Recyclable self-expanding drug coating mechanical balloon system

Abstract

The invention provides a recoverable self-expanding medicine coating mechanical balloon system, and relates to the technical field of interventional medical instruments, the recoverable self-expanding medicine coating mechanical balloon system comprises a mechanical balloon body, and a sealing head is arranged at the far end of the mechanical balloon body; the collecting sleeve is arranged on the mechanical balloon body in a sleeving manner and can slide relative to the mechanical balloon body; the inner push rod is connected to the near end of the mechanical balloon body; the outer push rod is arranged on the inner push rod in a sleeving mode, connected with the collecting sleeve and used for driving the collecting sleeve to slide relative to the mechanical balloon body; wherein an attaching layer is arranged on the peripheral face of the mechanical balloon body, a medicine layer is arranged on the surface, close to the collecting sleeve, of the attaching layer, and medicine on the medicine layer is protected through the collecting sleeve and the attaching layer. Medicine is wrapped by the collecting sleeve, the collecting sleeve is controlled by the inner push rod and the outer push rod to slide relative to the mechanical balloon body to achieve expansion and gathering of the mechanical balloon body, medicine release is achieved through the mechanical balloon body, and the problems that medicine conveying is difficult, and the medicine balloon is not prone to being in place are solved.

Description

Technical Field

[0001] The invention belongs to the technical field of interventional medical devices, and in particular relates to a recoverable self-expanding drug-coated mechanical balloon system. Background Art

[0002] Intracranial artery stenosis is one of the most common causes of stroke, with high disability and mortality rates. The number of deaths from stroke in China each year has exceeded that of tumors and cardiovascular diseases, becoming the number one cause of death. Atherosclerosis can lead to stenosis of the main intracranial arteries, most commonly the basilar artery, internal carotid artery, middle cerebral artery, internal carotid segment of vertebral artery, posterior cerebral artery, and anterior cerebral artery. The treatment of intracranial artery stenosis mainly includes drug therapy, interventional surgery and surgical treatment. Interventional surgery currently mainly includes balloon dilatation and intravascular stent implantation. Interventional surgery is gradually becoming popular because of its less trauma and faster recovery.

[0003] Intravascular stent implantation surgery involves permanently placing a bare metal stent or a drug-coated stent at the site of arterial lesions, which is released via balloon dilation or self-expansion to support the blood vessel wall. The restenosis rate of bare metal stents is as high as over 30%. Previous studies have found that the drug in drug-coated stents will dissipate after a period of time, and the drug-coated stent will become a bare stent again, causing stenosis problems to occur again.

[0004] Balloon dilatation is a procedure that uses standard puncture techniques to place a guide catheter proximal to the location of the stenosis. The balloon is then delivered to the lesion along a micro-guidewire through the guide catheter, inflated, dilated, and the stenotic lesion is decompressed. The balloon is then retrieved. The benefit of balloon dilatation is that the patient will not have an artificial implant after surgery.

[0005] Drug-coated balloons are balloons that use special technology to apply drugs that inhibit intimal hyperplasia to the balloon surface to achieve the effect of restenosis. However, after the drug is coated on the surface of ordinary balloons, the balloon becomes hard and often gets stuck in tortuous cerebral blood vessels and cannot move. The probability of intraoperative complications is high. At the same time, when the balloon expands the target lesion to cover the lesion with drugs, it will block the forward blood flow, so the expansion time is strictly limited, generally not more than 1 minute. Without the use of balloons, it is difficult for ordinary stents to attach drugs. Even if the drugs are successfully attached, friction with the catheter and contact with blood may occur during the process of transporting the drugs to the lesion, causing the drugs to be lost. Therefore, how to conveniently transport drugs to the lesion site in a relatively complete state without affecting blood flow has become a research direction in the industry.

[0006] Therefore, the inventors provide a retrievable self-expanding drug-coated mechanical balloon system. Summary of the invention

[0007] The purpose of the present invention is to provide a recyclable self-expanding drug-coated mechanical balloon system to solve the difficulty of delivering drugs to the lesion in a relatively complete state and to achieve a higher concentration of drugs covering the lesion.

