Binding member, conveying device and conveying system

Abstract

The present invention provides a restraint member for use in cooperation with a catheter and a tubular stent, and is adapted to enter and exit the catheter through an end face of the catheter under the action of an external drive. The restraint member includes a movable restraint portion for restraining an end portion of the tubular stent; when the restraint member is received in the catheter, an outer sidewall contour formed by the structure formed by the movable restraint portion is defined by an inner surface of the catheter; during a process in which an end face of the restraint member extends out of the end face of the catheter and moves away from the catheter, the movable restraint portion gradually releases the receiving relationship with the catheter and extends away from the axis of the restraint member, so as to gradually reduce the degree of restraint on the end portion of the tubular stent until the end portion of the tubular stent releases the restraint relationship with the movable restraint portion, thereby avoiding a forward jump phenomenon of the tubular stent during the delivery process and improving the accuracy of release positioning. The present invention further provides a delivery device and a delivery system.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a restraint member, a delivery device, and a delivery system. Background Art

[0002] Atherosclerotic occlusive disease is currently the main cause of stroke, heart attack, limb defects, and death globally. Atherosclerotic plaques form a hard layer along the arterial wall and include calcium, cholesterol, dense thrombus, and cell debris. One of the most widely used methods for treating clinically significant atherosclerotic plaques is balloon angioplasty, followed by stent implantation. Some fissure surfaces generated by the plaques ruptured during balloon angioplasty can form dissections, which may obstruct blood flow or cause acute vessel occlusion if the plaque bulges completely along the blood flow direction. There is evidence that dissections after balloon angioplasty must be treated to prevent occlusion and resolve residual stenosis. There is also evidence that in some cases, it is preferably to place a metal retaining structure such as a stent after angioplasty to keep the artery open and force the dissection material against the vessel wall to ensure the lumen for blood flow.

[0003] The invention application with the publication number CN111419495A discloses a self-expanding vascular stent delivery system. When the delivery system loads a self-expanding vascular stent, the delivery wire passes through a perforation at the head end of the vascular stent and exits from the inside of the push hose, so that when the delivery system delivers the stent, the stent can be pushed from the head end of the vascular stent through the delivery wire until the stent is completely pushed out of the delivery sheath, and then the tail end of the push hose is pinched and pushed forward to make the head end of the delivery sheath reach the support rod of the push hose, and at the same time, the push hose is withdrawn backward to prevent the vascular stent from shortening during the delivery process. However, the stent is prone to forward jump during the delivery process of this delivery system, the positioning is inaccurate, and it cannot act well on the lesion site. Most of the stent length is usually placed on the arterial part that does not require a stent and is only adjacent to the dissection or the diseased area, which may stimulate the artery's reaction to the stent and lead to recurrent stenosis. Especially for stents with a particularly short length, higher requirements are placed on their positioning accuracy.

[0004] Therefore, it is necessary to develop a new restraint member, a delivery device, and a delivery system to solve the above problems existing in the prior art. Summary of the Invention

[0005] The purpose of the present invention is to provide a restraint member, a delivery device, and a delivery system to avoid the forward jump phenomenon of a tubular stent during the delivery process and improve the accuracy of release positioning.

[0006] The restraint member of the present invention is used in cooperation with a catheter and a tubular stent, and enters and exits the catheter through the end face of the catheter under the action of an external drive.

[0007] To achieve the above object, the restraint member of the present invention includes a movable restraint portion for restraining the end portion of the tubular stent;

[0008] When the restraint member is received in the catheter, the outer sidewall of the structure formed by the movable restraint portion is defined by the inner surface of the catheter;

[0009] During the process that the end face of the restraint member extends out of the end face of the catheter and moves away from the catheter, the movable restraint portion gradually releases the receiving relationship with the catheter and extends away from the axis of the restraint member, so as to gradually reduce the degree of restraint on the end portion of the tubular stent until the end portion of the tubular stent releases the restraint relationship with the movable restraint portion.

