Device for adherent delivery and perfusion of medicine in injured blood vessel
By combining local drug delivery and infusion devices with anchoring devices, the problem of unstable attachment of drug-coated balloons or stents within blood vessels is solved, enabling precise quantitative release and absorption of drugs, improving treatment efficacy and reducing the risk of complications. This approach is suitable for the treatment of various vascular injuries.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-01-07
- Publication Date
- 2026-03-13
AI Technical Summary
Existing drug-coated balloons or stents are unstable in their attachment within blood vessels, leading to drug displacement, low drug utilization, and poor treatment efficacy. They also make it difficult to achieve precise quantitative drug release and absorption at the target lesion site.
Employing a local drug delivery and infusion device combined with an anchoring device, this device achieves precise quantitative release and absorption of drugs through a blood flow blocking anchoring balloon and a non-blood flow blocking mesh drug elution balloon. It is suitable for local anchoring of main or collateral vessels and provides two operating modes: blood flow blocking and non-blood flow blocking for the delivery of therapeutic substances.
It enables precise quantitative drug delivery, optimizes surgical procedures, improves treatment efficacy, and reduces the risk of complications. It is suitable for adhering drug delivery and perfusion to the vascular wall in cases of peripheral, intracranial, cardiac arterial, or venous vascular injuries.
Smart Images
Figure CN121648440A_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the field of medical device technology and relates to a delivery and perfusion device, specifically a device for delivering and perfusing drugs into damaged blood vessels. Background Technology
[0002] The vascular system plays a vital role in the transport of oxygen and nutrients and the removal of metabolic waste. Vascular damage is the root cause of a variety of diseases and disorders throughout the body, both directly and indirectly, leading to significant mortality and morbidity rates worldwide.
[0003] Vascular injury begins with endothelial damage and gradually develops under the influence of lipid infiltration and chronic inflammation, eventually leading to vascular deformation, rupture, stenosis, or impaired blood flow.
[0004] Current treatment options include conventional drug therapy and implantable or interventional device therapy. However, traditional drug therapy is slow to take effect and often has poor efficacy. Clinicians have increasingly adopted targeted drug delivery methods to treat specific lesions. For example, drug-coated balloon catheters used clinically have a surface coated with medication. The catheter is advanced along a guidewire to the target lesion site, and the distal balloon or stent inflates and completely adheres to the vessel wall, thereby achieving rapid drug release and immediate absorption by the vessel wall.
[0005] However, existing drug-coated balloons or stents have several drawbacks, such as limited drug delivery capacity and types, unstable adhesion to the vessel wall leading to drug migration in complex and rigid lesions, and short effective duration of action. These issues collectively result in insufficient actual drug dosage at the target lesion site, low drug utilization, and unsatisfactory treatment outcomes.
[0006] Therefore, how to ensure stable adhesion between drug-coated balloons or stents and the blood vessel wall has become an important issue that urgently needs to be addressed. Summary of the Invention
[0007] Therefore, the purpose of this invention is to provide a drug delivery and infusion device for damaged blood vessels that adheres to the vessel wall. The local drug delivery device works in conjunction with the anchoring mechanism. The combination of anchoring and local drug delivery can prevent the system from slipping and shifting, and achieve precise quantitative drug release and absorption at the target lesion site.
[0008] To achieve the above objectives, the present invention provides the following technical solution: This invention provides a device for intravascular drug delivery and infusion in damaged blood vessels, which consists of a local drug delivery device and an anchoring device working in tandem. The anchoring device, from distal to proximal, comprises a tip, a blood flow blocking anchoring balloon or a non-blood flow blocking mesh drug-eluting balloon, a pusher, and a Y-shaped hemostatic valve. The local drug delivery device, from distal to proximal, comprises a catheter tip, a drug-loaded balloon, a catheter shaft, a stress-relieving tube, and a three-lumen catheter seat. The local drug delivery device has an inflation channel, a delivery channel, and an infusion channel. The inflation channel connects to the drug-loaded balloon, and the pusher is axially inserted through the delivery channel.
[0009] The anchoring device is anchored to either the main branch vessel or the collateral vessel.
[0010] The types of drugs delivered include exosomes, stem cells, saline solution, contrast agents, and detection reagents.
[0011] Based on the above technical solution, further, the tip is provided with a tip marking band, the catheter tip is provided with a marking band, and two marking bands are provided on the inner side of the drug-loaded balloon.
[0012] Based on the above technical solution, the anchoring device is further provided with an anchoring device inflation channel and a control line fixing channel. A tip control line is passed through the control line fixing channel, and the distal end of the tip control line is connected to the tip. The anchoring device inflation channel is connected to the blood flow blocking anchoring balloon.
[0013] Based on the above technical solution, the drug-loaded balloon surface is loaded with anticoagulant or antiproliferative drugs, and the drug-loaded balloon has a diameter of 1.0-20.0 mm and a length of 10-40 mm.
[0014] Based on the above technical solution, the push rod is further made of Pebax, nylon, polytetrafluoroethylene or ultra-high molecular weight polyethylene, and has an outer diameter of 1.0~3.0mm.
[0015] Based on the above technical solution, the inflation pressure of the drug-loaded balloon is further specified as 6 atm-22 atm.
[0016] Based on the above technical solution, the blood flow blocking anchoring balloon is a waterproof balloon made of polyurethane or latex, with an expanded diameter of 1-20mm and a length of 10-100mm.
[0017] Based on the above technical solution, the non-blood flow blocking mesh drug-eluting balloon is a self-expanding stent, which can be a stent, a drug-eluting stent, or a membrane-coated drug-eluting stent; the non-blood flow blocking mesh drug-eluting balloon is made of nickel-titanium alloy and laser-etched into a mesh structure, with a diameter of 1-20 mm and a length of 10-100 mm after self-expansion.
[0018] Based on the above technical solution, further, an injection hole is provided at the distal end of the injection channel.
