Transseptal puncture system for easy positioning

Abstract

The present application provides an atrial septum puncture system that is easy to position, including a puncture sheath, the puncture sheath including a first curved section and a second curved section located between the proximal end and the distal end, the first curved section and the second curved section being pre-shaped for the puncture sheath, the first curved section being constructed to bend in a direction away from the atrial septum, and the second curved section being constructed to bend in a direction toward the atrial septum so that the distal end of the puncture sheath points to the atrial septum. The structure of the pre-shaped first curved section and the second curved section allows the structure of the puncture sheath to match the path from the inferior vena cava to the fossa ovalis of the atrial septum. During the surgical operation, after the operator pushes the distal end of the puncture sheath to the right atrium under the guidance of medical imaging, the operator only needs to perform axial pushing or rotation operation on the puncture sheath to make the distal end of the puncture sheath point to the position of the fossa ovalis of the atrial septum, thereby reducing the steps of adjusting the bend of the puncture sheath, reducing the operator's dependence on ultrasound, and making the operation simpler and more convenient.

Description

Technical Field

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

[0002] The atrial septum (IAS) lies between the left atrium (LA) and right atrium (RA) of the heart. Like the ventricular septum, it is oriented at a 45-degree angle to the sagittal plane and is composed of two layers of endocardium sandwiched between a small amount of myocardium and connective tissue. The fossa ovalis (FO) is located in the middle and lower third of the atrial septum and is shallowly concave. Its right side is concave, while its left side protrudes slightly into the left atrial cavity. The fossa ovalis is located at the thinnest part of the atrial septum, with a thickness of only 1 mm at its center. This location makes it an ideal site for transseptal puncture to enter the left atrium. Transseptal puncture requires alignment of the fossa ovalis to avoid inadvertently injuring the atrial septum at locations other than the fossa ovalis.

[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 troublesome. Therefore, puncturing the atrial septum allows the catheter to pass through the right atrium to the left atrium, making the operation of the left heart system inspection and treatment more simplified and 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 into the right atrium from the inferior vena cava (IVC). Since the distance between the inferior vena cava and the fossa oval 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 fossa oval for puncture is too large, resulting in difficulty in the bending operation and difficulty in puncturing the fossa oval, which can easily lead to accidental injury to the atrial septum at a location other than the fossa oval. Summary of the Invention

[0006] In order 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 for 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 the direction of 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. 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 to 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 spaced apart and arranged between the inner layer and the middle braided mesh layer of the puncture sheath.

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

[0015] In a preferred embodiment, it also includes an expander, the puncture sheath includes an outer sheath and a middle sheath, the middle sheath includes a second limiting groove, the expander includes a second limiting member matching the second limiting groove, and the axial length of the second limiting groove limits the distance the expander 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 to the non-pre-shaped puncture sheaths 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 puncture from the inferior vena cava to the fossa ovalis 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 surgical operation, after the operator pushes the distal end of the puncture sheath to the right atrium under the guidance of medical imaging, it only needs to push or rotate the puncture sheath axially to make the distal end of the puncture sheath point to the fossa ovalis position 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 following is a brief introduction to the drawings required for use in the embodiments. 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 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 structural diagram of the atrial septum puncture system provided in one embodiment of the present application.

[0022] Figure 3 This 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 the first traction mechanism of 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 in the AA direction.

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

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

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

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

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

[0032] Figure 13 yes Figure 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 this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this 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 refer to the accompanying illustrations to illustrate specific embodiments that may be implemented in the present application. Directional terms mentioned in this application, such as "upper," "lower," "front," "back," "left," "right," "inner," "outer," and "side," are only used with reference to the directions in the accompanying illustrations. Therefore, the directional terms used are intended to better and more clearly illustrate and understand the present application, and are not intended to indicate or imply that the devices or components referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present application.

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

[0037] It is worth noting that the "end" appearing 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 head, endpoint or end face, but also includes a portion extending from the end head, endpoint or end face to an axial distance and / or radial distance on the element to which the end head, endpoint or end face belongs. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly 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 understood as limiting this application.

[0038] Please also refer to Figures 2 to 3 The present application provides an atrial septum puncture system 1 that is easy to position, which 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, which 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 for 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 surgical operation, after the operator pushes the distal end 101 of the puncture sheath 10 to the right atrium under the guidance of medical imaging, 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 imaging, such as ultrasound, and making the operation simpler and more convenient.