[0010] The beneficial effect of the restraint member of the present invention is that: by restraining the end portion of the tubular stent through the movable restraint portion and during the process that the end face of the restraint member extends out of the end face of the catheter and moves away from the catheter, the movable restraint portion gradually releases the receiving relationship with the catheter and extends away from the axis of the restraint member, so as to gradually reduce the degree of restraint on the end portion of the tubular stent until the end portion of the tubular stent releases the restraint relationship with the movable restraint portion, which is beneficial to avoiding the forward jump phenomenon of the tubular stent during the transportation process and improving the accuracy of release positioning.

[0011] Preferably, when the restraint member is received in the catheter, the movable restraint portion is tubular. The beneficial effect thereof is that: it is beneficial to maintaining an appropriate degree of restraint on the tubular stent.

[0012] Preferably, at least part of the side surface of the tubular extension structure formed by the movable restraint portion extending during the process of gradually releasing the receiving relationship with the catheter is inclined to the axis of the restraint member. The beneficial effect thereof is that: it is beneficial to preventing the forward jump phenomenon by controlling the extension degree.

[0013] More preferably, the axis of the tubular extension structure coincides with the axis of the restraint member. The beneficial effect thereof is that: it is beneficial to the operation stability and accurate positioning.

[0014] More preferably, the angle formed by at least part of the side surface of the tubular extension structure and the axis of the restraint member is 5 - 40 degrees.

[0015] More preferably, the angle formed by part of the side surface of the tubular extension structure and the axis of the restraint member is 0 - 40 degrees.

[0016] More preferably, the movable restraint portion includes at least one movable restraint member. When the restraint member is received in the catheter, the movable restraint member forms an initial hollow structure to restrain the end portion of the tubular stent. The beneficial effect thereof is that: it is convenient to realize the movable controlled release of the tubular stent.

[0017] Further preferably, when the binding member is received in the catheter, the at least two movable binding members form the initial tubular structure; when the movable binding portion is gradually released from the receiving relationship with the catheter, the at least two movable binding members form a tubular extended structure.

[0018] Further preferably, each of the movable binding members is composed of opposite first-type sheet members. When the movable binding portion is gradually released from the receiving relationship with the catheter, the opposite first-type sheet members move away from each other, increasing the area of the hollow region in the formed hollow structure, thereby gradually releasing the binding on the end portion of the tubular stent.

[0019] Further preferably, the movable binding portion further includes at least one movable adapter; when the binding member is received in the catheter, the at least one movable adapter and the at least two movable binding members form the initial tubular structure; when the movable binding portion is gradually released from the receiving relationship with the catheter, the at least one movable adapter and the at least two movable binding members form the tubular extended structure.

[0020] Further preferably, the movable adapter includes at least one second-type sheet member. When the movable binding portion is gradually released from the receiving relationship with the catheter, the second-type sheet member extends away from the axis of the binding member or remains stationary relative to the axis of the binding member.

[0021] Preferably, the material of the movable binding portion is a shape memory material.

[0022] The delivery device of the present invention is used for the release of a tubular stent. The delivery device includes a catheter and the binding member. The binding member is received in the catheter, and the inner surface of the catheter defines the outer surface profile of the binding member located within the catheter. The beneficial effect is that: the binding member is received in the catheter, and the inner surface of the catheter defines the outer surface profile of the binding member located within the catheter, which is beneficial to avoiding the forward jump phenomenon of the tubular stent during transportation and improving the accuracy of release positioning.

[0023] Preferably, the inner surface profile of the catheter is adapted to the outer surface profile of the tubular stent.

[0024] Preferably, the delivery device further includes an inner tube that penetrates through the binding member and the catheter to support the tubular stent.

