Medical device for targeted delivery of medical agents and methods of use thereof

Abstract

The present disclosure pertains to a medical device, system, and method for targeted delivery of medical agents to specific locations within the vascular system. The system features an intravascular device comprising a tubular body having an inner lumen for maintaining antegrade blood flow and at least two inflatable annular members spaced along the tubular body. The annular members are configured to expand radially to define a confined treatment zone within the vessel, thereby enabling localized administration of medical agents while preserving physiological blood flow. The system further features a delivery system that includes a multi-lumen shaft configured to facilitate controlled inflation of the annular members and administration of the medical agents. In addition, the present disclosure pertains to a method of delivering medical agents to a targeted vascular location by advancing the intravascular device to the target site, inflating the annular members to form the confined treatment zone, and administering the agents through the multi-lumen shaft under predetermined pressure and flow conditions. Accordingly, the described technology enhances treatment precision and reduces systemic exposure of the medical agents in applications including tumor therapy, aneurysm, plaque and thrombus management.

Description

[0001] MEDICAL DEVICE FOR TARGETED DELIVERY OF MEDICAL AGENTS AND METHODS OF USE THEREOF

[0002] FIELD OF THE INVENTION

[0003] The present disclosure pertains to medical devices designed for the targeted delivery of medical agents, including therapeutic or diagnostic agents, to designated areas within the body.

[0004] BACKGROUND OF THE INVENTION

[0005] In interventional medicine, the targeted delivery of therapeutic and diagnostic agents to specific regions within the vascular system holds significant importance. Typically, conventional infusion techniques relying on standard catheters suffer from non-specific dispersion of agents, leading to systemic exposure and undesirable side effects in healthy tissues. For example, achieving sufficient concentration at the target site while preserving physiologic blood flow remains a considerable challenge in targeted therapeutic procedures. Moreover, uncontrolled backflow or leakage into adjacent vessels can compromise treatment efficacy and increase the risk of off-target effects. Addressing the complex manipulation and lengthy procedure times associated with existing approaches is necessary, as these factors contribute to patient risk and procedural complexity. If delivery platforms could provide reliable confinement of agents within a localized segment without obstructing antegrade blood flow, precision would be enhanced, systemic toxicity reduced, and interventional workflows optimized.

[0006] A medical device that enables precise formation of an isolated treatment zone within a blood vessel, while maintaining continuous antegrade flow, would be desirable. Additionally, a device that allows controlled infusion of therapeutic and diagnostic fluids under dynamic pressure conditions and prevents retrograde dispersion would be advantageous. A platform compatible with standard interventional techniques and adaptable to various vascular anatomies would also be beneficial. The described invention offers a solution to these requirements.SUMMARY OF THE INVENTION

[0007] In one aspect, the system described may include an intravascular device for targeted delivery of a medical agent. The device may include a tubular body having a proximal end, a distal end, and an inner lumen configured to maintain antegrade blood flow. The intravascular device may further include at least two inflatable annular members disposed about an exterior surface of the tubular body and spaced apart along the longitudinal axis of the tubular body, each annular member being inflatable to expand radially into contact with a vessel wall and thereby form a confined zone between the vessel wall, the annular members, and the tubular body. The system may also include a delivery subsystem comprising a multi-lumen shaft configured to independently provide inflation fluid to each of the annular members and to deliver a medical agent into the confined zone. Accordingly, when the annular members are inflated, the confined zone is created for localized delivery of the medical agent while antegrade blood flow continues through the inner lumen.

[0008] In various embodiments of the system, the tubular body may be made of a biocompatible polymer or metallic alloy. Each inflatable annular member may include an elastomeric bladder, and each bladder may be fluidly coupled to a dedicated inflation lumen of the multi-lumen shaft. The multilumen shaft may include separate lumens for inflation fluid and for the medical agent. The inflatable annular members may define the confined zone with a length selectable based on the longitudinal spacing between the members.

[0009] A further aspect is a method of localized intravascular therapy. A further aspect is a use of the herein intravascular system for localized intravascular delivery of a medical agent in a blood vessel. The method / use may include advancing the intravascular system over a guidewire into a target blood vessel. The method / use may include deploying the tubular body to allow blood passage through the inner lumen of the tubular body. The method / use may include inflating the annular members so that they seal circumferentially against the vessel wall and define a confined zone. The method / use may include delivering a medical agent from one of the lumens of the shaft into the confined zone while maintaining antegrade flow through the inner lumen of the tubular body. The method / use may include thereafter either deflating the annular members and retracting the system or detaching the delivery subsystem and leaving the tubular body and annular members implanted.An aspect of the invention pertains to an intravascular system for targeted delivery of a medical agent, comprising:

[0010] a tubular body having a proximal end, a distal end, and an inner lumen configured to maintain antegrade blood flow;

[0011] at least two inflatable annular members disposed about an exterior surface of the tubular body and spaced apart along a longitudinal axis of the tubular body, each inflatable annular member configured to expand radially to contact a vessel wall and form a confined zone between the vessel wall, the annular members, and the tubular body; and

[0012] a delivery system comprising a shaft with a plurality of lumens, the lumens configured to independently provide inflation fluid to the inflatable annular members and deliver a medical agent to the confined zone;

[0013] wherein the system is configured such that, when the inflatable annular members are inflated, the confined zone is formed for localized delivery of the medical agent while antegrade blood flow is maintained through the inner lumen of the tubular body.

[0014] In one or more embodiments, the tubular body comprises at least one radial aperture formed through a side wall thereof, the aperture being configured to deliver the medical agent into the confined zone.

[0015] In one or more embodiments, the delivery system shaft comprises a plurality of lumens selected from: a lumen for guidewire introduction or axial medical agent delivery; a lumen for inflating the tubular body; a lumen for delivering the medical agent through the tubular body aperture(s); and a lumen for inflating the annular members.

[0016] In one or more embodiments, the delivery system shaft comprises four lumens, the lumens comprising: a first lumen for guidewire introduction or axial medical agent delivery; a second lumen for inflating the tubular body; a third lumen for delivering the medical agent through the tubular body apertures; and a fourth lumen for inflating the annular members.

[0017] In one or more embodiments, the tubular body is inflatable upon introduction of fluid into the inner lumen of the tubular body.In one or more embodiments, the tubular body is configured to be filled with a radio-opaque contrast media.

[0018] In one or more embodiments, at least one of the inflatable annular members is configured to be filled with a radio-opaque contrast media.

[0019] In one or more embodiments, the inflatable annular members are deflatable upon removal of the inflation fluid to permit retraction of the intravascular system from the blood vessel.

[0020] In one or more embodiments, the tubular body is deflatable upon removal of the inflation fluid to permit retraction of the intravascular system from the blood vessel.

[0021] In one or more embodiments, the system further comprising a front aperture at the distal end of the tubular body, the front aperture being in fluid communication with one of the lumens of the delivery system for axial delivery of the medical agent.

[0022] In one or more embodiments, the medical agent is selected from a physiological agent, a therapeutic agent and a diagnostic agent.

[0023] In one or more embodiments, the medical agent comprises at least one of a chemotherapeutic agent, an embolic agent, an adhesive, a contrast media, ethanol, or a radioactive agent.

[0024] In one or more embodiments, the delivery system is detachable from the tubular body so that the tubular body and the inflatable annular members remain implanted in the vessel while maintaining antegrade blood flow.

[0025] In one or more embodiments, each of the lumens of the delivery system is fluidly isolated from the other lumens so as to permit simultaneous, independent pressure control for inflation of the tubular body, inflation of the inflatable annular members, and delivery of the medical agent.

[0026] In one or more embodiments, the system further comprising at least one radiopaque marker disposed on the tubular body at a position adjacent the at least one radial aperture to facilitate fluoroscopic alignment of the confined zone with a target treatment site.In one or more embodiments, the device is configured such that antegrade blood flow through the inner lumen of the tubular body is maintained at no less than 10% of the vessel’s baseline blood flow rate. In one or more embodiments, the device is configured such that antegrade blood flow through the inner lumen of the tubular body is maintained at no less than 10%, 20%, 30%, 40%, or 50% of the vessel’s baseline blood flow rate.

