CN113599038A - Drug-withdrawable perfusion stent system - Google Patents

Abstract

Translated fromChinese

本发明提供了一种可撤回药物灌注支架系统，属于医疗器械技术领域，包括：内管及外管，内管及外管的近端连接有推送装置；内管的远端具有尖端；灌注微管，呈螺旋状，灌注微管上开设有微孔；灌注管，灌注管的近端伸出外管的近端并连接有给药装置；球囊；充盈口，适于与充气装置连通；灌注微管具有收拢状态和扩张状态；球囊具有使支撑所述灌注微管进一步扩张并切割靶病变的膨胀状态。本发明提供的可撤回药物灌注支架系统，此药物灌注支架不会留存在体内，同时，此种方式阻断血流的时间短，仅在使灌注微管二次扩张时对血液阻断，灌注微管完成二次扩张后，球囊即收缩至收缩状态，还能够持续进行给药，控制给药时间，整个操作过程简便，易于操作。

The invention provides a retractable drug perfusion stent system, belonging to the technical field of medical devices, comprising: an inner tube and an outer tube, the proximal ends of the inner tube and the outer tube are connected with a pushing device; the distal end of the inner tube has a tip; The tube is helical, and the perfusion microtube is provided with micro holes; the perfusion tube, the proximal end of the perfusion tube protrudes from the proximal end of the outer tube and is connected with a drug delivery device; a balloon; a filling port, suitable for communication with an inflation device; Microtubules have a collapsed state and an expanded state; the balloon has an expanded state that further expands supporting the perfused microtubules and cuts the target lesion. In the retractable drug perfusion stent system provided by the present invention, the drug perfusion stent will not remain in the body, and at the same time, the time of blocking blood flow in this way is short, and the blood is blocked only when the perfusion microtubule is expanded twice, and the perfusion After the second expansion of the microtubule is completed, the balloon is contracted to a contracted state, and the drug can be continuously administered, and the administration time can be controlled. The entire operation process is simple and easy to operate.

Description

Drug-withdrawable perfusion stent system

Technical Field

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relates to the technical field of medical instruments, in particular to a drug-infusion stent system capable of being withdrawn.

Background

At present, the intracavity interventional therapy becomes the first choice treatment means of lower limb arteriosclerosis obliterans, and more medicine-carrying apparatuses are reported to be applied to the treatment of the lower limb arteriosclerosis obliterans in recent years, such as medicine eluting stents, medicine coating balloons 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.

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, and the drug coating balloon needs to block blood flow during expansion administration, so that the adherence time and the drug absorption rate of the drug coating balloon are limited, thereby providing a recoverable drug perfusion stent system.

To solve the above problems, the present invention provides a retractable drug-infused stent system comprising:

the inner tube and the outer tube are sleeved on the inner tube in a sliding manner, and the near ends of the inner tube and the outer tube 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 perfusion micro-tube is in a spiral shape, a micro-hole is formed in the perfusion micro-tube, the perfusion micro-tube is sleeved at the far end of the inner tube, and one end, close to the near end of the inner tube, of the perfusion micro-tube is connected with the inner tube;

the perfusion tube is sleeved on the inner tube and positioned in the outer tube, the far end of the perfusion tube is communicated with the perfusion micro-tube, and the near end of the perfusion tube extends out of the near end of the outer tube and is connected with a drug delivery device;

the balloon is sleeved on the inner tube and is positioned in an inner space formed by the spiral perfusion micro-tube, and one end of the balloon is connected with the far end of the inner tube;

the filling opening is arranged on the pushing device and is communicated with the balloon through an inflation tube, and the filling opening is suitable for being communicated with an inflation device;

the perfusion microtube is in a furled state and is contained in the outer tube, and the perfusion microtube is also in an expanded state which is separated from the limit of the outer tube and is automatically expanded to be attached to the wall of the blood vessel and attached to the target lesion; the balloon has an inflated state that further expands the supporting perfusion microtubes and cuts a target lesion, and a deflated state that fits to the inner tube; the pushing device is suitable for driving the inner tube and the outer tube to slide mutually, so that the perfusion microtube is switched between a folded state and an expanded state.

Optionally, the pushing device includes:

the near ends of the inner tube, the inflation tube and the perfusion tube are all connected to the first tube seat, and the filling opening is formed in the first tube seat;

and the second tube seat is connected with the outer tube, and the inner tube, the inflation tube and the filling tube penetrate through the second tube seat and penetrate through the outer tube.

