Atrial septum puncture system convenient to position

Abstract

The atrial septum puncture system comprises a puncture sheath tube, the puncture sheath tube comprises a first bent section and a second bent section which are located between the near end and the far end, the first bent section and the second bent section are formed by pre-molding the puncture sheath tube, the first bent section is constructed to be bent in the direction away from the atrial septum, and the second bent section is constructed to be bent in the direction away from the far end of the atrial septum. The second bent section is constructed to be bent in the direction of the atrial septum so that the far end of the puncture sheath tube can point to the atrial septum. The pre-molded first bent section and the pre-molded second bent section enable the structure of the puncture sheath tube to be matched and conform to the path from the inferior vena cava to the atrial septum fossa ovalis, during surgical operation, after an operator pushes the far end of the puncture sheath tube to the right atrium under the guidance of a medical image, the puncture sheath tube can be pushed or rotated in the axial direction, and the puncture operation can be completed. Therefore, the far end of the puncture sheath tube can point to the position of the atrial septum fossa ovale, the bending adjusting step of the puncture sheath tube is reduced, the dependence of an operator on ultrasound is reduced, and the operation is more simplified and convenient.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an atrial septum puncture system that facilitates positioning. Background Art

[0002] The atrial septum (IAS) is located between the left atrium (LA) and the right atrium (RA) of the heart. Like the ventricular septum, it is 45° to the sagittal plane and is composed of two layers of endocardium with a small amount of myocardium and connective tissue. The fossa oval (FO) is located in the middle and lower 1 / 3 of the atrial septum and is shallowly concave. The right side of the fossa oval is concave, and its left side protrudes slightly into the left atrial cavity. The fossa oval of the heart is located at the thinnest part of the atrial septum. The center of the fossa oval is only 1mm thick. This position is the ideal position for atrial septal puncture to enter the left atrium. Atrial septal puncture needs to be performed at the position of the fossa oval to avoid accidentally injuring the atrial septum that is not in the fossa oval.

[0003] Under normal circumstances, the percutaneous catheter cannot directly reach the left atrium in an antegrade manner. Although it can reach the left atrium in a retrograde manner through the two turns of the aortic valve and the mitral valve, the catheter operation is very cumbersome. Therefore, puncturing the atrial septum allows the catheter to pass through the right atrium to the left atrium, making the operation of left heart system inspection and treatment simpler and more convenient.

[0004] However, when the existing sheath is used in atrial septal puncture surgery, due to the large bending angle and complex structure of the path the sheath takes to reach the lesion site, improper use of the delivery device may cause the device to be pushed forward excessively, causing the device to damage human blood vessels or the heart.

[0005] like Figure 1 As shown, in the prior art, a non-pre-shaped atrial septal puncture sheath is pushed straight from the inferior vena cava (IVC) into the right atrium. Since the distance between the inferior vena cava and the oval fossa of the atrial septum is relatively close, the space for adjusting the atrial septal puncture sheath is small. The bending angle required to adjust the distal end of the atrial septal puncture sheath toward the oval fossa for puncture is too large, resulting in difficulty in the bending operation and difficulty in puncturing the oval fossa, thereby easily injuring the atrial septum at a location other than the oval fossa. Summary of the invention

[0006] To solve the above technical problems, the present application provides an atrial septum puncture system that is easy to position, including a puncture sheath, the puncture sheath including a proximal end and a distal end, the puncture sheath also including a first curved segment and a second curved segment located between the proximal end and the distal end, the first curved segment and the second curved segment are pre-molded by the puncture sheath, the first curved segment is constructed to bend in a direction away from the atrial septum, and the second curved segment is constructed to bend in a direction toward the atrial septum so that the distal end of the puncture sheath points to the atrial septum.

[0007] In a preferred embodiment, the first curved segment and the second curved segment are arc segments respectively, and there is a first straight segment between the first curved segment and the second curved segment, and the first curved segment, the first straight segment and the second curved segment together form a pre-shaped gap between the puncture sheath and the atrial septum.

[0008] In a preferred embodiment, the interval between the first curved section and the second curved section is 20 mm-60 mm.