[0019] Based on the above technical solution, the push rod has a multi-layer braided structure, and the tip control line is made of stainless steel or polytetrafluoroethylene; the Y-type hemostatic valve interface is threaded and made of polypropylene or polyethylene.
[0020] Compared with the prior art, the present invention has the following beneficial effects: 1. The local drug delivery device of the present invention works in conjunction with the anchoring mechanism. The anchoring combined with local wall-attached drug delivery can prevent the system from slipping and shifting, and achieve precise quantitative drug release and absorption at the target lesion site. The anchoring mechanism uses a blood flow blocking anchoring balloon and a non-blood flow blocking mesh drug elution balloon to achieve two working modes: targeted local delivery of therapeutic substances with blocked blood flow and targeted local delivery of therapeutic substances without blocked blood flow. Both can be used for local anchoring of main or collateral vessels.
[0021] 2. The infusion port design of this invention allows for precise adjustment of drug type and dosage. The blood flow blocking mode enables local high-concentration drug delivery, while the non-blocking mode controls vasodilation and drug delivery timing. Through the synergistic effect of these functions, the system optimizes surgical procedures, improves surgical efficiency, and achieves precise quantitative drug delivery, ultimately improving treatment outcomes while reducing the risk of complications.
[0022] 3. This invention can be used for the delivery and perfusion of drugs adhering to the vascular wall in peripheral, intracranial, cardiac arterial or venous vascular injuries, expanding functionality, facilitating surgery, achieving precise quantitative drug administration, improving treatment efficacy, reducing the risk of complications, and providing a more effective solution for the treatment of vascular lesions and related diseases and disorders. Attached Figure Description
[0023] To more clearly illustrate the embodiments of the present invention, the accompanying drawings involved in the embodiments will be briefly described below.
[0024] Figure 1 This is a schematic diagram of the anchoring device of the intravascular drug delivery and perfusion device of the present invention, which is anchored in the main branch blood vessel to block blood flow. Figure 2 This is a schematic diagram of the anchoring device of the intravascular drug delivery and perfusion device of the present invention, which is anchored in a collateral blood vessel to block blood flow. Figure 3 This is a schematic diagram of the structure of a local drug delivery device for intravascular drug adhesion and perfusion in damaged blood vessels according to the present invention; Figure 4 This is a schematic cross-sectional view of the catheter shaft of a drug delivery and infusion device for damaged blood vessels according to the present invention. Figure 5 This is a schematic diagram of the anchoring device structure of an intravascular drug delivery and perfusion device for damaged blood vessels according to the present invention; Figure 6 This is a schematic cross-sectional view of the push rod of a drug delivery and infusion device for damaged blood vessels according to the present invention. Figure 7 This is a schematic diagram of the anchoring device of the intravascular drug delivery and perfusion device of the present invention, anchored in the main branch blood vessel without blocking blood flow. Figure 8 This is a schematic diagram of the anchoring device of the intravascular drug delivery and perfusion device of the present invention, which is anchored in a collateral blood vessel without blocking blood flow. Figure 9 This is a schematic diagram of the expanded state of an anchoring device for an intravascular drug delivery and perfusion device that does not obstruct blood flow, according to the present invention. Figure 10 This is a schematic diagram of the contracted state of an anchoring device for an intravascular drug delivery and perfusion device that does not obstruct blood flow, according to the present invention. Figure 11 This is a schematic diagram of a drug-loaded balloon structure with a mesh-covered anchoring device for an intravascular drug delivery and perfusion device that does not obstruct blood flow, according to the present invention. Figure 12 This is a schematic diagram of the Y-type hemostatic valve structure of a drug delivery and perfusion device for damaged blood vessels according to the present invention. In the diagram: 100, Local drug delivery device; 110, Three-lumen catheter hub; 120, Stress relief tube; 130, Catheter shaft; 140, Drug-loaded balloon; 150, Catheter tip; 160, Marking strip; 111, Inflation channel; 112, Delivery channel; 113, Infusion channel; 131, Drug delivery chamber; 132, Inflation chamber; 200, Blood flow occlusion anchoring device; 210, Y-type hemostatic valve; 211, Anchoring device inflation channel; 212, Control line fixing channel; 220, Push rod; 230, Tip control line; 240, Blood flow occlusion anchoring balloon; 250, Tip; 260, Tip marking strip; 300, Blood vessel; 400, Bifurcation vessel; 500, Non-blood flow occlusion anchoring device; 540, Non-blood flow occlusion mesh drug elution balloon. Detailed Implementation
[0025] The present invention will now be described in detail with reference to embodiments. However, the implementation of the present invention is not limited thereto. Obviously, the embodiments described below are only some embodiments of the present invention. For those skilled in the art, other similar embodiments can be obtained without creative effort and all fall within the protection scope of the present invention. The anchoring device is configured to either obstruct blood flow (denoted as mechanism A) or not obstruct blood flow (denoted as mechanism B) when the intravascular drug delivery system is anchored in a blood vessel.
[0026] In some cases, for the sake of brevity, well-known structures and components are shown in simplified form. For clarity, some surfaces and details may be omitted from this description and the accompanying drawings. It should also be understood that the various components shown herein are not necessarily drawn to scale. In other words, features disclosed in various embodiments may be implemented using different internal dimensions and relative dimensions between components than those shown in the accompanying drawings.
[0027] In the context of this document, "substance" can refer to a single substance to be delivered from a local drug delivery device, or to multiple different substances or combinations of different substances to be delivered from a local drug delivery device. "Substance" can be a therapeutic agent or a diagnostic agent, such as a drug or a contrast agent.
[0028] In any embodiment of this document that includes a stent, the stent may be cylindrical, conical, or balloon-shaped.
[0029] In embodiments of the local drug delivery device described herein that include infusion orifices, the proximal infusion orifice is the infusion cavity of the catheter seat of the local drug delivery device or anchoring device, and the distal infusion orifice is a small hole on the surface of the balloon or a hole at the tip of the catheter. This infusion orifice can be, for example, a small hole on the balloon portion of a balloon catheter, allowing substances infused through the catheter to be released from these small holes, thereby achieving local drug delivery.
