Delivery system and physical location restriction device

Abstract

A delivery system (200) and a physical position limiting device (100), the device (100) includes a first moving member (11), a guide rod (12), a safety rod (131) and a second moving member (14), the guide rod (12) moves along its axial direction, at least one stage of position limiting grooves (121) are formed on the outer surface of the guide rod (12), each stage of position limiting grooves (121) includes a first partial track groove, a second partial track groove and a third partial track groove (121a, 121b, 121c) which are connected in sequence, the second partial track groove (121b) is connected to the first partial track groove (121a) and the third partial track groove (121b), respectively. The safety rod (131) is disposed at an angle to the first partial track groove (121c), a first end of the safety rod (131) is inserted into the first partial track groove (121a) and the safety rod (131) is disposed to be movable relative to the guide rod (12) along the position limiting groove (121), and a second moving member (14) is connected to the second end of the safety rod (131), and the second moving member (14) is disposed to rotate the safety rod (131) around the axial direction of the guide rod (12) by rotating, and move the first end of the safety rod (131) along the second partial track groove (121b). The device (100) can present the position limiting critical point to the operator through tactile sensation, effectively feedback accurate information of physical positioning, and realize simple, efficient, and accurate physical position limiting.

Description

[Technical field]

[0001] For all purposes, this application claims priority to Chinese Patent Application No. 202111121584.4, filed on September 24, 2021, and the entire contents disclosed in the above Chinese patent application are hereby incorporated by reference as part of this application.

[0002] The present disclosure relates to a delivery system and a physical position limiting device. [Background technology]

[0003] Position restriction generally refers to the restriction of the position of an object, for example, it specifies that the object is only in a certain area, or it specifies that the object must not be in a certain area. Position restriction generally allows a position restriction device to accurately specify whether an object has reached a set state, thereby notifying the operator or realizing automatic state update, etc. For example, when a transported object advances and moves to a certain position, it is necessary to notify the operator. In such a situation of position restriction notification, currently, it is usually required to realize the position restriction notification by a sensor, by using an acoustic optical method, etc., or to visually and continuously observe the entire operation process in order to ensure the accuracy of operation and the realization of the set state. At present, the industry lacks an effective and accurate physical position restriction device, and especially in the delivery system in the medical device field (e.g., in the prosthesis delivery field), the operator of the medical device needs to simultaneously observe the state of different positions of the patient and multiple devices, so it is difficult to achieve the continuous visual attention and the synchronization of the visual effect and the operation of the hand for any device throughout the entire operation process, and therefore, at present, there is a strong demand for a physical position restriction device that is accurate, effective, and easy to operate. Summary of the Invention [Means for solving the problem]

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

[0005] At least one embodiment of the present disclosure provides a physical position limiting device, including: a first moving member; a guide rod arranged to be driven by the first moving member to move along an axial direction of the guide rod, the guide rod having at least one stage of position limiting grooves formed on an outer surface thereof, the at least one stage of position limiting grooves generally extending along the axial direction of the guide rod, the position limiting grooves of each stage including a first partial track groove, a second partial track groove and a third partial track groove which are connected in sequence, the second partial track grooves being arranged at angles to the first partial track groove and the third partial track groove, respectively; a safety rod including first and second ends opposite to each other along a longitudinal direction of the rod, the first end of the safety rod being inserted into the position limiting groove, and the safety rod being arranged to be movable relative to the guide rod along the position limiting groove; and a second moving member connected to the second end of the safety rod, the second moving member being arranged to drive the second moving member to rotate around the safety rod around the axial direction of the guide rod by rotation, and to move the first end of the safety rod along the second partial track groove.

[0006] For example, in a physical position limitation device according to at least one embodiment of the present disclosure, the first partial track groove and the third partial track groove are arranged to extend along the axial direction of the guide rod, the second partial track groove is arranged to extend along the circumferential direction of the guide rod, and in the axial direction of the guide rod, the second partial track groove is located between the first partial track groove and the third partial track groove.

[0007] For example, in a physical position limiting device according to at least one embodiment of the present disclosure, the position limiting groove further includes a fourth partial track groove, and the fourth partial track groove is disposed so that the first end of the safety rod can pass through the fourth partial track groove. A distal end of the fourth partial track groove communicates with a proximal end of the third partial track groove, and a proximal end of the fourth partial track groove communicates with at least a portion of the first partial track groove, and the fourth partial track groove and the second partial track groove are not parallel to each other.

[0008] For example, in the physical position limiting device according to at least one embodiment of the present disclosure, the first partial track groove, the second partial track groove, the third partial track groove and the fourth partial track groove define a trapezoid or a triangle.

[0009] For example, in a physical position limiting device according to at least one embodiment of the present disclosure, the at least one stage of position limiting grooves is an N-stage position limiting groove, where N is an integer equal to or greater than 2. The first partial track groove of the i-th stage of position limiting grooves communicates with the third partial track groove of the (i-1)th stage of position limiting grooves, and the numerical value i of each stage is expressed 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 a prosthesis, including the physical position limiting device of any of the above embodiments, the delivery system including a first tube assembly arranged to place the prosthesis, and a two-tube assembly including a sheath, the sheath being fitted around at least a portion of the first tube assembly, and the axial directions of the sheath and the first tube assembly being parallel or coaxial with the axial direction of the guide rod, respectively. The sheath is fixedly connected to a first moving member, such that the first moving member can drive the sheath to move axially relative to the first tube assembly.

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

[0012] For example, the delivery system according to at least one embodiment of the present disclosure further includes a screw, the first moving member includes a first knob, the first knob is fitted to the screw, and the axial directions of the first knob and the screw are both parallel or coaxial with the axial direction of the guide rod, and the first knob is provided with a thread that matches the screw to achieve screw engagement, so that the first knob achieves relative movement along the axial direction of the first tube assembly through screw transmission when rotating in a circumferential direction.

[0013] For example, the delivery system according to at least one embodiment of the present disclosure further includes a first housing half, a second housing half, a third housing half, and a fourth housing half. A distal end of the screw is fixedly connected to the first housing half and the second housing half, respectively, and a proximal end of the screw is fixedly connected to the third housing half and the fourth housing half, respectively. The first housing half and the second housing half are located on opposite sides of a central axis of the delivery system, respectively, and the first housing half and the second housing half are fixedly connected to form a first housing, and the third housing half and the fourth housing half are located on opposite sides of a central axis of the delivery system, respectively, and the third housing half and the fourth housing half are fixedly connected to form a second housing.

[0014] For example, in a delivery system according to at least one embodiment of the present disclosure, the second tube assembly further includes a stabilizing tube, a distal end of the stabilizing tube being fitted over at least a portion of the sheath.

[0015] For example, in a delivery system according to at least one embodiment of the present disclosure, the sheath is a reducer, the reducer includes a first sheath portion and a second sheath portion arranged in sequence from a distal end to a 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 fitted outside the second sheath portion, and the diameter of the stabilizing tube is smaller than the diameter of at least a portion of the first sheath portion.

[0016] For example, the delivery system according to at least one embodiment of the present disclosure further includes a stabilizing tube fixing base and a sheath fixing base. The stabilizing tube extends from a distal end to the stabilizing tube fixing base and is disposed such that a proximal end of the stabilizing tube is fixedly connected to the stabilizing tube fixing base, the stabilizing tube fixing base is disposed inside the first housing, and the stabilizing tube fixing base is fixedly connected to the first housing half and the second housing half, respectively. The sheath extends from a distal end to the sheath fixing base and a proximal end of the second sheath portion is fixedly connected to the sheath fixing base, and the sheath fixing base is fixedly connected to the first knob. The guide rod is inserted into the screw, and the guide rod is fixedly connected to the sheath fixing base, so that the sheath fixing base can be driven to move by rotating the first knob, and the sheath 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 according to at least one embodiment of the present disclosure, the first tube assembly includes an inner tube and a prosthesis connecting member, the prosthesis connecting member is mounted on an outer surface of a distal end of the inner tube and the prosthesis connecting member is fixedly connected to the inner tube, and an engagement groove that fits the prosthesis is drilled in the prosthesis connecting member, thereby fitting and seating the prosthesis and releasably connecting it to the prosthesis.

[0018] For example, the delivery system according to at least one embodiment of the present disclosure further includes an inner tube fixing base, the inner tube is disposed to extend from a distal end to a proximal end side to the inner tube fixing base, the inner tube is fixedly connected to the inner tube fixing base, the inner tube fixing base is disposed inside the second housing, and the inner tube fixing base is fixedly connected to the third housing half and the fourth housing half, respectively.

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

[0020] For example, in a delivery system according to at least one embodiment of the present disclosure, the first tube assembly further includes an inner tube exhaust member and an end base, the inner tube exhaust member being connected to a proximal end of the inner tube and the end base being connected to a distal end of the inner tube.

[0021] For example, the delivery system according to at least one embodiment of the present disclosure further includes a safety connection member, the second movable member being a second knob, the axial direction of the second knob being parallel or coaxial with the axial direction of the guide rod, and the safety connection member being fixedly connected to the second end of the safety rod and the second knob, respectively, such that rotation of the second knob can drive the safety rod to rotate about the axial direction of the guide rod.

