A stable guidewire, a shape setting sheath and a guiding system for atrial septum puncture

Abstract

The utility model relates to a kind of stable guide wire, bending sheath and the guide system for atrial septum puncture, wherein, stable guide wire includes the support section and contact section set gradually, support section is set in proximal end, it is straight bar, for providing support force;Contact section is set in distal end, it has larger cross section than support section on axial projection, for contacting with endocardium in the process of atrial septum puncture, and the displacement caused by heart beat is buffered;Bending sheath, including first cavity and second cavity, first cavity is axially through, for the interventional instrument for setting atrial septum puncture;Second cavity is arranged in parallel with first cavity, second cavity is used for setting stable guide wire, and at least contact section of stable guide wire can be worn out by the distal end opening of second cavity.

Description

Technical Field

[0001] This utility model relates to the field of medical devices for cardiac surgery, and in particular to a stable guidewire, a bendable sheath, and a guidance system for atrial septal puncture. Background Technology

[0002] With the continuous development of interventional cardiac treatment techniques, transseptal puncture to access the left heart has become a key step in the minimally invasive treatment of various cardiovascular diseases. Transseptal puncture, as a technique for establishing a pathway from the right atrium to the left atrium, is of decisive significance for surgeries such as left atrial accessory structure occlusion, mitral valve repair, left atrial appendage occlusion, and radiofrequency ablation for atrial fibrillation.

[0003] However, in actual clinical practice, atrial septal puncture faces multiple challenges. Among them, due to the continuous beating of the heart, the puncture instrument is prone to displacement during positioning, resulting in inaccurate puncture location and significantly reducing the success rate of the puncture.

[0004] Therefore, how to develop an atrial septal puncture guidance system that can provide stable support, reduce puncture risks, and improve puncture success rate in the context of cardiac pulsation is a technical problem that urgently needs to be solved. Utility Model Content

[0005] This utility model discloses a stable guidewire, an adjustable sheath, and a guidance system for interventricular septal puncture, aiming to solve the technical problems existing in the prior art.

[0006] The present invention adopts the following technical solution:

[0007] In a first aspect, this utility model provides a stabilizing guidewire, which includes a support segment and a contact segment arranged sequentially. The support segment is located at the proximal end and is in the shape of a straight rod, used to provide support force. The contact segment is located at the distal end and has a larger cross-sectional area than the support segment in axial projection, used to contact the endocardium during atrial septal puncture and to buffer displacement caused by heartbeat.

[0008] As a preferred technical solution, the contact section has a spiral structure, which is coiled around the axis of the stabilizing guide wire in a clockwise or counterclockwise direction.

[0009] As a preferred technical solution, the contact section has a multi-turn conical spiral structure, and the spiral diameter of the conical spiral structure gradually increases from the proximal end to the distal end.

[0010] As a preferred technical solution, at least a portion of the contact section has a smaller elastic modulus or stiffness than the support section.

[0011] As a preferred technical solution, the contact section includes a shape memory alloy material.

[0012] Secondly, embodiments of the present invention provide a bending sheath, comprising:

[0013] The first cavity is axially penetrating and used for inserting interventional instruments for transatrial septal puncture.

[0014] The second cavity is arranged parallel to the first cavity. The second cavity is used to pass through the stabilizing guidewire as described in any of the preceding claims, and at least the contact segment of the stabilizing guidewire can be passed through the distal opening of the second cavity.

[0015] As a preferred technical solution, the cross-sectional area of ​​the second cavity is smaller than that of the first cavity, and the cross-sectional area of ​​the second cavity is larger than that of the stable guide wire in the compressed delivery state.

[0016] As a preferred technical solution, the distal opening of the first cavity is located on the distal end face of the bending sheath, and the distal opening of the second cavity is located on the distal sidewall of the bending sheath.

