Systems and methods for dispensing embolization particles for embolization

Abstract

Systems and methods for performing embolization to treat various medical indications and targets (e.g., bleeding, tumors) utilize a mixture of embolization particles and delivery media at very low concentrations of embolization material while intermittently injecting contrast agent boluses for visualizing progression of embolization. The systems and methods are also automated to minimize user interaction, and may also incorporate sensor and feedback control processes to control the systems and methods when performing embolization.

Description

Technical Field

[0001] The scope of this disclosure generally relates to medical systems and methods, and more specifically to systems and methods for dispensing embolic particles and contrast agents to effectively embolize blood vessels in target tissues of a patient. Background Technology

[0002] Embolizing blood vessels, such as arteries, with microembolic particles is a minimally invasive interventional radiology procedure used to treat a variety of medical conditions. It involves selectively blocking blood vessels by injecting tiny particles (such as polymer foam fragments or beads) into the artery via an intravascular catheter, thereby blocking blood flow to a specific area. This technique has been shown to be effective in managing bleeding, shrinking tumors, and treating certain vascular malformations.

[0003] Typically, the procedure begins with the patient lying on the examination table in the angiography room. After local anesthesia is administered, a small incision is made near an artery (e.g., in the groin area) to access the femoral artery. A catheter is inserted into the artery and guided through the vessel using fluorescence imaging, which provides real-time X-ray guidance.

[0004] A combination of angiography and path mapping techniques is typically used to carefully navigate the catheter to the target vessel. These imaging methods help interventional radiologists visualize vascular anatomy and identify vessels leading to sites of interest, such as the target artery and / or capillaries in the region of the target tissue to be treated by embolization. For example, the target artery and / or capillaries to be embolized can transport blood to the bleeding target tissue or to areas with tumors, fibromas, vascular malformations, or other conditions to be treated.

[0005] Once the catheter is positioned close to the target artery, contrast agent is injected through the catheter to confirm the precise location and assess blood flow. This helps in assessing and planning the microparticle injection to ensure that the microparticles are delivered accurately to the intended area.

[0006] After confirming the optimal location, a syringe filled with a mixture of embolic microparticles and contrast agent is injected into the catheter. The embolic microparticles are typically composed of biocompatible materials such as gelatin sponge or polyvinyl alcohol (PVA) and can be microspheres or other shapes ranging in size from 50 to 1,000 micrometers. The size of the particles used depends on the specific condition being treated and the size of the catheter used. The mixture of embolic microparticles and contrast agent flows through the catheter in the vascular system to the target location. Alternatively, the mixture of embolic microparticles and contrast agent is ejected from the distal end of the catheter and flows through the vascular system, with the embolic microparticles eventually reaching and settling into smaller vessels supplying the target tissue.

[0007] The operator uses a contrast agent to visualize the progression of the embolic particle / contrast agent mixture. To visualize the flow of the embolic particle / contrast agent mixture and the degree of flow reduction in the target vessel, short “puffs” (i.e., bursts of high concentration of the embolic particle / contrast agent mixture) are intermittently injected through the catheter. Without these “puffs,” the injected embolic particle / contrast agent mixture simply appears as a substantially uniform gray line along the flow path. In contrast, the “puffs” allow for effective visualization of flow velocity and perfusion depth, indicating the degree of flow reduction in the blood flow field, and monitoring the reduced clearance time and flow permeability of the contrast agent “puffs” indicates the progression of the embolism.

[0008] However, relatively high concentration bursts (“eruptions”) of embolic particle / contrast agent mixtures in relatively high-viscosity media tend to cause occlusive events in undesirable locations within the vessel, or undesirable proximal vascular aggregation. Consequently, the extent of distal penetration and the homogeneity of embolization are adversely affected. Furthermore, high-flow, high-viscosity injections are more prone to backflow, which is the reflux of embolic material or particles during the procedure. Backflow can occur when the embolic material travels downstream and then partially or completely reverses its course due to high pressure and / or excessive occlusion. This is undesirable because it leads to unintended embolization or reduced embolization effectiveness in other areas.

[0009] When embolic particles accumulate, they block or embolize blood vessels that obstruct blood flow, thereby causing localized ischemia (insufficient blood supply) to the target area of ​​the tissue. Vascular embolism can control bleeding in the treatment of hemorrhage, or cause tumor shrinkage in the treatment of tumor tissue by depriving the target tissue of nutrients and oxygen.

[0010] After the injection is completed, the catheter is removed and the incision is closed to prevent bleeding. The patient is then monitored for several hours as part of an outpatient procedure or overnight to ensure there are no immediate complications.

[0011] Arterial embolization using microparticles offers several advantages over traditional surgical interventions. It is less invasive, resulting in smaller incisions, less pain, and shorter hospital stays. The targeted approach minimizes damage to healthy tissue, making it an effective treatment option for both malignant and benign conditions.

[0012] The specific outcomes of arterial embolization vary depending on the underlying condition being treated. In cases of bleeding, the procedure can rapidly stop the bleeding and stabilize the patient. For tumors, embolization can lead to tumor shrinkage, reduce symptoms, and facilitate subsequent surgical resection. Arterial embolization using microparticles is a valuable interventional radiology technique for managing bleeding, shrinking tumors, controlling vascularized inflammation, and treating vascular malformations. By selectively blocking blood vessels, this minimally invasive procedure provides an effective alternative to traditional surgery, offering patients reduced risks, faster recovery times, and improved outcomes.

[0013] Nevertheless, there is still a need for improved devices, systems, and methods for performing arterial embolization that overcome the shortcomings and deficiencies of previous arterial embolization techniques. Summary of the Invention

[0014] This article discloses innovative systems and methods for performing embolization to treat various medical indications and targets, such as hemorrhage, tumors, fibroids, prostate, thyroid, geniculate artery, etc. In a highly innovative aspect, the systems and methods are configured to inject a mixture of embolic particles and a delivery medium into the delivery medium at a very low concentration of embolic material, while intermittently injecting contrast agent blobs to visualize the progress of the embolization procedure.

[0015] According to one disclosed embodiment, the embolization system includes a first dispenser for dispensing a mixture of embolic particles into a catheter. As some embodiments, the first dispenser may be a syringe, a pressure chamber connected to a pressure source, a gravity-feed dispenser with a valve for controlling the dispensing, a metering pump, or any other suitable dispenser capable of controlling the dispensing of fluid at a specified pressure, flow rate, or injection volume. The embolic particle mixture comprises a mixture of embolic particles and a delivery medium. In various aspects, the delivery medium may be saline, other compatible fluids for carrying the embolic particles, etc. The first dispenser is electronically controlled to controllably dispense the embolic particle mixture.

[0016] The embolization system also includes a second dispenser for dispensing contrast agent into the catheter. This second dispenser can be any of the dispenser types described for the first dispenser, and can be the same type or a different type.

[0017] The first and second dispensers are each connected to a manifold, which is in fluid communication with both the first and second dispensers, allowing the first and second dispensers to dispense into the manifold. The manifold has a dispensing outlet for dispensing from the manifold and into the catheter. Therefore, the embolization system can switch between injecting two distinct fluid mixtures for two different purposes: an embolic particle mixture without contrast agent for the target area of ​​the embolic tissue, and a contrast agent mixture including contrast agent for visualizing the embolization. The embolization system can dispense the two different fluid mixtures in a repeating pattern, distinguishing them from each other. In other aspects, the embolization system is also configured to automatically control (e.g., control the injection rate) the first dispenser when dispensing the embolic particle mixture and the second dispenser when dispensing the contrast agent. As used herein, the terms “automatically,” “automatically,” and / or other forms relating to the control of the dispensing / injection function mean that the flow rate, duration, and / or volume of the fluid dispensing is controlled without human action or intervention, but allow for manual or automatic triggering of “automatic” dispensing. For example, automatic injection (or automatic dispensing) can be an injection of flow rate and total fluid volume controlled by the system's controller, which is initiated by the user manually triggering the injection (such as by pressing a button on the controller).

