CN113633345A

CN113633345A - A stent system for endovascular calcification plaque treatment

Info

Publication number: CN113633345A
Application number: CN202110977756.1A
Authority: CN
Inventors: 赵文萱; 左斌
Original assignee: Jiangsu Pupeng Medical Technology Co ltd
Current assignee: Jiangsu Pupeng Medical Technology Co ltd
Priority date: 2021-08-24
Filing date: 2021-08-24
Publication date: 2021-11-12

Abstract

The invention provides a stent system for treating calcified plaque in a blood vessel, which comprises an expanding stent and a shock wave generating device, wherein the expanding stent is used for expanding the blood vessel and cutting the calcified plaque, an accommodating cavity is formed in the expanding stent, and the shock wave generating device comprises a liquid medium for generating shock waves, an accommodating bag for accommodating the liquid medium in the accommodating cavity, and an electrode pair which is arranged in the accommodating bag and is in contact with the liquid medium. By combining the expanded stent with the shock wave generating device, the expanded stent is used for cracking the calcified plaque, and then the cracked calcified plaque is broken by the shock wave, so that the calcified plaque treatment time can be shortened when the stent system for treating the calcified plaque in the blood vessel is used for treating the calcified plaque, the condition that the ischemia of an operation part of a patient occurs during long-time operation can be avoided, and the injury to the blood vessel can be reduced.

Description

A stent system for endovascular calcification plaque treatment

Technical Field

The invention relates to the field of medical instruments, in particular to the field of interventional medical instruments, and particularly relates to a stent system for treating calcified plaque in a blood vessel.

Background

The calcified plaque of the blood vessel refers to the calcium salt deposition in the blood vessel wall, which causes calcified plaque on the inner wall of the blood vessel, and the plaque is like bone and is attached to the blood vessel wall. Calcification of blood vessels leads to a decrease in the smoothness of the vessel walls, embrittlement and hardening of the blood vessels, and the compliance of blood flow in blood vessels becomes lower and lower as calcified plaques become more and more severe, which are common case manifestations of atherosclerosis, hypertension, diabetic vasculopathy, vascular injury, chronic kidney disease, aging, and the like.

Currently, the most common clinical approach to calcified plaque in blood vessels is treatment with angioplasty. Angioplasty is a minimally invasive operation that restores a narrowed blood vessel to its original shape, restores blood flow to a smooth state, and restores blood supply to a state close to normal, and is based on the principle that an expandable device (such as an expandable balloon) is placed in the blood vessel, and mechanical stress of the expandable device acts on a calcification focus to break the calcification focus, thereby restoring the blood vessel to a smooth state.

However, angioplasty is only suitable for centralized large calcified deposits, cannot treat calcified foci scattered or deep into ventricles, and has low and incomplete calcium removal efficiency; in addition, rapid expansion of the stent can cause sudden pressure changes in the vessel wall, which can easily damage the vessel and even cause thrombosis, and long-term operation can cause ischemia due to the stent blocking the vessel, thus the treatment effect has certain risks.

Disclosure of Invention

The invention provides a stent system for endovascular calcified plaque treatment, which can shorten the calcified plaque treatment time, avoid the condition that a patient is ischemic at an operation part during long-time operation and reduce the damage to a blood vessel.

The invention provides a stent system for treating calcified plaque in a blood vessel, which comprises an expanding stent and a shock wave generating device, wherein the expanding stent is used for expanding the blood vessel and cutting the calcified plaque, an accommodating cavity is formed in the expanding stent, and the shock wave generating device comprises a liquid medium for generating shock waves, an accommodating bag for accommodating the liquid medium in the accommodating cavity, and an electrode pair which is arranged in the accommodating bag and is in contact with the liquid medium.

Further, the stent system for treating the endovascular calcified plaque further comprises a control device, wherein the control device is connected with the expanding stent and the shock wave generating device and is used for expanding the expanding stent and controlling the electrode pair to generate shock waves through the liquid medium.

Further, the stent system for treating the endovascular calcified plaque further comprises an inner tube, the inner tube passes through the accommodating cavity of the expansion stent, and a guide wire is arranged in the inner tube in a penetrating manner.

