Pericardiocentesis guidewire kit

Abstract

The invention provides a pericardial puncture guidewire kit, comprising a pericardial puncture guidewire, wherein the pericardial puncture guidewire comprises an elastically deformable head, wherein the head comprises a head body and a needle tip deflected relative to the head body; according to the extension degree of the head in a catheter, the head can be deformed into a transmission form, a breakthrough form and a fully bent form respectively; in the transmission form, the head can be transmitted through the catheter, the head is fully deployed in the catheter or only the needle tip is exposed at the distal end of the catheter, and the distal end of the catheter is used to abut against the outer wall of the pericardium; in the breakthrough form, a part of the head extends from the distal end of the catheter, so that the needle tip punctures from the outer wall of the pericardium into the inner wall of the pericardium to be located between the inner wall of the pericardium and the myocardium, and the structure of the needle tip deflected relative to the head body is configured to enable the needle tip to deflect away from the inner wall of the pericardium; in the fully bent form, the head is completely extended from the distal end of the catheter and returns to a bent form, and the shape of the head is configured to enable the needle tip to be surrounded by the head body.

Description

Technical Field

[0001] The invention relates to the technical field of cardiac puncture medical devices, and in particular to a pericardial puncture guidewire kit. Background Art

[0002] The pericardium is a layer of connective tissue membrane structure tightly wrapped around the heart. During extracardiac surgery, a passage must be opened artificially in the pericardium that is close to the outer wall of the heart to facilitate the extraction of pericardial effusion or the insertion of an ablation catheter. The surgical instruments pass through this passage into the space between the outer wall of the heart and the pericardium.

[0003] Currently available pericardial puncture devices are of various shapes. For example, Chinese patent CN00257117.X discloses a non-invasive pericardial puncture needle, including an outer sleeve, a needle core and an end cap. The outer sleeve is a flexible sleeve that is hollow inside and is sleeved outside the needle core. The needle core is a solid puncture needle, which is fixed to the end of the outer sleeve by an end cap. After the needle core pierces the pericardium, the needle core is withdrawn, and the outer sleeve continues to be sent into the pericardial cavity to extract pericardial effusion, inject drugs or perform ablation. However, during clinical operation, the puncture needle often fails to puncture due to improper insertion of the needle, or causes serious damage to organs or peripheral blood vessels due to excessive insertion of the needle, thereby causing serious complications.

[0004] During the existing pericardiocentesis, the needle needs to be inserted little by little, and imaging equipment and contrast agents are used to help determine the position of the needle. After the puncture is successful, blood pressure and other information need to be monitored to determine whether the puncture is successful. The existing surgical method requires a lot of ultrasound or X-ray time to guide the puncture needle into the heart area. Since the tip of the needle is sharp, whether it is the Sosa method, the NIN method, or the Wire guide method, the needle tip needs to be carefully brought close to the pericardium, carefully pressed against it, and then carefully punctured, and finally the contrast agent is used to confirm whether the puncture is successful.

[0005] Existing technologies are mostly used for pericardial effusion puncture, which is not conducive to dry pericardial puncture. After pericardial effusion, there is a large amount of fluid between the pericardium and the myocardium, which will expand the gap between the pericardium and the myocardium, making pericardial puncture less dangerous under conventional technology; while in radiofrequency ablation of epicardial ventricular arrhythmias, most of them are dry pericardial punctures, and the distance between the pericardium and the myocardium is very small. The existing technology is extremely difficult to operate and the risk of puncture is extremely high, which often becomes an obstacle to the continuation of the operation. Summary of the invention

[0006] In view of this, an embodiment of the present invention provides a pericardial puncture guidewire kit to eliminate or improve one or more defects existing in the prior art.

[0007] In a first aspect, the present invention provides a pericardial puncture guidewire, the pericardial puncture guidewire comprising an elastically deformable head, the head comprising a head body and a needle tip deflected relative to the head body, the needle tip and an adjacent portion of the head body forming an "S"-shaped structure;

[0008] According to the extension degree of the head in the catheter, the head can be deformed into a transmission form, a breakthrough form and a fully bent form respectively; in the transmission form, the head can be transmitted through the catheter, the head is fully deployed in the catheter or only the needle tip is exposed at the distal end of the catheter, and the distal end of the catheter is used to abut against the outer wall of the pericardium; in the breakthrough form, a part of the head extends from the distal end of the catheter, so that the needle tip pierces from the outer wall of the pericardium into the inner wall of the pericardium to be located between the inner wall of the pericardium and the myocardium, and the structure of the needle tip deflected relative to the head body is configured to enable the needle tip to deflect away from the inner wall of the pericardium; in the fully bent form, the head is completely extended from the distal end of the catheter and returns to a bent form, and the shape of the head is configured to enable the needle tip to be surrounded by the head body.

[0009] In some embodiments, the pericardiocentesis guidewire further comprises a guidewire body, the head is located at the distal end of the guidewire body, the guidewire body comprises a first straight segment, and in the extension direction from the proximal end to the distal end of the pericardiocentesis guidewire, the head body of the head comprises a first curved segment, a second straight segment, a second curved segment and a third straight segment connected in sequence;

[0010] Wherein, the first curved segment is connected to the first straight segment, and the third straight segment is connected to the needle tip;

[0011] When the head is in the fully bent state, the second straight line segment is bent by the first bent segment to be parallel to or intersecting with the extension line of the first straight line segment, and the third straight line segment and the needle tip are bent to the inner side of the head by the second bent segment, and the extension line of the third straight line segment intersects with the second straight line segment, and the intersection position is close to one side of the first bent segment.