[0030] In one embodiment of mechanism A, the device for wall-adhesive drug delivery and perfusion in damaged blood vessels comprises two components: an anchoring device that blocks blood flow and a distal local drug delivery device, used in conjunction. During use, the distal local drug delivery device is advanced along a guidewire to the target vascular lesion site. The guidewire is then withdrawn, and the anchoring device is delivered through the lumen of the distal local drug delivery device to the vascular anchoring site. After fine-tuning the internal core wire to position the device at a predetermined location, the anchoring device is deployed under pressure to ensure the balloon portion adheres tightly to the blood vessel wall. Maintaining pressure, the Y-locking valve is tightened to secure the relative position of the entire system. The distal local drug delivery device is then deployed, and medication is administered locally through the perfusion port of either the anchoring device or the distal local drug delivery device, for example, delivering therapeutic or diagnostic agents to the damaged blood vessel. In this method, drug delivery sites include wall-adhesive drug delivery on the balloon surface and perfusion drug delivery via the catheter seat of the local drug delivery device.
[0031] In an embodiment of mechanism B, a vessel wall adhesion drug delivery and perfusion device for damaged blood vessels includes a non-obstructive anchoring device and a local drug delivery device, which work together. During use, the distal local drug delivery device is advanced along a guidewire to the target vascular lesion site. The guidewire is then withdrawn, and the anchoring device is delivered to the vascular anchoring site through the lumen of the distal local drug delivery device. After adjusting the internal core wire to position the device at the predetermined location, the tip-controlled guidewire is pushed, causing a self-expanding mesh-coated drug-eluting stent to be pushed out and deployed from the catheter lumen. The stent self-expands to match the vessel wall diameter, the anchoring device expands and adheres tightly to the vessel wall, and the Y-locking valve is tightened to fix the relative position of the entire system. The distal local drug delivery device is then expanded, and drug is administered locally through the perfusion port. Furthermore, after the mesh-coated drug-eluting stent expands, the drug carried on its surface is absorbed by the vessel wall. The drug can also be delivered to the distal end of the vessel through the perfusion port of the local drug delivery device or the perfusion device, ultimately achieving the purpose of vascular therapy. In this method, the drug delivery site is local wall-mounted delivery of the local drug delivery device and the anchoring device, and the drug is injected through the infusion port of the local drug delivery device and the anchoring device.
[0032] The drug delivery and perfusion device for damaged blood vessels provided by this invention has significant advantages over existing technologies. In one embodiment, combining a balloon dilation catheter with an anchoring device having a mesh or polymer balloon at the distal end enables vascular dilation while achieving precise local wall adhesion or selective regional drug delivery within the blood vessel. In some embodiments, the lumen of the device can deliver a variety of diagnostic or therapeutic substances for vascular injury, such as contrast agents, exosomes, stem cells, and diagnostic or therapeutic drugs.
[0033] Mechanism A: Local drug delivery and vascular occlusion. In one embodiment, a system for intravascular drug delivery or perfusion includes an anchoring device and a local drug delivery device. In another embodiment, the anchoring device is used to anchor the system to the vessel wall. In another embodiment, the anchoring device includes a balloon. In another embodiment, the system includes a catheter with the balloon located at the distal end of the catheter. In another embodiment, the balloon is inflatable and adheres to the vessel wall. In another embodiment, the anchoring device is used to occlude a blood vessel. In another embodiment, the anchoring device includes a non-perforated balloon that occludes the blood vessel when inflated and adhered to the vessel wall.
[0034] In embodiments, the local drug delivery device includes a lumen. In some embodiments, the system includes a guidewire located within the lumen of the local drug delivery device to allow the local drug delivery device to be advanced along the guidewire to the vascular lesion site. An anchoring device can be delivered to the vascular anchoring site through the lumen of the local drug delivery device. In one embodiment, the anchoring device is configured to anchor the entire intravascular delivery system within the blood vessel via a distal balloon. In some embodiments, the system includes an internal core wire for positioning the anchoring device in a predetermined location. In some embodiments, the local drug delivery device is configured to expand within the blood vessel. In some embodiments, the local drug delivery device is a balloon dilation catheter. In these embodiments, the balloon of the local drug delivery device is different from the balloon of the anchoring device. In these embodiments, the system includes two or more balloons. In some embodiments, the system includes two balloons.
[0035] In one embodiment, the local drug delivery device includes a drug-coated balloon. In one embodiment, the local drug delivery device includes an infusion port. In one embodiment, the local drug delivery device is configured to expand within a blood vessel to deliver drug locally through the infusion port or a coating on the device. In one embodiment, the target of local drug delivery is the vessel wall. In one embodiment, the local drug delivery device contacts the vessel wall to deliver the drug to the vessel wall. In one embodiment, the local drug delivery device is configured to perform distal drug delivery. In one embodiment, the target of distal drug delivery is a local vascular lumen at the location of the balloon or tip of the local drug delivery device. In one embodiment, the target of distal drug delivery is a local vascular lumen outside the vascular anchoring point. In one embodiment, the local drug delivery device is configured to perform both local and distal drug delivery simultaneously. In one embodiment, local drug delivery is performed through the infusion port. In one embodiment, the system includes a three-lumen catheter hub. In one embodiment, distal drug delivery is performed through the three-lumen catheter hub. In one embodiment, the local drug delivery device is configured to perform both local and distal drug delivery simultaneously. In one embodiment, the local drug delivery device is configured to perform both local and distal drug delivery simultaneously, wherein local drug delivery begins prior to distal drug delivery. In one embodiment, the local drug delivery device is configured to simultaneously perform local and distal drug delivery, wherein distal drug delivery begins prior to local drug delivery. In one embodiment, the local drug delivery device is configured to perform local drug delivery while a blood vessel is blocked during local drug delivery. In one embodiment, the local drug delivery device is configured to perform local drug delivery while an anchoring device blocks a blood vessel. In one embodiment, the local drug delivery device is configured to perform local drug delivery while both the anchoring device and the local drug delivery device block a blood vessel. In one embodiment, the local drug delivery device is configured to perform proximal drug delivery while the anchoring device blocks a blood vessel. In one embodiment, the local drug delivery device is configured to perform proximal drug delivery while both the anchoring device and the local drug delivery device block a blood vessel. In one embodiment, local drug delivery from the local drug delivery device may increase the amount of substance administered locally when a distal blood vessel is blocked. In one embodiment, the amount of substance administered when a blood vessel is blocked is increased compared to when the blood vessel is not blocked. In one embodiment, the anchoring device or the local drug delivery device is configured to block blood flow in a blood vessel. In one embodiment, the anchoring device or the local drug delivery device is configured to block blood flow within the blood vessel by expanding its balloon. The blockage of the blood vessel and the resulting blood flow obstruction cause blood to stagnate around the local drug delivery device, particularly at the local site where the substance is released by the local drug delivery device. The retention of blood at the site of local administration allows substances released by the local administration device to remain there, thereby increasing the amount of substance released and / or enhancing the likelihood that the substance will exert its effect at the site of local administration. Without vascular obstruction, blood flowing through the blood vessels would carry away the substance released by the local administration device, resulting in a reduction in the amount of substance reaching the site of local administration.In any of the above embodiments, the anchoring device, the local delivery device, or both can be used to block blood flow.
