Conveying system and physical limiting device

Abstract

The invention provides a conveying system and a physical limiting device. The device comprises a first moving part; the guide rod moves in the axial direction of the guide rod, at least one stage of limiting groove is formed in the outer surface of the guide rod, each stage of limiting groove comprises a first part groove rail, a second part groove rail and a third part groove rail which are communicated in sequence, and the second part groove rail and the first part groove rail and the third part groove rail are arranged in an angle mode; the first end of the safety rod is inserted into the first part grooved rail, and the safety rod is configured to move relative to the guide rod along the limiting groove; and the second moving part is connected with the second end of the bumper bar and is configured to drive the bumper bar to rotate in the axial direction of the guide rod through rotation, so that the first end of the bumper bar moves along the second part grooved rail. The device can prompt an operator of a limiting critical point through touch sense, effectively feeds back accurate information of physical positioning, and realizes simple, efficient and accurate physical limiting.

Description

[0001] This application is a divisional application of the invention patent application with the application date of September 24, 2021, application number 202111121584.4, and invention name “Conveying system and physical limiting device”. Technical Field

[0002] The present disclosure relates to a conveying system and a physical limiting device. Background Art

[0003] Limiting generally refers to limiting the position of an object, such as requiring an object to be in a certain area or not. Limiting can generally be achieved through a limiting device to accurately determine whether an object has reached a set state, thereby alerting the operator or achieving automatic status updates. For example, when an object is being transported and reaches a specific position, the operator needs to be alerted. In such limit reminder scenarios, sensors are currently used to detect the position and implement limit reminders through sound and light, or the operator must continuously observe the entire operation process visually to ensure accuracy and the realization of the set state. Currently, the industry lacks effective and accurate physical limit devices, especially in the delivery system of medical devices (such as artificial prosthesis delivery). Because medical device operators often need to observe the status of the patient and multiple devices at different positions simultaneously, it is difficult to maintain continuous visual attention throughout the operation of any single device and synchronize visual effects with manual operation. Therefore, there is an urgent need for accurate, effective, and easy-to-operate physical limit devices. Summary of the Invention

[0004] At least one embodiment of the present disclosure provides a conveying system, a conveying method, and a physical limiting device.

[0005] At least one embodiment of the present disclosure provides a physical limiting device, comprising a first moving component, a second moving component, a guide rod and a safety rod. The guide rod is configured to be driven by the first moving component to move axially along the guide rod, wherein at least one level of limiting groove is provided on the outer surface of the guide rod, and the at least one level of limiting groove extends as a whole along the axial direction of the guide rod, and each level of limiting groove comprises a first part groove rail, a second part groove rail and a third part groove rail that are connected in sequence, and the second part groove rail is arranged at an angle to the first part groove rail and the third part groove rail respectively. The safety rod comprises a first end and a second end opposite to each other along the length of the rod, wherein the first end of the safety rod is inserted into the limiting groove, and the safety rod is configured to be movable relative to the guide rod along the limiting groove. The second moving component is connected to the second end of the safety rod, and the second moving component is configured to drive the safety rod to rotate around the axial direction of the guide rod by rotation, so that the first end of the safety rod moves along the second part groove rail.

[0006] For example, in a physical limiting device provided in at least one embodiment of the present disclosure, the first portion of the groove rail and the third portion of the groove rail are configured to extend axially along the guide rod, the second portion of the groove rail is configured to extend circumferentially along the guide rod, and in the axial direction of the guide rod, the second portion of the groove rail is located between the first portion of the groove rail and the third portion of the groove rail.

[0007] For example, in a physical limiting device provided in at least one embodiment of the present disclosure, the limiting groove further includes a fourth groove rail portion, the fourth groove rail portion being configured to allow the first end of the safety bar to pass through. The distal end of the fourth groove rail portion is in communication with the proximal end of the third groove rail portion, the proximal end of the fourth groove rail portion is in communication with at least a portion of the first groove rail portion, and the fourth groove rail portion is not parallel to the second groove rail portion.

[0008] For example, in a physical limiting device provided in at least one embodiment of the present disclosure, the first portion of the groove rail, the second portion of the groove rail, the third portion of the groove rail, and the fourth portion of the groove rail form a trapezoid or a triangle.

[0009] For example, in a physical limiting device provided in at least one embodiment of the present disclosure, at least one level of limiting grooves is an N-level limiting groove, where N is an integer greater than or equal to 2. The first portion of the groove track of the i-th level limiting groove is connected to the third portion of the groove track of the (i-1)-th level limiting groove, wherein the values ​​of each level i are sequentially recorded as 1, 2, ..., N from the proximal end to the distal end.

[0010] At least one embodiment of the present disclosure provides a delivery system for an artificial prosthesis, comprising a physical limiting device as described in any of the above embodiments, and the delivery system further comprising a first tube assembly and a second tube assembly. The first tube assembly is configured to place an artificial prosthesis. The second tube assembly comprises a sheath tube, which is sleeved on the outside of at least a portion of the first tube assembly, and the axial directions of the sheath tube and the first tube assembly are respectively parallel to or coaxial with the axial direction of the guide rod. The sheath tube is fixedly connected to the first moving component, so that the first moving component drives the sheath tube to perform axial relative movement relative to the first tube assembly.

[0011] For example, in a conveying system provided by at least one embodiment of the present disclosure, the safety rod is stationary relative to the first tube assembly.

[0012] For example, at least one embodiment of the present disclosure provides a conveying system further comprising a screw, wherein the first moving component comprises a first knob, which is sleeved onto the screw, with the axial directions of the first knob and the screw being parallel or coaxial with the axial direction of the guide rod. The first knob is internally provided with threads that match the screw to achieve a helical fit, such that the first knob, when rotated circumferentially, achieves relative motion along the axial direction of the first tube assembly via threaded transmission.

[0013] For example, at least one embodiment of the present disclosure provides a conveying system further comprising a first half-shell, a second half-shell, a third half-shell, and a fourth half-shell. The distal ends of the screws are fixedly connected to the first and second half-shells, respectively, and the proximal ends of the screws are fixedly connected to the third and fourth half-shells, respectively. The first and second half-shells are positioned on either side of a central axis of the conveying system and are fixedly connected to form a first shell. The third and fourth half-shells are positioned on either side of the central axis of the conveying system and are fixedly connected to form a second shell.

[0014] For example, in a delivery system provided by at least one embodiment of the present disclosure, the second tube assembly further includes a stabilizing tube, and a distal end of the stabilizing tube is sleeved on the outside of at least a portion of the sheath tube.

[0015] For example, in at least one embodiment of the present disclosure, a delivery system is provided in which the sheath is a reducer, comprising a first sheath portion and a second sheath portion arranged in sequence from distal to proximal. The diameter of the first sheath portion is greater than the diameter of the second sheath portion, and the distal end of the stabilizing tube is disposed outside the second sheath portion, with the diameter of the stabilizing tube being smaller than the diameter of at least a portion of the first sheath portion.

[0016] For example, a delivery system provided by at least one embodiment of the present disclosure further includes a stabilizing tube fixing seat and a sheath fixing seat. The stabilizing tube is configured to extend from the distal end to the stabilizing tube fixing seat and the proximal end of the stabilizing tube is fixedly connected to the stabilizing tube fixing seat. The stabilizing tube fixing seat is disposed inside the first shell and is fixedly connected to the first half shell and the second half shell, respectively. The sheath tube extends from the distal end to the sheath tube fixing seat and the proximal end of the second sheath tube portion is fixedly connected to the sheath tube fixing seat, and the sheath tube fixing seat is fixedly connected to the first knob. The guide rod is inserted into the screw rod and is fixedly connected to the sheath tube fixing seat, so that the sheath tube fixing seat can be driven to move by rotating the first knob, and the sheath tube and the guide rod can be driven to move relative to each other along the axial direction of the first tube assembly.

[0017] For example, in a delivery system provided in at least one embodiment of the present disclosure, a first tube assembly includes an inner tube and an artificial prosthesis connector, the artificial prosthesis connector is arranged on the outer surface of the distal end of the inner tube and is fixedly connected to the inner tube; a card slot matching the artificial prosthesis is provided on the artificial prosthesis connector for the artificial prosthesis to be embedded and placed and is detachably connected to the artificial prosthesis.

[0018] For example, at least one embodiment of the present disclosure provides a delivery system further comprising an inner tube fixing seat. The inner tube is configured to extend from the distal end toward the proximal end to the inner tube fixing seat, and the inner tube is fixedly connected to the inner tube fixing seat. The inner tube fixing seat is disposed within the second housing and is fixedly connected to the third and fourth half housings, respectively.

[0019] For example, in a delivery system provided by at least one embodiment of the present disclosure, the inner tube includes a plurality of third tube sections connected in sequence along the axial direction of the first tube assembly and having different hardnesses, and the sheath tube includes a plurality of fourth tube sections connected in sequence along the axial direction of the first tube assembly and having different hardnesses.

[0020] For example, in a conveying system provided by at least one embodiment of the present disclosure, the first tube assembly further includes an inner tube emptying piece and an end base, the inner tube emptying piece is connected to the proximal end of the inner tube, and the end base is connected to the distal end of the inner tube.

