An adjustable curved delivery sheath for left atrial appendage occlusion

Abstract

The application relates to an adjustable bending conveying sheath tube for left atrial appendage plugging, which can flexibly adjust the bending angle and direction of the sheath tube through the combination of a pipe, a snake tube and an adjusting mechanism to adapt to the anatomical structure of the left atrial appendage of different patients, a plurality of first adjusting channels are arranged in the pipe, the snake tube is internally provided with corresponding second adjusting channels, the first adjusting channels and the second adjusting channels are aligned and communicated, the accurate movement of adjusting wire bundles is guaranteed, the adjusting member in the adjusting mechanism drives the movement of the adjusting wire bundles through rotation, and the adjusting wire bundles are matched with elastic members, so that the stability and controllability in the operation process are ensured. The design can adjust the shape of the sheath tube in real time, ensures the axial accurate butt joint of the plugging device and the left atrial appendage, avoids the poor plugging effect caused by the mismatch between the sheath tube and the anatomical axis of the atrial appendage in the prior art, therefore, the higher controllability and flexibility in the operation are realized, the accuracy and safety of the operation are improved, and the application has remarkable clinical application value.

Description

Technical Field

[0001] This utility model relates to a delivery sheath, and more particularly to an adjustable bendable delivery sheath for left atrial appendage occlusion. Background Technology

[0002] Left atrial appendage occlusion (LAA) is a common cardiac treatment widely used to prevent stroke caused by atrial fibrillation. Due to its unique anatomical location, the left atrial appendage is prone to thrombus formation, and thrombi that break off and enter the systemic circulation can cause serious complications such as embolism. The use of a LCA occluder can effectively prevent thrombus formation, thereby reducing the risk of stroke. With advancements in medical technology, LCA occlusion has gradually become a routine cardiac interventional procedure with high clinical demand.

[0003] Most existing left atrial appendage occlusion devices employ a sheath delivery system with a fixed angle and design. Current sheath designs typically use a simple, fixed form, primarily operating through a pre-set delivery channel and curved shape.

[0004] However, the anatomical shape and location of the left atrial appendage vary from person to person, meaning that existing structures may not be able to accurately adapt to the anatomical characteristics of all patients in practice. This is especially true when dealing with atrial appendages on different axes, often resulting in misalignment between the occluder and the left atrial appendage, leading to poor occlusion. Furthermore, traditional sheaths do not adequately consider how to flexibly adjust the bending direction and angle of the tubing, thus lacking flexibility and operational controllability. Therefore, there is an urgent need to develop an adjustable-bend delivery sheath for left atrial appendage occlusion to address these issues. Utility Model Content

[0005] The purpose of this invention is to provide an adjustable bendable delivery sheath for left atrial appendage occlusion that improves the controllability and precision of surgical procedures.

[0006] The technical solution adopted by this utility model to solve the above problems is: an adjustable bendable delivery sheath for left atrial appendage occlusion, characterized in that it comprises:

[0007] The pipe fitting includes a conveying channel, the extension direction of the conveying channel is parallel to the extension direction of the pipe fitting, and the conveying channel is connected to the end of the pipe fitting. The interior of the pipe fitting is provided with at least two through first adjustment channels along its own extension direction.

[0008] A serpentine tube is provided at one end of the tube fitting. The interior of the serpentine tube has at least two through-type second adjustment channels along its own extension direction. Each second adjustment channel is aligned and connected to each first adjustment channel in a one-to-one correspondence manner.

[0009] The regulating mechanism includes:

[0010] A housing is disposed at the other end of the pipe fitting. The housing includes a receiving space and a port. The receiving space is connected to the conveying channel and the first adjusting channel.

[0011] At least two adjustment harnesses are provided, each adjustment harness being movably disposed in each of the first adjustment channels in a one-to-one correspondence manner. One end of each adjustment harness passes through the first adjustment channel to extend into the second adjustment channel and is connected to the end of the serpentine tube opposite to the tube fitting. The other end of the adjustment harness extends into the accommodating space.

[0012] At least two adjusting members are provided, the adjusting members are rotatably disposed within the accommodating space, and one end of the adjusting members extends to the outside of the housing. Each adjusting member is connected to one end of each adjusting wire harness located within the accommodating space in a one-to-one correspondence manner, so that the adjusting wire harness can be pulled by rotating the adjusting members.

[0013] At least two elastic elements are disposed in the accommodating space, and each elastic element is connected to each of the adjusting elements in a one-to-one correspondence. The elastic elements are configured to apply a spring force opposite to the first direction to the adjusting element when the adjusting element rotates in a first direction to pull the adjusting wire harness to move in a direction closer to the housing.

[0014] A delivery pipe, one end of which is inserted into the receiving space via the port and connected to one end of the fitting connected to the housing, the other end of which extends beyond the adjustment mechanism.

[0015] Preferably, the pipe fitting has a plurality of first through holes corresponding one-to-one with each of the first adjustment channels when viewed from a cross-section perpendicular to its extension direction. The first through holes are arranged in a circular array around the axis of the pipe fitting, and the distance between any two first through holes is equal.