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

[0009] A recyclable self-expanding drug-coated mechanical balloon system comprises a mechanical balloon body, wherein a sealing head is arranged at the distal end of the mechanical balloon body;

[0010] A contraction sleeve, which is sleeved on the mechanical balloon body and can slide relative to the mechanical balloon body;

[0011] An inner push rod connected to the proximal end of the mechanical balloon body;

[0012] An outer push rod, sleeved on the inner push rod, connected to the contraction sleeve, and used to drive the contraction sleeve to slide relative to the mechanical balloon body;

[0013] Wherein, a coating layer is arranged on the outer peripheral surface of the mechanical balloon body, a drug layer is arranged on the surface of the coating layer close to the shrinking sleeve, and the shrinking sleeve and the coating layer cover the drug on the drug layer.

[0014] Preferably, a sliding layer is provided on the contact surface between the shrink sleeve and the drug layer, and the sliding layer is one or more of PE and PI.

[0015] Preferably, the application layer is one or more of a sugar coating, glycosaminoglycan, a biofilm, and a hydrogel.

[0016] Preferably, at least one rib is provided on the shrink sleeve, and the rib is annular in the cross section of the shrink sleeve.

[0017] Preferably, the ribs protrude radially from the surface of the shrink sleeve.

[0018] Preferably, a groove is provided on the outer peripheral surface of the mechanical balloon body, the coating layer is arranged at the bottom of the groove, and the coating layer does not protrude from the opening of the groove.

[0019] Preferably, the sealing head comprises a connecting portion connected to the distal end of the mechanical balloon body, and a sealing end connected to the connecting portion, and the sealing head prevents blood from flowing into the distal end of the mechanical balloon body.

[0020] Preferably, a sealing assembly is provided at the distal end of the contraction sleeve, and the sealing assembly comprises a rubber ring having a tendency to shrink toward the middle.

[0021] Preferably, the outer push rod is a cylindrical rod body with a hollow interior, the inner push rod is slidably connected to the interior of the outer push rod, and the distal end of the outer push rod includes a connecting rod, and the distal end of the connecting rod is connected to the contraction sleeve.

[0022] Preferably, the connecting rod is in the shape of a hollow cylinder, and the portion where the inner push rod is connected to the mechanical balloon body is sealed inside.

[0023] Beneficial effects:

[0024] (1) The present invention covers the drug by setting a shrink sleeve, and controls the shrink sleeve to slide relative to the mechanical balloon body through the inner push rod and the outer push rod to achieve the expansion and gathering of the mechanical balloon body, and releases the drug through the mechanical balloon body, thereby solving the problem of difficulty in drug delivery and difficulty in placing the drug balloon in place;

[0025] (2) The present invention provides a patch layer and a drug layer. After release, the mechanical balloon body expands to expand the patch layer, and the drug layer is applied to the inner wall of the blood vessel and fully adheres to the lesion, thereby achieving a good treatment effect. The patch layer has good biocompatibility and automatically ablates after being attached to the inner wall of the blood vessel for a period of time, and has little impact on the patient's health.

[0026] (3) The present invention provides a sealing head, a contracting sleeve, a connecting rod, an outer push rod and an inner push rod. When the sealing head, the contracting sleeve, the connecting rod, the outer push rod and the inner push rod are gathered together, they form a sealed space, thereby reducing the possibility of blood entering the interior of the mechanical balloon body and contacting the application layer during transportation;

[0027] (4) When the present invention delivers drugs to the lesion site for expansion through the drug-mechanical balloon, it does not affect the forward blood flow, thereby reducing the risk of distal ischemia events caused by blocking blood flow during the traditional drug balloon expansion process. At the same time, the mechanical balloon is self-expanding, which reduces the risk of dissection complications caused by re-expansion when the drug covers the lesion site. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The drawings constituting a part of the present application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. Among them:

[0029] Figure 1 This is a schematic diagram of the main structure of the mechanical balloon of this application in a gathered state.

[0030] Figure 2 This is a schematic diagram of the cross-sectional structure of the mechanical balloon of the present application when it is located in the microcatheter. For the sake of easy identification, the section lines at the outer push rod 4, the inner push rod 3 and the connecting rod 41 are not shown.

[0031] Figure 3This is a schematic cross-sectional structural diagram of the mechanical balloon of the present application in a gathered state. For ease of identification, the section lines at the outer push rod 4, the inner push rod 3 and the connecting rod 41 are not shown.

[0032] Figure 4 for Figure 3 A schematic diagram of the enlarged structure.

