Implant conveying system
By designing an implant delivery system that includes channels that can open or close, the problem of blocking blood flow in the semi-release state of the body stent is solved, enabling easier branch stent implantation path establishment and blood flow smoothly.
Patent Information
- Application Number
- CN202311665254.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-12-05
- Publication Date
- 2025-06-06
- Estimated Expiration
- 2043-12-05
AI Technical Summary
During the implantation of the branch stent, the semi-release state of the main stent will block blood flow, resulting in the blood flow blockage for too long, which will adversely affect the patient's health.
An implant delivery system is designed, including a first tubular member and a second tubular member, and by restraining the assembly, the distal end of the second tubular member is bound into a compressed state when the first tubular member is in a radially deployed state, forming an open or closed channel to maintain blood flow smoothly.
Through this system, the guidewire can be more easily extended from the channel, reducing the difficulty of establishing the branch stent implantation path, shortening the implant surgery time, and ensuring smooth blood flow.
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Figure CN120093493A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and in particular to an implant delivery system. Background Art
[0002] This section merely provides background information related to the present disclosure and is not necessarily prior art.
[0003] Aortic dissection, also known as aortic dissecting aneurysm, is caused by various reasons, the aortic intima is torn, blood flows into the arterial wall, causing the aortic wall to be layered and separated, and a hematoma is formed. Aortic dissection is a vascular disease that seriously endangers life and health, with a high mortality rate.
[0004] At present, there are two main ways to treat aortic dissection: surgical treatment and minimally invasive treatment. Among them, surgical treatment is achieved through thoracotomy and laparotomy, resection of the intimal tear, and reconstruction of the blood flow channel with artificial blood vessels, while minimally invasive interventional treatment is achieved by implanting a covered stent at the lesion site to isolate the blood flow of the aortic dissection and maintain the normal blood flow channel. Compared with surgical treatment, minimally invasive interventional treatment is increasingly used in conventional treatment because of its advantages such as less trauma, faster recovery, and fewer complications.
[0005] Generally, the covered prosthesis is usually a straight-tube stent. However, when the lesion site of aortic dissection involves or is close to the branch vessels, such as the dissection lesion site of the ascending aorta involves or is close to the aortic coronary vessels, the dissection lesion of the ascending aorta involves or is close to the branch vessels of the aortic arch, and the lesion site of the abdominal aorta is close to the renal artery, in order to cover the lesion site or to increase sufficient anchoring area, the covered stent may cover or block the opening of the branch vessels, coronary vessels or renal artery, etc. In this case, it is usually necessary to implant the main stent and the branch stent (or bypass stent) at the same time at the lesion site for treatment. The main stent and the branch stent cooperate with each other to maintain the smooth blood flow of the aorta and the branch vessels.
[0006] Generally, the implantation operation is performed as follows: first, the main stent is delivered to the corresponding part, then the main stent is partially released, and then the branch stent is delivered to the corresponding part, and then the branch stent is released so that the branch stent cooperates with the main stent, and finally the main stent is completely released to complete the operation. As a result, during the release of the branch stent, since the main stent is located in the blood vessel and is in a semi-released state and is not fully opened, it will block the blood flow to a certain extent. When the time to release the branch stent is too long, the blood flow blockage time will also be longer, which will have an adverse effect on the patient's health, and in severe cases, it may even be life-threatening.
[0007] At present, some researchers have improved the main stent to ensure smooth blood flow during the implantation of branch stents. An opening that can be opened and closed is formed on the main stent, and the opening divides the main stent into a proximal part and a distal part. During the implantation process, the distal part is released, and the proximal part is compressed by the sheath, so that the opening is opened to maintain smooth blood flow or implant the branch stent. With this structure, since the main stent itself has self-expandability, when the opening is opened, the part of the main stent that is not bound by the sheath will have a tendency to expand circumferentially, so that the opening cannot be fully opened. When establishing the implantation path of the branch stent, the guide wire is easy to enter the sheath along the inner wall of the main stent that is not fully expanded to form an incorrect path, which makes it more difficult to establish the implantation path of the branch stent. Summary of the invention
[0008] Based on this, it is necessary to provide an implant delivery system that can reduce the difficulty of establishing a branch stent implantation path.
[0009] An implant delivery system comprises: an implant, wherein the implant comprises a first tubular member and a second tubular member, the first tubular member is provided with a first tubular cavity, the second tubular member is provided with a second tubular cavity, the first tubular member is connected to the second tubular member, and the distal end portion of the second tubular member is accommodated in the first tubular member so that the outer wall of the second tubular member cooperates with the inner wall of the first tubular member to form an openable or closable channel; and a conveyor, wherein the conveyor comprises a sheath core, an outer sheath tube and a constraint assembly, the outer sheath tube is hollow and sleeved on the outside of the sheath core, a loading chamber with an opening is formed between the outer sheath tube and the sheath core, the loading chamber is used to accommodate the compressed implant, the outer sheath tube can slide relative to the sheath core to release the implant, the constraint assembly is connected to the second tubular member, and the constraint assembly is used to releasably constrain the distal end of the second tubular member into a compressed state to open the channel when the first tubular member is in a radially expanded state.
[0010] In one of the embodiments, the restraint assembly includes a bolt rod and a bolt rope, wherein the extension direction of the bolt rod is consistent with the sheath core, and the bolt rod is movably received in the outer sheath tube along the axial direction and is movably connected to the bolt rope; in a loaded state, the bolt rope releasably binds the distal end of the second tubular member to the sheath core along the radial direction, and when the bolt rope is connected to the bolt rod, the bolt rope binds the distal end of the second tubular member, and when the bolt rope is separated from the bolt rod, the binding of the bolt rope on the second tubular member disappears.
[0011] In one embodiment, at least one restraining ring is disposed at the distal end of the second tubular member, and the tether is passed through the restraining ring and tightened to releasably radially restrain the distal end of the second tubular member to the sheath core.
[0012] In one of the embodiments, the tether rope is folded in half to form a sleeve end and an open end, the sleeve end is sleeved on the bolt rod, and the open end is sequentially passed through the at least one restraint ring and then extends along the sheath core to the outside of the conveyor.
[0013] In one embodiment, the tether rope includes two free ends and at least one return portion arranged between the two free ends, the return portion corresponds to the restraining ring one by one, the return portion passes through the restraining ring and is sleeved on the bolt rod, and the free end extends along the sheath core to the outside of the conveyor; or, when the number of the restraining rings is an even number, the number of the return portions is half of the restraining rings, and a restraining ring is respectively passed through the two ends of the return portion.
[0014] In one embodiment, the constraint assembly further includes a constraint control member, which is connected to both the bolt rod and the bolt rope, and is used to control the bolt rod and the bolt rope to move axially toward the proximal end of the conveyor.
[0015] In one of the embodiments, the constraint control member includes: a mounting seat, which is arranged at the proximal end of the sheath core, and the mounting seat is provided with a bolt rod mounting hole for the bolt rod to pass through, and a bolt rope mounting hole for the bolt rope to pass through; a bolt rod release key, which is engaged with the mounting seat, and the bolt rod release key is connected to the proximal end of the bolt rod, and when the bolt rod release key is separated from the mounting seat, the bolt rod can be driven to move axially away from the mounting seat; and a bolt rope release key, which is engaged with the mounting seat, and the bolt rope release key is connected to an open end or a free end of the bolt rope, and when the bolt rope release key is separated from the mounting seat, the bolt rope can be driven to move axially away from the mounting seat.
[0016] In one embodiment, the conveyor further comprises an outer sheath tube driving assembly for driving the outer sheath tube to slide axially relative to the sheath core, the outer sheath tube driving assembly comprising: a slide rail extending in the axial direction; a base connected to the proximal end of the slide rail, the sheath core passes through the slide rail and the proximal end of the sheath core is connected to the base; and a driving member slidably assembled with the slide rail, the outer sheath tube passes through the slide rail and the proximal end of the outer sheath tube is connected to the driving member, the driving member slides along the slide rail to drive the outer sheath tube to slide relative to the sheath core.