[0016] Preferably, the number of the adjusting wire harness, the number of the adjusting member, and the number of the elastic member are all four. Each adjusting member is connected to each adjusting wire harness and each elastic member in a one-to-one correspondence. When viewed from a cross section perpendicular to the extension direction of the pipe, the cross sections of the four adjusting wire harnesses are distributed in a cross shape, with the four adjusting wire harnesses distributed at the four corners of the cross.

[0017] Preferably, the number of adjusting wire harnesses, the number of adjusting members, and the number of elastic members are all six. Each adjusting member is connected to each adjusting wire harness and each elastic member in a one-to-one correspondence. When viewed from a cross-section perpendicular to the extension direction of the pipe, the cross-sections of the six adjusting wire harnesses are divided into three groups. The cross-sections of the two adjusting wire harnesses in each group are symmetrically distributed, and the centers of symmetry of the two adjusting wire harness cross-sections in each group coincide. Furthermore, the included angle of the line connecting the centers of the cross-sections of the adjusting wire harnesses in adjacent groups is the same.

[0018] Preferably, each of the adjustment members has an included angle at one end extending outside the housing.

[0019] Preferably, the outer surface of the serpentine tube is covered with a protective layer, and an annular member is provided at one end of the serpentine tube away from the tube fitting. The inner diameter of the annular member is larger than the inner diameter of the serpentine tube, and the side of the annular member away from the serpentine tube is constructed as an arc surface.

[0020] Preferably, the pipe fitting is a flexible pipe fitting, and the adjusting wire harness is a metal wire.

[0021] Preferably, the housing is further provided with a fixing post, and the portion of the adjusting member located inside the accommodating space is provided with an arc-shaped groove, the center of the arc-shaped groove being collinear with the rotation axis of the adjusting member, and the fixing post passing through the arc-shaped groove.

[0022] Preferably, the elastic element is a spring, the inner wall of the arc-shaped groove is provided with a first protrusion structure, the periphery of the fixed column is provided with a second protrusion structure, one end of the spring is sleeved on the outside of the first protrusion structure, the other end of the spring is sleeved on the outside of the second protrusion structure, and the spring is configured to be compressed when the adjusting element rotates.

[0023] The beneficial effects of the embodiments of this utility model are as follows:

[0024] 1. This technique, employing an adjustable delivery sheath with multiple adjustment channels, a serpentine tube, and an adjustment mechanism, allows for flexible adjustment of the sheath's bending angle and direction, effectively adapting to the varying anatomical structures and locations of the left atrial appendage in different patients. Through the coordination of the adjustment harness and adjustment components, the sheath's shape can be adjusted in real-time during surgery, ensuring axial alignment between the occluder and the left atrial appendage. This avoids the problems of poor occlusion and operational inconvenience caused by mismatch between the sheath and the atrial appendage's anatomical axis in existing techniques. Furthermore, it achieves greater controllability and flexibility during the procedure, enabling surgeons to precisely adjust the sheath's operating angle and direction based on the individual's left atrial appendage anatomy, thereby improving the safety and effectiveness of left atrial appendage occlusion. This technique has significant practical value in clinical practice, providing patients with more precise and customized treatment options.

[0025] 2. By employing a design where the first through holes on the cross-section of the tube are arranged in a circular array centered on the axis, and the distance between any two through holes is equal, it ensures that each first adjustment channel is evenly distributed within the tube, thereby improving the movement accuracy and stability of the adjustment harness. This design avoids the inaccurate adjustment problems caused by uneven channel distribution in existing technologies, thus achieving a smoother and more precise adjustment effect during operation. Through this structure, the adjustment harness can be subjected to force more evenly, thereby improving the controllability of the operation and the accuracy of the surgery, further optimizing the implementation effect of left atrial appendage occlusion. Attached Figure Description

[0026] Figure 1 This is a schematic structural diagram of an adjustable bending conveying sheath shown in one embodiment of the present invention.

[0027] Figure 2 This is a partial cross-sectional view of an adjustable bending conveying sheath shown in one embodiment of the present invention.

[0028] Figure 3 This is a utility model Figure 2 A magnified view of point A in the middle.

[0029] Figure 4 This is a schematic structural diagram showing the shell and the adjustable bending conveying sheath in a separated state in one embodiment of the present invention.

[0030] Figure 5 This is a schematic structural diagram of a serpentine tube shown in one embodiment of the present invention.

[0031] Figure 6 This is a schematic structural diagram of a pipe fitting shown in one embodiment of the present invention.

[0032] Figure 7 This is a schematic structural diagram showing the connection between the adjustment harness and the adjustment component in one embodiment of the present invention.

[0033] Wherein: 10, pipe fitting; 110, conveying channel; 120, first adjusting channel; 20, serpentine pipe; 210, second adjusting channel; 30, adjusting mechanism; 310, housing; 311, accommodating space; 312, fixed column; 3121, second protruding structure; 320, adjusting wire harness; 330, adjusting component; 331, arc groove; 3311, first protruding structure; 40, elastic component; 50, conveying pipe; 60, annular component. Detailed Implementation

[0034] The specific embodiments of this utility model will be described in further detail below with reference to the accompanying drawings and examples. The following examples are used to illustrate this utility model, but are not intended to limit its scope.

[0035] In the description of this application, it should be understood that the terms "center," "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as limiting the scope of protection of this application. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first," "second," etc., may explicitly or implicitly include one or more of that feature. In the description of this application, unless otherwise stated, "a plurality of" means two or more.