[0040] Further, please also refer to Figures 3 and 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 away from the atrial septum 5. Compared to prior art atrial septal puncture sheaths that are 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-shaped gap 9. This increases the operating space for axially pushing or rotating the puncture sheath 10 to align with the fossa ovalis, reducing the risk of accidentally injuring the atrial septum during operation of the puncture sheath 10. The second curved section 103 is configured to direct the distal end 101 of the puncture sheath 10 toward the atrial septum 5, reducing the number of steps required to adjust 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 each an arc, wherein the curvature of the second curved segment 103 is greater than the curvature of the first curved segment 102. The distance L1 between the first curved segment 102 and the second curved segment 103 is 20 mm to 60 mm, and the distance L1 can be calculated as the distance between the center points of the 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 toward the proximal end 100 of the puncture sheath 10, and a third straight section 106 connected to the second curved section 103 and extending toward 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 is 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-shaped bending angle of the first curved section 102. The angle α determines the size of the pre-shaped gap 9 between the distal end 101 of the puncture sheath 10 and the atrial septum 5. This pre-shaped gap 9 determines the size of the operable space when the operator operates the puncture sheath 10 to align the distal end 101 with the fossa ovalis. It is understood that the larger the pre-shaped angle α, the larger the pre-shaped gap 9 between the distal end 101 of the puncture sheath 10 and the atrial septum 5, and the greater the operator's operating space; the smaller the pre-shaped angle α, the smaller the pre-shaped gap 9 between the distal end 101 of the puncture sheath 10 and the atrial septum 5, and the smaller the operator's operating space. Preferably, the angle α between the extension line of the second straight section 105 and the first straight section 104 ranges from 30° to 50°.

[0046] It is understood that 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°, for example, 70°, 80°, 90° or any other value between 70°-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 is 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 point 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-shaped by the puncture sheath 10 to match the path from the inferior vena cava to the fossa ovalis of the atrial septum 5. 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 position of the fossa ovalis 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 is understood that because the puncture sheath 10 is pre-shaped, only slight adjustments to the bending angles of the first curved section 102 and the second curved section 103 are required to precisely direct the distal end 101 of the puncture sheath 10 toward the fossa ovalis of the atrial septum 5. Thus, the bending force required to further adjust the first and second traction mechanisms 11, 12 is relatively small, and the operation time is shortened, thereby enabling convenient and rapid atrial septal puncture, reducing surgical time and difficulty.

[0051] Further, 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 first placed 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 placed. Then, the outer layer 107 is wrapped around the outside of the middle braided mesh layer 106. The outer layer 107 is melted through the heat shrink tubing, 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-shaped 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 must be removed after the puncture sheath 10 is hot-melted, the material of the inner layer 105 must have a smooth inner wall and not deform when the outer layer 107 melts. For example, PTFE can be used to form the inner layer 105 with a wall thickness of 0.05 mm to 0.30 mm. Preferably, the inner layer 105 is made of PTFE with a thickness of 0.10 mm.

[0054] Furthermore, if Figure 8 As shown, the intermediate braided mesh layer 106 is a mesh structure that primarily supports the sheath tube and facilitates imaging. For example, it can be a mesh tube structure formed by cutting a tube, such as a stainless steel tube, or a braided wire structure formed by weaving wires. The braided wires can be metal wires, such as stainless steel wire or tungsten wire, or non-metallic wires, such as polymer wires and synthetic fiber wires, to form the intermediate braided mesh layer 106 through weaving, winding, or other methods.

[0055] Preferably, the middle braided mesh layer 106 can be made of a radiopaque material to enhance the visualization of the puncture sheath 10 within the blood vessel. For example, it can be made of stainless steel wire or tungsten wire through braiding, winding, or other methods. In this embodiment, 0.12 mm round tungsten wire is preferred. The braid 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, typically polyamide (PA), polycarbonate (PC), thermoplastic polyurethanes (TPU), polyethylene (PE), polytetrafluoroethylene (PTFE), segmented polyether block amide (Pebax), etc. Due to the different primary functions of the curved and straight sections of the puncture sheath 10, 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, wire holes are provided on the outer walls of the first anchoring ring 110 and the second anchoring ring 120. The first traction wire 111 is connected to the first anchoring ring 110 through the wire holes, and the second traction wire 121 is connected to the second anchoring ring 120 through the wire holes.

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

[0060] Furthermore, the first anchoring ring 110 and the second anchoring ring 120 can be made of a 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 wire with a size of 0.05 mm to 0.40 mm, or nickel-titanium wire or tungsten wire. The first traction wire 111 and the second traction wire 121 can be single-strand wires composed of a single metal wire, or multi-strand wires composed of multiple metal wires.

