Disclosure of Invention
The invention aims to provide a covered stent, a covered stent conveyor and a covered stent conveying system, so as to relieve the technical problems in the prior art.
In order to achieve the above purpose, the embodiment of the present invention adopts the following technical scheme:
In a first aspect, embodiments of the present invention provide a stent graft comprising a stent and a stent graft attached to the stent graft, in particular, a tie-down line and a control line. The stent comprises a controllable stent and an auxiliary stent which are arranged from a distal end to a proximal end in the axial direction, wherein the diameter of the controllable stent after free release is larger than that of the auxiliary stent after free release. The control rope axially extends along the covered stent and penetrates through the controllable stent and the auxiliary stent; the control rope is at least provided with a hard structure in a far-end area, and the constraint rope circumferentially constrains the controllable support for a circle and then spirally winds the controllable support on the hard structure. An adapter which can be in butt joint with an operation cable of the conveyor in a releasable and separable manner is arranged at the proximal end of the control rope; the control cord is capable of withdrawing the stent graft in a proximal direction to release the stent graft.
In the stent graft provided by the embodiment of the invention, optionally and preferably, the stent graft further includes a connecting bracket axially arranged on the proximal side of the auxiliary bracket, and a connecting ring is fixedly or integrally connected to one side of the connecting bracket, which is close to the control rope; the outer peripheral surface and the inner peripheral surface of the adapter are provided with threads with opposite rotation directions, the outer peripheral surface of the adapter is in threaded connection with the inner peripheral surface of the connecting ring, and the threads on the inner peripheral surface of the adapter are used for being in threaded connection with the distal end of the operation cable of the conveyor.
In the covered stent provided by the embodiment of the invention, optionally and preferably, the controllable stent and/or a covered film connected to the controllable stent are provided with a plurality of tie rope threading structures along the circumferential direction of the controllable stent, and the tie ropes are wound on the hard structure after passing through each tie rope threading structure; and/or the controllable support and the auxiliary support are respectively provided with a rope threading part for the control rope to pass through.
In the covered stent provided by the embodiment of the invention, optionally and preferably, the area, corresponding to the auxiliary stent, on the control rope is of a flexible structure.
In the stent graft provided by the embodiment of the invention, optionally and preferably, a plurality of post-release rope threading holes for threading the fixing ropes are formed in the circumferential direction at the distal end of the stent graft connected to the controllable stent.
In a second aspect, embodiments of the present invention further provide a stent graft conveyor for conveying and releasing a stent graft provided in any of the alternative embodiments of the first aspect into a patient.
Specifically: the tectorial membrane support conveyer includes operating handle, operation cable, can axial slip's between the adjacent pipe layer outer tube, well pipe and inner tube.
The operating handle comprises a sheath, a regulating handle and a rear release handle; the proximal end of the outer tube is fixedly connected to the sheath, a cable handle is arranged on the sheath, a wiring channel communicated with the inner cavity of the outer tube is arranged in the cable handle so as to penetrate through the operation cable, and a cable fixing part capable of fixing the proximal end of the operation cable is arranged on the cable handle; the regulating handle is arranged at the proximal end side of the sheath, and the proximal end of the middle tube is fixedly connected with the regulating handle; the rear release handle is arranged at the proximal end side of the regulating handle and can axially move relative to the regulating handle, and the proximal end of the inner tube is fixedly connected with the rear release handle. The distal end of the inner tube is provided with a fixed fork; the distal end of the middle tube is provided with a guide head with a guide wire hole inside, and the proximal end of the guide head is provided with a jack for inserting each fork head of the fixed fork.
In the stent graft conveyor provided by the embodiment of the invention, optionally and preferably, the fixing fork is in an arc shape which turns outwards radially from the proximal end to the distal end, a notch is arranged on the side surface of the distal end of the fixing fork, and the edge of the notch is in a blade shape.
Further alternatively, the rear release handle is also capable of rotating circumferentially relative to the adjustment handle.
In addition, in the stent graft conveyor provided by the embodiment of the invention, optionally and preferably, an inner conical luer connector is arranged at the proximal end of the sheath, and an outer conical luer connector which can be in butt joint or separation with the inner conical luer connector is arranged at the distal end of the regulating handle; and/or a Y-shaped three-way hemostatic valve is arranged at the outlet of the wiring channel of the cable handle, and the cable fixing part is arranged at the outlet end of the main channel of the Y-shaped three-way hemostatic valve; and/or the remote end of the regulating handle is provided with a flushing pipeline and a flushing valve arranged on the flushing pipeline.