[0036] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art will understand the specific meaning of the above terms in this application based on the specific circumstances.

[0037] Please see Figures 1 to 7This application provides a preferred embodiment of an adjustable delivery sheath for left atrial appendage occlusion, comprising a fitting, a serpentine tube, an adjustment mechanism, and a delivery tube. The fitting includes a delivery channel extending parallel to the extension direction of the fitting and communicating with one end of the fitting. The fitting has at least two through-type first adjustment channels extending along its own extension direction. The serpentine tube is disposed at one end of the fitting, and has at least two through-type second adjustment channels extending along its own extension direction. Each second adjustment channel is aligned and communicated with each first adjustment channel in a one-to-one correspondence. The adjustment mechanism includes a housing, at least two adjustment harnesses, at least two adjustment members, and at least two elastic members. The housing is disposed at the other end of the fitting, and includes a receiving space and a port. The receiving space communicates with the delivery channel and the first adjustment channels. Each adjustment harness is movably disposed in each first adjustment channel in a one-to-one correspondence, with one end of each harness passing through the first adjustment channel to extend... The adjustment cable is inserted into the second adjustment channel and connected to one end of the serpentine tube away from the fitting. The other end of the adjustment cable extends into the receiving space. The adjustment member is rotatably disposed within the receiving space, and one end of the adjustment member extends to the outside of the housing. Each adjustment member is connected to one end of each adjustment cable located within the receiving space in a one-to-one correspondence manner, so that the adjustment cable can be pulled by rotating the adjustment member. The elastic member is disposed in the receiving space, and each elastic member is connected to each adjustment member in a one-to-one correspondence. The elastic member is configured to apply a spring force opposite to the first direction to the adjustment member when the adjustment member rotates in a first direction to pull the adjustment cable towards the housing. One end of the delivery tube is inserted into the receiving space through the port and connected to one end of the fitting connected to the housing. The other end of the delivery tube extends outside the adjustment mechanism.

[0038] Specifically:

[0039] The tubing is one of the main components of the device, featuring a delivery channel whose extension direction is parallel to that of the tubing, with the end of the delivery channel connected to the end of the tubing. At least two through-type first adjustment channels are formed within the tubing along its extension direction; the number and arrangement of these channels depend on specific implementation requirements. This design allows for precise movement of the adjustment harness within the tubing, thereby adjusting the bending direction and angle of the sheath. The tubing is made of biocompatible materials such as polymers, possessing sufficient strength while also exhibiting flexibility and adaptability to prevent deformation during operation and ensure effective docking with the left atrial appendage.

[0040] A serpentine tube is positioned at one end of the fitting, and its interior also features at least two through-type second adjustment channels. Each second adjustment channel of the serpentine tube is aligned and connected to the first adjustment channel in the fitting, ensuring that the adjustment harness can smoothly pass through the connecting channel between the two, thereby achieving precise adjustment of the sheath's bending shape. The serpentine tube's design facilitates bending while providing the necessary flexibility to adapt to different patients' atrial appendage positions and anatomical structures.

[0041] The adjustment mechanism mainly consists of a housing, adjustment harnesses, adjustment components, and elastic elements. The housing is located at the other end of the tube and has an internal accommodating space that connects to the conveying channel and the first adjustment channel. This design allows the adjustment harnesses to move freely within the accommodating space. One end of each adjustment harness passes through the first adjustment channel and extends to the second adjustment channel, connecting to one end of the serpentine tube. The other end of the adjustment harness extends into the accommodating space, cooperating with the adjustment component to rotate and adjust the pulling direction of the harness.

[0042] The adjusting element is rotatably mounted within the housing. Rotation of the adjusting element pulls the adjusting harness, thereby changing the bending angle of the sheath. Each adjusting element, connected to the adjusting harness, ensures that rotation moves the harness, adjusting the sheath angle. An elastic element, located within the accommodating space and connected to the adjusting element, provides the necessary counter-elastic force, ensuring the adjusting harness remains stable during adjustment and helping to control the flexibility of bending.

[0043] One end of the delivery tube is inserted into the housing's accommodating space via a port and connected to the other end of the fitting. The other end of the delivery tube extends outside the adjustment mechanism, providing a fluid delivery channel to deliver a stable medium during left atrial appendage occlusion. The design of the delivery tube ensures operational flexibility and suitability for a variety of clinical surgical needs.

[0044] In practical applications, doctors adjust the sheath's shape by rotating the adjusting component within the mechanism, which in turn moves the adjusting cable harness and changes the bending angle of the serpentine tube. During this process, the elastic component provides a counter-elastic force, ensuring stability and precision. Through this adjustment method, the sheath can be flexibly adapted and adjusted according to the patient's left atrial appendage anatomy and location, ensuring precise alignment between the occluder and the left atrial appendage.

[0045] During the procedure, the rotation of the adjusting element directly affects the pulling of the adjusting suture, thus changing the bending direction of the sheath. Guided by real-time imaging, the physician can precisely control the bending angle of the sheath by rotating the adjusting element to adapt to the patient's specific anatomy. Simultaneously, the elastic element provides the necessary counterforce during the procedure, ensuring that the adjusting suture maintains its desired shape stably after adjustment.