[0018] On the other hand, the first dispenser dispenses a low-concentration mixture of embolic particles in a relatively large volume. This avoids the use of significant concentrations of contrast agent, as in existing systems and methods for dispensing mixtures of embolic particles and contrast agent. The use of large volumes of contrast agent is not recommended because it is important to limit the amount of contrast agent injected into the patient to prevent kidney damage. This also allows the second dispenser to dispense a high concentration of contrast agent alone in a low volume without embolic particles, allowing for good visualization of blood flow (i.e., good visualization of the progression of the embolization procedure when blood flow is blocked by embolism). Furthermore, the contrast agent has a higher viscosity than the mixture of embolic particles and is therefore more likely to visualize stagnation or backflow within the artery.

[0019] On the other hand, the embolic particle mixture has a specific low concentration of embolic particles relative to the injected embolic particle mixture. For example, the low concentration of embolic particles relative to the embolic particle mixture can be 2.0%–0.05% by volume, or 1.0%–0.1% by volume. This is for cases where the total volume of the injected embolic particle mixture is in the range of 50–500 cc (cm³); the volume of the contrast agent diluted with saline is in the range of 10–50 cc; the cumulative injection time of the embolic particle mixture is in the range of 5–20 minutes; and the injection flow rate of the embolic particle mixture is in the range of 2.0–0.1 cc / sec. Therefore, the low concentration of embolic particles relative to the embolic particle mixture can be appropriately adjusted when these embolic characteristics vary from these ranges. The size of the embolic particles can also affect the low concentration of embolic particles relative to the embolic particle mixture.

[0020] In another aspect of the embolization system, both the first and second distributors include a powered syringe driven by an actuator configured to controllably distribute a pressurized fluid flow. As used herein, the term "powered" means that the device is not manually driven and includes, but is not limited to, electric, pneumatic, hydraulic, etc. For example, the powered syringe may be an electric syringe driven by an electric motor, and such electric syringes may be controllable by an electric motor controller configured to control the speed at which the plunger of the syringe is actuated, thereby controlling the flow rate and / or pressure distributed by the corresponding distributor.

[0021] In another aspect of the system, the first dispenser can separately dispense and mix the embolic particles and the delivery medium to prepare and dispense an embolic particle mixture. For example, the first dispenser may include a first sub-dispenser for dispensing the embolic particles into a mixer and a second sub-dispenser for dispensing the delivery medium into the mixer. The system may further include a mixer in fluid communication with the first and second sub-dispensers. The mixer is configured to mix the embolic particles and the delivery medium and output a well-mixed embolic particle mixture. In other aspects, the mixer may be a passive mixer, such as a flow-induced mixer, a static mixer, a vortex mixer, an active mixer, such as a mixer with a moving mixing element, or an integrated mixer with acoustic stirring or a piezoelectric transducer. In another aspect, the first and second sub-dispensers may include an electric syringe identical or similar to the electric syringe described herein.

[0022] In another aspect, the embolization system may include a controller operatively connected to the first and second dispensers. The controller is configured to automatically control the first and second dispensers to controllably dispense the embolic mixture from the first dispenser and to controllably dispense the contrast agent from the second dispenser. For example, the controller may have a computer processor or other electronic control logic configured to electronically control the operation of the first and second dispensers. In yet another aspect, the controller may be user-programmable to control the characteristics of dispensing the embolic particle mixture via the first dispenser and dispensing the contrast agent via the second dispenser. For example, the controller may be configured to allow a user to set one or more of the following characteristics of dispensing via the first and second dispensers: (1) the dispensing flow rate, (2) the dispensing pressure, (3) the frequency of dispensing the contrast agent, (4) the actuation of active mixing, etc.

[0023] In another aspect, the embolization system may include one or more sensors for monitoring and / or controlling the operation of the embolization system. In one aspect, the system may further include a first sensor operatively connected to the controller and configured to detect an attribute dispensed through at least one of the first and second dispensers, and output a first sensor signal associated with that attribute. For example, the first sensor may be a flow rate sensor for detecting the flow rate of the fluid dispensed by the first and second dispensers, or a pressure sensor for detecting the pressure of the fluid dispensed by the first and second dispensers. The controller utilizes the first sensor signal during feedback control to control the dispensed attribute (e.g., flow rate, pressure, concentration of the dispensed embolic particle mixture, or contrast agent, etc.). As an example, the controller may utilize the flow rate signal to control the operation of the first and / or second dispensers to adjust the flow rate of the dispensed fluid to a user-defined preset flow rate. The first sensor may be any suitable sensor, such as a flow rate sensor, pressure sensor, force sensor, actuator torque sensor, motor current sensor, etc.

[0024] In another aspect, the controller is configured to automatically perform embolization, including dispensing the embolized particle mixture at a predetermined flow rate or pressure controlled by the controller; and intermittently dispensing an abolus of contrast agent at a predetermined flow rate or pressure controlled by the controller.

[0025] In another aspect, the embolization system can also utilize controlled flow rectification and laminar flow effects to further prevent embolic material aggregation, surface adsorption, precipitation, and / or catheter blockage during the embolization procedure. For this purpose, the embolization system may also include a flow rectifier having an inlet and an outlet. The inlet is connected to and in fluid communication with the outlet of the manifold. The rectifier outlet may be connected to the proximal end of the catheter. The flow rectifier is configured to regulate the flow pattern of the embolic particle mixture as it flows through the rectifier to produce a more uniform flow of these embolic particles within the delivery medium. For example, the flow rectifier may be configured to produce laminar flow of the embolic particle mixture, wherein the embolic particles are aligned with the centerline of the flow of the embolic particle mixture at the outlet of the rectifier. In one embodiment, the flow rectifier may include an inner tube having a tapered outlet coaxially disposed in an outer tube having a tapered outlet, the inner tube outlet intersecting the outer tube outlet in the tapered outlet. The embolic particles flow through the inner tube and through a tapering outlet that straightens the particles into a narrow column (or even a single column) of embolic particles, while the delivery medium flows through the outer tube to create a laminar or reduced-turbulence flow at the outer tube outlet. Then, at the intersection of these two flows, the straightened embolic particles are positioned along the centerline of the combined flow of the embolic particles and the delivery medium.

[0026] In another embodiment, the embolization system can be similar in most respects to the embolization system described above, except that the system utilizes a first catheter for injecting the embolic particle mixture and a second catheter for injecting the contrast agent. Thus, the first catheter is connected to and in fluid communication with a first dispenser, and the second catheter is connected to and in fluid communication with a second dispenser. This eliminates the need for a manifold to receive and distribute fluid flows from the first and second dispensers into a single catheter. The first and second catheters can have various suitable configurations. In one aspect, the first catheter can be a microcatheter, and the second catheter can be a support catheter, guide catheter, or sheath catheter into which the microcatheter is inserted. In this configuration, the first dispenser injects the embolic particle mixture into and through the microcatheter, and the second dispenser injects the contrast agent into and through an annular cavity formed between the outer catheter and the microcatheter. The first and second catheters can be configured to have a common outlet or different axially separated outlets for injecting the corresponding fluid into a target area of ​​the tissue. Alternatively, the first and second catheters can be positioned side-by-side, with each catheter having a different outlet or a common outlet at the distal end of the corresponding first and second catheters. This configuration of the embolization system allows for the continuous infusion (i.e., without interruption) of the embolic particle mixture via a first catheter, while the contrast agent is injected in a pulsatile manner via a second catheter, simultaneously with the continuous injection of the embolic particle mixture.

