A vascular stenosis treatment device

Abstract

The present application provides a kind of vascular stenosis treatment device, it includes treatment component, the treatment component includes: balloon, the wall of the balloon has a plurality of first holes for liquid to pass, the balloon has unexpanded state and expanded state;Cover, the cover is covered outside the balloon and expands along with the balloon expansion, the cover has a plurality of second holes, when the balloon is in the expanded state, the aperture of the first hole is less than the aperture of the second hole.The vascular stenosis treatment device of the present application can realize accurate positioning, and the cover has a limiting effect on the liquid, so that the drug can be more uniformly and effectively act on the required position of the blood vessel wall, thereby improving the utilization rate of the drug, reducing the incidence of vascular restenosis, and improving the treatment effect.

Description

Technical Field

[0001] This invention belongs to the field of medical devices, specifically relating to a device for treating vascular stenosis. Background Technology

[0002] Since the 1970s, percutaneous endovascular balloon angioplasty has been used to treat vascular stenosis and revascularize occluded vessels caused by atherosclerosis. Balloon angioplasty involves inserting a catheter with an inflatable balloon into the vascular system. Under external pressure, the balloon inflates at the narrowed site of the vessel, applying radial pressure to the vessel wall to widen the narrowed or occluded area and improve blood flow. While the immediate efficacy of balloon angioplasty is satisfactory, complications, particularly restenosis, are common. These complications include damage to the vessel due to over-inflation of the balloon catheter during dilation, and in cases of severe hard calcification, insufficient balloon performance leading to ineffective vessel dilation. Consequently, its widespread clinical application is limited.

[0003] To improve the therapeutic effect of balloons, drug-coated balloons have been developed in the existing technology. However, the binding force of the balloon to the drug on its surface is weak. Therefore, during the process of delivering the balloon to the lesion site, a large amount of drug is lost and the amount of drug loss is uncontrollable, resulting in large fluctuations in the drug concentration received by the blood vessel wall.

[0004] Another existing method for treating vascular stenosis is endovascular stenting, which involves implanting a stent at the site of stenosis within the blood vessel. This method can effectively reduce the rate of in-stent restenosis, but 20-30% of patients still experience in-stent restenosis, and restenosis is difficult to manage.

[0005] To improve the treatment outcomes of endovascular stenting, drug-eluting stents have been developed in existing technologies. However, the presence of the polymer coating on the stent, which carries the drug, can cause long-term irritation between the stent and the vessel wall, potentially leading to late-stage thrombosis. Furthermore, in cases of severe calcification and stenosis, the stent may not adhere adequately to the vessel wall, preventing the medication from taking effect and ultimately resulting in in-stent restenosis.

[0006] Thrombolysis with medication carries the risk of massive bleeding and is therefore mostly used in emergency clinical settings. Furthermore, thrombolytic drugs cannot be administered continuously for extended periods (generally no more than 3-5 days), as this can easily lead to adverse reactions such as massive bleeding. Mechanical thrombectomy removes the thrombus through proximal vacuum aspiration or distal contact, pulling it into a proximal catheter to restore blood flow. However, because old thrombi are difficult to break, they often fail to enter the aspiration catheter smoothly or are captured by mechanical thrombectomy devices such as catheter thrombectomy frames, potentially leading to prolonged thrombectomy procedures and excessive blood loss in the patient. Summary of the Invention

[0007] The purpose of this invention is to provide a vascular stenosis treatment device with a different structure.

[0008] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:

[0009] A device for treating vascular stenosis includes a treatment component comprising:

[0010] A balloon having multiple first holes on its wall for liquid to pass through, the balloon having an uninflated state and an inflated state;

[0011] A covering element that covers the outside of the balloon and expands as the balloon expands, the covering element having a plurality of second holes, wherein when the balloon is in the expanded state, the diameter of the first hole is smaller than the diameter of the second hole.

[0012] Specifically, when the balloon transitions from an uninflated state to an inflated state, both the first hole on the balloon and the second hole on the covering material increase in size, and when the balloon is in the inflated state, the second hole increases in size more than the first hole.

[0013] Specifically, in the uninflated state, the coverage of the outer periphery of the balloon by the covering material is greater than that in the inflated state.