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 perfusion microtube is a NiTi shape memory alloy.

Optionally, the perfusion microtube is a double-helix microtube.

Optionally, the perfusion microtubules are multi-helical microtubules.

Optionally, a perfusion opening extends from the first tube holder, the proximal end of the perfusion tube is mounted in the perfusion opening, and the perfusion opening is adapted to be connected to a drug delivery device.

Optionally, the diameter of the perfusion microtube is in the range of 50 microns to 500 microns.

Optionally, the perfusion microtube is provided with a plurality of micropores uniformly.

The technical scheme of the invention has the following advantages:

1. according to the withdrawable drug perfusion stent system provided by the invention, the outer tube is slidably sleeved on the inner tube, the inner tube is connected with the perfusion micro-tube, the micro-hole is formed in the perfusion micro-tube, the perfusion micro-tube is in a folded state before reaching the target lesion position, and the far end of the outer tube is in contact with the tip end of the inner tube; when the drug perfusion stent reaches the lesion position, the pushing device is controlled to enable the inner tube and the outer tube to slide mutually, the outer tube gradually releases the perfusion microtubules in the process that the outer tube slides relative to the inner tube, the perfusion microtubules are switched from a folded state to an expanded state, the perfusion microtubules are separated from the limitation of the outer tube at the moment and automatically expand to be attached to the vascular wall and expand the target lesion, the balloon is inflated through the inflating device to enter an expanded state, the balloon is firstly contacted with the perfusion microtubules in the expanding process and then gradually expands to drive the perfusion microtubules to continue expanding, the perfusion microtubules cut the target lesion, the perfusion microtubules penetrate into the target lesion, and the balloon is deflated to restore the balloon to a contracted state to ensure that blood continues to circulate. The drug delivery device inputs drugs into the perfusion microtube through the perfusion tube, and the drugs are delivered to the target lesion through the micropores of the perfusion microtube; after the injection of the medicine is finished, the outer tube moves forward in the sliding process of the outer tube relative to the inner tube, the position of the inner tube is kept unchanged, when the end part of the outer tube meets the perfusion micro-tube, the perfusion micro-tube is folded again and enters the outer tube together with the balloon, the perfusion micro-tube enters the folded state, then the inner tube is drawn out, and the outer tube is driven to move out together under the action of the tip. The drug perfusion stent cannot be left in the body, meanwhile, the time for blocking blood flow is short, blood is blocked only when the perfusion microtubule is subjected to secondary expansion, the balloon is contracted to a contraction state after the perfusion microtubule finishes the secondary expansion, the drug can be continuously administered, the drug administration time is controlled, and the whole operation process is simple and convenient and is easy to operate.

2. The push device comprises a first tube seat and a second tube seat, the first tube seat is connected with the proximal end of the inner tube, the second tube seat is connected with the proximal end of the 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. According to the withdrawable drug perfusion stent system provided by the invention, the second tube seat is provided with the flushing port, the flushing port is communicated with the outer tube, and physiological saline can be injected through the flushing port to remove air.

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 retractable drug-infused stent system provided by an embodiment of the present invention;

FIG. 2 is a schematic diagram of a first structure of an perfusion microtube according to an embodiment of the present invention;

fig. 3 is a schematic diagram of a second structure of an perfusion microtube according to an embodiment of the present invention.

Description of reference numerals:

1. a tip; 2. a balloon; 3. perfusing a microtubule; 4. micropores; 5. an outer tube; 6. an infusion port; 7. flushing the opening; 8. an inner tube; 9. filling the mouth; 10. a wire guide opening; 11. a first stem; 12. a second stem; 13. a balloon tube; 14. and (4) filling a pipe.

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.

The present embodiment provides a specific embodiment of a retractable drug perfusion stent system, as shown in fig. 1 and 2, the pushing device includes afirst tube holder 11 and asecond tube holder 12, thefirst tube holder 11 is connected to the proximal end of the inner tube 8, thesecond tube holder 12 is connected to the proximal end of theouter tube 5, thesecond tube holder 12 is further connected to the proximal end of the perfusion tube, the distal end of the perfusion tube is fixed to the inner tube 8 in a binding manner, and the proximal end of the perfusion tube is communicated with theperfusion port 6 of thefirst tube holder 11, so that when the inner tube 8 and theouter tube 5 slide relative to each other by controlling thefirst tube holder 11 and thesecond tube holder 12, theouter tube 5 slides relative to the inner tube 8 and the perfusion tube, and no relative movement occurs between the perfusion tube and the inner tube 8.