[0017] In one embodiment, the slide rail is a hollow tube, and a slide hole extending axially is opened on the side wall. The driving member includes a sliding part, an operating part and a connecting key. The sliding part is accommodated in the slide rail and connected to the outer sheath tube, and the operating part is located outside the slide rail. One end of the connecting key is connected to the sliding part, and the other end extends from the slide hole and is connected to the operating part.
[0018] In one embodiment, the proximal end of the second tubular member is further provided with a hanging portion, and the conveyor further includes a hanging piece, which is fixed on the sheath core and detachably connected to the hanging portion. When the hanging portion is accommodated in the loading chamber, the hanging piece is connected to the hanging portion, and when the hanging portion is located outside the outer sheath tube, the hanging piece is disconnected from the hanging portion.
[0019] In one embodiment, the hanging part is a hanging ring, the hanging member is a hanging block, a receiving groove is provided on the side wall of the hanging block, and a positioning column is provided in the receiving groove, the hanging ring is sleeved on the positioning column and received in the receiving groove, when the notch of the receiving groove is covered by the outer sheath tube, the hanging member is connected to the hanging part, and when the notch of the receiving groove is not covered by the outer sheath tube, the connection between the hanging member and the hanging part is disconnected.
[0020] In one embodiment, the implant delivery system further comprises a branch stent, one end of which can be inserted into the channel when the channel is in an open state, and the branch stent is clamped by the first tubular member and the second tubular member when the channel is in a closed state.
[0021] In the implant delivery system provided by the embodiment of the present application, the inner wall of the first tubular member cooperates with the outer wall of the second tubular member to form a channel that can be opened and closed. When the implant is accommodated in the loading chamber as a whole, the first tubular member and the second tubular member are both in a compressed state, and the channel is closed. When the outer sheath is withdrawn, the first tubular member is released into an expanded state, and the second tubular member is still bound by the constraint assembly and in a compressed state, so that the channel is opened. Thus, the guide wire can be extended from the channel more easily, avoiding the situation where the guide wire extends from the inside of the second tubular member due to the distal end of the second tubular member showing an expansion trend when the first tubular member is in a released state, and the implantation path fails to be established, thereby reducing the difficulty of establishing a branch stent implantation path and effectively shortening the implantation operation time. BRIEF DESCRIPTION OF THE DRAWINGS
[0022] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.
[0023] in:
[0024] Figure 1 It is a structural schematic diagram of an implant delivery system according to an embodiment of the present invention;
[0025] Figure 2 is a schematic structural diagram of an implant according to an embodiment of the present invention;
[0026] Figure 3 for Figure 2 A cross-sectional view of the implant shown in the axial direction with the channel open;
[0027] Figure 4 It is a partial structural schematic diagram of an implant delivery system according to an embodiment of the present invention in a channel-open state;
[0028] Figure 5 A schematic structural diagram of a partial structure of an implant according to an embodiment of the present invention;
[0029] Figure 6 It is a structural schematic diagram of a part of the structure of an implant delivery system according to an embodiment of the present invention;
[0030] Figure 7 It is a schematic diagram of assembling a restraining assembly and a restraining ring according to an embodiment of the present invention;
[0031] Figure 8 It is a schematic diagram of the degree of channel opening of an implant in an embodiment of the present invention when it is not constrained by a constraining component;
[0032] Fig. 9 It is a schematic diagram of the degree of opening of the channel of an implant in a state of being constrained by a constraining component according to an embodiment of the present invention;
[0033] Fig.10 is a cross-sectional view of a conveyor according to an embodiment of the present invention;
[0034] Fig.11 An exploded view of a conveyor according to an embodiment of the present invention;
[0035] Fig.12 for Fig.10 A magnified view of part A;
[0036] Fig.13 for Fig.10 Magnified view of section B. DETAILED DESCRIPTION
[0037] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0038] In the description of the embodiments of the present invention, it should be noted that the orientations or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the embodiments of the present invention and simplifying the description, rather than indicating or implying that the devices or elements referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the embodiments of the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.
[0039] In the description of the embodiments of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a replaceable connection, or an integral connection, it can be a mechanical connection, it can be an electrical connection, it can be a direct connection, it can be indirectly connected through an intermediate medium, and it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the embodiments of the present invention can be understood according to specific circumstances.
[0040] In the field of interventional medical devices, the end of a medical device implanted in a human or animal body that is closer to the operator is generally called the "proximal end", and the end that is farther from the operator is called the "distal end". The "proximal end" and "distal end" of any component of the medical device are defined based on this principle. "Axial" generally refers to the length direction of the medical device when it is transported, and "radial" generally refers to the direction of the medical device that is not parallel to its "axial direction". The "axial" and "radial" of any component of the medical device are defined based on this principle. "Circumferential" refers to the circumferential direction, that is, the axial direction surrounding the lumen structure or column.
[0041] See also Figure 1 An embodiment of the present invention provides an implant delivery system, including an implant 1 and a conveyor 2, wherein the implant 1 is suitable for being implanted into a human tissue site to treat a lesion. The implant 1 is loaded into the conveyor 2, and is delivered to the tissue lesion site by the conveyor 2 and then released in steps. The released implant 1 is anchored on the tissue lesion site to play a therapeutic role.
[0042] See also Figure 1-4 In one embodiment, the implant 1 comprises a first tubular member 11 and a second tubular member 12. The delivery device 2 comprises a sheath core 21, an outer sheath tube 22 and a constraining component 23.
[0043] Among them, Figure 2-4 The first tubular member 11 is provided with a first lumen 110, the second tubular member 12 is provided with a second lumen 120, the second tubular member 12 is connected to the first tubular member 11, and the second tubular member 12 is partially accommodated in the first tubular member 11, and the outer wall of the second tubular member 12 cooperates with the inner wall of the first tubular member 11 to form an openable or closable passage 13. When the first tubular member 11 is in a fully expanded state and the second tubular member 12 is in a compressed state, the inner wall of the first tubular member 11 is separated from the outer wall of the second tubular member 12, and the passage 13 is opened; when the first tubular member 11 and the second tubular member 12 are both in a fully expanded state, the inner wall of the first tubular member 11 is attached to the outer wall of the second tubular member 12, and the passage 13 is closed.
[0044] like Figure 1 As shown, the sheath core 21 is supportive and can carry the implant 1. The outer sheath tube 22 is a hollow tube, which is sleeved outside the sheath core 21, and a loading cavity 220 is formed between the outer sheath tube 22 and the sheath core 21 (see Fig.10 ), the loading chamber 220 is used to accommodate the compressed implant 1. The constraint assembly 23 is connected to the second tubular member 12, and the constraint assembly 23 is used to releasably bind the distal end of the second tubular member 12 into a compressed state to open the channel 13 when the first tubular member 11 is in a radially expanded state.
[0045] In the implant delivery system provided in the above embodiment, when the implant 1 is in the delivery state, the implant 1 is sheathed on the sheath core 21 in a compressed state, and the second tubular member 12 is at least distally bound by the constraint assembly 23 and then accommodated in the outer sheath tube 22 together with the first tubular member 11. After the implant 1 is delivered to the tissue lesion site, by controlling the outer sheath tube 22 to slide proximally relative to the sheath core 21, a state in which only the first tubular member 11 is released and the proximal portion of the second tubular member 12 that does not extend into the first tubular member 11 is still accommodated in the outer sheath tube 22 and is not released can be formed. When the distal end of the second tubular member 12 is not radially compressed, at this time, the distal portion of the second tubular member 12 accommodated in the first tubular member 11 is subjected to the synergistic effect of the first tubular member 11 and the outer sheath tube 22, so that the channel 13 is opened to a certain extent but not completely opened. In order to make the channel 13 open to a greater extent so as to more easily establish a path for implanting the branch, the distal end of the second tubular member 12 (i.e., the portion of the second tubular member 12 housed in the first tubular member 11) is placed in a radially compressed state through the constraint component 23, so that the channel 13 is in a fully open state under the cooperation of the constraint component 23 and the outer sheath 22. The fully open channel 13, on the one hand, can facilitate the establishment of the branch stent implantation path, and avoid the situation in which the guide wire extends from the distal end of the second tubular member 12 into the second lumen 120 when establishing the branch stent implantation path, thereby effectively shortening the operation time. On the other hand, the blood flow can flow out more smoothly along the first lumen 110 through the channel 13, or the blood flow can flow out more smoothly along the channel 13 through the first lumen 110, so that the blood flow can be kept smooth in the process of implanting the branch stent, and the adverse effects on the patient's health caused by blood flow blockage can be prevented.
