Drug balloon assembly

Abstract

The utility model belongs to the field of medical instruments, and provides a medicine balloon assembly which comprises a balloon and a push rod. The surface of the balloon is used for being coated with medicine. A first pipeline and a second pipeline which are independent of each other are arranged in the pushing rod, and the first pipeline is used for allowing the guide wire to penetrate through. In the axial direction of the pushing rod, the balloon is arranged at one end of the pushing rod, and the second pipeline is communicated with the interior of the balloon and used for supplying fluid to the balloon so that the balloon can be expanded. When the balloon expands, the balloon is of an annular structure, a channel penetrating in the axial direction of the pushing rod is formed in the middle of the balloon, and the channel is used for blood flow to pass through. According to the medicine balloon assembly, through the design of the blood flow channel communicated with the balloon, medicine is stably released in a blood vessel, meanwhile, smooth blood flow is kept, and the safety and efficiency of treatment are improved.

Description

Technical Field

[0001] The utility model belongs to the field of medical devices, and particularly relates to a drug balloon assembly. Background Art

[0002] At present, the preferred method for treating in-stent restenosis is to use a drug balloon. By coating a drug on the surface of the drug balloon, and then sending the drug balloon to the lesion site and expanding it, the expansion of the drug balloon can not only dilate the blood vessel, but also accurately release the drug to the lesion site at the same time, so as to inhibit the proliferation of the vascular intima and reduce the occurrence of restenosis.

[0003] In order to release as much drug as possible to the lesion site and achieve a better therapeutic effect, it is often necessary to maintain the expanded state of the drug balloon for a long time to increase the contact time between the drug and the blood vessel wall; however, since the drug balloon blocks blood flow when it expands, especially when it acts on an important heart part, it will seriously affect the blood supply to the heart and bring risks to the patient. Summary of the Utility Model

[0004] In order to solve at least one of the above problems existing in the prior art, the utility model provides a drug balloon assembly, which realizes the smooth blood flow while stably releasing the drug in the blood vessel through the design of a blood flow channel penetrating the balloon, and improves the safety and efficiency of treatment.

[0005] To achieve the above object, the present application provides the following technical solutions:

[0006] The utility model provides a drug balloon assembly, which includes a balloon and a pusher rod. The surface of the balloon is used for coating the drug. The interior of the pusher rod has two independent pipelines, the first pipeline is used for a guide wire to pass through. Along the axial direction of the pusher rod, the balloon is arranged at one end of the pusher rod, and the second pipeline is communicated with the interior of the balloon and is used for supplying fluid to the balloon to make the balloon expand. Wherein, when the balloon expands, the balloon is in a ring structure and a channel penetrating along the axial direction of the pusher rod is formed in the middle of the balloon, and the channel is used for blood to flow through.

[0007] In the above solution, a drug balloon assembly is provided, which realizes the smooth blood flow while stably releasing the drug in the blood vessel through the design of a blood flow channel penetrating the balloon, and improves the safety and efficiency of treatment. Exemplarily, during the operation, the drug balloon assembly is installed on the guide wire, and along the guide wire, the assembly is pushed to the lesion of the heart blood vessel. Fluid is supplied to the balloon through the second pipeline to make the balloon expand and support on the blood vessel wall, and the drug is accurately released to the lesion site to achieve treatment. At the same time, since the balloon is in a ring structure after expansion and a through channel is formed in the middle of it, blood can flow through the balloon.

[0008] According to some embodiments of the present application, the cross-section of the balloon is in an annular structure.

[0009] In the above solution, by setting the balloon to have an annular cross-section, when the balloon expands, it can effectively abut against the blood vessel wall, improving the stability of the contact between the balloon and the blood vessel wall, reducing the risk that the drug cannot effectively act on the lesion site due to balloon misalignment, and thus making the drug balloon assembly highly reliable.

[0010] According to some embodiments of the present application, the balloon has a third pipeline. Along the axial direction of the push rod, the third pipeline penetrates through the opposite ends of the balloon. The third pipeline is communicated with the first pipeline for guiding a guide wire to pass through. The central axis of the channel is parallel to the central axis of the third pipeline.