[0027] An embolization system having a first catheter and a second catheter may include any one or more of the other aspects and features of an embolization system described herein.

[0028] Another embodiment disclosed herein relates to a method for performing a vascular embolization procedure. The method includes automatically controlling the variable injection of two distinctly different fluid mixtures having two different purposes: a mixture of embolic particles without contrast agent for embolizing a target area of ​​tissue, and a mixture of contrast agents including a contrast agent for visualizing the embolization. The method dispenses the two different fluid mixtures separately from each other in a controlled variable injection pattern. In another aspect, the dispensing of the embolic particle mixture and / or the contrast agent is automatically controlled by a controller.

[0029] This method involves injecting a mixture of embolic particles into a target area of ​​tissue via a catheter, the injection of which is automatically controlled by a controller. Contrast agent boluses are intermittently injected into the target area of ​​tissue via the catheter to monitor the progression of embolism in the target area of ​​tissue on a visualization system. Contrast agent boluses can be administered manually, such as by the user manually actuating a syringe filled with contrast agent. The advantage of manual contrast agent injection (or manual-triggered-automatic injection) is that the user can coordinate the contrast agent injection with the on and off of the angiography system, and thus limit radiation exposure. Alternatively, the injection of contrast agent boluses can also be automatically controlled by a controller. The controller can be the same as or similar to any controller disclosed herein.

[0030] In another aspect of this method, the injection of the embolic particle mixture is paused during intermittent injections of the contrast agent. This can result in a balanced pressure process or system, where the injection pressure remains substantially constant during the embolization procedure.

[0031] In another aspect of the method, the embolic particle mixture is a premixture of embolic particles and a delivery medium disposed in a first dispenser.

[0032] In another aspect of the method, the embolic particle mixture contains a specific low concentration of embolic particles within the injected embolic particle mixture. For example, the low concentration of embolic particles relative to the embolic particle mixture can be 2.0%–0.05% by volume, or 1.0%–0.1% by volume. This is in the case where the total volume of the injected embolic particle mixture is in the range of 50–500 cc (cubic centimeters); the volume of contrast agent injected is in the range of 10–50 cc, which can be further diluted with saline; the cumulative injection time of the embolic particle mixture is in the range of 5–20 minutes; and the injection flow rate of the embolic particle mixture is in the range of 2.0–0.1 cc / sec. Therefore, the low concentration of embolic particles relative to the embolic particle mixture can be appropriately adjusted as these embolic characteristics vary from these ranges. The size of the embolic particles can also affect the low concentration of embolic particles relative to the embolic particle mixture.

[0033] In another aspect, the method can be performed using any of the embolization systems described herein. For example, the embolic particle mixture can be dispensed by a first dispenser configured to dispense the embolic particle mixture into a catheter, while the contrast agent can be dispensed by a second dispenser configured to dispense the contrast agent into a catheter. In another aspect of the method, the first dispenser may include a first motorized syringe configured to controllably dispense a pressurized flow of the embolic particle mixture from the first motorized syringe, and the second dispenser may include a second motorized syringe configured to controllably dispense a pressurized flow of the contrast agent from the second motorized syringe.

[0034] On another front, these embolic particles and the delivery medium can be mixed as they are dispensed from their respective dispensers into a mixer. For example, the first dispenser may include a first sub-dispenser for dispensing embolic particles into the mixer and a second sub-dispenser for dispensing the delivery medium into the mixer. The mixer mixes the embolic particles and the delivery medium and outputs the embolic particle mixture at a low concentration as described herein. The first and second sub-dispensers may include corresponding powered injectors configured for controllably dispensing pressurized fluid flows.

[0035] In another aspect, a delivery medium (e.g., saline) can be injected at a controlled rate from a second sub-dispenser into a mixer or manifold, and then embolic particles are injected at a controlled rate from a first sub-dispenser into the mixer to generate and dispense a mixture of embolic particles. Then, to switch to dispensing contrast agent, a second dispenser injects the contrast agent into the mixer or manifold. This second sub-dispenser can simultaneously inject the delivery medium (e.g., saline) into the mixer or manifold while simultaneously injecting a high concentration of contrast agent into the mixer or manifold, thereby generating and dispensing a mixture of contrast agent at a reduced concentration. The second sub-dispenser can continuously inject the delivery medium at a varying or constant rate while switching from dispensing embolic particles by the first sub-dispenser in the first step to dispensing contrast agent from the second dispenser. A controller can control the dispensing rate of embolic particles plus delivery medium, or contrast agent plus delivery medium, to produce an appropriate dilution / concentration of the corresponding mixture. The controller can be programmable to set the desired dispensing rate and dilution / concentration of these corresponding mixtures.

[0036] In another aspect of the method, the first and second dispensers can be electrically controlled to controllably dispense the respective fluids. In yet another aspect of the method, the first and second dispensers can be operatively coupled to a controller that automatically controls the operation of the first dispenser to controllably dispense the embolic particle mixture from the first dispenser, and automatically controls the operation of the second dispenser to controllably dispense the contrast agent.

[0037] On the other hand, the method may also include selectively programming a controller to control the characteristics of the first dispenser dispensing the embolic particle mixture and the second dispenser dispensing the contrast agent. As some embodiments, the dispensing characteristics of the first and second dispensers may be (a) the dispensing flow rate, (2) the dispensing pressure, (3) the particle concentration in the embolic particle mixture, (4) the frequency of dispensing the contrast agent, and (5) the injection volume or time for dispensing the contrast agent, etc.

[0038] In another aspect, the method may further include the controller receiving a first sensor signal from a first sensor, the first sensor signal being related to the respective dispensing attributes of the first dispenser and the second dispenser. The controller may use a feedback control procedure based on the first sensor signal to control the dispensing of the first dispenser and the second dispenser. In other aspects, the first sensor may be a flow rate sensor, a pressure sensor, a force sensor, an actuator torque sensor, and / or a motor current sensor. In other aspects of the method, the dispensing attribute controlled by the controller may be the injection flow rate or injection pressure dispensed into the catheter via the first dispenser and the second dispenser. The controller uses a feedback control procedure to control the first dispenser and the second dispenser to achieve predetermined characteristics of dispensing into the catheter. The predetermined characteristics of dispensing into the catheter may include any one or more of the flow rate, pressure, and concentration of the dispensed embolic particle mixture or contrast agent.

[0039] In another aspect, the embolization system may also include an on / off switch, such as a button, touchscreen input, etc., to start and stop the injection of the embolic particle mixture. The start and stop of the injection of the embolic particle mixture can be controlled manually or automatically by a controller.

[0040] In another aspect, the embolization system can be configured to perform a priming process to remove any air from the system. For example, the system can be configured to automatically inject a delivery medium (e.g., saline) into the catheter and other components to purge air from the dispensing components of the embolization system.

[0041] In another aspect, the embolization system can also be configured to emit a signal indicating that a contrast agent bolus is about to be injected. This signal can be used to notify the user or the angiography system controller that a contrast agent bolus is about to be injected, allowing the angiography system to be activated manually or automatically to visualize the embolization procedure. The contrast agent signal can be an audible sound, an luminous indicator, or an electronic trigger. This allows the angiography system to activate only when needed and in time close to the injection of the contrast agent, limiting radiation exposure for the patient and user. The controller of the embolization system can be configured to communicate with the angiography system to transmit the contrast agent signal to the angiography system, which then activates the angiography system.