[0012] In some embodiments, the guide wire of the head is in the shape of a flat wire, and the guide wire of the guide wire body is in the shape of a round wire.

[0013] In some embodiments, the needle tip is a sharp tip, and the vertical angle and horizontal angle of the tip are both less than 25 degrees.

[0014] In some embodiments, the thickness of the second curved segment is smaller than the thickness of other parts of the head.

[0015] In some embodiments, the thickness of the needle tip is greater than the thickness of the third straight line segment.

[0016] In some embodiments, the third straight segment is thicker than the second curved segment.

[0017] In some embodiments, the thickness of the second curved segment is less than the thickness of the second straight segment.

[0018] In some embodiments, the thickness of the needle tip is between 0.12-0.16 mm.

[0019] In some embodiments, the thickness of the third straight line segment is between 0.10-0.14 mm.

[0020] In some embodiments, the thickness of the second curved segment is between 0.09-0.12 mm.

[0021] In some embodiments, the thickness of the second straight segment and the first curved segment is between 0.09 mm and 0.48 mm.

[0022] In some embodiments, the needle tip has a certain length, and its arc length is between 0.8-1.5 mm.

[0023] In some embodiments, the second curved segment has a length between 1.5-3.5 mm.

[0024] In some embodiments, the diameter of the first curved segment is greater than the diameter of the second curved segment.

[0025] In some embodiments, the needle tip is configured to be located at or close to the center of the first curved segment.

[0026] In some embodiments, the needle tip or the pericardial puncture guide wire is made of nickel-titanium alloy.

[0027] In a second aspect, the present invention provides a pericardial puncture guidewire kit including the above-mentioned pericardial puncture guidewire, wherein the pericardial puncture guidewire kit also includes a catheter for passing the pericardial puncture guidewire, and the distal end of the catheter has an inclined portion for abutting against the outer wall of the pericardium.

[0028] In some embodiments, the tube opening of the inclined portion of the catheter has a chamfer or a rounded corner, the side length of the chamfer is smaller than the curvature length of the needle tip, or the diameter of the rounded corner is smaller than the curvature diameter of the needle tip.

[0029] In some embodiments, the inclination angle of the inclined portion is 130-170°.

[0030] In some embodiments, the outer wall of the catheter has an insulating coating, and the setting length of the insulating coating is configured to be greater than the length of the catheter extending into the human body and less than the length of the entire tube; the catheter is made of metal, and its proximal outer wall is used to connect a wire clamp.

[0031] In some embodiments, the pericardiocentesis guidewire kit also includes a Y-type three-way connector, which is installed at the proximal end of the catheter, and has a side branch that is inclined to the axial direction of the catheter, for allowing the pericardiocentesis guidewire to pass through; based on the axial direction of the catheter, the side branch and the inclined portion of the catheter are located on the same side, so that the head at the distal end of the guidewire body, the axis of the catheter and the axis of the side branch are coplanar.

[0032] In some embodiments, the Y-type three-way connector is further provided with a pointing plate, and the pointing plate is arranged coplanar with the axis of the side branch.

[0033] In some embodiments, the pericardiocentesis guidewire kit further includes a locking connector, which is mounted at the end of the side branch and is used to fix the pericardiocentesis guidewire.

[0034] In some embodiments, the Y-type three-way connector also has a main branch arranged along the axial direction of the catheter, and the end of the main branch is used to connect an extension tube to inject contrast agent, or to connect a three-way valve cap to maintain sealing.

[0035] According to the technical solution described in the pericardiocentesis guidewire and pericardiocentesis guidewire kit provided in the embodiments of the present invention, the beneficial effects that can be obtained include at least:

[0036] The present invention sets the needle tip of the pericardial puncture guide wire head to deflect in a specific direction and bend in a special shape, thereby ensuring that during the puncture process of the guide wire, the needle tip is deflected in a direction away from the inner wall of the pericardium when the head is in a breakthrough state, thereby avoiding continuous puncture of the pericardium; when the head is in a fully bent state, the needle tip is surrounded by the head body, and this setting method can minimize the probability of the sharp needle tip structure contacting the non-puncture site of the pericardium and the myocardium, thereby avoiding continuous puncture of the pericardium and scratching of myocardial cells, and can minimize complications.

[0037] Additional advantages, purposes, and features of the present invention will be described in part in the following description, and will become apparent to those skilled in the art after studying the following, or may be learned from the practice of the present invention. The purposes and other advantages of the present invention may be achieved and obtained by the structures specifically indicated in the specification and the accompanying drawings.

[0038] Those skilled in the art will appreciate that the objectives and advantages that can be achieved with the present invention are not limited to the above specific description, and the above and other objectives that can be achieved by the present invention will be more clearly understood from the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The drawings described herein are used to provide a further understanding of the present invention, constitute a part of this application, and do not constitute a limitation of the present invention. The components in the drawings are not drawn to scale, but are only for illustrating the principles of the present invention. In order to facilitate the illustration and description of some parts of the present invention, the corresponding parts in the drawings may be enlarged, that is, they may become larger relative to other components in the exemplary device actually manufactured according to the present invention. In the drawings:

[0040] Figure 1 Schematic diagram of the structure of a pericardial puncture guidewire kit in one embodiment of the present invention.

[0041] Figure 2 Schematic diagram of the structure of a pericardial puncture guidewire in one embodiment of the present invention.

[0042] Figure 3 This is a schematic diagram of a state in which the pericardial puncture guidewire kit is attached to the outer wall of the pericardium in one embodiment of the present invention.

