A conveying system

Abstract

This invention relates to a conveying system, which includes a sheath assembly and a handle assembly. The sheath assembly includes an outer sheath and an inner sheath, with the outer sheath sleeved over the inner sheath and the distal end of the inner sheath disposed within the outer sheath. The handle assembly includes a sliding assembly and an elastic element. The sliding assembly includes a driving element, an outer tube connector, and an inner tube connector. The proximal end of the outer sheath is connected to the inner tube connector after passing through it, and the proximal end of the inner sheath is connected to the inner tube connector. The elastic element is disposed at the proximal end of the driving element. When a force is applied, the driving element moves towards its proximal end, causing the outer tube connector to move towards its proximal end. The elastic element deforms, and the movement of the outer tube connector causes the outer sheath to move towards its proximal end. When the force is removed, the outer sheath and the outer tube connector remain stationary relative to the handle assembly. The elastic element returns to its original shape and causes the driving element to move towards its distal end to reset. Subsequently, when a force is applied again, the driving element moves towards its proximal end, causing the inner tube connector to move towards its proximal end. The elastic element deforms, and the movement of the inner tube connector causes the inner sheath to move towards its proximal end. The delivery system of this invention can quickly connect native blood vessels and artificial blood vessels, improve surgical efficiency, effectively shorten surgical time, and provide convenient and quick visual operation.

Description

Technical Field

[0001] This invention relates to the field of interventional medicine, and more specifically to a delivery system. Background Technology

[0002] Medical delivery systems are widely used in surgical treatments. Their main function is to compress and fix a stent via a delivery device, then insert it into the body through minimally invasive interventions, surgical procedures, and auxiliary pathways to deliver the stent to the lesion site for treatment. Common aortic arch diseases include aortic aneurysms (dissecting aneurysms, pseudoaneurysms, intramural hematomas), atherosclerosis, aortic dissection, and aortic ulcers. Aortic diseases are primarily treated surgically. Current treatment methods include ascending aortic replacement surgery and artificial vascular aortic arch replacement with stent placement (Sun's procedure). These surgeries require open-chest surgery, cardiac arrest, and the establishment of cardiopulmonary bypass to replace or block blood flow to the lesion site in order to achieve the surgical goal. This is mainly due to the complex structure of the aorta, making some areas difficult to access internally, increasing surgical time and the risk of complications. These complications can include prolonged cardiopulmonary bypass, brain injury, insufficient blood supply to the lower limbs and spine, thrombosis, or kidney failure. Meanwhile, the existing methods of connecting native blood vessels to artificial blood vessels require a lot of time and involve complex and numerous steps, further increasing the surgeon's operation time, difficulty, and complexity. Therefore, there is an urgent need to shorten the operation time. Summary of the Invention

[0003] To overcome the problems existing in the prior art, the present invention provides a conveying system.

[0004] The present invention provides a conveying system that solves the technical problem by including a sheath assembly and a handle assembly. The sheath assembly includes an outer sheath and an inner sheath, with the outer sheath sleeved over the inner sheath and the distal end of the inner sheath disposed within the outer sheath. The handle assembly includes a sliding assembly and an elastic element. The sliding assembly includes a driving element, an outer tube connector, and an inner tube connector. The proximal end of the outer sheath passes through the inner tube connector and connects to it. The proximal end of the inner sheath is connected to the inner tube connector. The elastic element is disposed within the driving element. The force is applied to the proximal and / or distal ends of the component; a force is applied to move the drive component proximal to the proximal end and drive the outer tube connector proximal to the proximal end, the elastic element deforms, and the movement of the outer tube connector can drive the outer sheath tube proximal to the proximal end. After the force is removed, the outer sheath tube and the outer tube connector are stationary relative to the handle assembly, the elastic element returns to its original shape and drives the drive component to move distal to the repositioning point, and then a force is applied again to move the drive component proximal to the proximal end and drive the inner tube connector proximal to the proximal end, the elastic element deforms, and the movement of the inner tube connector can drive the inner sheath tube proximal to the proximal end.

[0005] In some embodiments of the present invention, the sliding component further includes a button, the driving component includes a driving engagement part, a driving body and a driving snap-fit ​​part, the driving engagement part is disposed on the side of the driving body away from the sheath assembly, the driving engagement part is connected to the button, the driving snap-fit ​​part is disposed on the side of the driving body close to the sheath assembly, and the driving snap-fit ​​part can snap-fit ​​with the outer tube connector or the inner tube connector.

[0006] In some embodiments of the present invention, the driving member further includes a driving passage portion, which is disposed on the side of the driving body near the sheath assembly along the axial direction of the sheath assembly, and the driving passage portion is disposed on the central axis of the driving body along the axial direction, and the driving engagement portion is disposed on the side of the driving passage portion.

[0007] In some embodiments of the present invention, the outer tube connector includes a first body, a first through portion, and a first mating portion. The first through portion is disposed on the side of the first body near the sheath assembly and is disposed on the central axis of the first body in the axial direction. The first mating portion is disposed in the proximal end of the first through portion and can be housed in the proximal end of the drive through portion. The side of the first body near the drive member is recessed in a direction away from the drive member to form a first snap-fit ​​portion, and the drive snap-fit ​​portion can cooperate with the first snap-fit ​​portion.

[0008] In some embodiments of the present invention, the handle assembly further includes a housing, in which the proximal ends of the elastic member, the drive member, the outer tube connector, the inner tube connector, and the sheath assembly are all housed. One end of the elastic member abuts against the distal end face of the drive body, and the other end abuts against the distal end of the housing, and / or one end of the elastic member abuts against the proximal end face of the drive body, and the other end abuts against the proximal end of the housing.