[0042] Therefore, this paper discloses an improved embolization system and method capable of dispensing a low-concentration mixture of embolic particles. The system and method use a low concentration of embolic particles in the embolic particle mixture, thereby reducing the likelihood of occlusion (i.e., embolization of non-target vessels) and backflow. Furthermore, the embolization system and method have the ability to inject a contrast agent bolus separately from the injection of the embolic particle mixture. In this way, a spray or bolus of contrast agent can be injected without injecting a relatively large burst of embolic particle mixtures that tend to cause occlusion and backflow. Moreover, using electronic control and automation, the system and method can be used comfortably by physicians for extended periods of time, allowing for injection of very low concentrations of embolic particle mixtures for longer periods than with previous manually controlled systems, without causing fatigue and also reducing the risk of human error during the embolization procedure inherent in such manual systems (such as those described above). Attached Figure Description

[0043] The accompanying drawings illustrate the design and utility of various aspects of this disclosure, wherein similar elements are indicated by common reference numerals. These drawings are not necessarily drawn to scale. To better understand how the above and other advantages and purposes are obtained, a more specific description of this disclosure, shown in the accompanying drawings, will be presented. For illustrative purposes and to facilitate the following detailed description, these drawings depict only exemplary aspects of this disclosure and are therefore not intended to limit its scope.

[0044] Figure 1 This is a schematic side view of an embolization system according to an embodiment disclosed herein.

[0045] Figure 2 It describes what is used for Figure 1 A diagram illustrating the balanced pressure distribution scheme of the embolization system.

[0046] Figure 3 It is a description used for Figure 1 A diagram illustrating the balanced flow velocity distribution scheme of the embolization system.

[0047] Figure 4 This is a schematic side view of an embolization system according to another embodiment disclosed herein.

[0048] Figure 5 This is a schematic diagram of an embolization system according to yet another embodiment disclosed herein.

[0049] Figure 6 It describes what is used for Figure 5 A diagram illustrating the balanced pressure distribution scheme of the embolization system.

[0050] Figure 7 It describes what is used for Figure 5 A diagram illustrating the balanced flow velocity distribution scheme of the embolization system.

[0051] Figure 8 This is a schematic side view of the outlet of the embolic particle mixture flow, showing how embolic particles aggregate and block.

[0052] Figure 9 This is a schematic side view of a flow rectifier used in conjunction with the embolization system disclosed herein.

[0053] Figure 10 This is a schematic side view of the distal end of an embolization system attached to a connector and catheter assembly according to another embodiment disclosed herein. Detailed Implementation

[0054] This specification describes exemplary embodiments, aspects, and applications of this disclosure. However, this disclosure is not limited to these exemplary embodiments, aspects, and applications, or the manner in which they operate or are described herein. Furthermore, the drawings may show simplified or partial views, and the dimensions of the elements in the drawings may be enlarged or disproportionate. Moreover, throughout the drawings, elements with similar structures or functions are indicated by the same reference numerals. Furthermore, the aspects shown need not possess all the features or advantages shown. Features or advantages described in connection with a particular aspect are not necessarily limited to that aspect and may be practiced in any other aspect, even if not stated so.

[0055] For terms defined below, these definitions will apply unless otherwise specified in the claims or elsewhere in this specification.

[0056] When referencing a series of elements (e.g., elements a, b, c), such a reference is intended to include any one of the listed elements themselves, any combination of fewer than all the elements listed, and / or any combination of all the elements listed.

[0057] As used herein, “substantially” means sufficient for the intended purpose. Therefore, the term “substantially” allows for minor, insignificant variations from absolute or perfect condition, dimensions, measurements, results, etc., as would be expected by one of ordinary skill in the art, but which do not significantly affect overall performance. The term “a” means more than one.

[0058] Whether explicitly stated or not, all numerical values ​​herein are assumed to be modified by the term “about.” The term “about” generally refers to a range of numbers that a person skilled in the art would consider equal to the listed values ​​(i.e., having the same function or result). In many cases, the term “about” may include numbers rounded to the nearest significant figure. A range of numerical values ​​described by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0059] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural indicators unless otherwise clearly indicated. As used in this specification and the appended claims, the term “or” is generally used in its meaning to include “and / or” unless otherwise clearly stated.

[0060] Reference Figure 1 This illustration shows an embodiment of an embolization system 100 for performing medical embolization to embolize a target area of ​​tissue within the human body. The embolization system 100 includes a first dispenser 102 and a second dispenser 104 housed within a housing 106. The first dispenser 102 is used to receive and dispense a fluid comprising an embolic particle mixture 103, which includes a mixture of embolic particles and a delivery medium. The second dispenser 104 is used to dispense a fluid comprising a contrast agent 105 for visualizing the embolization procedure using the embolization system 100.

[0061] exist Figure 1 In the illustrated embodiment, the first dispenser 102 and the second dispenser 104 each include electrically operated syringes 108a and 108b. Each electrically operated syringe 108a and 108b includes a barrel 110a and 110b (also referred to as chambers 110a and 110b) and plungers 112a and 112b. The barrel is used to contain the corresponding fluid to be dispensed, and the plungers are disposed in the barrels 110a and 110b to expel the fluid from the barrels 110a and 110b. Each syringe 108a and 108b also has syringe outlet ports 114a and 114b at the distal end of the barrels 110a and 110b.

[0062] Each electric syringe 108a, 108b also includes actuators 116a, 116b for actuating plungers 112a, 112b. In the illustrated embodiment, actuators 116a, 116b include electric motors 118a, 118b and connectors 120a, 120b connecting the electric motors 118a, 118b to the plungers 112a, 112b. Connectors 120a, 120b may be one or more gears 122a, 122b (e.g., pinions or worm gears) or other connecting devices for converting the rotational motion of the electric motors 118a, 118b into linear motion of the plungers 112a, 112b. The plungers 112a and 112b may have rack-type gears 124a and 124b that cooperate with gears 122a and 122b to convert the rotational motion of gears 122a and 122b into the linear motion of plungers 112a and 112b.

[0063] Outlet port 114a is connected to and in fluid communication with manifold 126, and outlet port 114b is also connected to and in fluid communication with manifold 126, such that the first distributor 102 and the second distributor 104 dispense corresponding fluids into manifold 126. Manifold 126 has outlet 128 that ejects fluid from the first distributor 102 and the second distributor 104 out of manifold 126 and into conduit 130. Embolization system 100 has connector 129 configured to connect to proximal connector 131 of conduit 130.

[0064] In optional features, the first dispenser 102 may also include a mixer 107 configured to mix the embolic particle mixture 103 within the first dispenser 102. For example, the embolic particles used may have a tendency to settle over time. The mixer 107 helps maintain a uniform concentration of particles within the embolic particle mixture 103 to be injected into the first dispenser 102. The mixer 107 can be any suitable mixer, such as a stirring rod, a recirculation or pulse pump, a vibrator, a tilting device, a means for rotating or shaking the first dispenser 102, etc.

[0065] The embolization system 100 has a control module 136 (also referred to as "controller 136") for monitoring and controlling the operation of the embolization system 100. The control module 136 may include a pair of manual on / off switches 138a, 138b for opening and closing the first dispenser 102 and the second dispenser 104, respectively. This allows the user to manually open and close the first dispenser 102 to controllably dispense the embolic particle mixture 103 into the catheter 130, and allows the user to manually open and close the second dispenser 104 to controllably dispense the contrast agent 105. Manual operation can be used to start the system 100 by purging any trapped air from the system 100. The on / off switches 138a, 138b may be adjustable to change the actuation rate of the electric syringes 108a, 108b, thereby controlling the flow rate of the dispensing from the first dispenser 102 and the second dispenser 104. For example, on / off switches 138a and 138b can be variable speed buttons or slide switches, which respectively change the speed of motors 116a and 116b, which in turn changes the rate at which plungers 112a and 112b are advanced, thereby changing the dispensed flow rate. Control module 136 may also include a flow rate indicator showing the dispensed flow rate. In the case where syringes 108a and 108b serve as dispensers 102 and 104, the flow rate is proportional to the speed of plungers 112a and 112b and can be directly calculated based on the dimensions of the syringe barrels 110a and 110b.

