Interventional catheter system for vascular calcification treatment

Abstract

The invention relates to an interventional catheter system for vascular calcification treatment, which comprises an imaging positioning module, an interventional catheter, a local sealing unit, a therapeutic agent release unit and a control unit, and is characterized in that the system identifies and positions a vascular calcification focus in real time through the imaging module, and navigates the interventional catheter to the focus under the guidance of an image; a treatment cavity for temporarily blocking blood flow is formed through expansion of the local sealing unit, a treatment agent is accurately released in the cavity through the treatment agent release unit, and the control unit coordinates navigation, sealing and release operation of the whole process. A local static and visual precise treatment environment is constructed for calcification lesions in a continuous blood flow environment for the first time, and high-concentration enrichment and retention of a therapeutic agent at the lesions are achieved, so that the decalcification curative effect is remarkably improved, meanwhile, the drug action range is strictly limited, systemic exposure, hypocalcemia and other side effects are effectively avoided, and the treatment effect is good. And the treatment safety is greatly improved.

Description

Technical Field

[0001] This invention relates to the field of biomedical engineering, and more specifically to an interventional catheter system for the treatment of vascular calcification. Background Technology

[0002] Vascular calcification is a common and challenging pathological manifestation in atherosclerotic cardiovascular disease. It is characterized by the abnormal deposition of calcium salts in the vessel walls, leading to loss of vascular elasticity and luminal narrowing, thereby significantly increasing the risk of major cardiovascular events such as myocardial infarction and stroke. Effective intervention for vascular calcification has always been a major challenge in the field of interventional cardiovascular therapy.

[0003] Current mainstream treatment strategies, whether drug therapy or interventional procedures, are constrained by a fundamental contradiction: the irreconcilable conflict between the continuous blood flow within the blood vessels and the static, high-concentration drug environment required for safe, precise, and efficient chemotherapy at the local lesion site on the vessel wall. Systemic drug therapy, such as intravenous infusion of ethylenediaminetetraacetic acid (EDTA), while providing chemical chelation, is rapidly diluted in systemic circulation, making it difficult to achieve effective concentrations at the target lesion, and simultaneously causing systemic toxic side effects such as hypocalcemia. Local mechanical interventions, represented by balloon angioplasty and intravascular shock wave lithotripsy (IVL), can physically destroy calcified plaques, but cannot remove the calcified material itself, and may even cause embolism or vascular damage due to fragments, and lacks the chemical reversal effect on the calcification process. In recent years, local drug delivery technologies, such as drug-coated balloons, have attempted to limit treatment to the lesion site. However, the release process is passive and uncontrollable, and the drug is quickly lost under the flushing of blood flow, making it impossible to achieve effective retention on the surface of a specific plaque for a sufficient period of time. More importantly, the whole process lacks real-time feedback and precise control, making the treatment like a "blind operation" and the effect difficult to guarantee.

[0004] Therefore, the predicament of existing technologies can be summarized as follows: they either sacrifice systemic safety, lack chemotherapy efficacy, or cannot overcome the dilution effect of blood flow, or a combination of these. At their core, none of them provide a systemic solution to temporarily construct a precisely located, physically isolated, drug-concentrated, and process-visible therapeutic microenvironment for static vascular calcification lesions within a dynamic blood flow environment. Clinical practice urgently requires an integrated interventional system that can integrate real-time imaging guidance, local blood flow isolation, targeted and controllable release, and closed-loop process monitoring. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides an interventional catheter system for the treatment of vascular calcification, aiming to solve one or more of the problems in the prior art.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: an interventional catheter system for the treatment of vascular calcification, comprising: an imaging positioning module for acquiring and displaying images of a target vascular region in real time to identify and locate calcified lesions; an interventional catheter, the distal end of which is configured to be navigable to the calcified lesion; a local closure unit disposed at the distal end of the interventional catheter and configured to expand within the vascular segment where the calcified lesion is located to form a treatment chamber that temporarily blocks blood flow; a therapeutic agent release unit disposed on the interventional catheter and located within the treatment chamber defined by the local closure unit, configured to release a therapeutic agent into the treatment chamber; and a control unit communicatively connected to the imaging positioning module, the local closure unit, and the therapeutic agent release unit for coordinating the navigation of the interventional catheter, the formation and release of the treatment chamber, and the release of the therapeutic agent.

[0007] Furthermore, the imaging positioning module includes a first ultrasound probe disposed outside the body for performing ultrasound imaging.