In a third aspect, an embodiment of the present invention further provides a stent graft delivery system, including a fixing rope, a stent graft provided by any of the foregoing optional embodiments of the first aspect, and a stent graft delivery device provided by any of the foregoing optional embodiments of the second aspect;
Specifically, a plurality of fixing rope rings are arranged at intervals in the circumferential direction of the far end of the tectorial membrane bracket in a penetrating mode, and the fixing rope rings are wound on the tectorial membrane bracket in a penetrating mode through the same fixing rope or are respectively arranged on the tectorial membrane bracket in a penetrating mode through the fixing ropes. The loading state is as follows: the distal end of the operation cable is detachably connected with the adapter; each fixed fork is used for limiting each fixed rope loop between the corresponding fixed fork and the guide head so as to retract the distal opening of the covered stent.
In particular, in the context of the present invention, the foregoing "and/or" means "and/or" preceding structures are provided simultaneously or selectively with "and/or" following structures.
The tectorial membrane support that this embodiment provided can select specific release pattern according to patient's specific pathological change position, pathological change type after carrying into patient in vivo through tectorial membrane support conveyer to guarantee the adherence after the tectorial membrane support implants, prevent the aversion, and strengthen treatment, its operation step is simple and can change release mode at any time, and fix a position accurately, can avoid tectorial membrane support selection error to cause the operation failure, thereby improved the operation success rate, prognosis is better.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention. The components of the embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the invention, as presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
It should be noted that: like reference numerals and letters designate like items in the drawings, and thus once an item is defined in one drawing, no further definition or explanation thereof is necessary in the subsequent drawings.
In the description of the present invention, it should be noted that, directions or positional relationships indicated by terms such as "proximal", "distal", "front", "rear", "inner", "outer", etc., are directions or positional relationships based on those shown in the drawings, or are directions or positional relationships conventionally put in use of the inventive product, are merely for convenience of describing the present invention and simplifying the description, and are not indicative or implying that the apparatus or element to be referred to must have a specific direction, be configured and operated in a specific direction, and thus should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like, are used merely to distinguish between descriptions and should not be construed as indicating or implying relative importance.
In the description of the present invention, it should also be noted that, unless explicitly specified and limited otherwise, the terms "disposed," "mounted," and "connected" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.
Some embodiments of the present invention are described in detail below with reference to the accompanying drawings. The following embodiments and features of the embodiments may be combined with each other without conflict.
Example 1
This embodiment provides a stent graft, referring to fig. 1 and 2, which includes a tie-down cord 2 and a control cord 31 in addition to a stent included in a general stent graft and a stent graft 100 connected to the stent.
In operation, one end (rear end) of the covered stent and the covered stent conveyer close to the operator is a respective proximal end, and one end (front end) entering a blood vessel of a patient is a respective distal end: the stent part of the covered stent comprises a controllable stent 11 and an auxiliary stent 12 which are axially arranged from the distal end to the proximal end, wherein the diameter of the controllable stent 11 after free release is larger than that of the auxiliary stent 12 after free release. The control rope 31 extends along the axial direction of the covered stent and penetrates through the controllable stent 11 and the auxiliary stent 12; at least the distal end region of the control cord 31 is a rigid structure 310, and the tethering cord 2 is spirally wound around the rigid structure 310 after circumferentially tethering the controllable support 11 for one revolution. An adaptor 311 which can be detachably connected with an operation cable of the conveyor is arranged at the proximal end of the control rope 31; the control cord 31 can be withdrawn proximally out of the stent graft to release the stent graft.