[0025] The delivery system of the present invention includes a driving portion and the delivery device, and the driving portion is connected to the binding member of the delivery device. Description of the Drawings

[0026] Figure 1 Schematic diagram of the first working state of a conveying device in the prior art;

[0027] Figure 2 Schematic diagram of the second working state of a conveying device in the prior art;

[0028] Figure 3 Schematic diagram of the third working state of a conveying device in the prior art;

[0029] Figure 4 Schematic diagram of a conveying device according to an embodiment of the present invention;

[0030] Figure 5 For Figure 4 The first schematic diagram of the binding member shown;

[0031] Figure 6 For Figure 5 The schematic diagram of the binding member shown along the B direction;

[0032] Figure 7 For Figure 4 The second schematic diagram of the binding member shown;

[0033] Figure 8 For Figure 4 The third schematic diagram of the binding member shown;

[0034] Figure 9 For Figure 8 The schematic diagram of the binding member shown along the B direction;

[0035] Figure 10 Schematic diagram of another conveying device of the present invention. Detailed implementation manners

[0036] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Apparently, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without making creative efforts shall fall within the protection scope of the present invention. Unless otherwise defined, the technical terms or scientific terms used herein shall have the ordinary meanings understood by those of ordinary skill in the art belonging to the field of the present invention. The words such as "including" used herein are intended to mean that the elements or items appearing before this word cover the elements or items listed after this word and their equivalents, without excluding other elements or items.

[0037] Figure 1 Shows the first working state of a conveying device in the prior art. Refer to Figure 1, the tubular stent 12 and the delivery portion 11 are housed within the catheter 13. The delivery portion 11 is used in conjunction with the catheter 13 and the tubular stent 12. Among them, there is a weak adhesive force or direct contact between the delivery portion 11 and the tubular stent 12.

[0038] Figure 2 shows the second working state of the delivery device in the prior art. Refer to Figure 2 , by the action of an external driving force, the tubular stent 12 moves relative to the catheter 13 in the opposite direction of A, so that the tubular stent 12 is separated from the catheter 13 and delivered to the lesion site. The tubular stent 12 has a self-expanding property. When the tubular stent 12 is released from the restraint of the catheter 13, the shape of the released portion of the tubular stent 12 is no longer restricted by the catheter 13.

[0039] Figure 3 shows the third working state of the delivery device in the prior art. Refer to Figure 3 , the tubular stent 12 moves relative to the catheter 13 in the opposite direction of A. Until the tubular stent 12 is completely released from the restraint of the catheter 13, due to the self-expanding property of the tubular stent 12, the tubular stent 12 is prone to forward jump and deviate from the central axis 14 of the catheter, resulting in inaccurate positioning of the tubular stent 12 and inability to act well on the lesion site.

[0040] Since most of the tubular stent 12 usually needs to be placed on the arterial part that does not require a stent and is only adjacent to the dissection or the diseased area, if a forward jump occurs, it will stimulate the artery's response to the stent, resulting in recurrent stenosis. In addition, especially for stents with a particularly short length, higher requirements are placed on their positioning accuracy. Therefore, in view of the above problems, the present invention provides a restraint member to prevent the tubular stent 12 from forward jumping during the delivery process and improve the accuracy of release positioning. The following are the specific embodiments of the present invention.

[0041] Figure 4 This is an assembly schematic diagram of a catheter, a tubular stent, and a restraint member according to an embodiment of the present invention. The active restraint portion 41 and the coupling portion 43 that are used to restrain the end of the tubular stent 12 form a restraint member to be used in conjunction with the catheter 13 and the tubular stent 12, and enter and exit the catheter 13 through the end face of the catheter 13 under the action of an external drive.

[0042] In some embodiments of the present invention, when the restraint member is received in the catheter 13, the outer wall of the structure formed by the movable restraint portion 41 is defined by the inner surface of the catheter 13; during the process that the end face of the restraint member extends out of the end face of the catheter 13 and moves away from the catheter 13, the movable restraint portion 41 gradually releases the receiving relationship with the catheter 13 and extends away from the axis of the restraint member, so as to gradually reduce the degree of restraint on the end of the tubular stent 12 until the end of the tubular stent 12 releases the restraint relationship with the movable restraint portion 41, which is beneficial to avoid the forward jumping phenomenon of the tubular stent 12 during the transportation process and improve the accuracy of release positioning.