[0046] This device is designed for left atrial appendage occlusion surgery, and is particularly suitable for routine cardiac interventional procedures in the operating room. Because the sheath shape needs to be adjusted according to the patient's specific anatomy during use, this device is suitable for most patients, including those of various body types and with different atrial appendage anatomy.

[0047] In this embodiment, the number and arrangement of the adjustment harness and adjustment components can be adjusted according to specific surgical needs. For example, for certain types of patients, more adjustment channels or a more flexible adjustment mechanism may be required. Furthermore, the material selection for the adjustment mechanism can also be optimized based on individual patient differences, such as using elastic components of different hardness or selecting lighter materials to improve operational comfort and convenience.

[0048] In this embodiment, by employing a technical solution involving multiple adjustment channels within the tube, a serpentine tube, and an adjustment mechanism, the device can flexibly adjust the bending angle and direction of the sheath, effectively adapting to the left atrial appendage anatomy of different patients. Through the coordination of the adjustment harness and the adjustment components, the sheath shape can be adjusted in real time, ensuring precise axial alignment between the occluder and the left atrial appendage. This avoids the problems of poor occlusion effect and inconvenient operation caused by mismatch between the sheath and the anatomical axis of the atrial appendage in existing technologies. Furthermore, this invention achieves greater controllability and flexibility during the surgical process, enabling surgeons to precisely adjust the operating angle and direction of the sheath according to the different anatomical characteristics of the left atrial appendage of each individual, thereby improving the safety and effectiveness of left atrial appendage occlusion surgery and possessing significant clinical application value.

[0049] Please see Figure 6 In some embodiments, the pipe has a plurality of first through holes corresponding one-to-one with each of the first adjustment channels when viewed from a cross-section perpendicular to its extension direction. The first through holes are arranged in a circular array around the axis of the pipe, and the distance between any two first through holes is equal.

[0050] Specifically, the design of the pipe fitting in this embodiment is crucial. It has multiple first through holes on a cross-section perpendicular to its extension direction, each corresponding to a first adjustment channel. Specifically, these first through holes are arranged in a circular array around the pipe fitting's axis. The distance between each through hole is uniform and equal, ensuring that each adjustment channel can precisely align and work effectively together. This structure allows the first adjustment channels to be evenly distributed within the pipe fitting, while simultaneously enhancing stability and accuracy during the adjustment process.

[0051] The fittings are round tubes, possessing strong corrosion resistance and biocompatibility, making them suitable for environments with prolonged human contact. The first adjustment channel, through precise machining and meticulous arrangement, ensures that each channel matches other components, thereby achieving precise control of the adjustment mechanism. This design allows the adjustment harness to move smoothly and evenly within each adjustment channel, providing precise bending adjustment.

[0052] The working principle of this invention is based on the combined effect of a first adjustment channel and multiple first through holes within the pipe fitting. By rotating the adjusting component in the adjusting mechanism, the adjusting wire harness moves along a predetermined path within the first adjustment channel, adjusting the bending direction of the pipe fitting. When the adjusting component rotates, the first through holes within the first adjustment channel help the adjusting wire harness move precisely within the channel, ensuring mechanical balance during the adjustment process, thereby smoothly controlling the bending direction and angle of the sheath. A key aspect of this process is the uniform spacing design of the first through holes, ensuring the accuracy and stability of the adjustment.

[0053] This technical solution is primarily applicable to interventional cardiac surgeries, especially left atrial appendage occlusion. The device can be used for extended periods in clinical settings and adapts to the common temperature and humidity conditions of operating rooms. Its design allows for adaptation to the anatomical features of different individuals, enabling physicians to flexibly adjust the sheath shape according to the patient's specific situation; therefore, this technical solution has a wide range of applications.

[0054] In this embodiment, the shape and size of the first through-hole can be adjusted according to specific needs to accommodate different patients. If higher precision is required or improved bending flexibility is needed in specific situations, more adjustment channels can be added or the layout of the first through-hole can be optimized. Furthermore, the choice of material can also be optimized based on individual patient differences; for example, materials of different strengths can be selected to improve stability or ease of operation.

[0055] In this embodiment, by employing a design that includes multiple first through holes in the tubing corresponding one-to-one with the first adjustment channel, and distributing these through holes in a uniform ring array, the problems of uneven adjustment and low adjustment accuracy in the prior art are solved. Through this design, the movement of the adjustment harness within the first adjustment channel is more stable and uniform, thereby improving the accuracy and stability of bending adjustments. This technical solution effectively avoids the mismatch between the occluder and the left atrial appendage caused by inaccurate adjustment, making the operation during surgery more controllable and greatly improving the safety and success rate of the surgery.

[0056] Furthermore, in some embodiments, when the number of adjusting wire harnesses is four, the number of adjusting members and the number of elastic members are also four. Each adjusting member is connected to each adjusting wire harness and each elastic member in a one-to-one correspondence. When viewed from a cross section perpendicular to the extension direction of the tube, the four adjusting wire harnesses are arranged in a cross shape to ensure the uniformity and stability of the adjusting wire harnesses during the adjustment process. Specifically, the four adjusting wire harnesses are distributed at the four corners of the cross, so that each adjusting wire harness can independently control different directions and angles of the sheath.