[0036] In one embodiment, the local drug delivery device is placed near a lesion in a peripheral, intracranial, or cardiac artery or vein. In another embodiment, the vascular anchoring point of the anchoring device is located at the lesion in a peripheral, intracranial, or cardiac artery or vein. In yet another embodiment, the vascular anchoring point of the anchoring device is located distal to a lesion in a peripheral, intracranial, or cardiac artery or vein. In yet another embodiment, the local drug delivery device is placed near a lesion in a peripheral, intracranial, or cardiac artery or vein, wherein this placement is also distal to another lesion in a peripheral, intracranial, or cardiac artery or vein. In one embodiment, the vascular anchoring point of the anchoring device is located at the lesion in a peripheral, intracranial, or cardiac artery or vein, wherein this vascular anchoring point is also distal to another lesion in a peripheral, intracranial, or cardiac artery or vein. In one embodiment, the blood vessel where the local drug delivery device is located is narrowed. In one embodiment, the blood vessel where the vascular anchoring point of the anchoring device is located is narrowed. In one embodiment, the vascular anchoring point of the anchoring device is located at a different blood vessel location than the local drug delivery device. In one embodiment, the vascular anchoring point of the anchoring device is adjacent to the blood vessel location of the local drug delivery device. In one embodiment, the vascular anchoring point of the anchoring device is located in the main branch of the blood vessel. In another embodiment, the vascular anchoring point of the anchoring device is located in a collateral branch of the blood vessel. In yet another embodiment, the vascular anchoring point of the anchoring device is located on the main branch of the blood vessel, and the vascular location of the local drug delivery device is also located on the main branch of the blood vessel. In some embodiments, the vascular anchoring point of the anchoring device is located on the main branch of the blood vessel, and the vascular location of the local drug delivery device is also located on the main branch of the same blood vessel. In some embodiments, the vascular anchoring point of the anchoring device is located on a collateral branch of the blood vessel, while the vascular location of the local drug delivery device is located on the main branch of the same blood vessel.
[0037] In any of the above embodiments, "configured" to achieve the action or effect can refer to the occurrence of the action or effect. For example, "configured" to anchor the system to the blood vessel wall can mean that the system is already anchored to the blood vessel wall.
[0038] In other embodiments, any of the above embodiments may be combined together. For example, in another embodiment, a system for intravascular drug delivery or perfusion includes an anchoring device and a local drug delivery device, wherein the anchoring device is a non-perforated balloon configured to occlude the blood vessel when expanded and attached to the vessel wall; the anchoring device is configured to deliver the drug to the vascular anchoring site through the lumen of the local drug delivery device; and wherein the local drug delivery device is a balloon configured to expand within the blood vessel to allow local drug delivery through an infusion port or a coating on the balloon.
[0039] In one embodiment, a method of delivering a substance into a subject's blood vessel via an intravascular route includes: delivering the substance through a system comprising a local delivery device, the local delivery device being secured within the blood vessel by an anchoring device. In some embodiments, the anchoring device comprises a balloon. In some embodiments, the local delivery device comprises a catheter, and the balloon of the anchoring device is located at the distal end of the catheter. In some embodiments, the method includes inflating the balloon to adhere to the blood vessel wall. In some embodiments, the anchoring device occludes the blood vessel. In some embodiments, the anchoring device comprises a non-perforated balloon. In some embodiments, the method includes inflating the balloon to adhere to the blood vessel wall, thereby occluding the blood vessel while securing the system within the blood vessel.
[0040] In one embodiment, the local drug delivery device includes a lumen. In some embodiments, the method includes advancing the local drug delivery device along a guidewire within its lumen to a vascular lesion site. In some embodiments, the method includes delivering an anchoring device through the lumen of the local drug delivery device to a vascular anchoring site. In some embodiments, the entire intravascular delivery system is secured within the blood vessel via the anchoring device through the lumen of the local drug delivery device. In some embodiments, the method includes positioning the anchoring device in a predetermined location using an internal core wire. In some embodiments, the method includes expanding the local drug delivery device intravascularly. In some embodiments, the local drug delivery device is a balloon catheter. In these embodiments, the balloon of the local drug delivery device is different from the balloon of the anchoring device. In these embodiments, the method uses two or more balloons. In some embodiments, the method uses two balloons, one located in the anchoring device and the other located in the local drug delivery device.