[0066] The embolization system 100 may also include one-way valves 132a, 132b between the syringe outlet ports 114a, 114b and the manifold 126 to prevent fluid from flowing back from one of the distributors 102, 104 to the other distributor 102, 104.

[0067] To monitor and control the dispensing of the embolization system 100, including automatic dispensing as described herein, the system 100 includes sensors 134 for sensing the properties of the fluid at the corresponding sensor 134 location and outputting a sensor signal associated with that property. Figure 1 In one embodiment, the embolization system 100 includes a first sensor 134a, a second sensor 134b, a third sensor 134c, and a fourth sensor 134d. Sensors 134a-134d can be any suitable sensor, such as a pressure sensor, flow rate sensor, light absorption sensor, etc. In one embodiment, sensors 134a, 134b, and 134c are each pressure sensors for correspondingly detecting the fluid pressure at the outlet of the first distributor 102, the fluid pressure at the outlet of the second distributor 104, and the fluid pressure in the manifold 126. The fourth sensor 134d is a differential pressure flow sensor for detecting the flow rate at the outlet of the manifold 126.

[0068] To control the dispensing of the embolization system 100, each of the first dispenser 102, the second dispenser 104, and the sensors 134a-134d is operatively connected to a controller 136. The controller 136 is an electronic controller having a microprocessor or electronic control logic (e.g., logic circuitry) 138, a memory 140, and a software application 142. The controller 136g can also be configured to receive sensor output signals from each of the sensors 134a-134d and use the sensor signals to monitor and control the operation of the embolization system 100. As some embodiments, the controller 136 can use the output signals to determine the flow rate and / or fluid pressure of the embolic particle mixture 103 dispensed by the first dispenser 102, the flow rate and / or fluid pressure of the contrast agent dispensed by the second dispenser 104, and the flow rate and / or fluid pressure of the fluid dispensed into the catheter 130. The software application 142 includes a control module 144 for controlling the operation of the embolization system 100 based on signals from any one or more of the sensors 134a-134d. The controller 136 utilizes the control module 144 to control the operation of the first distributor 102 and the second distributor 104, including controlling the distribution flow rate, the distribution pressure, the timing of the on / off cycle of the distribution, and / or the volume of fluid distributed during the on / off cycle. The control module 144 may include a feedback control algorithm that controls the distribution of the first distributor 102 and the second distributor 104 based on any one or more sensor signals from sensors 134a-134d.

[0069] The controller 136 can be selectively programmed by a user to set one or more operational features of the embolization system 100 during operation in a target area for embolization of tissue. The controller 136 includes an input device 146 that allows the user to select various operational parameters of the embolization system 100. The input device 146 can be any suitable input device, such as a keyboard, touchscreen, button panel, touchpad, etc. In some instances, the user can set the flow rate of the first dispenser 102 and / or the second dispenser 104, the pressure of the first dispenser 102 and / or the second dispenser 104, the duration and / or rate of the on / off cycle of the first dispenser 102 and / or the second dispenser 104, the cycle time between the second dispenser 104 dispensing the contrast agent bolus 105 and subsequent contrast agent boluses 105, and / or dispensing the embolic particle mixture 103, the size of the contrast agent bolus 105 dispensed by the second dispenser 104 (e.g., the volume or time of dispensing), the total amount of the embolic particle mixture 103 to be dispensed (by volume), weight or other suitable measurement, the total dispensing time of the embolization procedure, etc. The software application 142 may include multiple pre-programmed dispensing procedures with different preset dispensing parameters selectable by the user. The pre-programmed dispensing procedures may have user-selectable characteristics, such as flow rate, pressure, total amount of the embolic particle mixture, injection frequency of the contrast agent 105, etc.

[0070] The embolization system 100 may also include other sensors 134e-134h for detecting operational attributes of the electric syringes 108a and 108b and outputting corresponding control signals related to these operational attributes. These other sensors 134e-134h are also operatively coupled to a controller 136, which is configured to receive sensor output signals from each sensor 134e-134h and use these sensor signals to monitor and control the operation of the embolization system 100. For example, sensors 134e and 134f may be torque sensors that measure the torque on plungers 112a and 112b, respectively. The torque on plungers 112a and 112b can be used by the controller 136 to indirectly determine the outlet pressures of the first distributor 102 and the second distributor 104. Similarly, sensors 134g and 134h may be motor current sensors that measure the current in motors 118a and 118b, respectively. The motor current can also be used to indirectly determine the operational properties of the electric syringes 108a and 108b, such as the flow rates dispensed by the first dispenser 102 and the second dispenser 104, respectively. Sensors 134g and 134h can be motion sensors configured to detect the movement (linear motion) of the plungers 112a and 112b or the rotation of the motors 118a and 118b (rotation sensors), which can be used to determine the flow rates dispensed by the first dispenser 102 and the second dispenser 104, respectively. The control module 144 can utilize the output signals from sensors 134e-134h to monitor and control the dispensing of the first dispenser 102 and the second dispenser 104, including in a feedback control algorithm.

[0071] The embolization system 100 may include one or more pressure-reducing valves and / or regulators 148 to regulate the pressure of fluid flow within or outside the system 100. Figure 1 In some embodiments, a pressure reducing valve or regulator 148 may be installed at the outlet of manifold 126 to regulate the pressure of fluid distributed from embolization system 100. The pressure reducing valve or regulator 148 may be installed at the outlet of first distributor 102, the outlet of second distributor 104, the outlet of manifold 126, or any one or more within manifold 126 to regulate the flow rate and pressure of the distributed fluid within or outside the system, regulate the concentration of the fluid (e.g., the concentration of a mixture of embolic particle solution and contrast agent), and / or facilitate the mixing of the constituent fluids. In the case of pressure reducing valve 148, it also functions as a passive overpressure prevention device.

[0072] The embolization system 100 may also include a pressure or force limiter between the motors 118a, 118b and the connections 120a, 120b to the plungers 112a, 112b to prevent overpressurization of the distributed fluid, such as a torque limiter, a slipper clutch, etc.

[0073] The use and operation of the embolization system 100 in performing embolization to embolize a target area of ​​tissue will now be described. A catheter 130 is inserted through an incision in the patient's body and advanced to a target location near the target area of ​​the tissue to be embolized. The catheter 130 can be positioned within the patient's body before or after connection to the embolization system 100, although positioning the catheter 130 before connection is more convenient, ensuring that the embolization system 100 does not interfere with manipulating the catheter 130. The embolization system 100 is then connected to the catheter 130. The system 100 can also be connected to the catheter 130 via a secondary fluid connection, such as a rotary hemostatic valve (RHV) or a fluid management stopcock or manifold.