[0009] In a preferred embodiment, the puncture sheath also includes a second straight section connected to the first curved section and extending toward the proximal end of the puncture sheath, and a third straight section connected to the second curved section and extending toward the distal end of the puncture sheath, the angle between the extension line of the second straight section and the first straight section is in the range of 30°-50°, and the angle between the third straight section and the extension line of the first straight section is in the range of 70°-90°.

[0010] In a preferred embodiment, the puncture sheath is provided with a first traction mechanism and a second traction mechanism, the first traction mechanism is configured to traction and bend the first curved section of the puncture sheath, and the second traction mechanism traction and bend the second curved section of the puncture sheath.

[0011] In a preferred embodiment, the puncture sheath includes an inner layer, an intermediate woven mesh layer and an outer layer, the first traction mechanism and the second traction mechanism are both arranged between the inner layer and the intermediate woven mesh layer, the first traction mechanism includes a first anchoring ring and a first traction wire connected to the first anchoring ring, and the second traction mechanism includes a second anchoring ring and a second traction wire connected to the second anchoring ring.

[0012] In a preferred embodiment, the first traction wire and the second traction wire are arranged between the inner layer and the middle braided mesh layer of the puncture sheath tube at intervals.

[0013] In a preferred embodiment, the first traction mechanism further includes a first hollow tube, and the first hollow tube covers the first traction wire. The second traction mechanism further includes a second hollow tube, and the second hollow tube covers the second traction wire.

[0014] In a preferred embodiment, the puncture sheath includes an outer sheath and a middle sheath, the outer sheath includes a first limiting groove, the middle sheath includes a first limiting piece matching the first limiting groove, and the axial length of the first limiting groove limits the distance that the middle sheath is pushed in the outer sheath.

[0015] In a preferred embodiment, it also includes a dilator, the puncture sheath includes an outer sheath and a middle sheath, the middle sheath includes a second limiting groove, and the dilator includes a second limiting member matching the second limiting groove, and the axial length of the second limiting groove limits the distance that the dilator is pushed in the middle sheath.

[0016] In a preferred embodiment, the puncture sheath includes an inner layer, an intermediate woven mesh layer and an outer layer. A developing mark group is provided between the inner layer and the intermediate woven mesh layer of the puncture sheath. The developing mark group includes a plurality of equidistantly arranged developing rings, and the developing rings are metal rings that are radiation-proof.

[0017] Compared with the non-pre-shaped puncture sheath in the prior art, the puncture sheath of the atrial septum puncture system provided by the present application includes a pre-shaped first curved section and a second curved section to match the path of the puncture from the inferior vena cava to the oval fossa of the atrial septum, so that the distal end of the puncture sheath basically points to the atrial septum, reducing the steps of bending the puncture sheath. During the operation, after the operator pushes the distal end of the puncture sheath to the right atrium under the guidance of medical images, it is only necessary to push or rotate the puncture sheath axially to make the distal end of the puncture sheath point to the oval fossa of the atrial septum, reducing the steps of bending the puncture sheath, reducing the operator's dependence on ultrasound, and making the operation simpler and more convenient. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present application and, together with the description, serve to explain the principles of the present application.

[0019] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0020] Figure 1 It is a schematic diagram of the puncture path of the non-preformed atrial septal puncture sheath in the prior art.

[0021] Figure 2 It is a schematic diagram of the structure of the atrial septum puncture system provided in one embodiment of the present application.

[0022] Figure 3 It is a schematic diagram of the puncture path of the atrial septum puncture system provided in one embodiment of the present application.

[0023] Figure 4 yes Figure 2 Schematic diagram of the structure of the puncture sheath.

[0024] Figure 5 It is a structural schematic diagram of a first traction mechanism in another embodiment of the present application.

[0025] Figure 6 It is a partial cross-sectional view of a puncture sheath according to another embodiment of the present application.

[0026] Figure 7 yes Figure 6 Cross-section view along the AA direction.

[0027] Figure 8 yes Figure 6 Schematic diagram of the structure of the middle woven mesh layer.

[0028] Fig. 9 It is a schematic structural diagram of an atrial septum puncture system provided in yet another embodiment of the present application.