[0021] For example, a conveying system provided by at least one embodiment of the present disclosure also includes a safety connector, wherein the second moving component is a second knob, the axial direction of the second knob is parallel to or coaxial with the axial direction of the guide rod, and the safety connector is fixedly connected to the second end of the safety rod and the second knob, respectively, so that the safety rod can be driven to rotate around the axial direction of the guide rod by rotating the second knob.

[0022] For example, in a conveying system provided in at least one embodiment of the present disclosure, the second shell is a cylinder and the second knob is nested on the outer surface of the cylinder, so that the second knob cannot move along the axial direction of the guide rod and can rotate around the axial direction of the guide rod.

[0023] For example, in a delivery system provided in at least one embodiment of the present disclosure, the artificial prosthesis includes an artificial heart valve, a covered stent, or an artificial blood vessel.

[0024] For example, in a delivery system provided by at least one embodiment of the present disclosure, when the first end of the safety rod is inserted into the first part of the groove, at least part of the artificial prosthesis is placed in the cavity between the sheath of the second tube assembly and the first tube assembly, and the cavity is gradually opened or closed when the sheath of the second tube assembly undergoes axial relative movement relative to the first tube assembly to release the artificial prosthesis or recover the artificial prosthesis.

[0025] For example, in a delivery system provided by at least one embodiment of the present disclosure, when the first end of the safety rod is located at the proximal end within the first portion of the groove track, the cavity in which the prosthesis is disposed between the sheath tube of the second tube assembly and the first tube assembly is the first cavity. When the first end of the safety rod is positioned at the distal end within the first portion of the groove track, a third cavity in which a portion of the prosthesis is disposed between the sheath tube of the second tube assembly and the first tube assembly is the second cavity, wherein the space in the second cavity is smaller than the space in the first cavity.

[0026] At least one embodiment of the present disclosure provides a method for conveying an artificial prosthesis, the method comprising: controlling the movement of a first moving component to drive the guide rod to move axially along the guide rod and driving the sheath tube of the second tube assembly to perform axial relative movement relative to the first tube assembly, wherein the sheath tube of the second tube assembly is fixedly connected to the first moving component, the first tube assembly is configured to place the artificial prosthesis, the sheath tube of the second tube assembly is sleeved on the outside of at least a portion of the first tube assembly, the axial directions of the sheath tube of the second tube assembly and the first tube assembly are respectively parallel or coaxial with the axial direction of the guide rod, at least one level of limiting groove is provided on the outer surface of the guide rod, and at least one level of limiting groove extends as a whole along the axial direction of the guide rod, and each level of limiting groove includes a first part groove rail, a second part groove rail and a third part groove rail that are connected in sequence, and the second part groove rail is respectively connected to the first part groove rail and The third part of the groove is arranged at an angle; the first end of the safety rod is inserted into the first part of the groove, and the guide rod is moved axially toward the proximal end so that the first end of the safety rod can be limited in the first part of the groove near one end of the second part of the groove (for example, the distal end in the first part of the groove); in response to the artificial prosthesis meeting the target requirements, the second moving component is controlled to rotate, driving the safety rod to rotate axially, so that the first end of the safety rod is transferred from the first part of the groove through the second part of the groove to at least part of the third part of the groove, so that the guide rod is driven by the first moving component to move axially toward the proximal end when the third part of the groove is in a state where the first end of the safety rod can pass through, and the sheath tube of the second tube assembly is driven by the first moving component to make axial relative movement relative to the first tube assembly, wherein the second moving component is fixedly connected to the safety rod.

[0027] For example, a delivery method provided by at least one embodiment of the present disclosure also includes: in response to the artificial prosthesis not meeting the target requirements, controlling the first moving component to move in the opposite direction to drive the sheath tube of the second tube assembly to move axially relative to the first tube assembly and drive the guide rod to move axially toward the distal end.

[0028] For example, a conveying method provided by at least one embodiment of the present disclosure also includes: in response to the first end of the safety rod being near the distal end in the third part groove rail, controlling the first moving component to move in the opposite direction, driving the sheath tube of the second tube assembly to make axial relative movement relative to the axial direction of the first tube assembly and driving the guide rod to move axially toward the distal end, so that the first end of the safety rod passes from the third part groove rail through the fourth part groove of the limit groove and returns to the first part groove rail, wherein the first end of the fourth part groove rail is connected to the proximal end of the third part groove rail, the second end of the fourth part groove rail is connected to at least part of the first part groove rail, and the fourth part groove rail is not parallel to the second part groove rail, so as to allow the first end of the safety rod to move toward the proximal end along the fourth part groove rail.

[0029] For example, in a delivery method provided in at least one embodiment of the present disclosure, the delivery method also includes: when the first end of the safety rod is inserted into the first part of the groove, at least part of the artificial prosthesis is placed in the cavity between the sheath of the second tube assembly and the first tube assembly, and the sheath of the second tube assembly is driven to perform axial relative movement relative to the first tube assembly, so that the cavity is gradually opened or closed to release the artificial prosthesis or recover the artificial prosthesis.

[0030] Compared with the prior art, the beneficial effects of at least one embodiment of the present disclosure include at least: the device or method of the embodiment of the present disclosure can achieve physical limitation, can prompt the operator of the limit critical point through tactile sensation, and effectively feedback accurate information of physical positioning, thereby achieving simple, efficient and precise physical limitation. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present disclosure or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present disclosure. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0032] Figure 1 A schematic structural diagram of a physical limiting device provided in some embodiments of the present disclosure;

[0033] Figure 2-Figure 3 Schematic diagrams of the outer surface of a guide rod provided in some embodiments of the present disclosure from different perspectives;

[0034] Figure 4a The embodiment of the present disclosure provides an axial viewing angle from the proximal end to the distal end. Figure 1 The omitted schematic diagram after retaining the safety device and the second moving part;

[0035] Figure 4b Some embodiments of the present disclosure provide Figure 4a sectional view of

[0036] Figures 5a to 5f A schematic diagram of an operating method of a physical limiting device provided in some embodiments of the present disclosure;

[0037] Figure 6 A schematic diagram of a cascade of two-stage limiting grooves provided in some embodiments of the present disclosure;

[0038] Figure 7 A schematic diagram of an artificial prosthesis delivery system provided in some embodiments of the present disclosure;

[0039] Figure 8 A partial schematic diagram of a first pipe assembly and a second pipe assembly provided for some embodiments of the present disclosure;

[0040] Figure 9 An axial cross-sectional view of a delivery system for an artificial prosthesis provided in some embodiments of the present disclosure;

[0041] Figures 10a-10c A schematic diagram of an operating method of a delivery system for an artificial prosthesis provided in some embodiments of the present disclosure. DETAILED DESCRIPTION

[0042] The following will be combined with the accompanying drawings in the embodiments of the present disclosure to clearly and completely describe the technical solutions in the embodiments of the present disclosure. Obviously, the embodiments described are only part of the embodiments of the present disclosure, not all of the embodiments. Based on the embodiments of the present disclosure, all other embodiments obtained by ordinary technicians in this field without making any creative efforts shall fall within the scope of protection of the present disclosure.

[0043] Unless otherwise defined, all terms (including technical and scientific terms) used in the embodiments of the present disclosure have the same meaning as commonly understood by those skilled in the art to which the present disclosure belongs. It should also be understood that terms such as those defined in common dictionaries should be interpreted as having meanings consistent with their meanings in the context of the relevant technology, and should not be interpreted in an idealized or extremely formal sense, unless explicitly defined in this manner in the embodiments of the present disclosure.

[0044] The words "first", "second" and similar words used in the embodiments of the present disclosure do not indicate any order, quantity or importance, but are only used to distinguish different components. Words such as "one", "an" or "the" do not indicate a quantity limitation, but rather indicate the existence of at least one. Similarly, words such as "include" or "comprise" mean that the elements or objects preceding the word include the elements or objects listed after the word and their equivalents, without excluding other elements or objects. Words such as "connect" or "connected" are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. Flowcharts are used in the embodiments of the present disclosure to illustrate the steps of the method according to the embodiments of the present disclosure. It should be understood that the previous or subsequent steps are not necessarily performed in exact order. Instead, the various steps may be processed in reverse order or simultaneously. At the same time, other operations may be added to these processes, or one or more steps may be removed from these processes.

[0045] The inventors have discovered that with the aging of the population, the incidence of valvular heart disease has increased significantly. Traditional treatments include conservative medication and surgical valve replacement. Medication has little effect on improving prognosis, and while surgical valve replacement can significantly improve patient outcomes, it carries high risks for many elderly patients with a history of open-chest surgery or severely impaired cardiopulmonary function, and may even negate the opportunity for surgery. Against this backdrop, transcatheter aortic valve replacement has been a milestone in the diagnosis and treatment of valvular heart disease in recent years.