[0014] According to some specific and preferred embodiments, in the expanded state, the positions of the plurality of first holes correspond to the positions of the plurality of second holes, thereby forming a plurality of relatively independent drug delivery spaces between the balloon and the covering.

[0015] According to some specific and preferred embodiments, in the unexpanded state, the positions of the first hole and the second hole correspond to each other.

[0016] According to some specific and preferred embodiments, one second hole corresponds to one or more first holes.

[0017] Furthermore, when one second hole corresponds to one first hole, the centerline of the first hole coincides with the centerline of the second hole; when one second hole corresponds to two or more first holes, the two or more first holes are evenly distributed within the range of the second hole.

[0018] Furthermore, one second hole corresponds to two to five first holes.

[0019] Specifically, the number and diameter of the first holes are set such that, in the expanded state, the medicine can be sprayed out from the first holes, and in the unexpanded state and during the movement from the unexpanded state to the expanded state, the medicine is retained inside the balloon or only a small amount of medicine seeps out from the first holes.

[0020] According to some specific and preferred embodiments, in the expanded state, the cross-sectional area of ​​the second hole is 10-50 mm. 2 .

[0021] According to some specific and preferred embodiments, in the expanded state, the second hole is prismatic in shape.

[0022] According to some specific and preferred embodiments, in the expanded state, the pore diameter of the first hole is 10 to 80 μm.

[0023] According to some specific and preferred embodiments, the distal end of the covering is fixedly connected to the distal end of the balloon, and the proximal end of the covering is fixedly connected to the proximal end of the balloon.

[0024] According to some specific and preferred embodiments, the covering is configured such that when the balloon expands, part or all of the covering moves relative to the outer surface of the balloon to produce a cutting effect.

[0025] Furthermore, when the balloon transitions from an uninflated state to an inflated state, the contact area between part or all of the covering and the outer peripheral surface of the balloon changes to enable the covering to cut the lesion site within the blood vessel.

[0026] According to a more specific and preferred embodiment, the covering includes a plurality of covering elements and a plurality of connection points;

[0027] When the covering is in the unexpanded state, the length of each covering element extends along the axis of the covering, and multiple covering elements are distributed along the circumferential direction.

[0028] Two adjacent covering elements are fixedly connected by a plurality of connection points, and two adjacent connection points on the same covering element are located on opposite sides of the covering element and are staggered from each other.

[0029] When the covering element transitions from the unexpanded state to the expanded state, the covering element flips over, and two adjacent connection points connected to the same covering element move toward the balloon and away from the balloon, respectively.

[0030] Furthermore, the plurality of connection points are located in a plurality of mutually parallel planes, the planes being perpendicular to the axis of the covering, and the distance between any two adjacent planes being equal.

[0031] Furthermore, when the covering is in its unexpanded state, the width of the covering element is greater than the thickness of the covering element.

[0032] Furthermore, when the covering is in its unexpanded state, the width of the covering element is 2 to 10 times the thickness of the covering element.

[0033] Furthermore, the length of the connection point is 0.5–3 mm.

[0034] Furthermore, the thickness of the connection point is 0.02–0.2 mm.

[0035] Furthermore, the width of the connection point is 0.1 to 0.5 mm.

[0036] Furthermore, the thickness of the connection point is equal to the thickness of the covering element.

[0037] Furthermore, multiple coating elements and multiple connection points together form multiple second holes, and in the expanded state, the coating elements surround the outside of the first holes to form multiple independent drug delivery spaces.

[0038] According to a more specific and preferred embodiment, the covering is formed by cutting a cylindrical tube.

[0039] According to a more specific and preferred embodiment, the covering is made of metal, including but not limited to one or more of shape memory alloys, stainless steel, titanium alloys, nickel alloys, and cobalt-chromium alloys.

[0040] According to a more specific and preferred embodiment, when the covering is in the expanded state, the second hole is prismatic, and in the same prismatic shape, the connection point at two opposite vertices of the prismatic shape is located inside the covering, and the connection point at the other two opposite vertices of the prismatic shape is located outside the covering.

[0041] Furthermore, the covering also includes a first connector located at the distal end of the covering and a second connector located at the proximal end of the covering, wherein the first connector is fixedly connected to the distal end of the balloon and the distal end of the covering element, respectively, and the second connector is fixedly connected to the proximal end of the balloon and the proximal end of the covering element, respectively.