[0027] In another aspect the invention provides an intravascular device for targeted delivery of a medical agent, comprising:

[0028] a tubular body having a proximal end, a distal end, and an inner lumen configured to maintain antegrade blood flow; and

[0029] at least two inflatable annular members disposed about an exterior surface of the tubular body and spaced apart along a longitudinal axis of the tubular body, each inflatable annular member configured to expand radially to contact a vessel wall and form a confined zone between the vessel wall, the annular members, and the tubular body;

[0030] wherein the device is configured such that, when the inflatable annular members are inflated, the confined zone is formed for localized delivery of the medical agent while antegrade blood flow is maintained through the inner lumen of the tubular body.

[0031] In one or more embodiments, the tubular body comprises at least one radial aperture formed through a side wall thereof, the aperture being configured to deliver the medical agent into the confined zone.

[0032] In one or more embodiments, the tubular body is inflatable upon introduction of fluid into the inner lumen of the tubular body.

[0033] In one or more embodiments, at least one of the inflatable annular members is configured to be filled with a radio-opaque contrast media.

[0034] In one or more embodiments, the device further comprises a front aperture at the distal end of the tubular body, the front aperture being configured for axial delivery of the medical agent.In one or more embodiments, the tubular body and the inflatable annular members are deflatable upon removal of the inflation fluid to permit retraction of the intravascular device from the blood vessel.

[0035] In one or more embodiments, the medical agent comprises at least one of a chemotherapeutic agent, an embolic agent, an adhesive, a contrast media, ethanol, or a radioactive agent.

[0036] In one or more embodiments, the device further comprising at least one radiopaque marker disposed on the tubular body at a position adjacent the at least one radial aperture to facilitate fluoroscopic alignment of the confined zone with a target treatment site.

[0037] In another aspect the invention provides use of an intravascular system or a method of localized intravascular therapy, comprising:

[0038] advancing the herein intravascular system of over a guidewire into a target blood vessel; deploying the tubular body in the blood vessel to allow passage of blood through the inner diameter of the tubular body;

[0039] inflating the inflatable annular members so that they circumferentially seal against the vessel wall and define the confined zone between the annular members, the vessel wall, and the tubular body;

[0040] delivering the medical agent from one of the lumens of the delivery system into the confined zone while antegrade blood flow continues through the inner lumen of the tubular body; and thereafter either:

[0041] deflating the inflatable annular members and optionally the tubular body and withdrawing the intravascular system from the vessel; or

[0042] detaching the delivery system and leaving the tubular body and inflatable annular members implanted while maintaining antegrade blood flow through the tubular body.

[0043] In one or more embodiments, the medical agent is delivered into the confined zone at a pressure between 40 and 300 mmHg to promote penetration of the medical agent through the vessel wall into perivascular tissue.In one or more embodiments, the method further comprising simultaneously delivering a first medical agent through at least one radial aperture of the tubular body into the confined zone and delivering a second, different medical agent through the front aperture at the distal end of the tubular body to an antegrade location downstream of the confined zone.

[0044] In one or more embodiments, the target blood vessel is adjacent to a tumor and the medical agent comprises an anticancer agent, and the method further comprises delivering the chemotherapeutic agent into the confined zone to treat the tumor while maintaining antegrade blood flow through the tubular body.

[0045] In one or more embodiments, the target blood vessel comprises an aneurism, and the method further comprises delivering an embolic agent into the confined zone to fill and / or seal the aneurism while maintaining antegrade blood flow through the tubular body.

[0046] In one or more embodiments, the target blood vessel comprises a ruptured blood vessel, and the method further comprises delivering a ruptured vessel treatment into the confined zone to seal the rupture while maintaining antegrade blood flow through the tubular body.

[0047] In one or more embodiments, the target blood vessel comprises intraluminal plaque or thrombus, and wherein the inflatable annular members are positioned such that the plaque or thrombus lies between said inflatable annular members; the method further comprises inflating the tubular body to press the plaque or thrombus against the vessel wall and delivering a medical agent into the confined zone to treat the plaque or thrombus while maintaining antegrade blood flow through the tubular body.

[0048] In one or more embodiments, the method further comprises aspirating fluid from the confined zone to remove residual medical agents, contrast media, blood, admixtures or any other fluid while antegrade blood flow is maintained through the tubular body.

[0049] In another aspect the invention provides use of an intravascular system or a method of treating cancer, comprising: advancing an intravascular system comprising a tubular body having an inner lumen and at least two inflatable annular members into a target blood vessel adjacent to a tumor; inflating the inflatable annular members so that they circumferentially seal against the vessel walland define a confined zone between the annular members, the vessel wall, and the tubular body; delivering an anticancer medical agent into the confined zone while antegrade blood flow is maintained through the inner lumen of the tubular body; and optionally delivering a medical agent in an antegrade direction through a front aperture at the distal end of the tubular body to a downstream location.

[0050] In another aspect the invention provides use of an intravascular system or a method of treating an aneurysm, comprising: advancing an intravascular system comprising a tubular body having an inner lumen and at least two inflatable annular members into a target blood vessel; positioning the tubular body and inflatable annular members such that, upon inflation, they circumferentially seal against the vessel wall and define a confined zone that isolates an aneurysmal neck; delivering a medical agent comprising an embolic agent into the confined zone to fill and / or seal the aneurysm while antegrade blood flow is maintained through the inner lumen of the tubular body; and thereafter optionally deflating the inflatable annular members and, when applicable, the tubular body, and retracting the intravascular system from the vessel.

[0051] In another aspect the invention provides use of an intravascular system or a method of treating a ruptured blood vessel, comprising: advancing an intravascular system comprising a tubular body having an inner lumen and at least two inflatable annular members into a target blood vessel; inflating the inflatable annular members to circumferentially seal against the vessel wall and define a confined zone spanning the rupture; delivering a medical agent comprising a ruptured vessel treatment into the confined zone to seal the rupture while maintaining antegrade blood flow through the inner lumen of the tubular body; and subsequently deflating the inflatable annular members and, optionally, the tubular body, and retracting the intravascular system from the vessel.

[0052] In another aspect the invention provides use of an intravascular system or a method of treating intraluminal plaque or thrombus, comprising: advancing an intravascular system comprising a tubular body having an inner lumen and at least two inflatable annular members into a target blood vessel; positioning the inflatable annular members such that the plaque or thrombus lies between said annular members; inflating the tubular body to press the plaque or thrombus against the vessel wall; delivering a medical agent into the confined zone to treat the plaque or thrombus while antegrade blood flow is maintained through the inner lumen of the tubular body; and thereafteroptionally deflating the inflatable annular members and, when applicable, the tubular body, and retracting the intravascular system from the vessel.

[0053] In another aspect the invention provides use of an intravascular device for targeted delivery of a medical agent, comprising: a tubular body sized for placement within a blood vessel and defining an inner lumen configured to preserve antegrade blood flow; and at least two inflatable annular members disposed about an exterior surface of the tubular body and spaced apart along a longitudinal axis thereof, the annular members being configured, upon inflation, to expand radially to contact the vessel wall and define a confined zone between the annular members, the vessel wall, and the tubular body; wherein, when the tubular body is positioned within the blood vessel and the annular members are inflated, antegrade blood flow through the inner lumen of the tubular body is maintained at no less than one-quarter (>25%) of the baseline blood flow of the blood vessel.

[0054] BRIEF DESCRIPTION OF THE DRAWINGS

[0055] FIG. 1 A shows a system for targeted delivery of medical agents within a blood vessel.

[0056] FIG. IB is a cross-sectional view of the system for targeted delivery of medical agents showing the tubular body, inner lumen thereof, and inflatable annular members encircling the tubular body.

[0057] FIG. 1C is a cross-sectional view of a shaft of a delivery system of the herein system for targeted delivery of medical agents, the longitudinal shaft comprising multiple lumens for therapy delivery and device operation.

[0058] FIG. 2A depicts the introduction of the system for targeted delivery of medical agents into a blood vessel.

[0059] FIG. 2B depicts the herein system for targeted delivery of medical agents when introduced into a blood vessel and wherein the tubular body is deployed and inflated by injection of a medical agent thereto.FIG. 2C depicts the herein system for targeted delivery of medical agents when introduced into a blood vessel and wherein the tubular body is in an inflated configuration and the annular members are further inflated by injection of a medical agent thereto.

[0060] FIG. 2D depicts the system for targeted delivery of medical agents when the tubular body and the inflatable annular members are in an inflated configuration, facilitating a confined zone for targeted medical agent(s) administration.

[0061] FIG. 2E depicts the system for targeted delivery of medical agents facilitating targeted medical agent delivery while maintaining antegrade blood flow.