[0043] In a preferred embodiment, as Figure 4 shown, when the restraint member (not labeled in the figure) is received in the catheter 13, the movable restraint portion 41 is tubular, which is beneficial to maintaining an appropriate degree of restraint on the tubular stent 12.

[0044] It should be further noted here that the shape of the movable restraint portion 41 is not specifically limited and may also be cylindrical or cuboid, and the specific shape is set according to the shape of the catheter 13.

[0045] In a preferred embodiment, the movable restraint portion 41 is made of a shape memory material of nickel-titanium alloy.

[0046] Figure 5 This is a schematic diagram of the first structure of the restraint member of the present invention in the state of the tubular expansion structure. Figure 6 For Figure 5 the schematic diagram of the structure of the restraint member along the B direction shown, combined with Figure 4 , Figure 5 and Figure 6 shown, the movable restraint portion 41 includes a movable restraint member 5. When the restraint member is received in the catheter 13, the movable restraint member 5 forms an initial hollow structure 42 to restrain the end of the tubular stent 12, which is convenient for realizing the active controlled release of the tubular stent 12.

[0047] In some embodiments of the present invention, the number of the movable restraint members 5 is at least 1.

[0048] In some embodiments of the present invention, the movable restraint member 5 includes first type sheet members that are mutually adapted in pairs. When the movable restraint portion 41 gradually releases the receiving relationship with the catheter 13, the opposite first type sheet members move away from each other, so that the area of the hollow region in the formed initial hollow structure 42 increases, thereby gradually releasing the restraint on the end of the tubular stent 12.

[0049] Furthermore, when the restraining member is received in the catheter 13, the at least two movable restraining members 5 form the initial tubular structure; when the movable restraining portion 41 gradually releases the receiving relationship with the catheter 13, the at least two movable restraining members 5 form the tubular extension structure.

[0050] Furthermore, the first type of sheet-like member includes a first blade 51 and a second blade 52 respectively having a first notch 511 and a second notch 512, and the combining portion 43 is used to fix the first blade 51 and the second blade 52. When the first blade 51 and the blade 52 are compressed into the catheter 13, they will be closed. At the same time, the first notch 511 and the second notch 512 at the front end of the first blade 51 and the second blade 52 can constitute the initial hollow structure 42, so as to grasp the tubular bracket 12 with a similar structure at the rear end.

[0051] In a preferred embodiment, at least part of the side surface of the tubular extension structure formed by the active restraining part 41 when gradually releasing the receiving relationship with the catheter 13 is inclined to the axis of the restraining part, which is beneficial to prevent the forward jump phenomenon by controlling the extension degree. Figure 5 , the movable restraining member 5 is inclined to the central axis 53 of the restraining member.

[0052] Furthermore, the axis of the tubular extension structure coincides with the axis of the restraining member, which is beneficial to operational stability and accurate positioning. Figure 4 and Figure 5 , each of the movable restraining members 5 has the same degree of inclination relative to the central axis 53 of the restraining member, so that the central axis 53 of the restraining member and the axis of the tubular extension structure (not shown in the figure) are aligned.

[0053] In some embodiments of the present invention, when the movable restraining portion 41 gradually releases the receiving relationship with the catheter 13, the central axis 53 of the restraining member coincides with the central axis 14 of the catheter, further ensuring operational stability and positioning accuracy.

[0054] Preferably, the angle formed between at least part of the side surface of the tubular extension structure and the axis of the restraint is 5-40 degrees. Figure 5 The angle formed by each movable restraining member 5 and the axis 53 of the restraining member is 5-40 degrees.

[0055] In some embodiments of the present invention, the angles formed between different movable restraining members 5 and the axis 53 of the restraining member are the same or different.

[0056] In some embodiments of the present invention, the angles formed by the two opposite movable restraining members 5 and the axis 53 of the restraining members are the same.