[0011] In the above solution, by setting the third pipeline for the guide wire to pass through, the balloon and the guide wire can share a part of the space, reducing the occupation of the space in the blood vessel and making the whole interventional mechanism compact. At the same time, setting the central axis of the channel parallel to the central axis of the third pipeline can reduce the risk of uneven balloon expansion caused by setting the third pipeline, enabling the balloon to stably support on the blood vessel wall.

[0012] According to some embodiments of the present application, a recess is formed on the outer peripheral surface of the balloon. Along the axial direction of the push rod, the recess is located between the opposite ends of the balloon.

[0013] In the above solution, by setting the recess on the outer peripheral surface of the balloon, on the one hand, it can increase the contact area between the drug and the balloon, facilitating the increase of the drug coating amount and the improvement of the adhesion between the drug and the balloon, reducing the risk that the drug falls off during movement and affecting the treatment efficiency. On the other hand, by setting the recess for buffering the deformation of other parts of the balloon, it can avoid damage to the blood vessel wall caused by excessive balloon expansion.

[0014] According to some embodiments of the present application, the drug balloon assembly further includes a protective sleeve. The protective sleeve is disposed on the outer peripheral surface of the push rod in a position-adjustable manner and is used to wrap the balloon.

[0015] In the above solution, by setting the protective sleeve, the balloon can be wrapped when the balloon is not expanded, playing a role in protecting the balloon.

[0016] According to some embodiments of the present application, the protective sleeve includes a body and a cover. Along the axial direction of the push rod, the body and the cover are connected to each other. Along the radial direction of the push rod, the size of the body is smaller than that of the cover, and the size of the cover is larger than that of the balloon. The cover is used to cover the balloon.

[0017] In the above solution, by setting the size of the body to be smaller than that of the cover, the protective sleeve can have a smaller volume under the condition of being able to protect the balloon, thereby reducing the overall size of the drug balloon assembly and reducing the interference risk with other structural components of the interventional surgical instruments, which is beneficial to the smooth operation of the interventional surgery.

[0018] According to some embodiments of the present application, along the axial direction of the push rod, a locking portion is formed at one end of the body facing away from the balloon, and a locking cooperation portion is provided on the outer peripheral surface of the push rod. The locking portion is used for detachably connecting with the locking cooperation portion so that the protective sleeve is locked or unlocked to the push rod.

[0019] In the above solution, by providing a locking portion at one end of the body to cooperate with the locking cooperation portion on the push rod, the protective sleeve can be in a state of being locked to the push rod to protect the balloon, and in a state of being unlocked to the push rod to enable the balloon to expand.

[0020] According to some embodiments of the present application, the locking portion includes an internal thread formed on the inner wall of the body, and the locking cooperation portion includes an external thread formed on the outer peripheral surface of the push rod.

[0021] According to some embodiments of the present application, the locking portion includes a protrusion formed on the inner wall of the body, and the locking cooperation portion includes a groove formed on the outer peripheral surface of the push rod.

[0022] According to some embodiments of the present application, an air inlet pipe is provided at one end of the push rod facing away from the balloon, and the air inlet pipe is communicated with the second pipeline.

[0023] The technical solution provided by the present application has the following beneficial effects:

[0024] 1) Sustainable drug delivery: Since the design of the annular balloon allows blood flow to pass through the middle of the balloon, the drug can be continuously delivered to the stenosis site under long-term balloon dilation.

[0025] 2) Maintaining heart blood supply: Since a channel is formed in the middle of the annular balloon to allow blood flow to pass through, blood flow will not be blocked, which helps to maintain heart blood supply.

[0026] 3) Better treatment effect: Since the drug can be in contact with the stenosis site for a longer time, a better treatment effect can be obtained and the risk of recurrence can be reduced. Description of the Drawings

[0027] Figure 1 It is a schematic diagram of the drug balloon assembly in some embodiments of the present application when the balloon is not expanded.

[0028] Figure 2 It is a side view of the balloon in some embodiments of the present application when it is not expanded.

[0029] Figure 3 This is a schematic diagram of a drug balloon assembly during balloon dilation in some embodiments of the present application.

[0030] Figure 4 This is a side view of the balloon during dilation in some embodiments of the present application.

[0031] Figure 5 This is a schematic diagram of a drug balloon assembly and a guide wire in some embodiments of the present application.