[0029] Fig.10 yes Fig. 9 Schematic diagram of the assembly of the inner and outer sheaths, the middle sheath and the dilator.

[0030] Fig.11 yes Fig.10 A partial cross-sectional view of .

[0031] Fig.12 yes Fig.11 Magnified view of the X in the middle.

[0032] Fig.13 yes Fig. 9 Partial cross-sectional view of the assembly of the middle dilator and the middle sheath.

[0033] The following specific embodiments will further illustrate the present application in conjunction with the above-mentioned drawings. DETAILED DESCRIPTION

[0034] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0035] In addition, the following descriptions of the embodiments are with reference to the attached diagrams to illustrate specific embodiments that the present application can be implemented in. Directional terms mentioned in the present application, such as "upper", "lower", "front", "back", "left", "right", "inner", "outer", "side", etc., are only with reference to the directions of the attached diagrams. Therefore, the directional terms used are for better and clearer explanation and understanding of the present application, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present application.

[0036] It should be noted that, in order to more clearly describe the structure of the interatrial septal puncture system for easy positioning provided by the present application, the limiting terms "proximal end" and "distal end" described in the specification of the present application are conventional terms in the field of interventional medicine. Specifically, "distal end" refers to the end away from the operator during the surgical operation, and "proximal end" refers to the end close to the operator during the surgical operation; the direction of the central axis of rotation of an object such as a cylinder or a tube is defined as the axial direction; the circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius); the radial direction is the direction along the diameter or radius.

[0037] It is worth noting that the "end" in the terms "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "terminal end", "two ends", "free end", "upper end", "lower end", etc. is not limited to the end, endpoint or end face, but also includes a portion extending from the end, endpoint, or end face on the element to which the end, endpoint, or end face belongs for an axial distance and / or radial distance. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as those generally understood by technicians in the technical field to which this application belongs. The customary terms used in the specification of this application are only for the purpose of describing specific embodiments and are not to be construed as limitations on this application.

[0038] Please also read Figures 2 to 3 The present application provides an atrial septum puncture system 1 that is easy to position, and is used to puncture the oval fossa of the atrial septum 5 of the heart. The atrial septum puncture system 1 includes a puncture sheath 10, and the puncture sheath 10 includes a proximal end 100 and a distal end 101. The puncture sheath 10 also includes a first curved segment 102 and a second curved segment 103 located between the proximal end 100 and the distal end 101. The first curved segment 102 and the second curved segment 103 are pre-molded by the puncture sheath 10. The first curved segment 102 is constructed to bend in a direction away from the atrial septum 5, and the second curved segment 103 is constructed to bend in a direction toward the atrial septum 5 so that the distal end 101 of the puncture sheath 10 points to the atrial septum 5.

[0039] The first curved section 102 and the second curved section 103 are pre-shaped for the puncture sheath 10 to match and conform to the path from the inferior vena cava to the fossa ovalis of the atrial septum 5, so that the distal end 101 of the puncture sheath 10 basically points to the atrial septum 5, reducing the steps of bending the puncture sheath 10. During the operation, after the operator pushes the distal end 101 of the puncture sheath 10 to the right atrium under the guidance of the medical image, it is only necessary to push or rotate the puncture sheath 10 axially to make the distal end 101 of the puncture sheath 10 point to the fossa ovalis position of the atrial septum 5, reducing the steps of bending the puncture sheath 10, reducing the operator's dependence on medical images, such as ultrasound, and making the operation simpler and more convenient.

[0040] Please also refer to Figure 3 to Figure 4 The first curved segment 102 and the second curved segment 103 are arc segments respectively, and there is a first straight segment 104 between the first curved segment 102 and the second curved segment 103. The first curved segment 102, the first straight segment 104 and the second curved segment 103 together form a pre-shaped gap 9 between the puncture sheath 10 and the atrial septum 5.

[0041] The first curved section 102 is configured to bend in a direction away from the atrial septum 5. Compared with the atrial septum puncture sheath in the prior art that is too close to the atrial septum 5, the first curved section 102 increases the distance between the distal end 101 of the puncture sheath 10 and the atrial septum 5, thereby forming a pre-molded gap 9, increasing the operating space for axially pushing or rotating the puncture sheath 10 to align with the oval fossa, and reducing the risk of accidentally injuring the atrial septum when operating the puncture sheath 10. The second curved section 103 is configured to make the distal end 101 of the puncture sheath 10 point to the atrial septum 5, reducing the number of steps for adjusting the bend of the puncture sheath 10.