[0008] Furthermore, the partially enclosed unit includes at least one inflatable balloon.

[0009] Furthermore, the local closure unit includes a first balloon and a second balloon spaced apart along the axial direction of the interventional catheter, and the therapeutic agent release unit is located between the first balloon and the second balloon.

[0010] Furthermore, the therapeutic agent release unit includes an ultrasound-responsive acoustic carrier, which contains a therapeutic agent and can control the release of the therapeutic agent under the action of ultrasound energy.

[0011] Furthermore, the ultrasonically responsive acoustic carrier is a microbubble, nanocapsule, liposome, or polymer micelle.

[0012] Furthermore, the invention is characterized by including a feedback monitoring module, which includes a sensing unit disposed at the distal end of the interventional catheter for monitoring at least one physiological or chemical parameter within the treatment chamber; the control unit is also used to adjust the release parameters of the therapeutic agent release unit based on the monitoring data from the sensing unit.

[0013] Furthermore, the sensing unit is at least one of a calcium ion concentration sensor, a temperature sensor, or a blood flow velocity sensor.

[0014] Furthermore, the therapeutic agent is a calcium chelating agent.

[0015] Furthermore, the calcium chelating agent is ethylenediaminetetraacetic acid.

[0016] The interventional catheter system for the treatment of vascular calcification described in this invention has the following advantages: through the systematic integration of imaging positioning, local closure, precise release and centralized control, it creates a temporary, static, and visualized precise treatment environment for calcified lesions within a continuously flowing blood vessel for the first time. This achieves high-concentration local enrichment and retention of therapeutic agents at the lesion site, greatly improving decalcification efficiency. At the same time, it strictly limits the range of drug action, effectively avoiding systemic exposure to chelating agents such as EDTA and the resulting side effects such as hypocalcemia, thus significantly improving treatment safety. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the internal structure of the catheter according to an embodiment of the present invention; Figure 2 This is an operation flowchart of an embodiment of the present invention; Figure 3 This is a schematic diagram of the release of the acoustic carrier according to an embodiment of the present invention; Figure 4 This is a block diagram illustrating the closed-loop control principle of an embodiment of the present invention.

[0018] Explanation of reference numerals in the attached diagram: 1. Interventional catheter; 11. Guidance lumen; 12. Medication lumen; 13. Signal lumen; 2. Distal balloon; 3. Proximal balloon; 4. Second ultrasound probe; 5. Acoustic carrier; 6. Acoustic carrier release tip Detailed Implementation Typical embodiments embodying the features and advantages of the present invention will be described in detail in the following description. It should be understood that the present invention can have various variations in different embodiments without departing from the scope of the present invention, and the descriptions and illustrations herein are for illustrative purposes only and not intended to limit the present invention.

[0019] In the description of this application, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," and "counterclockwise," etc., indicating orientation or positional relationships based on the orientation or positional relationships shown in the accompanying drawings, are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of the stated features. In the description of this application, "a plurality of" means two or more, unless otherwise explicitly specified.

[0020] The technical solution of the present invention will now be described in detail and completely with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are for illustrative purposes only and are not intended to limit the scope of the invention.

[0021] like Figures 1 to 4 As shown, this invention provides an interventional catheter system 1 for the treatment of vascular calcification. This system aims to fundamentally solve the problem that existing treatment methods cannot safely, accurately, and efficiently chemically intervene in calcified lesions of the vascular wall within continuously flowing blood. Its core concept lies in precisely delivering a miniaturized device integrating local isolation and controlled release functions to the lesion site through real-time image guidance. This actively creates a temporary, static therapeutic microenvironment within the target vascular segment, thereby achieving the targeted action of high-concentration therapeutic agents on the lesion site and minimizing systemic side effects.

[0022] The core components of this system include an imaging and positioning module, interventional catheter 1, a local closure unit, a therapeutic agent release unit, and a control unit. These components work together to complete the entire process from identification and positioning to precise treatment.

[0023] The imaging and positioning module provides visual navigation for the entire procedure. It includes a first externally placed ultrasound probe (not shown) for real-time ultrasound imaging of the target vascular area. The first ultrasound probe emits and receives ultrasound waves, thereby generating images of the blood vessel in real time. Calcified plaques typically appear as bright, hyperechoic areas with acoustic shadowing on ultrasound images, making them easily identifiable. The processed image signals are displayed visually on the control unit's screen, allowing the operator to accurately determine the location, length, and extent of the calcified plaques, and providing real-time path reference for the subsequent navigation of interventional catheter 1.