The tectorial membrane support is loaded in the conveyer during operation, is conveyed to the position of the vascular lesion of the patient by the conveyer, then the conveyer is operated to release the tectorial membrane support, the release mode is carried out step by step according to the position condition of the vascular lesion of the patient, and different release modes are selected in real time to finish release by observing the shape of the vascular lesion of the patient and specific lesion types through developing instrument equipment in the process, so that the device has selectivity, and the better treatment effect is achieved. Specifically:
Firstly, conveying the covered stent to a lesion position of a patient by using a conveyor, exposing the covered stent in the blood vessel but not separating from the conveyor, and observing the adherence of the far-end part of the covered stent and the lesion treatment effect (generally, the interlayer lesions need better radial supporting force to press and close the interlayer);
Step two, the release mode is selected according to the observed condition to release the tectorial membrane stent, which is divided into:
(1) First release mode: referring to fig. 9, if the stent graft achieves better adherence and lesion treatment effect in the first step, the conveyor is operated, the distal end of the operation cable of the conveyor is separated and released from the adapter 311, the stent graft is completely released at the current position in the blood vessel, the conveyor is withdrawn, the stent graft left in the blood vessel of the patient comprises the control rope 31, so that the controllable stent 11 is still circumferentially restrained by the restraint rope 2, unnecessary expansion of the blood vessel caused by the spring-open of the controllable stent 11 is avoided, and the body health of the patient is damaged;
(2) Second release mode: referring to fig. 10, if the stent graft fails to achieve superior adherence and lesion treatment in the first step, the conveyor is operated, the operation cable is withdrawn in the proximal direction, the control string 31 is withdrawn in the proximal direction, the stent graft is released, the stent graft left in the blood vessel of the patient does not include the control string 31, the tether string 2 previously wound around the hard structure 310 of the control string 31 is released, and thus the controllable stent 11 is sprung out to enhance adherence, prevent displacement, and enhance treatment (the treatment effect for the interlayer lesion is particularly remarkable, and the controllable stent 11 is preferably released at the site of the interlayer breach to enhance the pressure closure effect for the breach), and then the stent graft is completely released at the current site in the blood vessel, and the conveyor is withdrawn.
Therefore, the covered stent provided by the embodiment can select a specific release mode according to the specific lesion position and the specific lesion type of a patient after being conveyed into the patient through the conveyor, so as to ensure the adherence and the anti-displacement performance of the covered stent after being implanted, enhance the treatment effect, have simple operation steps, can change the release mode at any time, and are accurate in positioning, can avoid surgical failure caused by the selection error of the covered stent, thereby improving the success rate of the surgery and having better prognosis.
In this embodiment, the proximal end of the control cord 31 and the distal end of the operation cable of the conveyor are butted to the adaptor 311 in a detachable manner, and there are various alternative arrangements, including but not limited to a double-cable structure formed by passing the operation cable of the conveyor through the adaptor 311, a structure that one end of the operation cable is pulled to withdraw the operation cable to complete detachment when detachment is required, or a structure that the distal end of the operation cable of the conveyor and the adaptor 311 are connected in a hooked manner, or a structure that the two are wound and fixed by means of another releasable wire, and the releasable wire is withdrawn to complete detachment when detachment is required.
Of the above many alternative constructions, it is preferable that: with continued reference to fig. 1 and with simultaneous reference to fig. 6, 7 and 8, the stent graft further comprises a connecting bracket 13 axially arranged on the proximal side of the auxiliary bracket 12, and a connecting ring 131 is fixedly or integrally connected to the connecting bracket 13 on the side close to the control cord 31; the outer circumferential surface and the inner circumferential surface of the adaptor 311 are provided with threads with opposite rotation directions, and the outer circumferential surface of the adaptor 311 is in threaded connection with the inner circumferential surface of the connection ring 131, and the threads on the inner circumferential surface of the adaptor 311 are used for being in threaded connection with the distal end of the operation cable of the conveyor. In the first release mode, the operation cable is rotated along the first circumferential direction to enable the operation cable to be screwed off the adapter 311, and then the covered stent is completely released at the current position in the blood vessel; in the second release mode, the operation cable is rotated along the second circumferential direction opposite to the first circumferential direction, and the outer circumferential surface and the inner circumferential surface of the adaptor 311 are provided with threads with opposite rotation directions, so that the operation cable can be rotated to be separated from the connection ring 131 of the connection bracket 13 together with the adaptor 311, then the operation cable is withdrawn in the proximal direction, the control rope 31 can be withdrawn from the stent graft, and the stent graft is completely released at the current position in the blood vessel. The release mode is simple and efficient to operate, and is convenient for operators to rapidly complete the operation. The connecting bracket 13 is optionally, but not limited to, a sculptured bracket.
