A drug delivery balloon with a NiTi alloy support lining

Abstract

The present invention provides a drug delivery balloon with a NiTi alloy support lining, relating to the field of interventional medical device technology. The drug delivery balloon comprises an outer tube, a balloon body, and an inner tube. The balloon body is fixedly mounted to the outer wall of the inner tube and communicates with the interlayer between the outer and inner tubes. The balloon body comprises an outermost polymer layer, and an alloy support layer is provided inside the polymer layer. The alloy support layer self-expands at a first preset temperature. By replacing a drug eluting balloon with a drug delivery balloon having a microporous surface, the present invention allows for drug expansion and drug delivery by injecting the drug into the balloon after it is pushed into place. The drug composition can be flexibly adjusted according to the treatment purpose, thereby resolving the problem of coating loss in eluting balloons during the push process and ensuring the treatment effect.

Description

Technical Field

[0001] The present invention belongs to the technical field of interventional medical devices, and in particular relates to a drug delivery balloon with a NiTi alloy support lining. Background Art

[0002] Intracranial atherosclerosis is a common cerebrovascular disease characterized by the formation of plaques within the blood vessel walls, which can cause narrowing or blockage, leading to insufficient cerebral blood flow and, in severe cases, serious consequences such as cerebral infarction or cerebral hemorrhage. Currently, treatments for intracranial atherosclerosis primarily include medication, interventional therapy, and surgery. However, existing treatments have limitations, such as the inability to completely remove the lesions, the potential for restenosis after surgery, and postoperative complications.

[0003] Interventional therapy plays an important role in the treatment of intracranial atherosclerosis, with balloon angioplasty being a common treatment option. Balloon angioplasty involves delivering a balloon to the site of stenosis via a catheter. The balloon is then inflated to dilate the blood vessels and improve blood flow. However, traditional balloon angioplasty has limitations, such as the risk of vascular damage or postoperative restenosis during the dilation process, which restricts its application in the treatment of intracranial atherosclerosis. In recent years, with the advancement of medical technology, a new treatment method has gradually gained attention: drug-eluting balloon therapy. This technology combines the advantages of balloon angioplasty and drug therapy, delivering drugs directly to the lesion through balloon dilation to achieve a localized therapeutic effect. This method can effectively reduce the risk of postoperative restenosis, reduce the likelihood of complications, and improve the success rate of treatment.

[0004] Although drug-eluting balloons offer new hope for treating vascular stenosis, the device itself still suffers from numerous shortcomings. For example, in terms of drug selection and coating preparation technology, different anti-cell proliferation drugs have significant differences in their physical and chemical properties. Therefore, drug dispersants and carriers must be selected based on the drug's characteristics, leading to high manufacturing costs for drug-eluting balloons. Furthermore, drug-eluting balloons also face stringent requirements for the firmness of their surface coatings, ensuring that the balloons do not fall off the balloon surface due to friction and blood flow during delivery to the lesion. Furthermore, drug surface modification—that is, how to improve drug adhesion to the vascular endothelial surface and resist blood flow erosion—is also a crucial issue.

[0005] Furthermore, conventional balloons and drug-eluting balloons remain compressed and folded before placement at the lesion site. Once implanted at the stenosis site, saline or contrast agent is injected into the balloon, inflating it to the appropriate size under pressure to re-expand the stenotic vessel. However, micropores on the surface of drug-eluting balloons prevent the balloon from reaching the required inflation pressure, resulting in incomplete expansion and reduced dilation effectiveness at the stenotic site.

[0006] Therefore, it is necessary to provide an improved technical solution to the above-mentioned deficiencies in the prior art. Summary of the Invention

[0007] The purpose of the present invention is to provide a drug delivery balloon with a NiTi alloy support lining to solve the problem that the coating firmness of the drug eluting balloon is unstable and the coating is easily peeled off or the drug is lost during the pushing process.