Specifically, the inflation tube is sleeved on the inner tube 8, the perfusion tube is sleeved on the inflation tube, theouter tube 5 is sleeved on the perfusion tube, the inner tube 8, the inflation tube, the perfusion tube and theouter tube 5 are not communicated with each other pairwise, the distal end of the inflation tube is tightened on the inner tube 8, and the proximal end of theballoon 2 passes through the tightening part of the inflation tube and is communicated with the space between the inflation tube and the inner tube 8; the far end of the perfusion tube is bound on the inflation tube, and the near end of theperfusion microtube 3 passes through the binding part of the perfusion tube and is communicated with the space between the perfusion tube and the inflation tube. The drug delivery device is communicated with the space between the filling pipe and the inflation pipe through the fillingport 6, so that the drugs can enter the filling pipe, wherein the drug delivery device can be an injector, and the injection end of the injector is connected with the filling port.

In this embodiment, the proximal end of the inner tube 8 is connected to the first tube holder 11, and the distal end is provided with the tip 1; the outer tube 5 is sleeved on the inner tube 8 in a sliding manner, the far end of the inner tube 8 is connected with the perfusion micro-tube 3, the micro-hole 4 is formed in the perfusion micro-tube 3, the perfusion micro-tube 3 is in a folded state before the perfusion micro-tube 3 reaches the target lesion position, and the far end of the outer tube 5 is arranged in contact with the tip 1 on the inner tube 8; when the administration perfusion support reaches the lesion position, the pushing device is controlled to enable the inner tube 8 and the outer tube 5 to slide mutually, in the process that the outer tube 5 slides relative to the inner tube 8, the outer tube 5 gradually releases the perfusion microtube 3 to enable the perfusion microtube 3 to be switched from a folded state to an expanded state, at the moment, the perfusion microtube 3 is separated from the limit of the outer tube 5 and automatically expands to be attached to the vessel wall and expand the target lesion, at the moment, the balloon 2 is inflated through the inflating device to enable the balloon 2 to enter an expanded state, the balloon 2 is firstly contacted with the inner surface of a spiral structure formed by the perfusion microtube 3 in the expanding process, then the perfusion microtube 3 is driven to continue to expand, at the moment, the perfusion microtube 3 cuts the target lesion, so that the perfusion microtube 3 extends deeply into the target lesion, deflating the saccule 2 to restore the saccule 2 to a contracted state and ensure the blood to continuously circulate, and embedding the perfusion microtube 3 at the position of the target lesion. The drug delivery device inputs drugs into theperfusion microtube 3 through the perfusion tube, and the drugs are delivered to the target lesion through themicropores 4 of theperfusion microtube 3; after the injection of the medicine is finished, in the process that theouter tube 5 slides relative to the inner tube 8, theouter tube 5 advances, the position of the inner tube 8 is kept unchanged, when theperfusion micro-tube 3 meets the end part of theouter tube 5, theperfusion micro-tube 3 is furled again and enters theouter tube 5 together with theballoon 2 to enter a furled state, then the inner tube 8 is drawn out, and theouter tube 5 is driven to move out together under the action of thetip 1. Theouter tube 5 is moved firstly, the position of the drug perfusion bracket is kept still, and the drug perfusion bracket can be prevented from scratching blood vessels. The drug perfusion stent cannot be left in the body, meanwhile, the time for blocking blood flow is short in the mode, blood is blocked only when theperfusion microtube 3 is expanded for the second time, after theperfusion microtube 3 completes the second expansion, theballoon 2 is contracted to a contraction state, the drug can be continuously administered, the drug administration time is controlled, and the whole operation process is simple and convenient and easy to operate.

Specifically, thefirst tube seat 11 is provided with a fillingopening 9, the proximal end of the inflation tube is connected to the fillingopening 9, and the inflation device can inflate theballoon 2 through the fillingopening 9. The inflation device can be a pressure pump, the output end of the pressure pump is connected to the fillingopening 9, air is blown into the inflation tube to expand theballoon 2, after theperfusion microtube 3 is cut to a target lesion, the air is pumped out through the pressure pump to enable theballoon 2 to return to a contraction state, and blood flow is not blocked; the inflation device may be any device that can be inflated with gas and can perform suction, and is not limited as long as theballoon 2 can be switched between the inflated state and the deflated state.