[0046] It is understandable that the first tubular member 11 and the second tubular member 12 can be directly connected or indirectly connected through other components. The first tubular member 11 and the second tubular member 12 can be coaxially arranged or non-coaxially arranged. The channel 13 can be presented as an annular channel, so that the blood flow is smoother and the effect is better. The channel 13 can also be multiple, and the multiple channels 13 are arranged at intervals along the circumference of the second tubular member 12. The channel 13 can also be presented as a non-annular channel.
[0047] It can also be understood that the sheath core 21 is an internal hollow structure, so that the guide wire guiding the implant 1 implant path can pass through the sheath core 21 to establish an introduction path. In addition, the distal end of the sheath core 21 is provided with a Tip head, which is a double-conical head end, which is used to ensure the smooth advancement of the sheath core 21 in the tissue and to ensure that the Tip head does not scratch the structure in the tubular member 1 after the tubular member 1 is released. The Tip head can be fixed to the sheath core 21 by bonding, threaded connection, etc.
[0048] It can also be understood that, in other embodiments, the constraint assembly 23 can also constrain the entire second tubular member 12, and the length of the axial constraint of the second tubular member 12 by the constraint assembly 23 can be unlimited, as long as the constraint assembly 23 constrains at least the distal end of the second tubular member 12, the purpose of causing the channel 13 to be fully opened can be achieved.
[0049] Please continue reading Figure 2-4 In one embodiment, the first tubular member 11 includes a first coated stent 111 and a connecting member 112 , and the second tubular member 12 includes a second coated stent 121 and a sealing assembly 122 .
[0050] The first lumen 110 is provided on the first stent graft 111, the second lumen 120 is provided on the second stent graft 121, the distal end of the connector 112 is connected to the proximal end of the first stent graft 111, the proximal end of the connector 112 is connected to the distal end of the second stent graft 121, and the connector 112 is used to connect the first stent graft 111 and the second stent graft 121. The proximal end of the sealing component 122 is connected to the second stent graft 121, and the distal end axially extends away from the second stent graft 121 to be at least partially accommodated in the first lumen 110. The portion of the sealing component 122 accommodated in the first lumen 110 is an annular structure and has a free end. The annular structure surrounds the longitudinal central axis of the first stent graft 111. The sealing component 122 can be expanded or contracted synchronously with the second stent graft 121, and the channel 13 is formed by the outer wall of the portion of the sealing component 122 accommodated in the first lumen 110 and the inner wall of the first stent graft 111. When the first stent graft 111 is in a radially expanded state and the second stent graft 121 is in a radially compressed state, the outer wall of the sealing assembly 122 is spaced from the inner wall of the first stent graft 111, and the channel 13 is in an open state and connected to the first lumen 110. When the first stent graft 111 and the second stent graft 121 are both in a radially expanded state, the outer wall of the sealing assembly 122 fits against the inner wall of the first stent graft 111, and the channel 13 is in a closed state.
[0051] It is understandable that, in the present embodiment, the first coated support 111 and the second coated support 121 are connected by the connector 112, so that the expansion or contraction movement between the first coated support 111 and the second coated support 121 can be performed independently without interfering with each other, so that the channel 13 can be opened more conveniently and quickly, and the blood flow can be quickly smoothed and it is conducive to shortening the operation time. In addition, the setting of the connector 112 can enable the channel 13 to be opened to the greatest extent, so as to better ensure the smooth blood flow. In other embodiments, the connector 112 can also be omitted, so that the distal end of the first coated support 111 and the proximal end of the second coated support 121 are directly connected by point connection, that is, the connection point (connection part) between the first coated support 111 and the second coated support 121 is a plurality of discrete points (parts), which are not completely closed in the circumferential direction. For example, a point connection can be formed by suturing.
[0052] In addition, in the present embodiment, by providing a sealing component 122, and by forming a channel 13 by the sealing component 122 and the first coated support 111, the radial dimension setting of the second coated support 121 can be less restricted, that is, the outer diameter of the distal end of the second coated support 121 can be equal to the outer diameter of the proximal end of the first coated support 111, and the outer diameter of the distal end of the second coated support 121 can also be smaller than the outer diameter of the proximal end of the first coated support 111. In this way, the shape of the implant 1 can be more diverse, so as to adapt to more shapes of anatomical structures for implantation. In other embodiments, the sealing component 122 can also be omitted, so that the channel 13 is formed by the inner wall of the first coated support 111 and the outer wall of the second coated support 121. It can be understood that at this time, the connection position between the connector 112 and the first coated support 111 and the second coated support 121 will change accordingly to ensure that the second coated support 121 can be at least partially accommodated in the first lumen 110. It can also be understood that when the second tubular member 12 includes the sealing component 122, the constraint component 23 at least constrains the distal end of the sealing component 122 so that the channel 13 is fully opened, and when the sealing component 122 is omitted, the constraint component 23 at least constrains the distal end of the second stent graft 121 so that the channel 13 is fully opened. It should be noted that the first stent graft 111, the second stent graft 121 and the sealing component 122 themselves can be an integral equal-diameter structure or a variable-diameter structure. As long as the formation of the channel 13 can be ensured, the shapes of the first stent graft 111, the second stent graft 121 and the sealing component 122 themselves are not limited.
[0053] In other embodiments, the connector 112 and the sealing assembly 122 may be omitted at the same time, so that the first stent graft 111 and the second stent graft 121 are directly connected to form a channel 13, such as: connecting the first stent graft 111 and the second stent graft 121 at multiple discrete connection positions in the circumferential direction to form multiple channels 13 that can be opened and closed and are spaced apart along the circumference of the second stent graft 121; or, the first stent graft 111 and the second stent graft 121 are directly connected and only part of the area is connected, and part of the area is not connected, then a non-annular channel 13 is formed in the unconnected area. It can be understood that at this time, in the part where the first stent graft 111 and the second stent graft 121 overlap, the radial dimension of the second stent graft 121 can only be slightly smaller than the radial dimension of the first stent graft 111, thereby ensuring that the channel 13 can be closed on the basis of ensuring the formation of the channel 13.
[0054] Please continue reading Figure 2 In one embodiment, the connecting member 112 is a corrugated rod, the distal end of which is mutually connected with the first stent graft 111, thereby realizing the hinge connection with the first stent graft 111, and the proximal end of which is fixedly connected with the second stent graft 121. Thus, the connecting member 112 can rotate around the connection point between the connecting member 112 and the first stent graft 111 as the second stent graft 121 expands or contracts, thereby maintaining the connection between the first stent graft 111 and the second stent graft 121 without hindering the expansion or contraction of the second stent graft 121.
[0055] In other embodiments, the connecting member 112 may also be configured as a plurality of separate straight rods, one end of which is connected to the first coated support 111 , and the other end of which is connected to the second coated support 121 .
[0056] In addition, in the present embodiment, the connector 112 is a flexible member, for example, the connector 112 is made of polymer silk thread. It is understandable that when the connector 112 is a flexible member, in order to ensure the connection between the first coated support 111 and the second coated support 121 and not hinder the expansion or contraction of the second coated support 121, one end of the connector 112 can be fixedly connected to the first coated support 111 or the second coated support 121, and the other end is set to be hinged, or both ends are set to be hinged. In other embodiments, the connector 112 can also be a rigid member, for example, made of metal wire. It is understandable that when the connector 112 is a rigid member, in order to ensure the connection between the first coated support 111 and the second coated support 121 and not hinder the expansion or contraction of the second coated support 121, the two ends of the connector 112 need to be hinged to the first coated support 111 and the second coated support 121, respectively.