[0008] In order to achieve the above object, the present invention provides the following technical solutions:

[0009] A drug delivery balloon with a NiTi alloy support lining comprises an outer tube, a balloon body and an inner tube. The balloon body is fixedly mounted on the outer wall of the inner tube and communicates with the interlayer between the outer tube and the inner tube. The balloon body comprises an outermost polymer layer, an alloy support layer is provided on the inner side of the polymer layer, and the alloy support layer self-expands at a first preset temperature.

[0010] Preferably, the alloy support layer is made of NiTi alloy.

[0011] Preferably, the first preset temperature is higher than human body temperature.

[0012] Preferably, the polymer layer is provided with micropores, and the micropores connect the inside and outside of the balloon body.

[0013] Preferably, the polymer layer and the alloy support layer are subjected to heat pressing and / or heat shrinkage treatment.

[0014] Preferably, a wire is provided on the outside of the inner tube, the proximal end of the wire is electrically connected to the alloy support layer, and the distal end of the wire extends to the distal end of the inner tube.

[0015] Preferably, the first preset temperature is 40-45°C.

[0016] Preferably, the alloy support layer is a dense mesh stent woven from NiTi alloy wires.

[0017] Preferably, the alloy support layer is a cutting bracket obtained by laser cutting a NiTi alloy tube.

[0018] Preferably, the NiTi alloy tube is further pickled after being laser cut.

[0019] Preferably, the NiTi alloy tube is laser cut, pickled, and then polished.

[0020] Preferably, the alloy support layer has a rod width of 20 to 50 μm.

[0021] Beneficial effects:

[0022] (1) The present invention uses a drug delivery balloon with micropores on the surface instead of a drug eluting balloon, so that the drug can be injected into the balloon after it is pushed into place to achieve balloon expansion and drug delivery. The drug composition can be flexibly changed according to the treatment purpose, thereby solving the problem that the coating of the eluting balloon is easily lost during the pushing process, and ensuring the treatment effect;

[0023] (2) The drug delivery balloon has been changed from elution to injection, which can avoid drug loss during the delivery process and can flexibly adjust the dosage according to the degree of lesion development, making it more flexible to use and reducing the cost of the drug delivery balloon;

[0024] (3) By setting an alloy support layer inside the balloon, the alloy support layer is heated to self-expand after pushing, thereby completely expanding the drug delivery balloon, avoiding the problem of incomplete expansion caused by setting micropores on the balloon surface. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The drawings and the accompanying drawings, which constitute part of this application, are intended to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are intended to explain the present invention and do not constitute an undue limitation of the present invention. Among them:

[0026] Figure 1 This is an overall schematic diagram of the drug delivery balloon provided by an embodiment of the present invention.

[0027] Figure 2 This is a front view of the balloon body in an embodiment of the present invention.

[0028] Figure 3 This is a schematic structural diagram of the balloon body in Example 1 of the present invention.

[0029] Figure 4 Schematic diagram of the structure of the alloy support layer in Example 1 of the present invention.

[0030] Figure 5 Schematic diagram of the structure of the alloy support layer in Example 2 of the present invention.

[0031] Figure 6 This is a schematic structural diagram of the balloon body in Example 2 of the present invention.

[0032] In the figure: 100, balloon body; 200, outer tube; 300, inner tube; 101, polymer layer; 102, alloy support layer; 103, micropores. DETAILED DESCRIPTION

[0033] The technical solutions in the embodiments of the present invention are described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention are within the scope of protection of the present invention.

[0034] In the description of the present invention, it should be understood that descriptions involving orientations, such as up, down, front, back, left, right, etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they cannot be understood as limitations on the present invention.

[0035] In the description of the present invention, "several" means one or more, "many" means more than two, "greater than," "less than," and "exceed" are understood to exclude the number itself, while "above," "below," and "within" are understood to include the number itself. The use of "first" and "second" in the description is solely for the purpose of distinguishing technical features and should not be construed as indicating or implying relative importance, implicitly specifying the number of the indicated technical features, or implicitly specifying the order of the indicated technical features.

[0036] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be understood to indicate or imply relative importance or to implicitly indicate the quantity of the technical features indicated. Thus, features defined as "first" and "second" may explicitly or implicitly include one or more features.