[0032] The reference numerals in the figures are explained as follows:

[0033] 10 - drug balloon assembly, 11 - balloon, 110 - channel, 111 - third pipeline, 112 - recess, 12 - push rod, 120 - first pipeline; 121 - second pipeline, 122 - locking engagement part, 123 - intake pipe, 13 - protective sleeve, 130 - body, 131 - cover body, 132 - locking part, 20 - guide wire. Detailed implementation manners

[0034] To make the technical solutions, objectives, and advantages of the present utility model clearer, the present utility model will be further described in detail below through specific examples in conjunction with the accompanying drawings. It should be understood that the specific implementation manners described herein are only for explaining and illustrating the present utility model and are not used to limit the present utility model.

[0035] In the description of the present utility model, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings. It is only for the convenience of describing the present utility model and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present utility model. In addition, the terms "first", "second", and "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance.

[0036] In the description of the present utility model, it should be noted that unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For the fields of electricity and communication, it can be a wired connection or a wireless connection. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood according to specific situations.

[0037] Please refer to Figures 1 - 5 , Figure 1Schematic diagram of the drug balloon assembly in some embodiments of the present application when the balloon is not expanded. Figure 2 Side view of the balloon when not expanded in some embodiments of the present application. Figure 3 Schematic diagram of the drug balloon assembly in some embodiments of the present application when the balloon is expanded. Figure 4 Side view of the balloon when expanded in some embodiments of the present application. Figure 5 Schematic diagram of the drug balloon assembly and the guide wire in some embodiments of the present application.

[0038] The drug balloon assembly 10 includes a balloon 11 and a push rod 12. The surface of the balloon 11 is for coating with drugs. Inside the push rod 12, there are independent first and second pipelines 120 and 121. The first pipeline 120 is for the guide wire 20 to pass through. Along the axial direction of the push rod 12, the balloon 11 is arranged at one end of the push rod 12. The second pipeline 121 is in communication with the inside of the balloon 11 and is used to supply fluid to the balloon 11 to make the balloon 11 expand. Wherein, after the balloon 11 expands, the balloon 11 has an annular structure and a channel 110 axially penetrating through the middle of the balloon 11 is formed. The channel 110 is for blood flow to pass through.

[0039] In some embodiments, the balloon 11 is made of any one of nylon, polyether block polyamide, thermoplastic polyurethane elastomer rubber, polyethylene.

[0040] In some embodiments, the push rod 12 can be made of polyolefin, polyvinylidene fluoride, polyamide, nylon-based polymer materials, modified nylon-based polymer materials, polymer copolymerization, blending or composite materials. In other embodiments, the push rod 12 can be made of metal materials, such as aluminum alloy, stainless steel or nitinol alloy, etc.

[0041] In some embodiments, the fluid can be liquid or gas.

[0042] In the above solution, a drug balloon assembly 10 is provided. Through the design of the blood flow channel 110 penetrating through the balloon 11, while stably releasing drugs in the blood vessel, the blood flow is kept unobstructed, and the safety and efficiency of treatment are improved. Exemplarily, during the operation, the drug balloon assembly 10 is installed on the guide wire 20; along the guide wire 20, the assembly is pushed to the lesion of the heart blood vessel, and fluid is supplied to the balloon 11 through the second pipeline 121 to make the balloon 11 expand and support on the blood vessel wall, and the drugs are accurately released to the lesion site to achieve treatment. At the same time, because the balloon 11 has an annular structure after expansion and a through channel 110 is formed in the middle, blood can flow through the balloon 11.

[0043] According to some embodiments of the present application, the cross-section of the balloon 11 has an annular structure.

[0044] In the above solution, by setting the balloon 11 to have an annular cross-section, when the balloon 11 expands, it can effectively abut against the blood vessel wall, improving the stability of the contact between the balloon 11 and the blood vessel wall, reducing the risk that the drug cannot effectively act on the lesion site due to the dislocation of the balloon 11, and thus making the drug balloon assembly 10 highly reliable.

[0045] In some other embodiments, the cross-section of the balloon 11 can also be in the shape of an elliptical ring or a square ring, etc. When the balloon 11 expands and supports against the blood vessel wall, it can fit the shape of the blood vessel.