[0017] As a preferred technical solution, a traction wire is threaded through the inner wall of the bending sheath, and the distal end of the traction wire is fixedly connected to the distal end of the bending sheath. The proximal end of the traction wire can be tightened or loosened to achieve control of the bending angle of the distal end of the bending sheath.

[0018] As a preferred technical solution, the proximal end of the bending sheath is also provided with a bending control handle, and the proximal end of the traction wire is inserted into the bending control handle. The bending control handle includes a handle housing, a fixing tube, a bending knob, a bending drive component, and a bending moving component.

[0019] The fixed tube is fixed inside the handle housing. The bending adjustment knob is connected to the bending adjustment drive and is sleeved on the outside of the fixed tube. The bending adjustment drive is threadedly connected to the bending adjustment moving part. The bending adjustment moving part is sleeved on the outer periphery of the fixed tube and connected to the proximal end of the traction wire. By rotating the bending adjustment knob, the bending adjustment moving part can be driven to move axially, thereby adjusting the tension of the traction wire and realizing the bending angle control of the distal end of the bending sheath.

[0020] Thirdly, embodiments of the present invention provide a guiding system for interventricular septal puncture, including a bending sheath and a stabilizing guidewire;

[0021] The stabilizing guidewire includes a support segment and a contact segment arranged sequentially. The support segment is located at the proximal end and is straight, used to provide support force. The contact segment is located at the distal end and has a larger cross-sectional area in axial projection than the support segment. It is used to contact the endocardium during atrial septal puncture and to buffer displacement caused by heartbeat.

[0022] The bending sheath includes a first cavity and a second cavity. The first cavity is axially continuous and is used to insert interventional instruments for interatrial septal puncture. The second cavity is arranged parallel to the first cavity and is used to insert a stabilizing guidewire. At least the contact portion of the stabilizing guidewire can be passed through the distal opening of the second cavity.

[0023] The technical solution adopted in this utility model can achieve the following beneficial effects:

[0024] This invention primarily provides a stabilizing guidewire, an adjustable sheath, and a guidance system for atrial septal puncture. The stabilizing guidewire includes a contact segment and a support segment. The contact segment has a larger cross-sectional area in its axial projection than the support segment, resulting in a larger contact area when the stabilizing guidewire contacts the endocardium, thus reducing local pressure and preventing endocardial damage. Furthermore, the contact segment is preferably configured with a helical structure, providing a three-dimensional elastic buffering effect like a spring to adapt to positional changes caused by cardiac pulsation, effectively stabilizing the entire puncture system. In addition, the contact segment is preferably made of a shape memory alloy material, possessing superelasticity and biocompatibility. It not only maintains a straight shape during delivery for easy transit through the vascular system but also returns to a preset helical shape after release within the body, providing stable and gentle contact force, significantly improving the safety of the procedure.

[0025] Furthermore, the adjustable sheath of this invention is configured with a dual-lumen structure, separating the puncture channel from the stabilization support function. The first lumen is specifically used for inserting interatrial septal puncture instruments to ensure unobstructed puncture path, while the second lumen is specifically used for delivering the stabilizing guidewire. Its lateral opening design allows the stabilizing guidewire to contact the endocardium at a suitable angle, providing additional fixation points and buffer areas for the entire system.

[0026] Finally, as a complete guidance system, this invention organically combines a stabilizing guidewire and a bending-adjustable sheath. Through a dual-lumen design, the two key aspects of positioning stability and puncture operation can be performed independently and in a coordinated manner. The stabilizing guidewire, through its elastic contact with the inner wall of the superior vena cava, effectively counteracts displacement caused by cardiac pulsation, providing a stable operating platform for the puncture instrument. Simultaneously, the bending-adjustable sheath provides precise puncture path guidance. The synergistic effect of both significantly improves the safety and success rate of atrial septal puncture. Attached Figure Description

[0027] To more clearly illustrate the technical solutions of the embodiments of this utility model, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of this utility model. The illustrative embodiments of this utility model and their descriptions explain this utility model and do not constitute an improper limitation of this utility model. In the accompanying drawings:

[0028] Figure 1This is a schematic diagram of the structure of a stabilizing guidewire in one embodiment of the present invention.