[0043] Figure 4 This is a schematic diagram of a state in which the needle tip of a pericardial puncture guidewire exits a catheter in one embodiment of the present invention.

[0044] Figure 5 This is a schematic diagram of a state in which the needle tip of a pericardial puncture guidewire breaks through the pericardium in one embodiment of the present invention.

[0045] Figure 6 This is a schematic diagram of the state of the pericardial puncture guide wire after passing through the pericardium in one embodiment of the present invention.

[0046] Reference numerals:

[0047] 1. Pericardiocentesis guidewire; 2. Catheter; 3. Y-type three-way connector; 4. Locking connector; 5. Three-way valve plug cap;

[0048] 11. guide wire body; 111. first straight line segment;

[0049] 12. head; 121. first curved segment; 122. second straight segment; 123. second curved segment; 124. third straight segment; 125. needle tip;

[0050] 21. inclined portion; 211. chamfer;

[0051] 31. Side branch; 32. Main branch; 33. Pointing plate. DETAILED DESCRIPTION

[0052] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments and the accompanying drawings. Here, the illustrative embodiments of the present invention and their descriptions are used to explain the present invention, but are not intended to limit the present invention.

[0053] It should also be noted that, in order to avoid obscuring the present invention due to unnecessary details, only structures and / or processing steps closely related to the solutions according to the present invention are shown in the accompanying drawings, while other details that are not closely related to the present invention are omitted.

[0054] It should be emphasized that the term “include / comprising” when used herein refers to the presence of features, elements, steps or kits, but does not exclude the presence or addition of one or more other features, elements, steps or kits.

[0055] It should also be noted that, unless otherwise specified, the term “connection” herein may refer not only to a direct connection but also to an indirect connection involving an intermediate.

[0056] Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In the accompanying drawings, the same reference numerals represent the same or similar components, or the same or similar steps.

[0057] The present invention improves the shape of the pericardiocentesis guidewire and the shape of the catheter, and when the pericardiocentesis guidewire or pericardiocentesis guidewire kit is used, it can ensure that pericardiocentesis is safe and efficient when it is clinically required. The technical solution provided by the present invention has the advantages of greatly reducing the operation time, radiation time, improving the success rate of the operation and reducing the complications of the operation.

[0058] In a first aspect, the present invention provides a pericardial puncture guide wire 1, such as Figure 2 As shown, the pericardiocentesis guidewire 1 has an elastically deformable head 12, which has 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 pericardiocentesis surgery, while the head 12 can be used to completely enter the interval between the pericardium and the myocardium.

[0059] like Figure 4-Figure 6 As shown, according to the extension degree of the head 12 in the catheter 2, the head 12 can be deformed into a transmission shape, a breakthrough shape and a completely bent shape respectively due to its certain elasticity, toughness and strength.

[0060] 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, with the head 12 fully deployed in the catheter or only the needle tip 125 exposed at the distal end of the catheter 2 (refer to Figure 4 As shown in the position, the distal end of the catheter 2 (away from the instrument operator) is used to abut or cling to the outer wall of the pericardium to prepare for the puncture operation of the needle tip 125.

[0061] refer to Figure 5In the breakthrough configuration, a portion of the head 12 extends from the distal end of the catheter 2, so that the needle tip 125 penetrates from the pericardial outer wall into the pericardial inner wall to be located between the pericardial inner wall and the myocardium, and the needle tip 125 is configured to deflect relative to the head body so that the needle tip 125 deflects away from the pericardial inner wall. Figure 5 As shown, a part of the head 12 is a part of the needle tip 125 and the head body. The needle tip 125 is deflected relative to the head body, which means that the adjacent section of the needle tip 125 and the head body does not extend in a straight line, that is, the needle tip 125 is deflected in a direction away from the inner wall of the pericardium in this state, so as to avoid continuous puncture of the pericardium.

[0062] refer to Figure 6 In the fully bent state, the head 12 completely extends from the distal end of the catheter 2. The head 12 returns to the fully bent state without the restriction of the catheter 2. 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 state is also the original state of the head 12. The needle tip 125 described here being surrounded by the head body means that, within the plane of the fully bent state, the periphery of the needle tip 125 has the head body structure; in other words, the needle tip 125 is curled up inside the head 12; this setting can minimize the probability of the sharp needle tip 125 structure contacting the non-puncture site of the pericardium and the myocardium, so as to avoid continuous puncture of the pericardium and scratching of myocardial cells, and can minimize complications.

[0063] In the above embodiment, the present invention can ensure that the guide wire is more flexible during operation through reasonable head design and the application of elastic materials, and can be smoothly guided to the target site (the pericardial site that needs to be punctured), reducing the difficulty and risk of operation. The length of the needle tip is designed to be appropriate to ensure that it can penetrate the target tissue, while not being too long to cause unnecessary tissue damage or affect the accuracy of puncture.

[0064] The present invention can ensure that the guide wire can move in a direction away from the myocardium under the bending stress of the head 12 during the puncture process by setting the needle tip to deflect in a specific direction and a special shape of bending, which helps to reduce or avoid damage to other cardiac tissues. Due to the improved shape of the head 12 and the needle tip 125, the use of the guide wire can make the operation in the operation faster and more accurate, thereby greatly shortening the operation time and reducing the exposure time of patients and medical staff to radiation. Accurate puncture and guidance reduce mispuncture, tissue damage and operational errors, thereby reducing the probability of complications and improving the success rate of the operation.

