阅读说明：本技术 一种可撤回药物涂层支架 (Drug-coating stent capable of being withdrawn ) 是由 王川 张昱昕 吴占伟 刘鹏飞 张宇 于 2021-09-02 设计创作，主要内容包括：本发明提供了一种可撤回药物涂层支架,属于医疗器械技术领域,包括：内管、中层管及外管,内管、中层管及外管的近端连接有推送装置；内管的远端具有尖端；自膨胀式支架,表面具有尖刺,自膨胀式支架表面设有药物涂层,且自膨胀式支架连接在中层管的远端端部；自膨胀式支架具有收拢状态,自膨胀式支架还具有扩张状态。本发明提供的可撤回药物涂层支架,自膨胀式支架的表面具有尖刺,可以穿透钙化病变和血管内膜,进入血管中膜和外膜,进行深层给药,提高药物利用率；此药物涂层支架不会留存在体内,同时,此种方式不会阻断血流,还能够控制给药时间,整个操作过程简便,易于操作。(The invention provides a drug coating stent capable of being withdrawn, which belongs to the technical field of medical instruments and comprises: the near ends of the inner pipe, the middle layer pipe and the outer pipe are connected with a pushing device; the distal end of the inner tube has a tip; the surface of the self-expansion type stent is provided with sharp spines, the surface of the self-expansion type stent is provided with a drug coating, and the self-expansion type stent is connected to the far end part of the middle-layer tube; the self-expanding stent has a collapsed state and the self-expanding stent also has an expanded state. According to the retractable drug-coated stent provided by the invention, the surface of the self-expandable stent is provided with the spikes, so that calcified lesions and intima of a blood vessel can be penetrated into the media and adventitia of the blood vessel, deep administration is carried out, and the utilization rate of drugs is improved; the drug-coated stent can not be retained in vivo, and meanwhile, the mode can not block blood flow, can also control the administration time, and has simple and convenient whole operation process and easy operation.)

1. A retrievable drug-coated stent, comprising:

the inner tube (15), the middle tube (6) and the outer tube (4) are sleeved from inside to outside in sequence, and the near ends of the inner tube (15), the middle tube (6) and the outer tube (4) are connected with a pushing device;

the distal end of the inner tube (15) has a tip (1), and the distal end of the outer tube (4) is suitable for being arranged in contact with the tip (1);

the surface of the self-expansion type stent (2) is provided with sharp spines (11), the surface of the self-expansion type stent (2) is provided with a drug coating, the self-expansion type stent (2) is sleeved on the inner tube (15) and is positioned at the far end of the inner tube (15), the self-expansion type stent (2) is connected to the far end part of the middle-layer tube (6), and the self-expansion type stent (2) is positioned in a space between the outer tube (4) and the inner tube (15);

from inflation formula support (2) have accomodate in the folded state in outer tube (4), from inflation formula support (2) still have and break away from outer tube (4) restriction, expand by oneself to adhere to the wall of a blood vessel and expand to prick the expansion state of target pathological change to spine (11), pusher is suitable for the drive inner tube (15) and well stratum basale (6) with outer tube (4) carry out mutual sliding, make from inflation formula support (2) switch between folded state and expansion state.

2. The retractable drug-coated stent of claim 1, wherein the pushing means comprises:

the first pipe seat (9) is connected with the near end of the inner pipe (15) and the near end of the middle-layer pipe (6);

and the second pipe seat (10) is connected with the outer pipe (4), and the inner pipe (15) penetrates through the second pipe seat (10) and is arranged in the outer pipe (4) in a penetrating manner.

3. The drug-coated stent of claim 2, further comprising a flushing port (5) disposed on the second tube holder (10), the flushing port (5) communicating with the outer tube (4).

4. The retractable drug-coated stent of claim 2, further comprising:

the balloon (3) is sleeved on the inner pipe (15) and is positioned inside the self-expansion type bracket (2), and one end of the balloon (3) is connected with the far end of the middle-layer pipe (6);

and the filling opening (7) is arranged on the first tube seat (9), and the filling opening (7) is communicated with the balloon (3) through a space between the middle-layer tube (6) and the inner tube (15).

5. The stent with a drug coating capable of being withdrawn according to claim 4, further comprising a fixed seat (14), wherein the fixed seat (14) is connected with the end part of the distal end of the middle tube (6), and the self-expanding stent (2) is fixedly connected with the fixed seat (14) through a connecting rod (13).