Furthermore, the expansion bracket comprises a plurality of bracket rods, each bracket rod extends along the axial direction of the inner tube, the plurality of bracket rods are distributed at intervals along the circumferential direction of the inner tube, and the accommodating cavity is formed among the plurality of bracket rods.

Further, the support rod at least comprises a first connecting rod, a second connecting rod and a third connecting rod, the second connecting rod is connected between the first connecting rod and the third connecting rod, an included angle is formed between the extending direction of the first connecting rod and the extending direction of the third connecting rod, the third connecting rod of the support rod is far away from one end of the second connecting rod and fixed on the inner tube, one end of the first connecting rod, far away from the second connecting rod, can slide relative to the inner tube, the support system for treating the calcified plaque in the blood vessel further comprises a handle, and the handle is connected with one end of the first connecting rod, far away from the second connecting rod.

Further, the control device also comprises a limiting device for locking the expansion form of the expansion bracket.

Further, a protective layer is coated on the support rod.

Furthermore, the control device further comprises a filling tube for filling or extracting the liquid medium into or out of the accommodating bag, the filling tube is sleeved outside the inner tube and connected with the accommodating bag, and a pipeline of the filling tube is formed between the filling tube and the inner tube.

Furthermore, the control device also comprises a high-voltage generator, a connector and a wire, wherein the high-voltage generator is connected with the electrode pair sequentially through the connector and the wire, and the connector is connected between the wire and the high-voltage generator.

Further, the electrode pair is arranged on the outer side wall of the inner tube and exposed in the accommodating bag.

Furthermore, there are a plurality of electrode pairs, and a plurality of electrode pairs are arranged on the inner tube at intervals along the length direction of the inner tube.

Further, the containing bag is a balloon arranged in the expansion bracket, and one end of the balloon is connected with the filling tube.

Further, the inner surface or the outer surface of the expansion bracket is covered with a flexible film, and the accommodating bag is enclosed by the flexible film.

Furthermore, the flexible membrane is a hydrophobic flexible membrane, and micropores communicated with the inside and the outside of the accommodating bag are formed in the flexible membrane.

Further, the density of the micropores on the flexible membrane was 0.5 g/cc.

Furthermore, a positioning wire is arranged in the accommodating bag, one end of the positioning wire is connected with one support rod, and the other end of the positioning wire is connected with the other support rod after winding the inner pipe.

In summary, the stent system for endovascular calcified plaque treatment provided by the invention combines the expanded stent and the shock wave generating device, so that the expanded stent is used for calcified plaque to generate cracks, and then the calcified plaque generating cracks is crushed by the shock wave, which can shorten the calcified plaque treatment time, avoid the situation that a patient is ischemic at an operation part during long-time operation, and reduce the damage to blood vessels.

Further, the protective layer is coated on the stent rod, so that the blood vessel wall of the expanded stent can be prevented from being damaged after the expanded stent is expanded.

Furthermore, through the inner tube for the guide wire to pass through, the filling tube for the liquid medium to be filled and drawn out and the arrangement of the electrode pair, the electrode pair can be directly contacted with the liquid medium in the accommodating bag, so that the liquid medium can generate vapor bubbles quickly to generate shock waves.

Further, the flexible film covering the inner surface or the outer surface of the expansion bracket is arranged to the accommodating bag, so that the damage to the blood vessel wall after the expansion of the expansion bracket can be further prevented.

Furthermore, through setting up the micropore on flexible membrane, when the shock wave launches, can reduce the absorption and the reflection of the bag wall of holding bag to the shock wave energy, strengthen the utilization ratio of shock wave energy, further accelerate the cracked speed of calcification plaque.

Furthermore, through the arrangement of the positioning wires, when the calcified plaque is concentrated on one side of the blood vessel, the electrode pair can be prevented from moving away from the calcified plaque, so that the electrode pair is close to the calcified plaque, and the effect of shock waves is ensured.

The foregoing description is only an overview of the technical solutions of the present invention, and in order to make the technical means of the present invention more clearly understood, the present invention may be implemented in accordance with the content of the description, and in order to make the above and other objects, features, and advantages of the present invention more clearly understood, the following preferred embodiments are described in detail with reference to the accompanying drawings.