[0065] To further explain the shape of the head 12 of the pericardial puncture guide wire 1, as at least one achievable manner, Figure 2As shown, 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. The straight segment of the guidewire body 11 has good rigidity and straight transmission force, which is convenient for transmitting the pressure applied to the needle tip 125.

[0066] like Figure 2 As shown, in the extension direction 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. The head body is designed to consist of four continuous parts, roughly forming an unclosed long waist-shaped structure, and the needle tip 125 is located inside the long 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, thereby minimizing complications.

[0067] Among them, 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; when the head 12 is in a fully bent state, the second straight segment 122 is bent by the first curved segment 121 to be parallel to the first straight segment 111 or to intersect with its extended line (but the lengths of the two straight segments are designed not to cross or interfere), and the third straight segment 124 and the needle tip 125 are bent to the inner side of the head 12 by the second curved segment 123, and the extended line of the third straight segment 124 intersects with the second straight segment 122, and the intersection position is close to one side of the first curved segment 121.

[0068] The first curved segment 121, as the starting part of the guide wire from the straight segment to the curved shape, determines the starting direction of the head 12. The bending angle of the first curved segment 121 can be configured to be 180 degrees, that is, the guide wire can turn around. The second straight segment 122 is guided by the first curved segment 121 to form a straight section parallel to the first straight segment 111. This straight segment can maintain a certain stability and directionality through the guidance of the curved segment, so that it can accurately point to the target part during the subsequent puncture operation. The second curved segment 123 connects the second straight segment 122 with the third straight segment 124, and further bends the third straight segment 124 and the needle tip 125 to the inner side of the head 12, ensuring that the needle can be accurately positioned toward the target position. The bending angle of the second curved segment 123 can be configured to be greater than 180 degrees, that is, the guide wire can turn around again and extend inward. The other left and right of the second curved segment 123 can be used as a soft segment, that is, its supporting force or strength is less than that of other parts, and can be used 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 the arc transition makes the needle tip deviate to the side of the first straight segment 111, so that the direction of the needle tip is inconsistent with the curling direction of the guide wire head 12, avoiding continuous puncture of the myocardium or other parts of the pericardium.

[0069] In the above embodiment, after the head 12 of the guide wire completely enters the punctured pericardium, its curved structure is completely released and can be restored to its original curved shape, and the needle tip is surrounded inside to protect the adjacent myocardial tissue or pericardial tissue in other parts.

[0070] In the above embodiment, the second straight line segment 122 is parallel to the first straight line segment 111, but is not limited to this, and can also be configured as a non-parallel structure; similarly, the second straight line segment 122 intersects with the extension line of the third straight line segment 124, but is not limited to this, and can also be configured as a parallel structure, but the needle tip needs to be configured on the inner side of the head and in a shape bent toward the first straight line segment 111.

[0071] In some embodiments, the guide wire of the head 12 is flat, that is, the cross section of this part is flat, so that the guide wire is softer in the curved part, avoiding damage to tissue in complex blood vessels or organ structures, while providing better control and adaptability. The flat wire design also helps to pass through curved, narrow or irregular anatomical structures more smoothly. The guide wire of the guide wire body 11 is round, that is, its main part is round, and has better hardness than the flat wire to stabilize the transmission pressure or thrust.

[0072] In some embodiments, the needle tip is a sharp tip, and the tip is specially designed or processed to have a sharp penetration capability. The sharp needle tip can more easily penetrate the skin, tissue or other media, reducing pain and damage during insertion. The vertical angle and horizontal angle of the needle tip are both less than 25 degrees. This design makes the penetration angle of the needle tip very shallow, the needle tip can contact the surface at a smaller angle, and can also avoid excessive deviation, so that the target position of the pericardium can be pierced more easily, smoothly and accurately.

[0073] 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 hardness or support of the second curved segment 123 is less than that of its adjacent parts, and it is used as a soft segment. This ensures that even if the needle tip accidentally penetrates the myocardium, due to the existence of the soft segment, the needle tip will not continue to penetrate, but will be brought out by the soft segment, avoiding serious complications.

[0074] 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 0.12-0.16 mm; the thickness of the third straight segment 124 is between 0.10-0.14 mm. During the puncture operation, the needle tip 125 needs to have sufficient support to maintain its shape and stability. During the puncture process, the needle will face certain external forces (such as the reaction force and resistance of the pericardium, etc.). Its thickness is relatively large to ensure that the needle part is strong enough and has a certain rigidity to withstand the pressure required during the puncture process and help the needle to penetrate the pericardium smoothly.

[0075] In some embodiments, the third straight segment 124 is thicker than the second curved segment 123; the thickness of the second curved segment 123 is thinner than the thickness of the second straight segment 122. For example, the thickness of the second curved segment 123 is between 0.09-0.12 mm; the thickness of the second straight segment 122 and the first curved segment 121 is between 0.09-0.48 mm. The design of the second curved segment 123 (soft segment) is used to increase safety; specifically, the lack of support of the soft segment prevents the needle tip from further penetrating into the tissue due to excessive rigidity, but brings 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 process, coating or design of different materials.

[0076] In addition, from the second straight segment 122 or the first curved segment 121 to the proximal end of the guide wire, its wall thickness gradually increases, and its cross-sectional shape gradually transitions from flat wire to round wire until the proximal end of the head 12, that is, the wall thickness of this section is 0.09-0.48mm and gradually increases. The wall thickness of the head 12 (the first curved segment 121 and the second straight segment 122) gradually decreases from the proximal end to the distal end, so that these parts can both ensure flexibility and provide greater structural support when necessary.