[0041] In one embodiment, a method of treating a disease or condition related to vascular lesions includes administering the substance of any of the above embodiments. In other embodiments, any of the above embodiments may be combined together. For example, in another embodiment, a method of delivering a substance into a subject's blood vessel via an intravascular route includes: administering the substance via a local drug delivery device, the local drug delivery device being secured within the blood vessel by an anchoring device, wherein the anchoring device is a non-perforated balloon; the method includes: inflating the balloon to adhere to the blood vessel wall and occlude the blood vessel; the method includes: delivering the anchoring device to the vascular anchoring site through the lumen of the local drug delivery device; the method includes: inflating the local drug delivery device within the blood vessel to achieve wall-adherent drug delivery; and the method includes: locally administering the therapeutic substance through an infusion port in the local drug delivery device.
[0042] Mechanism B: Local drug delivery without obstructing blood vessels. In some embodiments, a system for intravascular drug delivery or perfusion includes an anchoring device and a local drug delivery device. In some embodiments, the anchoring device is used to anchor the system to a vessel wall. In some embodiments, the anchoring device includes a stent. In some embodiments, the stent is a mesh-covered stent. In some embodiments, the stent is a drug-eluting stent. In some embodiments, the stent is a mesh-covered drug-eluting stent. In some embodiments, the system includes a catheter containing a self-expanding stent. In some embodiments, the self-expanding stent is self-expanding to adhere to the vessel wall. In some embodiments, the anchoring device does not obstruct the vessel. In some embodiments, the anchoring device includes a stent that does not obstruct the vessel when it expands to adhere to the vessel wall.
[0043] In one embodiment, the local drug delivery device includes a lumen, and an anchoring device is configured to be delivered through the lumen of the local drug delivery device to a vascular anchoring site. The anchoring device is configured to anchor the entire intravascular delivery system within the blood vessel through the lumen of the local drug delivery device. In one embodiment, the system includes a guidewire located within the lumen of the local drug delivery device to allow the local drug delivery device to be advanced along the guidewire to the vascular lesion site. In one embodiment, the system includes an internal core wire for positioning the anchoring device in a predetermined location. In one embodiment, the system is configured such that a self-expanding stent deploys from the lumen of the anchoring device when the tip of the control guidewire is actuated. In one embodiment, the local drug delivery device is a balloon dilation catheter. In one embodiment, the stent is a drug-eluting stent. In one embodiment, the stent is a mesh-covered stent. In one embodiment, the stent is a mesh-coated drug-eluting stent.
[0044] In one embodiment, a local drug delivery device is configured to expand within a blood vessel. In some embodiments, the local drug delivery device includes a balloon catheter. In some embodiments, the local drug delivery device includes a drug-coated balloon. In some embodiments, the local drug delivery device includes an infusion port. In some embodiments, the local drug delivery device is configured to expand within a blood vessel to deliver medication locally through an infusion port in the local drug delivery device or a coating on the device. In some embodiments, the target for local drug delivery is the vessel wall. In some embodiments, the local drug delivery device contacts the vessel wall to deliver substance to the vessel wall. In some embodiments, the anchoring device is a drug-eluting stent configured to deliver medication locally upon expansion. In some embodiments, the anchoring device is a drug-eluting stent configured to deliver medication locally to the vessel wall upon expansion. In one embodiment, the system is configured to locally deliver substance to the vessel wall via a drug-eluting stent (an anchoring device) and a local drug delivery device.
[0045] In one embodiment, a local drug delivery device is configured for distal drug delivery. In some embodiments, distal drug delivery refers to delivering a drug to a location other than where the local drug delivery device is located. In some embodiments, distal drug delivery refers to delivering a drug to a location other than where the local drug delivery device is located. In some embodiments, distal drug delivery refers to delivering a drug to a location other than a vascular anchor point. In some embodiments, a local drug delivery device is configured for both local and distal drug delivery. In some embodiments, local drug delivery is performed through an infusion port. In some embodiments, local drug delivery is performed through a coating on the local drug delivery device. In some embodiments, the system includes a three-lumen catheter hub. In some embodiments, distal drug delivery is performed through a three-lumen catheter hub. In some embodiments, a local drug delivery device is configured for both local and distal drug delivery, wherein local and distal drug delivery are performed simultaneously. In some embodiments, a local drug delivery device is configured for both local and distal drug delivery, wherein local drug delivery begins prior to distal drug delivery. In one embodiment, a local drug delivery device is configured to perform both local and distal drug delivery, wherein distal drug delivery begins prior to local drug delivery.
[0046] In one embodiment, the local drug delivery device is placed near a lesion in a peripheral, intracranial, or cardiac artery or vein. In another embodiment, the vascular anchoring point of the anchoring device is located at the lesion in a peripheral, intracranial, or cardiac artery or vein. In yet another embodiment, the local drug delivery device is placed distal to a lesion in a peripheral, intracranial, or cardiac artery or vein. In yet another embodiment, the vascular anchoring point of the anchoring device is located distal to a lesion in a peripheral, intracranial, or cardiac artery or vein. In yet another embodiment, the local drug delivery device is placed near a lesion in a peripheral, intracranial, or cardiac artery or vein, wherein this placement location is also distal to another lesion in a peripheral, intracranial, or cardiac artery or vein. In one embodiment, the vascular anchoring point of the anchoring device is located at the lesion in a peripheral, intracranial, or cardiac artery or vein, wherein the vascular anchoring point of the anchoring device is also distal to another lesion in a peripheral, intracranial, or cardiac artery or vein. In one embodiment, the blood vessel where the local drug delivery device is located is narrowed. In yet another embodiment, the blood vessel where the vascular anchoring point of the anchoring device is located is narrowed. In one embodiment, the vascular anchoring point of the anchoring device is different from the vascular location of the local drug delivery device. In one embodiment, the vascular anchoring point of the anchoring device is adjacent to or the same as the vascular location of the local drug delivery device. In one embodiment, the vascular anchoring point of the anchoring device is located in the main branch of the blood vessel. In one embodiment, the vascular anchoring point of the anchoring device is located in a collateral branch of the blood vessel. In one embodiment, the vascular anchoring point of the anchoring device is located on the main branch of the blood vessel, and the vascular location of the local drug delivery device is also located on the main branch of the blood vessel. In some embodiments, the vascular anchoring point of the anchoring device is located on the main branch of the blood vessel, and the vascular location of the local drug delivery device is also located on the main branch of the same blood vessel. In some embodiments, the vascular anchoring point of the anchoring device is located on a collateral branch of the blood vessel, while the vascular location of the local drug delivery device is located on the main branch of the same blood vessel.