6. The retractable drug coated stent of claim 1 wherein the self-expandable stent (2) is a NiTi shape memory alloy.

7. The retractable drug-coated stent of claim 1 wherein the self-expandable stent (2) is a tubular braided stent.

8. The retractable drug-coated stent of claim 1 further comprising visualization markers (12) disposed on the inner tube (15) and located at the ends of the self-expanding stent (2).

9. The retractable drug-coated stent of claim 8 wherein the visualization marker (12) has two, and the two visualization markers (12) are respectively located at both ends of the self-expandable stent (2).

Technical Field

The invention relates to the technical field of medical instruments, in particular to a stent with a drug coating capable of being withdrawn.

Background

At present, the intracavity interventional therapy becomes the first choice treatment means for the lower limb arteriosclerosis obliterans, and in recent years, more and more medicine-carrying apparatuses are reported to be applied to the treatment of the lower limb arteriosclerosis obliterans, such as a medicine eluting stent, a medicine coating balloon and the like. Compared with the traditional balloon forming operation and a metal bare stent, the drug eluting stent and the drug coating balloon can effectively improve the smooth rate of target lesion.

Wherein, the drug eluting stent can be permanently remained in the body when in use, and the physiological load of the artery of the lower limb is complex, the fracture rate of the stent is high, the secondary intracavity intervention operation is difficult, and the choice is small. Although the number of implanted stents can be reduced by the drug-coated balloon, the drug-coated balloon has large dosage and low drug utilization rate, and the drug-coated balloon needs to block blood flow when being expanded for administration, so that the adherence time and the drug absorption rate of the drug-coated balloon are limited. Moreover, when the drug coating saccule adheres to the wall, the drug coating saccule can only adhere to the surface of the target lesion to administer the drug to the surface of the target lesion, so that the drug gradually permeates into the deep part of the target lesion, and the administration efficiency is lower.

Disclosure of Invention

Therefore, the invention aims to solve the technical problems that the drug eluting stent in the prior art is easy to break in vivo, the drug coating balloon has large dosage and low drug utilization rate, the drug coating balloon needs to block blood flow during expansion administration, the wall sticking time and the drug absorption rate of the drug coating balloon are limited, and the administration efficiency is low, thereby providing the recoverable drug coating stent.

To solve the above technical problems, the present invention provides a drug-coating-retrievable stent, comprising:

the inner pipe, the middle-layer pipe and the outer pipe are sequentially sleeved from inside to outside, and the near ends of the inner pipe, the middle-layer pipe and the outer pipe are connected with pushing devices;

the distal end of the inner tube has a tip, and the distal end of the outer tube is suitable for being arranged in contact with the tip;

the surface of the self-expansion type stent is provided with sharp spines, the surface of the self-expansion type stent is provided with a drug coating, the self-expansion type stent is sleeved on the inner tube and is positioned at the far end of the inner tube, the self-expansion type stent is connected to the far end part of the middle-layer tube, and the self-expansion type stent is positioned in a spacing space between the outer tube and the inner tube;

the self-expansion type stent is accommodated in a furled state in the outer tube, the self-expansion type stent is separated from the restriction of the outer tube, self-expands to an expanded state which adheres to the wall of a blood vessel and expands to a sharp thorn to pierce a target lesion, and the pushing device is suitable for driving the inner tube and the middle-layer tube to slide with the outer tube, so that the self-expansion type stent is switched between the furled state and the expanded state.

Optionally, the pushing device includes:

the first pipe seat is connected with the near end of the inner pipe and the near end of the middle pipe;

and the second pipe seat is connected with the outer pipe, and the inner pipe penetrates through the second pipe seat and is arranged in the outer pipe in a penetrating manner.

Optionally, the device further comprises a flushing port arranged on the second pipe seat, and the flushing port is communicated with the outer pipe.

Optionally, the method further includes:

the balloon is sleeved on the inner pipe and is positioned in the self-expansion type bracket, and one end of the balloon is connected with the far end of the middle-layer pipe;

and the filling opening is arranged on the first tube seat and is communicated with the balloon through a space between the middle-layer tube and the inner tube.

Optionally, the self-expansion type support is fixedly connected with the fixing seat through a connecting rod.

Optionally, the self-expandable stent is a NiTi shape memory alloy.