[0074] The user can then use the embolization system 100 in manual or automatic mode to embolize a target area of ​​tissue. The first dispenser 102 is filled with an embolic particle mixture 103. The embolic particle mixture 103 may have a low concentration of embolic particles in the range of 2.0%-0.05% by volume, or 1.0%-0.1% by volume. Several factors are considered when setting the target concentration of the embolic particles and the embolic particle mixture 103, such as the total volume of the embolic particle mixture 103 to be used for embolization, the injection flow rate, and the size and amount of embolic particles required for the specific clinical situation or the specific target area or tissue volume to be embolized. The embolic particle concentration range disclosed herein is estimated for a total volume of the embolic particle mixture 103 to be injected in the range of 100-500 cc (cubic centimeters); an injection cumulative time of the embolic particle mixture in the range of 5-20 minutes; and an injection flow rate of the embolic particle mixture in the range of 2.0-0.1 cc / s. Therefore, given variations in these embolic characteristics from these ranges, a low concentration of embolic particles based on the embolic particle mixture can be appropriately adjusted. The total volume of the contrast agent diluted with saline can be injected in the range of 10-50 cc.

[0075] The second dispenser 104 is filled with contrast agent 105 suitable for a visualization system used to monitor the procedure. In manual mode, the user actuates the first dispenser 102 and / or the second dispenser 104 as needed to dispense desired amounts of the embolic particle mixture 103 and contrast agent 105, respectively. The controller 136 can be configured to provide the user with dispensing information, such as the pressure, flow rate, and volume of the dispensed fluid. This dispensing information may be displayed on a display 137 operatively connected to the controller 136 (e.g., the display 137 may be part of the controller 136), or provided to the user in some other suitable manner, such as by transmitting the dispensing information to an external device (e.g., a computing device, such as a laptop computer, smartphone, etc.) via a communication link (e.g., a wired or wireless link, such as WiFi, Bluetooth, etc.). The user can use the dispensing information to monitor and control the embolization procedure using the embolization system 100.

[0076] In a manual mode of using the embolization system 100, the user manually operates the on / off switch 138a to actuate the first motorized syringe 108a of the first dispenser 102 to dispense the embolic particle mixture 103 into the catheter 130, through which the mixture is delivered to the target area. The user can control the flow rate of the dispensed embolic particle mixture using the on / off switch 138a or via a corresponding programmable controller 136. The user intermittently operates the manual on / off switch 138b to actuate the second motorized syringe 108b of the second dispenser 102 to dispense contrast agent bolus 105 into the catheter 130, which is delivered to the target area through the catheter 130. During the dispensing of contrast agent 105 and the ejection of contrast agent 105 from the catheter at the target location, the user can track the contrast agent 105 as it is injected into the target area to observe and monitor the progress of embolism in the target area of ​​the tissue using a visualization system such as a fluorescence microscope or other suitable X-ray system adapted to detect contrast agents and anatomical structures within the patient and generate real-time images displayed on a monitor. The user can temporarily pause the dispensing of the embolic particle mixture 103 while dispensing the contrast agent 105, and then resume dispensing the embolic particle mixture 105 to push the contrast agent 105 through the catheter 130 and into the target area of ​​the tissue. Alternatively, the user can continuously dispense the embolic particle mixture 103 while simultaneously dispensing the contrast agent 105.

[0077] To use the embolization system 100 in automatic mode, the user uses the input device 146 to select desired operating parameters of the embolization system 100, such as the flow rate of the first dispenser 102 and / or the second dispenser 104, the pressure of the first dispenser 102 and / or the second dispenser 104, the on / off cycle of the first dispenser 102 and / or the second dispenser 104, the cycle time between dispensing a bolus of contrast agent 105 by the second dispenser 104, the size of the contrast agent bolus 105 injected by the second dispenser 104 (e.g., the volume or time of dispensing), the total amount (by volume), weight or other suitable measurement) of the embolization particle mixture 105 to be dispensed, the total dispensing time of the embolization procedure, etc., or a pre-programmed dispensing procedure. If necessary, the user setting the dispensing procedure can select any one or more features, such as flow rate, pressure, total amount of embolization particle mixture, injection frequency of contrast agent 105, etc.

[0078] The user then initiates the automated embolization procedure on the embolization system 100 by inputting a “start” command using input device 146. Controller 136 automatically operates the embolization system 100 to execute a selected automated embolization dispensing procedure using components such as the first dispenser 102, the second dispenser 104, sensor 134, valves, and regulator 148, all controlled by controller 136. In a typical automated embolization procedure, the embolization system 100 actuates the first dispenser 102 to dispense the embolic particle mixture 103 into the conduit 130, thereby injecting the embolic particle mixture 103 into the target area at a flow rate, pressure, and / or volume controlled by controller 136. This can be accomplished using a feedback control process based on sensor signals from any one or more of sensors 134a-134e. The embolization system 100 intermittently actuates the second dispenser 104 to dispense contrast agent bolus 105 into the catheter 130 to inject contrast agent 105 into the target area. This can also be accomplished using a feedback control process based on sensor signals from any one or more of the sensors 134a-134e.

[0079] The embolization system 100 can also be configured to emit a contrast agent signal indicating that a contrast agent bolus 105 is about to be injected. This signal can be used to notify the user or the angiography system controller that the contrast agent bolus 105 is about to be injected, allowing the angiography system to be manually or automatically activated to visualize the embolization procedure. The contrast agent signal can be an audible sound, an luminous indicator, or an electronic trigger. This allows the angiography system to activate only when needed and in time close to the injection of the contrast agent, limiting radiation exposure for the patient and user. The controller 136 of the embolization system 100 can be configured to communicate with the angiography system to transmit the contrast agent signal to the angiography system, which then activates the angiography system. When contrast agent 105 is injected from catheter 130 at the target location, the user can track the contrast agent 105 as it is injected into the target area and spreads through the target area of ​​the tissue to observe and monitor the progression of embolism in the target area of ​​the tissue using a visualization system such as a fluorescence microscope or other suitable X-ray system adapted to detect contrast agents and anatomical structures in the patient and generate real-time images displayed on a monitor.

[0080] Turning Figure 2 and Figure 3 Two different control schemes for dispensing the mixture of embolic particles and contrast agents are described. Figure 2 A diagram depicts a balanced pressure scheme in which the dispensing / injection pressure is controlled and the flow rate is any flow rate derived from the controlled dispensing / injection pressure. Balanced pressure schemes can be used to ensure that a safe pressure is always maintained for injecting fluid into a specific anatomical structure within a target area. Figure 2 As shown, in the balanced pressure scheme, during the dispensing of contrast agent bolus 105 by the second dispenser 104, the dispensing of the embolic particle mixture 103 by the first dispenser 102 is paused. This maintains a substantially constant injection pressure at the output of manifold 126, where only a small pressure increase is possible during the injection of contrast agent bolus 105. The embolization system 100 can be configured to operate using a balanced pressure scheme that uses a pressure reducing valve and / or regulator 148 and / or by configuring a controller 136 to control the dispensing to maintain a set dispensing / injection pressure. For example, the pressure reducing valve and / or regulator 148 can be configured to control the dispensing pressure and / or the controller 136 can, for example, control the actuation of the electric syringes 108a, 108b by controlling the current on the motors 134h, 134g to obtain the desired dispensing pressure through the first dispenser 102 and the second dispenser 104.

[0081] In comparison, Figure 3A graph depicting a balanced flow rate scheme is shown, in which the dispensing / injection flow rate is controlled and the pressure is any pressure derived from the controlled dispensing / injection flow rate. This scheme may be preferred to ensure a desired flow rate (or the number of embolic particle dispensing rates proportional to the flow rate of the embolic particle mixture 103, assuming a relatively constant concentration) of the embolic particle mixture 103 during embolization using the embolization system 100. Figure 3 As shown, in the balanced flow rate scheme, the distribution of the embolic particle mixture 103 by the first distributor 102 can be continuous during the distribution of the contrast agent injection 105 by the second distributor 104, in order to maintain the set flow rate of the embolic particle mixture. Also as... Figure 3 As shown, this results in an increase in injection pressure at the output of manifold 126 during the injection of contrast agent bolus 105. The embolization system 100 can operate in a balanced flow rate scheme by configuring controller 136 to control the flow rates of the first dispenser 102 and the second dispenser 104, for example, by controlling the actuation speed of the corresponding electric syringes 108a, 108b, i.e., the speed at which plungers 112a, 112b are advanced, which can be proportional to the speed of the corresponding motors 134g, 134h.