[0057] See also Figure 3-4 In one embodiment, the sealing assembly 122 includes a sealing membrane 1221 and at least two driving rods 1222 .
[0058] The proximal end of the sealing film 1221 is connected to the second stent graft 121, and the distal end thereof is axially extended toward the side where the first stent graft 111 is located to be at least partially accommodated in the first lumen 110, and the portion of the sealing film 1221 accommodated in the first lumen 110 has a free end, and the sealing film 1221 has an unfolded and folded state, and the outer wall of the portion of the sealing film 1221 accommodated in the first lumen 110 cooperates with the inner wall of the first stent graft 111 to form a channel 13. The proximal end of the driving rod 1222 is connected to the second stent graft 121, and the distal end thereof is axially extended toward the side where the first stent graft 111 is located to be at least partially accommodated in the first lumen 110, and the portion of the driving rod 1222 accommodated in the first lumen 110 has a free end, and the driving rod 1222 is connected to the sealing film 1221, and the driving rod 1222 is used to drive the sealing film 1221 to unfold as the second stent graft 121 expands or to drive the sealing film 1221 to fold as the second stent graft 121 contracts.
[0059] By configuring the sealing component 122 to include a sealing film 1221 and a driving rod 1222, when a branch stent is implanted in the channel 13, since there are no extra stent units on the sealing film 1221 to block it, the sealing film 1221 can be more tightly wrapped around the side wall of the branch stent, thereby ensuring a better anti-internal leakage effect. In addition, since there are no extra stent units on the sealing film 1221 and it has good flexibility, it can prevent the branch stent from being squeezed together by the first coating stent 111 and the sealing component 122, and the shape of the branch stent can be better maintained.
[0060] It is understandable that the specific extension direction of the driving rod 1222 only needs to satisfy: when the first coated stent 111 and the second coated stent 121 are both in a radially expanded state, the portion of the driving rod 1222 accommodated in the first coated stent 111 fits against the inner wall of the first coated stent 111. For example, in one embodiment, the first coated support 111 is an equal-diameter cylindrical structure, and the drive rod 1222 is completely accommodated in the first coated support 111 when the first coated support 111 and the second coated support 121 are both in the expanded state, then the drive rod 1222 is a straight rod structure as a whole; or, in other embodiments, the first coated support 111 is still an equal-diameter cylindrical structure, but the drive rod 1222 is only partially accommodated in the first coated support 111 when the first coated support 111 and the second coated support 121 are both in the expanded state, then the portion of the drive rod 1222 accommodated in the first coated support 111 is a straight rod that fits the inner wall of the first coated support 111, and the extension direction of the portion of the drive rod 1222 not accommodated in the first coated support 111 can form a non-zero angle with the extension direction of the portion of the drive rod 1222 accommodated in the first coated support 111. Alternatively, if the first coated stent 111 is a variable diameter cylindrical structure, the portion of the driving rod 1222 accommodated in the first coated stent 111 is a curved rod with a bending angle that fits the inner wall of the first coated stent 111, and its bending angle matches the internal shape of the first coated stent 111.
[0061] It should be noted that the proximal end of the driving rod 1222 can be fixed to the second coated stent 121 by welding, suturing, etc., or it can be woven from the braided wire on the second coated stent 121. The specific connection method can be selected according to the usage.
[0062] In one embodiment, the driving rod 1222 is a long rod-shaped structure, and its cross section is rectangular. In other embodiments, the cross section of the driving rod 1222 may also be circular, fan-shaped, elliptical or other polygonal shapes, or the driving rod 1222 may also be a spiral structure formed by winding braided wire. In one embodiment, the sealing film 1221 is integrally formed with the film on the second film-covered stent 121. In other embodiments, the sealing film 1221 may also be sutured to the distal end of the second film-covered stent 121 by sutures. The sealing film 1221 may be an integrally formed annular sheet body, or it may be composed of a plurality of arc-shaped sheet bodies spliced together. It is understandable that the material of the sealing film 1221 may be a material with good biocompatibility such as nylon, polyester cloth or PTFE film. It should be noted that the material of the sealing film 1221 is not limited to the materials mentioned above, and the material of the sealing film 1221 may be a flexible material that can block blood flow and is suitable for implantation in the human body. The connection between the sealing film 1221 and the driving rod 1222 may be achieved by suturing, heat treatment coating or bonding.
[0063] It should be noted that in other embodiments, the driving rod 1222 and the sealing film 1221 may also be connected to the middle or distal end of the second stent graft 121. However, the way in which the driving rod 1222 and the sealing film 1221 are connected to the distal end of the second stent graft 121 is more convenient to assemble and does not affect the shape of the second stent graft 121.
[0064] Please continue reading Figure 3-4 In one embodiment, the distal end of the sealing film 1221 is also connected to the first coated support 111 at a point, that is, the sealing film 1221 is connected to the first coated support 111 at multiple discrete points and is not completely closed in the circumferential direction. And the connection point between the sealing film 1221 and the first coated support 111 and the connection point between the connector 112 and the first coated support 111 are located on the same axis on the first coated support 111. The distal end of the sealing film 1221 and the distal end of the driving rod 1222 are arranged on the same radial plane (the radial plane refers to a plane perpendicular to the longitudinal center axis of the implant 1), and the distal end of the driving rod 1222 is also provided with a restraint ring 14, and the restraint assembly 23 restrains the distal end of the sealing assembly 122 by passing through each restraint ring 14.
[0065] Before the branch stent is implanted, the outer sheath 22 is withdrawn to release the first stent graft 111, so that the first stent graft 111 is in a radially expanded state, and the proximal part of the second stent graft 121 is in a radially compressed state. At this time, the proximal end of the driving rod 1222 drives the proximal end of the sealing film 1221 to form a folded state under the restriction of the second stent graft 121, and the distal end of the driving rod 1222 drives the distal end of the sealing film 1221 to form a completely folded state under the constraint of the constraint component 23, and the channel 13 is in a completely open state. The folded sealing film 1221 divides the gap between the sealing component 122 and the first stent graft 111 due to the point connection with the first stent graft 111, that is, a plurality of different channels 13 are formed. After the branch stent is implanted in a specific channel 13, by releasing the distal end of the driving rod 1222 and the second coated stent 121, the proximal end of the connecting piece 112 and the driving rod 1222 will move toward the side close to the inner wall of the first coated stent 111 as the second coated stent 121 is unfolded, and driven by the driving rod 1222, the sealing film 1221 will also unfold until the second coated stent 121 is in a radially unfolded state. At this time, in the channel 13 where the branch stent is implanted, the driving rod 1222 is attached to the side wall of the branch stent, and the sealing film 1221 is wrapped around the branch stent under the action of the driving rod 1222 to wrap the branch stent, and in the channel 13 where no branch stent is implanted, the driving rod 1222 drives the sealing film 1221 to adhere to the inner wall of the first coated stent 111 to seal the channel 13.
[0066] By point-connecting the sealing film 1221 with the first coated stent 111, the implant 1 has a channel 13 in each implantation direction, and the boundary of the channel 13 is obvious, so as to facilitate the rapid positioning and implantation of the branch stent. At the same time, the sealing film 1221 is connected to the first coated stent 111, so that the first coated stent 111 can cooperate with the driving rod 1222 to better tension the sealing film 1221 and limit the branch stent, thereby improving the assembly stability of the branch stent. The setting of the constraint ring 14 allows the constraint component 23 to restrain the distal end of the sealing component 122 by passing through the constraint ring 14, which is equivalent to the constraint ring 14 limiting the axial displacement of the constraint component 23 in the sealing component 12, thereby preventing the constraint component 23 from slipping from the distal end of the sealing component 122 to the proximal end in advance during the stent delivery process, so that the distal end of the sealing component 122 is not restrained, thereby enhancing the constraint stability of the constraint component 23. In addition, the size of the constraint ring 14 can be set so that the projected area of the constraint ring 14 on the first coating support 111 is larger than the projected area of the same length of the driving rod 1222 on the first coating support 111. In this case, when the channel 13 is in a closed state, the constraint ring 14 can also increase the tightness of the contact between the sealing film 1221 and the first coating support 111, thereby expanding the function of the constraint ring 14.