[0057] Adjustable components are housed within the accommodating space. Each component achieves its adjustment function through connection with the adjustment harness. Rotation of the adjustable component drives the adjustment harness to move, thereby changing the shape and angle of the sheath. Each adjustable component is connected to a corresponding elastic component, which provides a counterforce to ensure stable operation of the adjustment harness during movement, preventing excessive pulling and damage to other components. The connection design between the elastic component and the adjustable component ensures flexibility and stability during adjustment.

[0058] This structural design ensures uniform force distribution during adjustment, avoiding inaccurate adjustments caused by mechanical imbalances. Each adjustment harness in the device is independently controlled, enabling precise adjustment of the sheath shape according to different operational needs, thus adapting to the left atrial appendage anatomy of different patients.

[0059] During the procedure, the physician rotates the adjusting mechanism, which pulls and moves the adjusting wire bundles, thereby adjusting the bending angle of the sheath. The cross-shaped distribution of the four adjusting wire bundles ensures even force distribution, allowing for precise bending adjustments of the sheath in multiple directions. As the adjusting mechanism rotates, each adjusting wire bundle moves in its corresponding direction, thus changing the shape of the sheath to adapt to different anatomical forms of the left atrial appendage. An elastic element provides the necessary counterforce during adjustment, ensuring stable operation of each adjusting wire bundle and guaranteeing accuracy and flexibility during the adjustment process.

[0060] In this embodiment, by employing a design where four adjustment harnesses, adjustment components, and elastic components are connected one-to-one, and the cross-sections of the adjustment harnesses are distributed in a cross shape, this technology effectively solves the problems of inconvenience and low adjustment precision caused by uneven adjustment in existing technologies. The uniform distribution of the four adjustment harnesses ensures that the sheath can be evenly stressed in multiple directions, thereby achieving precise shape adjustment. The cooperation of the elastic component makes the adjustment process more stable, avoiding instability caused by excessive pulling. Through this design, doctors can flexibly adjust the shape of the sheath according to the patient's individual anatomy, thereby improving the controllability and accuracy of the surgical procedure and significantly enhancing the safety and success rate of left atrial appendage occlusion.

[0061] Furthermore, in some embodiments, when the number of adjusting wire harnesses is six, the number of adjusting members and the number of elastic members are also six. Each adjusting member is connected one-to-one with each adjusting wire harness and each elastic member to ensure balance and stability during the adjustment process. To optimize the mechanical structure, the six adjusting wire harnesses are divided into three groups when viewed from a cross-section perpendicular to the extension direction of the pipe fitting. Each group contains two adjusting wire harnesses, and the cross-sections of these two adjusting wire harnesses are symmetrically distributed. The centers of symmetry of the cross-sections of the two adjusting wire harnesses in each group coincide, ensuring force balance during the adjustment process. In addition, the angle between the lines connecting the centers of the cross-sections of adjacent adjusting wire harnesses in each group is the same. This design further optimizes the stress on the adjusting wire harnesses, ensuring accuracy and controllability during the adjustment process.

[0062] Specifically, the adjustment harness is made of wear-resistant and highly biocompatible materials, such as PTFE or medical-grade stainless steel, allowing for long-term use without damage during surgery. The adjustment components are machined with high precision to ensure smooth rotation during operation. The elastic components typically possess good elasticity and resilience to ensure the adjustment harness returns to its precise position during adjustment.

[0063] During the procedure, the doctor adjusts the position of the suture bundles by rotating the adjustment mechanism, thereby changing the shape of the sheath. The design of six adjustment suture bundles allows each bundle to independently adjust the bending angle of the sheath. Because the cross-sections of the two adjustment suture bundles in each group are symmetrically distributed, force can be applied evenly during adjustment, avoiding overstretching or uneven force in one direction. When the adjustment suture bundle is pulled, the elastic element provides a reverse restoring force, ensuring the stability of the adjustment and preventing excessive or uneven adjustment.

[0064] During adjustment, the distribution of the six adjustment harnesses ensures a balanced adjustment force, preventing interference between the movements of each harness and thus guaranteeing precise control of the sheath bending angle. This design also enables high synchronization of each action during adjustment, improving the efficiency and accuracy of the entire adjustment mechanism.

[0065] In this embodiment, the use of six adjustment harnesses, divided into three groups with two harnesses symmetrically distributed within each group and maintaining the same angle between groups, effectively solves the problems of uneven adjustment and insufficient precision in existing technologies. This design ensures that each adjustment harness is evenly stressed during adjustment, achieving more precise and stable morphological adjustments and avoiding operational difficulties and inefficiencies caused by uneven adjustment. Simultaneously, the counterforce of the elastic element ensures the stability of the adjustment process, allowing for smooth adjustments each time. This technical solution significantly improves the controllability and precision of left atrial appendage occlusion surgery, effectively enhancing the safety and success rate of the procedure, and possesses high clinical application value.

[0066] In other embodiments, the number and distribution of the adjustment sutures can be adjusted according to the patient's specific needs. For example, when higher precision adjustment is required, the number of adjustment sutures can be increased, or the arrangement of the adjustment sutures can be adjusted according to specific surgical requirements. Alternative solutions also include optimizing the selection of materials for the adjustment and elastic components, such as using lighter materials to reduce the burden of operation, or selecting elastic component materials of different strengths to improve the comfort and accuracy of operation depending on the surgical environment.