[0022] For example, in a delivery system according to at least one embodiment of the present disclosure, the second housing is a cylindrical body and the second knob is fitted to the outer surface of the cylindrical body, such that the second knob cannot move in the axial direction of the guide rod but can rotate around the axial direction of the guide rod.

[0023] For example, in a delivery system according to at least one embodiment of the present disclosure, the prosthesis may include a prosthetic heart valve, a covered stent, or a vascular graft.

[0024] For example, in a delivery system according to at least one embodiment of the present disclosure, when a first end of the safety rod is inserted into the first partial track groove, at least a portion of the prosthesis is placed in a cavity between the sheath of the second tube assembly and the first tube assembly, and the cavity gradually opens and closes as the sheath of the second tube assembly moves axially relative to the first tube assembly to release or retrieve the prosthesis.

[0025] For example, in a delivery system according to at least one embodiment of the present disclosure, when the first end of the safety rod is positioned proximally within the first partial track groove, the prosthesis is positioned in a first cavity between the sheath of the second tube assembly and the first tube assembly, and when the first end of the safety rod is positioned distally within the first partial track groove, a portion of the prosthesis is positioned in a second cavity between the sheath of the second tube assembly and the first tube assembly, the space of the second cavity being smaller than the space of the first cavity.

[0026] At least one embodiment of the present disclosure provides a method for delivering a prosthesis, the method comprising: controlling a first moving member to move, driving a guide rod to move along an axial direction of the guide rod, and driving a sheath of a second tube assembly to move axially relative to the first tube assembly, the sheath of the second tube assembly being fixedly connected to the first moving member, the first tube assembly being arranged to place the prosthesis, the sheath of the second tube assembly being fitted on the outside of at least a part of the first tube assembly, the axial directions of the sheath of the second tube assembly and the first tube assembly being parallel or coaxial with the axial direction of the guide rod, at least one stage of position limiting grooves being opened on the outer surface of the guide rod, the at least one stage of position limiting grooves being entirely extended along the axial direction of the guide rod, the position limiting grooves of each stage including a first partial track groove, a second partial track groove and a third partial track groove being sequentially connected to each other, the second partial track groove being angled with the first partial track groove and the third partial track groove, respectively; the prosthesis includes a step of arranging the safety rod in such a manner that the guide rod is inserted into the first partial track groove and the guide rod is moved along the axial direction toward the proximal end, thereby positioning the first end of the safety rod at one end of the first partial track groove close to the second partial track groove (e.g., the distal end in the first partial track groove); and in response to the prosthesis satisfying a target requirement, controlling the second moving member to rotate and driving the safety rod to rotate about the axial direction, whereby the first end of the safety rod rotates from the first partial track groove through the second partial track groove to at least a part of the third partial track groove, whereby the guide rod is driven by the first moving member to move along the axial direction toward the proximal end under a condition in which the third partial track groove can pass the first end of the safety rod, and the first moving member drives the sheath of the second tube assembly to move axially relative to the first tube assembly, the second moving member being fixedly connected to the safety rod.

[0027] For example, a delivery method according to at least one embodiment of the present disclosure further includes, in response to the prosthesis not meeting a target requirement, controlling the first moving member to move in a reverse direction, driving the sheath of the second tube assembly to move axially relative to the first tube assembly, and driving the guide rod to move axially toward the distal end.

[0028] For example, the delivery method according to at least one embodiment of the present disclosure further includes the steps of: in response to a first end of the safety rod being close to a distal end in the third partial track groove, controlling the first moving member to move in a reverse direction, driving the sheath of the second tube assembly to move axially relative to an axial direction of the first tube assembly, and driving the guide rod to move along the axial direction toward the distal end, so that the first end of the safety rod moves from the third partial track groove through the fourth partial track groove of the position limiting groove and back into the first partial track groove, wherein the first end of the fourth partial track groove communicates with a proximal end of the third partial track groove, the second end of the fourth partial track groove communicates with at least a portion of the first partial track groove, and the fourth partial track groove and the second partial track groove are not parallel, thereby allowing the first end of the safety rod to move along the fourth partial track groove to the proximal end.

[0029] For example, in a delivery method according to at least one embodiment of the present disclosure, the delivery method further includes a step of placing at least a portion of the prosthesis in a cavity between the sheath of the second tube assembly and the first tube assembly when the first end of the safety rod is inserted into the first partial track groove, and driving the sheath of the second tube assembly to move axially relative to the first tube assembly, thereby gradually opening and closing the cavity, thereby releasing the prosthesis or retrieving the prosthesis.

[0030] Compared with the prior art, the beneficial effects of at least one embodiment of the present disclosure include at least the following: the device or method of the embodiment of the present disclosure can realize physical positional constraint, and can present the positional constraint critical point to the operator through tactile sensation, effectively feeding back accurate information of physical positioning, thereby realizing simple, efficient and accurate physical positional constraint.

[0031] In order to more clearly describe the embodiments of the present disclosure or the technical solutions of the prior art, the following briefly describes the drawings that need to be used in the description of the embodiments or the prior art, and it is obvious that the drawings described below are only some embodiments of the present disclosure, and those skilled in the art can obtain other drawings based on these drawings without requiring creative labor. [Brief description of the drawings]

[0032] [Figure 1] FIG. 1 is a structural schematic diagram of a physical position restriction device according to some embodiments of the present disclosure. [Diagram 2] FIG. 2 is a schematic diagram of different angles of an outer surface of a guide rod according to some embodiments of the present disclosure. [Diagram 3] FIG. 3 is a schematic diagram of different angles of an outer surface of a guide rod according to some embodiments of the present disclosure. [Figure 4a] FIG. 4a is a simplified schematic diagram of the safety device and second moving member of FIG. 1 viewed from the proximal end to the distal end along an axial direction according to some embodiments of the present disclosure. [Figure 4b] FIG. 4b is a cross-sectional view of FIG. 4a according to some embodiments of the present disclosure. [Figure 5a] FIG. 5a is a schematic diagram of a method of operation of a physical location restriction device according to some embodiments of the present disclosure. [Figure 5b] FIG. 5b is a schematic diagram of a method of operation of a physical location restriction device according to some embodiments of the present disclosure. [Figure 5c] FIG. 5c is a schematic diagram of a method of operation of a physical location restriction device according to some embodiments of the present disclosure. [Figure 5d]FIG. 5d is a schematic diagram of a method of operation of a physical location restriction device according to some embodiments of the present disclosure. [Figure 5e] FIG. 5e is a schematic diagram of a method of operation of a physical location restriction device according to some embodiments of the present disclosure. [Figure 5f] FIG. 5f is a schematic diagram of a method of operation of a physical location restriction device according to some embodiments of the present disclosure. [Figure 6] FIG. 6 is a schematic diagram of a cascade of two-stage position limiting grooves according to some embodiments of the present disclosure. [Figure 7] FIG. 7 is a schematic diagram of a prosthesis delivery system according to some embodiments of the present disclosure. [Figure 8] FIG. 8 is a top view schematic diagram of a first tube assembly and a second tube assembly according to some embodiments of the present disclosure. [Figure 9] FIG. 9 is an axial cross-sectional view of a prosthesis delivery system according to some embodiments of the present disclosure. [Figure 10a] FIG. 10a is a schematic diagram of a method of operation of a prosthesis delivery system according to some embodiments of the present disclosure. [Figure 10b] FIG. 10b is a schematic diagram of a method of operation of a prosthesis delivery system according to some embodiments of the present disclosure. [Figure 10c] FIG. 10c is a schematic diagram of a method of operation of a prosthesis delivery system according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0033] Hereinafter, the technical solutions of the embodiments of the present disclosure will be described clearly and completely with reference to the drawings of the embodiments of the present disclosure, and it is obvious that the described embodiments are only some embodiments of the present disclosure, and not all embodiments. Based on the embodiments of the present disclosure, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present disclosure.

[0034] 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. It should be further understood that, for example, those terms defined in common dictionaries should be interpreted to have a meaning consistent with the meaning in the context of their related art, and should not be interpreted in an idealized or highly formalized sense, unless expressly defined in the embodiments of the present disclosure.

[0035] The terms "first", "second" and similar terms used in the embodiments of the present disclosure do not indicate any order, number or importance, but merely distinguish different components. The terms "one", "one" or "the" and similar terms do not indicate a number limitation, but indicate the presence of at least one. Similarly, the terms "comprise" or "include" and similar terms include the elements or components listed before the term and the elements or components listed after the term and their equivalents, but do not exclude other elements or components. The terms "connect" or "couple" and similar terms are not limited to physical or mechanical connections, but may include electrical connections, whether directly or indirectly connected. The embodiments of the present disclosure use flow charts to describe steps of the methods according to the embodiments of the present disclosure. As should be understood, the preceding or following steps are not necessarily performed in precise order. Conversely, various steps can be processed in reverse order or simultaneously. Also, other operations can be added to these processes, or a step or steps can be removed from these processes.