[0067] It is understandable that, in other embodiments, the sealing film 1221 may also be connected only to the driving rod 1222, that is, the sealing film 1221 is not connected to the first film support 111, and in the contracted state, the first film support 111 is in contact with the sealing film 1221, but there is no connection point between the two. In this way, the sealing component 122 can also play a better sealing role, and the first film support 111 and the sealing component 122 do not interfere with each other, thereby not affecting the opening and closing of the channel 13. It is understandable that when the sealing film 1221 is not connected to the first film support 111, the constraint component 23 can constrain the sealing component 12 by simultaneously restraining the sealing film 1221 and the driving rod 1222.
[0068] It can also be understood that in other embodiments, the restraint ring 14 can also be omitted. When the restraint ring 14 is omitted, the distal end of the drive rod 1222 can be set to extend beyond the distal end of the sealing membrane 1221, so that the restraint assembly 23 can restrain the distal end of the sealing assembly 122 by restraining the distal end of the drive rod 1222.
[0069] It should be noted that when the sealing film 1221 is connected to the first stent graft 111 to form a plurality of mutually unconnected channels 13, the size of each channel 13 when expanded is preferably matched with the size of the branch stent to be implanted.
[0070] Also, see Figure 2 and Figure 5 In order to further enhance the installation stability of the branch stent, an extension edge 1223 is also connected to the distal end of the sealing film 1221. The extension direction of the extension edge 1223 is parallel to the extension direction of the first coated stent 111, and the axial height of the distal end of the extension edge 1223 is higher than the height of the wave crest of the connecting member 112. The axial distal end height of the constraint ring 14 is flush with the distal end of the extension edge 1223. The extension edge 1223 is used to extend the axial length of the channel 13. Under the action of the extension edge 1223, the axial length of the channel 13 is extended to a certain extent, thereby making the structure of the channel 13 more perfect, which is more conducive to the path establishment of the branch stent and maintaining the stability of the branch stent.
[0071] See also Figure 6 In one embodiment, the restraint assembly 23 includes a bolt rod 231 and a bolt rope 232 .
[0072] The extension direction of the bolt rod 231 is consistent with the sheath core 21, and the bolt rod 231 is movably received in the outer sheath tube 22 along the axial direction and movably connected with the bolt rope 232. In the loaded state, the bolt rope 232 can releasably bind the distal end of the second tubular member 12 to the sheath core 21 along the radial direction. When the bolt rope 232 is connected to the bolt rod 231, the bolt rope 232 binds the distal end of the second tubular member 12. When the bolt rope 232 is separated from the bolt rod 231, the binding of the bolt rope 232 to the second tubular member 12 disappears.
[0073] The implant delivery system provided in the above embodiment utilizes the bolt rod 231 and the bolt rope 232 to bind the second tubular member 12, and has a simple structure and is easy to operate.
[0074] Please continue reading Figure 6 In one embodiment, the distal ends of the driving rods 1222 are provided with restraint rings 14 one by one, and the tether ropes 232 pass through the restraint rings 14 to form a movable connection with the tether rod 231 . The tether ropes 232 are tightened to restrain the distal ends of the sealing components 122 .
[0075] Specifically, in the present embodiment, the bolt rope 232 is folded in half to form a sleeve end 2321a and an open end 2322a, wherein the sleeve end 2321a refers to one end of the bolt rope formed with a sleeve after being folded in half, and the open end 2322a refers to one end including two line segments, wherein the sleeve end 2321a is sleeved on the bolt rod 231, and the open end 2322a extends along the sheath core 21 to the outside of the conveyor 2 after passing through all the restraining rings 14 in sequence and being tightened.
[0076] When the distal end of the sealing assembly 122 is to be restrained, the tether 232 can be folded in half to form a sleeve end 2321a and an open end 2322a. The sleeve end 2321a is then sleeved on the bolt rod 231. The two segments of the open end 2322a are then simultaneously inserted from the side of one of the restraining rings 14 close to the sheath core 21 and passed out from the side of the restraining ring 14 away from the sheath core 21. The open end 2322a is then inserted from the side of the next restraining ring 14 close to the sheath core 21 and passed out from the side of the restraining ring 14 away from the sheath core 21. The above insertion and withdrawal steps are repeated in sequence until the tether 232 passes through all the restraining rings 14. After some of the restraining rings 14 are installed, the open end 2322a is lowered from the distal end of the sheath core 21 so that the open end 2322a is overlapped on the sleeve end 2321a, and then the open end 2322a is extended along the sheath core 21 to the outside of the conveyor 2. At this time, by pulling the open end 2322a, due to the existence of the bolt rod 231, the sleeve end 2321a of the bolt rope 232 cannot move. Therefore, each restraining ring 14 will approach each other under the driving force of the bolt rope 232 until each restraining ring 14 is in contact with the sheath core 21. At this time, the sealing film 1221 is fully tensioned under the drive of the driving rod 1222, and the channel 13 is fully opened. After the branch stent is implanted, the bolt rod 231 can be pulled out first. At this time, the sleeve end 2321a of the bolt rope 232 loses the restriction of the bolt rod 231 and can move freely, thereby losing the driving effect on the constraint ring 14, and each constraint ring 14 will separate from each other under the action of the self-expansion of the driving rod 1222. At this time, the bolt rope 232 can be removed from the conveyor 2 by pulling the open end 2322a.
[0077] The method of threading the tether rope 232 is simple and easy to operate.
[0078] Please continue reading Figure 7-9 In one embodiment, a restraining ring 14 is provided at the distal end of each driving rod 1222, and a tether 232 passes through each restraining ring 14 and forms a movable connection with the tether rod 231, thereby restraining the distal end of the sealing assembly 122. Different from the previous embodiment, the tether 232 is provided in a different manner.
[0079] Specifically, in this embodiment, the bolt rope 232 includes a return portion 2321b and two free ends 2322b. The return portion 2321b is arranged between the two free ends 2322b, and the number of the return portions 2321b corresponds to the number of the restraining rings 14. After the return portion 2321b passes through the restraining ring 14, it is sleeved on the bolt rod 231 to form a movable connection with the bolt rod 231, and the two free ends 2322b extend along the sheath core 21 to the outside of the conveyor 2.
[0080] In this embodiment, when the constraint ring 14 is not constrained by the constraint assembly 23, the constraint rings 14 are separated by a certain distance under the self-expansion of the sealing assembly 122, and the channel 13 is not fully opened (such as Figure 8 As shown). If the restraining rings 14 are marked in sequence in the clockwise direction as the first ring 14a, the second ring 14b, the third ring 14c, the fourth ring 14d, the fifth ring 14e and the sixth ring 14f, when the distal end of the sealing assembly 122 is to be restrained, first, one free end 2322b of the tether 232 can be extended along the sheath core 21 to the restraining ring 14, while the other free end 2322b of the tether 232 is exposed outside the conveyor 2, and then the free end 2322b at the restraining ring 14 is first inserted into the first ring 14a, and then the free end 2322b is folded back around the bolt rod 231 to form a folded portion 2321b and then The free end 2322b that has passed through the first ring 14a is passed through the second ring 14b, and the free end 2322b is folded back around the bolt rod 231 again to form a folded portion 2321b, and then passed through the second ring 14b. The above-mentioned insertion-folding-passing-out steps are repeated in sequence until the bolt rope 232 passes through all the restraining rings 14, and the free end 2322b that has been passed through is extended along the sheath core 21 to the outside of the conveyor. Finally, the two free ends 2322b are pulled at the same time. Under the limiting effect of the bolt rod 231, each restraining ring 14 is driven to approach each other and finally restrained on the sheath core 21. When the restraint is to be released, the bolt rod 231 can be pulled out first, and then one of the free ends 2322b can be pulled to remove the bolt rod 231 and the bolt rope 232 from the conveyor 2.