[0057] In some specific embodiments of the present invention, in combination with Figure 4 、 Figure 5 and Figure 6 as shown, the movable restraint member 5 includes eight first-type sheet members that are pairwise adapted to grasp the tubular stent 12 having an adapted structure.

[0058] In some embodiments of the present invention, different movable restraint members 5 are arranged opposite to each other in pairs.

[0059] Figure 7 FIG. is the second schematic structural view of the restraint member of the present invention. In combination with Figure 4 and Figure 7 as shown, the movable restraint member 5 includes four first-type sheet members that are pairwise adapted to grasp the tubular stent 12 having an adapted structure.

[0060] It should be noted that the number and relative positions of different movable restraint members 5 are not specifically limited.

[0061] Figure 8 FIG. is the third schematic structural view of the restraint member of the present invention. Figure 9 is Figure 8 the schematic structural view of the restraint member shown in the B direction. In combination with Figure 4 、 Figure 8 and Figure 9 as shown, the movable restraint portion 41 includes at least one movable adapter 8; when the restraint member (not labeled in the figure) is received in the catheter 13, the at least one movable adapter 8 and the at least one movable restraint member 5 form the initial tubular structure; when the movable restraint portion 41 gradually releases the receiving relationship with the catheter 13, the at least one movable adapter 8 and the at least one movable restraint member 5 form the tubular expansion structure.

[0062] Furthermore, when the movable adapter 8 and the movable restraint member 5 are received in the catheter 13 together, the movable adapter 8 plays a role of positioning, preventing the movable restraint member 5 from shifting to both sides due to the lack of a fixing device around, and thus being unable to cooperate better with the tubular stent 12.

[0063] Furthermore, the angle formed by the movable adapter 8 and the axis of the restraint member is 0-40 degrees.

[0064] In some embodiments of the present invention, the angle formed by the movable adapter 8 and the axis of the restraint member is the same as or different from the angle formed by the movable restraint member 5 and the axis of the restraint member.

[0065] In some embodiments of the present invention, the angles formed by different movable adapters 8 and the axis of the restraint member are not completely the same.

[0066] In a specific embodiment, in combination with Figure 4 , Figure 8 and Figure 9 as shown, the movable adapter 8 is a second type of sheet-like member. When the movable restraint portion 41 gradually releases the housing relationship with the catheter 13, the second type of sheet-like member extends away from the axis of the restraint member. When the movable adapter 8 and the movable restraint member 5 are received into the catheter 13 together, the movable adapter 8 plays a positioning role to prevent the movable restraint member 5 from shifting to both sides due to the absence of a fixing device around it.

[0067] In some embodiments of the present invention, during the process that the movable restraint portion 41 gradually releases the housing relationship with the catheter 13, the movable adapter 8 is in a static state relative to the axis of the restraint member.

[0068] In some embodiments of the present invention, the movable adapters 8 are arranged in pairs opposite to each other.

[0069] In some embodiments of the present invention, the movable adapters 8 and the movable restraint member 5 are arranged at intervals.

[0070] It should be noted that there are no specific limitations on the number of the movable adapters 8, their relative positions, and the relative positions between the movable adapters 8 and the movable restraint member 5.

[0071] Figure 10 is a schematic diagram of another conveying device of the present invention. In combination with Figure 4 and Figure 10 , the conveying device includes the catheter 13, the restraint member, the tubular stent 12, and the inner tube 9. The restraint member is received in the catheter 13. The inner surface of the catheter 13 defines the outer surface contour of the restraint member located within the catheter 13, which is beneficial to avoiding the phenomenon of forward jumping of the tubular stent 12 during the conveying process and improving the accuracy of release positioning. The inner tube 9 penetrates through the restraint member and the catheter 13 to support the tubular stent 12.

[0072] Furthermore, the inner surface contour of the catheter 13 is adapted to the outer surface contour of the tubular stent 12.