[0009] In some embodiments of the present invention, the inner tube connector includes a second body, a second through portion, and a second snap-fit ​​portion. The second through portion extends axially from the distal end face of the second body through the proximal end face of the second body and extends to the proximal end of the second body. The second through portion is disposed on the center line in the axial direction of the second body. The proximal end face of the second body extends to the proximal end to form a second snap-fit ​​portion, which can snap-fit ​​with the drive snap-fit ​​portion.

[0010] In some embodiments of the present invention, a retaining ring is provided on the inner wall of the housing near the inner tube connector, and the second main body is recessed in the direction of the retaining ring toward the driving member to form a retaining ring engaging portion, the retaining ring being able to engage with the retaining ring engaging portion, and a portion of the retaining ring being exposed on the side of the retaining ring engaging portion; an unlocking portion is provided on the side of the driving main body extending toward the retaining ring, and a portion of the unlocking portion being able to contact the retaining ring exposed on the retaining ring engaging portion.

[0011] In some embodiments of the present invention, the proximal end of the unlocking part is connected to the driving body, the distal end of the unlocking part is a free end, the distal end of the driving latching part is connected to the driving body, the proximal end of the driving latching part is a free end, and the free end of the distal end of the unlocking part is closer to the distal end than the free end of the proximal end of the driving latching part.

[0012] In some embodiments of the present invention, the proximal end of the outer sheath tube facing the inner tube connector is cut axially to form a cut segment, the portion of the inner sheath tube overlapping the cut segment is exposed outside the outer sheath tube, the proximal end of the cut segment passes through the drive passage and the first passage and enters the first mating part to connect with the first mating part, and the portion of the proximal end of the inner sheath tube exposed outside the outer sheath tube is connected with the second passage.

[0013] In some embodiments of the present invention, in the initial state, the driving engagement portion engages with the first engagement portion, the second passage portion is housed within the first passage portion, the second engagement portion is disposed on the side of the first engagement portion away from the driving member, and the retaining spring engages with the retaining spring engagement portion; after the driving member moves towards the proximal end, causing the outer tube connector and the outer sheath to move towards the proximal end, the outer tube connector and the outer sheath remain stationary, and the driving member resets towards the distal end; after the driving member resets, the unlocking portion contacts the retaining spring exposed in the retaining spring engagement portion, causing the retaining spring to deform and separate from the retaining spring engagement portion, and the second engagement portion engages with the driving engagement portion. At this time, the driving member moves towards the proximal end, causing the inner tube connector and the inner sheath to move towards the proximal end.

[0014] In some embodiments of the present invention, after the movement of the outer tube connector causes the outer sheath to move proximally, the distal end of the outer sheath is located on the proximal side of the distal end of the inner sheath; or after the movement of the outer tube connector causes the outer sheath to move proximally, the distal end face of the outer sheath and the distal end face of the inner sheath are located on the same plane, and then the drive member moves proximally, causing the inner sheath and the outer sheath to move proximally together.

[0015] In some embodiments of the present invention, the delivery system further includes an implantation device, wherein the distal end of the inner sheath is disposed within the outer sheath, the implantation device includes a body and an action portion disposed on the outer surface of the body, the proximal end of the body is housed within the distal end of the inner sheath, and the distal end of the body and the action portion are exposed at the distal end of the inner sheath and housed within the outer sheath.

[0016] In some embodiments of the present invention, the portion of the proximal end of the implantable device housed in the inner sheath accounts for 1 / 4 to 3 / 4 of the overall volume of the implantable device, and the portion of the distal end of the implantable device housed in the outer sheath accounts for 3 / 4 to 1 / 4 of the overall volume of the implantable device.

[0017] Compared with existing technologies, the delivery system of the present invention has the following advantages: it simplifies the complex suturing method of directly suturing native and artificial blood vessels, reducing the difficulty of surgery and the time required for suturing. Simultaneously, it eliminates the need for alignment of the native and artificial blood vessels; after stent release, the stent provides support for the native blood vessel, facilitating suturing and reducing the overall difficulty and risk of the surgery. Furthermore, the two-stage stent release design reduces the stroke during button-release, thereby reducing the axial length of the handle assembly and its overall volume. This makes the handle assembly more compact and lightweight, easier for the surgeon to hold and operate during surgery, reducing the difficulty of the procedure. Simultaneously, the two-stage release design ensures accurate connection between the native and artificial blood vessels, preventing accidental release of the stent without completing the connection between the native and artificial blood vessels compared to a single-stage release handle. It also reduces the gap at the junction of the native and artificial blood vessels, minimizing the stent length and reducing adverse reactions such as inflammation and foreign body sensation in patients. Attached Figure Description

[0018] Figure 1 This is a three-dimensional structural diagram of the conveying system provided in an embodiment of the present invention.

[0019] Figure 2 This is an exploded structural diagram of the conveying system provided in an embodiment of the present invention.

[0020] Figure 3 This is an exploded structural diagram of the sliding component of the conveying system provided in an embodiment of the present invention.

[0021] Figure 4 This is a schematic diagram of the release bracket state of the conveying system provided in an embodiment of the present invention.

[0022] Figure 5 This is a schematic diagram of another release bracket state of the conveying system provided in an embodiment of the present invention.

[0023] Figure 6 This is a three-dimensional structural diagram of the drive component and outer tube connector of the conveying system provided in the embodiment of the present invention.

[0024] Figure 7 This is a three-dimensional structural diagram of the inner tube connector and the outer tube connector of the conveying system provided in the embodiment of the present invention.

[0025] Figure 8 This is a three-dimensional structural diagram of the housing and retaining ring of the conveying system provided in an embodiment of the present invention.

[0026] Figure 9 This is a three-dimensional structural diagram of the cooperation between the snap ring and the inner tube connector of the conveying system provided in the embodiment of the present invention.

[0027] Figure 10 This is a schematic diagram of the connection between the proximal end of the sheath assembly of the delivery system provided in this embodiment of the invention and the outer tube connector and the inner tube connector.