[0077] In some embodiments, the needle tip 125 has a certain length and is curved, and its arc length is between 0.8-1.5 mm. Considering the size of the needle tip, it is necessary to puncture a channel of a predetermined size in the pericardium to facilitate the extraction of pericardial effusion or the implantation of an ablation catheter. If the size of the needle tip is set too long, the contact length is too large, the required pressure is large, and it is easy to cause unnecessary damage to the pericardium. The embodiment of the present invention sets the curved needle tip within a certain length range, which helps to reduce damage to the pericardium during puncture, provides better control, and facilitates smooth puncture.

[0078] In some embodiments, the diameter of the second curved section 123 is between 1.5-3.5 mm. The design of the diameter of the second curved section 123 is kept within the range of 1.5-3.5 mm in order to achieve the best balance during the pushing and puncturing process: it avoids the risk of the guide wire being entangled with the pericardium and other tissues due to a too small diameter, and avoids excessive pushing resistance due to a too large diameter.

[0079] In some embodiments, the combination of the needle tip 125, the third straight segment 124 and the second curved segment 123 is roughly "S" shaped. The design of this S-shaped structure, in cooperation with the needle tip 125, the third straight segment 124 and the second curved segment 123, can ensure the precise control and movement direction of the needle tip during the puncture process. By ensuring that the needle tip moves away from the pericardium after puncture, this design greatly improves the safety of puncture, especially during pericardial puncture, reducing the risk of accidentally puncturing the pericardium or other important tissues. At the same time, this design also provides a better guidewire guidance function, ensuring the success rate and safety of the surgical operation.

[0080] In some embodiments, the diameter of the first curved section 121 is greater than the diameter of the second curved section. This design allows the needle tip 125 to be surrounded by the head 12. In some embodiments, the needle tip is configured to be located at or near the center of the first curved section 121. Since the needle tip is located near the center of the curved section, the position of the needle tip can be more easily controlled during the puncture process or after the puncture is completed, reducing the risk of puncturing surrounding tissues and effectively avoiding unnecessary damage.

[0081] In some embodiments, the needle tip 125 or the pericardial puncture guidewire 1 is made of nickel-titanium alloy. Based on 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, especially in pericardial puncture and other precision operations. Nickel-titanium alloy has a shape memory effect and can maintain a memory shape during use. The superelasticity of nickel-titanium alloy enables the nickel-titanium alloy material to withstand a large force and return to its original shape when bent or compressed, which is particularly important for guidewires that need to be flexibly bent and pass through narrow channels. For example, during pericardial puncture, the guidewire needs to flexibly enter the complex pericardial structure. Nickel-titanium alloy will not produce obvious toxicity or immune response to tissues in the body, reducing invasiveness and discomfort to patients. The use of nickel-titanium alloy can achieve a slender, soft guidewire or needle, making the puncture less traumatic and the patient's recovery faster. Flexibility and shape memory effect enable the instrument to enter the target area more accurately, thereby reducing unnecessary tissue damage and complications.

[0082] In the above embodiments, in addition to nickel-titanium alloy, the material of the needle tip 125 or the pericardial puncture guide wire 1 can also be made of cobalt-chromium alloy, nickel-cobalt alloy, polymer material and other materials. The specific selection depends on the needs of the operation, the operation accuracy requirements, and the biocompatibility, corrosion resistance and mechanical properties of the material.

[0083] Most of the existing technical methods are used to puncture the pericardium after myocarditis or cardiac tamponade. This kind of pericardium is not completely attached to the heart, and there is a large distance in between. Therefore, the clinical data is much better than that of dry pericardium. Even so, there is at least 4% puncture injury. The reason is that it is a very dangerous process to touch the heart with a sharp tip during the beating of the heart. The existing technology has a high risk of complications, and the complications range from mild pericardial hemorrhage, which requires emergency rescue; severe complications include myocardial injury and coronary artery injury, which require emergency thoracotomy in most cases and are life-threatening.

[0084] In a second aspect, the present invention provides a pericardial puncture guidewire 1 kit comprising the pericardial puncture guidewire 1, such as Figure 1 , Figure 3 and Figure 4 As shown, the pericardial puncture guidewire kit also includes a catheter 2 for the pericardial puncture guidewire 1 to pass through, and the distal end of the catheter 2 has an inclined portion 21 for abutting against the outer wall of the pericardium. The design angle of the inclined portion 21 enables the distal end of the catheter 2 to better fit the outer wall of the pericardium. Since the shape and position of the pericardium are relatively complex, the catheter 2 needs to accurately and stably contact the outer wall of the pericardium during the puncture process. The selection of the angle of the inclined portion 21 can ensure that the catheter contacts the outer wall of the pericardium more smoothly, thereby avoiding deflection or slippage and maintaining stable positioning.

[0085] Furthermore, the inclination angle of the inclined portion 21 is 130-170°. This angle can provide a good pericardium contact, and can also allow the catheter 2 to easily pass through the pericardium after the guide wire passes through. This inclination angle can be used as a physical guide to make it easier for the catheter 2 to enter the pericardial cavity during the puncture process. A suitable inclination angle will reduce the difficulty of the entry angle, so that the catheter 2 can remain stable when passing through the pericardium, and is not easy to deviate or damage surrounding tissues.