[0042] Furthermore, the balloon includes a first head located at the distal end, a second head located at the proximal end, and a sac body fixedly connected to the first head and the second head respectively. The first connector is fixedly connected to the first head, the second connector is fixedly connected to the second head, and the covering element extends across the entire outer peripheral surface of the balloon.

[0043] Furthermore, the medicine is sprayed out from the first hole at the same time or after the covering is cut.

[0044] According to some specific and preferred embodiments, during the movement from the inflated state and / or from the uninflated state to the inflated state, the balloon is in contact with the covering. That is, the covering cannot self-inflate, but can only inflate under the force of the balloon's expansion.

[0045] Furthermore, the vascular stenosis treatment device also includes a first catheter partially located inside the balloon and sealed to or integrally formed with the distal end of the balloon, a second catheter sleeved outside the first catheter and sealed to or integrally formed with the proximal end of the balloon, and catheter seats connected to the proximal ends of the first catheter and the second catheter respectively, forming a drug delivery channel between the first catheter and the second catheter.

[0046] Compared with the prior art, the present invention has the following advantages:

[0047] The vascular stenosis treatment device of the present invention can achieve precise positioning, and the covering has a restrictive effect on the drug solution, thereby enabling the drug to act more evenly and effectively on the required location of the blood vessel wall, thus improving the drug utilization rate, reducing the incidence of restenosis, and improving the treatment effect. Attached Figure Description

[0048] Figure 1 A front view of a vascular stenosis treatment device according to a specific embodiment in its undilated state;

[0049] Figure 2 A partial cross-sectional view of a vascular stenosis treatment device according to a specific embodiment in its undilated state;

[0050] Figure 3 A front view of a vascular stenosis treatment device in an expanded state according to a specific embodiment;

[0051] Figure 4 A partial cross-sectional view of a vascular stenosis treatment device in an expanded state according to a specific embodiment;

[0052] Figure 5 for Figure 2 A magnified view of the far end;

[0053] Figure 6 for Figure 4 A magnified view of the far end;

[0054] Figure 7 for Figure 6 Enlarged view of point A;

[0055] Figure 8 A front view of the cover in its unexpanded state, according to one embodiment;

[0056] Figure 9 A front view of the cover in an expanded state according to one embodiment;

[0057] Figure 10 for Figure 9 BB cross-section;

[0058] Figure 11 A front view of the relative positions of the first and second holes in an expanded state, according to another embodiment;

[0059] Figure 12 A front view of the relative positions of the first and second holes in an expanded state, according to another embodiment. Detailed Implementation

[0060] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below. The technical features involved in the various embodiments of this application can be combined with each other as long as they do not conflict with each other.

[0061] In the description of this application, it should be understood that the terms "far end" and "proximal end" are defined from the perspective of the operator, with the far end referring to the end furthest from the operator and the proximal end referring to the end closest to the operator.

[0062] The terms “center,” “longitudinal,” “lateral,” “length,” “width,” “thickness,” “upper,” “lower,” “front,” “rear,” “left,” “right,” “vertical,” “horizontal,” “top,” “bottom,” “inner,” “outer,” “clockwise,” “counterclockwise,” “axial,” “radial,” and “circumferential” indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0063] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0064] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0065] In this application, unless otherwise expressly specified and limited, "above" or "below" a second feature can mean that the first and second features are in direct contact, or that they are in indirect contact through an intermediate medium. Furthermore, "above," "over," and "on top" of a second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" a second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature. It should be noted that when an element is referred to as "fixed to" or "set on" another element, it can be directly on the other element or there may be an intermediate element present. When an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element present. The terms "vertical," "horizontal," "above," "below," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible embodiments.

[0066] Figures 1 to 4 An exemplary vascular stenosis treatment device is shown, which includes a treatment component 1, a first catheter 2, a second catheter 3, and a catheter seat 4.