Optionally, the self-expanding stent is a tubular braided stent.

Optionally, the self-expandable stent further comprises a development mark, which is arranged on the inner tube and is positioned at the end part of the self-expandable stent.

Optionally, the number of the development marks is two, and the two development marks are respectively located at two ends of the self-expandable stent.

The technical scheme of the invention has the following advantages:

1. the retractable drug-coated stent provided by the invention has the advantages that the outer tube is slidably sleeved on the inner tube, the self-expansion stent is fixedly connected to the inner tube, the surface of the self-expansion stent is provided with sharp spines, the drug coating is arranged on the self-expansion stent, the self-expansion stent is in a furled state before the drug-coated stent reaches a lesion position, and the far end of the outer tube is in contact with the sharp end on the inner tube; when the drug-coated stent reaches the lesion position, the pushing device is controlled to enable the inner tube and the outer tube to slide mutually, in the process that the outer tube slides relative to the inner tube, the outer tube gradually releases the self-expansion type stent, the self-expansion type stent is switched from a folded state to an expanded state, the self-expansion type stent is separated from the limitation of the outer tube, automatically expands to be attached to the blood vessel wall and expands the spine to penetrate into the target lesion, calcified lesions and the blood vessel intima can be penetrated, the blood vessel intima and the media coat can enter the blood vessel adventitia, deep drug delivery is carried out, and the drug utilization rate is improved; after the drug is released, in the process that the inner tube slides relative to the outer tube, the inner tube and the middle-layer tube are drawn out outwards, the position of the outer tube is kept unchanged, the end part of the self-expansion type support is connected to the middle-layer tube, the self-expansion type support is driven to move together in the process that the inner tube and the middle-layer tube are drawn out, when the self-expansion type support meets the end part of the outer tube, the self-expansion type support is drawn into the outer tube again, enters a drawing state, continues to draw out the inner tube, and drives the outer tube to move out together under the action of the tip. The drug-coated stent can not be retained in vivo, and meanwhile, the mode can not block blood flow, can also control the administration time, and has simple and convenient whole operation process and easy operation.

2. The retractable drug-coated stent provided by the invention comprises a pushing device and a pushing device, wherein the pushing device comprises a first tube seat and a second tube seat, the first tube seat is connected with the near end of an inner tube, the second tube seat is connected with the near end of an outer tube, and the inner tube and the outer tube can slide mutually by controlling the first tube seat and the second tube seat.

3. The retractable drug-coated stent provided by the invention is characterized in that the second tube seat is provided with a flushing port, the flushing port is communicated with the outer tube, and physiological saline can be injected through the flushing port to remove air.

4. The stent with the drug coating capable of being withdrawn provided by the invention also comprises a balloon which is sleeved on the inner tube and is positioned in the self-expansion stent, the balloon is communicated with the filling opening on the first tube seat, the balloon can be inflated through the filling opening, the balloon can be pushed to expand again in the inflation and expansion process, and the spine of the self-expansion stent is further assisted to penetrate into a target lesion for deep administration.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic structural view of a stent with a drug coating for withdrawal provided by an embodiment of the present invention;

fig. 2 is a schematic view of a connection structure of a balloon and a self-expanding stent in a retractable drug-coated stent provided by an embodiment of the invention.

Description of reference numerals:

1. a tip; 2. a self-expanding stent; 3. a balloon; 4. an outer tube; 5. flushing the opening; 6. a middle-layer pipe; 7. filling the mouth; 8. a wire guide opening; 9. a first stem; 10. a second stem; 11. pricking with a sharp point; 12. developing the mark; 13. a connecting rod; 14. a fixed seat; 15. an inner tube.

Detailed Description

The technical solutions of the present invention will be described clearly and completely with reference to the accompanying drawings, and it should be understood that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In addition, the technical features involved in the different embodiments of the present invention described below may be combined with each other as long as they do not conflict with each other.

