Disclosure of Invention
The invention aims to at least solve the problem of difficult implantation of a bridging stent. This object is achieved by:
the invention provides a lumen stent, comprising:
The main body support is of a tubular structure with openings at two ends;
the branch bracket is arranged in the lumen of the main body bracket, and at least part of the area of the branch bracket can move relative to the main body bracket;
The connecting piece is arranged between the inner surface of the main body support and the inner surface of the branch support, and is elastic and used for limiting the movable range of the branch support.
In one embodiment, one end of the connecting piece is connected with the main body support, the other end of the connecting piece is connected with the branch support, and on the same longitudinal section, the range of an included angle between the length extending direction of the connecting piece and the outer surface of the branch support is 0-90 degrees.
In one embodiment, one end of the connector is disposed closer to the proximal end of the body mount than the other end of the connector.
In one embodiment, the connector comprises a resilient section and a connecting section, the resilient section comprising a helical structure or a planar folded structure.
In one embodiment, the elastic segment is in a stretched state.
In one embodiment, the lumen stent comprises a plurality of connecting pieces, and the connecting pieces are arranged along the axial direction of the branch stent or are arranged in a staggered manner.
In one embodiment, the connecting piece comprises a middle section and elastic sections arranged at two ends of the middle section, the middle section is arc-shaped and connected with the branch support or the main body support, and the elastic sections connected with two ends of the middle section are respectively arranged at two sides of the branch support.
In one embodiment, the connecting piece comprises at least one support rod capable of recovering deformation, the support rod is fitted on the inner surface and/or the outer surface of the branch support, and one end of the support rod is closer to the proximal end of the branch support than the other end of the support rod.
In one embodiment, a window is arranged on the surface of the main body support, the inner cavity of the branch support is communicated with the window, and an annular support piece is arranged at the edge of the window.
In one embodiment, a window is arranged on the surface of the main body support, an inner cavity of the branch support is communicated with the window, the branch support comprises a main body section and a transition section, the transition section is connected with the window in a sealing manner, one end of the main body section is connected with the transition section, and the other end of the main body section is a free end.
In one embodiment, the axial direction of the main body section and the axial direction of the main body support range from 0 ° to 15 °.
According to the lumen stent, the implantation channel of the bridging stent is established through the branch stent, so that the bridging stent is inserted into the branch vessel through the branch stent, the branch vessel can be reconstructed, and meanwhile, the elastic force for recovering deformation can be provided for the branch stent through the arrangement of the connecting piece, so that the branch stent can be ensured to have deformation within a certain range. When the bridging support is inserted into the branch support, the branch support deforms under the action of the bridging support so as to facilitate the implantation process of the branch support, and the displacement of the main support cannot be caused, when the bridging support is implanted, the deformed branch support is restored to the original state under the elastic force of restoring deformation provided by the connecting piece, so that a channel is effectively established for the implantation of the bridging support, the implantation of the bridging support is facilitated, the bridging support blocking phenomenon caused by the displacement of the main support is prevented, the normal circulation of blood in a branch vessel cannot be influenced by the bridging support after the implantation, and the use safety and reliability of the lumen support are ensured.
Detailed Description
Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention may be embodied in various forms and should not be limited to the embodiments set forth herein. These embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concept of the invention to those skilled in the art.
It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless an order of performance is explicitly stated. It should also be appreciated that additional or alternative steps may be used.
Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.
For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.
For purposes of more clarity in describing the structure of the present application, the terms "proximal" and "distal" are defined herein as terms commonly used in the interventional medical arts. Specifically, "distal" means the end from which blood flows, and "proximal" means the end from which blood flows, for example, after implantation of a stent, blood flows from the proximal end toward the distal end of the stent, and "axial" means the length direction thereof, and "radial" means the direction perpendicular to the "axial".