[0067] To facilitate rotating the adjusting element by pressing one end of the adjusting element that extends outside the housing, please refer to [link / reference needed]. Figures 1 to 2 In some embodiments, each of the adjustment members has an included angle at one end extending outside the housing.

[0068] Each adjustment element has an included angle at its outer end, allowing the physician to operate from a more comfortable and intuitive angle. This angled design ensures the physician can easily apply appropriate force, enabling the adjustment element to rotate smoothly, thereby moving the adjustment harness and adjusting the sheath's shape and angle. The included angle is crucial for the physician's operation; without an angle or with an excessively small angle, adjacent adjustment elements may interfere, causing inconvenience and affecting adjustment accuracy. Therefore, a well-designed included angle effectively avoids this interference, ensuring each adjustment element can rotate freely and providing a smoother operating experience.

[0069] Adjustment components are typically made of biocompatible metals or high-strength polymers, possessing excellent wear resistance and corrosion resistance, making them suitable for maintaining high precision and stability during long-term use. The shape and dimensions of the adjustment components are precisely designed to ensure stable operation with the adjustment harness during rotation, preventing inaccurate adjustment due to looseness or mismatch.

[0070] During the procedure, the surgeon presses the outer end of the adjustment mechanism, causing it to rotate. This rotation moves the internal adjustment harness, adjusting the bending angle and shape of the sheath to suit the different left atrial appendage anatomy of each patient. The outer end of the adjustment mechanism is designed with an appropriate angle, allowing the surgeon to apply force at a more comfortable and ergonomic angle. This well-designed angle avoids interference between adjacent adjustment mechanisms, ensuring each mechanism can rotate independently and smoothly, thus achieving precise control. If the angle is too small, interference may occur, leading to inconvenience and affecting the efficiency and accuracy of the surgery. Therefore, the appropriate angle design improves operational flexibility and precision, enabling the surgeon to quickly and accurately adjust the sheath shape.

[0071] In this embodiment, by employing an angled design at the outer end of the adjusting member, the solution effectively solves the problems of interference between adjacent adjusting members and operational inconvenience caused by excessively small angles in existing technologies. The rationally designed angle allows the adjusting member to rotate independently and smoothly, avoiding inaccurate adjustments due to excessive force concentration or imbalance, thereby improving the precision and controllability of adjustments during surgery. Surgeons can apply force at a more comfortable angle during operation, ensuring accurate adjustments each time. This technical solution significantly improves the operational efficiency and precision of left atrial appendage occlusion surgery and has high clinical application value.

[0072] Please see Figure 1 , Figure 4 and Figure 7 In some embodiments, the outer surface of the serpentine tube is covered with a protective layer, and an annular member is provided at the end of the serpentine tube opposite to the fitting. The inner diameter of the annular member is larger than the inner diameter of the serpentine tube, and the side of the annular member opposite to the serpentine tube is constructed as an arc surface. The fitting is a flexible fitting, and the adjusting wire harness is a metal wire.

[0073] In this embodiment, the outer surface of the serpentine tube is covered with a protective layer, which is typically made of a high-strength polymer or other biocompatible materials, exhibiting good wear resistance and corrosion resistance. The protective layer serves to protect the serpentine tube from physical damage that may occur during surgery, especially in complex or confined spaces, preventing wear or damage to the tube surface, thereby extending the device's lifespan and improving operational safety.

[0074] The serpentine tube, a key component of this technical solution, possesses unique flexibility and bendability. It typically consists of multiple segments or stacked structures, each designed to bend freely in all directions. The outer surface of the serpentine tube is covered with a protective layer, usually made of wear-resistant and corrosion-resistant polymer materials (such as PTFE or other medical polymers). This protective layer not only provides physical protection but also prevents direct contact with patient tissues, reducing friction and potential damage. The inner diameter of the serpentine tube is designed to allow for a tight fit with the fitting, ensuring smooth fluid and force transmission. An annular component is located at the end of the serpentine tube facing away from the fitting, with an arc-shaped design on the opposite side. This arc-shaped design provides a smooth transition area, reducing friction with surrounding tissues and making the device operate more smoothly while preventing excessive friction from damaging the surgical site. The inner diameter of this annular component is larger than that of the serpentine tube to avoid affecting material delivery within the fitting's internal transport channels. The annular component has an arc-shaped structure on the side facing away from the serpentine tube.

[0075] The serpentine sheath, as an existing technology, is widely used in applications requiring high flexibility and adjustability, especially in medical devices demanding maneuverability. Its unique structural design allows it to adapt to various bending angles and complex spatial requirements, easily accommodating the diversity of patient anatomy. The primary reason for choosing the serpentine sheath is its superior flexibility and controllability. Its structure allows for free bending in all directions, enabling precise morphological adjustments based on the patient's individual anatomy during the procedure. This flexibility is crucial for left atrial appendage occlusion surgery, as the anatomy of the left atrial appendage varies from person to person, and the serpentine sheath provides precise adjustment capabilities despite these differences. Furthermore, the serpentine sheath structure ensures stable force transmission. During the procedure, the force transmitted by the sheath can be evenly applied to the sheath by adjusting the suture bundle, achieving precise sheath bending. The advantage of this structure lies in providing flexible yet precise control, significantly improving surgical controllability and success rates, especially in cardiac surgeries requiring high operational precision. Based on the above advantages, the serpentine tube becomes an indispensable component of the device. Its flexibility and high-precision adjustment capabilities solve the problem that traditional rigid tubes cannot cope with the differences in patient anatomy, providing a superior solution.