[0033] Figure 5 This is a schematic diagram of the cross-sectional structure of the present application when the contraction sleeve moves a certain distance toward the proximal end. For the sake of easy identification, the section lines at the outer push rod 4, the inner push rod 3 and the connecting rod 41 are not shown.

[0034] Figure 6 This is a schematic diagram of the overall structure of the mechanical balloon of this application in a gathered state.

[0035] Figure 7 for Figure 6 A partial cross-sectional structural schematic diagram used to show the connection relationship between the constriction sleeve and the mechanical balloon body.

[0036] Figure 8 It is a schematic diagram of the overall structure of the sealing head.

[0037] Fig. 9 It is a schematic diagram of the overall structure of the convergence sleeve.

[0038] In the figure: 1. Mechanical balloon body; 11. Application layer; 12. Drug layer; 13. Groove; 2. Constriction sleeve; 21. Sliding layer; 22. Ribs; 23. Sealing assembly; 3. Inner push rod; 4. Outer push rod; 41. Connecting rod; 5. Sealing head; 51. Connecting part; 52. Sealing end. DETAILED DESCRIPTION

[0039] 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 belong to the scope of protection of the present invention.

[0040] In the description of the present invention, it should be understood that descriptions involving orientations, such as up, down, front, back, left, right, etc., and orientations or positional relationships indicated are based on the orientations or positional relationships shown in the accompanying drawings, and 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, and therefore should not be understood as a limitation on the present invention.

[0041] In the description of the present invention, "several" means one or more, "more" means more than two, "greater than", "less than", "exceed" etc. are understood as not including the number itself, and "above", "below", "within" etc. are understood as including the number itself. If there is a description of "first" or "second", it is only used for the purpose of distinguishing the technical features, and cannot be understood as indicating or implying the relative importance or implicitly indicating the number of the indicated technical features or implicitly indicating the order of the indicated technical features.

[0042] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more features.

[0043] In the description of the present invention, it should be noted that, unless otherwise clearly stipulated 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 connection between two elements, indirect connection, or an interactive relationship between two elements.

[0044] In the description of the present invention, "before use" refers to the state of the recoverable self-expanding drug-coated mechanical balloon system before use, before entering the human body, or before coming into contact with body fluids such as blood and tissue fluid in the human body, and "during use" refers to the state of the recoverable self-expanding drug-coated mechanical balloon system after entering the human body or coming into contact with body fluids such as blood and tissue fluid in the human body.

[0045] In the description of the present invention, the "gathered state" refers to the state in which the "mechanical balloon body" is adhered to each other within a partial length range or the entire length range.

[0046] In the description of the present invention, "in vivo environment" refers to the environment below the epidermis of the skin where body fluids exist, such as the dermis and subcutaneous tissue, or the inside of blood vessels and organs.

[0047] When considering the orientation of the technical features of the present application, the end that is first placed in the blood vessel during surgery is the distal end, and the end closer to the operator is the proximal end.

[0048] The present invention will be described in detail below in conjunction with embodiments. It should be noted that the embodiments and features in the embodiments of the present invention can be combined with each other without conflict.

[0049] The present invention aims at the problem that the drug balloon in the prior art is hard and often gets stuck in the tortuous cerebral blood vessels and cannot move, resulting in difficulty in drug delivery. A recyclable self-expanding drug-coated mechanical balloon system is provided, in which the drug is coated on the mechanical balloon body, a contraction sleeve 2 is set to cover the drug, and the contraction sleeve 2 is controlled by the inner push rod 3 and the outer push rod 4 to slide relative to the mechanical balloon body 1 to release the drug, thereby solving the problem that the drug delivery is difficult and the drug balloon is not easy to be in place.

[0050] In one embodiment of the present invention, referring to Figure 1 , Figure 2 and Figure 3 A recyclable self-expanding drug-coated mechanical balloon system includes a mechanical balloon body 1, which is in a gathered state in a microcatheter. The mechanical balloon body 1 is laser cut from nickel-titanium alloy wires, which are interwoven and wound with each other. In other embodiments of the present application, the mechanical balloon body 1 is laser cut from stainless steel. A sealing head 5 is integrally formed or welded at the distal end of the mechanical balloon body 1, and the sealing head 5 itself does not allow blood to pass through along the length direction of the mechanical balloon body 1;