[0062] FIG. 2F depicts the herein system wherein the device facilitates delivery of a medical agent via a side branch blood vessel while concurrently maintaining antegrade blood flow. The device further enables forward (antegrade) delivery of a medical agent in the main vessel. In certain embodiments, the system can perform parallel injections of two different agents and / or deliver medical agents to separate body locations simultaneously.

[0063] FIG. 2G depicts the retraction of the system including deflated annular members and tubular body.

[0064] FIG. 3 illustrates high-pressure administration of a medical agent using the system, highlighting that high-pressure injection drives the medical agent into and through the vessel wall to perivascular tissue. The elevated injection pressure enables efficient penetration across the blood vessel wall, enhancing targeted delivery outside the lumen while the device maintains antegrade blood flow.

[0065] FIG. 4A depicts the introduction of the system into a blood vessel near a side blood vessel branch feeding a tumor.

[0066] FIG. 4B depicts the system when in an inflated configuration, the system allows to maintain antegrade blood flowFIG. 4C depicts the system when in an inflated configuration creating a confined zone near a tumor, the system allows a targeted delivery of medical agents while maintaining antegrade blood flow.

[0067] FIG. 4D depicts the system when in an inflated configuration creating a confined zone near a tumor, the system allows a targeted delivery of medical agents to the tumor through the side branch and / or while maintaining antegrade blood flow and antegrade medical agent administration.

[0068] FIG. 4E depicts the intravascular device when disconnected from the delivery system, the intravascular device allows antegrade blood flow while isolating / starving a side branch blood vessel that feeds a tumor.

[0069] FIG. 4F illustrates the retraction of the system from the blood vessel.

[0070] FIG. 5 depicts the system for targeted delivery of medical agents for treatment of a ruptured blood vessel. When the intravascular device is inflated, it establishes a confined zone that enables localized administration of a medical agent to the region surrounding the rupture while maintaining antegrade blood flow. In certain embodiments, the medical agent is a medical glue or adhesive formulated to seal the ruptured vessel.

[0071] FIG. 6 depicts the system when used for treating intraluminal plaque, the intravascular device, when in an inflated configuration, opens the blood vessel and further creates a confined zone that allows targeted delivery of medical agents to the surrounding of the plaque, while maintaining antegrade blood flow

[0072] FIG. 7 depicts the system when used for treating a blood vessel aneurism, the intravascular device, when in an inflated configuration, creates a confined zone that enables localized / targeted delivery of medical agents to fill and / or seal the aneurism, while maintaining antegrade blood flow.

[0073] FIG. 8 is a flowchart diagram outlining steps for using the system for targeted delivery of medical agents to deliver therapeutic agents to a target body location.DETAILED DESCRIPTION OF THE INVENTION

[0074] The present disclosure pertains to a medical device, system, and method for the targeted delivery of medical agents, including therapeutic and diagnostic agents, to specific locations within the body. The disclosed technology is particularly relevant in the field of interventional medicine, where precision in the administration of medical agents plays a significant role in enhancing treatment efficacy and reducing systemic side effects. The described device and methods aim to overcome challenges associated with conventional delivery systems, such as non-targeted dispersion, retrograde flow of the medical agent, and the difficulty in maintaining antegrade blood flow during localized treatment.

[0075] The embodiments described herein are presented for illustrative purposes and are not intended to limit the scope of the described subject matter. Those skilled in the art will understand that certain widely recognized components, techniques, and processes may not be described in detail to ensure clarity of the described subject matter. Furthermore, various modifications, substitutions, and rearrangements of the disclosed features and configurations may be made without departing from the principles and scope of the described subject matter, as defined by the appended claims.

[0076] In the field of interventional medicine, the targeted delivery of therapeutic and diagnostic agents to specific regions within the body, particularly the vascular system, presents significant challenges. Conventional delivery systems, such as standard catheters, and microcatheters often result in non-specific dispersion of medical agents, leading to systemic exposure and undesirable side effects in healthy tissues. These systems lack the ability to confine therapeutic agents to a localized treatment area while maintaining antegrade blood flow, which is necessary for preserving proper physiological function. Furthermore, uncontrolled backflow or leakage into adjacent vessels can compromise treatment efficacy and increase the risk of off-target effects. Procedures such as regional chemotherapy, transarterial chemoembolization, and endovascular embolization are affected by these limitations, as they require precise delivery of high concentrations of therapeutic agents to localized areas, such as tumors, while minimizing exposure to surrounding healthy tissues. Additionally, existing devices often involve complex manipulation and prolonged procedure times, which increase patient risk and procedural complexity. There is also a need for streamlined methods and devices that preserve antegrade blood flow during focal therapy,including: a method and a device for treating vessel rupture by creating a confined zone and locally administering an adhesive or polymer to seal the rupture while maintaining forward flow through the device; a method and a device for treating plaque or thrombus by radially displacing or compressing the plaque layer and delivering an anti-proliferative or lytic agent into the confined zone with continuous antegrade flow; and a method and a device for treating an aneurysm by isolating the aneurysmal neck within the confined zone and filling or sealing the aneurysm sac with a suitable material, all while maintaining antegrade blood flow through the tubular member. There is also a need for methods and devices that preserve antegrade blood flow during focal therapy, including the need for a method for transvascular administration of medical agents that enables precise, confined delivery with minimized systemic exposure. These methods and devices address the dual objectives of targeted therapy and physiologic flow preservation, reducing systemic exposure and procedural complexity.

[0077] The present disclosure addresses these challenges by providing a novel medical device, system, and method for the targeted delivery of medical agents to specific locations within the body. The disclosed device features a hollow tubular structure and at least two inflatable annular members encircling the tubular structure. These inflatable annular members can be selectively inflated to create a confined treatment zone within a blood vessel, allowing for precise delivery of therapeutic agents while maintaining antegrade blood flow. The tubular structure may also be inflatable, or expandable further enhancing the device's adaptability to various vascular anatomies. The system includes a delivery mechanism, such as a microcatheter or catheter with multiple lumens, which facilitates the controlled infusion of therapeutic agents and inflation of the device components. By preventing retrograde flow and ensuring localized delivery, the disclosed approach significantly reduces systemic exposure and minimizes off-target effects. Additionally, the device can be deflated, and / or contracted and retracted or detached and left implanted within the blood vessel, providing flexibility in its application.

[0078] The described concept enhances existing methods by facilitating the creation of a localized treatment zone within the vascular system, ensuring that therapeutic agents remain concentrated in the intended area. This is accomplished without impeding antegrade blood flow, which is important for preserving physiological function. The device's capacity to administer agents under dynamic pressure conditions, along with its compatibility with widely used interventionaltechniques, streamlines procedural workflows and minimizes complexity. Additionally, the system's ability to adapt to diverse vascular anatomies and deliver multiple therapeutic agents simultaneously through dedicated lumens broadens its applicability and effectiveness. By addressing the challenges associated with conventional delivery systems, the described approach represents a notable improvement in the precision, safety, and efficiency of targeted medical agent delivery in interventional procedures.

[0079] The herein system essentially comprises a tubular body having a proximal end, a distal end, and an inner lumen configured to maintain antegrade blood flow;

[0080] at least two inflatable annular members disposed about an exterior surface of the tubular body and spaced apart along a longitudinal axis of the tubular body, each inflatable annular member configured to expand radially to contact a vessel wall and form a confined zone between the vessel wall, the annular members, and the tubular body; and

[0081] a delivery system comprising a shaft with a plurality of lumens, the lumens configured to independently provide inflation fluid to the inflatable annular members and deliver a medical agent to the confined zone;

[0082] wherein the system is configured such that, when the inflatable annular members are inflated, the confined zone is formed for localized delivery of the medical agent while antegrade blood flow is maintained through the inner lumen of the tubular body.