[0037] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the term "connection" should be understood in a broad sense. For example, it can be a fixed connection or a movable connection, a detachable connection or a non-detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or mutual communication; it can be a direct connection, or an indirect connection through an intermediate medium, and it can be internal communication between two elements, indirect communication, or an interactive relationship between two elements.

[0038] In the description of the present invention, "proximal end" refers to the end close to the operator, and "distal end" refers to the end far away from the operator. Generally, the left side in the drawings of the present invention is the "proximal end" and the right side is the "distal end".

[0039] The present invention will be described in detail below with reference to the embodiments. It should be noted that the embodiments and features of the embodiments of the present invention can be combined with each other without conflict.

[0040] The present invention aims to solve the problem of unstable coating firmness of current drug eluting balloons and provide a drug delivery balloon with a NiTi alloy support lining. Figures 1 to 3 As shown, it includes an outer tube 200, a balloon body 100 and an inner tube 300. The balloon body 100 is fixedly installed on the outer wall of the inner tube 300 and is connected to the interlayer between the outer tube 200 and the inner tube 300. A medium (such as saline) can be filled into the balloon through the interlayer to make it expand, thereby dilating the blood vessels. The balloon body 100 includes an outermost polymer layer 101, and an alloy support layer 102 is provided on the inner side of the polymer layer 101. The alloy support layer 102 self-expands at a first preset temperature.

[0041] In the present invention, the polymer layer 101 is made of elastic polymer materials commonly used in the art, so that it can easily expand to dilate blood vessels after being filled with a medium. The alloy support layer 102 is made of a memory alloy, preferably a NiTi alloy, and the first preset temperature is its Af point.

[0042] In the present invention, the first preset temperature is higher than human body temperature to prevent the alloy support layer 102 from expanding before the drug delivery balloon is pushed into place. More specifically, the first preset temperature is 40-45°C (e.g., 40°C, 41°C, 42°C, 43°C, 44°C, 45°C).

[0043] In a preferred embodiment of the present invention, the polymer layer 101 is provided with micropores 103, which connect the inner and outer sides of the balloon body 100, and the pore diameters of the micropores 103 are independently selected from 10μm-5mm (for example, 10μm, 30μm, 50μm, 100μm, 500μm, 1mm, 2mm, 3mm, 5mm).

[0044] In a preferred embodiment of the present invention, the polymer layer 101 , the alloy support layer 102 and the inner tube 300 are subjected to heat pressing and / or heat shrinking treatment so that the polymer layer 101 , the alloy support layer 102 and the inner tube 300 are laminated together.

[0045] In a preferred embodiment of the present invention, a wire is provided on the outside of the inner tube 300, the proximal end of the wire is electrically connected to the alloy support layer 102, and the distal end of the wire extends to the distal end of the inner tube 300. After the distal end of the wire is connected to an external power source, the current can be used to heat the alloy support layer 102 to a first preset temperature, thereby causing it to expand on its own and inflate the balloon.

[0046] In some embodiments of the present invention, Figure 3 、 4As shown, the alloy support layer 102 is a dense mesh stent woven from NiTi alloy wires. In other embodiments, as shown in FIG. Figure 5 、 6 As shown, the alloy support layer 102 can also be a cutting bracket obtained by laser cutting of a NiTi alloy tube. Furthermore, after laser cutting, the NiTi alloy tube is also pickled to reduce the rod width of the cutting bracket. After pickling, it can also be polished. After pickling and polishing, the rod width of the alloy support layer 102 is 0.02 to 0.05 μm (for example, 0.02 μm, 0.03 μm, 0.04 μm, 0.05 μm).

[0047] The drug delivery balloon with a NiTi alloy support lining of the present invention is described in detail below through specific examples.

[0048] Example 1

[0049] This embodiment provides a drug delivery balloon with a NiTi alloy support lining, such as Figures 1 to 3 As shown, it includes an outer tube 200, a balloon body 100 and an inner tube 300, wherein the balloon body 100 is fixedly installed on the outer wall of the inner tube 300 and is connected to the interlayer between the outer tube 200 and the inner tube 300. The balloon body 100 includes an outermost polymer layer 101, and an alloy support layer 102 is provided on the inner side of the polymer layer 101. The polymer layer 101 and the alloy support layer 102 are subjected to hot pressing treatment to make them fit tightly.