[0086] In some embodiments, Figure 4 As shown, the tube mouth position of the inclined portion 21 of the catheter 2 has a chamfer 211 or a fillet, and the side length of the chamfer 211 is less than the curvature length of the needle tip, or the diameter of the fillet is less than the curvature diameter of the needle tip. The curvature diameter of the needle tip should be slightly larger than the side length / fillet diameter of the corresponding side chamfer 211 of the catheter 2, so that during puncture, the tube mouth of the catheter 2 can smoothly cooperate with the needle tip, so that the catheter 2 maintains appropriate support force and shape stability. In this way, not only the guidance and accuracy during the puncture process are ensured, but also the catheter 2 is prevented from getting stuck or damaging the pericardial tissue during operation.

[0087] The present invention provides the outer wall of the pericardium to be attached by using a catheter without a sharp tip, and then uses a pericardial puncture guide wire that follows the catheter bend to lift and puncture the pericardium to form a puncture. Since the direction of the needle tip is always away from the direction of the heart, it will not cause accidental puncture to damage the internal organs. At the same time, since the diameter of the pericardial puncture guide wire is small, even if it is punctured by mistake, it will not cause serious complications.

[0088] In some embodiments, the outer wall of the catheter 2 has an insulating coating, and 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 entire tube length; the coating can reduce friction resistance and isolate electrical signals. Optionally, the total length of the catheter 2 is in the range of 150mm-210mm, and the length of the coating is required to be in the range of 120mm-190mm, which can ensure that when passing through the human body, no erroneous judgment is made due to electromyographic signals.

[0089] Furthermore, the catheter 2 is made of metal, and its proximal outer wall is used to connect the wire clamp. During the puncture process, a tail wire can be connected to the needle body, and real-time electrical signals can be used to detect whether the puncture is successful or not. By ensuring that the length of the insulating coating does not cover the entire catheter 2, it can be ensured that the metal material portion of the catheter 2 can be connected to the wire clamp for real-time electrical signal detection and conduction. In this way, the wire clamp can contact the metal portion of the catheter 2 at the proximal end of the catheter to achieve accurate transmission and monitoring of electrical signals. This method of electrical signal detection is very useful, especially during cardiac surgery or puncture. The accuracy of the puncture can be monitored in real time according to the form of the electrical signal and the position of the puncture guide wire can be assisted to ensure that the operator can promptly determine whether the puncture is successful.

[0090] In some embodiments, Figure 1 As shown, the pericardiocentesis 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 inclined to the axial direction of the catheter 2, and is used for allowing the pericardiocentesis guidewire 1 to pass through; based on the axial direction of the catheter 2, 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.

[0091] The Y-type three-way connector 3 not only serves as an extension of the catheter 2, but also plays a directional role, helping the guidewire to smoothly pass through the catheter 2 in a specific direction and angle. The direction of the side branch 31 of the Y-type three-way is consistent with the direction of the head 12 of the guidewire, making the movement trajectory of the guidewire more stable and avoiding the deviation of the guidewire. Through this coplanar design, the instability during the guidewire puncture process is reduced. The curved design of the guidewire tip ensures that the guidewire tip is always facing the direction of the operation during the operation, ensuring that the guidewire can accurately puncture toward the predetermined target, especially when performing high-precision operations such as pericardial puncture, the accuracy of the direction is crucial.

[0092] Furthermore, the Y-type three-way connector 3 is also provided with a pointing plate 33, and the pointing plate 33 is arranged coplanar with the axis of the side branch 31. The design of the pointing plate 33 provides a clear visual reference for the operator, helping them to determine the precise direction of the guidewire according to the layout of the Y-type three-way connector. By observing the pointing plate 33, the operator can determine the direction and position of the guidewire needle tip without directly viewing the guidewire or X-ray image, which greatly improves the convenience and safety of the operation.

[0093] In some embodiments, the pericardiocentesis guidewire kit further includes a locking joint 4, which is installed at the end of the side branch 31 and is used to fix the pericardiocentesis guidewire 1. The locking joint 4 can be selected as a locking nut to ensure that the guidewire does not deviate, making the operation more stable.

[0094] In some embodiments, the Y-type three-way connector 3 also has a main branch 32 arranged along the axial direction of the catheter 2, and the end of the main branch 32 is used to connect an extension tube to inject contrast agent, or to connect a three-way valve plug cap 5 to maintain sealing. This design enables the Y-type three-way connector 3 to not only have the guide wire support and pointing functions, but also add the additional functions of injecting contrast agent and maintaining sealing. The end of the main branch 32 can be connected to an extension tube, and the connection between the main branch 32 and the extension tube allows the operator to inject contrast agent through the interface, and the contrast agent flows smoothly into the pericardial cavity or the target area, thereby providing real-time imaging support. When performing puncture or interventional operations, with the use of contrast agents, the puncture path and the specific position of the pericardial cavity can be more intuitively seen, avoiding mispuncture or inaccurate operation, thereby ensuring safety and effect. Another function is that the end of the main branch 32 can also be connected to a three-way valve plug cap 5 for maintaining sealing. Ensuring the sealing of the system is the key to preventing infection or leakage, especially in operations such as pericardial puncture, any slight leakage may have serious consequences. By simply inserting or removing the plug cap, the operator can flexibly control the sealing and opening status of the system, which is convenient for adjustment at different stages of the operation. For example, in some steps of the operation, the guidewire path needs to be kept sealed, while in other steps, it needs to be opened to inject contrast agent.

[0095] In order to further explain the working principle and puncture process of the pericardial puncture guide wire 1 kit in the embodiment of the present invention, the following Figure 3 , Figure 5 and Figure 6 Detailed description.