In addition, as for the other structure of the stent graft provided in this embodiment, optionally and preferably, referring to fig. 3 to 5, a plurality of tie-down line threading structures 1101 are provided on the controllable stent 11 and/or the stent graft 100 connected to the controllable stent 11 along the circumferential direction of the controllable stent 11, and the tie-down line 2 is wound around the hard structure 310 at the distal end of the control line 31 after passing through each tie-down line threading structure 1101; wherein, "and/or" indicates that the location of the tether line threading structure 1101 includes: (1) a cover 100 provided on the controllable bracket 11; (2) is arranged on the controllable bracket 11; (3) A tie-down rope threading structure 1101 is arranged on the controllable bracket 11 and the covering film 100 of the controllable bracket 11; when the tie-down line threading structure 1101 is disposed on the covering film 100, the controllable support 11 may be sewn on the covering film 100 without sewing, and when the tie-down line threading structure 1101 is disposed on the controllable support 11, the tie-down line threading structure may be a spiral coil structure spirally wound on the controllable support 11, or the controllable support 11 may be an engraved support as shown in fig. 4, and integrally formed on a main body beam of the controllable support 11.
In addition, as shown in fig. 3 to 6, a rope threading part 101 through which the control rope 31 passes may be provided on each of the controllable bracket 11, the auxiliary bracket 12 and the connection bracket 13 to plan a threading path of the control rope 31, thereby ensuring smoothness of operation of the control rope 31 by the conveyor operation cable.
In this embodiment, in order to achieve flexibility, it is preferable and optional to make the region of the control cord 31 corresponding to the auxiliary support 12 have a flexible structure.
In addition, in order to further improve the accuracy of the release position of the stent graft, in the stent graft provided in the embodiment of the present invention, optionally and more preferably, a plurality of post-release rope holes 1102 for threading the fixing ropes are provided at the distal end of the stent graft 100 connected to the controllable stent 11 along the circumferential direction for post-release (for a specific use manner, refer to the second embodiment of the present disclosure).
Example two
This embodiment provides a stent graft delivery device for delivering and releasing a stent graft provided in any of the alternative embodiments of the previous embodiment into a patient.
Specifically, referring to fig. 11 to 16, the stent graft conveyor includes an operating handle, an operating cable 32, and an outer tube 4, a middle tube 5, and an inner tube 6 axially slidable between adjacent tube layers.
The operating handle specifically comprises a sheath 7, a regulating handle 8 and a rear release handle 9.
The proximal end of the outer tube 4 is fixedly connected to the sheath 7, the sheath 7 is provided with a cable handle 71, a cable passage communicated with the inner cavity of the outer tube 4 is arranged in the cable handle 71 so as to penetrate the operation cable 32, the cable handle 71 is provided with a cable fixing part 712 capable of fixing the proximal end of the operation cable 32, the cable fixing part 712 comprises, but is not limited to, a knob which is spirally connected to the outlet end of the cable passage on the cable handle 71, and the operation cable 32 is fixed to the cable fixing part 712 in a pressing and fixing mode after being transmitted along the cable passage, or other optional structures capable of fixing the proximal end of the operation cable 32 are selected. Furthermore, it may be preferable for the outer tube 4 to be provided with a double-lumen structure, one lumen for the operation cable 32 to be threaded, and the other lumen for the middle tube 5 to be threaded.
The regulating handle 8 is arranged at the proximal end side of the sheath 7, and the proximal end of the middle tube 5 is fixedly connected with the regulating handle 8.
The rear release handle 9 is arranged on the proximal side of the regulating handle 8 and can axially move relative to the regulating handle 8, and the proximal end of the inner tube 6 is fixedly connected with the rear release handle 9. The distal end of the inner tube 6 is provided with a fixed fork 61; the distal end of the middle tube 5 is provided with a guide head 51 with a guide wire hole inside, and the proximal end of the guide head 51 is provided with an insertion hole for inserting each fork head of the fixed fork 61.
The loading state is as follows: the relative positions of the sheath 7, the regulating handle 8 and the rear release handle 9 are regulated, so that the covered stent is sleeved outside the distal end of the middle tube 5 and compressed inside the outer tube 4; a plurality of fixing rope rings 10 are penetrated at intervals in the circumferential direction of the far end of the covered stent, and each fixing fork 61 limits each fixing rope ring 10 between the corresponding fixing fork 61 and the guide head 51 so as to converge the far end opening of the covered stent. The operation cable 32 is passed through the routing channel on the cable handle 71 and the outer tube, and the distal end thereof is detachably connected to the adaptor 311 at the proximal end of the stent graft control cord 31, and the proximal end thereof is fixed to the cable fixing portion 712 by various alternative connection methods according to the first embodiment.