[0047] In any of the above embodiments, "configuring" to achieve the action or effect can mean that the action or effect actually occurs. For example, "configuring" to anchor the system to the blood vessel wall can mean that the system is already anchored to the blood vessel wall.
[0048] In other embodiments, any of the above embodiments may be used in combination. For example, in another embodiment, a system for intravascular drug delivery or perfusion includes an anchoring device and a local drug delivery device, wherein the anchoring device is a non-perforated balloon configured to occlude the blood vessel when expanded and attached to the vessel wall; the anchoring device is configured to deliver the drug to the vascular anchoring site through the lumen of the local drug delivery device; and the local drug delivery device is configured to expand within the blood vessel to allow local drug delivery through an infusion port or a coating on the balloon.
[0049] In one embodiment, a method of delivering a substance into a subject's blood vessel via an intravascular route includes: delivering the substance via a local drug delivery device, the local drug delivery device being secured within the blood vessel by an anchoring device. In some embodiments, the anchoring device includes a stent. In some embodiments, the stent is a mesh-covered stent. In some embodiments, the stent is a drug-eluting stent. In some embodiments, the stent is a mesh-covered drug-eluting stent. In some embodiments, the system includes a catheter, and the catheter contains a retractable stent. In some embodiments, the method includes placing the retractable stent, allowing it to self-expand and adhere to the vessel wall. In some embodiments, the method includes expanding the stent to adhere to the vessel wall. In some embodiments, the anchoring device does not obstruct blood flow. In some embodiments, the anchoring device is a stent, and expanding the stent to adhere to the vessel wall does not obstruct blood flow.
[0050] In one embodiment, the local drug delivery device includes a lumen. In one embodiment, the method includes delivering an anchoring device through the lumen of the local drug delivery device to a vascular anchoring site. In one embodiment, the entire intravascular delivery system is secured within the blood vessel via the anchoring device through the lumen of the local drug delivery device. In one embodiment, the method includes advancing the local drug delivery device along a guidewire within its lumen to a vascular lesion site. In one embodiment, the method includes positioning the local drug delivery device in a predetermined location using an internal core wire. In one embodiment, the method includes actuating the tip of a control guidewire to deploy a retractable stent from the lumen of the local drug delivery device. In one embodiment, the local drug delivery device is a catheter. In one embodiment, the stent is a drug-eluting stent. In one embodiment, the stent is a mesh-covered stent. In one embodiment, the stent is a mesh-covered drug-eluting stent.
[0051] In other embodiments, any of the above embodiments may be used in combination. For example, in another embodiment, a method of delivering a substance into a subject's blood vessel via an intravascular route includes: delivering the substance via a local drug delivery device, the local drug delivery device being secured within the blood vessel by an anchoring device, wherein the anchoring device is a drug-eluting stent; the method includes: delivering the stent through the lumen of the local drug delivery device to the vascular anchoring site, such that the stent adheres to the blood vessel wall without obstructing the blood vessel; wherein the local drug delivery device is a balloon catheter; the method includes: dilating the local drug delivery device within the blood vessel; and the method includes: locally delivering the substance through an infusion port in the local drug delivery device or through a coating on the local drug delivery device.
[0052] In other embodiments, any of the above embodiments may be used in combination. For example, in another embodiment, a method of delivering a substance into a subject's blood vessel via an intravascular route includes: delivering the substance via a local drug delivery device, the local drug delivery device being secured within the blood vessel by an anchoring device, wherein the anchoring device is a drug-eluting stent; the method includes: delivering the stent through the lumen of the local drug delivery device to the vascular anchoring site, such that the stent adheres to the blood vessel wall without obstructing blood flow; wherein the local drug delivery device is a balloon dilation catheter; the method includes: dilating the local drug delivery device within the blood vessel; and the method includes: locally delivering the substance through an infusion port in the local drug delivery device or through a coating on the local drug delivery device.
[0053] The terms “comprising,” “constituting,” and “composed of” as used herein are open-ended terms. For example, “A comprises B” means that A may contain: (i) only B; or (ii) B combined with one or more other components (in any number). In contrast, “composed of,” “constituting of,” and “component of” are closed-ended terms. For example, “A is composed of B” means that A contains only B and no other components in the same context.
[0054] The combinations described herein, such as "at least one of A, B, or C", "one or more of A, B, or C", "at least one of A, B, and C", "one or more of A, B, and C", and "A, B, C, or any combination thereof", include any combination of A, B, and / or C, and may contain multiple A, multiple B, or multiple C. Specifically, combinations such as "at least one of A, B, or C", "one or more of A, B, or C", "at least one of A, B, and C", "one or more of A, B, and C", and "A, B, C, or any combination thereof" may contain only A, only B, only C, A and B, A and C, B and C, or A, B, and C, and any such combination may contain one or more members of its constituent parts A, B, and / or C. For example, a combination of A and B may contain one A and multiple B, multiple A and one B, or multiple A and multiple B.
[0055] It should be understood that the above advantages and benefits may relate to one embodiment or multiple embodiments. Aspects related to one embodiment are intended to be used in conjunction with other embodiments. Any interpretations relating to one embodiment apply to similar features of other embodiments, and elements of multiple embodiments may be combined to form other embodiments. These embodiments are not limited to embodiments that solve any or all of the described problems, nor are they limited to embodiments that have any or all of the described advantages and benefits.