Specifically, the number ofperfusion microtubes 3 is not particularly required, and as shown in fig. 2 and fig. 3, theperfusion microtubes 3 may be set as single-helix microtubes, double-helix microtubes, or multiple-helix microtubes, and may be determined by themselves according to actual administration requirements. The micro-holes 4 on theperfusion microtube 3 may be arranged in a plurality of evenly distributed holes so as to evenly release the drug to the target lesion site. The drug delivery device continuously injects the drug into the target lesion site through themicro-holes 4 of theperfusion micro-tube 3.

Specifically, the administration device may be an injector, and an injection end of the injector is connected with theperfusion port 6 to inject the drug into theperfusion microtube 3; the drug delivery device can also be a pressure pump, the output end of the pressure pump is connected with theperfusion port 6, and the drug is input into theperfusion microtube 3 through the pressure pump, so that the drug has certain pressure in the delivery process; the administration device can also be an infusion bottle, the output end of the infusion bottle is connected with theinfusion port 6, and continuous administration of theinfusion microtube 3 can be realized; the administration device may be any other device as long as it can be connected to theperfusion port 6 and can administer the drug into theperfusion microtube 3.

In this embodiment, the diameter of theperfusion microtube 3 ranges from 20 micrometers to 500 micrometers, and the diameter of themicropore 4 ranges from 1 micrometer to 100 micrometers, and the diameter of theperfusion microtube 3 and the diameter of themicropore 4 can be selected according to actual administration conditions.

In this embodiment, theperfusion microtube 3 is made of a NiTi shape memory alloy, has superelasticity and shape memory properties, and is in a radially expanded state at a temperature of about 37 ℃.

Thesecond tube holder 12 is provided with a flushing port 7, the flushing port 7 is communicated with theouter tube 5, and the flushing port 7 can inject physiological saline to remove air.

In this embodiment, the end of thefirst tube seat 11 is provided with aguide wire opening 10, and a guide wire can be inserted into the inner tube 8 through theguide wire opening 10.

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.

Claims (9)