[0067] Treatment component 1 includes a balloon 11 and a covering 12, the covering 12 covering the outside of the balloon 11 (see Figure 5 and Figure 6The balloon 11 has an uninflated state and an inflated state, wherein the outer diameter of the uninflated state is smaller than the outer diameter of the balloon 11 in the inflated state; the covering element 12 expands along with the balloon 11. The expansion of the balloon 11 causes the covering element 12 to expand together. Since the overall stiffness of the covering element 12 is greater than that of the balloon 11, the expansion effect of the treatment component 1 on the stenotic site of the blood vessel can be improved, preventing the balloon 11 from being deformed by insufficient expansion force due to compression of the stenotic site. This can inhibit the incidence of restenosis, making it particularly suitable for treating atherosclerotic stenosis and severely calcified stenosis.

[0068] The distal end of balloon 11 is fixedly connected to or integrally formed with the distal end of the first catheter 2 to seal between the distal ends of balloon 11 and the first catheter 2. The proximal end of balloon 11 is fixedly connected to or integrally formed with the distal end of the second catheter 3 to seal between the proximal end of balloon 11 and the distal end of the second catheter 3. The second catheter 3 is sleeved outside the first catheter 2, forming a drug delivery channel 13 between the first catheter 2 and the second catheter 3. This drug delivery channel 13 communicates with balloon 11, allowing drug to be delivered into balloon 11 through the drug delivery channel 13 to inflate balloon 11.

[0069] like Figure 5 and Figure 6 As shown, in some embodiments, the balloon 11 includes a first head 111 located distally, a second head 112 located proximally, and a balloon body 113 fixedly connected to the first head 111 and the second head 112, respectively. Channels extending axially are formed inside the first head 111 and the second head 112, and the inner diameter of the channel formed in the second head 112 is larger than the inner diameter of the channel formed in the first head 111. The distal end of the first catheter 2 is fixedly connected to or integrally formed with the proximal end of the first head 111. An axially extending cavity is formed inside the first catheter 2, and the inner diameter of the cavity of the first catheter 2 is equal to the inner diameter of the channel formed in the first head 111. Furthermore, the inner wall of the first catheter 2 is flush with the inner wall of the first head 111 to facilitate the passage of a guidewire through the cavity of the first catheter 2 and the channel in the first head 111. The distal end of the second catheter 3 is fixedly connected to the proximal end of the second head 112 or integrally formed. The interior of the second catheter 3 has a cavity extending along the axial direction. The inner diameter of the cavity of the second catheter 3 is equal to the inner diameter of the channel formed in the second head 112. Furthermore, the inner wall of the second catheter 3 is flush with the inner wall of the second head 112 to facilitate the flow of the drug solution in the drug delivery channel 13.

[0070] The distal end of the covering 12 is fixedly connected to the first head 111, and the proximal end of the covering 12 is fixedly connected to the second head 112. The covering 12 extends across the entire outer peripheral surface of the balloon 11 (see...). Figure 5 and Figure 6This design ensures that the covering 12 is less likely to separate from the balloon 11 during balloon expansion, thus preventing the covering 12 from falling off and migrating to other parts of the blood vessel and reducing the risk of damage to the blood vessel wall.

[0071] In some embodiments, the covering 12 cannot expand on its own; it can only expand along with the balloon 11 under the force of its expansion. More preferably, the covering 12 is configured to expand synchronously with the balloon 11, meaning that the balloon 11 and the covering 12 remain in contact during the expansion state and / or during the transition from the unexpanded state to the expanded state. Of course, the contact between the balloon 11 and the covering 12 defined here does not mean that the entire area of ​​the balloon 11 and the covering 12 are in contact; contact is considered sufficient as long as the portion of the balloon 11 exerting a force on the covering 12 is in contact. By making the covering 12 expand along with the balloon 11, the relative position of the covering 12 and the balloon 11 remains essentially unchanged, thereby facilitating the correspondence between the first hole 114 of the balloon 11 and the second hole 124 of the covering 12 (described in detail below).

[0072] In some embodiments, the covering 12 is configured such that when the balloon 11 is inflated, part or all of the covering 12 moves relative to the outer surface of the balloon 11, thereby creating a cutting effect. This allows the covering 12 to expand and cut the lesion within the blood vessel as the balloon 11 is inflated. In some cases, the contact area between part or all of the covering 12 and the outer peripheral surface of the balloon 11 changes between the inflated and non-inflated states to achieve cutting of the lesion within the blood vessel; that is, during inflation, part or all of the covering 12 can be rotated at a certain angle, changing from being tightly attached to the outer surface of the balloon 11 to being vertical, thereby cutting the lesion within the blood vessel.