[0036] The inventors have found that with the aging of the population, the incidence of valvular heart disease increases obviously. Traditional treatment methods include conservative drug therapy and surgical valve replacement treatment. Drug therapy has very little effect on improving prognosis, while surgical valve replacement can obviously improve the prognosis of patients. However, for many elderly patients with a history of open chest and severely impaired cardiopulmonary function, surgery is risky, and the opportunity for surgery is lost. Under this background, transcatheter aortic valve replacement is a breakthrough in the field of valvular heart disease treatment in recent years.

[0037] During the implantation process of the artificial heart valve in this operation, the operator needs to accurately grasp the release position and release form of the valve prosthesis. During the process of identifying the position of the valve prosthesis, the imaging is unclear, the operation is unstable, or other factors interfere, which makes the positioning of the valve prosthesis more difficult. And when using a normal artificial heart valve implantation device, once the operator completes the positioning and starts to release the valve prosthesis, the entire release process is irreversible, and the operator has almost no opportunity to adjust the position and form of the prosthesis, and the fault tolerance rate of the operation process is very low, so the operator needs to grasp the length of the valve released from the delivery system in real time, which is very difficult.

[0038] There are two main ways for the operator to know the length of the valve released from the delivery system. The first method uses ultrasound images and digital subtraction angiography to judge the release status of the prosthesis by comparing the relative position of the development marker and the valve prosthesis. In this method, the operator cannot accurately control the release length of the valve due to the development delay. The second method obtains the information of the release length of the valve by reading the release stroke mark on the handle or tube. In this method, there is a certain included angle between the operator's observation position and the stroke mark during the operation process, and parallax occurs in the reading process, so the operator cannot know the accurate information of the release length of the valve.

[0039] Accordingly, the present disclosure proposes a simple, efficient and accurate physical location restriction device, a system and method for using the physical location restriction device.

[0040] At least one embodiment of the present disclosure provides a physical position limiting device, comprising: a first moving member, a guide rod, a safety rod, and a second moving member; the guide rod is arranged to be driven by the first moving member to move along the axial direction of the guide rod; at least one stage of position limiting grooves is formed on an outer surface of the guide rod; the at least one stage of position limiting grooves extends generally along the axial direction of the guide rod; each stage of position limiting grooves includes a first partial track groove, a second partial track groove, and a third partial track groove, which are connected in sequence; and the second partial track groove is respectively a first partial track groove and a third partial track groove. The safety rod includes a first end and a second end disposed oppositely along a longitudinal direction of the rod, the first end of the safety rod is inserted into the position limiting groove, and the safety rod is disposed to be movable relative to the guide rod along an extension direction of the position limiting groove, the second moving member is fixedly connected to the second end of the safety rod, and the second moving member is disposed to rotate to rotate the safety rod around the axial direction of the guide rod and move the first end of the safety rod along the second partial track groove.

[0041] At least one embodiment of the present disclosure further provides a method corresponding to the above physical location limitation device.

[0042] The physical position limitation device or method according to the above-mentioned embodiments of the present disclosure can realize physical position limitation, and can present the position limitation critical point to the operator through tactile feedback, effectively feeding back accurate information of physical positioning, thereby realizing simple, efficient and accurate physical position limitation.

[0043] Hereinafter, embodiments and examples of the present disclosure will be described in detail with reference to the drawings.

[0044] For the convenience of explanation in this specification, in some embodiments of the present disclosure, a first axial side is referred to as the left side in the figure, and a second axial side is referred to as the right side in the figure. For example, a direction perpendicular to the axial direction in some embodiments of the present disclosure can be referred to as the up-down direction in the figure. However, the up-down orientation in the embodiments of the present disclosure all refer to the orientation in the figure, and do not affect the orientation in actual application, and the embodiments of the present disclosure are not limited thereto.

[0045] For example, regarding the limitation on the axial direction, for ease of explanation, in at least one embodiment of the present disclosure, the side closer to the operator is regarded as the proximal end or proximal end side, and the side farther from the operator is regarded as the distal end or distal end side. For example, the left side of the figure is regarded as the distal end, and the right side of the figure is regarded as the proximal end. Note that the distal end and proximal end of the present disclosure are all relative positions, for example, indicating opposite sides of some members themselves, or indicating opposite sides in a certain direction, that is, the proximal end of the present disclosure indicates one side, and the distal end indicates the other side opposite to the proximal end. The meanings and actions of elements or members of the embodiments of the present disclosure are not limited to their names, and cannot be interpreted in an idealized or highly formalized sense, which does not limit the embodiments of the present disclosure.

[0046] FIG. 1 is a structural schematic diagram of a physical location restriction device 100 according to some embodiments of the present disclosure.

[0047] 1, the physical position limiting device 100 includes a first moving member 11, a guide rod 12, a safety device 13, and a second moving member 14. The first moving member 11 is arranged to drive the guide rod 12, whereby 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 position limiting device 100.

[0048] In some examples, the first moving member 11 may be a rotating member that rotates around the axial direction of the guide rod 12. For example, the first moving member 11 converts rotation into linear movement via an intermediate member, thereby driving the guide rod 12 to move along the axial direction of the guide rod 12. For example, as shown in FIG. 1, the first moving member 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 arranged to drive the guide rod 12 to move along the axial direction of the guide rod 12 by its own rotation (specific examples will be described later).

[0049] The structure of the first moving member 11 is not limited thereto, and falls within the scope of protection of the embodiments of the present disclosure as long as it is a member or assembly that can move the guide rod 12 along the axial direction of the guide rod 12. For example, the first moving member 11 may be a member that moves linearly along the axial direction.

[0050] 2 and 3 are schematic three-dimensional views of the outer surface of the guide rod 12 at different angles according to some embodiments of the present disclosure. Fig. 3 is a schematic view of the state after the guide rod 12 of Fig. 2 has been rotated a certain angle around its axial center.

[0051] 2 and 3, at least one stage of position limiting grooves 121 is formed on the outer surface of the guide rod 12, and the at least one stage of position limiting grooves 121 generally extends along the axial direction of the guide rod 12. Each stage of the position limiting grooves 121 includes a first partial track groove 121a, a second partial track groove 121b, and a third partial track groove 121c which are connected in sequence. The second partial track groove 121b is disposed at an angle to the first partial track groove 121a and the third partial track groove 121c, respectively.

[0052] In addition, when the position limiting groove 121 extends entirely along the axial direction of the guide rod 12, it does not mean that the first partial track groove 121a, the second partial track groove 121b, and the third partial track groove 121c all extend along the axial direction, but rather that the overall extension direction formed by the first partial track groove 121a, the second partial track groove 121b, and the third partial track groove 121c being connected in sequence is along the axial direction of the guide rod 12, and any of the first partial track groove 121a, the second partial track groove 121b, and the third partial track groove 121c may not extend along the axial direction of the guide rod 12, and may extend almost along the axial direction of the guide rod 12.

[0053] 2 and 3, the first partial track groove 121a and the third partial track groove 121c are arranged to extend parallel to the axial direction of the guide rod 12. The second partial track groove 121b is arranged to extend along the circumferential direction of the guide rod 121. In the axial direction of the guide rod 121, the second partial track groove 121b is located between the first partial track groove 121a and the third partial track groove 121c.

[0054] For example, the first partial track groove 121a, the second partial track groove 121b and the third partial track groove 121c are all grooves having a predetermined depth opened on the outer circumferential surface of the guide rod 12, and elements such as the cross-sectional shape and depth of each track groove are not limited.

[0055] In some examples, the shape of any partial track groove of the position limiting groove 121 in the extension direction may not be a straight line segment in the strict sense, for example, it is basically a straight line. Also, for example, the extension direction of the second partial track groove 121b may not be the circumferential direction of the guide rod 121 in the strict sense, for example, it is approximately the same as the circumferential direction of the guide rod 121.

[0056] In at least one embodiment of the present disclosure, the second partial track groove 121b being arranged at an angle to the first partial track groove 121a and the third partial track groove 121c means that, on the outer circumferential surface of the guide rod 12, the second partial track groove 121b is not only not parallel to the first partial track groove 121a, but also not parallel to the third partial track groove 121c.

[0057] Figure 4a is a simplified schematic diagram of the safety device 13 and second moving member 14 of Figure 1 under an angle viewed from the proximal end to the distal end along an axial direction according to some embodiments of the present disclosure, and Figure 4b is a cross-sectional view taken along section line AA of Figure 4a.

[0058] 4a and 4b, the safety device 13 includes a safety rod 131, which includes a first end (i.e., one end of the safety rod 131 closer to the guide rod 12) and a second end (i.e., one end of the safety rod 131 farther from the guide rod 12) that are disposed oppositely along the longitudinal direction of the rod. The first end of the safety rod 131 is inserted into the first partial track groove 121a of the position limiting groove 121. The safety rod 131 is disposed so as to be movable relative to the guide rod 12 along the extending direction of the position limiting groove 121.