[0028] Figure 11 This is a schematic diagram of the structure of the conveying system provided in this embodiment of the invention after the drive component and the outer tube connector have moved.

[0029] Figure 12 This is a top view of the drive component, outer tube connector, inner tube connector, and housing of the conveying system provided in this embodiment of the invention.

[0030] Figure 13 yes Figure 12 A schematic diagram of the cross-sectional structure along the middle AA.

[0031] Figure 14 This is a schematic diagram of the structure of the conveying system provided in this embodiment of the invention, after the drive component is reset and connected to the inner tube connector.

[0032] Figure 15 This is a schematic diagram of the implantation device of the delivery system provided in an embodiment of the present invention.

[0033] Explanation of reference numerals in the attached drawings: 100, conveying system; 1, sheath assembly; 11, outer sheath; 111, cutting section; 12, inner sheath; 2, handle assembly; 21, sliding assembly; 211, driving component; 2110, mounting part; 2111, driving body; 2112, driving mating part; 2113, driving locking part; 2114, driving passage part; 2115, unlocking part; 212, outer tube connector; 2121, first body; 2122, second... 2123. First connecting part; 2124. First snap-fit ​​part; 213. Inner tube connector; 2131. Second main body; 2132. Second connecting part; 2133. Second snap-fit ​​part; 2134. Snap-fit ​​part main body; 2135. Snap-fit ​​groove; 2136. Snap-fit ​​spring; 214. Button; 22. Elastic element; 23. Housing; 231. Snap-fit ​​spring; 232. Slide rail; 10. Bracket; 101. Main body bracket; 102. Skirt. Detailed Implementation

[0034] Exemplary embodiments of the invention will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the invention and to fully convey the scope of the invention to those skilled in the art.

[0035] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0036] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0037] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0038] To more clearly describe the structure of this application, the terms "proximal" and "distal" are used herein as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end furthest from the operator during the surgical procedure, "proximal" refers to the end closest to the operator during the surgical procedure, "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial".

[0039] Please see Figure 1This invention provides a delivery system 100 for delivering implantable devices, such as heart valves, occluders, and vascular stents, into the human body. The delivery system 100 is particularly suitable for the docking of native and artificial blood vessels during aortic arch surgery. The following detailed description uses the docking of native and artificial blood vessels during aortic arch surgery as an example. The delivery system 100 includes a sheath assembly 1 and a handle assembly 2. The sheath assembly 1 includes an outer sheath 11 and an inner sheath 12. The outer sheath 11 is sleeved outside the inner sheath 12, and the distal end of the inner sheath 12 is disposed within the outer sheath 11. The outer sheath 11 and the inner sheath 12 are coaxially arranged. The outer sheath 11 and the inner sheath 12 can move axially relative to each other. The stent to be implanted into the human body can be partially installed within the distal end of the inner sheath 12 and partially installed within the distal end of the outer sheath 11.

[0040] Please see Figure 2 and Figure 3 The handle assembly 2 includes a sliding assembly 21 and an elastic element 22. The sliding assembly 21 includes a driving element 211, an outer tube connector 212, and an inner tube connector 213. The proximal end of the outer sheath 11 is connected to the outer tube connector 212 after passing through the inner tube connector 213, and the proximal end of the inner sheath 12 is connected to the inner tube connector 213. The elastic element 22 is disposed at the proximal end and / or distal end of the driving element 211. A force is applied to move the drive member 211 proximally, causing the elastic member 22 to deform and move the outer tube connector 212 proximally. The movement of the outer tube connector 212 causes the outer sheath 11 to move proximally. After the force is removed, the outer sheath 11 remains stationary relative to the handle assembly 2. The elastic member 22 returns to its original shape and moves the drive member 211 distally to reset. Subsequently, a force is applied again to move the drive member 211 proximally and move the inner tube connector 213 proximally. The elastic member 22 deforms, and the movement of the inner tube connector 213 causes the inner sheath 12 to move proximally.

[0041] In a specific embodiment of the present invention, the elastic element 22 is disposed at the proximal end of the driving element 211. The elastic element 22 is a spring structure, and the distal end of the elastic element 22 is connected to the proximal end of the driving element 211. The proximal end of the elastic element 22 is connected to the inner wall of the proximal end of the handle assembly 2. A force is applied to move the driving element 211 towards the proximal end and compress the elastic element 22. The movement of the driving element 211 towards the proximal end causes the outer tube connector 212 to move towards the proximal end. The movement of the outer tube connector 212 towards the proximal end causes the outer sheath tube 11 to move towards the proximal end, thereby releasing the bracket housed in the distal end of the outer sheath tube 11. Subsequently, the force applied to the driving element 211 is removed, and the elastic element 22 returns to its original state, thereby causing the driving element 211 to return to its distal end. The driving element 211 can move along the sheath tube assembly 1 as a guide rail. The drive member 211 moves distally under the restoring force of the elastic member 22, but does not drive the outer tube connector 212 distally. Furthermore, the force of the elastic member 22 restoring its original shape does not act on the outer tube connector 212. Therefore, after the force applied to the drive member 211 is removed, the drive member 211 returns to its distal position, and the outer sheath 11 and outer tube connector 212 remain stationary. Only the portion of the stent located distal to the outer sheath 11 is released. At this point, the released stent portion and the native blood vessel can be simply sutured, thus connecting the stent to the native blood vessel. Subsequently, force can be applied to the drive member 211 to move proximally, causing the inner tube connector 213 to drive the inner sheath 12 proximally. The proximal movement of the inner sheath 12 releases the stent portion installed within it, thus completely releasing the stent. At this point, the completely released stent and the artificial blood vessel can be simply sutured, thus completing the connection between the native blood vessel and the artificial blood vessel through the stent. In other specific embodiments of this invention, the elastic element 22 may also be disposed on the distal end side of the driving element 211, that is, the proximal end of the elastic element 22 is connected to the distal end face of the driving element 211, and the distal end of the elastic element 22 is connected to the inner wall of the distal end of the handle assembly 2. When the driving element 211 moves towards the proximal end, the elastic element 22 stretches and deforms; when the driving element 211 returns to its original shape towards the distal end, the elastic element 22 restores its original shape and pulls the driving element 211 back to its distal end. The elastic element 22 may also be disposed simultaneously at both the distal and proximal ends of the driving element 211, that is, at least two elastic elements 22 are included, one of which is disposed at the distal end of the driving element 211, and the other of which is disposed at the proximal end of the driving element 211.