Drawings

Fig. 1 is a schematic structural diagram of a stent system for endovascular calcified plaque treatment according to a first embodiment of the present invention.

Fig. 2 is a schematic right view of the stent system of fig. 1 for endovascular calcified plaque treatment.

Fig. 3 is a schematic view of a receiving capsule of the stent system for endovascular calcified plaque treatment in fig. 1.

Fig. 4 is a schematic structural view of an expanded stent of the stent system for endovascular calcified plaque treatment according to the second embodiment of the present invention.

Fig. 5 is a schematic view showing the internal structure of the stent system of fig. 4.

Detailed Description

To further explain the technical means and effects of the present invention adopted to achieve the predetermined objects, the following detailed description is given with reference to the accompanying drawings and preferred embodiments.

The invention provides a stent system for angioplasty, which can shorten the treatment time of calcified plaque, avoid the situation that a patient is ischemic at an operation part during long-time operation, and reduce the damage to blood vessels.

Fig. 1 is a schematic structural view of a stent system for endovascular calcified plaque treatment according to a first embodiment of the present invention, fig. 2 is a schematic structural view of a right side view of the stent system for endovascular calcified plaque treatment in fig. 1, and fig. 3 is a schematic structural view of a housing capsule of the stent system for endovascular calcified plaque treatment in fig. 1. As shown in fig. 1 to 3, a stent system for endovascular calcified plaque treatment according to a first embodiment of the present invention includes an expanding stent 10 for expanding a blood vessel and cutting calcified plaque, a receiving chamber (not shown) is formed in the expanding stent 10, and a shock wave generating device includes a liquid medium for generating shock waves, a receiving bag 21 (see fig. 2) for receiving the liquid medium in the receiving chamber, and an electrode pair 22 disposed in the receiving bag 21 and in contact with the liquid medium.

In the present embodiment, the liquid medium and the electrode pair 22 for generating the shock wave are disposed in the accommodation chamber of the stent 10 by disposing the stent 10. When the treatment of the calcified plaque in the blood vessel is carried out, the expansion stent 10 can be expanded firstly, so that the expansion stent 10 is tightly attached to the blood vessel wall after being expanded, and the calcified plaque in the blood vessel is cut to form cracks; then, the liquid medium can be filled into the accommodating bag 21, so that the accommodating bag 21 is inflated; then, through the control of the electrode pair 22, the electrodes generate electric arcs, the liquid medium generates steam bubbles, the bubbles rapidly expand and then collapse to generate shock waves, and the shock waves can break calcified plaques after cracks are generated; after the treatment is completed, the liquid medium in the containing bag 21 can be withdrawn, so that the initial outer diameter of the stent 10 is restored, and finally the stent system is taken out of the human body; when treatment is needed in the same area, the stent system can continue to reach the lesion and repeat the above steps. That is, by combining the expanded stent 10 with the shock wave generating device, the expanded stent 10 is used to crack the calcified plaque, and then the cracked calcified plaque is crushed by the shock wave, which enables the stent system for endovascular calcified plaque treatment to shorten the time of calcified plaque treatment, avoid the occurrence of ischemia of the operative site of a patient during a long operation, and reduce the damage to the blood vessel.

Further, the stent system for endovascular calcified plaque treatment further comprises a control device, which is connected with the expandable stent 10 and the shock wave generator, and is used for expanding the expandable stent 10 and controlling the electrode pair 22 to generate the shock wave through the liquid medium.

Further, as shown in fig. 3, in the present embodiment, the stent system for endovascular calcified plaque treatment further comprises an inner tube 32, the inner tube 32 passes through a receiving cavity in the stent 10, and a guide wire (not shown) can be inserted into the conduit of the inner tube 32 to guide the stent system. The guide wire may be controlled through a guide wire control port 321 outside the body to guide the entire stent system.

More specifically, with continued reference to fig. 1, the stent 10 includes a plurality of stent rods 11, each stent rod 11 extends along the axial direction of the inner tube 32, the plurality of stent rods 11 are arranged at intervals along the circumferential direction of the inner tube 32, and the accommodating cavities are formed between the plurality of stent rods 11.