[0046] According to some embodiments of the present application, the balloon 11 has a third pipeline 111. Along the axial direction of the push rod 12, the third pipeline 111 penetrates through the opposite ends of the balloon 11. The third pipeline 111 is communicated with the first pipeline 120 for guiding the guide wire 20 to pass through, and the central axis of the channel 110 is parallel to the central axis of the third pipeline 111.

[0047] In the above solution, by setting the third pipeline 111 for the guide wire 20 to pass through, the balloon 11 and the guide wire 20 can share a part of the space, reducing the occupation of the space inside the blood vessel and making the whole interventional mechanism compact in volume. At the same time, by setting the central axis of the channel 110 parallel to the central axis of the third pipeline 111, the risk of uneven expansion of the balloon 11 caused by setting the third pipeline 111 can be reduced, enabling the balloon 11 to stably support against the blood vessel wall.

[0048] According to some embodiments of the present application, a recess 112 is formed on the outer peripheral surface of the balloon 11. Along the axial direction of the push rod 12, the recess 112 is located between the opposite ends of the balloon 11.

[0049] In the above solution, by providing the recess 112 on the outer peripheral surface of the balloon 11, on the one hand, it can increase the contact area between the drug and the balloon 11, facilitating the increase of the drug coating amount and the improvement of the adhesion between the drug and the balloon 11, reducing the risk that the drug falls off during movement and affects the treatment efficiency; on the other hand, by providing the recess 112 for buffering the deformation of other parts of the balloon 11, it can avoid damage to the blood vessel wall caused by excessive expansion of the balloon 11.

[0050] According to some embodiments of the present application, the drug balloon assembly 10 further includes a protective sleeve 13. The protective sleeve 13 is disposed on the outer peripheral surface of the push rod 12 in a position-adjustable manner. The protective sleeve 13 is used to wrap the balloon 11.

[0051] In the above solution, by providing the protective sleeve 13, the balloon 11 can be wrapped when the balloon 11 is not expanded, so as to protect the balloon 11.

[0052] According to some embodiments of the present application, the protective sheath 13 includes a body 130 and a cover 131. Along the axial direction of the push rod 12, the body 130 and the cover 131 are connected to each other; along the radial direction of the push rod 12, the size of the body 130 is smaller than that of the cover 131, and the size of the cover 131 is larger than that of the balloon 11, and the cover 131 is used to cover the balloon 11.

[0053] In the above solution, by setting the size of the body 130 to be smaller than that of the cover 131, the protective sheath 13 can have a smaller volume under the condition of being able to protect the balloon 11, thereby reducing the overall size of the drug balloon assembly 10 and reducing the interference risk with other structural components of the interventional surgical instruments, which is beneficial to the smooth operation of the interventional surgery.

[0054] According to some embodiments of the present application, along the axial direction of the push rod 12, a locking portion 132 is formed at one end of the body 130 facing away from the balloon 11. A locking mating portion 122 is provided on the outer peripheral surface of the push rod 12. The locking portion 132 is used for detachably connecting with the locking mating portion 122 so that the protective sheath is locked or unlocked from the push rod 12.

[0055] In the above solution, by providing the locking portion 132 at one end of the body 130 to cooperate with the locking mating portion 122 on the push rod 12, the protective sheath can be in a state of being locked to the push rod 12 to protect the balloon 11, and in a state of being unlocked from the push rod 12 so that the balloon 11 can expand.

[0056] According to some embodiments of the present application, the locking portion 132 includes an internal thread formed on the inner wall of the body 130, and the locking mating portion 122 includes an external thread formed on the outer peripheral surface of the push rod 12.

[0057] According to some other embodiments of the present application, the locking portion 132 includes a protrusion formed on the inner wall of the body 130, and the locking mating portion 122 includes a groove formed on the outer peripheral surface of the push rod 12.

[0058] According to some embodiments of the present application, an air inlet pipe 123 is provided at one end of the push rod 12 facing away from the balloon 11, and the air inlet pipe 123 is communicated with the second pipeline 121. The air inlet pipe 123 can be connected to the air outlet of an air pump.