[0059] In some examples, the safety rod 131 is stationary and can move relative to the guide rod 12, i.e., the safety rod 131 slides relatively within different track grooves of the position limiting groove 121 of the guide rod 12, so that the guide rod 12 moves to the proximal end (or moves to the distal end) and the safety rod 131 is stationary, and therefore the safety rod 131 moves to the distal end (or moves to the proximal end) relative to the guide rod 12. Thus, the present disclosure realizes the physical position limit of the guide rod by setting the safety rod 131 to be stationary and utilizing the relative movement between it and the guide rod, which is simple in configuration, easy to operate, and relatively stable and accurate.

[0060] Note that the safety rod 131 being stationary refers to being stationary relative to the current operator, and may also refer to the entire current delivery system being stationary relative to a certain environment.

[0061] As a result, the first partial track groove 121a and the third partial track groove 121c are positioned to allow the first end of the safety rod 131 to pass therethrough, thereby allowing the guide rod 12 to move smoothly along the axial direction of the guide rod, for example, when the guide rod 12 moves along the axial direction of the guide rod to the proximal end (i.e., moves to the right along the axial direction), the safety rod 131 passes through the first partial track groove 121a and the third partial track groove 121c relatively from the proximal end in the axial direction to the distal end in the axial direction.

[0062] For example, as the guide rod 12 moves axially toward the proximal end, the first end of the safety rod 131 can reach from the proximal end within the first partial track groove 121a to the distal end relative to the guide rod 12, and can be positionally restricted to one end within the first partial track groove 121a that is closer to the second partial track groove 121b (i.e., the distal end within the first partial track groove 121a).

[0063] In some examples, the second end of the safety rod 131 is fixedly connected to the second moving member 14. The safety rod 131 is driven by rotation of the second moving member 14 and is arranged to rotate about the axial direction of the physical position limiting device 100, so that the first end of the safety rod 131 rotates from the first partial track groove 121a of the position limiting groove 121 through the second partial track groove 121b to the third partial track groove 121c.

[0064] 2, the position limiting groove 121 further includes a fourth partial track groove 121d. The third partial track groove 121c, the fourth partial track groove 121d and the first partial track groove 121a are sequentially connected to each other, and the fourth partial track groove 121d is disposed at an angle to the third partial track groove 121c and the first partial track groove 121a, respectively. The distal end of the fourth partial track groove 121d is connected to the proximal end of the third partial track groove 121c, and the fourth partial track groove 121d extends away from the second partial track groove 121b, so that the proximal end of the fourth partial track groove 121d is connected to at least a part of the first partial track groove 121a, and the fourth partial track groove 121d is not parallel to the second partial track groove 121b, thereby allowing the first end of the safety rod 131 to move along the fourth partial track groove 121d to the proximal end. As a result, the fourth partial track groove 121d is an oblique groove type, for example, an oblique groove inclined from the upper left to the lower right in FIG. 5a, and is easily retrieved.

[0065] For example, the distance from the proximal end of the oblique groove type fourth partial track groove 121d to the straight line on which the second partial track groove 121b is located is smaller than the distance from the proximal end of the fourth partial track groove 121d to the straight line on which the second partial track groove 121b is located.

[0066] In some examples, the fourth partial track groove 121d is positioned to allow the first end of the safety rod 131 to pass therethrough, thereby allowing the guide rod 12 to move smoothly along the axial direction of the guide rod, for example, when the guide rod 12 moves along the axial direction of the guide rod to the distal end (i.e., moves axially to the left), the safety rod 131 passes through the fourth partial track groove 121d relatively from the axial distal end to the axial proximal end, thereby achieving the retrieval action of the physical position limiting device 100.

[0067] 2, the first partial track groove 121a, the second partial track groove 121b, the third partial track groove 121c and the fourth partial track groove 121 of the position limiting groove 121 define a trapezoid, so that the position limiting groove 121 has an overall "alternate" shape. This is merely an example and is not a limitation of the present disclosure.

[0068] As shown in Figures 4a and 4b, the safety device 13 further includes a safety connecting member 132, a second end of the safety rod 131 is fixedly connected to the safety connecting member 132, and the safety connecting member 132 is further fixedly connected to a second moving member 14, such that the movement of the second moving member 14 can drive the safety rod 131 to rotate around the axial direction of the physical position limiting device 100.

[0069] As shown in FIGS. 4a and 4b, the second moving member 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 to or coaxial with the axial direction of the guide rod 12.

[0070] In some examples, the second knob 141 and the safety mechanism 13 are fixedly connected by a form fit or an interference fit, which is merely exemplary and not intended to be a limitation of this disclosure.

[0071] Hereinafter, a method of using a physical position restriction device according to an embodiment of the present disclosure will be described based on the state diagrams of FIGS. 5a to 5f.

[0072] As shown in FIG. 5a, the first end of the safety rod 131 is inserted into the right end of the first partial track groove 121a on the outer surface of the guide rod 12. The first moving member 11 is controlled to move, and the guide rod 12 is driven to move along the axial direction to the proximal end. At this time, the safety rod 131 gradually moves relatively from the proximal end of the first partial track groove 121a to the distal end of the first partial track groove 121a, as shown in FIG. 5b. Under this state, the safety rod 131 reaches the position limiting position of the first partial track groove 121a. Due to the blocking effect of the distal end inner wall of the first partial track groove 121a, the safety rod 131 cannot continue to move relatively forward with the movement of the guide rod 12. That is, the first moving member 11 and the guide rod 12 are restricted by the safety rod 131 in the first partial track groove 121a and cannot continue to move along the axial direction, thereby achieving a physical position limiting effect. In this way, the position limiting critical point is presented to the operator through the tactile sensation of the first moving member, and accurate information on physical positioning is effectively fed back to the operator, thereby realizing simple, efficient and accurate physical position limiting.

[0073] For example, after realizing the position limit, the second moving member 14 is rotated to rotate the physical position limiting device 100 about the axial direction, so that the first end of the safety rod 131 rotates from the distal end of the first partial track groove 121a (i.e., one end of the second partial track groove 121b close to the first partial track groove 121a) through the second partial track groove 121b into the third partial track groove 121c (e.g., rotates to the proximal end or center position of the third partial track groove 121c). This means that the relative axial movement between the safety rod 131 and the guide rod 12 is unlocked, as shown in FIG. 5c. Under this state, the guide rod 12 can continue to move axially toward the proximal end by being driven by the first moving member 11, and the first end of the safety rod 131 slides relatively within the third partial track groove 121c from the proximal end of the third partial track groove 121c to the distal end of the third partial track groove 121c along the axial direction, as shown in FIG. 5d.

[0074] For example, in the return phase (which may be called the withdrawal phase) after the safety rod 131 reaches the distal end of the third partial track groove 121c, the guide rod 12 also moves in the reverse direction due to the driving of the first moving member 11 moving in the reverse direction, that is, the guide rod 12 moves to the distal end along the axial direction, and the safety rod 131 slides relatively to the proximal end along the axial direction in the third partial track groove 121c. The safety rod 131 first reaches the proximal end of the third partial track groove 121c, and then transitions to the distal end in the diagonal groove type fourth partial track groove 121d, as shown in FIG. 5e. The safety rod 131 continues to slide relatively within the fourth partial track groove 121d, moves relatively to the proximal end within the fourth partial track groove 121d, then transitions to the distal end within the first partial track groove 121a, slides relatively to the distal end of the first partial track groove 121a, and finally reaches the proximal end of the first partial track groove 121a, thereby completing the return process, as shown in FIG. 5f.

[0075] As a result, by using the fourth partial track groove 121d of the diagonal groove type as the position limiting groove 121 in at least one embodiment of the present disclosure, there is no need to operate the second moving member 14 (e.g., the second knob 141), and the second moving member 14 can be driven to passively rotate to the initial position (i.e., reset) by simply operating the first moving member 11 (e.g., the first knob 111), making the entire operating process simpler and more efficient.

[0076] Although the physical position limiting device of the embodiment described above with reference to Figures 1 to 5f relates to only one stage of position limiting groove 121, the present disclosure is not limited thereto, and the physical position limiting device of the present disclosure may further include two or more stages of position limiting groove 121.

[0077] For example, a physical position limiting device according to an embodiment of the present disclosure may include N stages of position limiting grooves 121, where N is an integer greater than or equal to 2, the first partial track groove 121a of the i-th stage of the position limiting groove 121 communicates with the third partial track groove 121c of the i-1th stage of the position limiting groove 121, and the numerical value i of each stage from the axial proximal end to the axial distal end is expressed as 1, 2, ..., N.

[0078] FIG. 6 is a schematic diagram of a cascade of two-stage position limiting grooves 121 according to some embodiments of the present disclosure.

[0079] For example, as shown in FIG. 6, the first stage position limiting groove of the two stages of position limiting grooves 121 includes a first partial track groove 121a, a second partial track groove 121b, a third partial track groove 121c, and a fourth partial track groove 121d. The second stage position limiting groove includes a first partial track groove 121a', a second partial track groove 121b', a third partial track groove 121c', and a fourth partial track groove 121d'. The left end of the first stage third partial track groove 121c and the right end of the second stage first partial track groove 121a' are connected to each other or are integrally formed, thereby realizing a cascade of two stages of position limiting grooves 121. In the embodiment of the present disclosure, the cascade method and specific structure and configuration of three or more stages of position limiting grooves 121 can be referred to the example of FIG. 6 and will not be described here repeatedly.