[0083] As used herein the term “inflatable annular member” refers to flexible, ring-shaped components encircling the tubular body of the medical device, which can be inflated to create a confined zone within a blood vessel for localized delivery of medical agents. In certain embodiments, the annular members are compliant and configured to expand against the blood vessel walls to create a sealed, confined region that prevents retrograde flow. The annular members may be filled with a radioopaque contrast media to render the device visible under fluoroscopy, or with saline or other physiological media, and may be designed with selected compliance, wall thickness, and burst pressure to match vessel size and desired sealing performance. In addition to forming a sealed, confined region, the inflatable annular members function as anchoring elements that engage the vessel wall to stabilize and anchor the device within the blood vessel during deployment and agent delivery.The term “tubular body” refers to a hollow, cylindrical structure that constitutes the primary part of the intravascular device, enabling blood to pass through the inner lumen and supporting the administration of medical agents. The tubular body may be configured as either inflatable or non-inflatable. In inflatable embodiments, the tubular body can include a compliant or semi-compliant wall constructed from polymers such as polyurethane, polyethylene (including LDPE / HDPE), Pebax, nylon, PET, PTFE, silicone, or multilayer polymer composites, optionally reinforced with fibers or mesh, to permit controlled radial expansion upon introduction of an inflation fluid. The inflation fluid may include a medical agent including physiological media (e.g., saline), therapeutic or diagnostic media, or a radio-opaque contrast media to enhance fluoroscopic visibility. In non-inflatable embodiments, the tubular body may comprise a fixed- diameter structure formed from metals, metal alloys, or polymeric materials, including nitinol (e.g., a sealed, covered nitinol stent or stent-graft), stainless steel, or high-strength polymers, optionally with a biocompatible coating or a polymeric cover to prevent leakage and guide flow. In certain embodiments, a covered nitinol stent with a sealed outer layer (e.g., ePTFE, polyurethane, or PET) is used to provide structural support, resist collapse, and maintain antegrade flow while cooperating with the inflatable annular members to establish the confined zone. Multilayer constructions combining a nitinol support scaffold with an inner or outer polymeric film may be used to balance flexibility, kink resistance, sealing, and radiopacity. The tubular body may incorporate liners or coatings such as PTFE, FEP, HDPE, parylene, silicone, or heparin-bonded or other hemocompatible coatings to reduce friction, enhance chemical compatibility with therapeutic and diagnostic agents, and mitigate protein adhesion.

[0084] The term “tubular body inner lumen” refers to the internal cavity within the tubular body, configured to be filled with a medical agent. The Tubular body inner lumen is further used for the delivery of medical agents.

[0085] The term “retrograde flow” refers to the backward flow of blood or medical agents in a direction opposite to the typical flow within a blood vessel, which can lead to non-target delivery and reduced treatment efficacy.The term “microcatheter” refers to a small, flexible and long catheter used in interventional procedures to navigate through blood vessels and deliver medical agents or fluids to specific target locations.

[0086] The term “delivery system” refers to a mechanism, such as a catheter or microcatheter, equipped with multiple lumens to facilitate the controlled delivery of medical agents and the inflation of device components. The shaft is attached to the intravascular device at the proximal section thereof and specifically to the tubular body of the intravascular device. In certain embodiments, the multilumen shaft is a multi- durometer polymer extrusion providing a proximal region of higher stiffness for pushability and torque response and a distal region of lower durometer for flexibility and atraumatic navigation. The shaft may incorporate internal liners or coatings on one or more lumens — such as PTFE, FEP, HDPE, parylene, silicone, or heparin-bonded or other hemocompatible coatings — to reduce friction, enhance chemical compatibility with therapeutic and diagnostic agents, and mitigate protein adhesion. The external wall may include metal or non-metal reinforcements in the form of braids, coils, or hybrid braid / coil combinations to improve kink resistance, hoop strength, and torque transmission; suitable reinforcements include stainless steel, nitinol, and cobalt-chromium wires, or high-performance fibers such as UHMWPE, PET, aramid, or liquid crystal polymer. In certain embodiments, the outer surface carries a hydrophilic coating to reduce insertion friction and improve trackability through introducers, guide catheters, and tortuous vasculature. The proximal end of the delivery system may terminate in a hub or manifold with four ports corresponding to the distinct lumens (e.g., guidewire / axial agent delivery, tubular body inflation, radial agent delivery to the confined zone, and annular member inflation), each port optionally including a luer connector, stopcock, or check valve to permit independent priming, pressure monitoring, and selective infusion. Distal radiopaque markers, such as platinumiridium or tantalum bands or powder, may be positioned or embedded at the shaft tip and / or at locations corresponding to apertures and annular members to facilitate fluoroscopic visualization and alignment. The distal tip may be soft and tapered to minimize vessel trauma and may include an atraumatic, rounded profile. The shaft dimensions, wall thicknesses, and reinforcement patterns can be tailored to achieve desired burst pressure, collapse resistance, and flow rates for the intended lumens while maintaining overall catheter profile compatible with standard introducers and guide systems.As used herein, the term “medical agent” (MA) refers to any substance, composition, formulation, or material configured for local administration to a target tissue, (such as organ, cavity, or vasculature) to produce a therapeutic, prophylactic, diagnostic, palliative, ablative, embolic, or physiological effect. The term “medical agent” (MA) encompasses therapeutic agents, diagnostic agents, and / or physiological media. Therapeutic agents refer to substances used to treat medical conditions. By way of non-limiting examples, cancer therapy encompasses anti-cancer agents including without limitation, chemotherapeutic drugs (e.g., doxorubicin, cisplatin, irinotecan, paclitaxel), targeted or immunotherapy agents (e.g., bevacizumab, pembrolizumab), ablation agents (e.g., ethanol) for ablative therapy, radiotherapeutic agents (e.g., Y-90 microspheres, 1-131 compounds), and embolic materials for chemoembolization (e.g., drug-eluting beads). Aneurysm treatment or agent encompasses embolic coils, liquid embolics and adhesives (e.g., cyanoacrylate glues, ethylene-vinyl alcohol copolymer such as Onyx-like formulations), space-filling polymers and hydrogels. Ruptured vessel treatment may include, without limitation, medical glues and adhesives (e.g., cyanoacrylate, fibrin sealant), hemostatic polymers, thrombogenic agents, and rapidly setting embolic liquids. Thrombosis and plaque treatments include, without limitation, thrombolytics and fibrinolytics (eg., tissue plasminogen activator (TP A), urokinase), antithrombotics, anti-proliferative drugs (e.g., paclitaxel, sirolimus / limus family), sclerosing agents, and plaque-modifying or anti-inflammatory agents. Diagnostic agents include, without limitation, substances used to aid in the identification or monitoring of medical conditions, such as contrast media for imaging purposes. Diagnostic agents include, without limitation, iodinated contrast media for fluoroscopy / CT, gadolinium-based agents for MRI where appropriate, and nuclear tracers for functional imaging.

[0087] Physiological media include, without limitation, saline and phosphate buffer saline (PBS) or any other biocompatible fluids.

[0088] The medical agent can be used as an inflation fluid. Inflation fluid refers to a liquid introduced to expand inflatable components of the device, including the inflatable annular members and, in certain embodiments, the tubular body. The inflation fluid can be a physiological solution (e.g., saline), a radio-opaque contrast media to enhance fluoroscopic visibility, or a compatible therapeutic or diagnostic medium when clinically appropriate.The term “inflated configuration” refers to the state of the inflatable annular members and optionally the tubular body when these are expanded by the injection of fluid, enabling the creation of a confined zone within a blood vessel.

[0089] The term “deflated configuration” refers to the state of the inflatable annular members and optionally the tubular body when the injected fluid is removed, allowing the device to be retracted from the blood vessel.

[0090] The term “Side Branch Blood Vessel (BBV)” refers to a smaller vessel branching off from a main blood vessel, which may serve as a pathway for targeted delivery of medical agents to specific areas, such as tumors.

[0091] The term “Aneurysm (A)” refers to a localized dilation or ballooning of a blood vessel, which can be treated using the disclosed medical device to seal the affected area and deliver therapeutic agents.

[0092] The term “Intraluminal plaque (P)” refers to a buildup of fatty deposits within the inner walls of blood vessels, which can be treated using the disclosed medical device to open the vessel and deliver targeted medical agents.

[0093] The term “Ruptured blood vessel (RBV)” refers to an injury in a blood vessel, often caused by trauma, which can be treated using the disclosed medical device to seal the rupture and deliver therapeutic agents to the affected area.

[0094] The term “Antegrade blood flow” refers to the forward movement of blood through a blood vessel, traveling in alignment with the heart's pumping action.