Embodiment one
As shown in fig. 1, the lumen stent 100 of the present embodiment includes a main body stent 10, a branch stent 20, and a connector 30. The main body stent 10 includes a pulsator 11 and a tubular coating film 12, and a plurality of pulsators 11 are disposed at intervals in an axial direction and connected through the coating film 12, so that the main body stent 10 is formed in a tubular structure having openings at both ends. Wherein, the surface of the main body support 10 is provided with a window 121, and the window 121 is arranged at a position on the covering film 12 without the wave ring 11, so as to ensure that the bridging support for implantation can smoothly pass through the window 121. The branch stent 20 is disposed within the lumen of the main body stent 10 and communicates with the window 121. At least a partial region of the branch stent 20 may correspond to the movement of the main body stent 10. The connection member 30 connects the main body bracket 10 and the branch bracket 20, and serves to limit the movable range of the branch bracket 20. In other embodiments, the surface of the main body stent 10 may not be provided with a window 121, the lumen of the branch stent 20 communicates with the lumen of the main body stent 10, and the bridging stent may enter the main body stent 10 from the distal end of the main body stent 10 to communicate with the branch stent 20.
According to the lumen stent 100 of the present invention, the window 121 is provided on the surface of the main body stent 10, and the branch stent 20 communicating with the window 121 is provided in the lumen of the main body stent 10, the implantation channel of the bridge stent is established through the branch stent 20, the bridge stent is inserted into the branch vessel, thereby reconstructing the branch vessel, and the connecting member 30 is provided between the main body stent 10 and the branch stent 20, the connecting member 30 is used for providing a force for restoring the original state to the branch stent 20, and can ensure that the branch stent 20 has a deformation within a certain range, and when the bridge stent is inserted into the branch stent 20, the branch stent 20 is partially deformed under the action of the bridge stent, thereby facilitating the implantation of the bridge stent. After the implantation of the bridging stent is completed, the deformed branched stent 20 is restored to the original state under the force of restoring the deformation provided by the connecting piece 30, so that a channel is effectively established for the implantation of the bridging stent, the implantation of the bridging stent is facilitated, and the safety and reliability of the use of the lumen stent 100 are ensured.
The branched stent 20 includes a band (not numbered) and a cover (not numbered) through which a plurality of bands are connected. As shown in fig. 2, the branch stent 20 includes a main body section 21 and a transition section 22. The distal end of the transition section 22 is sealingly connected to the window 121, and the distal end of the body section 21 is connected to the proximal end of the transition section 22, the proximal end of the body section 21 being the free end and disposed toward the proximal end of the body mount 10. For convenience of description and analysis of the branch stent 20, the structure of the branch stent 20 is disassembled in fig. 2, so that a detachable two-stage structure is formed between the main body section 21 and the transition section 22. In other examples of the present embodiment, the insertion end 21 and the transition section 22 may be formed as a single body by providing a plurality of wave rings at intervals and coating the outer portions thereof with a coating film. Wherein the axis of the main body section 21 is substantially parallel to the axis of the main body support 10, and the transition section 22 comprises a small diameter end 221 and a large diameter end 222, wherein the small diameter end 221 is connected with the distal end of the main body section 21, and the radial dimension of the small diameter end 221 is consistent with the radial dimension of the main body section 21, so that the natural transition between the main body section 21 and the transition section 22 is realized. The large diameter end 222 is connected with the window 121, and the radial dimension of the large diameter end 222 is consistent with the dimension of the window 121, so that the sealing connection between the transition section 22 and the window 121 is realized. The surface between the small diameter end 221 and the large diameter end 222 transitions naturally, and the transition section 22 curves slightly distally. The distal end of the transition section 22 and the window 121 may be connected by stitching, etc., and an annular support may be provided at the edge of the large diameter end 222 of the transition section 22 or at the edge of the window 121 to maintain the stability of the window 121.
The diameter dimension range of the main body section 21 of this embodiment may be selected to be 4mm to 16mm, and the axial length dimension range may be selected to be 2mm to 20mm. The shape of the window 121 of the body stent 10 is not limited and may be circular, oval or any other shape, and the radial dimension of the window 121 is preferably larger than the diameter dimension of the body section 21 to facilitate implantation of the bridging stent.