[0042] like Figure 4 As shown, the first curved segment 102 and the second curved segment 103 are respectively a circular arc, wherein the curvature of the second curved segment 103 is greater than the curvature of the first curved segment 102. The spacing distance L1 between the first curved segment 102 and the second curved segment 103 is 20 mm-60 mm, and the spacing distance L1 can be calculated as the distance between the center points of the respective circular arcs of the first curved segment 102 and the second curved segment 103.

[0043] It can be understood that the specific spacing distance L1 between the first curved section 102 and the second curved section 103 can be any value between 20 mm and 60 mm, for example, 20 mm, 30 mm, 40 mm, 50 mm, 60 mm, etc.

[0044] like Figure 4As shown, the puncture sheath 10 also includes a second straight section 105 connected to the first curved section 102 and extending to the proximal end 100 of the puncture sheath 10, and a third straight section 106 connected to the second curved section 103 and extending to the distal end 101 of the puncture sheath 10. The angle α between the extension line of the second straight section 105 and the first straight section 104 is in the range of 30°-50°, and the angle β between the third straight section 106 and the extension line of the first straight section 104 is in the range of 70°-90°.

[0045] It can be understood that the angle α between the extension line of the second straight section 105 and the first straight section 104 is in the range of 30°-50°, for example, 30°, 40°, 50° or any other value between 30°-50°. The angle α between the extension line of the second straight section 105 and the first straight section 104 is the pre-molded bending angle of the first curved section 102, and the angle α determines the size of the pre-molded gap 9 between the distal end 101 of the puncture sheath 10 and the atrial septum 5, and the pre-molded gap 9 determines the size of the operable space for the operator to operate the puncture sheath 10 so that the distal end 101 is aligned with the oval fossa. It can be understood that the larger the pre-molded angle α is, the larger the pre-molded gap 9 between the distal end 101 of the puncture sheath 10 and the atrial septum 5 is, and the larger the operator's operating space is; the smaller the pre-molded angle α is, the smaller the pre-molded gap 9 between the distal end 101 of the puncture sheath 10 and the atrial septum 5 is, and the smaller the operator's operating space is. Preferably, the angle α between the extension line of the second straight section 105 and the first straight section 104 is in the range of 30°-50°.

[0046] It can be understood that the angle β between the third straight section 106 and the extension line of the first straight section 104 ranges from 70° to 90°, for example, 70°, 80°, 90° or any other value between 70° and 90°. The angle β between the third straight section 106 and the extension line of the first straight section 104 is the pre-shaped bending angle of the second curved section 103, and the angle β determines the angle at which the distal end 101 of the puncture sheath 10 points to the atrial septum puncture. It can be understood that if the pre-shaped angle β is too large, the distal end 101 of the puncture sheath 10 cannot point to the oval fossa of the atrial septum 5 for puncture; if the pre-shaped angle β is too small, the distal end 101 of the puncture sheath 10 cannot point to the oval fossa of the atrial septum 5 for puncture. Preferably, the angle β between the third straight section 106 and the extension line of the first straight section 104 is in the range of 70°-90°, so that the distal end 101 of the puncture sheath 10 can be directed to the oval fossa of the atrial septum 5 for puncture, and the atrial septum will not be accidentally injured due to the puncture angle being too large or too small.

[0047] In some embodiments, please refer to Figures 5 to 7The puncture sheath 10 is provided with a first traction mechanism 11 and a second traction mechanism 12 . The first traction mechanism 11 is configured to tractionally adjust the first curved section 102 of the puncture sheath 10 , and the second traction mechanism 12 tractionally adjusts the second curved section 103 of the puncture sheath 10 .