After the stent is conveyed in place, the sheath 7 is retracted relative to the regulating handle 8 or the regulating handle 8 is pushed forward relative to the sheath 7, so that the stent graft is exposed out of the outer tube 4 to realize the first release of the first step; then, a specific release mode is selected according to the actual condition of the patient, the proximal end of the operation cable 32 is released from the cable fixing part 712 on the cable handle 71, and the operation cable 32 is controlled to release the covered stent for the second step according to the selected specific release mode; then, the release handle is retracted relative to the regulating handle 8, so that the fixing fork 61 releases all the fixing rope rings 10, and the release handle is released after the film covered stent is completed; finally, the entire delivery device is withdrawn and the stent graft is left in the patient in accordance with the selected release pattern.
In the stent graft conveyor provided by the embodiment of the invention, optionally and preferably, each fixing rope loop 10 is fixed on the guide head 51, as shown in fig. 16, the fixing fork 61 is in an arc shape which turns outwards radially from the proximal end to the distal end, a notch 610 is arranged on the side surface of the distal end of the fixing fork 61, and the edge of the notch 610 is in a blade shape; in the loading state, the fixing fork 61 limits each fixing rope loop 10 penetrating through the proximal end of the covered stent in the notch 610, and when the release handle is retracted relative to the regulating handle 8, each fixing rope loop 10 can be cut to release the covered stent quickly. Further alternatively, the rear release handle 9 can also be rotated circumferentially with respect to the regulating handle 8 to enhance the cutting effect. In this embodiment, a part of each fixing rope loop 10 is preferably fixed to the guide head 51 to prevent the cut rope body from being plugged, and specific fixing methods include, but are not limited to, individually fixing each fixing rope loop 10 to the guide head 51 by bonding, or passing through a hole provided in the guide head 51, binding, or other fixing methods, or fixing the two ends of the rope body to the guide head 51 by bonding, or passing through a hole provided in the guide head 51, binding, or other fixing methods by taking another rope body to pass through all fixing rope loops 10.
In addition, in the stent graft conveyor provided by the embodiment of the invention, optionally and preferably, the proximal end of the sheath 7 is provided with an inner cone luer connector, the distal end of the regulating handle 8 is provided with an outer cone luer connector which can be in butt joint with or separated from the inner cone luer connector, the relative position relationship between the regulating handle 8 and the sheath 7 is realized through two luer connectors, the regulation and the control are more convenient, and the relative axial movement of the regulating handle 8 and the sheath 7 in some operation steps can be avoided, so that the conveying reliability is further ensured.
In addition, optionally and preferably, a Y-shaped three-way hemostasis valve 711 is disposed at the outlet of the routing channel of the cable handle 71, and the cable fixing portion 712 is disposed at the outlet end of the main channel of the Y-shaped three-way hemostasis valve 711. Optionally and preferably, the distal end of the control handle 8 is provided with a flushing line 81 and a flushing valve 82 provided in the flushing line 81.
Example III
The present embodiment provides a stent graft delivery system, including a fixation rope, a stent graft provided by any one of the optional implementations of the previous embodiment, and a stent graft delivery device provided by any one of the optional implementations of the previous embodiment; specifically, the distal end of the stent graft is circumferentially provided with a plurality of fixing ropes 10 at intervals, and the plurality of fixing ropes 10 are wound on the stent graft by the same fixing rope or respectively arranged on the stent graft by a plurality of fixing ropes. The loading state is as follows: the distal end of the operation cable 32 is detachably abutted against the adaptor 311 in a specific connection manner with reference to the first embodiment; each fixing fork 61 respectively limits each fixing rope loop 10 between the corresponding fixing fork 61 and the guide head 51 so as to converge the distal opening of the covered stent.
Specific delivery and release patterns, as well as some more specific alternative variants, can be obtained with reference to the first and second embodiments.
Finally, it should be noted that:
1. The support structures in this embodiment include, but are not limited to, wavy support ring structures shown in the drawings, and for other grid type supports and other structures, accessory structures can be correspondingly arranged; the stent is made of materials including but not limited to nickel-titanium alloy;
2. In the present specification, "and/or" means "and/or" preceding structure is provided simultaneously or selectively with "and/or" following structure;
3. In the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described by differences from other embodiments, and identical and similar parts between the embodiments are only required to be seen with each other; the above embodiments in the present specification are only for illustrating the technical solution of the present invention, and are not limiting; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.