[0096] Figure 3 FIG. 1 is a schematic diagram of a state in which the pericardial puncture guide wire 1 kit is attached to the outer wall of the pericardium in one embodiment of the present invention. Figure 3 As shown, during the operation, the catheter 2 needs to be placed against the pericardium with its back facing away, and at the same time, the outlet of the tube (the end of the inclined portion 21) is tangent to the arc surface of the heart, so as to ensure that the puncture guidewire is punctured in an upward direction. Since the Y-type tee has a directional function, it is ensured that the needle tip 125 of the pericardial puncture guidewire 1 is always facing above the opening. At the same time, based on the shape of the guidewire and the fixing effect of the locking nut, the direction of the needle tip of the pericardial puncture guidewire 1 can be determined according to the directional plate 33 of the Y-type tee connector 3. After confirming the direction of the catheter 2 through heart beats and images, move the catheter 2 back and forth to ensure that the pericardium appears as shown in the figure. Figure 3 The folds will cover a portion of the opening of the catheter 2.

[0097] Figure 4 FIG. 1 is a schematic diagram of a state in which the needle tip 125 of the pericardiocentesis guidewire 1 is out of the catheter 2 in one embodiment of the present invention, and the pericardiocentesis guidewire 1 is pushed out as shown in FIG. Figure 4As shown, the needle tip will briefly puncture downward 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, the impact can be ignored. If the pericardium is slightly far away from the catheter 2, the guide wire will continue to be pushed forward and upward ( Figure 5 ), once the guide wire contacts the pericardium, relying on the supporting force of the third straight segment 124, the needle tip 125 of the guide wire can also easily pass through the pericardium to complete the puncture.

[0098] After the puncture is successful, since the head 12 is made of nickel-titanium alloy wire and has good resilience, the head 12 will return to its original shape after the puncture is successful ( Figure 6 ), this shape can be maintained in the pericardial cavity, and because the head 12 of the pericardial puncture guide wire 1 is designed to be curved around the needle tip, it is ensured that the myocardial cells and pericardium are not scratched after the needle tip punctures.

[0099] In some embodiments, the guide wire described above can be used as a disposable consumable. The disposable guide wire is discarded after each surgery or operation, which effectively prevents cross-contamination of the guide wire between multiple patients. The use of disposable instruments can avoid problems such as material fatigue, wear or incomplete cleaning due to repeated use. Disposable guide wires do not need to go through cumbersome disinfection and cleaning procedures. This not only reduces the hospital's disinfection burden, but also eliminates potential problems in the cleaning process. Disposable guide wires are made of high-quality materials and undergo strict quality control. Each guide wire is brand new before use and meets the design specifications, which ensures its performance and reliability. Disposable instruments do not need to be inspected and prepared before use, saving time before surgery.

[0100] The pericardiocentesis guidewire kit in the embodiment of the present invention is not only suitable for pericardial effusion puncture, but also suitable for dry pericardiocentesis, and has simple operation and low puncture risk.

[0101] According to the technical solution described in the pericardiocentesis guidewire and pericardiocentesis guidewire kit provided in the embodiments of the present invention, the beneficial effects that can be obtained include at least:

[0102] (1) Traditional pericardial puncture guidewires usually require a sharp tip close to the heart for positioning and puncture, which may cause accidental injury or damage to the heart structure. The pericardial puncture guidewire kit of the present invention does not require a sharp tip close to the heart. The guidewire kit design allows the pericardial puncture guidewire to be smoothly attached to the pericardial surface and punctured smoothly. After puncture, it moves away from the myocardium, reducing damage to the heart tissue and avoiding the potential dangers of traditional sharp punctures. Since the direct contact between the sharp part and the heart is reduced, the probability of bleeding and other complications is also reduced.

[0103] (2) Due to the optimized structure and materials of the pericardial puncture guidewire and catheter, they can quickly approach the target area, reducing the time required for frequent adjustment of the guide and confirmation of the position in traditional surgery. Especially in complex or emergency situations, reducing the operation time is crucial to the safety of patients.

[0104] (3) Traditional pericardial puncture usually requires the injection of contrast agent and the confirmation of puncture success through imaging examination, while the guidewire kit in the present invention uses electrocardiogram signals to monitor the puncture effect in real time. This method does not rely on the injection of contrast agent, which not only saves the use of contrast agent but also reduces the patient's exposure to radiation. The correctness of the puncture can be confirmed immediately with the help of electrocardiogram, avoiding the delay that may be caused by imaging examination.

[0105] (4) During traditional pericardial puncture, improper operation of the puncture guide needle may cause a large cardiac perforation, which may lead to pericardial tamponade, an acute and serious complication that may endanger the patient's life. The guide wire can effectively prevent the puncture needle from entering the deep structure of the heart or causing excessive puncture. Due to the flexibility and guiding function of the guide wire itself, it can help the operator control the direction and depth of the puncture, reducing the risk of accidental injury during puncture. The design of the guide wire head and curved needle tip allows the puncture path to be precisely controlled, reducing unnecessary puncture force, thereby reducing the possibility of cardiac perforation.

[0106] (5) Traditional pericardial puncture usually requires the operator to frequently confirm whether the needle tip is accurately touching the pericardium during the puncture process. However, when using the pericardial puncture guidewire kit of the present invention, the operator does not need to repeatedly confirm whether the needle tip is close to the pericardium. A blunt needle tip close to the pericardium will not cause complications. Therefore, the operator can safely close and puncture. At the same time, since the pericardial puncture guidewire has a guiding function, there is no need to replace the guidewire after a successful puncture.

[0107] In the present invention, 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 features of other embodiments or replace features of other embodiments.