[0073] In some embodiments, the covering 12 includes multiple covering elements 121, multiple connection points 123, a first connector 127, and a second connector 128. In this embodiment, the covering 12 is formed by cutting a cylindrical tube. For example, a portion of the tube can be laser-cut to form multiple second holes 124, and the remaining portion of the tube constitutes the multiple covering elements 121, multiple connection points 123, the first connector 127, and the second connector 128. The material of the covering 12 includes, but is not limited to, metals, including but not limited to shape memory alloys, stainless steel, titanium alloys, nickel alloys, and cobalt-chromium alloys, or one or more of these.

[0074] Among them, such as Figure 5 and Figure 6As shown, the first connector 127 is fixedly connected to the first head 111 of the balloon 11 and the distal end of the covering element 121, respectively, and the second connector 128 is fixedly connected to the second head 112 of the balloon 11 and the proximal end of the covering element 121, respectively. The covering element 121 extends on the outer peripheral surface of the entire balloon 11.

[0075] In this implementation, such as Figure 8 As shown, when the covering 12 is in its unexpanded state, the length of each covering element 121 extends along the axial direction of the covering 12, and multiple covering elements 121 are evenly distributed along the circumference of the covering 12. According to some embodiments, the number of covering elements 121 is 10 to 14, such as... Figure 10 As shown, the number of covering elements 121 is 12. When the covering element 12 is in its unexpanded state, the width of the covering element 121 is greater than its thickness, resulting in a long, thin sheet-like shape and a thinner contact surface with the narrowed portion of the blood vessel, thus providing better cutting performance. Furthermore, in the expanded state, a certain distance is created between the balloon 11 and the blood vessel wall for drug delivery, which facilitates the action of the drug solution on the blood vessel wall (see [link]). Figure 9 Preferably, the width of the covering element 121 is 2 to 10 times the thickness of the covering element 121, and more preferably, the thickness of the covering element 121 is 0.02 to 0.2 mm.

[0076] like Figure 8 As shown, adjacent covering elements 121 are fixedly connected by multiple connection points 123. Two adjacent connection points 123 on the same covering element 121 are located on opposite sides of the covering element 121 and are staggered. Preferably, the multiple connection points 123 are located in multiple parallel planes perpendicular to the axis of the covering element 12, and the distance between adjacent planes is equal, thus making the shapes of the second holes 124 approximately the same. Preferably, the length of the connection point 123 is 0.5–3 mm; the thickness of the connection point 123 is 0.02–0.2 mm; and the width of the connection point 123 is 0.1–0.5 mm. More preferably, the thickness of the connection point 123 is equal to the thickness of the covering element 121.

[0077] In this application, the thickness of the element refers to the distance between the two surfaces of the element in the radial direction of the treatment device, the width of the element refers to the distance between the two sides of the element in the circumferential direction of the treatment device, and the length of the element refers to the distance between the two end faces of the element in the axial direction of the treatment device. Furthermore, the thickness, width, and length are all measured values ​​when the treatment device is in an unexpanded state.

[0078] like Figure 8 and Figure 9As shown, multiple covering elements 121 and multiple connection points 123 together form multiple second holes 124. In the expanded state, the cross-sectional area of ​​the second holes 124 is 10-50 mm. 2 When the covering element 12 transitions from an unexpanded state to an expanded state, the covering element 121 flips over. That is, the surface of the covering element 121 that was originally attached to the balloon 11 moves away from the balloon 11. This allows the covering element 121 to cut the vascular lesion site while expanding, and because the covering element 121 is relatively narrow, it can achieve a better cutting effect on the vascular lesion site. When the covering element 121 flips over, two adjacent connection points 123 connected to the same covering element 121 move towards and away from the balloon 11, respectively. When the covering element 12 is in the expanded state, the second hole is approximately prismatic. In the same prismatic shape, the connection points 123 at the two opposite vertices of the prismatic shape are located inside the covering element 12, and the connection points 123 at the other two opposite vertices of the prismatic shape are located outside the covering element 12. The covering element 121 surrounds the outside of the first hole 114 to form multiple independent drug delivery spaces.