[0042] It should be noted that, in a specific embodiment of the present invention, the distal portion of the stent to be implanted into the human body is bound and installed within the outer sheath 11, and the proximal portion is bound and installed within the distal end of the inner sheath 12. To ensure that the stent can be completely released, after the movement of the outer tube connector 212 causes the outer sheath 11 to move proximally, the distal end of the outer sheath 11 is located on the proximal side of the distal end of the inner sheath 12, that is, at this time the distal end of the inner sheath 12 is exposed beyond the distal end of the outer sheath 11, as shown below. Figure 4 As shown. This ensures that the portion of the stent housed distal to the outer sheath 11 can be fully released, and that the portion of the stent housed distal to the inner sheath 12 is not obstructed by the distal end of the outer sheath 11 during release. Subsequently, when a force is applied to move the drive member 211 proximally, the drive member 211 only moves the inner tube connector 213 and the inner sheath 12 proximally, thereby releasing the portion of the stent housed within the inner sheath 12. Alternatively, when a force is applied to move the drive member 211 proximally, the drive member 211 moves both the inner sheath 12 and the outer sheath 11 proximally simultaneously. In other specific embodiments of this invention, after the outer tube connector 212 moves the outer sheath 11 towards its proximal end, the distal end face of the outer sheath 11 and the distal end face of the inner sheath 12 are located on the same plane. That is, at this time, the distal end face of the inner sheath 12 is not exposed beyond the distal end face of the outer sheath 11, and the distal end face of the inner sheath 12 is flush with the distal end face of the outer sheath 11. Figure 5 As shown. At this time, the portion of the support stored at the distal end of the outer sheath tube 11 has been released. Subsequently, the drive member 211 moves towards the proximal end, causing the inner sheath tube 12 and the outer sheath tube 11 to move towards the proximal end together, thereby releasing the portion of the support stored in the inner sheath tube 12.

[0043] The first embodiment of this invention provides a delivery system 100 that connects the native and artificial blood vessels through a simple suturing method using a stent. This simplifies the complex suturing process of directly suturing the native and artificial blood vessels, reducing the difficulty of the surgery and the time required for suturing. Furthermore, directly suturing the artificial and native blood vessels is difficult due to the softness and poor support of the native vessels, making alignment challenging and potentially damaging. By connecting the native and artificial blood vessels with a stent, the system simply delivers the stent to the designated position and then releases it, eliminating the need for alignment. After release, the stent provides support for the native blood vessel, facilitating suturing and reducing the overall difficulty and risk of the surgery. Moreover, the two-stage stent release design reduces the travel of the button 214 during stent release, thereby reducing the axial length and overall volume of the handle assembly 2. This makes the handle assembly 2 more compact and lightweight, easier for the surgeon to hold and operate during surgery, and reduces the difficulty of the surgical procedure. Simultaneously, after the first stent release, the distal end of the stent is positioned within the native blood vessel, completing the connection between the stent and the native vessel. If necessary, the position of the artificial blood vessel can be adjusted so that the ends of the native and artificial blood vessels abut against each other, allowing for a second stent release to complete the connection. This two-stage release design ensures accurate connection between the native and artificial blood vessels, preventing accidental release by the physician without completing the connection between the native and artificial blood vessels. It also reduces the gap at the junction of the native and artificial blood vessels, minimizing stent length and reducing adverse reactions such as inflammation and foreign body sensation in patients. Furthermore, the invention includes an inner sheath 12 and an outer sheath 11. The stent is loaded in segments onto the inner and outer sheaths, and the segmented release of the inner and outer sheaths facilitates the loading of variable-diameter stents and stents with skirts. For example, if a variable-diameter bracket is used, the smaller diameter section can be installed inside the inner sheath 12, while the larger diameter section is exposed outside the distal end of the inner sheath 12 and installed inside the distal end of the outer sheath 11. This arrangement ensures stable release of the variable-diameter bracket. When the outer sheath 11 is retracted to release the larger diameter section of the bracket, the inner sheath 12 provides positioning and fixation, preventing the bracket from moving during retraction. Alternatively, if a bracket with a skirt is used, the skirt and the distal end of the bracket can be exposed outside the distal end of the inner sheath 12. The distal end of the inner sheath 12 abuts against the skirt, thus positioning and fixing the bracket and reducing the force required for release.

[0044] It should be noted that the delivery system 100 is also applicable to the delivery of medical devices such as occluders and heart valves. For example, when delivering an occluder, the two-stage release structure can precisely release one occluder disc of the occluder before releasing the remaining occluder disc.