[0046] During the artificial heart valve implantation procedure, the operator needs to accurately grasp the position and shape of the valve prosthesis release. In the process of determining the position of the valve prosthesis, unclear angiography, unstable operation, or interference from other factors make the positioning of the valve prosthesis more difficult. Moreover, with conventional artificial heart valve implantation devices, once the operator completes positioning and begins to release the valve prosthesis, the entire release process is irreversible, and the operator has almost no opportunity to adjust the position and shape of the prosthesis, making the operation process extremely error-tolerant. Therefore, the operator needs to grasp the length of the valve released from the delivery system in real time, which is extremely difficult.

[0047] There are two main ways for the operator to understand the length of the valve released from the delivery system: the first is to use ultrasound imaging and digital subtraction angiography to compare the relative positions of the imaging marker and the valve prosthesis to determine the release of the prosthesis. In this method, due to the delay in imaging, the operator cannot accurately control the release length of the valve. The second method is to obtain information on the valve release length by reading the release stroke mark on the handle or tubing. In this method, since the operator's observation position during the operation is at a certain angle to the stroke mark, parallax occurs during the reading process, and the operator cannot obtain accurate information on the valve release length.

[0048] Therefore, the present disclosure proposes a simple, efficient and precise physical limiting device, as well as a system and method using the physical limiting device.

[0049] At least one embodiment of the present disclosure provides a physical limiting device, comprising: a first moving component; a guide rod, configured to be driven by the first moving component to move axially along the guide rod, wherein at least one level of limiting groove is provided on the outer surface of the guide rod, and the at least one level of limiting groove extends as a whole along the axial direction of the guide rod, and each level of limiting groove comprises a first part groove rail, a second part groove rail and a third part groove rail that are connected in sequence, and the second part groove rail is arranged at an angle to the first part groove rail and the third part groove rail respectively; a safety rod, comprising a first end and a second end arranged opposite to each other along the length direction of the rod, wherein the first end of the safety rod is inserted into the limiting groove and the safety rod is configured to be movable relative to the guide rod in the extension direction of the limiting groove; a second moving component, fixedly connected to the second end of the safety rod, and the second moving component is configured to drive the safety rod to rotate around the axial direction of the guide rod by rotation, so that the first end of the safety rod moves along the second part groove rail.

[0050] At least one embodiment of the present disclosure further provides a method corresponding to the above-mentioned physical limiting device.

[0051] The physical limiting device or method of the above-mentioned embodiment of the present disclosure can realize physical limiting, and can prompt the operator of the limiting critical point through tactile sensation, effectively feedback the accurate information of physical positioning, thereby realizing simple, efficient and accurate physical limiting.

[0052] The embodiments of the present disclosure and examples thereof are described in detail below with reference to the accompanying drawings.

[0053] It should be noted that, for the convenience of expression in this article, some embodiments of the present disclosure record the first axial side as the left side in the diagram and the second axial side as the right side in the diagram. For example, the directions perpendicular to the axial direction involved in some embodiments of the present disclosure can be recorded as the up and down directions in the diagram, but the up and down directions involved in the embodiments of the present disclosure all represent the directions in the diagram and do not affect the directions in actual applications. The embodiments of the present disclosure do not limit this.

[0054] For example, with respect to the limitation on the axial direction, for the convenience of description, at least one embodiment of the present disclosure regards the side close to the operator as the proximal end or the proximal side and the side away from the operator as the distal end or the distal side. For example, the left side in the diagram is regarded as the distal end and the right side in the diagram is regarded as the proximal end. It should be noted that the distal end and the proximal end in the present disclosure are all relative positions, for example, they represent the two opposite sides of some components themselves, or they represent the two opposite sides in a certain direction, that is, the proximal end in the present disclosure represents one side, and the distal end represents the other side opposite to the proximal end. The meaning and function of the elements or objects in the embodiments of the present disclosure are not limited to their names, and cannot be interpreted in an idealized or extremely formalized sense, which does not limit the embodiments of the present disclosure.

[0055] Figure 1A schematic structural diagram of a physical limiting device 100 provided in some embodiments of the present disclosure.

[0056] like Figure 1 As shown, the physical limiting device 100 includes a first moving component 11, a guide rod 12, a safety device 13, and a second moving component 14. The first moving component 11 is configured to drive the guide rod 12 so that the guide rod 12 moves along the axial direction of the guide rod 12. For example, the axial direction of the guide rod 12 can be regarded as the axial direction of the entire physical limiting device 100.

[0057] In some examples, the first moving component 11 may be a rotating component that rotates around the axial direction of the guide rod 12. For example, the first moving component 11 converts the rotation into linear motion through an intermediate component to drive the guide rod 12 to move along the axial direction of the guide rod 12. For example, Figure 1 As shown, the first moving component 11 is a first knob 111 (e.g., a manual knob), the axial direction of the first knob 111 is parallel to or coaxial with the axial direction of the guide rod 12, and the first knob 111 is configured to drive the guide rod 12 to move along the axial direction of the guide rod 12 by its own rotation (specific examples can be seen in the description below).

[0058] The structure of the first moving component 11 is not limited thereto, and any component or assembly that can move the guide rod 12 along the axial direction of the guide rod 12 falls within the scope of protection of the embodiments of the present disclosure. For example, the first moving component 11 can also be a component that moves linearly along the axial direction.

[0059] Figure 2 and Figure 3 Schematic perspective views of the outer surface of the guide rod 12 provided in some embodiments of the present disclosure from different perspectives. Figure 3 for Figure 2 Schematic diagram of the guide rod 12 after it rotates a certain angle around the axial direction.

[0060] like Figure 2 and Figure 3 As shown, the outer surface of the guide rod 12 is provided with at least one level of limiting grooves 121, which extend entirely along the axial direction of the guide rod 12. Each level of limiting grooves 121 includes a first groove section 121a, a second groove section 121b, and a third groove section 121c, which are sequentially connected. The second groove section 121b is arranged at an angle to the first groove section 121a and the third groove section 121c.

[0061] It should be noted that the limiting groove 121 extends along the axial direction of the guide rod 12 as a whole, which does not mean that the first part groove rail 121a, the second part groove rail 121b and the third part groove rail 121c all extend along the axial direction, but means that the first part groove rail 121a, the second part groove rail 121b and the third part groove rail 121c are connected in sequence to form an overall extension direction along the axial direction of the guide rod 12, wherein any one of the first part groove rail 121a, the second part groove rail 121b and the third part groove rail 121c may not extend along the axial direction of the guide rod 12, or may extend approximately along the axial direction of the guide rod 12.

[0062] like Figure 2 and Figure 3 As shown, the first and third groove rail sections 121a, 121c are configured to extend in an axial direction parallel to the guide rod 12. The second groove rail section 121b is configured to extend in a circumferential direction of the guide rod 121. In the axial direction of the guide rod 121, the second groove rail section 121b is located between the first and third groove rail sections 121a, 121c.

[0063] For example, the first portion of the groove rail 121a, the second portion of the groove rail 121b and the third portion of the groove rail 121c are all grooves with a certain depth opened on the outer circumferential surface of the guide rod 12, and the cross-sectional shape and depth of each portion of the groove rail are not limited.

[0064] In some examples, the shape of any portion of the limiting groove 121 in the extension direction may not be a strictly straight segment, for example, it may be substantially straight. For another example, the extension direction of the second portion of the groove 121b may not be strictly the circumferential direction of the guide rod 121, for example, it may be substantially consistent with the circumferential direction of the guide rod 121.

[0065] In at least one embodiment of the present disclosure, the second portion of the groove rail 121b is arranged at an angle to the first portion of the groove rail 121a and the third portion of the groove rail 121c, respectively, which means that on the outer circumferential surface of the guide rod 12, the second portion of the groove rail 121b is a section of the groove rail that is neither parallel to the first portion of the groove rail 121a nor parallel to the third portion of the groove rail 121c.

[0066] Figure 4a The embodiment of the present disclosure provides an axial viewing angle from the proximal end to the distal end. Figure 1 The schematic diagram after retaining the safety device 13 and the second moving component 14 is omitted. Figure 4b For the Figure 4a Section view along section line AA.

[0067] like Figure 4a and Figure 4bAs shown, the safety device 13 includes a safety lever 131. The safety lever 131 includes a first end (i.e., the end of the safety lever 131 closer to the guide rod 12) and a second end (i.e., the end of the safety lever 131 farther from the guide rod 12) disposed opposite each other along the rod length. The first end of the safety lever 131 is inserted into the first portion of the groove track 121a of the retaining groove 121. The safety lever 131 is configured to be movable relative to the guide rod 12 along the extension direction of the retaining groove 121.

[0068] In some examples, the safety rod 131 is stationary and can move relative to the guide rod 12, that is, the safety rod 131 slides relative to each other in different sections of the limiting groove 121 of the guide rod 12 because the guide rod 12 moves proximally (or distally) and the safety rod 131 is stationary, so that the safety rod 131 moves distally (or proximally) relative to the guide rod 12. Therefore, the present disclosure sets the safety rod 131 to be stationary and uses its relative movement with the guide rod to achieve physical limitation of the guide rod, which has a simple structure, is easy to operate, and has good stability and accuracy.

[0069] It should be noted that the safety bar 131 being stationary refers to being stationary relative to the current operator, and may also refer to being stationary relative to the current environment of the entire conveying system.