[0079] The design of the covering 12 structure ensures that the covering 12 expands together with the balloon 11 and has good support, which can provide positioning for the balloon 11, so that the drug can be accurately applied to the required site and improve the accuracy of treatment.

[0080] To avoid drug loss during delivery of the drug-loaded balloon 11, this application creates multiple first holes 114 in the wall of the balloon 11, and delivers therapeutic drug solution into the balloon 11 to expand the balloon 11 and spray the drug, thereby reducing drug loss during delivery, increasing the drug concentration, and making the dosage more precise and controllable.

[0081] By controlling the number and diameter of the first holes 114, the resistance to drug leakage from the balloon 11 can be controlled, thus ensuring that the balloon 11 only ejects drugs under a set pressure. Since the balloon 11 extends into the blood vessel, the blood in the vessel exerts a certain pressure on the balloon 11. Therefore, during balloon 11 expansion, the external pressure prevents the drug from flowing out of the first holes 114, or only a small amount leaks out, thereby reducing drug loss. This ensures that the drug can be ejected from the first holes 114 in the expanded state, while in the unexpanded state and during the transition from the unexpanded state to the expanded state, the drug remains inside the balloon 11 or only a small amount leaks out from the first holes 114. Preferably, in the expanded state, the diameter of the first holes 114 is 20–70 μm. Here, "ejection" refers to the drug being ejected in a linear pattern, while "leakage" refers to the drug only overflowing from the surface of the balloon 11 in droplet form.

[0082] By controlling the size, number, and distribution of the first holes 114, the timing of the liquid injection from the first holes 114 can be controlled, either simultaneously with or after the cutting of the covering component 12. The distribution of the first holes 114 can be as follows: Figure 3 As shown, the distribution is on the entire outer peripheral surface of the balloon 11, or as... Figure 11 The opening shown is only located in the upper half of balloon 11. The location of the first orifice 114 can be adjusted according to the location where drug delivery is needed for the intravascular lesion.

[0083] In the expanded state, the diameter of the first hole 114 is smaller than the diameter of the second hole 124. The covering element 121 surrounds the outside of the first hole 114, and the positions of the multiple first holes 114 correspond to the positions of the multiple second holes 124, thus forming multiple relatively independent drug delivery spaces between the balloon 11 and the covering element 12. Specifically, one second hole 124 corresponds to one or more first holes 114. For example, Figure 3 as well as Figure 11 This diagram illustrates a second hole 124 corresponding to a first hole 114. Preferably, the centerline of the first hole 114 coincides with the centerline of the second hole 124. For example, Figure 12 The diagram shows that one second hole 124 corresponds to two or more first holes 114. Preferably, one second hole 124 corresponds to two to five first holes 114. To ensure the speed of drug administration and the uniformity of the drug solution, it is preferable that two or more first holes 114 are evenly distributed within the area where the second hole 124 is located.

[0084] In some implementations, the positions of the first hole 114 and the second hole 124 correspond to each other in the unexpanded state, which helps to ensure that the positions of the first hole 114 and the second hole 124 correspond to each other after expansion, and makes it less likely that the first hole 114 will be blocked by the covering element 121.

[0085] In the uninflated state, the coverage of the outer periphery of the balloon 11 by the covering member 12 is greater than that in the inflated state. In the uninflated state, the second hole 124 is a narrow slit. When the balloon 11 transitions from the uninflated state to the inflated state, both the first hole 114 on the balloon 11 and the second hole 124 on the covering member 12 deform. In the inflated state, the deformation of the second hole 124 is greater than that of the first hole 114. Furthermore, both the first hole 114 and the second hole 124 enlarge during the transition from the uninflated state to the inflated state.

[0086] See Figures 1 to 4The proximal ends of the first catheter 2 and the second catheter 3 are respectively connected to the catheter base 4. The connection methods can be arbitrarily combined, as long as they enable the expansion of the balloon 11 and the infusion of medication into the blood vessel. For example, the connection methods can be: the first catheter 2 is slidably connected to the catheter base 4, and the second catheter 3 is fixedly connected to the catheter base 4; the first catheter 2 is fixedly connected to the catheter base 4, and the second catheter 3 is slidably connected to the catheter base 4; or both the first catheter 2 and the second catheter 3 are slidably connected to the catheter base 4. This allows the axial displacement of the balloon 11 in both its uninflated and inflated states to be achieved through the relative sliding of the catheters and the catheter base 4.