[0095] The term “Confined zone (CZ)” refers to a localized area within a blood vessel created by the inflation of the inflatable annular members, and formed between the inflatable annular members, the inner wall of the blood vessel and the outer wall of the tubular body. The confirmed zone is designed to isolate a specific region for targeted delivery of medical agents while maintaining antegrade blood flow.FIG. 1A shows a system 100 for targeted delivery of medical agents within a blood vessel BV. The system 100 includes an intravascular device 101 and a delivery system 120. The intravascular device 101 comprises a tubular body 104 and at least two inflatable annular members 103. The tubular body 104 extends between a proximal section 107, and a distal section 106. The intravascular device 101 includes one or more side apertures 102 configured for radial injection of a medical agent. The intravascular device may further include a front aperture 114 that enables forward / axial delivery of medical agents. The tubular body 104 may be inflatable, i.e., the tubular body 104 may be manufactured as a longitudinal cylinder that is constructed from a double wall with a tubular body inner lumen 111 that can be inflated by a fluid, e.g., an injection of a medical agent. This configuration allows the tubular body 104 to expand and create a tubular structure providing a defined channel for blood flow. The tubular body may comprise a double-wall construction with internal connection points or welds that join the walls at selected locations to define chambers, maintain geometry under pressure, and facilitate structural integrity and controlled radial expansion of the tubular body.

[0096] The inflatable annular members 103 encircle the tubular body 104 from the exterior surface thereof and can be inflated to conform to the vessel anatomy and form a confined treatment zone CZ within the blood vessel BV, enabling localized delivery of medical agents while maintaining antegrade blood flow. According to embodiments of the invention, the intravascular device 101 comprises two or more inflatable annular members 103. The inflatable annular members 103 are spaced apart along the exterior of the tubular body 104. When inflated, the spaced annular members 103 cooperate with the tubular body 104 to form a confined zone CZ into which a medical agent MA is introduced. In certain configurations, more than two inflatable annular members 103 may be provided to extend or segment the confined zone CZ to suit anatomical and procedural requirements. The inflatable annular members 103 are configured to expand radially until contacting the inner wall of a blood vessel, thereby establishing a seal that confines the medical agent MA within the CZ while permitting antegrade blood flow through the tubular body 104. The inflatable annular members 103 also serve for anchoring the device at a selected location within the vessel, engaging the vessel wall to stabilize positioning during deployment and delivery.

[0097] The system 100 further comprises a delivery system 120 comprising a multi-lumen shaft 121. Shaft 121 is attached to the intravascular device 101 at the distal section thereof and specifically to thetubular body 104 of the intravascular device 101. Shaft 121 includes a plurality of lumens. The shaft 121 may include one or more lumens selected from: a first lumen 110 for guidewire and / or medical agent axial delivery via forward aperture 114, a second lumen 108 for the tubular body inflation with a medical agent, a third lumen 112, for medical agent delivery, via the one or more aperture(s) 102 within tubular body 104, and a fourth lumen 113 for inflating the annular members 103. This configuration allows simultaneous operation of device functions and precise agent delivery.

[0098] FIG. IB is a cross-sectional view of a system 100 for targeted delivery of medical agents within a blood vessel BV. System 100 includes an intravascular device 101 with a tubular body 104 and at least two inflatable annular members 103. The tubular body 104 defines a tubular body inner lumen 105 for maintaining antegrade blood flow.

[0099] The inflatable annular members 103 are spaced along the exterior of the tubular body 104 and each includes an inflatable annular member inner lumen 109 for controlled inflation. When inflated, the annular members 103 form a confined treatment zone CZ within the blood vessel BV, enabling localized delivery of medical agents MA while minimizing retrograde flow.

[0100] The delivery system 120 is fluidly connected to the intravascular device 101 and includes multiple lumens for introducing medical agents MAs and inflating device components. The tubular body inner lumen 105 and the inflatable annular member inner lumen 109 are each in fluid communication with the delivery system 120 for precise operation and inflation.

[0101] In some embodiments, the tubular body 104 is constructed like an inflatable cylinder that defines an inflatable tubular body inner lumen 111 that can be inflated when a medical agent MA is introduced thereto. This configuration enables the tubular body 104 to define a tubular hollowed structure supporting the formation of a channel for blood flow and a confined treatment zone CZ. The configuration enables effective, localized delivery of therapeutic agents while maintaining physiological blood flowthrough the device 101.

[0102] FIG. 1C shows a cross-sectional view of a multi-lumen shaft 121 of the delivery system 120. The shaft 121 includes one or more lumens as follows: a first lumen 110 for guidewire or medical agent MA introduction, a second lumen 108 for inflating the tubular body 104, a third lumen 112 formedical agent delivery through an aperture 102 of the tubular body 104, and a fourth lumen 113 for inflating the annular members 103.

[0103] The arrangement of these lumens allows simultaneous navigation, inflation / deflation of device components, and targeted delivery of medical agents, supporting efficient and precise operation during interventional procedures.

[0104] FIG. 2A shows an intravascular system 100 introduced into a blood vessel BV in a deflated state. The system 100 includes an intravascular device 101 with a tubular body 104 and at least two inflatable annular members 103, and a multi-lumen shaft 121 advanced over a guidewire 130. The guidewire 130 enables navigation of the system 100 to the target site. In this configuration, the tubular body 104 and annular members 103 are collapsed to facilitate smooth advancement through the vessel and catheters used to introduce the system into the blood vessel. The multi-lumen shaft 121 provides channels for guidewire passage, inflation and deflation of device components, and medical agent delivery, supporting controlled deployment, operation, and retrieval.

[0105] FIG. 2B shows the intravascular device 101 introduced into a blood vessel BV, with the tubular body 104 deployed and inflated by injection of a medical agent MA. The tubular body 104, connected to the multi-lumen shaft 121 of the delivery system 120, defines a tubular body inner lumen 105 to maintain antegrade blood flow B during the procedure. The tubular body 104 is inflatable, expanding upon introduction of the medical agent MA via the second lumen 108 of the multi-lumen shaft 121. In some embodiments, the medical agent MA can be a radio opaque contrast media, making the tubular body visible under fluoroscopy imaging. This expansion allows the tubular body 104 to provide a defined channel for blood flow. The delivery system 120 enables controlled inflation of the tubular body 104, establishing a localized treatment zone within the blood vessel B V when the annular members 103 are in an inflated configuration.

[0106] FIG. 2C shows the system 100 for targeted delivery of medical agents within a blood vessel BV, with the tubular body 104 in an inflated configuration and the inflatable annular members 103 further inflated. The intravascular device 101 includes the tubular body 104 and at least two inflatable annular members 103 spaced along the exterior of the tubular body.The inflatable annular members 103 are inflated via the fourth lumen 113 of the delivery system 120, forming a confined zone CZ between the tubular body 104, the annular members 103, and the vessel wall. The inflatable annular members 103, when inflated further serve as anchoring elements that engage the vessel wall and stabilize the device within the blood vessel. This confined zone CZ enables localized delivery of medical agents MA while maintaining antegrade blood flow through the tubular body 104. In some embodiments, the annular members 103 can be filled with the MA being a radio opaque contrast media such that the entire intravascular device 101 can be visible under fluoroscopy imaging. The annular members 103 seal against the vessel wall to prevent retrograde flow and confine the medical agent MA within the CZ. This configuration supports precise, targeted delivery and reduces systemic exposure.

[0107] FIG. 2D shows system 100 with the tubular body 104 and inflatable annular members 103 in an inflated state within a blood vessel BV, forming a confined zone CZ. The confined zone CZ enables localized delivery of medical agents MA while maintaining antegrade blood flow through the tubular body 104. The inflatable annular members 103 seal against the vessel wall to prevent retrograde flow, ensuring the medical agent MA remains concentrated in the target area. The delivery system 120 introduces the medical agent MA via the third lumen 112, which exits through the aperture 102 into the confined zone CZ. This configuration allows precise administration of therapeutic or diagnostic agents while preserving physiological blood flow and minimizing systemic exposure.

[0108] FIG. 2E shows the system 100 for targeted delivery of medical agents MA within a blood vessel BV while maintaining antegrade blood flow B. System 100 includes an intravascular device 101 with a tubular body defining an inner lumen 105 and inflatable annular members 103. The inner lumen 105 allows continuous antegrade blood flow B during medical agent delivery. In some embodiments, the medical agent MA may be introduced via a first lumen 110 of a delivery system 120, enabling antegrade medical agent MA administration. The annular members 103 seal against the vessel wall to prevent retrograde flow to side branch blood vessel BBV and off-target dispersion therethrough, while the inner lumen 105 maintains physiological blood flow.