[0059] Some embodiments of the present application illustrate the use of the above-described drug balloon assembly:

[0060] 1. Before using the drug balloon assembly to treat coronary artery stenosis, first use a contrast guide wire to assist the guiding catheter to the opening of the coronary artery, and then withdraw the contrast guide wire;

[0061] 2. Insert the guide wire to the distal end of the coronary artery, and use a conventional balloon to dilate the lesion site through the guide wire at the lesion site;

[0062] 3. Advance the extension catheter along the guide wire to a position distal to the cardiovascular lesion;

[0063] 4. Mount the drug balloon assembly onto the guide wire, and then push the balloon along the guide wire through the extension catheter to a position distal to the cardiovascular lesion (the protective sheath is locked with the push rod);

[0064] 5. Withdraw the extension catheter, leaving the balloon at a position distal to the cardiovascular lesion;

[0065] 6. Retract the balloon to the lesion site by pulling the push rod;

[0066] 7. Release the locking state between the protective sheath and the push rod, and withdraw the protective sheath to expose the balloon;

[0067] 8. Inflate the balloon through the pipeline inside the balloon push rod to expand the balloon;

[0068] 9. After the drug on the balloon has basically diffused into the blood vessel wall (2 - 5 minutes), release the air inside the balloon through the pipeline inside the push rod. The balloon shrinks. Pull the push rod outwards to retract the balloon into the protective sheath, and then withdraw all the devices as a whole by pulling the extension catheter out of the body.

[0069] The above are only the preferred embodiments of the present utility model and are not used to limit the present utility model. For those skilled in the art, various modifications and changes can be made to the present utility model. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present utility model shall be included within the protection scope of the present utility model.

Claims

1. A drug balloon assembly, characterized in that, include: A balloon, the surface of which is used to coat a drug; A push rod having a first pipeline and a second pipeline independent of each other inside, wherein the first pipeline is used for the guide wire to pass through; The balloon is arranged at one end of the pushing rod along the axial direction of the pushing rod, and the second pipeline is communicated with the interior of the balloon and is used to supply fluid to the balloon so as to expand the balloon; When the balloon is inflated and expanded, the balloon takes on an annular structure and a channel penetrating along the axial direction of the push rod is formed in the middle of the balloon, and the channel is used for blood flow to pass through.

2. The drug balloon assembly according to claim 1, characterized in that: The cross section of the balloon is in a circular ring structure.

3. The drug balloon assembly according to claim 1, characterized in that: The balloon has a third pipeline, which runs through two opposite ends of the balloon along the axial direction of the push rod. The third pipeline is connected to the first pipeline for the guide wire to pass through, and the central axis of the channel is parallel to the central axis of the third pipeline.

4. The drug balloon assembly according to claim 1, characterized in that: A concave portion is formed on the outer peripheral surface of the balloon, and along the axial direction of the pushing rod, the concave portion is located between two opposite ends of the balloon.

5. The drug balloon assembly according to any one of claims 1 to 4, characterized in that: The medicine balloon assembly further comprises a protective cover, which is adjustably disposed on the outer peripheral surface of the push rod and is used to wrap the balloon.

6. The drug balloon assembly according to claim 5, characterized in that: The protective cover includes a body and a cover. Along the axial direction of the push rod, the body and the cover are connected to each other. Along the radial direction of the push rod, the size of the body is smaller than the size of the cover, and the size of the cover is larger than the size of the balloon. The cover is used to cover the balloon.

7. The drug balloon assembly according to claim 6, characterized in that: Along the axial direction of the push rod, a locking portion is formed at one end of the body away from the balloon, and a locking fitting portion is provided on the outer peripheral surface of the push rod. The locking portion is used to be detachably connected to the locking fitting portion so that the protective cover is locked or unlocked to the push rod.

8. The drug balloon assembly according to claim 7, characterized in that: The locking portion includes an internal thread formed on the inner wall of the body, and the locking matching portion includes an external thread formed on the outer peripheral surface of the pushing rod.

9. The drug balloon assembly according to claim 7, characterized in that: The locking portion includes a protrusion formed on the inner wall of the body, and the locking matching portion includes a groove formed on the outer peripheral surface of the pushing rod.

10. The drug balloon assembly according to claim 1, characterized in that: An air inlet pipe is arranged at one end of the push rod away from the balloon, and the air inlet pipe is communicated with the second pipeline.

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