[0048] It can be understood that the first curved segment 102 and the second curved segment 103 are pre-molded by the puncture sheath 10 to match and conform to the path from the inferior vena cava to the oval fossa of the atrial septum 5, and the first traction mechanism 11 and the second traction mechanism 12 respectively fine-tune the bending angles of the first curved segment 102 and the second curved segment 103 to further meet the requirements of the atrial septum puncture path, so that the distal end 101 of the puncture sheath 10 can more accurately point to the oval fossa position of the atrial septum 5.

[0049] Specifically, the operator transports the distal end 101 of the puncture sheath 10 from the inferior vena cava to the right atrium, and makes the distal end 101 of the puncture sheath 10 basically point to the atrial septum 5 through axial pushing or rotation operation, and then further adjusts the bending angles of the first curved segment 102 and the second curved segment 103 of the puncture sheath 10 through the first traction mechanism 11 and the second traction mechanism 12 respectively, so as to adjust the distal end 101 of the puncture sheath 10 to more accurately point to the oval fossa position of the atrial septum 5, thereby completing the atrial septum puncture operation.

[0050] It can be understood that, since the puncture sheath 10 is pre-shaped, it only needs to slightly adjust the bending angles of the first curved section 102 and the second curved section 103 to accurately point the distal end 101 of the puncture sheath 10 to the oval fossa of the atrial septum 5. In this way, the bending force required for further bending of the first traction mechanism 11 and the second traction mechanism 12 is small, and the operation time is short, so that the atrial septum puncture can be performed conveniently and quickly, reducing the operation time and reducing the difficulty of the operation.

[0051] For further information, please also refer to Figures 5 to 8 The puncture sheath 10 includes an inner layer 105, an intermediate woven mesh layer 106 and an outer layer 107. The first traction mechanism 11 and the second traction mechanism 12 are both arranged between the inner layer 105 and the intermediate woven mesh layer 106. The first traction mechanism 11 includes a first anchoring ring 110 and a first traction wire 111. The second traction mechanism 12 includes a second anchoring ring 120 and a second traction wire 121.

[0052] Specifically, during the molding process of the puncture sheath 10, the inner layer 105 is firstly put on the hot-melt core shaft, the first traction mechanism 11 and the second traction mechanism 12 are fixed, and then the middle braided mesh layer 106 is put on, and then the outer layer 107 is covered on the outside of the middle braided mesh layer 106, and the outer layer 107 is melted through the heat shrink tube, so that the inner layer 105, the first traction mechanism 11, the second traction mechanism 12, the middle braided mesh layer 106 and the outer layer 107 are melted into a whole. After the puncture sheath 10 is hot-melt molded, the puncture sheath 10 is pre-molded to form the first curved section 102 and the second curved section 103 according to the cardiovascular structure of the atrial septal puncture path.

[0053] Furthermore, since the hot-melt mandrel needs to be withdrawn after the hot-melt of the puncture sheath 10 is completed, the material of the inner layer 105 requires a high inner wall finish and the inner layer 105 will not deform when the outer layer 107 is melted. For example, a PTFE material can be selected to make the inner layer 105 with a wall thickness of 0.05 mm-0.30 mm. Preferably, the inner layer 105 is made of a PTFE material with a thickness of 0.10 mm.

[0054] Furthermore, if Figure 8 As shown, the middle braided mesh layer 106 is a mesh structure, and the middle braided mesh layer 106 mainly plays the role of supporting the sheath tube and developing. For example, it can be a mesh tube structure formed by cutting a tube, such as a stainless steel tube or other metal tube; or it can be a mesh tube structure formed by braiding wires, and the braiding wires can be metal wires, such as stainless steel wires or tungsten wires, etc.; or non-metal wires, such as polymer wires and synthetic fiber wires, etc., and the middle braided mesh layer 106 is formed by braiding, winding, etc.

[0055] Preferably, the middle braided mesh layer 106 can be made of a radiopaque material to enhance the visualization effect of the puncture sheath tube 10 in the blood vessel. For example, stainless steel wire or tungsten wire can be selected and made by braiding, winding, etc. In this embodiment, 0.12 mm round tungsten wire is preferred. The braiding density of the braided mesh tube of the middle braided mesh layer 106 is 30 PPI to 60 PPI.