As shown in fig. 1 to 3, the connector 30 of the present embodiment has elasticity, and includes an elastic section 31 and connection sections (hereinafter referred to as a first connection section 32 and a second connection section 33 for convenience of description) provided at both ends of the elastic section 31, wherein the first connection section 32 is connected to the main body bracket 10, and the second connection section 33 is connected to the branch bracket 20. On the same longitudinal section, the range of the included angle between the length extending direction of the connecting piece 30 and the outer surface of the branch support 20 is 0-90 degrees, that is, the range of the included angle between the stress direction of the connecting piece 30 and the outer surface of the branch support 20 is 0-90 degrees, and in some implementations, before the bridge support is implanted, the elastic section 31 of the connecting piece 30 can be in a stretched state, so that a certain tensile force is provided for the branch support 20 through the connecting piece 30, the deformed branch support 20 is ensured to be restored to the original state (or at least partially restored to the original state) under the action of the connecting piece 30, and meanwhile, a certain movable space of the branch support 20 relative to the main body support 10 is provided, but the connecting piece 30 can also play a certain binding role, so that the movable range of the branch support 20 is limited, and the branch support 20 is prevented from shaking under the impact of blood, and the normal flow of the blood is further influenced. It will be appreciated that in some embodiments, the connector 30 may also be in a natural relaxed state prior to the bridge stent being implanted.
It will be appreciated that in other embodiments, the connector may be provided with only one connecting section, in which case the other end of the resilient section is directly connected to the branch or body bracket.
Specifically, the connecting piece 30 may be formed by spatial spiral or planar folding and shaping of single-strand or multi-strand nickel titanium wires or stainless steel wires, or may be made of folding type biocompatible film-coating materials, such as vascular prostheses, etc. In order to ensure that the connecting element 30 can be fully stretched when being subjected to proper traction force, the connecting element can be restored to the original state after the force is removed and maintain certain stability, the range of values of the stiffness coefficient K of the elastic section 31 of the connecting element 30 is 0< K <100N/M.
The first connecting section 32 of the connecting member 30 may be disposed closer to the proximal end of the main body stent 10 than the second connecting section 33 (i.e., the stress direction of the connecting member 30 and the outer surface of the branch stent 20 have an included angle greater than 0 degrees), so that the branch stent 20 is always disposed toward the proximal end of the lumen stent 100 under the tensile force of the connecting member 30, and further the branch stent 20 is sufficiently close to the inner surface of the main body stent 10, thereby reducing or eliminating the gap between the main body stent 10 and the branch stent 20, and further minimizing the influence of the branch stent 20 on the blood flow in the main body stent 10 and reducing the formation of thrombus.
As shown in fig. 4, the connecting member 30 is disposed between the outer surface of the branch stent 20 far away from the central axis of the main body stent 10 and the main body stent 10, so that the branch stent 20 is connected with the main body stent 10, the branch stent 20 is attached to the inner surface of the main body stent 10, and the deformation of the branch stent 20 is reduced, and meanwhile, the influence on the blood flow in the lumen of the main body stent 10 due to the large spatial distribution range of the connecting member 30 in the lumen of the main body stent 10 is avoided. Accordingly, the first connection sections 32 associated with the inner surface of the main body stent 10 are preferentially distributed in a circumferential region corresponding to a level above a level tangent to the lower edge of the proximal surface of the branch stent 20, wherein the dotted line in fig. 4 shows the level tangent to the lower edge of the proximal surface of the branch stent 20.
Before implantation into the body, the range of the included angle between the axial direction of the main body section 21 and the axial direction of the main body stent 10 is 0-15 degrees, preferably 0 degrees, and the setting of the included angle can reduce the difficulty of implantation of the bridging stent to a certain extent and does not have great influence on the blood flow in the lumen of the main body stent 10.
As shown in fig. 1 and 4, the number of the connectors 30 in the present embodiment is two, and the two connectors 30 are disposed on the same side of the branch frame 20 along the axial direction. In other examples of the present embodiment, one or more connectors 30 may be provided, for example, a plurality of connectors 30 may be provided on the same side of the branch frame 20 in the axial direction, and a plurality of connectors may be provided in an axial direction or in a staggered manner. The displacement amount of the body section 21 is gradually reduced from the proximal end toward the distal end of the body section 21, so that the deformable lengths of the plurality of connection members 30 provided in the axial direction of the body section 21 can be gradually reduced, and the lengths of the connection members 30 can be correspondingly reduced, thereby reducing the cost. In other embodiments, one or more connectors 30 may also be provided on the transition section 22.