[0076] The tubing itself is made of flexible materials, such as high-strength medical polymers, possessing sufficient flexibility and bendability to adapt to the needs of different patient anatomy structures, ensuring that the sheath can be flexibly adjusted in shape during surgery. The adjustment harness is made of metal wire, possessing high strength and durability, and can stably transmit force during adjustment, ensuring the accuracy and stability of the adjustment process.

[0077] The working principle of this technical solution is based on the coordinated operation of the serpentine tube and fittings. During the procedure, the surgeon adjusts the suture bundle to move the serpentine tube, adjusting the bending angle and shape of the sheath to precisely align with the patient's left atrial appendage. Because the serpentine tube is covered with a protective layer, the surgeon can ensure the tube's protection while avoiding surface damage. During the operation, the annular fitting provides stable support, and the curved design ensures smooth operation, reduces friction with surrounding tissues, and lowers the difficulty of the procedure.

[0078] The adjustment harness, as the force transmission component, is made of metal wire and possesses excellent rigidity and tensile strength, ensuring smooth application and transmission of force during adjustment. The flexible design of the tubing allows it to bend during operation, adapting to different patient anatomy and enabling more precise adjustment.

[0079] In this implementation, the use of a protective layer covering the outer surface of the serpentine tube, the arc-shaped design of the annular component, and the combination of flexible tubing and wire adjustment harness effectively solves the problems of device damage, inconvenient operation, and insufficient precision in existing technologies. The protective layer design effectively extends the service life of the serpentine tube and avoids physical damage; the annular component design enhances the stability of the device and reduces friction with tissue through its arc surface, ensuring a smoother surgical procedure. The combination of flexible tubing and wire adjustment harness improves the flexibility and precision of the device during operation, allowing surgeons to adjust the sheath shape according to the patient's specific anatomical characteristics, thereby improving the safety and success rate of the surgery. This technical solution has significant application value in left atrial appendage occlusion surgery, significantly improving surgical efficiency and operational precision.

[0080] Please see Figures 2 to 3 In some embodiments, a fixing post is also provided inside the housing, located within the accommodating space, and works in conjunction with the rotating structure of the adjusting member. The portion of the adjusting member located inside the accommodating space has an arc-shaped groove, the center of which is collinear with the rotation axis of the adjusting member, and the fixing post passes through the arc-shaped groove. Therefore, with this design, the rotation of the adjusting member can proceed along a fixed arc-shaped trajectory, ensuring the accuracy and stability of each adjustment. The elastic element is a spring, with a first protrusion structure on the inner wall of the arc-shaped groove and a second protrusion structure on the periphery of the fixing post. One end of the spring is sleeved outside the first protrusion structure, and the other end is sleeved outside the second protrusion structure. The spring is configured to compress when the adjusting member rotates.

[0081] Specifically, the fixed post is inserted into the arc-shaped groove, and its cooperation with the adjusting component ensures that the movement of the adjusting component is not disturbed by other factors, thereby improving the flexibility and accuracy of adjustment. The elastic component adopts a spring design, with one end of the spring sleeved on the outside of the first protrusion structure on the inner wall of the arc-shaped groove, and the other end sleeved on the outside of the second protrusion structure around the fixed post. The spring is designed to compress when the adjusting component rotates, providing the necessary restoring force to ensure that the adjusting component can smoothly return to the predetermined position.

[0082] The inner wall of the arc-shaped groove has a first protrusion, while the periphery of the fixed column has a second protrusion. These two protrusions limit the spring's movement trajectory and ensure that the spring effectively provides elastic force, preventing excessive displacement of the adjusting component during rotation. This design allows the spring to apply force evenly as the adjusting component rotates, ensuring consistent force and precision in each adjustment.

[0083] During operation, the doctor adjusts the bending angle of the sheath by rotating the adjusting component. The rotation of the adjusting component is constrained by the fixed post within the arc-shaped groove, ensuring it rotates along a predetermined arc trajectory. The spring compresses during rotation, providing appropriate restoring force to ensure the adjusting component smoothly returns to its initial position during operation. The design of the first and second protruding structures ensures the spring is not easily slipped during movement, further improving the stability and reliability of the device.

[0084] This structure allows for precise control of the movement of the adjusting element, preventing adjustment errors caused by excessive compression or relaxation of the spring. Through the coordinated action of the adjusting element, spring, and fixation post, the surgeon can make precise adjustments to the sheath shape during the procedure, ensuring accurate alignment of the occluder with the left atrial appendage.

[0085] This embodiment, through the combined design of a fixed column and an arc-shaped groove, along with precise spring control, effectively solves the problems of inaccurate adjustment and unstable operation in existing technologies. This design ensures that the adjusting component is precisely restricted during rotation, avoiding unnecessary displacement or interference and providing higher operational precision. The spring's compression function provides the necessary restoring force for the adjusting component, ensuring recovery speed and accuracy after each operation. This technical solution significantly improves the controllability and flexibility during surgery, enabling surgeons to more accurately adjust the sheath shape, thereby improving the success rate and safety of left atrial appendage occlusion surgery.