[0056] Furthermore, the outer layer 107 of the puncture sheath 10 can be made of a polymer elastomer, which is a thermoplastic material, usually: polyamide (PA), polycarbonate (PC), thermoplastic polyurethanes (TPU), polyethylene (PE), polytetrafluoroethylene (PTFE), block polyether amide (Pebax), etc. Since the main functions of the curved section and the straight section of the puncture sheath 10 are different, the hardness requirements of the outer layer 107 are also different.

[0057] Preferably, the outer layer 107 of the first curved section 102 and the second curved section 103 of the puncture sheath 10 is made of Pebax with a hardness of 20D-50D, and the outer layer 107 of the second straight section 105, the first straight section 104 and the third straight section 106 is made of Pebax with a hardness of 60D-80D.

[0058] Furthermore, the outer walls of the first anchoring ring 110 and the second anchoring ring 120 are both provided with threading holes, and the first traction wire 111 is connected to the first anchoring ring 110 through the threading holes, and the second traction wire 121 is connected to the second anchoring ring 120 through the threading holes.

[0059] Specifically, the threading hole can be circular, square, polygonal or other special shapes, etc., which is not limited in the present application.

[0060] Furthermore, the first anchoring ring 110 and the second anchoring ring 120 can be made of metal or alloy, such as stainless steel, tungsten, platinum iridium, etc. The first traction wire 111 and the second traction wire 121 can be round or flat stainless steel wires with a size of 0.05mm-0.40mm, or nickel titanium wires or tungsten wires. The first traction wire 111 and the second traction wire 121 can be single-strand wires composed of a single metal wire, or multiple-strand wires wound by multiple metal wires.

[0061] Preferably, the first traction wire 111 and the second traction wire 121 are made of multiple strands of fine stainless steel wire. It is understandable that the multiple strands have good toughness, which prevents the first traction wire 111 and the second traction wire 121 from breaking and failing due to repeated bending, thereby improving the reliability of the first traction mechanism 11 and the second traction mechanism 12.

[0062] Furthermore, the first traction wire 111 and the second traction wire 121 are arranged between the inner layer 105 and the middle braided mesh layer 106 of the puncture sheath 10 at intervals.

[0063] It can be understood that the first traction wire 111 and the second traction wire 121 are arranged on the inner side of the middle woven mesh layer 106, and the middle woven mesh layer 106 can provide support for the first traction wire 111 and the second traction wire 121, so that a part of the pulling force exerted on the first traction wire 111 and the second traction wire 121 acts on the woven mesh, thereby preventing the first traction wire 111 and the second traction wire 121 from separating and falling off from the puncture sheath 10, thereby improving the reliability of the first traction mechanism 11 and the second traction mechanism 12.

[0064] Preferably, if Figure 7 As shown, the interval angle γ between the first traction wire 111 and the second traction wire 121 is 120°, and the first traction wire 111 and the second traction wire 121 are embedded between the inner layer 105 and the middle woven mesh layer 106 of the puncture sheath 10 with an interval of 120°. The interval angle γ of 120° makes the bending directions of the first curved segment 102 and the second curved segment 103 different, thereby further bending the puncture sheath 10 to form a three-dimensional structure to match and conform to the path from the inferior vena cava to the oval fossa of the atrial septum 5.

[0065] Furthermore, the first traction mechanism 11 further includes a first hollow tube 112 , which covers the first traction wire 111 , and the second traction mechanism 12 further includes a second hollow tube 122 , which covers the second traction wire 121 .

[0066] Specifically, the first hollow tube 112 provides a channel for axial movement of the first traction wire 111, and the second hollow tube 122 provides a channel for axial movement of the second traction wire 121. The first hollow tube 112 and the second hollow tube 122 are both PI tubes made of organic polymer material polyimide, and the inner diameter range of the first hollow tube 112 and the second hollow tube 122 is 0.3mm-0.8mm.

[0067] Furthermore, the proximal ends of the first traction wire 111 and the second traction wire 121 are connected to the control handle 40. By adjusting the corresponding control knob on the control handle 40, the first curved section 102 and / or the second curved section 103 of the puncture sheath 10 can be further bent. The present application does not limit the structure of the control handle 40 and its connection method.

