnecessary puncture force and thus lowering the likelihood of cardiac perforation.
[0103] (5) Traditional pericardiocentesis usually requires the operator to frequently check whether the needle tip is accurately contacting the pericardium during the puncture process. However, using the pericardiocentesis guidewire kit of this disclosure, the operator does not need to repeatedly check whether the needle tip is in contact with the pericardium, and a blunt needle tip in contact with the pericardium will not cause complications. Therefore, the operator can confidently place the needle tip in contact with the pericardium and perform the puncture. At the same time, since the pericardiocentesis guidewire has a guiding function, it is not necessary to replace the guidewire after the puncture is successful.
[0104] In this disclosure, features described and / or illustrated for one embodiment may be used in the same or similar manner in one or more other embodiments, and / or combined with or in place of features of other embodiments.
[0105] The above description is merely a preferred embodiment of this disclosure and is not intended to limit this disclosure. Various modifications and variations can be made to the embodiments of this disclosure by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this disclosure should be included within the protection scope of this disclosure.
Claims
1. A pericardial puncture guidewire, characterized in that, The pericardial puncture guidewire (1) includes a head (12) with elastic deformability, the head (12) having a head body and a needle tip (125) deflected relative to the head body, the needle tip (125) and its adjacent portion of the head body forming an "S" shaped structure. Depending on the extent to which the head (12) protrudes within the conduit, the head (12) can be deformed into a transmission form, a breakthrough form, and a fully bent form. In the delivery mode, the head (12) can be delivered through a catheter, with the head (12) fully extended inside the catheter or only the needle tip (125) exposed at the distal end of the catheter, the distal end of the catheter being used to abut against the outer wall of the pericardium. In the breakthrough mode, a portion of the head (12) extends from the distal end of the catheter, such that the needle tip (125) penetrates from the outer wall of the pericardium into the inner wall of the pericardium, so as to be located between the inner wall of the pericardium and the myocardium. The construction configuration of the needle tip (125) deflected relative to the head body is such that the needle tip (125) deflects away from the inner wall of the pericardium. In the fully bent configuration, the head (12) extends completely from the distal end of the catheter and returns to the bent configuration. The head (12) is shaped to allow the needle tip (125) to be surrounded by the puncture guidewire and the head body.
2. The pericardial puncture guidewire according to claim 1, characterized in that, The pericardial puncture guidewire (1) also includes a guidewire body (11), the head (12) is located at the distal end of the guidewire body (11), and the guidewire body (11) includes a first straight segment (111); Extending from the proximal end to the distal end of the pericardial puncture guidewire (1), the head body of the head (12) includes a first curved segment (121), a second straight segment (122), a second curved segment (123), and a third straight segment (124) connected in sequence. Wherein, the first curved segment (121) is connected to the first straight segment (111), and the third straight segment (124) is connected to the needle tip (125); In the fully bent state of the head (12), the second straight segment (122) is bent by the first bent segment (121) to be parallel to or intersect the extension of the first straight segment (111). The third straight segment (124) and the needle tip (125) are bent by the second bent segment (123) to the inside of the head (12). The extension of the third straight segment (124) intersects the second straight segment (122), and the intersection position is close to the side of the first bent segment (121).
3. The pericardial puncture guidewire according to claim 1, characterized in that, The guide wire of the head (12) is flat and the guide wire of the guide wire body (11) is round.
4. The pericardial puncture guidewire according to claim 1, characterized in that, The needle tip is a sharp point, with both the vertical and horizontal angles of the tip being less than 25 degrees.
5. The pericardial puncture guidewire according to claim 2, characterized in that, The thickness of the second curved segment (123) is less than the thickness of other parts of the head (12); and / or, The thickness of the needle tip (125) is greater than the thickness of the third straight segment (124); The thickness of the third straight segment (124) is greater than that of the second curved segment (123); and / or, The thickness of the second curved segment (123) is less than the thickness of the second straight segment (122).
6. The pericardial puncture guidewire according to claim 5, characterized in that, The thickness of the needle tip (125) is between 0.12 and 0.16 mm; and / or, The thickness of the third straight segment (124) is between 0.10 and 0.14 mm; and / or, The thickness of the second curved segment (123) is between 0.09 and 0.12 mm; and / or, The thickness of the second straight segment (122) and the first curved segment (121) is between 0.09 and 0.48 mm.
7. The pericardial puncture guidewire according to claim 2, characterized in that, The needle tip (125) has a certain length, with an arc length between 0.8 and 1.5 mm; and / or, The second bending segment (123) has a span between 1.5 and 3.5 mm; and / or, The diameter of the first curved segment (121) is larger than the diameter of the second curved segment; and / or, The needle tip is configured to be located at or near the center of the first curved segment (121).
8. The pericardial puncture guidewire (1) according to claim 1, characterized in that, The needle tip (125) or the pericardial puncture guide wire (1) is made of nickel-titanium alloy.
9. A pericardial puncture guidewire kit comprising the pericardial puncture guidewire (1) as described in any one of claims 1 to 8, characterized in that, The pericardial puncture guidewire kit also includes a catheter (2) for the pericardial puncture guidewire (1) to pass through, the distal end of the catheter (2) having an inclined portion (21) for abutting against the outer wall of the pericardium.
10. The pericardial puncture guidewire kit according to claim 9, characterized in that, The inlet of the inclined portion (21) of the conduit (2) has a chamfer (211) or a rounded corner, wherein the side length of the chamfer (211) is less than the bending length of the needle tip, or the diameter of the rounded corner is less than the bending diameter of the needle tip; and / or, The tilt angle of the inclined part (21) is 130-170°.
11. The pericardial puncture guidewire kit according to claim 9, characterized in that, The outer wall of the catheter (2) has an insulating coating. The length of the insulating coating is configured to be greater than the length of the catheter (2) extending into the human body and less than the length of the entire tube. The catheter (2) is made of metal, and its proximal outer wall is used to connect a wire clamp.
12. The pericardial puncture guidewire kit according to claim 9, characterized in that, The pericardial puncture guidewire kit also includes a Y-type three-way connector (3), which is installed at the proximal end of the catheter (2). The Y-type three-way connector (3) has a side branch (31) that is axially inclined to the catheter (2) for the pericardial puncture guidewire (1) to pass through. With the axial direction of the catheter (2) as a reference, the side branch (31) and the inclined portion (21) of the catheter (2) are located on the same side, so that the head (12) at the distal end of the guidewire body (11), the axis of the catheter (2) and the axis of the side branch (31) are coplanar.
13. The pericardial puncture guidewire kit according to claim 12, characterized in that, The Y-type tee connector (3) is further provided with a guide plate (33), which is coplanar with the axis of the side support (31); and / or, The pericardial puncture guidewire kit also includes a locking connector (4), which is mounted at the end of the side branch (31) for securing the pericardial puncture guidewire (1); and / or, The Y-type three-way connector (3) also has a main branch (32) arranged axially along the conduit (2), the end of which is used to connect an extension tube for injecting contrast agent, or to connect a three-way valve plug (5) to maintain a seal.