[0024] The interventional catheter 1, serving as the acoustic carrier 5 for system execution, is a flexible, multi-lumen tubular structure. Its body is typically designed with at least three independent lumens: a guide lumen 11 for passing through a guidewire, allowing the catheter 1 to be smoothly advanced to the target location using mature percutaneous interventional techniques; a drug delivery lumen 12, with its proximal end connected to an external micro-infusion device and its distal end leading to a therapeutic agent delivery unit located on the catheter 1 for delivering drug-loaded formulations; and a signal lumen 13 for accommodating potentially needed sensor cables, balloon inflation tubing, and the lead wires of the acoustic carrier delivery tip 6 integrated on the catheter 1. The material of the interventional catheter 1 must possess good biocompatibility, appropriate flexibility, and delivery force; for example, it can be made of medical polymer materials such as polyurethane.

[0025] The local closure unit is one of the key features of this invention, its function being to artificially construct a static treatment space within dynamic blood flow. In a preferred design, this unit consists of two inflatable balloons arranged axially along the interventional catheter 1 at a certain distance (e.g., 10-20 mm), referred to as the distal balloon 2 and the proximal balloon 3, respectively. These two balloons are fitted onto the surface of the interventional catheter 1 and connected to an external balloon pressure pump through independent microcavities within the interventional catheter 1. When the tip of the interventional catheter 1 accurately reaches and crosses the calcified lesion under image guidance, an appropriate amount of saline or contrast agent is injected into the two balloons via the pressure pump, causing the balloons to inflate until they adhere tightly to the inner wall of the blood vessel. In this way, a closed "treatment chamber" is formed between the two balloons, temporarily isolated from the preceding and following blood flow, completely surrounding the target calcified plaque. The balloon material is preferably non-compliant polyethylene terephthalate (PET) to ensure stable shape after inflation, uniform pressure on the blood vessel wall, and rapid retraction to restore blood flow after deflating.

[0026] The therapeutic agent delivery unit is located between the two balloons, and its delivery port must be located within the treatment chamber enclosed by the two balloons. This unit is responsible for delivering the therapeutic agent to the lesion surface in a controlled manner. An innovative approach is to use an ultrasound-responsive drug delivery carrier 5. For example, the active ingredient for treating vascular calcification—ethylenediaminetetraacetic acid (EDTA) or a salt solution thereof—is encapsulated within an ultrasound-sensitive delivery carrier 5. This delivery carrier 5 can be a microbubble with a phospholipid shell encapsulating a gas core, or it can be a polymer nanocapsule or liposome. These drug-loaded particles are pre-suspended in a physiologically compatible solution and infused into the treatment chamber through the drug delivery chamber 12.

[0027] To achieve precise triggering and release of the therapeutic agent, the system is equipped with two ultrasonic energy sources that can work independently or in combination: 1. Acoustic carrier release tip (catheter integration): Integrated into the distal end of interventional catheter 1 and located in the treatment chamber area, it can directly emit ultrasound waves of a specific frequency to the drug-loaded acoustic carrier 5.

[0028] 2. Second ultrasound probe 4 (external): During treatment, it is placed outside the patient's body surface and aimed at the target treatment area to emit penetrating ultrasound energy into the treatment chamber from the outside.

[0029] When drug release is required, the control unit triggers one or both of the aforementioned ultrasonic energy sources to emit 3MHz ultrasonic energy that directly acts on the drug-loaded acoustic carrier 5 within the treatment chamber area. This triggers acoustic cavitation rupture of the drug-loaded microbubbles or structural rupture of the nano-acoustic carrier 5, resulting in the instantaneous or on-demand release of EDTA at the lesion site. By adjusting the ultrasonic emission parameters (such as power, pulse interval, and duration), the release rate and total amount of drug can be precisely controlled, achieving a precise treatment mode of "targeted delivery, as much as needed."