As shown in fig. 5, in another example of the present embodiment, the connection members 30 are simultaneously provided on both side surfaces of the branch stent 20, and the main body stent 10 and the branch stent 20 are simultaneously connected through the connection members 30 on both sides, so that the stress of the branch stent 20 is more balanced, and the stability of the branch stent 20 is further improved.
In this embodiment, the first connecting section 32 and the second connecting section 33 of the elastic member 30 may be connected to the wave ring or the covering film of the main body support 10 and the branch support 20, preferably connected to the wave ring, respectively, so as to avoid damaging the covering film 12 under the tensile force of the connecting member 30 and avoid the occurrence of internal leakage.
As shown in fig. 6, in another example of the present embodiment, the connecting member 30 includes a middle section 34 and elastic sections 31 provided at both end portions of the middle section 34. The middle section 34 is arc-shaped and is connected to the branch stent 20, specifically, the middle section 34 is connected to the outer surface of the branch stent 20 facing the central axis of the main body stent 10, and the middle section 34 may conform to a part of the outer surface of the branch stent 20, so that the middle section 34 completely conforms to the outer surface of the branch stent 20 facing the central axis of the main body stent 10, or has other shapes, and only partially conforms to the outer surface of the branch stent 20 facing the central axis of the main body stent 10. The elastic sections 31 at the two end parts of the middle section 34 are respectively arranged at two sides of the branch support 20, and the elastic sections 31 at the two sides are connected with the main support 10 through the first connecting section 32, so that the connecting piece 34 forms a U-shaped structure, the contact area between the connecting piece 30 and the embedded branch 20 is enlarged, the tension force provided by the connecting piece 30 to the branch support 20 is distributed more uniformly, the damage to the coating film of the branch support 20 is reduced, and the deformation resistance and the deformation recovery capability of the branch support 20 are further improved. Wherein the elastic section 31 may be crimped or welded or integrally formed with the intermediate section 34 through the second connecting section 32.
The lumen stent 100 of the present embodiment may further include a plurality of windows 121 and a plurality of branch stents 20 on the surface of the main stent 10, and the plurality of windows 121 may be disposed at intervals along the axial direction of the main stent 10, so that a specific fixing position of the main stent 10 may be adjusted according to the structure of an arterial vessel, thereby performing the reconstruction of the blood vessel of a plurality of branch vessels. It will be appreciated that in this embodiment, the main body section of the branch stent is closer to the proximal end of the main body stent than the transition section, and in other embodiments, the main body section of the branch stent may be closer to the distal end of the main body stent than the transition section, or when a plurality of branch stents are provided, one of the main body sections of the branch stents is closer to the proximal end of the main body stent and the other main body section of the branch stent is closer to the distal end of the main body stent.
In other examples of the present embodiment, the intermediate section 34 is a partial structure of the branch stent 20, that is, the intermediate section 34 is one of a plurality of wave rings constituting the branch stent 20, and the wave rings are provided in a broken state, and one elastic section 31 is provided at each broken position of both ends of the wave ring. In other examples of this embodiment, the middle section 34 may be further connected to the main body support 10, or the middle section 34 is a part of the main body support 10, and the composition structure is consistent with the relationship between the middle section 34 and the branch support 20, which will not be described herein.
In other embodiments, the surface of the main body stent 10 may form a concave section (not shown), the concave section may be formed as an inclined plane at an angle to the surface of the main body stent 10, a window 121 may be disposed on the inclined plane, and the distal end of the transition section 22 may also be connected to the inclined plane on the concave section, where the concave section may provide a larger expansion space for the bridging stent at the connection site of the bridging stent and the main body stent 10 when the bridging stent is implanted, so that the bridging stent is not easily occluded during and after implantation.