[0082] Now go to Figure 4 Another embodiment of the embolization system 200 will be disclosed. Embolization system 200 is identical to embolization system 100, except that the first distributor 102 and the second distributor 104 are not electrically operated syringes 108a, 108b, but rather a first pressurized distributor 202a and a second pressurized distributor 202b. Each of the first pressurized distributor 202a and the second pressurized distributor 202b includes pressure chambers 110a, 110b and pressure sources 204a, 204b. Pressure sources 204a, 204b may be a gas (e.g., internal compressed air) source, fluid pump, or pressure tank / container / chamber / bag for pressurizing pressure chambers 110a, 110b. Figure 4 As shown, pressure sources 204a and 204b can be located on the embolization system 200 or external to the embolization system 200. In the latter case, the embolization system 100 has a connector to connect pressure sources 204a and 204b to the external pressure sources 204a and 204b. Pressure reducing valves 206a and 206b and / or regulators can be used to control the pressure provided by pressure sources 206a and 206b to pressurize pressure chambers 110a and 110b.

[0083] The first pressurized distributor 202a and the second pressurized distributor 202b also include a first distribution valve 208a and a second distribution valve 208b at corresponding outlets 114a and 114b, respectively. The first distribution valve 208a and the second distribution valve 208b are operably connected to the controller 136 so that the controller can open and close the distribution valves 208a and 208b to distribute the corresponding fluids from the pressurized distributors 202a and 202b. The first and second pressurized distributors 202a and 202b operate to distribute pressurized flows of the embolic particle mixture 103 and the contrast agent 105 by pressurizing chambers 110a and 110b and subsequently opening the corresponding distribution valves 208a and 208b, and closing the corresponding distribution valves 208a and 208b to stop distributing the embolic particle mixture 103 and the contrast agent 105, respectively.

[0084] The monitoring and control of the embolization system 200 are the same as those described for embolization 100, except that dispensing is controlled by controlling the first and second pressurized dispensers 202a, 202b instead of the electric syringes 108a, 108b. Similarly, the use and operation of the embolization system 200 when performing embolization to embolize a target area of ​​tissue are the same as those of the embolization system 100, except that dispensing is performed by controllably operating the first and second pressurized dispensers 202a, 202b instead of the electric syringes 108a, 108b.

[0085] Now for reference Figure 5 Another embodiment of the embolization system 300 will be described below. The embolization system 300 is very similar to the embolization system 100, except that the embolization system 300 is configured to separately dispense embolic particles 302 (in a carrier fluid at a high concentration of embolic particles 302) and a delivery medium 304, and to mix the embolic particles and the delivery medium to prepare and dispense an embolic particle mixture 103. This is similar to the embolization system 100 described herein, wherein the first dispenser 102 includes a first sub-dispenser for dispensing embolic particles and a second sub-dispenser for dispensing the delivery medium, and the embolic particles and the delivery medium are mixed to produce an embolic particle mixture dispensed by the first dispenser 102. This allows the embolization system 300 to vary the concentration of the embolic particle mixture and also allows the user to selectively control the concentration of the embolic particle mixture. Figure 5This is a partial view of the embolization system 300 and does not show all details of the actuation mechanisms of the first sub-dispenser 306, the second sub-dispenser 308, and the second dispenser 104, nor does it show the manual on / off switches 138a, 138b or the controller 136. It should be understood that the actuation mechanisms of the first sub-dispenser 306, the second sub-dispenser 308, and the second dispenser 104 may be the same as or similar to the actuation mechanisms of the embolization system 100 (i.e., the electric syringes 108a, 108b) and / or the embolization system 200 (i.e., the pressurized dispensers 202a, 202b), as described herein. It should also be understood that the embolization system 300 includes manual on / off switches 138a, 138b and the controller 136 that are the same as or similar to those of the embolization systems 100 and 200, and that such elements function as described herein.

[0086] like Figure 5 As shown, the embolization system 300 includes a first sub-distributor 306 for distributing embolic particles 306. The combination of the first sub-distributor 306 and the second sub-distributor 308 can be considered as the first distributor 102 of the embolization system 300. The embolization system 300 also includes additional sensors 134 for the first and second sub-distributors 306 and 308, for sensing the properties of the fluid at the respective sensor 134 locations and outputting sensor signals associated with those properties. The additional sensors 134 are also operatively connected to the controller 136. A manual on / off switch 138 may include separate switches for actuating the first sub-distributor 306 and actuating the second sub-distributor 308, allowing a user to manually change the concentration of embolic particles 304 in the embolic particle mixture 103 by using these switches. Alternatively, a single manual switch 138a may actuate both the first sub-distributor 306 and the second sub-distributor 308, and the flow rates of the corresponding first sub-distributors 306 and second sub-distributors 308 may be controlled by the controller 136 to achieve a selected concentration. For example, a user can use input device 146 to select a concentration (which may be constant or variable, as described herein), and controller 136 can control the flow rates of the corresponding distributions of the first sub-distributor 306 and the second sub-distributor 308 to achieve the selected concentration.

[0087] The embolization system 300 also includes a mixer 310 connected to and in fluid communication with the outlet 128 of the manifold 126. The mixer 310 can be any suitable mixer configured to mix embolization particles 302 and delivery medium 304 and output the embolization particle mixture 103 through the outlet 312 of the mixer 310. The mixer 310 can be a passive mixer (such as a flow-induced mixer, a static mixer, or a vortex mixer) or an active mixer (such as a mixer with a moving mixing element, or a mixer with a non-moving mixing element having an acoustic transducer or a mechanical wave emitter).

[0088] The monitoring and control of the embolization system 300 are the same as those described for embolization 100, except that they add the function of separately dispensing embolic particles 306 via a first sub-dispenser 306 and separately dispensing the delivery medium 304 via a second sub-dispenser 308, and mixing the dispensed embolic particles 306 and delivery medium 304 to produce an embolic particle mixture 103 dispensed from the mixer and distributed into the catheter 130. Therefore, the controller 136 and software application 142 are also configured to change the concentration of the embolic particle mixture and allow the user to selectively control the concentration of the embolic particle mixture. As some embodiments, the controller 136 and software application 142 are configured to allow the user to select the concentration of the embolic particle mixture 103 using the input device 146, which can be a user-selected constant concentration or a variable concentration. The flow rate of the mixed embolic particle mixture 103 can also be selected by the user or set in a pre-programmed dispensing procedure. For example, controller 136 and software application 142 may include a preset program that changes the concentration during the embolization process, such as gradually increasing or decreasing the concentration during portions of the embolization process, and / or using a constant concentration during portions of the embolization process. The concentration variation can be within a user-selectable range of concentrations that define minimum and maximum concentrations, or minimum and maximum flow rates that define the number of embolic particles allocated (i.e., the number of embolic particles per unit time). Controller 136 can then determine the concentration of the embolic particle mixture 103 and the flow rate of the allocated embolic particle mixture 103 to achieve a programmed flow rate for the number of embolic particles.