[0109] FIG. 2F shows a system 100 for targeted delivery of medical agents MA via a side branch blood vessel BBV while maintaining antegrade blood flow B in the main blood vessel BV. The tubularbody 104 includes one or more apertures 102 for delivering medical agents MA to a confined zone CZ and into the side branch blood vessel BBV. The annular members 103, when inflated, seal against the vessel wall to form the confined zone CZ and prevent retrograde flow, ensuring localized delivery. Delivery system 120 introduces medical agent MA through lumen 112 and aperture 114, enabling targeted delivery to the side branch while maintaining antegrade blood flow B through the inner lumen 105. This configuration enables precise administration of medical agents to both the side branch blood vessel and the main vessel in an antegrade direction, optionally in parallel, without compromising flow in the main vessel.

[0110] In one embodiment, different medical agents are delivered through apertures 102 and 114. In another embodiment, the agent delivered via aperture 102 is different from the agent delivered via aperture 114.

[0111] FIG. 2G shows the retraction of the system 100 from a blood vessel BV. The intravascular device 101, including the tubular body 104 and inflatable annular members 103, is shown in a deflated state. Deflation of the tubular body 104 and annular members 103 is achieved by withdrawing fluid via the multi-lumen shaft 121. This reduces the device profile, allowing smooth and safe removal from the blood vessel BV. The multi-lumen shaft 121 remains attached to the intravascular device 101 during retraction, enabling controlled withdrawal and minimizing vessel trauma. This configuration supports efficient device removal after targeted agent delivery.

[0112] FIG. 3 shows an intravascular device 101 within a blood vessel BV configured for high-pressure administration of a medical agent MA. The medical agent MA is delivered through an aperture 102 in the tubular body 104 into a confined zone CZ defined by the tubular body 104, the inflatable annular members 103 and the wall of a blood vessel BV. The confined zone CZ localizes the medical agent MA at the target site, minimizing systemic exposure. High-pressure injection through aperture 102 enables the medical agent MA to penetrate the blood vessel B V wall and reach adjacent tissue. For example, the injection pressure may be between 40 and 300 mmHG. This configuration enables precise, high-pressure delivery of medical agents while preserving physiological blood flow B, improving treatment efficacy and reducing off-target effects.FIG. 4A shows the introduction of system 100 into a blood vessel BV near a side branch supplying / feeding a tumor T. The system 100 includes an intravascular device 101 with at least two spaced apart inflatable annular members 103 and a multi-lumen shaft 121, advanced over a guidewire 130. The intravascular device 101 is in a deflated state, allowing smooth navigation and minimal vessel obstruction. The guidewire 130 enables precise positioning of the system 100 at the target site near the side branch that feeds a tumor T.

[0113] FIG. 4B shows intravascular device 101 in an inflated configuration within a blood vessel BV. The inflatable annular members 103, when expanded, make contact with the vessel wall to create a confined zone CZ, allowing localized delivery of medical agents to the tumor T while inhibiting retrograde flow and enabling antegrade blood B flow.

[0114] FIG. 4C illustrates system 100 when a medical agent MA is delivered through an aperture 102 in the tubular body 104 into the confined zone CZ, delivering the medical agent to a blood vessel feeding the tumor T, while enabling antegrade blood B flow and minimizing systemic dispersion.

[0115] FIG. 4D shows system 100 with medical agent MA delivery through aperture 102 and further through shaft distal aperture 114 for delivering medical agents MA to the side branch blood vessel BBV to treat the tumor and further provide antegrade MA delivery. Optionally, for tumor therapy and distal visualization, a therapeutic agent is delivered through aperture 102 into the confined zone to treat the tumor while contrast media is concurrently delivered through aperture 114 to visualize distal vessels under fluoroscopy, and vice versa. The tubular body inner lumen 105 maintains antegrade blood flow B during MA agent delivery. The annular members 103 seal against the vessel wall, ensuring agents remain concentrated in the confined zone CZ and side branch blood vessel BBV. System 100 supports delivery of various medical agents MA, such as chemotherapy, embolic agents, contrast media, an alcohol (ethanol), or radioactive agents, under controlled conditions. This configuration enables effective, localized treatment of tumors T with reduced systemic exposure.

[0116] By way of example, via aperture 114 the system can deliver a first medical agent while concurrently delivering a second medical agent via aperture 102. In one embodiment, contrast media is injected through aperture 114 to visualize distal vessels under fluoroscopy while atherapeutic agent is delivered through aperture 102 into the confined zone CZ. In another embodiment, contrast media or a diagnostic agent may be infused through aperture 102 while a therapeutic agent is advanced antegrade through aperture 114 toward distal targets. In another embodiment, distal vessels are treated through aperture 114 with a medical agent that differs from the agent delivered via aperture 102, such as an embolic agent of a different particle size, a distinct chemotherapy formulation, or a radiotherapeutic agent, thereby enabling tailored therapy at separate downstream locations. The agent delivered into the confined zone via aperture 102 may differ from, or be the same as, the agent advanced antegrade via aperture 114.

[0117] FIG. 4E shows an intravascular device 101 left implanted in a blood vessel BV after disconnection from the delivery system. The device 101 maintains antegrade blood flow B in the main vessel while isolating a side branch blood vessel that supplies a tumor T. The inflatable annular members 103 remain inflated to seal against the vessel wall, preventing blood flow into the side branch and thereby starving the tumor T. The multi-lumen shaft 121 is detached, with the distal section 121B remaining with the device 101. This configuration enables the device 101 to provide sustained embolization of the side branch while preserving blood flow B in the main vessel.

[0118] FIG. 4F shows the retraction of the system 100 from a blood vessel B V after targeted delivery of medical agents. The tubular body 104 and inflatable annular members 103 are deflated by withdrawing inflation fluid through the delivery system, minimizing their profile for safe removal. The deflated configuration reduces vessel trauma during withdrawal. The delivery system remains attached to the tubular body 104 and inflatable annular members 103, allowing controlled retraction. The system 100 can be reused or disposed of as needed. Efficient deflation and retraction of the system 100 supports safe device removal, reduces vascular complications, and maintains vessel integrity.

[0119] FIG. 5 shows system 100 for targeted delivery of medical agents MA to a ruptured blood vessel RV. When inflated, the annular members 103 and tubular body 104 form a confined zone CZ within the blood vessel BV, enabling localized delivery of medical agents MA to the area around the rupture while maintaining antegrade blood flow B through the tubular body 104. The medical agent MA is delivered into the confined zone CZ via an aperture 102 in the tubular body 104. The annular members 103 seal against the vessel wall, preventing retrograde flow and ensuring themedical agent remains concentrated at the rupture site. The tubular body 104 maintains a lumen for continuous blood flow during treatment. This configuration allows precise administration of therapeutic agents, such as adhesives or polymers, to seal the ruptured vessel RV while preserving physiological blood flow and minimizing systemic exposure.

[0120] After retraction, system 100 may be reused or disposed of as appropriate. Efficient deflation and withdrawal support safe device removal, reduce vascular complications, and preserve vessel integrity. Advantageously, only the treated zone, specifically the ruptured vessel wall at the targeted location remains sealed due to the therapeutic action of the medical agent, while the remainder of the vessel is remained open following treatment.

[0121] FIG. 6 shows a system 100 for targeted delivery of medical agents MA to treat intraluminal plaque P or thrombus in a blood vessel BV. The inflatable annular members 103, when inflated, press plaque P / thrombus against the vessel wall, creating a pressurizing confined zone CZ. This opens the vessel and maintains a flow channel through the tubular body 104. Medical agents MA may be delivered into the confined zone CZ via a delivery system 120 with a multi-lumen shaft 121. This configuration concentrates the therapeutic agent at plaque P / thrombus, reduces systemic exposure, and preserves blood flow B during treatment. After retraction, system 100 may be reused or disposed of as appropriate. Efficient deflation and withdrawal support safe device removal, reduce vascular complications, and preserve vessel integrity. Because antegrade blood flow is maintained through the tubular body during therapy, the system permits prolonged or staged administrations while preserving downstream blood flow and reducing ischemic risk.