In order to facilitate the expansion of the expandable stent 10, the stent rod 11 is bent, and specifically, the stent rod includes at least a first connecting rod 111, a second connecting rod 112 and a third connecting rod 113, the second connecting rod 112 is connected between the first connecting rod 111 and the third connecting rod 113, and an included angle is formed between the extending direction of the first connecting rod 111 and the extending direction of the third connecting rod 113 and the extending direction of the second connecting rod 112. The end of the third link 113 of the plurality of support rods 11 away from the second link 112 is fixed to the outer sidewall of the inner tube 32. An end of the first link 111 remote from the second link 112 is slidable relative to the inner tube 32. The stent system further comprises a handle 31, the handle 31 is connected to an end of the first link 111 away from the second link 112 through a sleeve sleeved outside the inner tube 32, and the inner tube 32 can move axially relative to the sleeve. In use, the handle 31 may be fixed and then the inner tube 32 may be pulled to cause relative movement between the inner tube 32 and the cannula. Since the end of the third link 113 away from the second link 112 is fixed to the outer side wall of the inner tube 32. One end of the first link 111 away from the second link 112 can slide relative to the inner tube 32, so that the expandable stent 10 is pressed by the movement of the inner tube 32 to change the included angles between the first link 111 and the third link 113 and the second link 112, thereby controlling the expansion and contraction of the expandable stent 10.

Further, the stent rod 11 may be formed by cutting a metal tube or by weaving, and may be made of nitinol, L605, stainless steel, or the like, and preferably, the stent 10 may have a fusiform shape when viewed from the side of the stent 10. The stent 10 may be heat-set in advance, and the material and shape are set so as to ensure that the stent 10 can be expanded and contracted at least 3 times to ensure an initial outer diameter for continuously crossing the lesion region.

Further, the control means further includes a stopper (not shown) for locking the expanded form of the expanded stent 10, and when the expanded stent 10 is expanded to the set position, the expanded form of the expanded stent 10 is locked by the stopper and after the calcified plaque is broken, the locking is released so that the expanded stent 10 can be restored to the original diameter by the relative movement between the inner tube 32 and the sleeve.

Further, in order to prevent the stent strut 11 from damaging the vessel wall when the stent 10 is expanded, the stent strut 11 may be coated with a protective layer 114, and the protective layer 114 may be formed by winding or weaving a polymer thread.

With continued reference to fig. 2 and 3, in the present embodiment, the control device further includes a filling tube 23 for filling or withdrawing the liquid medium into or out of the accommodating bag 21, and the filling tube 23 is sleeved outside the inner tube 32, specifically, between the inner tube 32 and the sleeve, and is connected to the accommodating bag 21. That is, the conduit of the filling tube 23 is formed between the filling tube 23 and the inner tube 32. In this embodiment, the receiving bag 21 may be a balloon disposed in the receiving cavity of the expandable stent 10. One end of which is fixedly connected to the outer side wall of the inner tube 32 and the other end is connected to the filling tube 23 to complete the sealing of the balloon. The fluid medium can be filled or withdrawn from the receiving bag 21 through the filling opening 231 located outside the body via the filling tube 23. The balloon is made of balloon conventional materials.

Further, the control device further comprises a high voltage generator 33, a connector 34 and a lead, wherein the high voltage generator 33 is connected with the electrode pair 22 through the connector 34 and the lead in sequence, and the connector 34 is connected between the lead and the high voltage generator 33. The above-mentioned leads can be introduced into the tract of the filling tube 23 through the lead control port 341 so that the voltage and/or current pulses generated by the high voltage generator 33 are transmitted to the pair of electrodes 22 in the receiving bag 21 through the connector 34 and the leads.

Further, with reference to fig. 3, in the present embodiment, the electrode pair 22 may be fixed on the outer sidewall of the inner tube 32 by welding or bonding, and exposed in the accommodating bag 21. Two electrodes of the electrode pair 22 are spaced apart from each other, and when the liquid medium is filled in the accommodating bag 21, the electrode pair 22 is in contact with the liquid medium. By arranging the electrode pair 22, the liquid medium can be better subjected to vapor bubble generation to generate shock waves.

Further, there may be a plurality of electrode pairs 22, and a plurality of electrode pairs 22 are arranged at intervals along the length direction of the inner tube 32.