[0029] Figure 2 This is a schematic diagram of the structure of the bending sheath in one embodiment of the present utility model.

[0030] Figure 3 This is a schematic diagram illustrating the working state of the stable guidewire in the heart in one embodiment of the present invention.

[0031] Figure 4 This is a schematic diagram of the bending control handle in one embodiment of the present utility model.

[0032] Figure 5 This is a cross-sectional view of the bending control handle in one embodiment of the present utility model.

[0033] Explanation of reference numerals in the attached figures:

[0034] Stable guide wire 11, contact section 111, support section 112, bending sheath 21, first cavity 211, second cavity 212, bending control handle 22, fixing tube 221, bending knob 222, bending drive component 223, bending moving component 224. Detailed Implementation

[0035] To make the objectives, technical solutions, and advantages of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this utility model, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly stated otherwise.

[0036] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance. The term "proximal end" refers to the end along the length of the stabilizing guidewire that is closer to the operator; the term "distal end" refers to the end along the length of the stabilizing guidewire that is farther from the operator.

[0037] Those skilled in the art will understand that, in order to achieve their respective functions and meet the requirements of surgical procedures, the specific shape, size, angle, etc., of each structure can be adaptively adjusted. Obviously, the described embodiments are only a part of the embodiments of this utility model, and not all of them. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of this utility model.

[0038] refer to Figure 1 To address the problems existing in the prior art, this utility model provides a stabilizing guidewire 11, which includes a proximal support section 112 and a distal contact section 111. The support section 112 has a straight rod-like structure to provide greater axial stiffness, support force, and pushing performance. The contact section 111 has a larger cross-sectional area in axial projection than the support section 112, and is used to contact the endocardium during atrial septal puncture and to buffer displacement caused by heartbeat.

[0039] In some embodiments, at least a portion of the contact segment 111 has a smaller elastic modulus or stiffness than the support segment 112, or has a smaller diameter than the support segment 112.

[0040] Preferably, the contact segment 111 is made of a shape memory alloy material, such as nickel-titanium alloy. Due to its shape memory properties, superelasticity and biocompatibility, it can provide a gentler touch when in contact with the endocardium, reduce mechanical stimulation to the fragile endocardium, and can also be delivered in a straightened state and return to the preset shape after being released in the body. After returning to the preset shape, even if it undergoes repeated deformation, it can still return to the corresponding shape without permanent deformation.

[0041] In some embodiments, the contact segment 111 has a helical structure, and the helical structure is coiled around the axis of the stabilizing guidewire in a clockwise or counterclockwise direction. In this case, the contact segment 111 can provide a three-dimensional elastic buffering effect like a spring. When the heartbeat causes changes in the size of the heart chambers, the helical structure can compress or extend like a spring to adapt to the positional changes caused by the heartbeat, effectively stabilizing the entire puncture system. In addition, the helical structure also provides multi-point contact support, so that the stabilizing guidewire 11 will not pierce the endocardium due to single-point contact, significantly reducing the risk of perforation. Specifically, in this embodiment, the direction of rotation, number of turns, pitch, and other parameters of the helical structure are not specifically limited. Those skilled in the art can customize and select them according to specific clinical needs.

[0042] In some embodiments, the contact segment 111 has a multi-turn conical spiral structure, and the spiral diameter of the conical spiral structure gradually increases from the proximal end to the distal end. In this case, the conical spiral structure not only provides an elastic buffering effect in three-dimensional space, but also allows smaller spirals to enter larger spirals when the conical spiral structure is compressed, reducing the axial dimension of the compressed state. Secondly, the conical spiral structure significantly increases the contact area with the endocardium. Compared to a straight guidewire, a spiral of the same length can provide several times the contact area of ​​a straight line, which not only disperses the contact pressure and avoids applying excessive local pressure to the endocardium, but also improves the stability of the guidewire and reduces the risk of accidental dislocation.