[0122] FIG. 7 shows a system 100 for targeted delivery of medical agents MA to an aneurysm A in a blood vessel V. When inflated, the tubular body 104 and annular members 103 form a confined zone CZ that isolates the aneurysm A. The medical agent MA is delivered through an aperture 102 in the tubular body 104 into the confined zone CZ, enabling precise treatment of the aneurysm A while minimizing systemic exposure. After retraction, system 100 may be reused or disposed of as appropriate. Efficient deflation and withdrawal support safe device removal, reduce vascular complications, and preserve vessel integrity. Advantageously, only the treated zone, specifically the aneurysm A, remains sealed due to the localized therapeutic action of the medical agent, while the remainder of the vessel is remained open following treatment.FIG. 8 shows a flowchart diagram outlining a method 1400 for targeted delivery of medical agents to a target body location using the system 100. The method is applicable to a variety of medical conditions, including but not limited to tumors, aneurysms, ruptured blood vessels, intraluminal plaque, thrombus, and other localized vascular or tissue pathologies. The system is further applicable for use in treatment of medical conditions that can be treated with vascular intervention therapies. Exemplary applications include percutaneous chemical ablations, such as ethanol injections for thyroid gland ablation; renal sympathetic denervation via percutaneous ethanol injection; venous ablation for superficial venous insufficiency; bronchial artery and nerve ablation; and targeted delivery to dialysis grafts or arteriovenous (AV) fistulas to open or maintain patency. In these procedures, the confined zone enables localized administration of ablative or therapeutic agents while maintaining antegrade blood flow through the tubular body, thereby enhancing precision, reducing systemic exposure, and supporting prolonged or staged delivery as clinically indicated.

[0123] The method begins with step 1402, which involves providing a system 100 for targeted delivery of a medical agent. The system 100 includes an intravascular device 101 comprising a tubular body 104 with an inner lumen 105 and at least two inflatable annular members 103. The tubular body 104 is configured to maintain antegrade blood flow, while the inflatable annular members 103 are designed to form a confined treatment zone within a blood vessel. The confined zone is created between the tubular body 104, the annular members 103 and the inner wall of the blood vessel.

[0124] In step 1404, the system 100 is introduced into the body, typically via a percutaneous vascular access technique. The introduction is performed using a delivery system 120, which may be advanced over a guidewire 130 to facilitate navigation through the vascular system to the desired target body location. The target body location may refer to a specific site within a blood vessel, such as a segment adjacent to a tumor, an aneurysm, a ruptured vessel, a region containing intraluminal plaque, or a thrombus.

[0125] Step 1406 involves positioning the intravascular device 101 of system 100 within a blood vessel in close proximity to the target body location. Accurate positioning may be achieved under imaging guidance, such as fluoroscopy, to ensure that the device is optimally located for subsequent therapy.In step 1408, the intravascular device 101 is deployed and the tubular body 104 is expanded. Expansion is typically achieved by injecting an inflation fluid, which can be a saline, or a medical agent such as a diagnostic media (e.g., a contrast media), or a therapeutic agent, into the inner lumen 111 of the tubular body 104 via the delivery system 120. Since tubular body 104 is hollow, the expansion creates a defined channel for blood flow through the inner lumen 105, thereby maintaining antegrade blood flow during the procedure.

[0126] Step 1410 consists of inflating the inflatable annular members 103 against the wall of the blood vessel. Inflation is performed by introducing an inflation fluid, such as saline or contrast media, through a dedicated lumen of the delivery system 120 into the annular members 103. The inflated annular members 103 establish a confined treatment zone (CZ) between the tubular body 104, the annular members 103, and the vessel wall, effectively isolating the target body location for localized therapy.

[0127] In step 1412, a medical agent is radially injected into the confined zone CZ for targeted delivery to the body location. The medical agent may include, but is not limited to, chemotherapy drugs, radioactive agents, embolic agents, adhesives, contrast media, ethanol, or saline. The system 100 allows for the delivery of one or more medical agents, either simultaneously or sequentially, to the target site. For example, chemotherapy may be delivered to a tumor, an adhesive may be delivered to seal a ruptured vessel, or a polymer may be delivered to treat an aneurysm. Optionally, an aspiration step is further applicable, the aspiration step is conducted in order to withdraw fluid from the confined zone, thereby permitting removal of residual medical agents, contrast media, blood, or admixtures from the confined zone under controlled negative pressure while maintaining antegrade blood flow through the inner lumen of the tubular body. The aspiration may be conducted by aspirating any fluids from aperture 102.

[0128] Step 1414 provides for two alternative actions following therapy. The intravascular device 101 may be disconnected from the delivery system 120 and left implanted in the blood vessel, for example to provide sustained embolization or vessel support, or vessel side branch sealing. Alternatively, the device may be contracted by deflating the tubular body 104 and annular members 103 via withdrawal of the inflation fluid through the delivery system 120. Once deflated,the device is retracted from the body location or removed entirely from the body, minimizing trauma to the vessel and surrounding tissues.

[0129] This method enables precise, localized treatment of a wide range of vascular and tissue conditions while maintaining physiological blood flow and minimizing systemic exposure to medical agents. The system 100 is compatible with standard interventional techniques and can be adapted to various vascular anatomies and clinical scenarios.

[0130] GENERAL DEFINITIONS

[0131] As used herein the terms ‘a’ and ‘an’ may mean ‘one’ or ‘more than one.

[0132] As used herein the terms ‘comprising’, ‘including’, ‘containing’, ‘featuring’, ‘having’ and any forms of the terms thereof are inclusive and open ended and do not exclude additional elements or method steps, which are not recited.

[0133] The term 'consisting essentially of as used herein means that the scope is limited to the specified elements and those that do not materially affect the basic and novel characteristic(s) of the claimed device and materials.

[0134] Each of the phrases 'consisting of and 'consists of, as used herein, means 'including and limited to'.

[0135] The term 'method', as used herein, refers to steps, procedures, manners, means, or / and techniques, for accomplishing a given task including, but not limited to, those steps, procedures, manners, means, or / and techniques, either known to, or readily developed from known steps, procedures, manners, means, or / and techniques, by practitioners in the relevant field(s) of the disclosed invention.

[0136] Throughout this disclosure, a numerical value of a parameter, feature, characteristic, object, or dimension, may be stated or described in terms of a numerical range format. Such a numerical range format, as used herein, illustrates implementation of some exemplary embodiments of theinvention, and does not inflexibly limit the scope of the exemplary embodiments of the invention. Accordingly, a stated or described numerical range also refers to, and encompasses, all possible sub-ranges and individual numerical values (where a numerical value may be expressed as a whole, integral, or fractional number) within that stated or described numerical range. For example, a stated or described numerical range 'from 1 to 6' also refers to, and encompasses, all possible subranges, such as 'from 1 to 3', 'from 1 to 4', 'from 1 to 5', 'from 2 to 4', 'from 2 to 6', 'from 3 to 6', etc., and individual numerical values, such as '1', '1.3', '2', '2.8', '3', '3.5', '4', '4.6', '5', '5.2', and '6', within the stated or described numerical range of 'from 1 to 6'. This applies regardless of the numerical breadth, extent, or size, of the stated or described numerical range.

[0137] All ranges disclosed herein include the endpoints. The use of the term “or” shall be construed to mean “and / or” unless the specific context indicates otherwise.

[0138] The term 'about', in some embodiments, refers to ±30 % of the stated numerical value. In further embodiments, the term refers to ±20 % of the stated numerical value. In yet further embodiments, the term refers to ±10 % of the stated numerical value.

Claims

CLAIMS1. An intravascular system for targeted delivery of a medical agent, comprising:a tubular body having a proximal end, a distal end, and an inner lumen configured to maintain antegrade blood flow;at least two inflatable annular members disposed about an exterior surface of the tubular body and spaced apart along a longitudinal axis of the tubular body, each inflatable annular member configured to expand radially to contact a vessel wall and form a confined zone between the vessel wall, the annular members, and the tubular body; anda delivery system comprising a shaft with a plurality of lumens, the lumens configured to independently provide inflation fluid to the inflatable annular members and deliver a medical agent to the confined zone;wherein the system is configured such that, when the inflatable annular members are inflated, the confined zone is formed for localized delivery of the medical agent while antegrade blood flow is maintained through the inner lumen of the tubular body.

2. The system of claim 1 , wherein the tubular body comprises at least one radial aperture formed through a side wall thereof, the aperture being configured to deliver the medical agent into the confined zone.

3. The system of claim 1, wherein the delivery system shaft comprises a plurality of lumens selected from: a lumen for guidewire introduction or axial medical agent delivery; a lumen for inflating the tubular body; a lumen for delivering the medical agent through the tubular body aperture(s); and a lumen for inflating the annular members.

4. The system of claim 3, wherein the delivery system shaft comprises four lumens, the lumens comprising: a first lumen for guidewire introduction or axial medical agent delivery; a second lumen for inflating the tubular body; a third lumen for delivering the medical agent through the tubular body apertures; and a fourth lumen for inflating the annular members.