[0051] The annular contraction sleeve 2 is sleeved on the mechanical balloon body 1 and can slide relative to the mechanical balloon body 1. The mechanical balloon body 1 passes through the interior of the contraction sleeve 2, and the mechanical balloon body 1 contacts the inner wall of the contraction sleeve 2, allowing the outer peripheral surface of the mechanical balloon body 1 to slide against the inner wall of the contraction sleeve 2. The contraction sleeve 2 is made of high-performance polymer materials, such as PTFE, PU, ​​and PEEK; the radial strength of the contraction sleeve 2 is greater than the radial strength of the mechanical balloon body 1. When the contraction sleeve 2 is sleeved on the mechanical balloon body 1, the mechanical balloon body 1 can be contracted to limit the expansion of the mechanical balloon body 1.

[0052] The inner push rod 3 is connected to the proximal end of the mechanical balloon body 1; the inner push rod 3 is generally made of polyurethane, polyethylene or stainless steel. The proximal end of the mechanical balloon body 1 is preferably fixedly connected to the inner push rod 3 by gluing or welding. In other embodiments of the present application, the inner push rod 3 is connected to the mechanical balloon body 1 by a thread or a lock. The inner push rod 3 is used to control the mechanical balloon body 1 to move toward the proximal end or the distal end.

[0053] Reference Figure 1 , Figure 2 , Figure 3 , Figure 5 and Figure 6The outer push rod 4 is sleeved on the inner push rod 3 and connected to the convergence sleeve 2, and is used to drive the convergence sleeve 2 to slide relative to the mechanical balloon body 1; the outer push rod 4 is made of polyurethane, polyethylene or stainless steel, and is cylindrical, with a through hole in the middle. There is no restriction on the shape of the through hole, and there is no restriction on the shape of the end opening of the through hole, and the inner push rod 3 is allowed to slide in the through hole. The distal end of the outer push rod 4 is connected to the convergence sleeve 2 by welding or bonding. Pulling the outer push rod 4 toward the proximal end can make the convergence sleeve 2 move toward the proximal end, and pushing the outer push rod 4 toward the distal end can make the convergence sleeve 2 move toward the distal end. By controlling the relative position of the outer push rod 4 and the inner push rod 3, the relative position of the convergence sleeve 2 and the mechanical balloon body 1 can be controlled.

[0054] Reference Figure 1 , Figure 2 , Figure 3 and Figure 4 , wherein a patch layer 11 is arranged on the outer peripheral surface of the mechanical balloon body 1, and a drug layer 12 is arranged on the surface of the patch layer 11 close to the shrink sleeve 2, and the shrink sleeve 2 and the patch layer 11 cover the drug on the drug layer 12 to protect the drug. The patch layer 11 is connected to the mechanical balloon body 1 by bonding. The patch layer 11 is a sugar coating or other biocompatible polymers, and the basic structure of the sugar coating is composed of polysaccharides, which provides adhesion and biocompatibility, increases glycoproteins, and enhances cell-to-cell interactions. At the same time, lipids and polymers such as polylactic acid and polyvinyl alcohol can also be added to improve the biocompatibility and stability of the patch layer 11.

[0055] The drug layer 12 is an antiproliferative drug, mainly paclitaxel or rapamycin, which can prevent restenosis in the mechanical balloon by inhibiting excessive proliferation of smooth muscle cells. The drug layer 12 is attached to the patch layer 11 by one or more methods such as spraying, soaking, and wrapping. The drug layer 12 also includes a polymer or a film-forming agent, such as hydroxypropyl methylcellulose (HPMC), which is used to coat the drug and provide a film to protect the stability of the drug or control the release. Gelatin is added to improve ductility. Plasticizers, such as glycerol or polyethylene glycol, are added to the film-forming agent to increase the flexibility of the sugar coating and prevent the coating from cracking.