[0068] In some embodiments, please refer to Figures 9 to 11 The puncture sheath 10 includes an outer sheath 13 and a middle sheath 14, the outer sheath 13 includes a first limiting groove 131, the middle sheath 14 includes a first limiting member 141 matching the first limiting groove 131, and the axial length of the first limiting groove 131 limits the distance that the middle sheath 14 is pushed in the outer sheath 13. The first limiting groove 131 includes a first stop surface 132 toward the distal end.

[0069] Understandable, please refer to Figures 10 to 12 When the middle sheath tube 14 of the puncture sheath tube 10 is axially pushed forward in the outer sheath tube 13 toward the distal end, when the first limiting member 141 moves axially in the first limiting groove 131 to the first stop surface 132, the middle sheath tube 14 cannot continue to be pushed toward the distal end, that is, the axial length of the first limiting groove 131 limits the distance that the middle sheath tube 14 is pushed in the outer sheath tube 13, thereby preventing the operator from mistakenly pushing the middle sheath tube 14 too far forward and damaging the atrial wall of the left atrium.

[0070] In some embodiments, please refer to Figures 9 to 13 The interatrial septal puncture system 1 for easy positioning also includes a dilator 20, the puncture sheath 10 includes an outer sheath 13 and a middle sheath 14, the middle sheath 14 includes a second limiting groove 142, the dilator 20 includes a second limiting member 201 matching the second limiting groove 142, and the axial length of the second limiting groove 142 limits the distance that the dilator 20 is pushed in the middle sheath 14. The second limiting groove 142 includes a second stop surface 143 toward the distal end.

[0071] It can be understood that during the process of axially advancing the dilator 20 in the middle sheath tube 14 toward the distal end, when the second limit member 201 moves axially in the second limit groove 142 to the second stop surface 143, the dilator 20 cannot continue to be pushed in the distal direction, that is, the axial length of the second limit groove 142 limits the distance that the dilator 20 is pushed in the middle sheath tube 14, thereby preventing the operator from mistakenly pushing the dilator 20 too far forward and damaging the atrial wall of the left atrium.

[0072] In some embodiments, please refer to Figure 2 and Figure 4 The puncture sheath 10 includes an inner layer 105, an intermediate woven mesh layer 106 and an outer layer 107. A developing mark group 30 is provided between the inner layer 105 and the intermediate woven mesh layer 106 of the puncture sheath 10. The developing mark group 30 includes a plurality of developing rings 301 arranged at equal intervals. The developing ring 301 is a metal ring that is radiation-proof.

[0073] It can be understood that, on the one hand, the development mark group 30 has a radiation-proof penetration function under medical imaging, and can clearly show the specific positions of the first curved section 102 and the second curved section 103 of the puncture sheath 10 in the human cardiovascular system, thereby assisting the operator to better position the instrument, reduce the operation time, and reduce the difficulty of the operation. On the other hand, the equal spacing of the multiple development rings 301 is also convenient for measuring the length of the blood vessel during the operation.

[0074] Specifically, the developing ring 301 is usually made of metal or alloy such as tantalum, tungsten, platinum iridium, etc., preferably metal tantalum. The developing mark group 30 includes at least two developing rings 301, and the developing ring 301 is annular. In other embodiments, the developing ring 301 can be replaced by a non-annular developing point or developing block.

[0075] Specifically, during the molding process of the puncture sheath 10, the inner layer 105 is firstly put on the hot-melt core shaft, the developing mark group 30 is fixed, and then the middle braided mesh layer 106 is put on, and then the outer layer 107 is covered on the outside of the middle braided mesh layer 106, and the outer layer 107 is melted through the heat shrink tube, so that the inner layer 105, the developing mark group 30, the middle braided mesh layer 106 and the outer layer 107 are melted into a whole. After the puncture sheath 10 is hot-melt molded, the puncture sheath 10 is pre-molded to form the first curved section 102 and the second curved section 103 according to the cardiovascular structure of the atrial septal puncture path.

[0076] It should be noted that, in this article, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0077] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other, and any combination of features in different embodiments is also within the protection scope of the present application. That is to say, the multiple embodiments described above can also be arbitrarily combined according to actual needs.

