A device for dilating blood vessels and collecting shed emboli

Abstract

The present disclosure relates to the technical field of medical devices, and particularly relates to a device for dilating blood vessels and collecting detached emboli. The device for dilating blood vessels and collecting detached emboli includes: an inflatable body; a membrane structure provided with a plurality of embolus inlets; the embolus inlets are normally closed openings and can be opened under the action of an external force; wherein, the membrane structure and the outer surface of the inflatable body form a squeezing space; when the outer surface of the inflatable body expands outwards, the membrane structure gradually contacts the blood vessel stenosis and undergoes mutual squeezing, and the squeezed-off emboli enter the squeezing space through the embolus inlets. The above technical solution not only realizes blood vessel dilation, but also can collect the detached emboli to prevent distal blood vessel embolism, simplifies the surgical operation, and reduces the occurrence of complications.

Description

Technical Field

[0001] The present disclosure relates to the technical field of medical devices, and particularly to a device for dilating blood vessels and collecting shed emboli. Background Art

[0002] Percutaneous Transluminal Angioplasty (PTA) is a commonly used vascular interventional therapy technique aimed at dilating stenotic or occluded blood vessels by inflating a balloon to restore blood flow. However, during this process, some complications may occur, one of which is the embolization of distal blood vessels by "debris" or "emboli" in the blood vessels. These "debris" or "emboli" usually refer to plaque emboli shed after mechanical stimulation of the blood vessel endothelium. During balloon dilation, the balloon exerts pressure on the blood vessel wall, which may cause tearing of the blood vessel endothelium, thereby releasing these emboli. If these emboli are not completely removed, they may cause serious complications such as cerebral infarction, myocardial infarction, or distal limb embolization. Summary of the Invention

[0003] To solve the problems in the related art, embodiments of the present disclosure provide a device for dilating blood vessels and collecting shed emboli.

[0004] Embodiments of the present disclosure provide a device for dilating blood vessels and collecting shed emboli, including:

[0005] An inflatable body;

[0006] A membrane structure provided with a plurality of embolus inlets; the embolus inlets are normally closed openings and can be opened under the action of an external force;

[0007] Wherein, the membrane structure and the outer surface of the inflatable body form a squeezing space; when the outer surface of the inflatable body expands outward, the membrane structure gradually contacts and squeezes against the stenotic part of the blood vessel, and the shed emboli enter the squeezing space through the embolus inlets.

[0008] According to an embodiment of the present disclosure, the embolus inlet is a one-way valve structure.

[0009] According to an embodiment of the present disclosure, the embolus inlet is an embolus channel formed by the outer surface of the membrane structure extending inward to the inside of the squeezing space.

[0010] According to an embodiment of the present disclosure, the membrane structure partially surrounds the inflatable body and forms a squeezing space with the outer surface of the inflatable body; or, the membrane structure completely surrounds the inflatable body and forms a squeezing space with the outer surface of the inflatable body.

[0011] According to an embodiment of the present disclosure, the inflatable body is an expandable balloon, and the number of the expandable balloons is at least one. The membrane structure completely surrounds the expandable balloon and forms a squeezing space with the outer surface of the expandable balloon; or,

[0012] The inflatable body includes two expandable balloons; the membrane structure connects the two expandable balloons and forms a squeezing space with the outer surfaces of the two expandable balloons; or,

[0013] The inflatable body includes a plurality of expandable balloons; the membrane structure connects the expandable balloons at both ends and forms a squeezing space with the outer surfaces of the expandable balloons at both ends; at least one expandable balloon in the middle is accommodated inside the squeezing space; or,

[0014] The inflatable body includes a plurality of expandable balloons; the membrane structure connects the expandable balloons at both ends and forms a squeezing space with the outer surfaces of the expandable balloons at both ends; wherein, one expandable balloon in the middle is integrated with the expandable balloons at both ends; or at least two expandable balloons in the middle are connected in sequence and then integrated with the expandable balloons at both ends.