[0056] Before use, the distal end of the contraction sleeve 2 is tightly fitted on the outer circumferential surface of the sealing head 5. First, a guide catheter is placed proximal to the lesion site through a standard puncture technique, and then a microcatheter is guided by a guide wire, transported from the guide catheter passage to the lesion site, and passed through the lesion site. After that, the guide wire in the microcatheter is withdrawn, and the mechanical balloon body 1 tightly wrapped by the contraction sleeve 2 is introduced into the microcatheter through the sheath, and reaches the lesion site along the inner cavity of the microcatheter, and the distal end of the mechanical balloon body 1 is flush with the distal end of the microcatheter. After that, the microcatheter is withdrawn, and the contraction sleeve 2 is moved proximally by pulling the outer push rod 4 proximally, so that the mechanical balloon body 1 and the application layer 11 and the drug layer 12 are gradually exposed. During the exposure process, the mechanical balloon body 1 automatically expands in the radial direction, driving the application layer 11 to expand, and the application layer 11 is attached to the inner wall of the blood vessel, and the drug on the drug layer 12 is fully in contact with and attached to the inner wall of the blood vessel at the lesion. After a certain period of adhesion, the outer push rod 4 is pushed distally to allow the contraction sleeve 2 to move distally, and the contraction sleeve 2 allows the mechanical balloon body 1 to gradually become a gathered state, reducing the impact of the recovery process on blood vessels and blood flow.

[0057] During the use of the mechanical balloon disclosed in the present invention, since the mechanical balloon body 1 is soft, less damage is caused to the inside of the patient's blood vessels, thereby reducing the probability of complications during and after the operation.

[0058] During transportation, the drug is wrapped by the shrinking sleeve 2, and the shrinking sleeve 2 fits tightly with the outer cylindrical surface of the sealing head 5, which can prevent blood from flowing into the mechanical balloon body 1 from the sealing head 5, ensuring sealing from multiple directions, making it difficult for the drug to come into contact with blood before being released, reducing the loss during drug transportation.

[0059] By using the mechanical balloon of the present invention, the loss rate of drugs during transportation in the microcatheter is low, and the therapeutic effect can be ensured. The mechanical balloon body 1 can reach a far location, and the mechanical balloon can be in place as long as the microcatheter can be released. Compared with the drug balloon, the mechanical balloon body 1 is softer and has better passability during transportation. For tortuous blood vessels, the drug can also be transported to the lesion in a relatively complete state.

[0060] In an optional embodiment of the present invention, a sliding layer 21 is provided on the contact surface between the contraction sleeve 2 and the drug layer 12, and the sliding layer 21 is one or more of PE and PI. The contraction sleeve 2 is connected to the sliding layer 21 by bonding. PE, PI and other materials have good surface sliding properties and anti-adhesion properties, and have low friction during sliding, which is used to reduce the drug shedding rate caused by friction during drug release.

[0061] In an optional embodiment of the present invention, the patch layer 11 is one or more of a sugar coating, glycosaminoglycan, a biofilm, and a hydrogel. The patch layer 11 has good biocompatibility, automatically ablates after being attached to the inner wall of the blood vessel for a period of time, and has little impact on the patient's health.

[0062] In an optional embodiment of the present invention, at least one rib 22 is provided on the contraction sleeve 2, and the rib 22 is annular in the cross section of the contraction sleeve 2. The rib 22 can be a memory alloy wire with a memory function, and the rib 22 is annular and sleeved on the outer circumferential surface of the contraction sleeve 2. The rib 22 is in a stretched state and has a tendency to contract toward the middle, and a force toward the middle is applied to the contraction sleeve 2 to ensure that the contraction sleeve 2 is tightly fitted with the mechanical balloon body 1. At the same time, the shape of the contraction sleeve 2 can be protected, so that the contraction sleeve 2 is not loose.

[0063] In another embodiment of the present application, the ribs 22 are integrally formed with the contraction sleeve 2 . The ribs 22 are made of the same material as the contraction sleeve 2 . The ribs 22 are used to enhance the structural strength of the contraction sleeve 2 .

[0064] In an optional embodiment of the present invention, the ribs 22 protrude radially from the surface of the contraction sleeve 2. During the process of transporting the mechanical balloon body 1 along the microcatheter, the portion of the ribs 22 protruding from the contraction sleeve 2 rubs against the microcatheter, reducing the friction area between the contraction sleeve 2 and the microcatheter, thereby reducing the possibility of the contraction sleeve 2 and the mechanical balloon body 1 slipping during the transport process.

[0065] In an optional embodiment of the present invention, a groove 13 is provided on the outer circumference of the mechanical balloon body 1, and the pasting layer 11 is arranged at the bottom of the groove 13, and the pasting layer 11 does not protrude from the opening of the groove 13. The pasting layer 11 is bonded to the bottom of the groove 13, and the height of the pasting layer 11 is lower than the depth of the groove 13. The purpose of the design here is to allow the shrink sleeve 2 to better cover the pasting layer 11 and the drug layer 12.