[0081] By adopting this threading method, during the process of pulling out the tether 232, the force exerted by the tether 232 on the restraint ring 14 is relatively small, thereby avoiding the displacement of the implant 1 caused by pulling the tether 232.
[0082] It is understood that in other embodiments, the tether 232 may also be inserted from the No. 1 ring 14a and formed a fold around the bolt rod 231 and then passed out from the No. 2 ring 14b, or the two ends of a part of the folded portion 2321b formed by the tether 232 around the bolt rod 231 extend from the same constraint ring 14, and the two ends of the other part of the folded portion 2321b extend from two constraint rings 14 respectively. The method of inserting the tether 232 only needs to satisfy the requirement that the constraint rings 14 can be pulled close to each other to be bound, and at the same time, an unresolvable knot will not be formed. It is understood that when the number of constraint rings 14 is an even number, the tether 232 may be inserted from the No. 1 ring 14a and formed a fold around the bolt rod 231 and then passed out from the No. 2 ring 14b, that is, a constraint ring 14 is respectively inserted at each end of the folded portion 2321b of the tether 232, so that the number of the folded portion 2321b is half of the number of the constraint rings 14.
[0083] It should be noted that the above uses the first ring 14a, the second ring 14b, the third ring 14c, the fourth ring 14d, the fifth ring 14e and the sixth ring 14f as examples to illustrate a method of constraining the sealing component 122 by the constraint component 23. However, in other embodiments, no matter what winding method is used to constrain the sealing component 11, the number of constraint rings 14 is not limited to six, and can be more than six or less than six. In addition, in this embodiment, the constraint ring 14 is in a circular ring shape. In other embodiments, the constraint ring 14 can also be set to a rectangular or triangular ring structure, or the constraint ring 14 is an incomplete ring. The specific structure of the constraint ring 14 is not limited, as long as it can move closer to each other with the tether 232 when the tether 232 is tightened.
[0084] It can be understood that in the above two threading methods, the bolt rod 231 can be located on the inner side of the second tubular member 12, or on the outer side of the second tubular member 12. However, when the bolt rod 231 is located on the inner side of the second tubular member 12 to abut against the sheath core 21, when the bolt rope 232 is pulled, the driving force applied to each restraint ring 14 can be more uniform.
[0085] See also Figure 10-12 In one embodiment, the constraint assembly 23 also includes a constraint control member 233, which is connected to the sheath core 21, the bolt rod 231 and the bolt rope 232, and the constraint control member 233 is used to control the bolt rod 231 and the bolt rope 232 to move axially toward the proximal end of the conveyor 2.
[0086] Specifically, in one embodiment, the restraint control member 233 includes a mounting seat 2331 , a bolt rod release button 2332 , and a bolt rope release button 2333 .
[0087] The mounting seat 2331 is fixedly connected to the proximal end of the sheath core 21, and the mounting seat 2331 is provided with a bolt rod mounting hole 23311 and a bolt rope mounting hole 23312, wherein the bolt rod mounting hole 23311 is used for accommodating and extending the bolt rod 231, and the bolt rope mounting hole 23312 is used for accommodating and extending the bolt rope 232. The bolt rod release key 2332 is engaged with the mounting seat 2331, and the bolt rod release key 2332 is connected to the proximal end of the bolt rod 231. When the bolt rod release key 2332 is separated from the mounting seat 2331, the bolt rod release key 2332 can drive the bolt rod 231 to move axially to a side away from the mounting seat 2331. The rope release key 2333 is also engaged with the mounting seat 2331, and is connected to the open end 2322a or the free end 2322b of the rope 232. When the rope release key 2333 is separated from the mounting seat 2331, the rope release key 2333 can drive the rope 232 to move axially to the side away from the mounting seat 2331.
[0088] It can be understood that the connection between the bolt rod release key 2332 and the mounting seat 2331 is achieved by the cooperation of a block (not shown) and a slot (not shown). The block is provided on the bolt rod release key 2332, and the slot is provided on the mounting seat 2331, or the block is provided on the mounting seat 2331, and the slot is provided on the bolt rod release key 2332. The bolt rod release key 2332 can be partially accommodated in the bolt rod mounting hole 23311 and connected to the side wall of the bolt rod mounting hole 23311. The connection between the bolt rope release key 2333 and the mounting seat 2331 is also achieved by the cooperation of a block and a slot. The block is provided on the bolt rope release key 2333, and the slot is provided on the mounting seat 2331, or the block is provided on the mounting seat 2331, and the slot is provided on the bolt rope release key 2333. The bolt release button 2333 may be partially accommodated in the bolt installation hole 23312 and may be engaged with the side wall of the bolt installation hole 23312 .
[0089] Please continue reading Figure 10-12 In one embodiment, a side catheter 24 is further provided in the conveyor. Two side catheters 24 are provided. The side catheters 24 are hollow tubes and are axially fixed on the outer surface of the sheath core 21. The proximal end of one of the side catheters 24 is connected with the bolt rod mounting hole 23311, which is used for accommodating and passing the bolt rod 231. The proximal end of the other side catheter 24 is connected with the bolt rope mounting hole 23312, which is used for accommodating and passing the bolt rope 232. The provision of the side catheter 24 prevents the bolt rod 231 and the bolt rope 232 from being interfered with by other components during the withdrawal process, thereby making the withdrawal of the bolt rod 231 and the bolt rope 232 smoother.
[0090] It is understandable that the number of the side catheter 24 is not limited, and only one side catheter may be provided to allow both the tether 232 and the tether rod 231 to pass through. For example, the side catheter 24 may be provided as a multi-lumen catheter, so that the tether rod 231 and the tether 232 do not interfere with each other. When the side catheter 24 is a multi-lumen catheter, the side catheter 24 is sleeved and fixed on the sheath core 21.
[0091] It can also be understood that the bolt rod 231 and the bolt rope 232 are both made of materials that can contact blood. For example, the bolt rod 231 can be made of stainless steel, nickel titanium or a polymer material that can contact blood, and the bolt rope 232 can be made of polyethylene, polyester or other materials. In addition, in other embodiments, the bolt rope 232 can also be made of a biodegradable material.
[0092] Please continue reading Figure 2 and Figure 10-11In one embodiment, a hanging portion 123 is further provided at the proximal end of the second tubular member 12, and the conveyor 2 also includes a hanging member 25, which is fixed on the sheath core 21, and the hanging member 25 is detachably connected to the hanging portion 123. When the implant 1 is at least partially accommodated in the loading chamber 220, the hanging member 25 is connected to the hanging portion 123, and when the outer sheath 22 completely releases the implant 1, the hanging member 25 is disconnected from the hanging portion 123.
[0093] The arrangement of the hanging portion 123 and the hanging member 25 can keep the implant 1 at a fixed axial position on the sheath core 21 before being fully released, thereby preventing the implant 1 from shifting due to excessive friction between the tether 232 and the implant 1 during pulling the tether 232.
[0094] For details, please continue to refer to Figure 2 and Fig.11 In one embodiment, the hanging portion 123 is a hanging ring, the hanging piece 25 is a hanging block, a receiving groove 251 is provided on the side wall of the hanging piece 25, and a positioning column 252 is provided in the receiving groove 251. When the second tubular member 12 is accommodated in the outer sheath tube 22 and is in a compressed state, the hanging portion 123 is sleeved on the positioning column 252, and the hanging portion 123 is accommodated in the receiving groove 251. When the notch of the receiving groove 251 is covered by the outer sheath tube 22, the second tubular member 12 is limited under the restriction of the outer sheath tube 22. When the outer sheath tube 22 is evacuated, the second tubular member 12 will be changed from a compressed state to an expanded state under the action of the self-expansion force, so that the hanging portion 123 is detached from the positioning column 252, that is, the hanging portion 123 is separated from the hanging piece 25, and the second tubular member 12 is separated from the sheath core 21.