[0030] The control unit serves as the command center coordinating the operation of all components, typically including an image display terminal, parameter input devices, and a central processing system. It receives and processes the real-time video stream from the first ultrasound probe, displaying it on the screen for the physician's reference. Simultaneously, it integrates control interfaces for the balloon pressure pump, drug infusion pump, the acoustic carrier release tip 6 integrated into catheter 1, and the external second ultrasound probe 4. The physician can set the balloon pressure, drug infusion rate, and ultrasound treatment parameters through the control unit. In a more preferred embodiment, the system can also incorporate a feedback monitoring module to achieve closed-loop control. This module acquires real-time environmental parameters within the treatment chamber by integrating micro-sensors (such as electrochemical sensors for monitoring changes in calcium ion concentration and thermistors for monitoring local temperature) at the tip of the interventional catheter 1. This data is fed back to the control unit, and after analysis by a built-in algorithm, treatment parameters can be automatically adjusted. For example, when the decrease in calcium ion concentration is detected to be slowing down, the system can determine that the decalcification reaction is nearing completion and automatically stop ultrasound emission and drug infusion, thereby achieving the therapeutic effect while avoiding overtreatment and resource waste.

[0031] The system's workflow can be summarized in the following sequential steps: First, the target blood vessel is scanned using an external ultrasound probe to pinpoint the precise location of the calcified lesion. Second, under real-time image guidance, the interventional catheter 1 is advanced along the guidewire to the lesion, aligning the treatment segment with the plaque. Next, two balloons, one before and one after the catheter tip, are simultaneously or sequentially inflated to create an isolated treatment chamber within the blood vessel. Then, a drug-loaded preparation is injected into the chamber through the drug-filled chamber 12, and the catheter-integrated acoustic carrier release tip 6 and / or the external ultrasound probe 4 are activated to trigger precise local drug release at the lesion. Throughout the treatment process, macroscopic observation can be performed using external imaging, and microscopic closed-loop adjustments can be made using sensor data. Finally, once the treatment is complete or the preset endpoint is reached, the balloons are deflated to restore blood flow, and the immediate efficacy is assessed again using external ultrasound. The catheter system can then be withdrawn, ending the procedure.

[0032] To more fully illustrate the technical content of the present invention and support the claimed scope of protection, two specific embodiments are provided below.

[0033] Example 1: An integrated intelligent treatment system This embodiment illustrates a typical and preferred implementation of the invention. The system employs a high-frequency ultrasound probe on the body surface for real-time imaging guidance. The interventional catheter 1 is a three-lumen design, comprising a guidance lumen 11, a drug delivery lumen 12, and a signal / pressure lumen. A miniature annular piezoelectric acoustic carrier release tip 6 is integrated at the distal end of the catheter, operating at a frequency of 3MHz, specifically for triggering drug release. The local closure unit utilizes two PET balloons. The therapeutic agent is EDTA-loaded phospholipid microbubbles, delivered through the drug delivery lumen 12. The feedback monitoring module includes a miniature fiber optic calcium ion sensor based on a fluorescent probe. All modules are uniformly controlled by an integrated console, which synchronously displays external ultrasound images and sensor data, and can automatically adjust the ultrasound pulse parameters of the catheter-integrated acoustic carrier release tip 6 and / or the second ultrasound probe 4 based on the real-time feedback calcium ion concentration curve, achieving intelligent closed-loop treatment. This system is particularly suitable for precise decalcification treatment in vascular segments with clear external imaging (such as the carotid artery and femoral artery).

[0034] Example 2: A simplified local treatment interventional catheter 1 This embodiment demonstrates another implementation of the core concept of the present invention, with a more simplified structure. The system also uses an external high-frequency first ultrasound probe for vascular imaging and localization. The interventional catheter 1 adopts a dual-lumen design (the guide lumen 11 shares a lumen with the drug / inflation system). The local closure unit uses only one balloon. The therapeutic agent release unit does not include the acoustic carrier 5 and the integrated transducer; instead, EDTA solution is manually injected directly through a side port at the catheter tip, relying on the retention area formed by the balloon closure to achieve local drug accumulation. Although this system does not employ ultrasound-triggered release and automatic feedback control, it still achieves high-concentration local drug accumulation in the target vascular segment through the basic mode of "external image-guided localization + balloon local blockade + direct intraluminal injection," effectively avoiding systemic side effects. This embodiment demonstrates the broad applicability and feasibility of the basic technical solution of the present invention (image-guided local closure and release).

[0035] Compared with existing technologies such as systemic EDTA chelation therapy, drug balloons, interventional catheter infusion systems, and intra-arterial lithotripsy (IVL), this invention has significant comprehensive advantages.

[0036] Firstly, regarding positioning accuracy, existing technologies cannot achieve real-time monitoring and precise positioning of drug release sites, relying on experience-based judgment for treatment, which is prone to significant deviations. In contrast, this invention uses ultrasound imaging guidance to achieve visualized identification and real-time positioning of lesions, enabling the drug release process to possess high spatial accuracy and repeatability.