[0066] Reference Figure 6 , Figure 7 and Figure 8 In an optional embodiment of the present invention, the sealing head 5 includes a connecting portion 51 connected to the distal end of the mechanical balloon body 1, and a sealing end 52 connected to the connecting portion 51, and the sealing head 5 prevents blood from flowing into the distal end of the mechanical balloon body 1. The connecting portion 51 and the distal end of the mechanical balloon body 1 can be connected by bonding, welding, etc., and the connection here needs to ensure sealing. The shape of the sealing head 5 is not limited, and it is required that it does not penetrate in the length direction of the mechanical balloon body 1, so as to ensure that blood cannot pass through the sealing head 5.

[0067] In an optional embodiment of the present invention, a sealing component 23 is provided at the distal end of the contraction sleeve 2, and the sealing component 23 includes a rubber ring with a tendency to shrink toward the middle. Specifically, the rubber ring is connected to the surface of the distal end of the contraction sleeve 2 by bonding, and the rubber ring is in a stretched state and has a tendency to shrink toward the center point of the rubber ring to ensure that the rubber ring is in close contact with the mechanical balloon body 1 or the sealing head 5, thereby enhancing the sealing between the contraction sleeve 2 and the mechanical balloon body 1 or the sealing head 5.

[0068] In an optional embodiment of the present invention, the outer push rod 4 is a cylindrical rod body with a hollow interior, the inner push rod 3 is slidably connected to the outer push rod 4, and the distal end of the outer push rod 4 includes a connecting rod 41, and the distal end of the connecting rod 41 is connected to the convergence sleeve 2. The outer push rod 4 and the connecting rod 41 are fixed by welding, and bonding can also be used here. The distal end of the connecting rod 41 is fixed to the convergence sleeve 2 by bonding. The purpose of the design here is to control the relative position of the convergence sleeve 2 and the mechanical balloon body 1 by controlling the outer push rod 4 and the inner push rod 3, and the sliding between the outer push rod 4 and the inner push rod 3 is limited to the length direction of itself.

[0069] In an optional embodiment of the present invention, the connecting rod 41 is in the shape of a hollow cylinder, and seals the portion where the inner push rod 3 is connected to the mechanical balloon body 1. The connecting rod 41 connects the outer push rod 4 and the contraction sleeve 2, and transmits the force from the outer push rod 4 to the contraction sleeve 2. A sealed space is formed to prevent blood from flowing into the internal space of the mechanical balloon body 1 from the connection portion 51 between the inner push rod 3 and the mechanical balloon body 1.

[0070] The following is a detailed description of a recyclable self-expanding drug-coated mechanical balloon system of the present invention through specific embodiments.

[0071] Example 1

[0072] This embodiment provides a recyclable self-expanding drug-coated mechanical balloon system.

[0073] Reference Figure 1 , Figure 2 and Figure 3 As shown, a recyclable self-expanding drug-coated mechanical balloon system includes an outer push rod 4 and an inner push rod 3. The outer push rod 4 is provided with a through hole for the inner push rod 3 to slide. The shape of the through hole is not limited. Specifically, the outer push rod 4 and the inner push rod 3 are sleeved together, and relative sliding can occur between the two.

[0074] The distal end of the inner push rod 3 is connected to the mechanical balloon body 1 by bonding or welding. The mechanical balloon body 1 is preferably made of nickel-titanium alloy wires cut by laser, and the nickel-titanium alloy wires are interwoven and wound together.

[0075] A sealing head 5 is welded or bonded to the distal end of the mechanical balloon body 1. The sealing head 5 includes an integrally formed connecting portion 51 and a sealing portion. The sealing portion is a solid block that does not allow blood to pass through the sealing portion. The proximal diameter of the connecting portion 51 is greater than or equal to the distal diameter of the mechanical balloon body 1 in the gathered state.

[0076] Reference Figure 3 , Figure 4 , Figure 5 , Figure 6 and Figure 7A groove 13 is provided on the outer peripheral surface of the mechanical balloon body 1, and a patch layer 11 is bonded to the bottom surface of the groove 13. Specifically, the patch layer 11 is made of a sugar coating, and the basic structure of the sugar coating is composed of polysaccharides. Glycoproteins, lipids and polylactic acid are added to the sugar coating to improve the biocompatibility and stability of the patch layer 11. The patch layer 11 will naturally ablate in the blood vessel after a period of time, and because the components are biocompatible, it has little impact on the patient's health.