[0070] Thus, the first portion of the groove track 121a and the third portion of the groove track 121c are configured to allow the first end of the safety rod 131 to pass through, so as to allow the guide rod 12 to move smoothly along the axial direction of the guide rod. For example, the guide rod 12 moves proximally along the axial direction of the guide rod (i.e., moves to the right along the axial direction). At this time, the safety rod 131 passes relatively from the axial proximal end toward the axial distal end in the first portion of the groove track 121a and the third portion of the groove track 121c.

[0071] For example, based on the axial movement of the guide rod 12 toward the proximal end, the first end of the safety rod 131 can reach the distal end from the proximal end in the first part of the groove 121a relative to the guide rod 12, and can be limited to one end in the first part of the groove 121a close to the second part of the groove 121b (that is, the distal end in the first part of the groove 121a).

[0072] In some examples, the second end of the safety lever 131 is fixedly connected to the second moving component 14. The safety lever 131 is configured to rotate around the axial direction of the physical limiting device 100 by rotating the second moving component 14, so that the first end of the safety lever 131 rotates from the first portion of the groove track 121a of the limiting groove 121 to the third portion of the groove track 121c via the second portion of the groove track 121b.

[0073] like Figure 2As shown, the limiting groove 121 further includes a fourth part groove track 121d. The third part groove track 121c, the fourth part groove track 121d, and the first part groove track 121a are connected in sequence. The fourth part groove track 121d is arranged at an angle with respect to the third part groove track 121c and the first part groove track 121a respectively. The distal end of the fourth part groove track 121d is connected to the proximal end of the third part groove track 121c. The fourth part groove track 121d extends toward the side away from the second part groove track 121b, so that the proximal end of the fourth part groove track 121d is connected to at least part of the first part groove track 121a, and the fourth part groove track 121d is not parallel to the second part groove track 121b, allowing the first end of the bumper 131 to move toward the proximal end along the fourth part groove track 121d. Thus, the fourth part groove track 121d is in the form of an inclined groove, for example Figure 5a an inclined groove that slopes from the upper left to the lower right, facilitating the recycling function.

[0074] For example, the distance from the proximal end of the inclined groove-shaped fourth part groove track 121d to the straight line where the second part groove track 121b is located is less than the distance from the proximal end of the fourth part groove track 121d to the straight line where the second part groove track 121b is located.

[0075] In some examples, the fourth part groove track 121d is configured to allow the first end of the bumper 131 to pass through, so as to allow the guide rod 12 to move smoothly along the axial direction of the guide rod. For example, when the guide rod 12 moves distally along the axial direction of the guide rod (i.e., moves leftward along the axis), at this time, the bumper 131 relatively passes from the distal end of the axis to the proximal end of the axis in the fourth part groove track 121d, thereby realizing the recycling function of the physical limiting device 100.

[0076] As Figure 2 shown, the first part groove track 121a, the second part groove track 121b, the third part groove track 121c, and the fourth part groove track 121 of the limiting groove 121 enclose a trapezoid. Thus, the limiting groove 121 is in the overall shape of a character "互". This is merely exemplary and not a limitation of the present disclosure.

[0077] As Figure 4a and Figure 4b shown, the insurance device 13 further includes an insurance connecting piece 132. The second end of the bumper 131 is fixedly connected to the insurance connecting piece 132, and the insurance connecting piece 132 is also fixedly connected to the second moving part 14, so that the movement of the second moving part 14 can带动 the bumper 131 to rotate around the axis of the physical limiting device 100.

[0078] As Figure 4a and Figure 4b shown, the second moving part 14 includes a second knob 141. For example, the second knob 141 is a manual knob, and the axial direction of the second knob 141 is parallel or coaxial with the axial direction of the guide rod 12.

[0079] In some examples, the second knob 141 is fixedly connected to the safety device 13 by form fit or interference fit. This is merely exemplary and is not a limitation of the present disclosure.

[0080] Now according to Figures 5a-5f The state diagram describes the method of using the physical limiting device of the embodiment of the present disclosure.

[0081] like Figure 5a As shown, the first end of the safety rod 131 is inserted into the right end of the first groove 121a on the outer surface of the guide rod 12. The first moving component 11 is controlled to move to drive the guide rod 12 to move toward the proximal end along the axial direction. At this time, the safety rod 131 gradually moves relatively from the proximal end of the first groove 121a to the distal end of the first groove 121a, as shown in FIG. Figure 5b As shown. In this state, the safety rod 131 reaches the limit position of the first part groove 121a. Due to the blocking effect of the inner wall of the distal end of the first part groove 121a, the safety rod 131 can no longer continue to move forward relatively with the movement of the guide rod 12. That is, the first moving component 11 and the guide rod 12 can no longer continue to move in the axial direction due to the restriction of the safety rod 131 in the first part groove 121a, thereby realizing the physical limiting effect. Therefore, the operator is prompted to the limit critical point by the tactile sense of the first moving component, which effectively feeds back the accurate information of the physical positioning, thereby realizing simple, efficient and precise physical limiting.

[0082] For example, after the limit is achieved, by rotating the second moving part 14 to rotate it around the axial direction of the physical limit device 100, the first end of the safety rod 131 is rotated from the distal end of the first part groove track 121a (i.e., the end of the second part groove track 121b close to the first part groove track 121a) through the second part groove track 121b and into the third part groove track 121c (e.g., to the proximal end or middle position of the third part groove track 121c). This means that the axial relative movement between the safety rod 131 and the guide rod 12 is unlocked, as shown in FIG. Figure 5c In this state, the guide rod 12 can continue to move axially toward the proximal end under the drive of the first moving component 11, and the first end of the safety rod 131 slides relatively axially from the proximal end of the third part groove track 121c toward the distal end of the third part groove track 121c in the third part groove track 121c, as shown in FIG. Figure 5d shown.

[0083] For example, in the return phase (also called the recovery phase) after the safety rod 131 reaches the distal end of the third portion groove 121c, the guide rod 12 also moves in the reverse direction under the drive of the reverse-moving first moving component 11, that is, the guide rod 12 moves axially toward the distal end, and the safety rod 131 slides relatively axially toward the proximal end in the third portion groove 121c. The safety rod 131 first reaches the proximal end of the third portion groove 121c, and then transitions to the distal end in the oblique groove-type fourth portion groove 121d, as shown in FIG. Figure 5e The safety rod 131 continues to slide relatively in the fourth portion of the groove 121d until it moves relatively to the proximal end in the fourth portion of the groove 121d and then transitions to the distal end in the first portion of the groove 121a and slides relatively toward the distal end of the first portion of the groove 121a until it finally reaches the proximal end of the first portion of the groove 121, thereby completing the return process. Figure 5f shown.

[0084] Therefore, the limiting groove 121 in at least one embodiment of the present disclosure adopts a beveled fourth part groove rail 121d, which can drive the second moving part 14 to passively rotate to the initial position (i.e., reset) by operating the first moving part 11 (e.g., the first knob 111) without operating the second moving part 14 (e.g., the second knob 141), making the entire operation process more convenient and efficient.

[0085] It should be noted that the above reference Figures 1 to 5f The physical limiting device of the described embodiment only involves one level of limiting groove 121 , however, the present disclosure is not limited thereto, and the physical limiting device of the present disclosure may also include two levels or more than three levels of limiting grooves 121 .

[0086] For example, the physical limiting device of an embodiment of the present disclosure may include N levels of limiting grooves 121, where N is an integer greater than or equal to 2, and the first part of the groove track 121a of the i-th level limiting groove 121 is connected to the third part of the groove track 121c of the i-1-th level limiting groove 121, wherein the values ​​i of each level from the axial proximal end to the axial distal end are respectively recorded as 1, 2...N.

[0087] Figure 6 A schematic diagram of the cascade of two-stage limiting grooves 121 provided in some embodiments of the present disclosure.

[0088] For example, Figure 6As shown, the first-stage limiting groove in the two-stage limiting groove 121 includes a first-stage groove rail 121a, a second-stage groove rail 121b, a third-stage groove rail 121c and a fourth-stage groove rail 121d. The second-stage limiting groove includes a first-stage groove rail 121a', a second-stage groove rail 121b', a third-stage groove rail 121c' and a fourth-stage groove rail 121d'. The left end of the third-stage groove rail 121c of the first stage is connected to the right end of the first-stage groove rail 121a' of the second stage, or is formed into one body, thereby realizing the cascading of the two-stage limiting groove 121. In the embodiment of the present disclosure, the cascading method and specific structure and construction of the limiting grooves 121 with more than three stages can be referred to. Figure 6 The example is not repeated here.

[0089] In some examples, the overall shape structure of the limit slots at each level can be adjusted as needed. For example, the limit slots are not limited to Figure 2 The trapezoid shown, alternatively, as Figure 6 As shown, the first portion 121a, the second portion 121b, the third portion 121c and the fourth portion 121 of the limiting groove 121 may also form a triangle. This is merely exemplary and not a limitation of the present disclosure.

[0090] For example, in Figure 6 In the example, the structures of each level of the two-level limiting grooves 121 are the same. Of course, the present disclosure is not limited thereto, for example, the structures of the two-level limiting grooves 121 may also be different.