[0045] Please see Figure 1 - Figure 3The sliding component 21 further includes a button 214. The driving component 211 includes a driving body 2111, a driving mating part 2112, and a driving engaging part 2113. The driving mating part 2112 is disposed on the side of the driving body 2111 away from the sheath assembly 1, and the driving mating part 2112 is connected to the button 214. The driving engaging part 2113 is disposed on the side of the driving body 2111 near the sheath assembly 1, and the driving engaging part 2113 can engage with the outer tube connector 212 or the inner tube connector 213. The driving component 211 also includes a driving passage part 2114, which is disposed along the axial direction of the sheath assembly 1 on the side of the driving body 2111 near the sheath assembly 1, and the driving passage part 2114 is disposed on the central axis of the driving body 2111 along the axial direction. The driving engaging part 2113 is disposed on the side of the driving passage part 2114. Specifically, the driving engagement part 2112 is a protrusion on the outer surface of the driving body 2111. The button 214 can be connected to the driving engagement part 2112 by means of adhesive, snap-fit, or sleeve. The user can apply force to the button 214 to move the button 214 in the axial direction, thereby driving the driving component 211 to move in the axial direction. The driving snap-fit ​​part 2113 extends from the side of the driving body 2111 near the sheath assembly 1 towards the direction away from the driving body 2111. That is, the driving snap-fit ​​part 2113 is a strip-shaped structure with one end fixedly connected to the driving body 2111 and the other end being a free end. Therefore, when the free end of the driving snap-fit ​​part 2113 is subjected to a force in the direction of the driving body 2111, the driving snap-fit ​​part 2113 can deform, causing the free end of the driving snap-fit ​​part 2113 to move closer to the driving body 2111. The drive engagement portion 2113 can enter the outer tube connector 212 or the inner tube connector 213 and engage with it. It can also deform to separate from the outer tube connector 212 or the inner tube connector 213. The drive passage portion 2114 has an arc-shaped structure and is used for the passage of the outer sheath tube 11 and the proximal end of the inner sheath tube 12. There are two drive engagement portions 2113, each located on one side of the drive passage portion 2114, to ensure stability when engaged with the outer tube connector 212 or the inner tube connector 213.

[0046] Please see Figure 3 , Figure 6 and Figure 7The outer tube connector 212 includes a first body 2121, a first through portion 2122, and a first mating portion 2123. The first through portion 2122 is disposed on the side of the first body 2121 near the sheath assembly 1, and is located on the central axis of the first body 2121 along the axial direction. The first mating portion 2123 is disposed within the proximal end of the first through portion 2122 and can be housed in the proximal end of the drive through portion 2114. A first locking portion 2124 is recessed on the side of the first body 2121 near the drive member 211 in a direction away from the drive member 211, and the drive locking portion 2113 can engage with the first locking portion 2124. Specifically, the drive member 211 is disposed close to the first connector, and the side of the drive member 211 near the first connector is in contact with the side of the first connector near the drive member 211. The first passage portion 2122 has an arc-shaped structure. The first passage portion 2122 and the driving passage portion 2114 together form a roughly cylindrical cavity for the proximal ends of the outer sheath 11 and the inner sheath 12 to pass through. Simultaneously, the first mating portion 2123 is disposed within the cavity and is used to connect with the proximal end of the outer sheath 11. The first passage portion 2122 and the driving passage portion 2114 are coaxially arranged. There are two first locking portions 2124, each disposed on one side of the first passage portion 2122. The free ends of the two driving locking portions 2113 can respectively enter the two first locking portions 2124. The end faces of the free ends of the driving locking portions 2113 can abut against the inner walls of the first locking portions 2124, and the end faces of the free ends of the driving locking portions 2113 are closer to the distal end than the inner walls of the first locking portions 2124. Therefore, when the drive member 211 moves towards the proximal end, the drive engagement portion 2113 located at the distal end abuts against the first engagement portion 2124 which is closer to the proximal end, thereby driving the outer tube connector 212 to move towards the proximal end. The outer sheath tube 11 is connected to the first mating portion 2123, so when the outer tube connector 212 moves, it can drive the outer sheath tube 11 to move. When the force applied to the drive member 211 is removed, the elastic member 22 drives the drive member 211 to return to its distal end, and the drive engagement portion 2113 deforms, causing the free end of the drive engagement portion 2113 to approach the drive body 2111, thereby causing the drive engagement portion 2113 to move from inside the first engagement portion 2124 to outside the first engagement portion 2124, thereby separating the first engagement portion 2124 from the drive engagement portion 2113. Therefore, the resetting of the drive component 211 to the distal end will not cause the outer tube connector 212 to move to the distal end. The outer tube connector 212 and the outer sheath 11 remain stationary, while the drive component 211 moves to the distal end.

[0047] Please continue reading. Figure 2 and Figure 3 The handle assembly 2 further includes a housing 23, within which the elastic element 22, drive element 211, outer tube connector 212, inner tube connector 213, and the proximal end of the sheath assembly 1 are all housed. The drive element 211 has a cylindrical mounting portion 2110 at its proximal end, and the distal end of the elastic element 22 is fitted onto the mounting portion 2110, with the proximal end of the elastic element 22 abutting against the proximal inner wall of the housing 23. And / or the drive element 211 has a cylindrical mounting portion 2110 at its distal end, the proximal end of the elastic element 22 is fitted onto the mounting portion 2110, and the distal end of the elastic element 22 abuts against the distal inner wall of the housing 23. Please refer to... Figure 2 , Figure 3 and Figure 7 The inner tube connector 213 includes a second body 2131, a second passage portion 2132, and a second engaging portion 2133. The second passage portion 2132 extends axially from the distal end face of the second body 2131, through the proximal end face of the second body 2131, and to the outside of the proximal end of the second body 2131. The second passage portion 2132 is disposed on the centerline of the second body 2131 in the axial direction. The proximal end face of the second body 2131 extends proximally to form the second engaging portion 2133, which can engage with the driving engaging portion 2113. Specifically, the second body 2131 is disposed at the distal end of the outer tube connector 212, the proximal end of the second passage portion 2132 extends into the first passage portion 2122, and the second engaging portion 2133 is disposed on the side of the first engaging portion 2124 away from the driving member 211. The proximal end of the outer sheath 11 passes through the second passage 2132 and enters the first mating part 2123, while the proximal end of the inner sheath 12 is connected to the second passage 2132. The second locking part 2133 includes a locking part body 2134 and a locking groove 2135, with the locking part body 2134 recessed away from the driving member 211 to form the locking groove 2135. Similarly, when the driving locking part 2113 engages with the second locking part 2133, the end face of the free end of the driving locking part 2113 is closer to the distal end than the inner wall of the second locking part 2133. Consequently, when the driving member 211 moves towards the proximal end, the end face of the free end of the driving locking part 2113 abuts against the inner wall of the second locking part 2133, thereby driving the inner tube connector 213 to move towards the proximal end. In a specific embodiment of the present invention, the second passage portion 2132 is coaxially arranged with the driving passage portion 2114 and the first passage portion 2122 to ensure the alignment of the outer sheath tube 11 and the proximal end of the inner sheath tube 12 when they pass through each other.