5. The system of claim 1, wherein the tubular body is inflatable upon introduction of fluid into the inner lumen of the tubular body.

6. The system of claim 5, wherein the tubular body is configured to be filled with a radio-opaque contrast media.

7. The system of claim 1 , wherein at least one of the inflatable annular members is configured to be filled with a radio-opaque contrast media.

8. The system of claim 1, wherein the inflatable annular members are deflatable upon removal of the inflation fluid to permit retraction of the intravascular system from the blood vessel.

9. The system of claim 1 , wherein the tubular body is deflatable upon removal of the inflation fluid to permit retraction of the intravascular system from the blood vessel.

10. The system of claim 1, further comprising a front aperture at the distal end of the tubular body, the front aperture being in fluid communication with one of the lumens of the delivery system for axial delivery of the medical agent.

11. The system of claim 1 , wherein the medical agent is selected from a physiological agent, a therapeutic agent and a diagnostic agent.

12. The system of claim 11, wherein the medical agent comprises at least one of a chemotherapeutic agent, an embolic agent, an adhesive, a contrast media, ethanol, or a radioactive agent.

13. The system of claim 1, wherein the delivery system is detachable from the tubular body so that the tubular body and the inflatable annular members remain implanted in the vessel while maintaining antegrade blood flow.

14. The system of any of claims 1-13, wherein each of the lumens of the delivery system is fluidly isolated from the other lumens so as to permit simultaneous, independent pressure control for inflation of the tubular body, inflation of the inflatable annular members, and delivery of the medical agent.

15. The system of any of claims 1-14, further comprising at least one radiopaque marker disposed on the tubular body at a position adjacent the at least one radial aperture to facilitate fluoroscopic alignment of the confined zone with a target treatment site.

16. An intravascular device for targeted delivery of a medical agent, comprising:a tubular body having a proximal end, a distal end, and an inner lumen configured to maintain antegrade blood flow; andat least two inflatable annular members disposed about an exterior surface of the tubular body and spaced apart along a longitudinal axis of the tubular body, each inflatable annular member configured to expand radially to contact a vessel wall and form a confined zone between the vessel wall, the annular members, and the tubular body;wherein the device is configured such that, when the inflatable annular members are inflated, the confined zone is formed for localized delivery of the medical agent while antegrade blood flow is maintained through the inner lumen of the tubular body.

17. The intravascular device of claim 16, wherein the tubular body comprises at least one radial aperture formed through a side wall thereof, the aperture being configured to deliver the medical agent into the confined zone.

18. The intravascular device of claim 16, wherein the tubular body is inflatable upon introduction of fluid into the inner lumen of the tubular body.

19. The intravascular device of claim 16, wherein at least one of the inflatable annular members is configured to be filled with a radio-opaque contrast media.

20. The intravascular device of claim 16, further comprising a front aperture at the distal end of the tubular body, the front aperture being configured for axial delivery of the medical agent.

21. The intravascular device of claim 16, wherein the tubular body and the inflatable annular members are deflatable upon removal of the inflation fluid to permit retraction of the intravascular device from the blood vessel.

22. The intravascular device of claim 16, wherein the medical agent comprises at least one of a chemotherapeutic agent, an embolic agent, an adhesive, a contrast media, ethanol, or a radioactive agent.

23. The intravascular device of any of claims 16-22, further comprising at least one radiopaque marker disposed on the tubular body at a position adjacent the at least one radial aperture to facilitate fluoroscopic alignment of the confined zone with a target treatment site.

24. A method of localized intravascular therapy, comprising:advancing the intravascular system of claim 1 over a guidewire into a target blood vessel; deploying the tubular body in the blood vessel to allow passage of blood through the inner diameter of the tubular body;inflating the inflatable annular members so that they circumferentially seal against the vessel wall and define the confined zone between the annular members, the vessel wall, and the tubular body;delivering the medical agent from one of the lumens of the delivery system into the confined zone while antegrade blood flow continues through the inner lumen of the tubular body; and thereafter either:deflating the inflatable annular members and optionally the tubular body and withdrawing the intravascular system from the vessel; ordetaching the delivery system and leaving the tubular body and inflatable annular members implanted while maintaining antegrade blood flow through the tubular body.

25. The method of claim 24, wherein the medical agent is delivered into the confined zone at a pressure between 40 and 300 mmHg to promote penetration of the medical agent through the vessel wall into perivascular tissue.

26. The method of claim 24, further comprising simultaneously delivering a first medical agent through at least one radial aperture of the tubular body into the confined zone and delivering a second, different medical agent through the front aperture at the distal end of the tubular body to an antegrade location downstream of the confined zone.

27. The method of claim 24, wherein the target blood vessel is adjacent to a tumor and the medical agent comprises an anticancer agent, and the method further comprises delivering the chemotherapeutic agent into the confined zone to treat the tumor while maintaining antegrade blood flow through the tubular body.

28. The method of claim 24, wherein the target blood vessel comprises an aneurism, and the method further comprises delivering an embolic agent into the confined zone to fill and / or seal the aneurism while maintaining antegrade blood flow through the tubular body.

29. The method of claim 24, wherein the target blood vessel comprises a ruptured blood vessel, and the method further comprises delivering a ruptured vessel treatment into the confined zone to seal the rupture while maintaining antegrade blood flow through the tubular body.

31. The method of claim 24, wherein the target blood vessel comprises intraluminal plaque or thrombus, and wherein the inflatable annular members are positioned such that the plaque or thrombus lies between said inflatable annular members; the method further comprises inflating the tubular body to press the plaque or thrombus against the vessel wall and delivering a medical agent into the confined zone to treat the plaque or thrombus while maintaining antegrade blood flow through the tubular body.

32. A method of treating cancer, comprising: advancing an intravascular system comprising a tubular body having an inner lumen and at least two inflatable annular members into a target blood vessel adjacent to a tumor; inflating the inflatable annular members so that they circumferentially seal against the vessel wall and define a confined zone between the annular members, the vessel wall, and the tubular body; delivering an anticancer medical agent into the confined zone while antegrade blood flow is maintained through the inner lumen of the tubular body; and optionally delivering a medical agent in an antegrade direction through a front aperture at the distal end of the tubular body to a downstream location.

33. A method of treating an aneurysm, comprising: advancing an intravascular system comprising a tubular body having an inner lumen and at least two inflatable annular members into a target blood vessel; positioning the tubular body and inflatable annular members such that, uponinflation, they circumferentially seal against the vessel wall and define a confined zone that isolates an aneurysmal neck; delivering a medical agent comprising an embolic agent into the confined zone to fill and / or seal the aneurysm while antegrade blood flow is maintained through the inner lumen of the tubular body; and thereafter optionally deflating the inflatable annular members and, when applicable, the tubular body, and retracting the intravascular system from the vessel.

34. A method of treating a ruptured blood vessel, comprising: advancing an intravascular system comprising a tubular body having an inner lumen and at least two inflatable annular members into a target blood vessel; inflating the inflatable annular members to circumferentially seal against the vessel wall and define a confined zone spanning the rupture; delivering a medical agent comprising a ruptured vessel treatment into the confined zone to seal the rupture while maintaining antegrade blood flow through the inner lumen of the tubular body; and subsequently deflating the inflatable annular members and, optionally, the tubular body, and retracting the intravascular system from the vessel.

35. A method of treating intraluminal plaque or thrombus, comprising: advancing an intravascular system comprising a tubular body having an inner lumen and at least two inflatable annular members into a target blood vessel; positioning the inflatable annular members such that the plaque or thrombus lies between said annular members; inflating the tubular body to press the plaque or thrombus against the vessel wall; delivering a medical agent into the confined zone to treat the plaque or thrombus while antegrade blood flow is maintained through the inner lumen of the tubular body; and thereafter optionally deflating the inflatable annular members and, when applicable, the tubular body, and retracting the intravascular system from the vessel.

36. An intravascular device for targeted delivery of a medical agent, comprising: a tubular body sized for placement within a blood vessel and defining an inner lumen configured to preserve antegrade blood flow; and at least two inflatable annular members disposed about an exterior surface of the tubular body and spaced apart along a longitudinal axis thereof, the annular members being configured, upon inflation, to expand radially to contact the vessel wall and define a confined zone between the annular members, the vessel wall, and the tubular body; wherein, when the tubular body is positioned within the blood vessel and the annular members are inflated, antegradeblood flow through the inner lumen of the tubular body is maintained at no less than one-quarter (>25%) of the baseline blood flow of the blood vessel.

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