[0080] In some examples, the overall shape structure of the position limiting groove of each stage can be adjusted according to needs, for example, the position limiting groove is not limited to the trapezoid shown in Fig. 2, alternatively, the first partial track groove 121a, the second partial track groove 121b, the third partial track groove 121c and the fourth partial track groove 121 of the position limiting groove 121 can further define a triangle as shown in Fig. 6. This is merely an example and does not limit the present disclosure.

[0081] 6, the position limiting grooves of each stage among the two stages of the position limiting grooves 121 have the same structure. Of course, the present disclosure is not limited to this, and for example, the structures of the two stages of the position limiting grooves 121 may not be the same.

[0082] In some examples, some of the multi-stage position limiting grooves 121 may be trapezoidal, and other position limiting grooves 121 may be triangular. In other examples, the position limiting grooves 121 of each stage of the multi-stage position limiting grooves 121 are all trapezoidal. In some examples, the position limiting grooves 121 of each stage of the multi-stage position limiting grooves 121 are all triangular.

[0083] Thereby, at least one embodiment of the present disclosure can realize multiple positions or multiple stages of position limiting by cascading multiple stages of position limiting grooves, and can be realized with only one safety device 13 (e.g., safety rod 131) and one second movable member 14 (e.g., second knob 141), which is sufficiently simple and efficient, has a wider range of application, and has higher position limiting accuracy.

[0084] At least one embodiment of the present disclosure further provides a prosthesis delivery system, comprising a physical position limiting device according to any of the above embodiments.

[0085] Fig. 7 is a schematic diagram of an external view of a delivery system for a prosthesis according to some embodiments of the present disclosure, Fig. 8 is a structural diagram of a first tube assembly and a second tube assembly according to some embodiments of the present disclosure, and Fig. 9 is a schematic diagram of an internal view of a delivery system for a prosthesis according to some embodiments of the present disclosure.

[0086] As shown in FIG. 7, a prosthesis delivery system 200 in accordance with at least one embodiment of the present disclosure includes a first tube assembly 21, a second tube assembly 22, and a physical position limiting device 100.

[0087] In some examples, the first tube assembly 21 is positioned to place a prosthesis. At least a portion of the second tube assembly 22 is fitted onto the outside of 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 parallel to or coaxial with the axial direction of the physical position limiting device 100.

[0088] The physical position limiting device 100 includes a first moving member 11, a guide rod 12, a safety device 13, and a second moving member 14. For the specific structure, configuration, and technical effects of the physical position limiting device 100 of the delivery system 200 described below, please refer to the descriptions of Figures 1 to 6, and will not be described repeatedly here for the sake of clarity and simplicity of the description of this specification.

[0089] In some examples, at least a portion of the second tube assembly 22 (e.g., the sheath 221 described below) is fixedly connected to the first movable member 11, thereby driving the second tube assembly 22 to move axially relative to the first tube assembly 21.

[0090] As described above, the safety rod 131 being stationary may refer to being stationary relative to the current operator (or may refer to the entire current delivery system being stationary relative to the environment), whereby the safety rod 131 being stationary may, for example, be stationary relative to the first tube assembly 21, i.e., the first tube assembly 21 may be stationary relative to the current operator.

[0091] In some examples, the physical position limiting device 100 of the delivery system 200 further includes a screw 15. A thread that fits the screw 15 is provided inside the first moving member 11 (e.g., the first knob 111) to achieve screw engagement, so that the first moving member 11 can achieve relative movement along the axial direction by screw transmission when rotating in the circumferential direction, thereby driving the guide rod 12 to move along the axial direction of the physical position limiting device 100.

[0092] For example, the guide rod 12 is inserted into the screw 15 and can move relative to the screw 15, the first moving member 11 (e.g., the first knob 111) is fitted into the screw 15, and the axial directions of the first moving member 11 and the screw 15 are parallel to or coaxial with the axial direction of the guide rod 12. The first moving member 11 (e.g., the first knob 111) is fixedly connected to an intermediate member (e.g., the sheath fixed base 28 described below), and the intermediate member (e.g., the sheath fixed base 28 described below) is fixedly connected to the guide rod 12, so that the first moving member 11 (e.g., the first knob 111) can realize relative movement along the axial direction by screw transmission when rotating, and can drive the intermediate member (e.g., the sheath fixed base 28 described below) to move, thereby driving the guide rod 12 to move along the axial direction of the physical position limiting device 100.

[0093] In some examples, the delivery system 200 further includes a first housing and a second housing, the first housing including a first housing half 23 and a second housing half 24, and the second housing including a third housing half 25 and a fourth housing half 26.

[0094] For example, as shown in FIG. 7, the distal end of the screw 15 is fixedly connected to a first housing half 23 and a second housing half 24, respectively. The first housing half 23 and the second housing half 24 are located on either side of the central axis of the delivery system 200 (i.e., in the vertical direction in FIG. 7), and the first housing half 23 (i.e., the upper housing) and the second housing half 24 (i.e., the lower housing) are fixedly connected to form a first housing. For example, as shown in FIG. 7, the proximal end of the screw 15 is fixedly connected to a third housing half 25 and a fourth housing half 26, respectively. The third housing half 25 and the fourth housing half 26 are located on either side of the central axis of the delivery system 200 (i.e., in the vertical direction in FIG. 7), and the third housing half 25 (i.e., the upper housing) and the fourth housing half 26 (i.e., the lower housing) are fixedly connected to form a second housing.

[0095] The first and second housings of some embodiments of the present disclosure are each formed by assembling two housing halves, thus facilitating installation of the entire delivery system.

[0096] For example, in some other examples, the first housing half 23 and the second housing half 24 may be located on either side of the axis of the delivery system 200, and / or the third housing half 25 and the fourth housing half 26 may be located on either side of the axis of the delivery system 200. Or, in some further examples, the first housing and the second housing are each a one-piece structure.

[0097] 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 the operator).

[0098] Hereinafter, the structures of the first tube assembly 21 and the second tube assembly 22 will be described in detail with reference to FIG.

[0099] As shown in Fig. 8, the first tube assembly 21 includes a prosthesis connecting member 211 and an inner tube 213. For example, the inner tube 213 is a multi-layer tube 213, which is used to increase strength, but the present disclosure is not limited thereto. For ease of explanation, all the inner tubes 213 in the following are multi-layer tubes 213.

[0100] In some examples, the prosthesis connecting member 211 is disposed on an outer surface of at least a portion of the multi-layer tube 213 and fixedly connected to the multi-layer tube 213, for example, by glue. For example, the prosthesis connecting member 211 is disposed on an outer surface of a distal end of the multi-layer tube 213 and the prosthesis connecting member 211 is fixedly connected to the multi-layer tube 213.

[0101] According to at least one embodiment of the present disclosure, an engagement groove that fits the prosthesis is opened on the outer surface of the prosthesis connecting member 211, thereby fitting the prosthesis to the prosthesis and releasably connecting the prosthesis to the prosthesis. For example, in some examples, the engagement groove opened on the outer surface of the prosthesis connecting member 211 is a T-shaped recessed groove, and a T-shaped rod of the same shape is machined on the proximal end of the prosthesis. Of course, this is merely exemplary and does not limit the embodiments of the present disclosure, and the shape of the engagement groove of the prosthesis connecting member 211 may be any shape that fits the shape of the prosthesis.

[0102] In some examples, the prosthesis includes, but is not limited to, a prosthetic heart valve, and the embodiments of the present disclosure are not intended to be limiting or exhaustive. For example, in some other examples, the prosthesis is a covered stent or an artificial vascular prosthesis for treating vascular lesions such as aneurysms.

[0103] In some examples, the first tube assembly 21 further includes an end base 212, which is connected to a distal end of the multi-layer tube 213. For example, the end base 212 is a cone-shaped head, which is located at the most distal end of the delivery system and is removably connected to the distal end of the multi-layer tube 213. For example, as shown in Figure 9, the end base 212 is fixedly connected to the distal end of the multi-layer tube 213 via a screw. This is merely exemplary and is not a limitation of the present disclosure.

[0104] In some examples, the multi-layer tube 213 includes a plurality of third tubes having different hardnesses that are connected in sequence along the axial direction of the first tube assembly 21. For example, the multi-layer tube 213 is made of a composite of multiple layers and stages of polymer materials having different hardnesses, thereby having a plurality of straight segments having different hardnesses that are connected in the axial direction, thereby achieving that the straight segments that require strength have sufficient strength and the straight segments that require bending have sufficient flexibility, thereby enabling the delivery system including such a multi-layer tube 213 to enter the aortic arch (e.g., similar to a U-shape) and deliver the prosthetic heart valve.

[0105] In some examples, the second tube assembly 22 includes a sheath 221 and a stabilizing tube 222 , with the distal end of the stabilizing tube 222 fitted over at least a portion of the sheath 221 .