Further, in the present embodiment, the liquid medium may be a conductive liquid such as physiological saline.

Further, in this embodiment, the filling tube 23, the inner tube 32, and the guide wire for controlling the stent 10 may be inserted into the same protective sheath.

Further, a development point 321 is provided on the inner tube 32.

Fig. 4 is a schematic structural view of an expanded stent 10 of a stent system for endovascular calcified plaque treatment according to a second embodiment of the present invention, and fig. 5 is a schematic structural view of the inside of the stent system in fig. 4. As shown in fig. 4 and 5, the stent system for endovascular calcified plaque treatment according to the second embodiment of the present invention is substantially the same as the second embodiment, except that in the present embodiment, the inner surface or the outer surface of the stent 10 is covered with a flexible membrane, and the above-mentioned receiving bag 21 may be surrounded by the flexible membrane. The provision of the flexible membrane can further reduce damage to the vessel wall after the expansion of the stent 10.

One end of the flexible membrane may be sealingly connected to the filling tube 23 and the other end is fixed to the outer side wall of the inner tube 32. The flexible film may be disposed on the stent struts 11 of the stent 10 by means of weaving, heat pressing, or bonding, etc.

Further, the flexible film may be a hydrophobic flexible film, and the flexible film is formed with micro holes 24 communicating the inside and the outside of the receiving pocket 21. Through the arrangement of the micropores 24, when the shock wave is emitted, the absorption and reflection of the shock wave energy by the capsule wall of the containing capsule 21 can be reduced, the utilization rate of the shock wave energy is enhanced, and the fragmentation speed of the calcified plaque is further accelerated. The density of the micropores 24 on the flexible film was 0.5 g/cc.

Further, the flexible membrane may be made of a polymer material, and may have flexibility, foldability and insulating properties, which are capable of being expanded to at least twice the original diameter with the expanded stent 10. This flexible membrane can be designed as disposable consumptive material or used repeatedly's consumptive material, when it is used repeatedly's consumptive material, need disinfect before using.

Further, in this embodiment, a positioning wire 25 made of a flexible metal wire or a polymer fiber wire may be disposed in the receiving bag, one end of the positioning wire 25 is connected to one of the support rods 11, and the other end is connected to the other support rod 11 after winding the inner tube 32. The arrangement of the positioning wire 25 can limit the position of the electrode pair 22 on the inner tube 32, and when the calcified plaque is concentrated in one side area of the blood vessel, the positioning wire 25 can prevent the inner tube 32 from moving and shifting to the free area of the blood vessel on the side without the calcified plaque, so that the electrode pair 22 is far away from the area where the calcified plaque is positioned, and the effect of the shock wave is ensured.

In summary, the stent system for endovascular calcified plaque treatment provided by the present invention combines the expanded stent 10 with the shock wave generating device, so that the expanded stent 10 is used for calcified plaque to generate cracks, and then the calcified plaque generating cracks is broken by the shock wave, which enables the stent system for endovascular calcified plaque treatment to shorten the calcified plaque treatment time, avoid the situation that the operative site is ischemic when the patient is operated for a long time, and reduce the damage to the blood vessel.

Further, by coating the stent rod 11 with the protective layer 114, the expanded stent 10 can be prevented from damaging the blood vessel wall after expansion.

Further, the arrangement of the inner tube 32 for passing the guide wire, the filling tube 23 for filling and extracting the liquid medium, and the position of the electrode pair 22 can make the electrode pair 22 directly contact with the liquid medium in the accommodating bag 21, so as to rapidly generate vapor bubbles in the liquid medium to generate shock waves.

Further, by providing the accommodation bag 21 as a flexible film covering the inner surface or the outer surface of the expanded stent 10, it is possible to further prevent the expanded stent 10 from causing damage to the blood vessel wall after expansion.

Further, by arranging the micropores 24 on the flexible film, when the shock wave is emitted, the absorption and reflection of the shock wave energy by the wall of the containing bag 21 can be reduced, the utilization rate of the shock wave energy is enhanced, and the fragmentation speed of the calcified plaque is further accelerated.