[0108] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the embodiments of the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A pericardiocentesis guidewire, characterized in that: The pericardial puncture guide wire (1) comprises an elastically deformable head (12), wherein the head (12) comprises a head body and a needle tip (125) deflected relative to the head body, wherein the needle tip (125) and its adjacent portion and a first curved section at the distal end of the head body are combined to form an "S"-shaped structure; According to the extension degree of the head (12) in the catheter, the head (12) can be deformed into a transmission shape, a breakthrough shape and a fully bent shape respectively; In the delivery configuration, the head (12) can be delivered through a catheter, the head (12) is fully deployed in the catheter or only the needle tip (125) is exposed at the distal end of the catheter, and the distal end of the catheter is used to abut against the outer wall of the pericardium; In the breakthrough configuration, a portion of the head (12) extends from the distal end of the catheter, so that the needle tip (125) pierces from the pericardial outer wall into the pericardial inner wall to be located between the pericardial inner wall and the myocardium, and the needle tip (125) is configured to deflect relative to the head body so as to deflect away from the pericardial inner wall; In the fully bent state, the head (12) completely extends from the distal end of the catheter and returns to a bent state, and the shape of the head (12) is configured to enable the needle tip (125) to be surrounded by the pericardial puncture guide wire and the head body.

2. The pericardiocentesis guidewire according to claim 1, characterized in that: The pericardiocentesis guidewire (1) further comprises a guidewire body (11), the head (12) is located at the distal end of the guidewire body (11), and the guidewire body (11) comprises a first straight line segment (111); In the extending direction from the proximal end to the distal end of the pericardiocentesis guide wire (1), the head body of the head (12) comprises a first curved segment (121), a second straight segment (122), a second curved segment (123) and a third straight segment (124) which are 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); When the head (12) is in a fully bent state, the second straight line segment (122) is bent by the first bent segment (121) to be parallel to or intersecting with the extension line of the first straight line segment (111), and the third straight line segment (124) and the needle tip (125) are bent by the second bent segment (123) to the inner side of the head (12), and the extension line of the third straight line segment (124) intersects with the second straight line segment (122), and the intersection position is close to one side of the first bent segment (121).

3. The pericardiocentesis guidewire according to claim 2, characterized in that: The guide wire of the head (12) is in the shape of a flat wire, and the guide wire of the guide wire body (11) is in the shape of a round wire.

4. The pericardiocentesis guidewire according to claim 1, characterized in that: The needle tip is a sharp tip, and both the vertical angle and the horizontal angle of the tip are less than 25 degrees.

5. The pericardiocentesis guidewire according to claim 2, characterized in that: The thickness of the second curved section (123) is smaller 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 line segment (124); The third straight segment (124) is thicker than the second curved segment (123); and / or, The thickness of the second curved segment (123) is smaller than the thickness of the second straight segment (122).

6. The pericardiocentesis guidewire according to claim 5, characterized in that: The thickness of the needle tip (125) is between 0.12-0.16 mm; and / or, The thickness of the third straight line segment (124) is between 0.10-0.14 mm; and / or, The thickness of the second curved section (123) is between 0.09 mm and 0.12 mm; and / or, The thickness of the second straight section (122) and the first curved section (121) is between 0.09 mm and 0.48 mm.

7. The pericardiocentesis guidewire according to claim 2, characterized in that: The needle tip (125) has a certain length, and its arc length is between 0.8-1.5 mm; and / or, The second curved section (123) has a thickness between 1.5 and 3.5 mm; and / or, The diameter of the first curved section (121) is greater than the diameter of the second curved section; and / or, The needle tip is configured to be located at or close to the center of the first curved section (121).

8. The pericardiocentesis 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 pericardiocentesis guidewire (1) kit comprising the pericardiocentesis guidewire (1) according to any one of claims 1 to 8, characterized in that: The pericardiocentesis guidewire kit further comprises a catheter (2) for passing the pericardiocentesis guidewire (1), wherein the distal end of the catheter (2) comprises an inclined portion (21) for abutting against the outer wall of the pericardium.

10. The pericardiocentesis guidewire (1) kit according to claim 9, characterized in that: The tube opening 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 smaller than the curvature length of the needle tip, or the diameter of the rounded corner is smaller than the curvature diameter of the needle tip; and / or, The inclination angle of the inclined portion (21) is 130-170°.

11. The pericardiocentesis guidewire (1) kit according to claim 9, characterized in that: The outer wall of the catheter (2) has an insulating coating, and 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 for connecting a wire clamp.

12. The pericardiocentesis guidewire (1) kit according to claim 9, characterized in that: The pericardiocentesis guidewire kit further comprises a Y-shaped three-way connector (3), the Y-shaped three-way connector (3) being mounted at the proximal end of the catheter (2), the Y-shaped three-way connector (3) having a side branch (31) arranged obliquely with respect to the axial direction of the catheter (2) for allowing the pericardiocentesis 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), the axis of the catheter (2) and the axis of the side branch (31) are coplanar.

13. The pericardiocentesis guidewire (1) kit according to claim 12, characterized in that: The Y-shaped three-way connector (3) is further provided with a pointing plate (33), and the pointing plate (33) is arranged coplanar with the axis of the side branch (31); and / or, The pericardiocentesis guidewire kit further comprises a locking connector (4), wherein the locking connector (4) is mounted at the end of the side branch (31) and is used to fix the pericardiocentesis guidewire (1); and / or, The Y-shaped three-way connector (3) also has a main branch (32) arranged along the axial direction of the catheter (2), and the end of the main branch (32) is used to connect an extension tube to inject contrast agent, or to connect a three-way valve plug (5) to maintain sealing.

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