[0095] It is understandable that the size of the positioning column 252 can match the size of the hanging ring, or can be smaller than the size of the hanging ring, as long as the hanging ring can be separated from the positioning column 252 under the action of the self-expansion force of the second tubular member 12. In addition, the hanging portion 123 may not be a complete ring, for example, it may be a partially open C-shaped, that is, the hanging portion 123 only needs to meet the requirement that when the second tubular member 12 is in a compressed state, it does not move relative to the hanging member 25 in the axial direction.
[0096] In addition, in this embodiment, the hanging member 25 is arranged at the distal end of the side catheter 24, so that the hanging member 25 can also play a role in further fixing the side catheter 24 and the sheath core 21. In other embodiments, the hanging member 25 can also be arranged in the middle of the side catheter 24.
[0097] Please continue reading Figure 10-12In one embodiment, the conveyor 2 further includes an outer sheath tube driving assembly 26 , and the outer sheath tube driving assembly 26 is used to drive the outer sheath tube 22 to slide axially relative to the sheath core 21 .
[0098] In one embodiment, the outer sheath driving assembly 26 includes a slide rail 261 , a base 262 and a driving member 263 .
[0099] Among them, the proximal end of the sheath core 21 is fixedly assembled with the base 262; the proximal end of the slide rail 261 is connected to the base 262 and the slide rail 261 extends along the axial direction; the driving member 263 is slidably assembled with the slide rail 261, and the driving member 263 is connected to the proximal end of the outer sheath tube 22. When the driving member 263 slides along the slide rail 261, it drives the outer sheath tube 22 to slide relative to the sheath core 21.
[0100] See also Fig.11 In one embodiment, the proximal end of the sheath core 21 is fixedly connected to the base 262, the slide rail 261 is a hollow tube, the slide rail 261 is connected to the base 262, the slide rail 261 is sleeved on the outside of the sheath core 21, and a slide hole 2610 is opened on the side wall of the slide rail 261 (see Figure 1 ), the slide hole 2610 extends in the axial direction. The driving member 263 includes a sliding portion 2631, an operating portion 2632 and a connecting key 2633. Among them, the sliding portion 2631 is accommodated in the slide rail 261, the proximal end of the outer sheath tube 22 is connected to the sliding portion 2631, and the sliding portion 2631 is provided with a avoidance hole (not shown) for the sheath core 21 to pass through, the operating portion 2632 is located outside the slide rail 261, and the operating portion 2632 is used to receive the driving force applied by the operator, one end of the connecting key 2633 is connected to the sliding portion 2631, and the other end extends from the slide hole 2610 to be connected to the operating portion 2632. By pushing the operating portion 2632 to slide along the slide hole 2610, the sliding portion 2631 can be driven to slide along the slide rail 261, thereby driving the outer sheath tube 22 to slide relative to the sheath core 21. In this embodiment, the distal end of the slide rail 261 gradually narrows to form a conical head, and a channel (not marked in the figure) is formed at the end of the conical head for only the outer sheath tube 22 to pass through, thereby further ensuring the pushing stability of the outer sheath tube 22.
[0101] In the present embodiment, two slide holes 2610 are provided, and are symmetrically distributed on the side wall of the slide rail 261, and two operating parts 2632 are also provided accordingly, so that the driving member 263 can slide along the slide rail 261 more stably. In other embodiments, the slide holes 2610 can also be provided with three, four, six or other integers, and the operating parts 2632 can also be provided with other integers accordingly, so that it is convenient for the operator to select the operating part 2632 on the most convenient side to push. In addition, in the present embodiment, a groove (not marked in the figure) is provided on the slide part 2631, and the groove is connected with the avoidance hole, and the outer sheath tube 22 is accommodated in the groove and bonded to the slide part 2631 by medical glue. In other embodiments, the outer sheath tube 22 and the slide part 2631 can also be provided with a snap connection. Furthermore, in order to facilitate the pushing of the operating part 2632, in the present embodiment, the operating part 2632 is provided as an arched plate with an opening facing away from the side of the slide part 2631. The arched setting is more ergonomic, making it easier for the operator to apply force to the operating part 2632 and making it easier to operate.
[0102] It should be noted that, in the present embodiment, the driving member 263 is also provided with an exhaust hole 2630, the exhaust hole 2630 is connected with the avoidance hole and runs through the sliding part 2631, and the exhaust hole 2630 is used to discharge the gas or liquid in the gap between the outer sheath tube 22 and the sheath core 21. In addition, in order to further ensure the sealing of the conveyor 2, the proximal end of the driving member 263 is also provided with a sealing gasket 264 and a cover body 265, and the cover body 265 is screwed with the proximal end of the sliding part 2631 to clamp the sealing gasket 264, and the sealing gasket 264 is used to seal the avoidance hole. The setting of the sealing gasket 264 can prevent blood flow from the outer sheath tube 22 along the avoidance hole and backflow into the slide rail 261, thereby reducing the risk of surgery. It can be understood that the sealing gasket 264 and the cover body 265 are both provided with an avoidance channel for the sheath core 21 to pass through.
[0103] Please continue reading Fig.11In one embodiment, the slide rail 261 includes a front cover 2611, an upper shell 2612, a lower shell 2613 and a rear cover 2614. The upper shell 2612 and the lower shell 2613 are spliced to form the main body of the slide rail 261, and the front cover 2611 and the rear cover 2614 cooperate to achieve locking or unlocking between the upper shell 2612 and the lower shell 2613. In this embodiment, the front cover 2611 is threadedly matched with the upper shell 2612 and the lower shell 2613, and the rear cover 2614 is snap-fitted with the upper shell 2612 and the lower shell 2613. In other embodiments, the front cover 2611 and the upper shell 2612 and the lower shell 2613 can also be snap-fitted or other mechanically connected, and the rear cover 2614 and the upper shell 2612 and the lower shell 2613 can also be threadedly matched or other connected. It is understandable that the slide rail 261 is configured as a detachable assembly of an upper shell 2612 and a lower shell 2613 , and the locking threads are actually also distributed on the upper shell 2612 and the lower shell 2613 .
[0104] Please continue reading Figure 11-12 In one embodiment, a limit baffle 2615 is provided on the proximal end of the slide rail 261, and the limit baffle 2615 encloses a receiving cavity (not shown in the figure), and the base 262 is received in the receiving cavity to complete the connection with the slide rail 261. In other embodiments, the base 262 and the slide rail 261 can also be integrally formed or clamped, and the connection method between the two is not limited.
[0105] Please continue reading Figure 11-12 In one embodiment, the mounting seat 2331 in the constraint control member 233 is also accommodated in the accommodating cavity of the slide rail 261, and the mounting seat 2331 is located at the proximal end of the base 262, and a through hole 23313 is also provided on the mounting seat 2331. Three guide channels 2621 are provided on the base 262, and the distal end of each guide channel 2621 is respectively connected to the sheath core 21 and the two side guide tubes 24, and the proximal end of each guide channel 2621 is respectively connected to the bolt rod mounting hole 23311, the bolt rope mounting hole 23312 and the through hole 23313. The guide channel 2621 is used for the finger guide wire or bolt rod 231 and the bolt rope 232 to pass through. In order to ensure that the guide channel 2621 does not affect the smoothness of the finger guide wire or bolt rod 231 and the bolt rope 232 entering and exiting the guide channel 2621, the size of the guide channel 2621 is preferably 0.8-1.2 mm.
[0106] It should be noted that, in one embodiment, an exhaust channel 2622 is further provided on the base 262 , and the exhaust channel 2622 is connected to the three guide channels 2621 at the same time, and the exhaust channel 2622 is used for exhaust treatment.