[0037] Secondly, regarding the mechanism of action, traditional EDTA therapy results in systemic drug distribution, insufficient local concentration, and significant side effects. This invention employs a localized, precise release design, enabling EDTA to achieve a high local concentration at the lesion site, significantly improving calcification dissociation efficiency and reducing systemic toxicity.

[0038] In terms of safety, existing systemic or semi-systemic drug delivery methods are prone to causing hypocalcemia or renal burden. In contrast, this invention utilizes an ultrasound-guided local release mechanism, which controls the scope of drug action, significantly reduces systemic exposure, and makes the treatment process safer and more controllable.

[0039] In terms of therapeutic efficacy, traditional techniques often rely on single physical or chemical actions, making it difficult to achieve comprehensive treatment. This invention introduces a synergistic mechanism of ultrasound and chemical chelation (sonic-chemical synergistic effect), which can accelerate the reaction between EDTA and calcium ions under the action of ultrasound energy, achieving a more efficient calcium dissociation effect.

[0040] Finally, regarding system controllability, traditional interventional catheter systems lack imaging feedback and cannot adjust release parameters in real time. In contrast, this invention integrates ultrasound monitoring and a closed-loop control module, enabling real-time monitoring of the release process, drug diffusion, and therapeutic effect, achieving dynamic regulation and precise feedback.

[0041] In summary, this invention is superior to existing technologies in terms of positioning accuracy, mechanism of action, safety, therapeutic effect, and system controllability, and has significant technological innovation and application prospects.

[0042] The above description is merely a preferred embodiment of the present invention and does not limit the scope of the patent. Any equivalent structural or procedural transformations made based on the description and drawings of this invention, such as using different external imaging modalities (e.g., magnetic resonance imaging), different triggering energy forms (e.g., photothermal triggering), or directly or indirectly applying them to other related technical fields, should similarly be included within the scope of patent protection of this invention.

Claims

1. An interventional catheter system for the treatment of vascular calcification, characterized in that, include: The imaging and localization module is used to acquire and display images of the target vascular area in real time in order to identify and locate calcified lesions. An interventional catheter, the distal end of which is configured to be navigated to the calcified lesion; A local closure unit, located at the distal end of the interventional catheter, is configured to expand within the vascular segment where the calcified lesion is located to form a treatment chamber that temporarily blocks blood flow. A therapeutic agent delivery unit, disposed on the interventional catheter and located within the treatment chamber defined by the local closure unit, is configured to release a therapeutic agent into the treatment chamber; as well as The control unit is communicatively connected to the imaging positioning module, the local closure unit, and the therapeutic agent release unit, and is used to coordinate the navigation of the interventional catheter, the formation and release of the treatment chamber, and the release of the therapeutic agent.

2. The interventional catheter system according to claim 1, characterized in that, The imaging and positioning module includes a first ultrasound probe mounted externally for performing ultrasound imaging.

3. The interventional catheter system according to claim 1, characterized in that, The local closure unit includes at least one inflatable balloon.

4. The interventional catheter system according to claim 3, characterized in that, The local closure unit includes a first balloon and a second balloon spaced apart along the axial direction of the interventional catheter, and the therapeutic agent release unit is located between the first balloon and the second balloon.

5. The interventional catheter system according to claim 1, characterized in that, The therapeutic agent release unit includes an ultrasound-responsive acoustic carrier, which contains a therapeutic agent and can control the release of the therapeutic agent under the action of ultrasound energy.

6. The interventional catheter system according to claim 5, characterized in that, The ultrasonically responsive acoustic carrier is a microbubble, nanocapsule, liposome, or polymer micelle.

7. The interventional catheter system according to any one of claims 1 to 6, characterized in that, It also includes a feedback monitoring module, which includes a sensing unit disposed at the distal end of the interventional catheter for monitoring at least one physiological or chemical parameter in the treatment chamber; the control unit is further used to adjust the release parameters of the therapeutic agent release unit based on the monitoring data of the sensing unit.

8. The interventional catheter system according to claim 7, characterized in that, The sensing unit is at least one of a calcium ion concentration sensor, a temperature sensor, or a blood flow velocity sensor.

9. The interventional catheter system according to claim 1, characterized in that, The therapeutic agent is a calcium chelating agent.

10. The interventional catheter system according to claim 9, characterized in that, The calcium chelating agent is ethylenediaminetetraacetic acid.

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