[0106] 8, the sheath 221 has a reducer structure, and includes a first sheath portion 221a and a second sheath portion 221b arranged in sequence from the distal end to the proximal end, i.e., the first sheath portion 221a is closer to the distal end than the second sheath portion 221b. The diameter of the first sheath portion 221a is larger than the diameter of the second sheath portion 221b.

[0107] For example, the stabilizing tube 222 is fitted 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 diameter of the first sheath portion 221a and the diameter of the stabilizing tube 222, for example, the diameter of the stabilizing tube 222 is smaller than the diameter of the first sheath portion 221a, thus ensuring stable and accurate realization of full opening of the delivery system when the sheath 221 moves to a position where the first sheath portion 221a is locked by the distal end of the stabilizing tube 222.

[0108] In some examples, along the radial direction, the stabilizing tube 222, the second sheath portion 221b and the multi-layer tube 213 are arranged in order from outside to inside, as shown in FIG.

[0109] In some examples, the sheath 221 includes a plurality of fourth tubes connected in sequence along the axial direction and having different hardness. For example, different straight segments of the sheath 221 can be realized with different tube manufacturing methods to have straight segments with different hardness, so that the straight segments that require strength have sufficient strength and the straight segments that require bending have sufficient flexibility. This allows the delivery system including such a sheath 221 to enter the aortic arch (e.g., similar to a U-shape) and deliver the prosthetic heart valve.

[0110] For example, during installation, the T-shaped rod of the prosthesis is fitted into the T-shaped recessed groove of the prosthesis connecting member 211, and then when the sheath 221 of the second tube assembly 22 is closed (i.e., the sheath 221 moves to the left), the prosthesis is placed into the cavity formed by the sheath 221 and the first tube assembly 21. This is merely exemplary and is not a limitation of the present disclosure.

[0111] The above-described embodiments of the present disclosure realize the mounting of a prosthesis by a prosthesis connecting member having an engagement groove, can be adapted to various types of prostheses, and can ensure smooth release of the prosthesis, and is simple in configuration, easy to operate, and has a wide range of applications.

[0112] Hereinafter, the detailed structure of the delivery system 200 will be described with reference to Fig. 9. As shown in Fig. 9, the first moving member 11 may 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 is maintained coaxial with the axis line of the entire delivery system 200.

[0113] 9, the delivery system 200 basically further includes a stabilizing tube fixing base 27 disposed within the first housing. The stabilizing tube fixing base 27 is disposed within the first housing, and the stabilizing tube 222 extends from a distal end to the stabilizing tube fixing base 27, and the proximal end of the stabilizing tube 222 is fixedly connected to the stabilizing tube fixing base 27. The stabilizing tube fixing base 27 is fixedly connected to the first housing half 23 and the second housing half 24 that constitute the first housing, respectively. Thus, the stabilizing tube 222 and the stabilizing tube fixing base 27 are fixed relative to the first housing.

[0114] In some examples, the stabilizing tube fixing base 27 is fixedly connected to the stabilizing tube 222 by glue, and the stabilizing tube fixing base 27 is fixedly connected to the first housing half 23 and the second housing half 24 by form fitting, respectively. For example, the stabilizing tube fixing base 27 is cylindrical, and two rib plates are machined inside the first housing half 23 (and / or the second housing half 24), and the rib plates have semicircular openings for locking the stabilizing tube fixing base 27, thereby realizing the form fitting. This is merely an example and does not limit the present disclosure.

[0115] In some examples, the delivery system 200 further includes a sheath fixture 28. The sheath 221 extends from a distal end to the sheath fixture 28, and a proximal end of the second sheath portion 221b of the sheath 221 is fixedly connected to the sheath fixture 28. In some examples, the sheath fixture 28 is fixedly connected to the first knob 111.

[0116] For example, the sheath fixing base 28 is fixedly connected to the sheath 221 by glue. For example, the sheath fixing base 28 is fixedly connected to the first knob 111 by form fitting. For example, the guide rod 12 and the sheath fixing base 28 are fixedly connected by screws and glue. This is merely an example and does not limit the present disclosure.

[0117] 8 , the delivery system 200 further includes an inner tube fixing base 29. For example, when the inner tube 213 is a multi-layer tube 213, the inner tube fixing base 29 may be correspondingly referred to as a multi-layer tube fixing base 29. All the inner tube fixing bases 29 related below are described as the multi-layer tube fixing base 29.

[0118] For example, the multi-layer tube 213 extends from the distal end to the proximal end, extending to the multi-layer tube fixing base 29, and the multi-layer tube fixing base 29 is fixedly connected to the multi-layer tube 213, the multi-layer tube fixing base 29 is installed inside the second housing, and the multi-layer tube fixing base 29 is fixedly connected to the third housing half 25 and the fourth housing half 26, respectively, thereby fixedly connecting the first tube assembly 21 to the third housing half 25 and the fourth housing half 26, respectively, via a connecting member (e.g., the multi-layer tube fixing base 29).

[0119] In some examples, the multi-layer pipe fixing base 29 is fixedly connected to the multi-layer pipe 213 by glue, and the multi-layer pipe fixing base 29 is fixedly connected to the third housing half 25 and the fourth housing half 26 by form fitting, respectively. For example, the third housing half 25 and the fourth housing half 26 are stationary with respect to the multi-layer pipe fixing base 29 and the multi-layer pipe 213. In some examples, the second housing formed by fixedly connecting the third housing half 25 and the fourth housing half 26 is a cylindrical body, and the second knob 141 is fitted on the outer surface of the cylindrical body, so that the second knob 141 cannot move axially relative to the second housing but can rotate around the axial direction.

[0120] The above-described embodiments of the present disclosure can utilize a multi-layer tube fixture 29 to ensure stationary first tube assembly, allowing second tube assembly 22 to move axially relative to first tube assembly 21, ensuring smooth delivery and retrieval of the prosthesis.

[0121] In some examples, the first tube assembly 21 further includes an inner tube exhaust member 214. The inner tube exhaust member 214 is fixedly connected to the proximal end of the multi-layer tube 213. The operator needs to exhaust the air in the first tube assembly 21 before operation, and this is achieved by injecting saline into the delivery system 200 using a syringe, that is, the inner tube exhaust member 214 provides the operator with an interface that is compatible with a syringe, making it easy for the operator to perform the exhaust operation. In some examples, the inner tube exhaust member 214 is fixedly connected to the multi-layer tube 213 by glue. Of course, this is merely an example, and the embodiments of the present disclosure do not limit the manner in which the members are fixedly connected to each other.

[0122] In some examples, the guide rod 12 is installed inside the screw 15, and the guide rod 12 is fixedly connected to the sheath fixed base 28, so that the sheath fixed base 28 can be driven to move by rotating the first knob 111, thereby driving the sheath 221 and the guide rod 12 to move along the axial direction.

[0123] Thus, when the sheath 221 of the second tube assembly 22 moves axially toward the proximal end with the rotation of the first knob 111, and the stabilizing tube 222 is stationary (e.g., relative to the operator) and the diameter of the stabilizing tube 222 is smaller than the diameter of the first sheath portion 221a, the sheath 221 moves to a position where the first sheath portion 221a is locked by the distal end of the stabilizing tube 222, which can be described as the sheath 221 moving to the rightmost end, and at this time, the guide rod 12 is also located at the rightmost end (e.g., the position where the guide rod 12 is located when the safety rod 131 is located at the leftmost end of the third portion track groove 121c in FIG. 5d). This state is the state where the delivery system is fully opened.

[0124] When the first knob 111 is rotated, due to the characteristics of the screw transmission, the first knob 111 can be realized to move along the axial direction of the delivery system 200, and since the first knob 111 is fixedly connected to all of the sheath fixing base 28, the sheath 221 of the second tube assembly 22, and the guide rod 12, when the first knob 111 moves along the axial direction, it drives the sheath fixing base 28 to move axially, thereby driving the sheath 221 to move axially. Since the first tube assembly 21 is fixedly connected to the third housing half 25 and the fourth housing half 26 respectively, and all of them remain stationary relative to the operator, the sheath 221 of the second tube assembly 22 moves axially relative to the first tube assembly 21, thereby completing the delivery and release of the prosthesis (e.g., a heart valve).

[0125] 10a-10c are schematic illustrations of methods of operation of a prosthesis delivery system according to some embodiments of the present disclosure.

[0126] First, as shown in FIG. 10a, when the first end of the safety rod 131 is inserted into the first partial track groove 121a, at least a part of the prosthesis (e.g., the entire prosthesis or a part of the prosthesis) (e.g., the heart valve 3) 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 gradually opens and closes when the sheath 221 of the second tube assembly 22 moves axially relative to the first tube assembly 21, thereby releasing the prosthesis or retrieving the prosthesis.