Translated fromChinese

1.一种可撤回药物灌注支架系统，其特征在于，包括：1. A retractable drug perfusion stent system, characterized in that, comprising:内管(8)及滑动套设在所述内管(8)上的外管(5)，所述内管(8)及外管(5)的近端连接有推送装置；an inner tube (8) and an outer tube (5) slidably sleeved on the inner tube (8), and a push device is connected to the proximal ends of the inner tube (8) and the outer tube (5);所述内管(8)的远端具有尖端(1)，所述外管(5)的远端端部适于与所述尖端(1)接触设置；The distal end of the inner tube (8) has a tip (1), and the distal end of the outer tube (5) is adapted to be in contact with the tip (1);灌注微管(3)，呈螺旋状，所述灌注微管(3)上开设有微孔(4)，所述灌注微管(3)套设在所述内管(8)的远端，且所述灌注微管(3)靠近所述内管(8)近端的一端与所述内管(8)连接；The perfusion micro-pipe (3) is in a spiral shape, the perfusion micro-pipe (3) is provided with a micro-hole (4), and the perfusion micro-pipe (3) is sleeved on the distal end of the inner pipe (8), and one end of the perfusion microtube (3) close to the proximal end of the inner tube (8) is connected to the inner tube (8);灌注管，套设在所述内管(8)上，并位于所述外管(5)内，所述灌注管的远端与所述灌注微管(3)连通，所述灌注管的近端伸出所述外管(5)的近端并连接有给药装置；A perfusion tube is sleeved on the inner tube (8) and located in the outer tube (5), the distal end of the perfusion tube is communicated with the perfusion microtube (3), and the proximal end of the perfusion tube is in communication with the perfusion microtube (3). The end protrudes from the proximal end of the outer tube (5) and is connected with a drug delivery device;球囊(2)，套设在所述内管(8)上，并位于螺旋状灌注微管(3)形成的内部空间内，所述球囊(2)的一端与所述内管(8)的远端连接；A balloon (2) is sleeved on the inner tube (8) and is located in the inner space formed by the helical perfusion microtubes (3), and one end of the balloon (2) is connected to the inner tube (8). ) remote connection;充盈口(9)，设置在所述推送装置上，所述充盈口(9)通过充气管与所述球囊(2)连通，所述充盈口(9)适于与充气装置连通；a filling port (9), provided on the pushing device, the filling port (9) communicates with the balloon (2) through an inflation tube, and the filling port (9) is adapted to communicate with the inflation device;所述灌注微管(3)具有收纳在所述外管(5)内的收拢状态，所述灌注微管(3)还具有脱离所述外管(5)限制，自行扩张至与血管壁贴壁并与靶病变贴合的扩张状态；所述球囊(2)具有使支撑所述灌注微管(3)进一步扩张并切割靶病变的膨胀状态，所述球囊(2)还具有贴合至所述内管(8)的收缩状态；所述推送装置适于驱动所述内管(8)与所述外管(5)进行相互滑动，以使所述灌注微管(3)在收拢状态和扩张状态之间进行切换。The perfusion microtube (3) has a folded state accommodated in the outer tube (5), and the perfusion microtube (3) also has a limit of being separated from the outer tube (5) and self-expanding to adhere to the blood vessel wall. an expanded state in which the wall is in contact with the target lesion; the balloon (2) has an expanded state that further expands the perfusion microtubules (3) supporting the perfusion and cuts the target lesion, and the balloon (2) also has a fit to the retracted state of the inner tube (8); the pushing device is adapted to drive the inner tube (8) and the outer tube (5) to slide with each other, so that the perfusion microtubes (3) are retracted Toggle between state and expansion state.2.根据权利要求1所述的可撤回药物灌注支架系统，其特征在于，所述推送装置包括：2. The retractable drug perfusion stent system according to claim 1, wherein the pushing device comprises:第一管座(11)，所述内管(8)、充气管和灌注管的近端均连接在第一管座(11)上，所述充盈口(9)设置在所述第一管座(11)上；A first tube seat (11), the proximal ends of the inner tube (8), the inflation tube and the perfusion tube are all connected to the first tube seat (11), and the filling port (9) is provided on the first tube on seat (11);第二管座(12)，与所述外管(5)连接，所述内管(8)、充气管和灌注管贯穿所述第二管座(12)并穿设在所述外管(5)内。The second pipe seat (12) is connected to the outer pipe (5), the inner pipe (8), the inflation pipe and the perfusion pipe pass through the second pipe seat (12) and pass through the outer pipe ( 5) inside.3.根据权利要求2所述的可撤回药物灌注支架系统，其特征在于，还包括有冲洗口(7)，设置在所述第二管座(12)上，所述冲洗口(7)与所述外管(5)连通。3. The retractable drug perfusion stent system according to claim 2, characterized in that it further comprises a flushing port (7) disposed on the second tube seat (12), the flushing port (7) being connected to the The outer pipe (5) is communicated.4.根据权利要求1所述的可撤回药物灌注支架系统，其特征在于，所述灌注微管(3)为NiTi形状记忆合金。4. The retractable drug perfusion stent system according to claim 1, wherein the perfusion microtubes (3) are NiTi shape memory alloys.5.根据权利要求1所述的可撤回药物灌注支架系统，其特征在于，所述灌注微管(3)为双螺旋微管。5 . The retractable drug perfusion stent system according to claim 1 , wherein the perfusion microtubes ( 3 ) are double-helix microtubes. 6 .6.根据权利要求1所述的可撤回药物灌注支架系统，其特征在于，所述灌注微管(3)为多螺旋微管。6 . The retractable drug perfusion stent system according to claim 1 , wherein the perfusion microtubes ( 3 ) are multi-spiral microtubes. 7 .7.根据权利要求2所述的可撤回药物灌注支架系统，其特征在于，所述第一管座(11)上伸出有灌注口(6)，所述灌注管的近端与所述灌注口(6)连通，所述灌注口(6)适于连接给药装置。7. The retractable drug perfusion stent system according to claim 2, wherein a perfusion port (6) protrudes from the first tube seat (11), and the proximal end of the perfusion tube is connected to the perfusion tube A port (6) is communicated, and the infusion port (6) is suitable for connecting a drug delivery device.8.根据权利要求1－7中任一项所述的可撤回药物灌注支架系统，其特征在于，所述灌注微管(3)的直径范围为50微米－500微米。8. The retractable drug perfusion stent system according to any one of claims 1 to 7, wherein the perfusion microtubes (3) have a diameter ranging from 50 microns to 500 microns.9.根据权利要求1－7中任一项所述的可撤回药物灌注支架系统，其特征在于，所述微孔(4)在所述灌注微管(3)上均匀设有多个。9. The retractable drug perfusion stent system according to any one of claims 1-7, wherein a plurality of the micropores (4) are uniformly provided on the perfusion microtubes (3).

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