[0048] It should be noted that when the drive engagement portion 2113 engages with the first engagement portion 2124, the drive engagement portion 2113 has already deformed towards the drive body 2111. That is, the drive engagement portion 2113 engages with the first engagement portion 2124 only after deforming towards the drive body 2111. Therefore, after the drive engagement portion 2113 loses engagement with the first engagement portion 2124, the drive engagement portion 2113 will reset towards the second engagement portion 2133, thereby ensuring that when the drive member 211 resets towards the distal end, the drive engagement portion 2113 can engage with the second engagement portion 2133, which is farther away than the first engagement portion 2124. Furthermore, to ensure that the resetting of the driving component 211 to the distal end does not cause the outer tube connector 212 and the inner tube connector 213 to move to the distal end, a magnetic structure can be provided on the inner wall of the near end of the housing 23, and a magnetic structure can be provided at the near end of the outer tube connector 212 and the inner tube connector 213. After the driving component 211 moves the outer tube connector 212 or the inner tube connector 213 to the near end, the magnetic structure of the outer tube connector 212 or the inner tube connector 213 will magnetically engage with the magnetic structure on the inner wall of the housing 23, thereby causing the outer tube connector 212 or the inner tube connector 213 to be adsorbed on the inner wall of the housing 23 and not affected by the resetting of the driving component 211 to the distal end.

[0049] Please see Figure 6 - Figure 9 The housing 23 has a retaining ring 231 and a slide rail 232 on its inner wall near the inner tube connector 213. The slide rail 232 is axially oriented and provides support for the outer tube connector 212 and the inner tube connector 213, allowing them to move along the slide rail 232. The second body 2131 has a recessed retaining ring engagement portion 2136 on its side facing the drive member 211. The retaining ring 231 engages with the retaining ring engagement portion 2136, with a portion of the retaining ring 231 exposed on the side of the retaining ring engagement portion 2136. The engagement of the retaining ring 231 with the retaining ring engagement portion 2136 restricts the movement of the inner tube connector 213 towards its proximal end. The drive body 2111 has an unlocking portion 2115 extending towards the retaining ring 231 on its side, and part of the unlocking portion 2115 can contact the retaining ring 231 exposed in the retaining ring engaging portion 2136. Further, please refer to... Figure 10To enable relative movement between the outer sheath 11 and the inner sheath 12, the proximal end of the outer sheath 11 facing the inner tube connector 213 is axially cut to form a cut segment 111. The portion of the inner sheath 12 overlapping with the cut segment 111 is exposed outside the outer sheath 11. The proximal end of the cut segment 111 passes through the drive passage 2114 and the first passage 2122 and enters the first mating part 2123, connecting with the first mating part 2123. The portion of the proximal end of the inner sheath 12 exposed outside the outer sheath 11 is connected to the second passage 2132.

[0050] Please see Figure 11 - Figure 14 In a specific embodiment of the present invention, the overall working process of the conveying system 100 is as follows: In the initial state, the drive engagement part 2113 engages with the first engagement part 2124, the second passage part 2132 is housed within the first passage part 2122, the second engagement part 2133 is disposed on the side of the first engagement part 2124 away from the drive member 211, the retaining spring 231 engages with the retaining spring engagement part 2136, the cutting segment 111 passes through the drive passage part 2114 and enters the first mating part 2123 and is fixedly connected to the first mating part 2123, and the portion of the inner sheath tube 12 protruding from the outer sheath tube 11 can be fixed within the second passage part 2132 by means of adhesive application. Driving the button 214 to move towards the proximal end causes the drive member 211 to move towards the proximal end, causing the elastic member 22 to deform. After the driving member 211 moves the outer tube connector 212 and the outer sheath 11 towards the proximal end, since only the cutting segment 111 is connected to the first mating part 2123, the movement of the outer tube connector 212 will only drive the outer sheath 11 to move. The outer sheath 11 will move towards the proximal end relative to the inner sheath 12, thereby completing the first stage release of the stent (e.g., Figure 11 (As shown). After the external force applied to the driving member 211 is removed, the elastic member 22 returns to its original state, causing the driving member 211 to reset towards the distal end. At this time, the driving engagement part 2113 separates from the first engagement part 2124, and the movement of the driving member 211 towards the distal end will not cause the first engagement part 2124 to move. After the driving member 211 resets towards the distal end, the button 214 can be pushed towards the distal end again, so that the driving member 211 moves a small distance towards the distal end. Then, the unlocking part 2115 contacts the retaining spring 231. After the unlocking part 2115 contacts the retaining spring 231, the retaining spring 231 moves away from the retaining spring engagement part 2136 and deforms. The deformation of the retaining spring 231 causes the retaining spring 231 to disengage from the retaining spring engagement part 2136 (as shown). Figure 12(As shown in -14). At this time, the inner tube connector 213 is no longer restricted by the retaining spring 231, and the inner tube connector 213 can move towards the proximal end. After the driving member 211 is moved a short distance towards the distal end, the driving engagement part 2113 engages with the second engagement part 2133. At this time, the driving engagement part 2113 engages in the engagement groove 2135 (that is, the unlocking part 2115 first contacts the retaining spring 231, and then the driving engagement part 2113 engages with the second engagement part 2133; the free end of the distal end of the unlocking part 2115 is closer to the distal end than the free end of the proximal end of the driving engagement part 2113). At this time, the button 214 can be moved towards the proximal end, causing the driving member 211 to move towards the proximal end. The movement of the driving member 211 towards the proximal end will drive the inner tube connector 213 to move. Furthermore, since the unlocking part 2115 and the retaining ring 231 are still in contact at this time, the retaining ring 231 will not return to its original state and re-engage with the retaining ring engaging part 2136. Until the unlocking part 2115 moves proximally away from the retaining ring 231, the retaining ring engaging part 2136 has already passed proximally past the retaining ring 231, and the retaining ring 231 can no longer enter the retaining ring engaging part 2136. Therefore, the driving member 211 moves proximally, which will drive the inner tube connector 213 to move proximally. Since the portion of the inner sheath 12 proximally exposed outside the outer sheath 11 is connected to the second passage part 2132, the movement of the inner tube connector 213 will only drive the inner sheath 12 to move relative to the outer sheath 11. This completes the second stage release of the stent.