[0107] It is understandable that a leak-proof gasket (not shown) is provided at the proximal end of each guide channel 2621, and a channel is opened on the leak-proof gasket for the guide wire or the bolt rod 231 and the bolt rope 232 to pass through.
[0108] Please go back Figure 2-3 In one embodiment, the first tubular member 11 further includes a cover film 113. The distal end of the cover film 113 is connected to the proximal end of the first stent graft 111, and the proximal end extends toward a side close to the second stent graft 121 to form a free end. The cover film 113 is fixedly connected to the connector 112 along the extension direction of the connector 112.
[0109] In this embodiment, the outer diameter of the second stent graft 121 is smaller than the outer diameter of the first stent graft 111, the outer diameter of the distal end of the sealing film 1221 matches the inner diameter of the first stent graft 111, and the outer diameter of the proximal end of the sealing film 1221 matches the outer diameter of the second stent graft 121, so that the sealing film 1221 is in an inverted truncated cone shape when in a radially expanded state. The channel 13 is formed by the outer wall of the sealing film 1221 and the inner wall of the cover film 113.
[0110] When the first stent graft 111 is in a radially expanded state and the second stent graft 121 is in a radially compressed state, the driving rod 1222 drives the sealing film 1221 to form a folded state. At this time, the proximal end of the connector 112 is also in a contracted state under the drive of the second stent graft 121, while the distal end of the connector 112 is in an expanded state under the influence of the first stent graft 111, and drives the cover film 113 fixed on the connector 112 to be in an expanded state, so that a plurality of unconnected channels 13 are formed between the inner side of the cover film 113 and the outer side of the sealing film 1221. When the second stent graft 121 is transformed into a radially expanded state, the distal end of the connector 112 and the driving rod 1222 will expand outward, thereby driving the sealing film 1221 to abut against the cover film 113 to close the channel 13. By such arrangement, when the branch stent is clamped by the channel 13, both the inner and outer sides thereof are flexible films, i.e., the cover film 113 and the sealing film 1221 can better fit the shape of the branch stent, so that the branch stent can be more tightly wrapped, thereby making the implantable medical device 1 better in preventing internal leakage and fixing the branch stent.
[0111] It is understandable that the material of the cover film 113 can be selected from materials with good biocompatibility such as nylon, polyester, and polytetraethylene.
[0112] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.
[0113] The above disclosure is only the preferred embodiment of the present invention, which certainly cannot be used to limit the scope of the present invention. Therefore, equivalent changes made according to the claims of the present invention are still within the scope of the present invention.
Claims
1. An implant delivery system, It is characterized in that include: An implant, the implant comprising a first tubular member and a second tubular member, the first tubular member having a first lumen, the second tubular member having a second lumen, the first tubular member being connected to the second tubular member, and the distal end of the second tubular member being accommodated in the first tubular member so that the outer wall of the second tubular member cooperates with the inner wall of the first tubular member to form a passage that can be opened or closed; as well as, A conveyor, the conveyor comprising a sheath core, an outer sheath tube and a constraint assembly, the outer sheath tube is hollow and sleeved on the outside of the sheath core, a loading cavity with an opening is formed between the outer sheath tube and the sheath core, the loading cavity is used to accommodate the compressed implant, the outer sheath tube can slide relative to the sheath core to release the implant, the constraint assembly is connected to the second tubular member, the constraint assembly is used to releasably constrain the distal end of the second tubular member into a compressed state to open the channel when the first tubular member is in a radially expanded state.
2. The implant delivery system according to claim 1, It is characterized in that The restraint assembly includes a bolt rod and a bolt rope, wherein the bolt rod extends in the same direction as the sheath core, and the bolt rod is movably received in the outer sheath tube along the axial direction and movably connected to the bolt rope; In the loaded state, the tether releasably binds the distal end of the second tubular member to the sheath core in a radial direction; when the tether is connected to the bolt rod, the tether binds the distal end of the second tubular member; when the tether is separated from the bolt rod, the binding of the tether to the second tubular member disappears.
3. The implant delivery system according to claim 2, It is characterized in that The distal end of the second tubular member is provided with at least one restraining ring, and the tether is passed through the restraining ring and tightened to releasably radially restrain the distal end of the second tubular member to the sheath core.
4. The implant delivery system according to claim 3, It is characterized in that The bolt rope is folded in half to form a sleeve end and an open end, the sleeve end is sleeved on the bolt rod, and the open end is sequentially passed through the at least one restraint ring and then extends along the sheath core to the outside of the conveyor.
5. The implant delivery system according to claim 3, It is characterized in that The tether rope includes two free ends and at least one return portion arranged between the two free ends, the return portion corresponds to the restraining ring one by one, the return portion passes through the restraining ring and is sleeved on the bolt rod, and the free end extends along the sheath core to the outside of the conveyor; or, when the number of the restraining rings is an even number, the number of the return portions is half of the restraining rings, and a restraining ring is respectively passed through the two ends of the return portion.
6. The implant delivery system according to claim 4 or 5, It is characterized in that The constraint assembly also includes a constraint control member, which is connected to the bolt rod and the bolt rope at the same time, and is used to control the bolt rod and the bolt rope to move axially toward the proximal end of the conveyor.
7. The implant delivery system according to claim 6, It is characterized in that The restraint control element comprises: A mounting seat is arranged at the proximal end of the sheath core, and the mounting seat is provided with a bolt rod mounting hole for the bolt rod to pass through, and a bolt rope mounting hole for the bolt rope to pass through; A bolt rod release key is engaged with the mounting seat and connected to the proximal end of the bolt rod. When the bolt rod release key is separated from the mounting seat, the bolt rod can be driven to move axially away from the mounting seat; and The bolt rope release key is engaged with the mounting seat and connected to the open end or a free end of the bolt rope. When the bolt rope release key is separated from the mounting seat, it can drive the bolt rope to move axially away from the mounting seat.
8. The implant delivery system according to claim 1, It is characterized in that The conveyor further comprises an outer sheath tube driving assembly for driving the outer sheath tube to slide axially relative to the sheath core, and the outer sheath tube driving assembly comprises: A slide rail extending in an axial direction; a base connected to the proximal end of the slide rail, the sheath core passes through the slide rail and the proximal end of the sheath core is connected to the base; and, The driving member is slidably assembled with the slide rail, the outer sheath tube passes through the slide rail and the proximal end of the outer sheath tube is connected to the driving member, and the driving member slides along the slide rail to drive the outer sheath tube to slide relative to the sheath core.
9. The implant delivery system according to claim 8, It is characterized in that The slide rail is a hollow tube body, and a slide hole extending axially is opened on the side wall. The driving member includes a sliding part, an operating part and a connecting key. The sliding part is accommodated in the slide rail and connected to the outer sheath tube, and the operating part is located outside the slide rail. One end of the connecting key is connected to the sliding part, and the other end extends from the slide hole and is connected to the operating part.
10. The implant delivery system according to claim 1, It is characterized in that The proximal end of the second tubular member is also provided with a hanging portion, and the conveyor also includes a hanging piece, which is fixed on the sheath core and detachably connected to the hanging portion. When the hanging portion is accommodated in the loading chamber, the hanging piece is connected to the hanging portion, and when the hanging portion is located outside the outer sheath tube, the hanging piece is disconnected from the hanging portion.
11. The implant delivery system according to claim 10, It is characterized in that The hanging part is a hanging ring, and the hanging member is a hanging block. A receiving groove is provided on the side wall of the hanging block, and a positioning column is provided in the receiving groove. The hanging ring is sleeved on the positioning column and received in the receiving groove. When the notch of the receiving groove is covered by the outer sheath tube, the hanging member is connected to the hanging part. When the notch of the receiving groove is not covered by the outer sheath tube, the connection between the hanging member and the hanging part is disconnected.
12. The implant delivery system according to claim 1, It is characterized in that The implant delivery system further comprises a branch stent, one end of which can be inserted into the channel when the channel is in an open state, and the branch stent is clamped by the first tubular member and the second tubular member when the channel is in a closed state.
Citation Information
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