[0061] Preferably, the first traction wire 111 and the second traction wire 121 are made of a multi-strand wire wound from multiple strands of fine stainless steel wire. It is understood that the multi-strand wire has 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 pulling wire 111 and the second pulling wire 121 are spaced apart and arranged between the inner layer 105 and the middle braided mesh layer 106 of the puncture sheath 10 .

[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 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°. 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 at 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 . 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 for the first traction wire 111, and the second hollow tube 122 provides a channel for axial movement for 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 both 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. This 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 that matches the first limiting groove 131. The axial length of the first limiting groove 131 limits the distance the middle sheath 14 can be 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 During the process of the middle sheath tube 14 of the puncture sheath tube 10 being axially pushed toward the distal end in the outer sheath tube 13, 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 causing damage to the atrial wall of the left atrium.

[0070] In some embodiments, please refer to Figures 9 to 13 The transseptal puncture system 1 for easy positioning further 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 that matches the second limiting groove 142. The axial length of the second limiting groove 142 limits the distance the dilator 20 can be 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 when the expander 20 is axially advanced 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 expander 20 cannot continue to be pushed toward the distal end, that is, the axial length of the second limit groove 142 limits the distance that the expander 20 is pushed in the middle sheath tube 14, thereby preventing the operator from mistakenly pushing the expander 20 too far forward and causing damage to 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 marker group 30 is provided between the inner layer 105 and the intermediate woven mesh layer 106 of the puncture sheath 10. The developing marker group 30 includes a plurality of equally spaced developing rings 301, which are metal rings that are radiation-proof.

[0073] As can be understood, on the one hand, the imaging marker assembly 30 provides radiographic protection under medical imaging, clearly displaying the specific positions of the first curved section 102 and the second curved section 103 of the puncture sheath 10 within the human cardiovascular system, thereby assisting the operator in better positioning the instrument, reducing surgical time and difficulty. Furthermore, the equal spacing of the multiple imaging rings 301 facilitates intraoperative measurement of blood vessel length.

[0074] Specifically, the developing ring 301 is typically made of a metal or alloy such as tantalum, tungsten, platinum-iridium, or the like, preferably tantalum. The developing mark set 30 includes at least two developing rings 301, each of which is annular. In other embodiments, the developing rings 301 can be replaced with non-annular developing dots or blocks.

[0075] Specifically, during the molding process of the puncture sheath 10, the inner layer 105 is first placed on the hot melt mandrel, the imaging marker group 30 is fixed, and then the middle braided mesh layer 106 is placed. Then, the outer layer 107 is wrapped around the outside of the middle braided mesh layer 106. The outer layer 107 is melted through the heat shrink tubing, so that the inner layer 105, the imaging marker group 30, the middle braided mesh layer 106, and the outer layer 107 are melted into a single unit. After the puncture sheath 10 is hot-melt molded, it is pre-shaped 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 document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or device comprising the element.

[0077] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of this application can be combined with each other, and any combination of features in different embodiments is also within the scope of protection of this 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 for illustrative purposes only and do not represent the actual size of the product. Furthermore, the dimensional ratios between the components in the drawings are not intended to limit the actual product of the present application.

[0079] The above description is only a specific embodiment of the present invention, which enables those skilled in the art to understand or implement the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principles of the embodiments of the present application, 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 further 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 being pre-molded by the puncture sheath, the first curved segment being configured to bend in a direction away from the atrial septum, and the second curved segment being configured to bend in a direction toward the atrial septum so that the distal end of the puncture sheath points to the atrial septum; The first curved segment and the second curved segment are arc segments respectively, a first straight segment is provided 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; 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°.

2. The transseptal puncture system for facilitating positioning according to claim 1, characterized in that: The interval between the first curved section and the second curved section is 20 mm to 60 mm.

3. The transseptal puncture system for facilitating 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 is configured to traction and bend the second curved section of the puncture sheath.

4. The transseptal puncture system for facilitating positioning according to claim 3, 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.

5. The transseptal puncture system for facilitating positioning according to claim 4, 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.

6. The transseptal puncture system for facilitating positioning according to claim 4, 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.

7. The transseptal puncture system for facilitating 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.

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

9. The transseptal puncture system for facilitating positioning according to claim 1, characterized in that: The puncture sheath includes an inner layer, an intermediate braided mesh layer and an outer layer. A developing mark group is provided between the inner layer and the intermediate braided mesh layer of the puncture sheath. The developing mark group includes a plurality of developing rings arranged at equal intervals. The developing rings are metal rings that are radiation-proof.

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