Further, by providing the positioning wire 25, it is possible to prevent the electrode pair 22 from moving to the side away from the calcified plaque when the calcified plaque is concentrated on the blood vessel side, so that the electrode pair 22 approaches the calcified plaque, and to ensure the effect of the shock wave.

Although the present invention has been described with reference to a preferred embodiment, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.

Claims

1. A stent system for endovascular calcified plaque treatment characterized by: the shock wave generator comprises a liquid medium for generating shock waves, a containing bag for containing the liquid medium in the containing cavity, and an electrode pair which is arranged in the containing bag and is in contact with the liquid medium.

2. The stent system for endovascular calcified plaque treatment according to claim 1, wherein: the stent system for treating the endovascular calcified plaque further comprises a control device, wherein the control device is connected with the expansion stent and the shock wave generation device and is used for expanding the expansion stent and controlling the electrode pair to generate shock waves through the liquid medium.

3. The stent system for endovascular calcified plaque treatment according to claim 2, wherein: the stent system for treating the endovascular calcified plaque further comprises an inner tube, the inner tube penetrates through the accommodating cavity of the expansion stent, and a guide wire penetrates through the inner tube.

4. The stent system for endovascular calcified plaque treatment of claim 3, wherein: the expansion support comprises a plurality of support rods, each support rod extends along the axial direction of the inner tube, the support rods are arranged at intervals along the circumferential direction of the inner tube, and the accommodating cavities are formed among the support rods.

5. The stent system for endovascular calcified plaque treatment of claim 4, wherein: the stent rod at least comprises a first connecting rod, a second connecting rod and a third connecting rod, the second connecting rod is connected between the first connecting rod and the third connecting rod, an included angle is formed between the extending directions of the first connecting rod and the third connecting rod and between the extending directions of the second connecting rod, the third connecting rod of the stent rod is far away from one end of the second connecting rod and fixed on the inner tube, one end of the first connecting rod, far away from the second connecting rod, can slide relative to the inner tube, the stent system for treating the calcified plaque in the blood vessel further comprises a handle, and the handle is connected with one end of the first connecting rod, far away from the second connecting rod.

6. The stent system for endovascular calcified plaque treatment of claim 4, wherein: the control device also comprises a limiting device for locking the expansion form of the expansion bracket.

7. The stent system for endovascular calcified plaque treatment of claim 4, wherein: the support rod is coated with a protective layer.

8. The stent system for endovascular calcified plaque treatment of claim 4, wherein: the control device further comprises a filling pipe which fills or extracts the liquid medium into or out of the containing bag, the filling pipe is sleeved outside the inner pipe and connected with the containing bag, and a pipeline of the filling pipe is formed between the filling pipe and the inner pipe.

9. The stent system for endovascular calcified plaque treatment of claim 8, wherein: the control device further comprises a high-voltage generator, a connector and a wire, the high-voltage generator is connected with the electrode pair sequentially through the connector and the wire, and the connector is connected between the wire and the high-voltage generator.

10. The stent system for endovascular calcified plaque treatment of claim 8, wherein: the electrode pair is arranged on the outer side wall of the inner tube and exposed in the accommodating bag.

11. The stent system for endovascular calcified plaque treatment of claim 10, wherein: the electrode pairs are arranged on the inner tube at intervals along the length direction of the inner tube.

12. The stent system for endovascular calcified plaque treatment of claim 8, wherein: the holding bag is a balloon arranged in the expansion bracket, and one end of the holding bag is connected with the filling tube.

13. The stent system for endovascular calcified plaque treatment of claim 8, wherein: the inner surface or the outer surface of the expansion bracket is covered with a flexible film, and the accommodating bag is enclosed by the flexible film.

14. The stent system for endovascular calcified plaque treatment of claim 13, wherein: the flexible membrane is a hydrophobic flexible membrane, and micropores communicated with the inside and the outside of the accommodating bag are formed in the flexible membrane.

15. The stent system for endovascular calcified plaque treatment of claim 14, wherein: the density of the micropores on the flexible membrane was 0.5 g/cc.

16. The stent system for endovascular calcified plaque treatment of claim 13, wherein: and a positioning wire is arranged in the accommodating bag, one end of the positioning wire is connected with one support rod, and the other end of the positioning wire is wound on the inner pipe and then is connected with the other support rod.