[0073] In a specific embodiment, the conveying system includes a driving portion and the conveying device. The driving portion is connected to the restraint member of the conveying device. The specific implementation manner of the driving portion is a conventional technical means for those skilled in the art.

[0074] The embodiments of the present invention have been described in detail above. However, it will be obvious to those skilled in the art that various modifications and variations can be made to these embodiments. However, it should be understood that such modifications and variations are all within the scope and spirit of the present invention as described in the claims. Moreover, the present invention described herein can have other embodiments and can be implemented or realized in various ways.

Claims

1. A restraint member for use in conjunction with a catheter and a tubular stent, and adapted to enter and exit the catheter through an end face of the catheter under the action of an external drive, characterized in that, The binding member includes a movable binding portion for binding the end of the tubular stent; When the binding member is received in the catheter, the outer wall of the structure formed by the movable binding portion is defined by the inner surface of the catheter; During the process that the end face of the binding member extends out of the end face of the catheter and moves away from the catheter, the movable binding portion gradually releases the receiving relationship with the catheter and extends away from the axis of the binding member, so as to gradually reduce the degree of binding on the end of the tubular stent until the end of the tubular stent releases the binding relationship with the movable binding portion; The movable binding portion includes at least one movable binding piece. When the binding member is received in the catheter, the movable binding piece forms an initial hollow structure to bind the end of the tubular stent; When the binding member is received in the catheter, at least two of the movable binding pieces form an initial tubular structure; Each of the movable binding pieces is composed of opposite first-type sheet pieces. When the movable binding portion gradually releases the receiving relationship with the catheter, the opposite first-type sheet pieces move away from each other, increasing the area of the hollow region in the formed hollow structure, thereby gradually releasing the binding on the end of the tubular stent; The movable binding portion further includes at least one movable fitting; When the binding member is received in the catheter, the at least one movable fitting and the at least one movable binding piece form the initial tubular structure.

2. The restraint according to claim 1, wherein When the binding member is received in the catheter, the movable binding portion is tubular.

3. The restraint according to claim 1, wherein At least part of the side surface of the tubular extension structure formed by the movable binding portion extending during the process of gradually releasing the receiving relationship with the catheter is inclined to the axis of the binding member.

4. The restraint according to claim 3, wherein The axis of the tubular extension structure coincides with the axis of the binding member.

5. The restraint according to claim 3, characterized in that, The included angle formed by at least part of the side surface of the tubular extension structure and the axis of the binding member is 5-40 degrees.

6. The restraint according to claim 3, wherein The included angle formed by part of the side surface of the tubular extension structure and the axis of the binding member is 0-40 degrees.

7. The binding member according to claim 3, wherein When the movable binding portion gradually releases the receiving relationship with the catheter, the at least two movable binding pieces form the tubular extension structure.

8. The restraint according to claim 7, characterized in that When the movable binding portion gradually releases the receiving relationship with the catheter, the at least one movable fitting and the at least one movable binding piece form the tubular extension structure.

9. The restraint according to claim 8, wherein The movable fitting includes at least one second-type sheet piece. When the movable binding portion gradually releases the receiving relationship with the catheter, the second-type sheet piece extends away from the axis of the binding member or is stationary relative to the axis of the binding member.

10. The restraint according to claim 1, wherein The constituent material of the movable binding portion is a shape memory material.

11. A conveying device for releasing a tubular stent, characterized in that, The delivery device includes a catheter and the binding member according to any one of claims 1-10. The binding member is received in the catheter, and the inner surface of the catheter defines the outer surface contour of the binding member located in the catheter.

12. The conveying device according to claim 11, characterized in that, The inner surface contour of the catheter is adapted to the outer surface contour of the tubular stent.

13. The conveying device according to claim 11, characterized in that It further includes an inner tube, and the inner tube penetrates through the binding member and the catheter to support the tubular stent.

14. A conveying system, characterized in that, Comprising a driving part and the conveying device according to any one of claims 11-13, wherein the driving part is connected to the restraint of the conveying device.

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