[0056] The detailed description above is merely illustrative and is not intended to limit the invention or its applications and uses. The described embodiments are not limited to use with specific types of components or body parts. Therefore, although this embodiment is described as being implemented in an artery for ease of explanation, it should be understood that it can also be applied to various other parts of the body and various other systems and environments. Furthermore, this embodiment is not intended to be bound by any of the theories set forth in the foregoing sections. It should also be understood that the illustrations may contain exaggerated dimensions and graphic representations to better illustrate the references shown, and should not be considered limiting unless explicitly stated otherwise. Example 1
[0057] Figure 3 illustrates an example of a local drug delivery device 100 used in mechanisms A and B described herein. The device has a guidewire structure including a three-lumen catheter connector 110, a stress-relieving tube 120, a catheter shaft 130, a drug-coated balloon 140, a tip 150, and a marking tape 160. In some embodiments, these components are joined by welding, bonding, or crimping. The three-lumen catheter connector includes an inflation channel 111, a delivery channel 112, and an infusion channel 113. An orifice connects the infusion channel 113 to the delivery channel 112, allowing delivery of a substance, such as a drug, via the local drug delivery device when infused into the system through the infusion channel. The catheter shaft has a dual-lumen structure, as shown in the figure. Figure 4 As shown, the balloon includes a delivery chamber 131 and an inflation chamber 132. Inside the balloon, two marker bands 161 are located at the shoulder of the balloon, and one marker band 162 is located at the tip of the balloon. The balloon tip 150 is formed using a heat-shrink tapering process. The balloon surface is coated with a substance to be delivered to the blood vessel. The balloon surface is coated with one or more antiproliferative drugs, one or more anticoagulant drugs, or a combination thereof. These drugs are coated onto the balloon surface using ultrasonic spraying technology. Example 2
[0058] Figure 1An example of the coordinated operation of the local drug delivery device 100 and the blood flow occlusion anchoring device 200 in apparatus A is shown. In this embodiment, the operation is suitable for cases where the target lesion is located in a main blood vessel. The procedure is performed under X-ray guidance. The local drug delivery device 100 is advanced along the guidewire to the target lesion site within the blood vessel 300. The guidewire is then withdrawn from the body, and the blood flow occlusion anchoring device 200 is advanced through the delivery lumen 131 of the local drug delivery device 100 to the distal end of the blood vessel. The tip marking band 260 of the anchoring device is located 5–10 mm distal to the tip marking band 161 of the local drug delivery device. The tip control line 230 is adjusted to ensure that the anchoring device 200 is in the optimal position.
[0059] Tighten and lock the control line fixing port 212 of the Y-type hemostatic valve, and connect and fix the other end to the delivery channel 112 of the three-lumen catheter connector 110. Connect the pressure device to the perfusion port 211 of the blood flow occlusion anchoring device 200 and continuously inject filling fluid into the lumen. The filling fluid inflates the anchoring balloon through the inflation port, causing it to adhere tightly to the vessel wall. Then stop inflation.
[0060] Once the entire device is anchored in place, the drug-coated balloon of the local drug delivery device 100 is sequentially expanded. A high dose of vascular repair agent, such as exosomes or stem cell solutions, is locally infused into the blood vessel through perfusion channel 113. For details on the local drug delivery device, please refer to Figure 3. Figure 2 illustrates the same system, where the lesion is located at the junction of the collateral and main branches. Example 3
[0061] Figure 5 shows the blood flow occlusion anchoring device according to mechanism A. The device is an integrally exchangeable structure, including a Y-type hemostatic valve 210, a push rod 220, a blood flow occlusion anchoring balloon 240, a tip control guidewire 230, a tip 250, a tip marking strip 260, an infusion port 211, and a control guidewire fixation port 212. The Y-type hemostatic valve 210 has a threaded connection interface. The blood flow occlusion balloon 240 is made of a highly compliant polymer material such as polyurethane or latex. The push rod 220 has a three-layer structure, from the inside out: polytetrafluoroethylene (PTFE), a metal braided layer, and a soft polymer layer. The tip 250 is sealed and blow-molded into a tapered transition, with a marking strip at the tip. The catheter shaft within the blood flow occlusion anchoring balloon has side holes on opposite sides, as shown in Figure 6. Example 4
[0062] Figure 8 illustrates an example of the combined operation of the local drug delivery device and the non-flow-blocking anchoring device in Mechanism B. When the lesion is located at the junction of the main branch and the collateral branch, the non-flow-blocking anchoring device 500 can be used in conjunction with the local drug delivery device 100 to ensure the patency of the collateral vessel. The local drug delivery device 100 is advanced along the guidewire to the proximal end of the bifurcation. After the guidewire is withdrawn, the non-flow-blocking anchoring device 500 is advanced through the delivery lumen 131 of the local drug delivery device 100 to the distal bifurcation of the vessel. By controlling the guidewire 230 to adjust the direction of the tip 550, it is guided into the collateral vessel and to the predetermined position. Figure 7 illustrates the same system when the lesion is located in the main branch.
[0063] Gently push the guidewire 230 to deploy the retractable, film-coated drug-eluting stent from the push rod. The drug-eluting stent 540 self-expands and adheres to the vessel wall, securing the device in place. The Y-shaped hemostatic valve 210 is tightly screwed into the delivery channel 112 of the three-lumen catheter connector 110 to ensure the relative positioning of the coordinated systems.
[0064] The local drug delivery device is then inflated to allow for drug adhesion and delivery to the main branch vessel wall. A vascular repair solution, such as exosomes or stem cell solutions, is locally infused into the main branch vessel through perfusion channel 113. A syringe containing the drug is connected to a Y-type hemostatic valve to deliver the drug to collateral vessels. This allows for simultaneous drug delivery to both the main and collateral vessels while maintaining blood flow in the collateral vessels, thereby achieving local vascular repair. Example 5
[0065] Figure 9 shows the non-blood flow obstruction anchoring device of mechanism B. This non-blood flow obstruction anchoring device 500 includes a Y-type hemostatic valve 210, a push rod 220, a tip control wire 230, and a non-blood flow obstruction drug-eluting stent 540. The push rod has a single-cavity multi-layer braided structure, with an inner layer of polytetrafluoroethylene (PTFE), a middle layer of nitinol braided layer, and an outer layer of Pebax material.