[0015] According to an embodiment of the present disclosure, the outer surface of the inflatable body and / or the membrane structure is provided with protrusions and / or restraint structures.

[0016] According to an embodiment of the present disclosure, the outer surface of the inflatable body and / or the membrane structure is provided with spines and / or blades.

[0017] According to an embodiment of the present disclosure, the plurality of embolus inlets are circumferentially arranged on the membrane structure.

[0018] According to an embodiment of the present disclosure, the sizes of the plurality of embolus inlets are the same or different.

[0019] According to an embodiment of the present disclosure, the material of the membrane structure is selected from polytetrafluoroethylene, polyurethane, polyester, PEBAX, PEEK, nylon, bovine pericardium, gel or animal valve, etc.

[0020] According to the device for dilating blood vessels and collecting detached emboli provided by the embodiments of the present disclosure, the device for dilating blood vessels and collecting detached emboli includes: an inflatable body; a membrane structure provided with a plurality of embolus inlets; the embolus inlets are normally closed openings and can be opened under the action of an external force; wherein, the membrane structure and the outer surface of the inflatable body form a squeezing space; when the outer surface of the inflatable body expands outwards, the membrane structure gradually contacts the blood vessel stenosis and squeezes each other, and the detached emboli enter the squeezing space through the embolus inlets. After the inflatable body shrinks, the emboli are carried out of the blood vessel together. Through the device for dilating blood vessels and collecting detached emboli provided by the present application, both blood vessel dilation is achieved, and the detached emboli can be collected to prevent distal blood vessel embolism, and the detached emboli are removed from the blood vessel, simplifying the surgical operation and reducing the occurrence of complications.

[0021] It should be understood that the above general description and the following detailed description are only exemplary and explanatory, and cannot limit the present disclosure. Brief Description of the Drawings

[0022] In conjunction with the drawings, through the following detailed description of non-limiting embodiments, other features, objects and advantages of the present disclosure will become more apparent. In the drawings.

[0023] Figure 1 A structural diagram of a device for dilating blood vessels and collecting detached emboli according to an embodiment of the present disclosure is shown.

[0024] Figure 2 Shown Figure 1 An enlarged schematic view of part A.

[0025] Figures 3A - 3C A schematic flow diagram of a method for dilating blood vessels and collecting detached emboli according to an embodiment of the present disclosure is shown.

[0026] Figure 4 A structural diagram of a device for dilating blood vessels and collecting detached emboli according to another embodiment of the present disclosure is shown.

[0027] Figure 5 A structural diagram of a device for dilating blood vessels and collecting detached emboli according to another embodiment of the present disclosure is shown.

[0028] Figure 6 A structural diagram of a device for dilating blood vessels and collecting detached emboli according to still another embodiment of the present disclosure is shown. Detailed Description of the Embodiments

[0029] Hereinafter, exemplary embodiments of the present disclosure will be described in detail with reference to the drawings, so that those skilled in the art can easily implement them. In addition, for clarity, parts irrelevant to the description of the exemplary embodiments are omitted in the drawings.

[0030] In the present disclosure, it should be understood that terms such as "including" or "having" are intended to indicate the presence of features, numbers, steps, actions, components, parts, or combinations thereof disclosed in this specification, and are not intended to exclude the possibility of the presence or addition of one or more other features, numbers, steps, actions, components, parts, or combinations thereof.

[0031] In addition, it should be noted that, without conflict, the embodiments in the present disclosure and the features in the embodiments can be combined with each other. The present disclosure will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0032] Percutaneous Transluminal Angioplasty (PTA) is a commonly used vascular interventional therapy technique aimed at dilating stenotic or occluded blood vessels by balloon inflation to restore blood flow. However, during this process, some complications may occur, one of which is the embolization of distal blood vessels by "debris" or "emboli" in the blood vessels. These "debris" or "emboli" usually refer to plaque emboli that detach after mechanical stimulation of the vascular intima. During balloon dilation, the balloon exerts pressure on the vessel wall, which may cause tearing of the vascular intima, thereby releasing these emboli. If these emboli are not completely removed, they may cause serious complications such as cerebral infarction, myocardial infarction, or distal limb embolization.