[0086] The above description in this specification is merely illustrative of the present invention. Those skilled in the art to which this invention pertains may make various modifications or additions to the described specific embodiments or use similar methods to replace them, as long as they do not depart from the content of this specification or exceed the scope defined in the claims, all of which shall fall within the protection scope of this invention.

Claims

1. An adjustable-bend delivery sheath for left atrial appendage occlusion, characterized in that, include: The pipe fitting includes a conveying channel, the extension direction of the conveying channel is parallel to the extension direction of the pipe fitting, and the conveying channel is connected to the end of the pipe fitting. The interior of the pipe fitting is provided with at least two through first adjustment channels along its own extension direction. A serpentine tube is provided at one end of the tube fitting. The interior of the serpentine tube has at least two through-type second adjustment channels along its own extension direction. Each second adjustment channel is aligned and connected to each first adjustment channel in a one-to-one correspondence manner. The regulating mechanism includes: A housing is disposed at the other end of the pipe fitting. The housing includes a receiving space and a port. The receiving space is connected to the conveying channel and the first adjusting channel. At least two adjustment harnesses are provided, each adjustment harness being movably disposed in each of the first adjustment channels in a one-to-one correspondence manner. One end of each adjustment harness passes through the first adjustment channel to extend into the second adjustment channel and is connected to the end of the serpentine tube opposite to the tube fitting. The other end of the adjustment harness extends into the accommodating space. At least two adjusting members are provided, the adjusting members are rotatably disposed within the accommodating space, and one end of the adjusting members extends to the outside of the housing. Each adjusting member is connected to one end of each adjusting wire harness located within the accommodating space in a one-to-one correspondence manner, so that the adjusting wire harness can be pulled by rotating the adjusting members. At least two elastic elements are disposed in the accommodating space, and each elastic element is connected to each of the adjusting elements in a one-to-one correspondence. The elastic elements are configured to apply a spring force opposite to the first direction to the adjusting element when the adjusting element rotates in a first direction to pull the adjusting wire harness to move in a direction closer to the housing. A delivery pipe, one end of which is inserted into the receiving space via the port and connected to one end of the fitting connected to the housing, the other end of which extends beyond the adjustment mechanism.

2. The adjustable bendable delivery sheath for left atrial appendage occlusion according to claim 1, characterized in that, The pipe fitting has a plurality of first through holes corresponding one-to-one with each of the first adjustment channels when viewed from a cross-section perpendicular to its extension direction. Each of the first through holes is arranged in a circular array with the axis of the pipe fitting as the center, and the distance between any two of the first through holes is equal.

3. The adjustable bendable delivery sheath for left atrial appendage occlusion according to claim 2, characterized in that, The number of the adjusting wire harness, the number of the adjusting member, and the number of the elastic member are all four. Each adjusting member is connected to each adjusting wire harness and each elastic member in a one-to-one correspondence. When viewed from a cross section perpendicular to the extension direction of the pipe, the four adjusting wire harnesses are arranged in a cross shape, with the four adjusting wire harnesses distributed at the four corners of the cross.

4. An adjustable bendable delivery sheath for left atrial appendage occlusion according to claim 2, characterized in that, The number of the adjusting wire harness, the number of the adjusting member, and the number of the elastic member are all six. Each adjusting member is connected to each adjusting wire harness and each elastic member in a one-to-one correspondence. When viewed from a cross-section perpendicular to the extension direction of the pipe, the cross-sections of the six adjusting wire harnesses are divided into three groups. The cross-sections of the two adjusting wire harnesses in each group are symmetrically distributed, and the centers of symmetry of the two adjusting wire harness cross-sections in each group coincide. Furthermore, the included angle of the line connecting the centers of the cross-sections of the adjusting wire harnesses in adjacent groups is the same.

5. An adjustable bendable delivery sheath for left atrial appendage occlusion according to claim 1, characterized in that, Each of the aforementioned adjustment components has an included angle at one end extending outside the housing.

6. An adjustable bendable delivery sheath for left atrial appendage occlusion according to claim 1, characterized in that, The outer surface of the serpentine tube is covered with a protective layer. The end of the serpentine tube opposite to the tube is provided with an annular member. The inner diameter of the annular member is larger than the inner diameter of the serpentine tube, and the side of the annular member opposite to the serpentine tube is constructed as an arc surface.

7. An adjustable bendable delivery sheath for left atrial appendage occlusion according to claim 1, characterized in that, The pipe fitting is a flexible pipe fitting, and the adjustment harness is a metal wire.

8. An adjustable-bend delivery sheath for left atrial appendage occlusion according to claim 1, characterized in that, The housing is provided with a fixed post, and the portion of the adjusting member located inside the accommodating space is provided with an arc-shaped groove. The center of the arc-shaped groove is collinear with the rotation axis of the adjusting member, and the fixed post passes through the arc-shaped groove.

9. An adjustable-bend delivery sheath for left atrial appendage occlusion according to claim 8, characterized in that, The elastic element is a spring. The inner wall of the arc-shaped groove is provided with a first protrusion structure, and the periphery of the fixed column is provided with a second protrusion structure. One end of the spring is sleeved on the outside of the first protrusion structure, and the other end of the spring is sleeved on the outside of the second protrusion structure. The spring is configured to be compressed when the adjusting element rotates.

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