[0066] The drug-eluting stent is made of a nickel-titanium alloy with shape memory properties, and the stent is laser-etched into a mesh structure. Three longitudinal support rods are located along its main axis, with the proximal ends of the support rods braided and fixed to the tips of control wires. The drug-eluting stent is heat-treated at 400°C to 900°C to enhance its shape memory effect and superelasticity. The stent has a diameter of 1.0–20.0 mm and a length of 10–100 mm after expansion. Example 6
[0067] Figure 10 illustrates the non-blocking anchoring device in its contracted state. In this state, the mesh-covered drug-eluting stent is contracted within the pusher lumen. As the device advances to the target position, the tip control wire is pushed forward, exposing the mesh drug-eluting stent outside the catheter shaft. The mesh-encased drug-eluting balloon self-inflates and adheres to the vessel wall, thus providing anchoring.
[0068] The surface of the mesh balloon is covered with a polytetrafluoroethylene (PTFE) membrane coated with an antiproliferative drug. As the mesh-encapsulated drug-eluting balloon 540 expands and anchors to the blood vessel, drug delivery through local adhesion to the vessel wall is simultaneously achieved. After use, withdrawing the tip control guidewire 230 retracts the mesh-encapsulated drug-eluting balloon 540 into the pusher 220, allowing the entire device to be removed from the body. Example 7
[0069] The difference between this embodiment and embodiment 1 is that: The drug-loaded balloon 140 has a diameter of 1.0 mm and a length of 10 mm.
[0070] The outer diameter of the push rod 220 is 0.6mm.
[0071] The drug-loaded balloon 140 has an inflation pressure of 6 atm.
[0072] The blood flow occlusion anchoring balloon 240 has a diameter of 1 mm and a length of 10 mm after dilation.
[0073] The non-blocking blood flow self-expanding stent has a diameter of 1 mm and a length of 10 mm after self-expansion. Example 8
[0074] The difference between this embodiment and embodiment 1 is that: The drug-loaded balloon 140 has a diameter of 20.0 mm and a length of 40 mm.
[0075] The outer diameter of the push rod 220 is 3.0mm.
[0076] The drug-loaded balloon 140 has an inflation pressure of 22 atm.
[0077] The blood flow occlusion anchoring balloon 240 has a diameter of 20 mm and a length of 100 mm after dilation.
[0078] The non-blocking blood flow self-expanding stent has a diameter of 20mm and a length of 100mm after self-expansion.
[0079] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.
Claims
1. A device for intravascular drug delivery and perfusion in damaged blood vessels, characterized in that, The anchoring device (200) consists of, from distal to proximal, a tip (250), a blood flow blocking anchoring balloon (240) or a non-blood flow blocking mesh drug elution balloon (540), a push rod (220), and a Y-type hemostatic valve (210). The local drug delivery device (100) consists of, from distal to proximal, a catheter tip (150), a drug-loaded balloon (140), a catheter shaft (130), a stress relief tube (120), and a three-lumen catheter seat (110). The local drug delivery device (100) is provided with an inflation channel (111), a delivery channel (112), and an infusion channel (113). The inflation channel (111) is connected to the drug-loaded balloon (140), and the push rod (220) is axially inserted in the delivery channel (112).
2. The intravascular drug delivery and perfusion device for damaged blood vessels according to claim 1, characterized in that, The tip (250) is provided with a tip marking band (260), the catheter tip (150) is provided with a marking band (160), and the drug-loaded balloon (140) is provided with two of the marking bands (160) on its inner side.
3. The intravascular drug delivery and perfusion device for damaged blood vessels according to claim 1, characterized in that, The anchoring device (200) is provided with an anchoring device inflation channel (211) and a control line fixing channel (212). A tip control line (230) is passed through the control line fixing channel (212). The distal end of the tip control line (230) is connected to the tip (250). The anchoring device inflation channel (211) is connected to the blood flow blocking anchoring balloon (240).
4. The intravascular drug delivery and perfusion device for damaged blood vessels according to claim 1, characterized in that, The drug-loaded balloon (140) has an anticoagulant or antiproliferative drug on its surface, and the drug-loaded balloon (140) has a diameter of 1.0-20.0 mm and a length of 10-40 mm.
5. The intravascular drug delivery and perfusion device for damaged blood vessels according to claim 1, characterized in that, The push rod (220) is made of Pebax, nylon, polytetrafluoroethylene or ultra-high molecular weight polyethylene, and has an outer diameter of 1.0~3.0mm.
6. The intravascular drug delivery and perfusion device for damaged blood vessels according to claim 1, characterized in that, The drug-loaded balloon (140) has an inflation pressure of 6 atm-22 atm.
7. The intravascular drug delivery and perfusion device for damaged blood vessels according to claim 1, characterized in that, The blood flow blocking anchoring balloon (240) is a water-impermeable balloon made of polyurethane or latex, with a diameter of 1-20 mm and a length of 10-100 mm after expansion.
8. The intravascular drug delivery and perfusion device for damaged blood vessels according to claim 1, characterized in that, The non-blood flow blocking mesh drug-eluting balloon (540) is a self-expanding stent, which can be a stent, a drug-eluting stent, or a membrane-coated drug-eluting stent. The non-blood flow blocking mesh drug-eluting balloon (540) is made of nickel-titanium alloy and laser-etched into a mesh structure. After self-expansion, its diameter is 1-20 mm and its length is 10-100 mm.
9. A device for intravascular drug delivery and perfusion in damaged blood vessels according to claim 1, characterized in that, The injection channel (113) has an injection hole at its far end.
10. The intravascular drug delivery and perfusion device for damaged blood vessels according to claim 1, characterized in that, The push rod (220) has a multi-layer braided structure, and the tip control line (230) is made of stainless steel or polytetrafluoroethylene; the Y-type hemostatic valve (210) has a threaded interface and is made of polypropylene or polyethylene.