[0050] In this embodiment, Figure 3 、 4 As shown, the alloy support layer 102 is a dense mesh stent made of NiTi alloy, and its Af point temperature is 40-45°C. When the alloy support layer 102 is heated to the Af point temperature, it expands, changing from a compressed state to an expanded state, and completely expands the polymer layer 101. At this time, if the drug delivery balloon has been placed in the treatment position, the polymer layer 101 can be adhered to the inner wall of the blood vessel or plaque, and the blood vessel can be expanded.

[0051] The polymer layer 101 is provided with micropores 103 , which connect the inside and outside of the balloon body 100 . The drug solution injected into the balloon body 100 can be discharged through the micropores 103 and enter the blood vessel.

[0052] A wire is provided on the outside of the inner tube 300. The proximal end of the wire is electrically connected to the alloy support layer 102. The distal end of the wire extends to the distal end of the inner tube 300 and is connected to an external power source. After power is applied to the alloy support layer 102, it gradually heats up to the Af point, causing deformation to cause the balloon body 100 to expand.

[0053] In this embodiment, the alloy support layer 102 is a dense mesh stent woven from NiTi alloy wires.

[0054] Example 2

[0055] This embodiment provides a drug delivery balloon with a NiTi alloy support lining, which is improved on the basis of Example 1. Figure 5 、 6 As shown, the difference from Example 1 is that the alloy support layer 102 is a cutting bracket obtained by laser cutting a NiTi alloy tube.

[0056] After laser cutting, the NiTi alloy tube is pickled to reduce the width of the alloy support layer 102. In this embodiment, the width of the alloy support layer 102 after pickling is 20 to 50 μm.

[0057] Example 3

[0058] This embodiment provides a drug delivery balloon with a NiTi alloy support lining, which is improved on the basis of Example 2. Specifically, the NiTi alloy tube is laser cut and pickled, and then polished. In this embodiment, the rod width of the alloy support layer 102 after polishing is 20 to 20 μm.

[0059] In summary:

[0060] This invention replaces the drug-eluting balloon with a microporous drug delivery balloon. This allows for the injection of drugs into the balloon after it is positioned, achieving balloon expansion and drug delivery. The drug composition can be flexibly adjusted based on the therapeutic objective, thus resolving the issue of coating loss during the delivery process of the eluting balloon, ensuring therapeutic efficacy. An alloy support layer is also provided to ensure the balloon adheres well to the wall. This eluting balloon also prevents drug loss during delivery and allows for flexible adjustment of the dosage based on the progression of the lesion, providing greater flexibility and reducing the cost of the drug delivery balloon, which is of great significance for lowering medical costs.

[0061] The foregoing description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Those skilled in the art will readily appreciate that various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. A drug delivery balloon with a NiTi alloy support lining, comprising an outer tube, a balloon body, and an inner tube, wherein the balloon body is fixedly mounted on the outer wall of the inner tube and communicates with the interlayer between the outer tube and the inner tube, and the balloon body comprises an outermost polymer layer, characterized in that: An alloy support layer is provided on the inner side of the polymer layer, and the alloy support layer self-expands at a first preset temperature; The material of the alloy support layer is NiTi alloy; The first preset temperature is 40-45°C; The polymer layer is provided with micropores, and the micropores connect the inside and outside of the balloon body; The alloy support layer is a cutting bracket obtained by laser cutting a NiTi alloy tube, and the rod width of the alloy support layer is 20 to 50 μm; The polymer layer and the alloy support layer are subjected to heat pressing and / or heat shrinking treatment; After laser cutting, the NiTi alloy tube is pickled and polished.

2. The drug delivery balloon with a NiTi alloy support lining according to claim 1, characterized in that: A wire is provided on the outer side of the inner tube, the proximal end of the wire is electrically connected to the alloy support layer, and the distal end of the wire extends to the distal end of the inner tube.

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