[0043] In some embodiments, the support section 112 is made of stainless steel, such as 304, 316L, etc., or the support section 112 has a larger diameter than the contact section 111 to provide better torsional control and pushing stability. Specifically, medical-grade stainless steel has excellent mechanical properties and corrosion resistance, providing the support section 112 with the necessary rigidity and strength to ensure that bending or kinking does not occur during transport.

[0044] In some embodiments, the support section 112 may adopt a gradient structure, that is, the diameter and / or material hardness of the support section 112 gradually transition from the proximal end to the distal end, so as to avoid the formation of stress concentration points and improve the overall structural strength and safety of the stabilizing guide wire 11.

[0045] In some embodiments, the outer surfaces of the contact section 111 and / or the support section 112 may be further coated or covered, such as with a polymer coating, to improve biocompatibility and frictional properties, facilitating smooth sliding within the respective delivery lumen.

[0046] In one embodiment of this utility model, a bendable sheath 21 is also provided. The bendable sheath 21 is provided with a first cavity 211 and a second cavity 212. The first cavity 211 is axially penetrating and is used to insert an interventional device for interatrial septal puncture. The second cavity 212 is arranged parallel to the first cavity and is used to insert a stabilizing guidewire 11. Preferably, the second cavity 212 has an inlet at the proximal end of the bendable sheath 21 and an outlet near the distal end of the bendable sheath 21. At least the contact segment 111 of the stabilizing guidewire 11 can pass through the distal opening of the second cavity 212. The protruding contact segment 111 can contact the inner wall of the superior vena cava in the heart to buffer the device displacement caused by the heartbeat.

[0047] like Figure 2 In some embodiments, the first cavity 211 serves as the main channel, with a larger diameter and a circular or elliptical cross-sectional shape. Its distal opening is located at the distal end face of the bending sheath 21, i.e., the foremost end of the bending sheath 21, so that the interventional puncture instrument can extend straight out from the front end of the bending sheath 21. The second cavity 212 serves as the auxiliary channel, with a smaller cross-sectional area than the first cavity 211 and a circular cross-section. Its inner diameter is slightly larger than the outer diameter of the stabilizing guidewire 11, ensuring that the stabilizing guidewire 11 can move freely within the cavity without excessive shaking.

[0048] In some embodiments, unlike the first cavity 211, the distal opening of the second cavity 212 is located on the distal side of the bending sheath 21, rather than on the end face. When the stabilizing guidewire 11 extends from the side opening, it naturally forms a path at an angle to the axis of the first cavity 211. In particular, when the distal end of the bending sheath 21 is bent and reaches the interatrial septum, the stabilizing guidewire 11 can contact intracardiac structures at a different location than the dilating sheath 13, namely the superior vena cava, providing additional support points and buffer areas for the entire system.

[0049] In some embodiments, a traction wire is threaded through the inner wall of the bending sheath 21, the distal end of the traction wire is fixedly connected to the distal end of the bending sheath 21, and the proximal end of the traction wire can be tightened or loosened to achieve bending control of the distal end of the bending sheath 21.

[0050] Specifically, when the traction wire is subjected to tension, due to its asymmetrical position in the bending sheath 21, the bending sheath 21 will bend and deform, and the bending direction will always be towards the side where the traction wire is located. The greater the traction force, the greater the bending angle of the bending sheath 21.

[0051] In practice, the physician first adjusts the tension of the traction wire to make the bending sheath 21 form an appropriate bending shape to adapt to the patient's vascular anatomy. Then, the stabilizing guidewire 11 is sent to the target position through the second cavity 212 to provide support and cushioning. Finally, the corresponding puncture instrument is pushed to the interatrial septum position through the first cavity 211.