[0033] In view of the above defects, an embodiment of the present disclosure provides a device for dilating blood vessels and collecting detached emboli, including: an inflatable body; a membrane structure provided with a plurality of embolus inlets; the embolus inlets are normally closed openings and can be opened under the action of an external force; wherein, the membrane structure and the outer surface of the inflatable body form a squeezing space; when the outer surface of the inflatable body expands outward, the membrane structure gradually contacts the vascular stenosis and undergoes mutual squeezing, and the emboli detached by squeezing enter the squeezing space through the embolus inlets. After the inflatable body shrinks, it withdraws from the blood vessel together with the fragmented emboli. Through the device for dilating blood vessels and collecting detached emboli provided by the present application, both blood vessel dilation and the removal of detached emboli from the blood vessel are achieved, simplifying the surgical operation and reducing the occurrence of complications.

[0034] Figure 1 Shows a structural diagram of a device for dilating blood vessels and collecting detached emboli according to an embodiment of the present disclosure.

[0035] As Figure 1As shown, the device 10 for dilating blood vessels and collecting detached emboli includes: a catheter 11, an inflatable body 12, and a membrane structure 13. The catheter 11 is used to deliver the inflatable body 12 and the membrane structure 13 into the blood vessel or withdraw them from the blood vessel. The inflatable body 12 is an inflatable balloon fixed on the outer surface of the catheter 11. The membrane structure 13 is located on the outer surface of the inflatable body 12 and surrounds the inflatable body 12. The membrane structure 13 is fixedly arranged on the catheter 11, and a plurality of embolus inlets 14 are arranged on the membrane structure 13; the embolus inlets 14 are normally closed openings and can be opened under the action of an external force; wherein, an extrusion space a is formed between the membrane structure 13 and the outer surface of the inflatable body 12; when the outer surface of the inflatable body 12 expands outward, due to the normal closure of the embolus inlets 14, the extrusion space a is an airtight space and expands outward to dilate the blood vessel. The membrane structure 13 gradually contacts the blood vessel stenosis and is mutually extruded. The emboli detached by the extrusion open the embolus inlets 14, enter the extrusion space a through the embolus inlets 14, and then the embolus inlets 14 return to the normally closed state. The emboli falling into the extrusion space a are collected in the extrusion space a and cannot escape into the blood to cause distal vascular embolism.

[0036] In an embodiment of the present disclosure, the embolus inlet 14 is a one-way valve structure.

[0037] One implementation manner of the one-way valve structure is that the embolus inlet 14 is an embolus channel formed by the outer surface of the membrane structure 13 extending inwards into the extrusion space.

[0038] Figure 2 Shown Figure 1 is an enlarged schematic view of part A. Among them, the mark A1 shows the situation when the inflatable body 12 is not inflated, and the mark A2 shows the situation when the inflatable body 12 is inflated.

[0039] As Figure 2 shown, the embolus inlet 14 is an embolus channel formed by two membranes 141 and 142. When the inflatable body 12 is not inflated, the lower ends of the two membranes 141 and 142 are closed, and an opening is formed at the upper end. The distance of the opening is denoted as d. When the inflatable body 12 is inflated, the lower ends of the two membranes 141 and 142 still remain closed, and the distance d of the opening at the upper end increases, facilitating the entry of emboli into the extrusion space a under the extrusion force.

[0040] By setting the embolus inlet as a one-way valve structure, plaque emboli can only open the one-way valve structure from the outside and enter the extrusion space. For the plaque emboli inside the extrusion space, the one-way valve structure is closed, so they cannot be extruded outwards from the inside. This kind of embolus inlet that only allows entry but not exit ensures that plaque emboli will not enter the blood and reduces the occurrence of complications.