As shown in fig. 7 to 9, when the lumen stent 100 according to the present embodiment is used for reconstructing the superior arch branch artery 300, the lumen stent 100 is placed in the inferior arch left-locking femoral artery 200, and the window 121 is disposed corresponding to the entrance of the superior arch branch artery 300. The bridging stent 40 is delivered into the luminal stent 100 by a guidewire and sheath, the bridging stent 40 being disposed within the sheath, wherein the direction indicated by the dashed arrow in fig. 8 is the insertion direction of the guidewire and sheath, during which insertion the branched stent 20 is deformed with the main body section away from the inner surface of the main body stent, thereby facilitating implantation of the bridging stent. When the bridging stent 40 is extended out of the main stent 10 under the action of the guide wire and the sheath tube and placed in the above-arch branch artery 300, the guide wire and the sheath tube are withdrawn, and the bridging stent 40 is expanded and deformed, so that the above-arch branch artery 300 is reconstructed, normal blood circulation between the above-arch branch artery 300 and the below-arch left-locking femoral artery 200 is ensured, and simultaneously, after the guide wire and the sheath tube are withdrawn, the branching stent 20 is restored to the original position under the action of the elastic piece 30, the blood flow in the below-arch left-locking femoral artery 200 is not blocked, and meanwhile, the branching stent 20 does not swing along with the blood flow under the action of the connecting piece 30, so that the safety and the reliability of the use of the lumen stent 100 are improved.
Second embodiment
As shown in fig. 10, the lumen stent 100 of the present embodiment has substantially the same structure as that of the first embodiment, except for the structure and arrangement position of the connecting member 30.
As shown in fig. 11, the connector 30 of the lumen stent 100 of the present embodiment is attached to the inner surface and/or the outer surface of the branch stent 20, and one end of the connector 30 is closer to the proximal end of the branch stent 20 than the other end. The connection member 30 serves to provide the branch stent 20 with elastic force for restoring the deformation.
The connector 30 of the present embodiment includes a support rod, and the material of the support rod is preferably superelastic nickel-titanium alloy, and the diameter of the support rod is 0.05 mm-0.3 mm. In an example, the connecting member 30 and the branch stent 20 are in a split structure, specifically, the proximal end of the connecting member 30 is connected to the proximal end of the branch stent 20, and the distal end of the connecting member 30 is connected to the distal end of the branch stent 20, so as to provide the branch stent 20 with a supporting force in the axial direction, improve the capability of restoring deformation of the branch stent 20 in the axial direction, and allow the branch stent 20 to have a certain range of deformation, so as to prevent the branch stent 20 from collapsing during the implantation process of the bridge stent and affecting the subsequent implantation process of the bridge stent. The specific shape of the support rod is not required, and the support rod can be one or a combination of a plurality of straight lines, wavy lines or arc lines.
When the window 121 is provided with a supporting member, the distal end of the connecting member 30 is connected to the supporting member, and when the embedded branch 30 is subjected to the force of the guide wire and the sheath, the integrity of the main body section 21 and the transition section 22 is better due to the arrangement of the connecting member 30, and since the connecting member 30 is connected to the main body support 10, the embedded branch 20 is more stable, and after the bridge support is implanted, the deformed embedded branch 20 is easier to recover to the original state under the force of the main body support 10.
In other examples of this embodiment, the connector 30 may also be part of the structure of the branch stent 20. Specifically, the connecting piece 30 and the main body section 21 are in an integral structure, the proximal end of the connecting piece 30 is arranged at the proximal end of the main body section 21, the distal end of the connecting piece 30 extends to the transition section 22, specifically, is arranged at the distal end of the transition section 22, and is connected with the transition section 22 in a sewing, crimping, bonding and other modes, so that the setting of the connecting piece 30 along the axial direction of the branch bracket 20 is realized, the supporting force of the branch bracket 20 and the elasticity for restoring deformation are provided, the branch bracket 20 can be deformed to a certain extent after being axially extruded by the bridge bracket, the implantation process of the bridge bracket is facilitated, and the branch bracket 20 is restored to the original state through the action of the connecting piece 30 after the implantation of the bridge bracket is completed.
The present invention is not limited to the above-mentioned embodiments, and any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present invention are intended to be included in the scope of the present invention. Therefore, the protection scope of the invention is subject to the protection scope of the claims.