[0127] Next, as shown in FIG. 10b, when the first end of the safety rod 131 reaches one end (i.e., the distal end in the first partial track groove 121a) close to the second partial track groove 121b in the first partial track groove 121a, 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. As shown in FIG. 10b, when the first end of the safety rod 131 is restricted in position to the distal end in the first partial track groove 121a, a part 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, and at this time, the other part of the prosthesis (e.g., 75% of the prosthesis) is released outside the delivery system. The space of the second cavity A02 is smaller than the space of the first cavity A01. Of course, the embodiments of the present disclosure do not limit the percentage occupied by the released portion of the prosthesis when the position limiting position is reached, but only require that a portion of the prosthesis (i.e., 0%-100%, excluding 0% and 100% of the prosthesis) is within the cavity, and the relevant percentage of the prosthesis may be due to different prosthesis situations, and all examples will not be given or repeated herein.

[0128] As can be seen, in the illustration of Figures 10a and 10b, the cavity formed between the sheath 221 of the second tube assembly 22 and the first tube assembly 21 is open, and the prosthesis is gradually released.

[0129] For example, when the delivery device 200 reaches the state shown in FIG. 10b, that is, the guide rod 12 is restricted in position by the safety rod 131 of the safety device 13 and cannot continue to move along the axial direction, at this time, the operator can pause and judge whether the prosthesis meets the target requirements, the prosthesis will not be directly and completely released due to incorrect operation, and the operator's hands can move away from the delivery device 200 for a while to perform other surgical operations, such as angiography.

[0130] The delivery system for delivering the prosthesis according to the above-mentioned embodiments of the present disclosure has a physical position limiting device, which can effectively feed back accurate information about the release status of the prosthesis (e.g., whether the release length, release form, etc. meet the target requirements) to the operator, and present the position limiting critical point to the operator through touch (e.g., present the recoverable position critical point to the operator through touch), thereby realizing simple, efficient and accurate physical position limiting.

[0131] In some examples, when a part of the prosthesis is released, i.e., when the guide rod 12 is positionally restricted by the safety rod 131 of the safety device 13, if the operator determines that the prosthesis meets the intended requirements, the second moving member 14 is axially rotated to rotate the safety rod 131 from the distal end of the first partial track groove 121a through the second partial track groove 121b to within the third partial track groove 121c, and at this time, the guide rod 12 can continue to move axially toward the proximal end by the drive of the first knob 111, and the safety rod 13 slides relatively axially within the third partial track groove 121c to the distal end of the third partial track groove 121c, until it reaches the most distal end within the third partial track groove 121c. Then, the sheath 221 of the second tube assembly 22 is driven by the first moving member 11 to move axially relative to the first tube assembly 21, so that 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 and more of the prosthesis is released, until the whole prosthesis is completely released. That is, at this time, the prosthesis is released from the sheath 221, thereby completing the release and implantation of the prosthesis, as shown in FIG. 10c.

[0132] In some examples, the prosthesis is fully released when the safety rod 13 slides relative to the guide rod 12 to the distal-most end of the third portion track groove 121c, meaning that the delivery system is now fully open.

[0133] In addition, a case in which the prosthesis is completely released when the safety rod 13 has not slid relative to the guide rod 12 to the distal end of the third partial track groove 121c (e.g., a position close to the distal end or a central position within the third partial track groove 121c) is also included within the scope of the embodiments of the present disclosure, and the embodiments of the present disclosure are not limited thereto.

[0134] In some examples, after the safety rod 131 reaches its distal end in the third partial track groove 121c and completes the complete release of the prosthesis, the first knob 111 is controlled to rotate in the reverse direction (i.e., the first knob 111 moves axially toward the distal end), driving the sheath 221 of the second tube assembly 22 to move axially relative to the first tube assembly 21, and driving the guide rod 12 to move axially toward the distal end, thereby causing the safety rod 131 to move relatively from the third partial track groove 121c through the fourth partial track groove 121d of the position limiting groove, back into the first partial track groove 121a, and finally reaching the proximal end of the first partial track groove 121a, thereby achieving complete closure of the delivery system.

[0135] In some examples, when a part of the prosthesis is released, i.e., when the guide rod 12 is restricted in position by the safety rod 131 of the safety device 13, the operator determines that the prosthesis does not meet the intended requirements, by rotating the first knob 111 in the reverse direction, the sheath 221 of the second tube assembly 22 is driven to move to the distal end to close the cavity, thereby realizing the retrieval of the prosthesis. At this time, the operator can move or adjust the position, direction, etc. of the entire prosthesis delivery system, or perform other surgical operations such as angiography, and repeat the release and retrieval operations of the prosthesis again to completely release it until the intended requirements are met.

[0136] Thereby, the delivery system according to at least one embodiment of the present disclosure can realize the release, implantation and retrieval of the prosthesis under the condition of not being completely released, and can provide the operator with a larger fault tolerance space, thereby reducing the difficulty of the operator's operation. The delivery system according to at least one embodiment of the present disclosure can retrieve the prosthesis when the release position or shape is poor, and perform positioning and release operation again, and can continue to release the prosthesis when the release position or shape is good, which can further improve the accuracy of release, improve the implantation effect of the prosthesis, and improve the safety of retrieval.

[0137] As can be seen, the delivery method for delivering a prosthesis according to at least one embodiment of the present disclosure can achieve functions such as delivering the prosthesis, retrieving the prosthesis, releasing the prosthesis, and closing the delivery system.

[0138] 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 the prosthesis) may include more or fewer steps, and the order relationship between each step is not limited and can be determined according to actual needs. The delivery method is realized by a delivery device according to any of the above embodiments, and the content of the solution means of the delivery device related to the delivery method can be referred to the description of the above related embodiments, and will not be repeated here.

[0139] The delivery method for delivering an artificial prosthesis described below will be mainly described using an example of delivering an artificial heart valve prosthesis and opening a one-stage position limiting groove in the guide rod of the delivery system, but the delivery method of the present disclosure is not limited thereto, and the present disclosure is not limited thereto. Therefore, not all examples will be given here, and not all descriptions will be repeated.

[0140] In some examples, the operator can achieve a heart valve delivery and release function when rotating the first knob 111 to actuate the sheath 221 of the second tube assembly 22 to move axially toward the proximal end. The operator can achieve a heart valve retrieval and closing function after the delivery system is released when rotating the first knob 111 in the opposite direction to actuate the sheath 221 of the second tube assembly 22 to move axially toward the distal end.

[0141] In some instances, the method of operation for delivering a mechanical heart valve prosthesis includes one or more of the following steps.

[0142] For example, when the operator rotates the first knob 111, due to the characteristics of the screw transmission, the first knob 111 can be made to move along the axial direction of the guide rod 12, driving the sheath fixing base 28 to move axially, thereby driving the sheath 221 to move axially, and the sheath 221 of the second tube assembly 22 and the first tube assembly 21 move relative to each other in the axial direction.

[0143] For example, when the sheath 221 of the second tube assembly 22 moves to the proximal end, the cavity formed by the sheath 221 and the first tube assembly 21 gradually opens, gradually releasing the heart valve 3 inside the cavity. At the same time, the first knob 111 drives the guide rod 12 to move to the proximal end, and the safety rod 131 in the first partial track groove 121a of the guide rod 12 slides against the guide rod 12, and with the movement of the guide rod 12, the safety rod 131 moves from the proximal end in the first partial track groove 121a (in the initial state shown in FIG. 5a, the heart valve 3 is completely located in the cavity formed by the sheath 221 and the first tube assembly 21) to the distal end in the first partial track groove 121a (shown in FIG. 5b). At this time, due to the blocking effect of the inner wall of the first partial track groove 121a, when the first knob 111 is continued to be operated, the guide rod 12 is restricted in position by the safety rod 131 in the first partial track groove 121a and cannot continue to move to the proximal end, and the sheath 221 fixedly connected to the guide rod 12 cannot move to the proximal end, and the heart valve 3 cannot be further released, and at this time, the operator can be notified by touch that this position is the limit position where the heart valve 3 can be retrieved. For example, at this time, the heart valve 3 is in a 75% released state, and 25% is still in the cavity formed by the sheath 221 and the first tube assembly 21.

[0144] For example, when the operator judges that the heart valve 3 meets the target requirements (for example, the release form and position of the heart valve 3 are good or normal), he can rotate the second knob 141 to rotate the safety rod 131 from the distal end of the first partial track groove 121a through the second partial track groove 121b to the third partial track groove 121c, and the operator can continue to rotate the first knob 111, at this time, the guide rod 12 continues to move to the proximal end by the driving of the moving first knob 111, and the safety rod 13 continues to slide relatively in the third partial track groove 121c until it reaches the distal end of the third partial track groove 121c, and then, by the driving 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 continues to release the heart valve 3, until the whole heart valve 3 is completely released, completing the release and implantation of the heart valve 3, as shown in FIG. 10c.

[0145] For example, if it is determined that the heart valve 3 does not meet the intended requirements (e.g., the release morphology and position of the heart valve 3 are poor or abnormal), the first knob 111 is rotated in the reverse direction (i.e., the first knob 111 moves toward the distal end along the axial direction) and the sheath 221 of the second tube assembly 22 is driven to move toward the distal end to close the cavity, thereby achieving retrieval of the heart valve 3.