[0087] The treatment device of this application is used in accordance with the usual method of using interventional catheters. The device is placed in position, and pressure is applied to the balloon 11 from the catheter seat 4 to expand the balloon 11. The covering element 12 expands together with the balloon 11 under the force applied by the balloon 11. During the expansion process, the covering element 12 cuts the narrow part in the blood vessel. Then, the pressure is continued to be increased to a certain pressure. When the pressure is higher than the set value, the drug solution is continuously sprayed out. At the same time, the drug is confined within the limited drug delivery space surrounded by the blood vessel wall, the covering element 121 and the balloon 11 wall, so as to achieve the purpose of uniform drug delivery to the blood vessel wall.

[0088] The present invention has been described in detail above, with the aim of enabling those skilled in the art to understand and implement the invention. However, this description should not be construed as limiting the scope of protection of the invention. All equivalent changes or modifications made in accordance with the spirit and essence of the invention should be included within the scope of protection of the invention.

Claims

1. A device for treating vascular stenosis, comprising a treatment assembly (1), characterized in that: the treatment assembly (1) comprises: a balloon (11) having a plurality of first holes (114) for liquid to pass through on the wall of the balloon (11), the balloon (11) having an unexpanded state and an expanded state, the number and diameter of the first holes (114) being configured such that in the expanded state, liquid can be sprayed from the first holes (114), and in the unexpanded state and during the movement from the unexpanded state to the expanded state, liquid remains inside the balloon (11) or only a small amount of liquid seeps from the first holes (114); a cover member (12) covering the outside of the balloon (11) and expanding with the balloon (11), the cover member (12) having a plurality of second holes (124), the diameter of the first holes (114) being smaller than the diameter of the second holes (124) when the balloon (11) is in the expanded state, when the balloon (11) is converted from the unexpanded state to the expanded state, both the first holes (114) on the balloon (11) and the second holes (124) on the cover member (12) become larger, and in the expanded state, the balloon (11) is larger than the second holes (124), and in the expanded state, the positions of the plurality of first holes (114) correspond to the positions of the plurality of second holes (124), so that a plurality of relatively independent drug delivery spaces are formed between the balloon (11) and the cover member (12), when the balloon (11) is converted from the unexpanded state to the expanded state, part or all of the cover member (12) moves relative to the outer surface of the balloon (11), and part or all of the cover member (12) changes the contact area with the outer peripheral surface of the balloon (11) to achieve the cutting of the cover member (12) to the lesion site in the blood vessel.

2. The vascular stenosis treatment device according to claim 1, characterized in that: In the unexpanded state, the coverage of the cover member (12) on the outer peripheral surface of the balloon (11) is greater than the coverage of the cover member (12) on the outer peripheral surface of the balloon (11) in the expanded state.

3. The vascular stenosis treatment device according to claim 1, characterized in that: In the unexpanded state, the positions of the first holes (114) correspond to the positions of the second holes (124).

4. The vascular stenosis treatment device according to claim 1, characterized in that: One second hole (124) is provided with one or more first holes (114).

5. The vascular stenosis treatment device according to claim 4, characterized in that: When one second hole (124) is provided with one first hole (114), the axis of the first hole (114) coincides with the axis of the second hole (124); when one second hole (124) is provided with two or more first holes (114), the two or more first holes (114) are uniformly distributed within the range of the second hole (124).

6. The apparatus of claim 4, wherein: One second hole (124) is provided with 2-5 first holes (114).

7. The vascular stenosis treatment device according to claim 1, characterized in that: In the expanded state, the second hole (124) has a cross-sectional area of 10-50 mm 2 , and / or the second hole (124) has a shape that is prismatic, and / or the first hole (114) has a diameter of 10-80 μm.

8. The vascular stenosis treatment device according to claim 1, characterized in that: The distal end of the covering member (12) is fixedly connected with the distal end of the balloon (11), and the proximal end of the covering member (12) is fixedly connected with the proximal end of the balloon (11).