[0077] In one embodiment of the present application, the application layer 11 is glycosaminoglycan.

[0078] In one embodiment of the present application, the application layer 11 is a biological membrane.

[0079] In one embodiment of the present application, the application layer 11 is a hydrogel.

[0080] The patch layer 11 is provided with a drug layer 12. Specifically, the drug layer 12 is an anti-cell proliferation drug, mainly paclitaxel or rapamycin, and its mechanism of action is to prevent restenosis after surgery by inhibiting excessive proliferation of smooth muscle cells. The drug layer 12 also includes HPMC, which is used to coat the drug, provide a thin film to protect the stability of the drug, and reduce the impact of the outside world on the drug.

[0081] The total height of the patch layer 11 and the drug layer 12 is less than the depth of the groove 13 . The purpose of this design is to prevent the patch layer 11 and the drug layer 12 from protruding out of the groove 13 , thereby reducing friction on the drug layer 12 .

[0082] The distal end of the outer push rod 4 is welded with a connecting rod 41, which is a hollow cylinder. The distal end of the connecting rod 41 is bonded with a contraction sleeve 2, which is made of a high-performance polymer material, such as PTFE, PU, ​​PEEK. When the contraction sleeve 2 is put on the mechanical balloon body 1, the mechanical balloon body 1 is pressed into a gathered state. The contraction sleeve 2 is a hollow sleeve with no restrictions on its cross section and the shape of the hollow part, and it is necessary to allow the mechanical balloon body 1 to slide in the contraction sleeve 2.

[0083] By setting up an inner push rod 3, an outer push rod 4, and a contraction sleeve 2, and controlling the expansion and gathering of the mechanical balloon body 1 by controlling the contraction sleeve 2 through the outer push rod 4, the drug can be delivered to the lesion in a relatively complete manner, and the drug can be released inside the blood vessel, reducing the time that the drug is in contact with the blood in the blood vessel, thereby improving the integrity of the drug.

[0084] In a preferred embodiment of the present application, a sealing component 23 is provided at the distal end of the contraction sleeve 2, and the sealing component 23 includes a rubber ring with a tendency to shrink toward the middle. In other embodiments of the present application, the sealing component 23 includes a silicone ring, which has good sealing properties and has little effect on the physiological environment in the blood vessel. The sealing component 23 is used to cover the distal end of the contraction sleeve 2 to enhance the sealing properties at the distal end of the contraction sleeve 2.

[0085] Example 2

[0086] This embodiment further describes the contraction sleeve 2 based on the first embodiment.

[0087] Reference Figure 6 , Figure 7 and Figure 8 , three ribs 22 are arranged on the tightening sleeve 2, and the distances between the ribs 22 are equal. The ribs 22 are annular and are sleeved on the outer circumferential surface of the tightening sleeve 2. Preferably, the ribs 22 are memory alloy wires. After being stretched, the ribs 22 will have a movement tendency to restore the original state. In the initial state, the ribs 22 are in a stretched state and naturally have a movement tendency to shrink toward the middle of themselves, which strengthens the tightening sleeve 2 and prevents the tightening sleeve 2 from being in a loose state.

[0088] Example 3

[0089] In this embodiment, the contact surface between the contraction sleeve 2 and the drug layer 12 is further described.

[0090] Reference Figure 7 , Figure 8 and Fig. 9 A sliding layer 21 is bonded to the contact surface between the shrinking sleeve 2 and the drug layer 12. The material of the sliding layer 21 is PE or PI. PE, PI and other materials have good surface sliding properties and anti-adhesion properties. It is used to reduce the friction between the shrinking sleeve 2 and the drug layer 12. The amount of drug loss caused by friction when the shrinking sleeve 2 and the mechanical balloon body 1 move relative to each other is reduced.