[0091] In some examples, the limiting grooves 121 of some levels of the multi-stage limiting grooves 121 may be trapezoidal, while the limiting grooves 121 of other levels may be triangular. In other examples, the limiting grooves 121 of each level of the multi-stage limiting grooves 121 are trapezoidal. In still other examples, the limiting grooves 121 of each level of the multi-stage limiting grooves 121 are triangular.

[0092] Therefore, at least one embodiment of the present disclosure can achieve limiting at multiple positions or multiple stages through the cascade of multi-stage limiting grooves, and can be achieved with only one safety device 13 (such as a safety rod 131) and a second moving part 14 (such as a second knob 141). It is very simple and efficient, has a wider range of applications, and has higher limiting accuracy.

[0093] At least one embodiment of the present disclosure further provides a delivery system for an artificial prosthesis, which includes the physical limiting device of any of the above embodiments.

[0094] Figure 7 A schematic diagram of the appearance of a delivery system for an artificial prosthesis provided in some embodiments of the present disclosure. Figure 8 A structural diagram of a first pipe assembly and a second pipe assembly provided in some embodiments of the present disclosure, and Figure 9 An internal schematic diagram of a delivery system for an artificial prosthesis according to some embodiments of the present disclosure.

[0095] like Figure 7 As shown, the artificial prosthesis delivery system 200 according to at least one embodiment of the present disclosure includes a first tube assembly 21 , a second tube assembly 22 and a physical limiting device 100 .

[0096] In some examples, the first tube assembly 21 is configured to accommodate an artificial prosthesis. At least a portion of the second tube assembly 22 is sleeved outside at least a portion of the first tube assembly 21. The axial direction of the second tube assembly 22 and the axial direction of the first tube assembly 21 are respectively parallel to or coaxial with the axial direction of the physical stop device 100.

[0097] The physical limiting device 100 includes a first moving part 11, a guide rod 12, a safety device 13 and a second moving part 14. For the specific structure and construction of the physical limiting device 100 of the conveying system 200 and the technical effects thereof, please refer to Figures 1 to 6 For the sake of clarity and brevity in this article, the description will not be repeated here.

[0098] In some examples, at least a portion of the second tube assembly 22 (eg, the sheath 221 described below) is fixedly connected to the first moving component 11 , so that the first moving component 11 drives the second tube assembly 22 to perform axial relative movement relative to the first tube assembly 21 .

[0099] As described above, the safety rod 131 is stationary relative to the current operator (or can be stationary relative to the current environment of the entire conveying system). Therefore, the safety rod 131 is stationary relative to, for example, the first tube assembly 21, that is, the first tube assembly 21 can be stationary relative to the current operator.

[0100] In some examples, the physical stop device 100 of the conveying system 200 further includes a screw 15. The first moving component 11 (e.g., the first knob 111) is internally provided with threads that mate with the screw 15 to achieve a helical fit, so that the first moving component 11 can achieve relative axial motion through threaded transmission during circumferential rotation, thereby driving the guide rod 12 to move axially along the physical stop device 100.

[0101] For example, the guide rod 12 is inserted into the screw rod 15 and can move relative to the screw rod 15. The first moving component 11 (e.g., the first knob 111) is sleeved on the screw rod 15. The axial directions of the first moving component 11 and the screw rod 15 are parallel to or coaxial with the axial direction of the guide rod 12. The first moving component 11 (e.g., the first knob 111) is fixedly connected to an intermediate component (e.g., the sheath fixing seat 28 described below), and the intermediate component (e.g., the sheath fixing seat 28 described below) is fixedly connected to the guide rod 12, so that when the first moving component 11 (e.g., the first knob 111) is rotated, it can achieve relative axial movement through threaded transmission and drive the intermediate component (e.g., the sheath fixing seat 28 described below) to move, thereby driving the guide rod 12 to move along the axial direction of the physical limit device 100.

[0102] In some examples, the delivery system 200 further includes a first housing and a second housing, the first housing including a first half-shell 23 and a second half-shell 24 , and the second housing including a third half-shell 25 and a fourth half-shell 26 .

[0103] For example, Figure 7 As shown, the distal end of the screw 15 is fixedly connected to the first half shell 23 and the second half shell 24. The first half shell 23 and the second half shell 24 are respectively located on both sides of the central axis of the conveying system 200 (i.e. Figure 7 The first half shell 23 (i.e., the upper shell) and the second half shell 24 (i.e., the lower shell) are fixedly connected to form a first shell. Figure 7 As shown, the proximal end of the screw 15 is fixedly connected to the third half shell 25 and the fourth half shell 26. The third half shell 25 and the fourth half shell 26 are respectively located on both sides of the central axis of the conveying system 200 (i.e. Figure 7 The third half shell 25 (ie, the upper shell) and the fourth half shell 26 (ie, the lower shell) are fixedly connected to form a second shell.

[0104] In some embodiments of the present disclosure, the first shell and the second shell are respectively assembled from two half shells, which facilitates the installation of the entire conveying system.

[0105] It should be noted that the present disclosure is not limited thereto. For example, in other examples, the first half-shell 23 and the second half-shell 24 may be located on the left and right sides of the axis of the conveying system 200, and / or the third half-shell 25 and the fourth half-shell 26 may be located on the left and right sides of the axis of the conveying system 200, respectively. Alternatively, in still other examples, the first shell and the second shell are each an integral structure.

[0106] In some examples, the first tube assembly 21 is fixedly connected to the second housing, and both the first tube assembly 21 and the second housing remain stationary (eg, stationary relative to an operator).

[0107] The following will refer to Figure 8 The specific structures of the first pipe assembly 21 and the second pipe assembly 22 will be described in detail.

[0108] like Figure 8 As shown, the first tube assembly 21 includes an artificial prosthesis connector 211 and an inner tube 213. For example, the inner tube 213 is a multi-layer tube 213 to increase strength, but the present disclosure is not limited to this. For ease of description, all inner tubes 213 mentioned below are multi-layer tubes 213.

[0109] In some examples, the artificial prosthesis connector 211 is disposed on the outer surface of at least a portion of the multilayer tube 213 and is fixedly connected to the multilayer tube 213, for example, by glue. For example, the artificial prosthesis connector 211 is disposed on the outer surface of the distal end of the multilayer tube 213 and is fixedly connected to the multilayer tube 213.

[0110] According to at least one embodiment of the present disclosure, the outer surface of the prosthesis connector 211 is provided with a slot that matches the prosthesis, allowing the prosthesis to be inserted and placed, and to be detachably connected to the prosthesis. For example, in some examples, the slot on the outer surface of the prosthesis connector 211 is a T-shaped groove, and the proximal end of the prosthesis is machined with a T-shaped rod of the same shape. Of course, this is merely exemplary and does not limit the embodiments of the present disclosure; as long as the shape of the slot on the prosthesis connector 211 matches the shape of the prosthesis, any other shape will suffice.

[0111] In some examples, the artificial prosthesis includes but is not limited to an artificial heart valve, which is not limited or exhaustive in the embodiments of the present disclosure. For example, in other examples, the artificial prosthesis is a stent graft or artificial vascular prosthesis used to treat vascular lesions such as aneurysms.

[0112] In some examples, the first tube assembly 21 further includes an end base 212, which is connected to the distal end of the multi-layer tube 213. For example, the end base 212 is a conical head, which is located at the distal end of the delivery system and is detachably connected to the distal end of the multi-layer tube 213. Figure 9 As shown, the end base 212 is fixedly connected to the distal end of the multi-layer tube 213 by screw threads. This is merely exemplary and is not intended to be limiting of the present disclosure.

[0113] In some examples, the multilayer tube 213 includes multiple third tube segments, each having different hardnesses, connected in sequence along the axial direction of the first tube assembly 21. For example, the multilayer tube 213 may be composed of multiple layers and segments of a polymer material having different hardnesses, thereby comprising multiple axially connected straight segments of varying hardnesses. This ensures that the straight segments required for strength are sufficiently strong, while the straight segments required for bending are sufficiently flexible. Consequently, a delivery system including such a multilayer tube 213 can be used to deliver a prosthetic heart valve into the aortic arch (e.g., in a U-shaped configuration).

[0114] In some examples, the second tube assembly 22 includes a sheath tube 221 and a stabilizing tube 222 , wherein the distal end of the stabilizing tube 222 is sleeved outside at least a portion of the sheath tube 221 .

[0115] For example, Figure 8 As shown, the sheath tube 221 is a reducer structure, which includes a first sheath tube portion 221a and a second sheath tube portion 221b arranged in sequence from the distal end to the proximal end, that is, the first sheath tube portion 221a is closer to the distal end than the second sheath tube portion 221b. The diameter of the first sheath tube portion 221a is larger than the diameter of the second sheath tube portion 221b.

[0116] For example, the stabilizing tube 222 is sheathed around at least a portion of the second sheath portion 221b, i.e., the diameter of the stabilizing tube 222 is larger than the diameter of the second sheath portion 221b. Regarding the relationship between the diameters of the first sheath portion 221a and the stabilizing tube 222, for example, the diameter of the stabilizing tube 222 is smaller than the diameter of the first sheath portion 221a. This ensures that the delivery system is fully deployed stably and accurately when the sheath 221 moves to a position where the first sheath portion 221a is engaged by the distal end of the stabilizing tube 222.