9. The vascular stenosis treatment device according to claim 1, characterized in that: The covering member (12) comprises a plurality of covering elements (121) and a plurality of connecting points (123). In the non-expanded state of the covering member (12), the length of each covering element (121) extends along the axial direction of the covering member (12), and a plurality of covering elements (121) are distributed along the circumferential direction. The adjacent two covering elements (121) are fixedly connected through a plurality of connecting points (123), and the adjacent two connecting points (123) on the same covering element (121) are located on opposite sides of the covering element (121) and are arranged staggered. When the covering member (12) is converted from the non-expanded state to the expanded state, the covering element (121) is flipped, and the adjacent two connecting points (123) connected to the same covering element (121) move towards the balloon (11) and away from the balloon (11) respectively.

10. The vascular stenosis treatment device according to claim 9, characterized in that: The plurality of connecting points (123) are respectively located in a plurality of parallel planes, the planes are perpendicular to the axial line of the covering member (12), and the distance between adjacent two planes is equal.

11. The vascular stenosis treatment device according to claim 9, characterized in that: In the non-expanded state of the covering member (12), the width of the covering element (121) is greater than the thickness of the covering element (121).

12. The vascular stenosis treatment device according to claim 11, characterized in that: In the non-expanded state of the covering member (12), the width of the covering element (121) is 2-10 times the thickness of the covering element (121).

13. The apparatus of claim 9, wherein: The length of the connecting point (123) is 0.5-3mm; and / or, the thickness of the connecting point (123) is 0.02-0.2mm; and / or, the width of the connecting point (123) is 0.1-0.5mm; and / or, the thickness of the connecting point (123) is equal to the thickness of the covering element (121).

14. The apparatus of claim 9, wherein: The plurality of covering elements (121) and the plurality of connecting points (123) together form a plurality of second holes (124), and in the expanded state, the covering element (121) is arranged outside the first hole (114) to form a plurality of independent drug delivery spaces.

15. The apparatus of claim 1, wherein: The covering member (12) is cut from a cylindrical tube; and / or, the material of the covering member (12) is metal.

16. The apparatus of claim 15, wherein: The metal is one or more of memory alloy, stainless steel, titanium alloy, nickel alloy, and cobalt-chromium alloy.

17. The apparatus of claim 1, wherein: In the expanded state of the covering member (12), the second hole (124) is a polygon, and in the same polygon, the connecting points (123) at the opposite two vertices of the polygon are located on the inside of the covering member (12), and the connecting points (123) at the other two opposite vertices of the polygon are located on the outside of the covering member (12).

18. The apparatus of claim 9, wherein: The covering member (12) further comprises a first connecting member (127) at the distal end of the covering member (12) and a second connecting member (128) at the proximal end of the covering member (12), the first connecting member (127) being fixedly connected with the distal end of the balloon (11) and the distal end of the covering element (121) respectively, and the second connecting member (128) being fixedly connected with the proximal end of the balloon (11) and the proximal end of the covering element (121) respectively.

19. The vascular stenosis treatment device according to claim 18, characterized in that: The balloon (11) comprises a first head (111) at the distal end, a second head (112) at the proximal end, and a balloon body (113) fixedly connected with the first head (111) and the second head (112) respectively, the first connecting member (127) being fixedly connected with the first head (111), and the second connecting member (128) being fixedly connected with the second head (112), the covering element (121) extending on the outer circumferential surface of the entire balloon (11).

20. The apparatus of claim 1, wherein: The drug solution is sprayed from the first hole (114) while or after the cutting of the covering member (12).

21. The apparatus of claim 1, wherein: The balloon (11) is attached to the covering member (12) in the expanded state and / or during movement from the unexpanded state to the expanded state.

22. The apparatus of claim 1, wherein: The blood vessel stenosis treatment device further comprises a first catheter (2) partially located in the balloon (11) and having a distal end sealingly connected with or integrally formed with the distal end of the balloon (11), a second catheter (3) sleeved on the outside of the first catheter (2) and sealingly connected with or integrally formed with the proximal end of the balloon (11), and a catheter seat (4) connected with the proximal end of the first catheter (2) and the proximal end of the second catheter (3) respectively, a drug delivery channel (13) being formed between the first catheter (2) and the second catheter (3).

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