[0041] Figures 3A - 3CSchematic flow chart of a method for dilating blood vessels and collecting detached emboli according to an embodiment of the present disclosure.

[0042] The device for dilating blood vessels and collecting detached emboli of the present disclosure can be introduced into peripheral blood vessels or coronary blood vessels to dilate the stenotic part in blood vessel B.

[0043] The method flow for dilating blood vessels and collecting detached emboli is as follows: First, the inflatable body 12 and the membrane structure 13 are introduced into blood vessel B by means of a catheter 11. The inflatable body 12 is in a contracted state or an original state and can pass through the channel between the plaque P and the blood vessel wall without causing the detachment of emboli, as Figure 3A shown. Then, the inflatable body 12 and the membrane structure 13 are delivered to the lower part of the plaque P. The inflatable body 12 expands and squeezes the membrane structure 13, and the membrane structure 13 further squeezes the plaque P, so that some of the detached emboli P1 pass through the embolus inlet and enter the extrusion space a, as Figure 3B , shown in 3C.

[0044] It should be noted that Figure 1 in the illustrated embodiment, the membrane structure 13 completely surrounds the inflatable body 12 and forms an extrusion space a with the outer surface of the inflatable body 12. As an alternative, the membrane structure 13 can also partially surround the inflatable body 12 and form an extrusion space with the outer surface of the inflatable body 12.

[0045] In an embodiment of the present disclosure, the outer surface of the inflatable body 12 and / or the membrane structure 13 is provided with protrusions and / or restraint structures.

[0046] By providing protrusions, it is more beneficial to squeeze the plaque to make it detach to form emboli, so as to collect the detached emboli and remove them from the blood vessel by using the device for dilating blood vessels and collecting detached emboli of the present disclosure.

[0047] Among them, the protrusions can be spines, or blades, or include both spines and blades, or other similar structures. Specifically, reference can be made to the spine and blade structures of modified balloons, which will not be elaborated here.

[0048] The restraint structure can be a nitinol wire restraint structure for realizing controllable and uniform expansion. Specifically, reference can be made to the corresponding structure of the Chocolate TM PTA balloon, which will not be elaborated here.

[0049] In an embodiment of the present disclosure, the inflatable body 12 is an inflatable balloon. Figure 1The number of the dilation balloons shown is one. It can be understood that the number of the dilation balloons can also be two, three or more than three, and the adjacent dilation balloons are arranged at intervals or connected as a whole. Then, the membrane structure 13 entirely surrounds the dilation balloons and forms a squeezing space with the outer surfaces of the dilation balloons, so as to facilitate better exertion of the squeezing force. Those skilled in the art can flexibly adjust the number of the dilation balloons as needed, and the present disclosure does not limit this.

[0050] In the embodiment of the present disclosure, the plurality of embolus inlets 14 are circumferentially arranged on the membrane structure 13, facilitating the better entry of the shed emboli into the squeezing space.

[0051] In the embodiment of the present disclosure, the sizes of the plurality of embolus inlets 14 are the same or different. The process of melting a plurality of embolus inlets on the complete membrane structure can be adopted to form the embolus inlets. Specifically, during preparation, the opening inner diameters of the plurality of embolus inlets 14 can be the same or different. Since the membrane structure has a certain shrinkability, under the action of the squeezing force, even for relatively small embolus inlets, the plaque emboli are relatively easy to be squeezed in. Therefore, on the premise of not affecting the formation of the airtight space, the present disclosure does not limit the size of the embolus inlets 14.

[0052] In the embodiment of the present disclosure, the material of the membrane structure 13 is selected from polytetrafluoroethylene, polyurethane, polyester, PEBAX, PEEK, nylon, bovine pericardium, gel or animal valve, etc.

[0053] Figure 4 The structural diagram of the device for dilating blood vessels and collecting shed emboli according to another embodiment of the present disclosure is shown.