[0117] In some examples, along the radial direction, the stabilizing tube 222, the second sheath tube portion 221b and the multilayer tube 213 are arranged sequentially from the outside to the inside, as shown in FIG. Figure 8 shown.

[0118] In some examples, the sheath 221 comprises multiple fourth tube segments, connected sequentially along the axial direction and having varying degrees of hardness. For example, different straight segments of the sheath 221 utilize different tubing weaving methods to achieve varying degrees of hardness. This ensures that straight segments requiring strength have sufficient strength while segments requiring flexibility have sufficient flexibility. Thus, a delivery system including such a sheath 221 can access the aortic arch (e.g., in a U-shaped configuration) to deliver a prosthetic heart valve.

[0119] For example, during loading, the T-shaped rod of the prosthesis is inserted into the T-shaped groove on the prosthesis connector 211. Then, when the sheath 221 of the second tube assembly 22 is closed (i.e., when the sheath 221 moves leftward), the prosthesis is loaded into the cavity formed by the sheath 221 and the first tube assembly 21. This is merely exemplary and not intended to be limiting of the present disclosure.

[0120] The above-mentioned embodiment of the present disclosure realizes loading of artificial prostheses by providing artificial prosthesis connectors with slots, can adapt to various types of artificial prostheses, and can also ensure smooth release of artificial prostheses. It has a simple structure, convenient operation, and wide application.

[0121] The following will refer to Figure 9 Describe the detailed structure of the delivery system 200. Figure 9 As shown, the first moving component 11 can be, for example, a manual first knob 111. The axial direction of the first knob 111 is parallel to or coaxial with the axial direction of the guide rod 12. For example, the guide rod 12 remains coaxial with the axis of the entire conveying system 200.

[0122] like Figure 9 As shown, delivery system 200 further includes a stabilizing tube mount 27 disposed substantially within the first housing. Stabilizing tube mount 27 is disposed within the first housing, and stabilizing tube 222 extends from its distal end to stabilizing tube mount 27, with the proximal end of stabilizing tube 222 fixedly connected to stabilizing tube mount 27. Stabilizing tube mount 27 is fixedly connected to first and second half-housings 23, 24, respectively, forming the first housing. Thus, stabilizing tube 222 and stabilizing tube mount 27 are fixed relative to the first housing.

[0123] In some examples, the stabilizing tube holder 27 is fixedly connected to the stabilizing tube 222 using glue, and the stabilizing tube holder 27 is fixedly connected to the first and second housing halves 23, 24, respectively, through a form-fitting connection. For example, the stabilizing tube holder 27 may be cylindrical, and the first housing halves 23 (and / or the second housing halves 24) may have two ribs machined into their interiors, each with a semicircular opening for securing the stabilizing tube holder 27 to achieve a form-fitting connection. This is merely exemplary and not intended to be a limitation of the present disclosure.

[0124] In some examples, the delivery system 200 further includes a sheath mount 28. The sheath 221 extends from the distal end to the sheath mount 28, and the proximal end of the second sheath portion 221b of the sheath 221 is fixedly coupled to the sheath mount 28. In some examples, the sheath mount 28 is fixedly coupled to the first knob 111.

[0125] For example, the sheath holder 28 is fixedly connected to the sheath 221 by glue. For example, the sheath holder 28 is fixedly connected to the first knob 111 by form fit. For example, the guide rod 12 is fixedly connected to the sheath holder 28 by threads and glue. This is merely exemplary and does not limit the present disclosure.

[0126] like Figure 8 As shown, the conveying system 200 further includes an inner tube holder 29. For example, if the inner tube 213 is a multi-layer tube 213, the inner tube holder 29 may also be referred to as a multi-layer tube holder 29. All inner tube holders 29 mentioned below are described as multi-layer tube holders 29.

[0127] For example, the multi-layer tube 213 extends from the distal end toward the proximal end until it extends to the multi-layer tube fixing seat 29, and the multi-layer tube fixing seat 29 is fixedly connected to the multi-layer tube 213. The multi-layer tube fixing seat 29 is arranged inside the second shell and the multi-layer tube fixing seat 29 is fixedly connected to the third half shell 25 and the fourth half shell 26 respectively. Thus, the first tube assembly 21 is fixedly connected to the third half shell 25 and the fourth half shell 26 respectively through the connecting piece (such as the multi-layer tube fixing seat 29).

[0128] In some examples, the multi-layered tube holder 29 is fixedly connected to the multi-layered tube 213 using glue, and the multi-layered tube holder 29 is fixedly connected to the third and fourth housing halves 25, 26, respectively, through a form-fitting connection. For example, the third and fourth housing halves 25, 26 are stationary relative to the multi-layered tube holder 29 and the multi-layered tube 213. In some examples, the second housing formed by the fixed connection of the third and fourth housing halves 25, 26 is cylindrical, and the second knob 141 is sleeved on the outer surface of the cylinder, such that the second knob 141 cannot move axially relative to the second housing but can rotate about the axial direction.

[0129] The above embodiment of the present disclosure utilizes the multi-layer tube fixing seat 29 to ensure that the first tube assembly remains stationary, so that the second tube assembly 22 can move axially relative to the first tube assembly 21, thereby ensuring smooth transportation and recovery of the artificial prosthesis.

[0130] In some examples, the first tube assembly 21 further includes an inner tube evacuation member 214. The inner tube evacuation member 214 is fixedly connected to the proximal end of the multilayer tube 213. Because the operator needs to evacuate the air from the first tube assembly 21 before operation and inject saline solution into the delivery system 200 using a syringe, the inner tube evacuation member 214 provides the operator with an interface that can be matched with the syringe, facilitating the evacuation operation. In some examples, the inner tube evacuation member 214 is fixedly connected to the multilayer tube 213 using glue. Of course, this is merely exemplary, and the embodiments of the present disclosure do not limit the method of fixed connection between these components.

[0131] In some examples, the guide rod 12 is disposed inside the screw 15 and is fixedly connected to the sheath fixing seat 28 , so that the sheath fixing seat 28 can be driven to move by rotating the first knob 111 , thereby driving the sheath 221 and the guide rod 12 to move axially.

[0132] Thus, when the sheath tube 221 of the second tube assembly 22 moves axially toward the proximal end following the rotation of the first knob 111, since the stabilizing tube 222 is stationary (for example, relative to the operator) and the diameter of the stabilizing tube 222 is smaller than the diameter of a portion of the first sheath tube portion 221a, when the sheath tube 221 moves to a position where the first sheath tube portion 221a is caught by the distal end of the stabilizing tube 222, it can be recorded that the sheath tube 221 has moved to the rightmost end. At this time, the guide rod 12 is also located at the rightmost end (for example, Figure 5d The middle safety lever 131 is located at the leftmost end of the third portion of the groove track 121c, which is the position of the guide rod 12). This state is the state in which the conveying system is fully opened.

[0133] When the first knob 111 is rotated, the characteristics of the threaded transmission enable the first knob 111 to move axially along the delivery system 200. Furthermore, since the first knob 111 is fixedly connected to the sheath holder 28, the sheath 221 of the second tube assembly 22, and the guide rod 12, the axial movement of the first knob 111 drives the sheath holder 28 to move axially, thereby also driving the axial movement of the sheath 221. Since the first tube assembly 21 is fixedly connected to the third and fourth housing halves 25 and 26, respectively, and remains stationary relative to the operator, the sheath 221 of the second tube assembly 22 can move axially relative to the first tube assembly 21, thereby enabling the delivery and release of an artificial prosthesis (e.g., a heart valve).

[0134] Figures 10a-10c A schematic diagram of an operating method of a delivery system for an artificial prosthesis provided in some embodiments of the present disclosure.

[0135] First, if Figure 10a As shown, when the first end of the safety rod 131 is inserted into the first part groove 121a, at least part of the artificial prosthesis (such as the heart valve 3) (such as the entire artificial prosthesis or a part of the artificial prosthesis) is placed in the first cavity A01 between the sheath 221 of the second tube assembly 22 and the first tube assembly 21, and the first cavity A01 is gradually opened or closed when the sheath 221 of the second tube assembly 22 undergoes axial relative movement relative to the first tube assembly 21 to release the artificial prosthesis or recycle the artificial prosthesis.

[0136] Secondly, if Figure 10bAs shown, when the first end of the safety rod 131 reaches the end of the first groove 121a close to the second groove 121b (i.e., the distal end of the first groove 121a), the artificial prosthesis is placed in the second cavity A02 between the sheath 221 of the second tube assembly 22 and the first tube assembly 21. Figure 10b As shown, when the first end of the safety rod 131 is limited to the distal end within the first portion of the groove 121a, a portion of the prosthesis (e.g., 25% of the prosthesis) is placed in the second cavity A02 between the sheath 221 of the second tube assembly 22 and the first tube assembly 21. At this time, the remaining portion of the prosthesis (e.g., 75% of the prosthesis) is released to the outside of the delivery system. The space in the second cavity A02 is smaller than the space in the first cavity A01. Of course, the embodiments of the present disclosure do not limit the proportion of the released portion of the prosthesis when the limit position is reached. As long as a portion of the prosthesis (i.e., 0% to 100% of the prosthesis, excluding 0% and 100%) is within the cavity, the relevant percentage of the prosthesis can be determined according to different prosthesis conditions, and will not be exhaustively listed or elaborated here.