[0051] In other specific embodiments of the present invention, when the second segment of the support is released, the button 214 can be pressed towards the inner tube connector 213, causing the drive member 211 to move towards the cutting segment 111, thereby pressing the cutting segment 111 against the outer surface of the inner sheath tube 12. Moving the button 214 proximally at this time will cause the outer sheath tube 11 and the inner sheath tube 12 to move simultaneously towards the proximal end, thus achieving simultaneous proximal movement of the inner sheath tube 12 and the outer sheath tube 11.

[0052] Please see Figure 14 and Figure 15The delivery system further includes an implantation device, which includes a main body and an active part disposed on the outer surface of the main body. The proximal end of the main body is housed within the distal end of the inner sheath, while the distal end of the main body and the active part are exposed at the distal end of the inner sheath and housed within the outer sheath. In a specific embodiment of the present invention, the implantation device is exemplified by a stent, and the main body is the stent's main body. The active part disposed on the outer surface of the implantation device is exemplified by a skirt. To facilitate the suturing connection of the stent with native and artificial blood vessels, and the positioning of the stent when connected to native and artificial blood vessels, the delivery system 100 further includes a stent 10, which includes a main stent 101 and a skirt 102 disposed on the outer surface of the main stent 101. In a first embodiment of the present invention, a covering (not shown) is disposed on the main stent 101, which may be disposed on the inner surface, outer surface, or both surfaces of the main stent 101. Multiple skirts 102 are evenly disposed circumferentially on the main stent 101. One end of the skirt 102 is connected to the main stent 101, and the other end is free. During the first release of the stent 10, the skirt 102 is already exposed outside the outer sheath 11. At this point, the skirt 102 and the native blood vessel can be sutured together, thus connecting the stent 10 to the native blood vessel. Simultaneously, the distal end of the inner sheath 12 rests against the skirt 102, ensuring that the stent 10 does not shift proximally during suturing, thus ensuring accurate stent release and suturing. The skirt 102 facilitates the surgeon's suturing of the stent 10 to the native blood vessel, and a simple suture between the skirt 102 and the native blood vessel is sufficient to achieve a stable connection between the stent 10 and the native blood vessel, replacing the direct connection between the native blood vessel and the artificial blood vessel, avoiding the cumbersome and complex suturing method of direct connection. Then, the inner sheath 12 is moved proximally to release the proximal end of the main stent 101.

[0053] It should be noted that the portion of the implantable device proximal to the inner sheath 12 occupies 1 / 4 to 3 / 4 of the overall volume of the implantable device, while the portion distal to the implantable device occupies 3 / 4 to 1 / 4 of the overall volume of the implantable device. That is, the volume of the stent 10 housed in the inner sheath 12 and the outer sheath 11 can be adaptively set according to the requirement for the anchoring force of the stent 10 during initial release. For example, during the first stage of stent 10 release, the outer sheath 11 moves proximally to release 1 / 2 of the stent 10's volume; during the second stage of stent release, the inner sheath 12 moves proximally to release the remaining 1 / 2 of the stent 10's volume. Alternatively, if a better anchoring force is required for the first stage of stent 10 release, 2 / 3 of the stent 10's volume can be released during the first stage of release, and the remaining 1 / 3 of the stent 10's volume can be released during the second stage of release.

[0054] Compared with existing technologies, the delivery system of the present invention has the following advantages: it simplifies the complex suturing method of directly suturing native and artificial blood vessels, reducing the difficulty of surgery and the time required for suturing. Simultaneously, it eliminates the need for alignment of the native and artificial blood vessels; after stent release, the stent provides support for the native blood vessel, facilitating suturing and reducing the overall difficulty and risk of the surgery. Furthermore, the two-stage stent release design reduces the stroke during button-release, thereby reducing the axial length of the handle assembly and its overall volume. This makes the handle assembly more compact and lightweight, easier for the surgeon to hold and operate during surgery, reducing the difficulty of the procedure. Simultaneously, the two-stage release design ensures accurate connection between the native and artificial blood vessels, preventing accidental release of the stent without completing the connection between the native and artificial blood vessels compared to a single-stage release handle. It also reduces the gap at the junction of the native and artificial blood vessels, minimizing the stent length and reducing adverse reactions such as inflammation and foreign body sensation in patients.

[0055] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A delivery system for delivering an implant into the human body, characterized in that: The delivery system includes a sheath assembly and a handle assembly. The sheath assembly includes an outer sheath and an inner sheath. The outer sheath is sleeved over the inner sheath, and the distal end of the inner sheath is disposed within the outer sheath. The handle assembly includes a sliding assembly and an elastic element. The sliding assembly includes a drive element, an outer tube connector, and an inner tube connector. The proximal end of the outer sheath connects to the inner tube connector after passing through it, and the proximal end of the inner sheath connects to the inner tube connector. The elastic element is disposed at the proximal and / or distal end of the drive element. Applying force causes the drive member to move proximally and drives the outer tube connector to move proximally. The elastic member deforms, and the movement of the outer tube connector drives the outer sheath to move proximally. After the force is removed, the outer sheath and the outer tube connector remain stationary relative to the handle assembly. The elastic member returns to its original shape and drives the drive member to move distally to reset. Then, applying force again causes the drive member to move proximally and drives the inner tube connector to move proximally. The elastic member deforms, and the movement of the inner tube connector drives the inner sheath to move proximally.