[0052] In some embodiments, since the bending direction of the bending sheath 21 is approximately opposite to the direction in which the stabilizing guidewire 11 needs to provide support, the traction wire and the second cavity 212 are arranged opposite each other in the circumferential layout of the bending sheath 21. That is, the two are positioned approximately opposite each other on the cross section of the bending sheath 21. Optionally, the traction wire and the second cavity 212 are arranged 180 degrees apart in the circumferential direction. Since different patients have different physiological and pathological structures, this angle can be adjusted accordingly based on the anatomical differences of the patients.

[0053] like Figure 3Specifically, when the operator pulls the traction wire to bend the bending sheath 21 towards the interatrial septum, the contact segment 111 of the stabilizing guidewire 11, extending from the second cavity 212 on the opposite side, naturally abuts against the superior vena cava or the inner wall of the right atrium, forming a stable support point. This allows the entire system to maintain a relatively stable position in the dynamic cardiac environment. Simultaneously, the elastic structure of the contact segment 111 buffers the periodic displacement caused by cardiac pulsation, preventing accidental displacement of the puncture instrument during critical procedures. More importantly, when adjusting the tension of the traction wire, the operator can not only control the distal bending angle of the bending sheath 21 but also indirectly control the contact pressure between the stabilizing guidewire 11 and the endocardium. This ensures sufficient support while avoiding excessive local pressure that could damage the endocardium, significantly improving the safety and success rate of the interatrial septal puncture procedure.

[0054] In some embodiments, the proximal end of the bending sheath 21 is also provided with a bending control handle 22. By adjusting the bending control handle 22, the tension of the traction wire can be changed, and the bending of the distal end of the bending sheath 21 can be controlled.

[0055] like Figure 4 , Figure 5 In some embodiments, the bending control handle 22 includes a handle housing, a fixed tube 221, a bending knob 222, a bending drive 223, and a bending moving part 224. The fixed tube 221 is fixed inside the handle housing. The bending knob 222 is connected to the bending drive 223 and sleeved on the outside of the fixed tube 221. The bending drive 223 is threadedly connected to the bending moving part 224. The bending moving part 224 is sleeved on the outer periphery of the fixed tube 221 and connected to the proximal end of the traction wire. By rotating the bending knob 222, the bending moving part 224 can be driven to move axially, thereby adjusting the tension of the traction wire and realizing the bending angle control of the distal end of the bending sheath 21.

[0056] In some embodiments, the proximal end of the bending control handle 22 is provided with two cavities, wherein the smaller cavity is used to connect the tee tube, which is the entry position of the stabilizing guidewire 11, and can be used to empty the channel of the stabilizing guidewire 11; the larger cavity is located at the center of the proximal end of the handle and is directly connected to the first cavity 211 of the bending sheath 21, and is used to insert the puncture instrument.

[0057] In one embodiment of the present invention, a guidance system for interatrial septal puncture is also provided, including the bendable sheath 21 and the stabilizing guidewire 11 as described above. The two are used in combination. In use, the stabilizing guidewire 11 is inserted into the second cavity 212 of the bendable sheath 21, and at least the distal contact segment 111 can be inserted through the distal opening of the second cavity 212 and abut against the endocardium.

[0058] In some embodiments, the operation steps of the guidance system for transseptal puncture are as follows:

[0059] The physician uses a standard guiding sheath device to deliver the adjustable sheath 21 via the femoral vein to the right atrium. Then, using the bend control handle 22, the puncture instrument is fully inserted into the first cavity 211 of the adjustable sheath 21. Next, the stabilizing guidewire 11 is inserted into the second cavity 212 of the adjustable sheath 21. During the procedure, the physician first rotates the bend knob 222 to control the bending angle of the adjustable sheath 21, precisely positioning it at the atrial septal puncture site. Then, by operating the relevant operating parts of the puncture instrument, the physician performs the corresponding atrial septal puncture procedure. During the puncture, the contact section 111 of the stabilizing guidewire 11 provides the necessary support and cushioning to ensure that all instruments remain stable during the atrial septal puncture.