[0146] For example, when the sheath 221 moves to its proximal-most end (i.e., its right-most end), the guide rod 12 also moves to its proximal-most end, i.e., the safety rod 131 reaches its distal-most end within the third partial track groove 121c, and the delivery system is fully open, as shown in FIG. 10c. Under this condition, when it is necessary to close the delivery system, the operator drives the sheath 221 and the guide rod 12 to move axially toward the distal end by rotating the first knob 111, and as the sheath 221 and the guide rod 12 move to the central position, the safety rod 131 transitions from the third partial track groove 121c to the diagonal grooved fourth partial track groove 121d, then reaches into the first partial track groove 121a, and continues until it reaches the proximal most end of the first partial track groove 121a, whereby the second knob 141 can be driven to passively rotate to the initial position (i.e., reset), at which time the sheath 221 moves to the distal most end (i.e., the leftmost end), completely closing the delivery system and allowing it to be pulled back outside the body.

[0147] The delivery method according to at least one embodiment of the present disclosure provides a physical position limiting structure at a critical position during the release process, allowing the operator to use tactile and forced termination operations to achieve the precision of releasing at the critical position and stopping the operation, without the need to constantly observe the release length of the valve. The delivery method according to at least one embodiment of the present disclosure allows the operator to reset the second moving member when the delivery system is closed without the need to further operate it. In addition, the reset along the oblique groove during the withdrawal process of the delivery system allows the operator to easily achieve the closure of the delivery system after the valve prosthesis is completely released, without the need for further operations, making the entire surgical process safer and more efficient.

[0148] In addition, in the embodiments of the present disclosure, other related processes and technical effects of the delivery method may be referred to the above description of the delivery device, and will not be described again here.

[0149] The following points need to be explained:

[0150] (1) The drawings of the embodiments of the present disclosure only refer to structures related to the embodiments of the present disclosure, and other structures may refer to conventional designs.

[0151] (2) Where no contradiction exists, the embodiments and features of the embodiments of the present disclosure may be combined with each other to obtain new embodiments.

[0152] The above are merely specific embodiments of the present disclosure, but the scope of protection of the present disclosure is not limited thereto, and should be in accordance with the scope of protection of the claims.

Claims

1. A physical location restriction device, A first moving member; a guide rod, the guide rod being driven by the first moving member and arranged to move along the axial direction of the guide rod, the guide rod having at least one stage of position limiting grooves formed on an outer surface thereof, the at least one stage of position limiting grooves extending entirely along the axial direction of the guide rod, the position limiting grooves of each stage including first partial track grooves, second partial track grooves and third partial track grooves which are connected in order, the second partial track grooves being arranged at angles to the first partial track grooves and the third partial track grooves, respectively; a safety rod including a first end and a second end opposite to each other along a longitudinal direction of the safety rod, the first end being inserted into the position limiting groove, and the safety rod being disposed so as to be movable relative to the guide rod along the position limiting groove; a second moving member connected to a second end of the safety rod and arranged to rotate the second moving member around the safety rod about the axial direction of the guide rod, thereby moving the first end of the safety rod along the second partial track groove.

2. 2. The device described in claim 1, wherein the first partial track groove and the third partial track groove are arranged to extend along the axial direction of the guide rod, the second partial track groove is arranged to extend along the circumferential direction of the guide rod, and the second partial track groove is located between the first partial track groove and the third partial track groove in the axial direction of the guide rod.

3. 2. The device of claim 1, wherein the position limiting groove further includes a fourth partial track groove, the fourth partial track groove is arranged to allow the first end of the safety rod to pass therethrough, a distal end of the fourth partial track groove communicates with a proximal end of the third partial track groove, and a proximal end of the fourth partial track groove communicates with at least a portion of the first partial track groove, and the fourth partial track groove and the second partial track groove are not parallel to each other.

4. 4. The device according to claim 3, wherein the first partial track groove, the second partial track groove, the third partial track groove, and the fourth partial track groove define a trapezoid or a triangle.

5. 4. The device according to claim 3, wherein the at least one stage of position limiting grooves is N stages of position limiting grooves, N is an integer equal to or greater than 2, a first partial track groove of the i-th stage of the position limiting groove is connected to a third partial track groove of the (i-1)th stage of the position limiting groove, and the numerical values ​​i of the stages are denoted as 1, 2, ..., N in order from the proximal end to the distal end.

6. 10. A prosthetic delivery system including the physical position limiting device of claim 1, the delivery system further comprising: a first tube assembly positioned to receive the prosthesis; a second tube assembly including a sheath, the sheath being fitted around at least a portion of the first tube assembly, the axial directions of the sheath and the first tube assembly being parallel to or coaxial with the axial direction of the guide rod; The sheath is fixedly connected to the first moving member, such that the first moving member can drive the sheath to move axially relative to the first tube assembly.

7. The delivery system of claim 6 , wherein the safety rod is stationary relative to the first tube assembly.

8. further comprising a screw; 7. The delivery system of claim 6, wherein the first moving member includes a first knob, the first knob is fitted onto the screw, the axial directions of the first knob and the screw are both parallel to or coaxial with the axial direction of the guide rod, and the first knob has a thread therein that matches the screw to achieve threaded engagement, so that when the first knob rotates circumferentially, it achieves relative movement along the axial direction of the first tube assembly through screw transmission.

9. further comprising a first housing half, a second housing half, a third housing half, and a fourth housing half; 9. The delivery system of claim 8, wherein distal ends of the screws are fixedly connected to the first and second housing halves, respectively, and proximal ends of the screws are fixedly connected to the third and fourth housing halves, respectively, the first and second housing halves being located on opposite sides of a central axis of the delivery system and the first and second housing halves being fixedly connected to form a first housing, and the third and fourth housing halves being located on opposite sides of a central axis of the delivery system and the third and fourth housing halves being fixedly connected to form a second housing.

10. The delivery system of claim 9 , wherein the second tube assembly further comprises a stabilizing tube having a distal end fitted over at least a portion of the sheath.

11. 11. The delivery system of claim 10, wherein the sheath is a reducer, the reducer including a first sheath portion and a second sheath portion arranged in order from a distal end to a proximal end, the diameter of the first sheath portion being larger than the diameter of the second sheath portion, the distal end of the stabilizing tube being fitted onto the outside of the second sheath portion, and the diameter of the stabilizing tube being smaller than the diameter of at least a portion of the first sheath portion.

12. Further comprising a stabilizing tube fixture and a sheath fixture; the stabilizing tube extends from a distal end to the stabilizing tube fixing base, and the proximal end of the stabilizing tube is fixedly connected to the stabilizing tube fixing base, the stabilizing tube fixing base is installed inside the first housing, and the stabilizing tube fixing base is fixedly connected to the first housing half and the second housing half, respectively; the sheath extends from a distal end to the sheath fixing base, and a proximal end of the second sheath portion is fixedly connected to the sheath fixing base, and the sheath fixing base is fixedly connected to the first knob; 12. The delivery system of claim 11, wherein the guide rod is inserted into the screw, and the guide rod is fixedly connected to the sheath fixing base, such that rotation of the first knob can drive the sheath fixing base to move, and drive the sheath and the guide rod to move relative to each other along the axial direction of the first tube assembly.

13. the first tube assembly includes an inner tube and a prosthesis connecting member; the prosthesis connecting member is located on an outer surface of the distal end of the inner tube, and the prosthesis connecting member is fixedly connected to the inner tube; 12. The delivery system of claim 11, wherein the prosthesis connecting member has an engagement groove that fits over the prosthesis, thereby telescopically placing the prosthesis and releasably connecting it to the prosthesis.

14. Further including an inner pipe fixing base, 14. The delivery system of claim 13, wherein the inner tube is arranged to extend from the distal end to the inner tube fixing base proximal end side, and the inner tube is fixedly connected to the inner tube fixing base, the inner tube fixing base is installed inside the second housing, and the inner tube fixing base is fixedly connected to the third housing half and the fourth housing half, respectively.

15. 14. The delivery system of claim 13, wherein the inner tube includes a plurality of third tubes connected in sequence along the axial direction of the first tube assembly and having different hardnesses, and the sheath includes a plurality of fourth tubes connected in sequence along the axial direction of the first tube assembly and having different hardnesses.

16. 14. The delivery system of claim 13, wherein the first tube assembly further comprises an inner tube exhaust member and an end base, the inner tube exhaust member connected to a proximal end of the inner tube and the end base connected to a distal end of the inner tube.

17. Further comprising a safety connection member; the second moving member 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; 10. The delivery system of claim 9, wherein the safety connection member is fixedly connected to the second end of the safety rod and the second knob, respectively, such that rotation of the second knob can drive the safety rod to rotate about the axial direction of the guide rod.

18. 18. The delivery system of claim 17, wherein the second housing is a cylindrical body and the second knob is fitted to an outer surface of the cylindrical body, such that the second knob cannot move axially along the guide rod but can rotate around the axial direction of the guide rod.

19. 7. The delivery system of claim 6, wherein the prosthesis comprises a prosthetic heart valve, a coated stent, or a vascular graft.

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