2. The conveying system as described in claim 1, characterized in that: The sliding component further includes a button, and the driving component includes a driving engagement part, a driving body, and a driving snap-fit ​​part. The driving engagement part is disposed on the side of the driving body away from the sheath assembly, and the driving engagement part is connected to the button. The driving snap-fit ​​part is disposed on the side of the driving body close to the sheath assembly, and the driving snap-fit ​​part can snap-fit ​​with the outer tube connector or the inner tube connector.

3. The conveying system as described in claim 2, characterized in that: The driving component further includes a driving passage portion, which is disposed on the side of the driving body near the sheath assembly along the axial direction of the sheath assembly, and the driving passage portion is disposed on the central axis of the driving body along the axial direction. The driving engagement portion is disposed on the side of the driving passage portion.

4. The conveying system as described in claim 3, characterized in that: The outer tube connector includes a first body, a first through portion, and a first mating portion. The first through portion is disposed on the side of the first body near the sheath assembly and is located on the central axis of the first body in the axial direction. The first mating portion is disposed in the proximal end of the first through portion and can be housed in the proximal end of the drive through portion. The side of the first body near the drive member is recessed in the direction away from the drive member to form a first snap-fit ​​portion, which can mate with the first snap-fit ​​portion.

5. The conveying system as described in claim 4, characterized in that: The handle assembly also includes a housing, in which the elastic element, drive element, outer tube connector, inner tube connector, and the proximal end of the sheath assembly are all housed. One end of the elastic element abuts against the distal end face of the drive body, and the other end abuts against the distal end of the housing, and / or one end of the elastic element abuts against the proximal end face of the drive body, and the other end abuts against the proximal end of the housing.

6. The conveying system as described in claim 5, characterized in that: The inner tube connector includes a second body, a second through portion, and a second snap-fit ​​portion. The second through portion extends axially from the distal end face of the second body, through the proximal end face of the second body, and to the outside of the proximal end of the second body. The second through portion is disposed on the center line in the axial direction of the second body. The proximal end face of the second body extends to the proximal end to form the second snap-fit ​​portion, which can snap-fit ​​with the drive snap-fit ​​portion.

7. The conveying system as described in claim 6, characterized in that: A retaining ring is provided on the inner wall of the housing near the inner tube connector. The second main body is recessed towards the drive member on the side facing the retaining ring to form a retaining ring engagement portion. The retaining ring can engage with the retaining ring engagement portion, and part of the retaining ring is exposed on the side of the retaining ring engagement portion. An unlocking portion extending towards the retaining ring is provided on the side of the drive main body, and part of the unlocking portion can contact the retaining ring exposed on the retaining ring engagement portion.

8. The conveying system as described in claim 6, characterized in that: The proximal end of the unlocking part is connected to the driving body, and the distal end of the unlocking part is a free end. The distal end of the driving latching part is connected to the driving body, and the proximal end of the driving latching part is a free end. The free end of the distal end of the unlocking part is closer to the distal end than the free end of the proximal end of the driving latching part.

9. The conveying system as described in claim 8, characterized in that: The proximal end of the outer sheath tube is cut axially to form a cut section facing the inner tube connector. The portion of the inner sheath tube that overlaps with the cut section is exposed outside the outer sheath tube. The proximal end of the cut section passes through the drive passage and the first passage and enters the first mating part to connect with the first mating part. The portion of the proximal end of the inner sheath tube exposed outside the outer sheath tube is connected with the second passage.

10. The conveying system as described in claim 9, characterized in that: In the initial state, the drive engagement part engages with the first engagement part, the second passage part is housed within the first passage part, and the second engagement part is disposed on the side of the first engagement part away from the drive member. The retaining ring engages with the retaining ring engagement part. After the drive member moves towards the proximal end, causing the outer tube connector and the outer sheath to move towards the proximal end, the outer tube connector and the outer sheath remain stationary, and the drive member resets towards the distal end. After the drive member resets, the unlocking part contacts the retaining ring exposed in the retaining ring engagement part, causing the retaining ring to deform and separate from the retaining ring engagement part. The second engagement part engages with the drive engagement part. At this time, the drive member moves towards the proximal end, causing the inner tube connector and the inner sheath to move towards the proximal end.

11. The conveying system as claimed in claim 1, characterized in that: After the outer tube connector moves and drives the outer sheath to move proximally, the distal end of the outer sheath is located on the proximal side of the distal end of the inner sheath; or after the outer tube connector moves and drives the outer sheath to move proximally, the distal end face of the outer sheath and the distal end face of the inner sheath are located on the same plane, and then the driving member moves proximally, driving the inner sheath and the outer sheath together to move proximally.

12. The conveying system as described in any one of claims 2-11, characterized in that: The delivery system also includes an implantation device, which includes a main body and an action part disposed on the outer surface of the main body. The proximal end of the main body is housed within the distal end of the inner sheath, and the distal end of the main body and the action part are exposed at the distal end of the inner sheath and housed within the outer sheath.

13. The conveying system as described in any one of claims 12, characterized in that: The portion of the proximal end of the implantable device housed in the inner sheath accounts for 1 / 4 to 3 / 4 of the overall volume of the implantable device, while the portion of the distal end of the implantable device housed in the outer sheath accounts for 3 / 4 to 1 / 4 of the overall volume of the implantable device.

Images