[0137] From this we can see that in Figure Figure 10a and Figure 10b In the example, the cavity formed between the sheath tube 221 of the second tube assembly 22 and the first tube assembly 21 is opening, and the artificial prosthesis is gradually released.

[0138] For example, when the conveying device 200 reaches Figure 10b In the state shown, the guide rod 12 is limited by the safety rod 131 of the safety device 13 and can no longer move axially. At this time, the operator can pause and determine whether the artificial prosthesis meets the target requirements without causing the artificial prosthesis to be completely released directly due to misoperation. The operator's hand can temporarily leave the delivery device 200 to perform other surgical operations such as angiography.

[0139] The delivery system for delivering artificial prostheses in the above-mentioned embodiment of the present disclosure has a physical limiting device, which can effectively provide the operator with accurate information on the release status of the artificial prosthesis (for example, whether the release length, release shape, etc. meet the target requirements), and realize simple, efficient and precise physical limiting by tactilely prompting the operator of the limiting critical point (for example, by tactilely prompting the operator of the recoverable position critical point).

[0140] In some examples, when the artificial prosthesis is partially released, that is, the guide rod 12 is limited by the safety rod 131 of the safety device 13, if the operator determines that the artificial prosthesis meets the target requirements, the safety rod 131 is rotated axially by the second moving part 14 from the distal end of the first part groove 121a through the second part groove 121b to the third part groove 121c. At this time, the guide rod 12 can continue to move axially toward the proximal end under the drive of the first knob 111, and the safety rod 13 continues to slide relatively axially toward the distal end of the third part groove 121c in the third part groove 121c until it reaches the farthest end in the third part groove 121c. Furthermore, driven by the first moving part 11, the sheath 221 of the second tube assembly 22 moves axially relative to the first tube assembly 21, and the second cavity A02 between the sheath 221 of the second tube assembly 22 and the first tube assembly 21 continues to open (i.e., the space of the second cavity A02 becomes smaller and smaller), and more of the artificial prosthesis is released until the entire artificial prosthesis is completely released. That is, the artificial prosthesis is now detached from the sheath 221, thereby completing the release and implantation of the artificial prosthesis. Figure 10c shown.

[0141] In some examples, when the safety rod 13 slides relative to the guide rod 12 and reaches the farthest end of the third portion of the groove 121c, the artificial prosthesis is fully released, which also means that the delivery system is now fully opened.

[0142] It should be noted that if the safety rod 13 slides relative to the guide rod 12 and has not reached the farthest end of the third part groove rail 121c (for example, close to the farthest end or in the middle position within the third part groove rail 121c), the artificial prosthesis has been completely released, which is also within the scope of the embodiments of the present disclosure and is not limited to this.

[0143] In some examples, after the safety rod 131 reaches the distal end within the third portion of the groove 121c and completes the complete release of the artificial prosthesis, the first knob 111 is controlled to rotate in the opposite direction (i.e., the first knob 111 also moves axially toward the distal end), driving the sheath 221 of the second tube assembly 22 to perform axial relative movement relative to the first tube assembly 21, and driving the guide rod 12 to move axially toward the distal end, so that the safety rod 131 moves relatively, and returns from the third portion of the groove 121c to the fourth portion of the groove 121d of the limit groove to the first portion of the groove 121a, and finally reaches the proximal end of the first portion of the groove 121a to achieve complete closure of the conveying system.

[0144] In some examples, when the prosthesis is partially released, i.e., when the guide rod 12 is limited by the safety lever 131 of the safety device 13, if the operator determines that the prosthesis does not meet the target requirements, the operator can reversely rotate the first knob 111 to drive the sheath tube 221 of the second tube assembly 22 toward the distal end to close the cavity, thereby retrieving the prosthesis. At this point, the operator can move or adjust the position, direction, etc. of the entire prosthesis delivery system, or perform other surgical procedures such as angiography, and repeat the prosthesis release and retraction operations until the target requirements are met and the prosthesis is fully released.

[0145] Thus, the delivery system of at least one embodiment of the present disclosure can achieve both the release and implantation of an artificial prosthesis and its recovery in an incompletely released state, providing the operator with greater margin for error and thus reducing the difficulty of operation for the operator. The delivery system of at least one embodiment of the present disclosure can recover an artificial prosthesis when its release position or shape is not good and can perform positioning and release operations again, and can continue to release the artificial prosthesis when its release position or shape is better, further improving the release accuracy, enhancing the implantation effect of the artificial prosthesis, and also improving the safety of recovery.

[0146] It can be seen from this that the method for delivering an artificial prosthesis according to at least one embodiment of the present disclosure can achieve functions such as prosthesis delivery, prosthesis recovery, prosthesis release, and delivery system closure.

[0147] It should be noted that in the embodiments of the present disclosure, the delivery method (i.e., the method for operating the delivery system for an artificial prosthesis) may include more or fewer steps, and the order of the steps is not limited and can be determined based on actual needs. The delivery method is implemented based on the delivery device of any of the above-mentioned embodiments. The delivery device scheme involved in the delivery method can be referred to the above-mentioned relevant embodiments and will not be elaborated here.

[0148] The following method for delivering an artificial prosthesis is mainly explained by taking the example of delivering an artificial heart valve prosthesis and the guide rod of the delivery system having a first-level limit groove, but the delivery method disclosed in the present invention is not limited to this. The present disclosure does not limit this and will not be exhaustively listed or elaborated here.

[0149] In some examples, when the operator rotates the first knob 111 to move the sheath tube 221 of the second tube assembly 22 axially toward the proximal end, the heart valve delivery and release functions can be achieved. When the operator rotates the first knob 111 in the opposite direction to move the sheath tube 221 of the second tube assembly 22 axially toward the distal end, the heart valve recovery and post-delivery system closure functions can be achieved.

[0150] In some examples, a method of delivering a prosthetic heart valve prosthesis includes one or more of the following procedures.

[0151] For example, when the operator rotates the first knob 111, due to the characteristics of the threaded transmission, the first knob 111 can be rotated axially along the guide rod 12, driving the sheath fixing seat 28 to move axially, thereby also driving the sheath 221 to move axially, and the sheath 221 of the second tube assembly 22 and the first tube assembly 21 will undergo axial relative movement.

[0152] For example, when the sheath tube 221 of the second tube assembly 22 moves toward the proximal end, the cavity formed by the sheath tube 221 and the first tube assembly 21 gradually opens, and the heart valve 3 inside the cavity is gradually released. At the same time, the first knob 111 also drives the guide rod 12 to move toward the proximal end, and the safety rod 131 in the first groove 121a of the guide rod 12 slides relative to the guide rod 12. As the guide rod 12 moves, the safety rod 131 moves from the proximal end ( Figure 5a The heart valve 3 in the initial state shown is completely located in the cavity formed by the sheath tube 221 and the first tube assembly 21) and reaches the distal end in the first portion of the groove 121a (as shown in FIG. Figure 5b As shown, due to the blocking effect of the inner wall of the first groove 121a, when the first knob 111 is continued to be manipulated, the guide rod 12 is limited by the safety lever 131 within the first groove 121a and cannot move further proximally. Furthermore, the sheath 221, which is fixedly connected to the guide rod 12, cannot move further proximally, and the heart valve 3 cannot be further released. At this time, the operator is reminded through tactile sensation that this position is the limit of the retractable position of the heart valve 3. For example, the heart valve 3 is now 75% released, with 25% still within the cavity formed by the sheath 221 and the first tube assembly 21.

[0153] For example, when the operator determines that the heart valve 3 meets the target requirements (for example, the release shape and position of the heart valve 3 are better or normal), the second knob 141 is turned to make the safety rod 131 move from the distal end of the first part groove 121a through the second part groove 121b to the third part groove 121c. The operator can continue to turn the first knob 111. At this time, the guide rod 12 can continue to move proximally under the drive of the moving first knob 111. The safety rod 13 slides relatively in the third part groove 121c until it reaches the distal end of the third part groove 121c. Moreover, under the drive of the first knob 111, the cavity between the sheath 221 of the second tube assembly 22 and the first tube assembly 21 continues to open, and the heart valve 3 continues to be released until the entire heart valve 3 is completely released, completing the release and implantation of the heart valve 3. Figure 10c shown.

[0154] For example, when it is determined that the heart valve 3 does not meet the target requirements (for example, the release shape and position of the heart valve 3 are poor or abnormal), the first knob 111 is rotated in the opposite direction (that is, the first knob 111 also moves axially toward the distal end), driving the sheath 221 of the second tube assembly 22 to move distally to close the cavity, thereby realizing the recovery of the heart valve 3.