[0054] As Figure 4 shown, the device 20 for dilating blood vessels and collecting shed emboli includes: a catheter 21, dilation balloons 22, 23 and a membrane structure 24. The catheter 21 is used to deliver the dilation balloons 22, 23 and the membrane structure 24 into the blood vessel or withdraw them from the blood vessel. The dilation balloons 22, 23 are fixed on the outer surface of the catheter 21. The membrane structure 24 is connected to the dilation balloons 22, 23 and forms a squeezing space with the outer surfaces of the dilation balloons 22, 23. A plurality of embolus inlets 25 are arranged on the membrane structure 24; the embolus inlets 25 are normally closed openings and can be opened under the action of an external force; wherein, when the outer surfaces of the dilation balloon 22 and / or the dilation balloon 23 expand outwards, the squeezing space is an airtight space and expands outwards to dilate the blood vessel, the membrane structure 24 gradually contacts the blood vessel stenosis and undergoes mutual squeezing, and the shed emboli being squeezed open the embolus inlets 25 and enter the squeezing space through the embolus inlets 25.

[0055] In the embodiment of the present disclosure, the technical details of the catheter, the membrane structure and the embolus inlets can refer to the description of the above embodiment. AndFigure 1 The difference between the illustrated embodiment and this embodiment is that in this embodiment, by setting two dilation balloons, the blood on both sides of the thrombus can be blocked, and then the membrane structure is used to squeeze the vascular stenosis, ensuring that no detached emboli will flow into the blood during the squeezing process, improving the surgical safety and further reducing the occurrence of complications. And in the embodiment with one dilation balloon, as the dilation balloon expands, the circumferential squeezing space around the blood vessel will gradually shrink, and finally the outer surface of the dilation balloon will contact the membrane structure and the blood vessel wall. At this time, a relatively large squeezing force is required to squeeze the remaining plaque emboli into the axial squeezing space of the blood vessel. However, in the embodiment with two dilation balloons, this problem does not exist, and it is more convenient to squeeze the plaque emboli into the squeezing space.

[0056] Figure 5 Shows a structural diagram of a device for dilating blood vessels and collecting detached emboli according to another embodiment of the present disclosure.

[0057] As Figure 5 Shown, the device 30 for dilating blood vessels and collecting detached emboli includes: a catheter 31, dilation balloons 32, 33, and 34, and a membrane structure 35. The catheter 31 is used to deliver the dilation balloons 32, 33, and 34 and the membrane structure 35 into the blood vessel or withdraw them from the blood vessel. The dilation balloons 32, 34, and 33 are sequentially fixed on the outer surface of the catheter 31. The membrane structure 35 is connected to the dilation balloons 32 and 33 at both ends and forms a squeezing space with the outer surfaces of the dilation balloons 32 and 33 at both ends. The dilation balloon 34 in the middle is accommodated inside the squeezing space. A plurality of emboli inlets 36 are provided on the membrane structure 35. The emboli inlet 36 is a normally closed opening and can be opened under an external force. Among them, when the outer surface of the dilation balloon 32 and / or the dilation balloon 33 and / or the dilation balloon 34 expands outward, the squeezing space is an airtight space and expands outward to dilate the blood vessel. The membrane structure 35 gradually contacts the vascular stenosis and squeezes each other. The detached emboli open the emboli inlet 36 and enter the squeezing space through the emboli inlet 36.

[0058] In the embodiments of the present disclosure, the technical details of the catheter, the membrane structure, and the emboli inlet can refer to the descriptions of the above embodiments. And Figure 1The difference between the illustrated embodiment and this embodiment is that in this embodiment, by providing the expansion balloons at both ends, the blood on both sides of the thrombus can be blocked. Then, the expansion balloon in the middle is used to squeeze the membrane structure, and the membrane structure is used to squeeze the vascular obstruction, ensuring that no plaque emboli will flow into the blood during the squeezing process, improving the surgical safety and further reducing the occurrence of complications. Compared with the embodiment with two expansion balloons, by adding an expansion balloon in the middle, a better force for squeezing the vascular stenosis can be applied, facilitating better squeezing of the plaque emboli into the squeezing space. The number of expansion balloons shown in the figure in the middle is one. It can be understood that the number of expansion balloons in the middle can also be two or more, and two adjacent ones are arranged at intervals and then accommodated inside the squeezing space, so as to facilitate better application of the squeezing force. Those skilled in the art can flexibly adjust the number of expansion balloons according to needs.