[0091] In summary: by setting the sealing head 5, the constriction sleeve 2, the connecting rod 41 and the outer push rod 4, in the gathered state, the constriction sleeve 2 wraps the side of the mechanical balloon body 1, and the distal end of the constriction sleeve 2 covers the sealing head 5. When transported in the microcatheter, most of the blood can be isolated, reducing the loss of drugs during transportation. When in use, by pulling the outer push rod 4 proximally, the constriction sleeve 2 moves proximally, allowing the mechanical balloon body 1 to be slowly released, the radial constraint of the mechanical balloon body 1 is reduced, and the mechanical balloon body 1 automatically expands itself, driving the patch layer 11 to expand, allowing the patch layer 11 to fit on the inner wall of the blood vessel, and at the same time, the drug on the drug layer 12 is also in full contact with the lesion. After the application layer 11 adheres to the blood vessel wall, the inner push rod 3 is pulled proximally, and the mechanical balloon body 1 gradually returns to the contraction sleeve 2. During this recovery process, the mechanical balloon body 1 is restrained by the contraction sleeve 2 again and returns to the gathered state. Then the gathered mechanical balloon body 1 and the contraction sleeve 2 are pulled back together to complete the recovery. The mechanical balloon body 1 and the contraction sleeve 2 in the gathered state have less impact on the blood vessels and blood, and are easy to recover without implantation in the blood vessels. Even if restenosis occurs later, it is convenient for interventional surgery.

[0092] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A recyclable self-expanding drug-coated mechanical balloon system, characterized in that: It comprises a mechanical balloon body (1), wherein a sealing head (5) is provided at the distal end of the mechanical balloon body (1); A contraction sleeve (2) is sleeved on the mechanical balloon body (1) and can slide relative to the mechanical balloon body (1); An inner push rod (3) connected to the proximal end of the mechanical balloon body (1); An outer push rod (4) is sleeved on the inner push rod (3), connected to the contraction sleeve (2), and used to drive the contraction sleeve (2) to slide relative to the mechanical balloon body (1); A coating layer (11) is provided on the outer peripheral surface of the mechanical balloon body (1), a drug layer (12) is provided on the surface of the coating layer (11) close to the shrinking sleeve (2), and the shrinking sleeve (2) and the coating layer (11) cover the drug on the drug layer (12).

2. A recyclable self-expanding drug-coated mechanical balloon system according to claim 1, characterized in that: A sliding layer (21) is arranged on the contact surface between the shrink sleeve (2) and the drug layer (12), and the sliding layer (21) is one or more of PE and PI.

3. A recyclable self-expanding drug-coated mechanical balloon system according to claim 1, characterized in that: The application layer (11) is one or more of a sugar coating, glycosaminoglycan, a biological membrane, and a hydrogel.

4. A recyclable self-expanding drug-coated mechanical balloon system according to claim 1, characterized in that: At least one rib (22) is provided on the shrinking sleeve (2), and the rib (22) is annular in the cross section of the shrinking sleeve (2).

5. A retrievable self-expanding drug-coated mechanical balloon system according to claim 4, characterized in that: The ribs (22) protrude from the surface of the shrink sleeve (2) in the radial direction.

6. A retrievable self-expanding drug-coated mechanical balloon system according to claim 1, characterized in that: A groove (13) is provided on the outer peripheral surface of the mechanical balloon body (1), the application layer (11) is arranged at the bottom of the groove (13), and the application layer (11) does not protrude from the opening of the groove (13).

7. A retrievable self-expanding drug-coated mechanical balloon system according to claim 1, characterized in that: The sealing head (5) comprises a connecting portion (51) connected to the distal end of the mechanical balloon body (1), and a sealing end (52) connected to the connecting portion (51), and the sealing head (5) prevents blood from flowing into the distal end of the mechanical balloon body (1).

8. The recyclable self-expanding drug-coated mechanical balloon system according to claim 1, characterized in that: A sealing component (23) is provided at the distal end of the contraction sleeve (2), and the sealing component (23) comprises a rubber ring having a tendency to shrink toward the middle.

9. A retrievable self-expanding drug-coated mechanical balloon system according to any one of claims 1 to 8, characterized in that: The outer push rod (4) is a cylindrical rod body with a hollow interior. The inner push rod (3) is slidably connected to the interior of the outer push rod (4). The distal end of the outer push rod (4) includes a connecting rod (41), and the distal end of the connecting rod (41) is connected to the contraction sleeve (2).

10. A retrievable self-expanding drug-coated mechanical balloon system according to claim 9, characterized in that: The connecting rod (41) is in the shape of a hollow cylinder, and seals the connection portion between the inner push rod (3) and the mechanical balloon body (1).

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