[0155] For example, when the sheath tube 221 moves to the most proximal end (i.e., the rightmost end), the guide rod 12 also moves to the most proximal end, i.e., the safety rod 131 reaches the most distal end within the third portion of the groove 121c, and the delivery system is fully opened, as shown in FIG. Figure 10c In this state, if the delivery system needs to be closed, the operator rotates the first knob 111 to drive the sheath 221 and the guide rod 12 to move axially toward the distal end. When the sheath 221 and the guide rod 12 move to the intermediate position, the safety bar 131 transitions from the third groove 121c to the oblique groove of the fourth groove 121d, and then into the first groove 121a until it reaches the proximal end of the first groove 121a, thereby driving the second knob 141 to passively rotate to the initial position (i.e., reset). At this time, the sheath 221 moves to the distal end (i.e., the leftmost end), and the delivery system is completely closed and can be withdrawn outside the body.

[0156] The delivery method of at least one embodiment of the present disclosure sets a physical limit structure at a critical position during the release process, and can use tactile sensation and forced termination operation to achieve the accuracy of the operator's release to the critical position and stop action, without the need to constantly observe the release length of the valve. The delivery method of at least one embodiment of the present disclosure can also allow the operator to reset the delivery system without additional operation of the second moving part when the delivery system is closed. In addition, the reset along the inclined groove during the recovery process of the delivery system facilitates the operator to easily achieve the closure of the delivery system after the valve prosthesis is completely released without the need for additional operation, making the entire surgical process safer and more efficient.

[0157] It should be noted that, in the embodiments of the present disclosure, other relevant processes and technical effects of the conveying method can be referred to the above description of the conveying device and will not be repeated here.

[0158] There are a few points to note:

[0159] (1) The drawings of the embodiments of the present disclosure only relate to the structures involved in the embodiments of the present disclosure. Other structures may refer to conventional designs.

[0160] (2) In the absence of conflict, the embodiments of the present disclosure and the features therein may be combined with each other to form new embodiments.

[0161] The above description is only a specific embodiment of the present disclosure, but the protection scope of the present disclosure is not limited thereto. The protection scope of the present disclosure shall be based on the protection scope of the claims.

Claims

1. A physical limit device, comprising: a first moving part; a guide rod configured to be driven by the first moving component to move axially along the guide rod, wherein at least one level of limiting groove is formed on the outer surface of the guide rod, and the at least one level of limiting groove extends entirely along the axial direction of the guide rod, and each level of the limiting groove includes a first portion of the groove rail, a second portion of the groove rail, and a third portion of the groove rail that are connected in sequence, and the second portion of the groove rail is arranged at an angle to the first portion of the groove rail and the third portion of the groove rail; A safety rod, comprising a first end and a second end opposite to each other along the length direction of the rod, wherein the first end is inserted into the limiting groove, and the safety rod is configured to move relative to the guide rod along the limiting groove; a second moving component connected to the second end of the safety rod, and the second moving component is configured to drive the safety rod to rotate around the axial direction of the guide rod by rotating, so that the first end of the safety rod moves along the second portion of the groove track; The limiting groove also includes a fourth portion of the groove rail, which is configured to allow the first end of the safety rod to pass through, the distal end of the fourth portion of the groove rail is connected to the proximal end of the third portion of the groove rail, the proximal end of the fourth portion of the groove rail is connected to at least a portion of the first portion of the groove rail, and the fourth portion of the groove rail is not parallel to the second portion of the groove rail.

2. The device according to claim 1, wherein The first and third partial groove rails are configured to extend axially along the guide rod, and the second partial groove rail is configured to extend circumferentially along the guide rod. In the axial direction of the guide rod, the second partial groove rail is located between the first and third partial groove rails.

3. The device according to claim 1 or 2, wherein: The first partial groove rail, the second partial groove rail, the third partial groove rail and the fourth partial groove rail form a trapezoid or a triangle.

4. The device according to claim 1 or 2, wherein: The at least one level limit groove is an N-level limit groove, where N is an integer greater than or equal to 2, and the first part of the groove track of the i-th level limit groove is connected to the third part of the groove track of the i-1-th level limit groove, wherein, from the proximal end to the distal end, the value i of each level is sequentially recorded as 1, 2...N.

5. A delivery system for an artificial prosthesis, comprising the physical limiting device according to any one of claims 1 to 4, the delivery system further comprising: a first tube assembly configured to place the artificial prosthesis; a second tube assembly, comprising a sheath tube, wherein the sheath tube is sleeved on the outside of at least a portion of the first tube assembly, and the axial directions of the sheath tube and the first tube assembly are respectively parallel to or coaxial with the axial direction of the guide rod; The sheath tube is fixedly connected to the first moving component, so that the first moving component drives the sheath tube to perform axial relative movement relative to the first tube assembly.

6. The delivery system according to claim 5, wherein: The safety bar is stationary relative to the first tube assembly.

7. The conveying system of claim 5, further comprising a screw, wherein The first moving component includes a first knob, which is sleeved on the screw, and the axial directions of the first knob and the screw are parallel or coaxial with the axial direction of the guide rod. The interior of the first knob is provided with a thread matching the screw to achieve spiral fit, so that the first knob can achieve axial relative movement along the first tube assembly through thread transmission when it rotates circumferentially.

8. The delivery system of claim 7, further comprising a first half-shell, a second half-shell, a third half-shell, and a fourth half-shell, wherein The distal end of the screw is fixedly connected to the first half shell and the second half shell respectively, and the proximal end of the screw is fixedly connected to the third half shell and the fourth half shell respectively, wherein the first half shell and the second half shell are respectively located on both sides of the central axis of the conveying system and the first half shell and the second half shell are fixedly connected to form a first shell, and the third half shell and the fourth half shell are respectively located on both sides of the central axis of the conveying system and the third half shell and the fourth half shell are fixedly connected to form a second shell.

9. The delivery system of claim 8, wherein: The second tube assembly further includes a stabilizing tube, the distal end of which is sleeved on the outside of at least a portion of the sheath tube.

10. The delivery system of claim 9, wherein: The sheath is a reducer, which includes a first sheath portion and a second sheath portion arranged in sequence from the distal end to the proximal end. The diameter of the first sheath portion is larger than the diameter of the second sheath portion. The distal end of the stabilizing tube is sleeved on the outside of the second sheath portion, and the diameter of the stabilizing tube is smaller than the diameter of at least part of the first sheath portion.

11. The delivery system of claim 10, further comprising a stabilizing tube holder and a sheath tube holder, wherein: The stabilizing tube is configured to extend from a distal end to the stabilizing tube fixing seat, and a proximal end of the stabilizing tube is fixedly connected to the stabilizing tube fixing seat. The stabilizing tube fixing seat is disposed inside the first shell, and the stabilizing tube fixing seat is fixedly connected to the first half shell and the second half shell respectively. The sheath tube extends from a distal end to the sheath tube fixing seat, and a proximal end of the second sheath tube portion is fixedly connected to the sheath tube fixing seat, and the sheath tube fixing seat is fixedly connected to the first knob; The guide rod is inserted into the screw rod and is fixedly connected to the sheath tube fixing seat, so that the sheath tube fixing seat can be driven to move by rotating the first knob, and the sheath tube and the guide rod can be driven to move relative to each other along the axial direction of the first tube assembly.

12. The delivery system of claim 10, wherein: The first tube assembly includes an inner tube and an artificial prosthesis connector, The artificial prosthesis connector is arranged on the outer side of the distal end of the inner tube and is fixedly connected to the inner tube; The artificial prosthesis connector is provided with a slot matching the artificial prosthesis for the artificial prosthesis to be embedded and placed, and is detachably connected to the artificial prosthesis.

13. The delivery system of claim 12, further comprising an inner tube fixing seat, wherein The inner tube is configured to extend from the distal end toward the proximal end to the inner tube fixing seat, and the inner tube is fixedly connected to the inner tube fixing seat. The inner tube fixing seat is arranged inside the second shell, and the inner tube fixing seat is fixedly connected to the third half shell and the fourth half shell respectively.

14. The delivery system of claim 12, wherein: The inner tube includes a plurality of third tube sections connected in sequence along the axial direction of the first tube assembly and having different hardnesses, and the sheath tube includes a plurality of fourth tube sections connected in sequence along the axial direction of the first tube assembly and having different hardnesses.

15. The delivery system of claim 12, wherein: The first tube assembly further includes an inner tube emptying piece and an end base. The inner tube emptying piece is connected to the proximal end of the inner tube, and the end base is connected to the distal end of the inner tube.

16. The delivery system of claim 8, further comprising a safety connector, wherein: The second moving component is a second knob, and the axial direction of the second knob is parallel to or coaxial with the axial direction of the guide rod. The safety connector is fixedly connected to the second end of the safety rod and the second knob respectively, so that the safety rod can be driven to rotate around the axial direction of the guide rod by rotating the second knob.

17. The delivery system of claim 16, wherein: The second housing is a cylinder and the second knob is nested on the outer surface of the cylinder, so that the second knob cannot move along the axial direction of the guide rod but can rotate around the axial direction of the guide rod.

18. The delivery system according to any one of claims 5 to 17, wherein: The artificial prosthesis includes an artificial heart valve, a covered stent or an artificial blood vessel.

Images