[0059] Figure 6 FIG. shows a structural diagram of a device for dilating blood vessels and collecting shed emboli according to another embodiment of the present disclosure. Different from Figure 5 the illustrated embodiment, the expansion balloon 34 in the middle is integrated with the expansion balloons 32 and 33 at both ends, so as to better apply a force for squeezing the vascular stenosis. Other technical details can be referred to Figure 5 the illustrated embodiment and will not be elaborated here. It should be noted that the number of expansion balloons shown in the figure in the middle is one. Those skilled in the art can also set the number of expansion balloons in the middle to two or more according to needs, and two adjacent expansion balloons are integrated and then integrated with the expansion balloons at both ends, so as to facilitate better application of the squeezing force.

[0060] The above description is only the preferred embodiments of the present disclosure and the description of the applied technical principles. Those skilled in the art should understand that the scope of the invention involved in the present disclosure is not limited to the technical solutions formed by the specific combination of the above technical features, but should also cover other technical solutions formed by any combination of the above technical features or their equivalent features without departing from the inventive concept. For example, the technical solutions formed by mutually replacing the above features with the (but not limited to) technical features with similar functions disclosed in the present disclosure.

Claims

1. A device for dilating blood vessels and collecting shed emboli, characterized in that, Comprising: An inflatable body; A membrane structure provided with a plurality of embolus inlets; the embolus inlets are normally closed openings and can be opened under the action of an external force; Wherein, the membrane structure and the outer surface of the inflatable body form a squeezing space; when the outer surface of the inflatable body expands outward, the membrane structure gradually contacts the vascular stenosis and undergoes mutual squeezing, and the emboli shed by the squeezing enter the squeezing space through the embolus inlets; the squeezing space is an airtight space and expands outward to dilate the blood vessel; The inflatable body includes a plurality of dilation balloons; the membrane structure connects the dilation balloons at both ends and forms a squeezing space with the outer surfaces of the dilation balloons at both ends; at least one dilation balloon in the middle is accommodated inside the squeezing space.

2. The device for dilating blood vessels and collecting shed emboli according to claim 1, characterized in that, The embolus inlet is a one-way valve structure.

3. The device for dilating blood vessels and collecting shed emboli according to claim 2, characterized in that, The embolus inlet is an embolus channel formed by the outer surface of the membrane structure extending inward to the inside of the squeezing space.

4. The device for dilating blood vessels and collecting shed emboli according to claim 1, characterized in that, The membrane structure partially surrounds the inflatable body and forms a squeezing space with the outer surface of the inflatable body; or, the membrane structure completely surrounds the inflatable body and forms a squeezing space with the outer surface of the inflatable body.

5. The device for dilating blood vessels and collecting shed emboli according to claim 1, characterized in that, The outer surface of the inflatable body and / or the membrane structure is provided with protrusions and / or restraint structures.

6. The device for dilating blood vessels and collecting shed emboli according to claim 1, characterized in that The outer surface of the inflatable body and / or the membrane structure is provided with spines and / or blades.

7. The device for dilating blood vessels and collecting shed emboli according to claim 1, wherein The plurality of embolus inlets are circumferentially arranged on the membrane structure.

8. The device for dilating blood vessels and collecting shed emboli according to claim 1, characterized in that, The sizes of the plurality of embolus inlets are the same or different.

9. The device for dilating blood vessels and collecting shed emboli according to claim 1, wherein The material of the membrane structure is selected from polytetrafluoroethylene, polyurethane, polyester, PEBAX, PEEK, nylon, bovine pericardium, gel or animal valve.

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