A specific embodiment of the retractable drug-coated stent is provided in this embodiment, as shown in fig. 1 and fig. 2, an inner tube 15, a middle tube 6 and an outer tube 4 are sequentially sleeved from inside to outside, a self-expandable stent 2 is fixedly connected to an end of the middle tube 6, the self-expandable stent 2 is sleeved on the inner tube 15, the self-expandable stent 2 has a collapsed state and an expanded state, in the collapsed state, the self-expandable stent 2 is completely compressed and collapsed in the outer tube 4, and at this time, a distal end of the outer tube 4 contacts with the tip 1; in the expanded state, the outer tube 4 does not restrict the self-expandable stent 2, so that the self-expandable stent 2 can be automatically expanded under the action of self elasticity to adhere to the wall of a blood vessel. The surface of the self-expansion type stent 2 is provided with a spine 11, the self-expansion type stent 2 is provided with a drug coating, the self-expansion type stent 2 is in a furled state before the drug coating stent reaches a lesion position, and the far end of the outer tube 4 is arranged in contact with the tip 1 on the inner tube 15; when the drug-coated stent reaches the lesion site, the pushing device is controlled to enable the outer tube 4 to slide relative to the inner tube 15 and the middle tube 6, and in the process that the outer tube 4 slides relative to the inner tube 15 and the middle tube 6, the outer tube 4 gradually releases the self-expansion type stent 2 to enable the self-expansion type stent 2 to be switched from the folded state to the expanded state, at the moment, the self-expansion type stent 2 is separated from the limitation of the outer tube 4, automatically expands to be attached to the blood vessel wall and enables the spine 11 to expand to penetrate into the target lesion, calcified lesion and blood vessel intima can be penetrated, and the blood vessel intima and adventitia can enter the blood vessel intima to carry out deep administration, so that the drug utilization rate is improved; after the drug is released, in the process that the inner tube 15 slides relative to the outer tube 4, the inner tube 15 and the middle-layer tube 6 are drawn out, the position of the outer tube 4 is kept unchanged, the end part of the self-expansion type support 2 is connected to the middle-layer tube 6, the self-expansion type support 2 is driven to move together in the process that the inner tube 15 and the middle-layer tube 6 are drawn out, when the self-expansion type support 2 meets the end part of the outer tube 4, the self-expansion type support is drawn into the outer tube 4 again and enters a drawn state, the inner tube 15 is continuously drawn out, and the outer tube 4 is driven to move out together under the action of the tip 1. The drug-coated stent can not be retained in vivo, and meanwhile, the mode can not block blood flow, can also control the administration time, and has simple and convenient whole operation process and easy operation.

Specifically, the distal end of the middle-layer tube 6 is connected with a fixed seat 14, the self-expansion type support 2 is connected to the fixed seat 14 through a connecting rod 13, the fixed seat 14 is in a circular ring shape, and a gap is formed between the fixed seat 14 and the outer surface of the inner tube 15. The self-expansion type stent 2 is made of NiTi shape memory alloy and is a tubular braided stent.

In this embodiment, the pushing device includes a first tube seat 9 and a second tube seat 10, the proximal ends of the inner tube 15 and the middle tube 6 are both fixedly connected to the first tube seat 9, and the inner tube 15 and the middle tube 6 do not slide relatively; the proximal end of the outer tube 4 is connected to the second tube holder 10, and the mutual sliding between the outer tube 4 and the inner tube 15 and the middle tube 6 can be realized by controlling the first tube holder 9 and the second tube holder 10.

In this embodiment, the second tube holder 10 is provided with a flushing port 5, the flushing port 5 is communicated with the outer tube 4, and the flushing port 5 can inject physiological saline to remove air.

In this embodiment, the distal end of the inner tube 15 is provided with two development markers 12, the two development markers 12 are located at two sides of the drug coating portion of the self-expandable stent 2, and the development markers 12 are annular and are sleeved on the inner tube 15. The location of the drug-coated stent within the vessel can be visualized by the visualization marker 12.

Be equipped with on first tube socket 9 and be full of mouth 7, the cover is equipped with sacculus 3 on inner tube 15, and sacculus 3 is located inside from inflation formula support 2, and full of mouth 7 is through interval space and sacculus 3 intercommunication between intermediate tube 6 and the inner tube 15, can aerify sacculus 3 through full of mouth 7, can make sacculus 3 aerify the inflation in-process, promotes the support and carries out inflation many times, and supplementary prick target pathological change from the spine 11 of inflation formula support 2, carries out the deep drug delivery.

In this embodiment, the end of the first tube holder 9 is provided with a guide wire port 8, and a guide wire can be inserted into the inner tube 15 through the guide wire port 8.

It should be understood that the above examples are only for clarity of illustration and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. And are neither required nor exhaustive of all embodiments. And obvious variations or modifications therefrom are within the scope of the invention.