[0078] It should be noted that all the above drawings are illustrative illustrations of the present application and do not represent the actual size of the product. Moreover, the size ratio relationship between the components in the drawings is not intended to limit the actual product of the present application.

[0079] The above is only a specific implementation of the present invention, so that those skilled in the art can understand or implement the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principles of the embodiments of the present application, several improvements and modifications can be made, and these improvements and modifications are also considered to be within the scope of protection of the present application. Various modifications to these embodiments will be obvious to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features applied herein.

Claims

1. An atrial septal puncture system that is easy to position, comprising a puncture sheath, wherein the puncture sheath comprises a proximal end and a distal end, and is characterized in that: The puncture sheath also includes a first curved segment and a second curved segment located between the proximal end and the distal end. The first curved segment and the second curved segment are pre-molded by the puncture sheath. The first curved segment is constructed to bend in a direction away from the atrial septum, and the second curved segment is constructed to bend in a direction toward the atrial septum so that the distal end of the puncture sheath points to the atrial septum.

2. The easy-to-position transseptal puncture system according to claim 1, characterized in that: The first curved segment and the second curved segment are arc segments respectively, and there is a first straight segment between the first curved segment and the second curved segment. The first curved segment, the first straight segment and the second curved segment together form a pre-shaped gap between the puncture sheath and the atrial septum.

3. The easy-to-position transseptal puncture system according to claim 1, characterized in that: The interval between the first curved section and the second curved section is 20 mm-60 mm.

4. The easy-to-position transseptal puncture system according to claim 2, characterized in that: The puncture sheath also includes a second straight section connected to the first curved section and extending to the proximal end of the puncture sheath, and a third straight section connected to the second curved section and extending to the distal end of the puncture sheath, the angle between the extension line of the second straight section and the first straight section is in the range of 30°-50°, and the angle between the third straight section and the extension line of the first straight section is in the range of 70°-90°.

5. The interatrial septal puncture system for easy positioning according to claim 1, characterized in that: The puncture sheath is provided with a first traction mechanism and a second traction mechanism. The first traction mechanism is configured to traction and bend the first curved section of the puncture sheath, and the second traction mechanism traction and bend the second curved section of the puncture sheath.

6. The interatrial septal puncture system for easy positioning according to claim 5, characterized in that: The puncture sheath includes an inner layer, an intermediate woven mesh layer and an outer layer. The first traction mechanism and the second traction mechanism are both arranged between the inner layer and the intermediate woven mesh layer. The first traction mechanism includes a first anchoring ring and a first traction wire connected to the first anchoring ring. The second traction mechanism includes a second anchoring ring and a second traction wire connected to the second anchoring ring.

7. The interatrial septal puncture system for easy positioning according to claim 6, characterized in that: The first traction wire and the second traction wire are arranged between the inner layer and the middle braided mesh layer of the puncture sheath tube at intervals.

8. The interatrial septal puncture system for easy positioning according to claim 6, characterized in that: The first traction mechanism further includes a first hollow tube, which covers the first traction wire. The second traction mechanism further includes a second hollow tube, which covers the second traction wire.

9. The interatrial septal puncture system for easy positioning according to claim 1, characterized in that: The puncture sheath includes an outer sheath and a middle sheath, the outer sheath includes a first limiting groove, the middle sheath includes a first limiting piece matching the first limiting groove, and the axial length of the first limiting groove limits the distance the middle sheath is pushed in the outer sheath.

10. The interatrial septal puncture system for easy positioning according to claim 1, characterized in that: It also includes a dilator, the puncture sheath includes an outer sheath and a middle sheath, the middle sheath includes a second limiting groove, and the dilator includes a second limiting piece matching the second limiting groove, and the axial length of the second limiting groove limits the distance the dilator is pushed in the middle sheath.

11. The interatrial septal puncture system for easy positioning according to claim 1, characterized in that: The puncture sheath comprises an inner layer, an intermediate braided mesh layer and an outer layer. A developing mark group is arranged between the inner layer and the intermediate braided mesh layer of the puncture sheath. The developing mark group comprises a plurality of developing rings arranged at equal distances. The developing rings are metal rings that are radiation-proof.

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