[0060] The embodiments of the present invention have been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of the present invention without departing from the spirit and scope of the claims, and all of these forms are within the protection scope of the present invention.

Claims

1. A stable guidewire, characterized in that, The stabilizing guidewire includes a support section and a contact section arranged sequentially. The support section is located at the proximal end and is in the shape of a straight rod, used to provide support force. The contact section is located at the distal end and has a larger cross-sectional area in axial projection than the support section, used to contact the endocardium during atrial septal puncture and to buffer displacement caused by heartbeat.

2. The stabilizing guidewire according to claim 1, characterized in that, The contact section has a spiral structure, which is coiled around the axis of the stabilizing guide wire in a clockwise or counterclockwise direction.

3. The stabilizing guidewire according to claim 2, characterized in that, The contact section has a multi-turn conical spiral structure, and the spiral diameter of the conical spiral structure gradually increases from the proximal end to the distal end.

4. The stabilizing guidewire according to any one of claims 1-3, characterized in that, At least a portion of the contact segment has a smaller elastic modulus or stiffness than the support segment.

5. The stabilizing guidewire according to claim 4, characterized in that, The contact segment comprises a shape memory alloy material.

6. A bending sheath, characterized in that, include: The first cavity is axially penetrating and is used to insert interventional instruments for interatrial septal puncture. A second cavity is arranged parallel to the first cavity, the second cavity being used to pass through a stabilizing guidewire as described in any one of claims 1-5, and at least the contact segment of the stabilizing guidewire can be passed through the distal opening of the second cavity.

7. The bending sheath according to claim 6, characterized in that, The cross-sectional area of ​​the second cavity is smaller than that of the first cavity, and the cross-sectional area of ​​the second cavity is larger than that of the stable guide wire in the compressed delivery state.

8. The bending sheath according to claim 6, characterized in that, The distal opening of the first cavity is located on the distal end face of the bending sheath, and the distal opening of the second cavity is located on the distal sidewall of the bending sheath.

9. The bending sheath according to claim 6, characterized in that, A traction wire is threaded through the inner wall of the bending sheath. The distal end of the traction wire is fixedly connected to the distal end of the bending sheath. The proximal end of the traction wire can be tightened or loosened to control the bending angle of the distal end of the bending sheath.

10. The bending sheath according to claim 9, characterized in that, The proximal end of the bending sheath is also provided with a bending control handle, and the proximal end of the traction wire passes through the bending control handle. The bending control handle includes a handle housing, a fixing tube, a bending knob, a bending drive component, and a bending moving component. The fixed tube is fixed inside the handle housing. The bending adjustment knob is connected to the bending adjustment drive and sleeved on the outside of the fixed tube. The bending adjustment drive is threadedly connected to the bending adjustment moving part. The bending adjustment moving part is sleeved on the outer periphery of the fixed tube and connected to the proximal end of the traction wire. By rotating the bending adjustment knob, the bending adjustment moving part can be driven to move axially, thereby adjusting the tension of the traction wire and realizing the bending angle control of the distal end of the bending sheath.

11. A guiding system for atrial septal puncture, characterized in that, Includes a bending sheath and a stabilizing guidewire; The stabilizing guidewire includes a support section and a contact section arranged sequentially. The support section is located at the proximal end and is in the shape of a straight rod, used to provide support force. The contact section is located at the distal end and has a larger cross-sectional area in axial projection than the support section, used to contact the endocardium during atrial septal puncture and to buffer displacement caused by heartbeat. The bending sheath includes a first cavity and a second cavity. The first cavity is axially penetrating and is used to insert an interventional instrument for interatrial septal puncture. The second cavity is arranged parallel to the first cavity and is used to insert the stabilizing guidewire. At least the contact segment of the stabilizing guidewire can be exited through the distal opening of the second cavity.

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