[0089] Similarly, the use and operation of embolization system 300 in performing embolization to embolize a target area of ​​tissue is substantially the same as that of embolization system 100, except that embolic particles 302 and delivery medium 304 are separately dispensed via a first sub-dispenser 306 and a second sub-dispenser 308, and mixed to produce an embolic particle mixture 103 dispensed from mixer 310 and entering catheter 130, and the embolization system is capable of altering the concentration of embolic particles 302 in the embolic particle mixture 103 during the procedure. Catheter 130 is inserted and positioned at a target location near the target area of ​​the tissue to be embolized, as described herein with respect to embolization system 100. The first sub-dispenser 306 is filled with embolic particles 302, the second sub-dispenser 308 is filled with delivery medium 304, such as saline, water, and / or medication, and the second sub-dispenser 104 is filled with contrast agent 105 suitable for use with a visualization system to monitor the procedure. The user can then use embolization system 300 in manual or automatic mode to embolize a target area of ​​tissue.

[0090] In manual mode, the user actuates the first sub-dispenser 306 and the second sub-dispenser 308 as needed to dispense selected relative amounts of embolic particles 302 and delivery medium 304, thereby dispensing an embolic particle mixture 103 of selected concentration. For example, the relative amounts of embolic particles 302 and delivery medium 304 can be dispensed and mixed to produce an embolic particle mixture 103 having a low concentration of embolic particles in the range of 2.0%-0.05% or 1.0%-0.1% by volume relative to the embolic particle mixture 103. The user intermittently actuates the second dispenser 104 to intermittently dispense contrast agent boluses 105. The controller 136 can be configured to provide the user with dispensing information, such as the pressure, flow rate, and volume of the dispensed fluid. The allocation information may be displayed on a display 137 operatively connected to the controller 136 (e.g., the display 137 may be part of the controller 136), or provided to the user in some other suitable manner, such as by transmitting the allocation information to an external device (e.g., a computing device, such as a laptop computer, smartphone, etc.) via a communication link (e.g., a wired or wireless link, such as WiFi, Bluetooth, etc.). The user can use the allocation information to monitor and control the embolization procedure using the embolization system 100.

[0091] In one example of using the manual mode of the embolization system 300, the user operates a manual on / off switch 138a to actuate a first sub-dispenser 306 to dispense embolic particles 302 and actuates a second sub-dispenser 308 to dispense delivery medium 304 mixed in a mixer 310, thereby generating an embolic particle mixture 103 and dispensing it into a conduit 130, through which the embolic particle mixture 103 is delivered to a target area. The user can use a controller 136 to select the concentration of the embolic particle mixture 103, and the controller 136 then controls the relative amounts of embolic particles 302 dispensed by the first sub-dispenser 306 and delivery medium 304 dispensed by the second sub-dispenser 308 to produce the selected concentration. The controller 136 produces the selected concentration by controlling the relative flow rates of the embolic particles 302 dispensed by the first sub-dispenser 306 and delivery medium 304 dispensed by the second sub-dispenser 308. The user operates a manual on / off switch 138a to simultaneously actuate a first sub-dispenser 306 to dispense embolic particles 302 and actuate a second sub-dispenser 308 to dispense delivery medium 304. Embolic particles 302 and delivery medium 304 flow through manifold 126 and mix in mixer 310 to produce an embolic particle mixture 303 of a selected concentration. The embolic particle mixture 310 is injected into catheter 130 and flows through and out of the distal end of catheter 130 into a target area of ​​tissue. Alternatively, the user can manually and separately operate the first sub-dispenser 306 and the second sub-dispenser 304 to manually control the relative amounts of embolic particles 302 and delivery medium 304, thereby producing an embolic particle mixture 103 of manually controlled concentration. In this case, the manual on / off switch 138a may include separate switches for the first sub-dispenser 306 and the second sub-dispenser 308. Therefore, the user can control the flow rate of the dispensing embolized particle mixture 103 using switch 138a or by programming controller 136.

[0092] The user intermittently operates the manual on / off switch 138b to actuate the second dispenser 104, dispensing contrast agent 105 into catheter 130, through which the contrast agent 105 is delivered to the target area. While dispensing and ejecting the contrast agent 105 from the catheter at the target location, the user can track the contrast agent 105 as it is injected into the target area to observe and monitor the progress of embolism in the target area of ​​the tissue using a visualization system such as a fluorescence microscope or other suitable X-ray system adapted to detect contrast agents and anatomical structures within the patient and generate real-time images displayed on a monitor. The user can temporarily pause the dispensing of the embolic particle mixture 103 while dispensing the contrast agent 105, and then resume dispensing the embolic particle mixture 103 (or simply the delivery medium 304) to push the contrast agent 105 through catheter 130 and into the target area of ​​the tissue. Alternatively, the user may continuously dispense the embolic particle mixture 103 while simultaneously dispensing a contrast agent bolus 105.

[0093] On the other hand, the sub-dispenser operating mode can also be applied to the contrast agent 105. The system 100 can be configured to allow the user to select a set concentration of the contrast agent 105, and the system 100 is configured to dispense the contrast agent 105 from the second dispenser 104 and simultaneously dispense the delivery medium 304 from the second sub-dispenser 308, which is mixed in the mixer 310 to produce a set concentration of contrast agent dispensed by the system 100 into the catheter 130.

[0094] To use the embolization system 300 in automatic mode, the user uses the input device 146 to select desired operating parameters of the embolization system 300, such as the flow rate of the first distributor 102 and / or the second distributor 104, the pressure of the first sub-distributor 306, the second sub-distributor 308, and / or the second distributor 104, the on / off circulation of the embolic particle mixture 103 distributed by the first sub-distributor 306 and the second sub-distributor 308, and / or the distribution of the contrast agent 105 by the second distributor 104, the distribution of a clump of contrast agent 105 by the second distributor 104, and / or the circulation of the embolic particle mixture 103 distributed by the second distributor 104 (including the first distributor 102 and / or the second distributor 104). The timing duration and / or circulation rate of the on / off cycle of 04), the circulation time and / or dispensing of the contrast agent bolus 105 and the subsequent contrast agent bolus 105 between dispensings of 105 by the second dispenser 104, the size of the contrast agent bolus 105 of the second dispenser 104 (e.g., the volume or time of dispensing), the total amount of the embolization particle mixture 105 to be dispensed (by volume), weight or other suitable measurement), the total dispensing time of the embolization procedure, etc., or a pre-programmed dispensing procedure, and if necessary, the user setting the dispensing procedure can select any one or more features, such as flow rate, pressure, total amount of embolization particle mixture, injection frequency of contrast agent 105, etc.

[0095] The user then initiates the automated embolization procedure on the embolization system 300 by inputting a "start" command using input device 146. Controller 136 automatically operates the embolization system 300 to execute a selected automated embolization dispensing procedure using a first sub-dispenser 306, a second sub-dispenser 308, a second dispenser 104, sensor 134, valves, and regulator 148 controlled by controller 136. In a typical automated embolization procedure, the embolization system 300 simultaneously actuates the first sub-dispenser 306 to dispense embolic particles 302 and the second sub-dispenser 308 to dispense the delivery medium 304. Controller 136 controls the relative flow rates of the embolic particles 302 dispensed by the first sub-dispenser 306 and the delivery medium 304 dispensed by the second dispenser 308 to control the concentration of the embolic particle mixture and produce a concentration selected by the user or a pre-programmed dispensing procedure. The embolic particles 302 and the delivery medium 304 flow through a manifold and mix in mixer 310 to produce an embolic particle mixture 103 of the selected concentration. The embolic particle mixture 310 is injected into and flows through catheter 130 and out of the distal end of catheter 130 into the target area of ​​the tissue. The flow rate, pressure, and / or volume of the dispensed embolic particle mixture 103 is controlled by controller 136, which can be accomplished using a feedback control process based on sensor signals from any one or more of sensors 134a-134e. The embolization system 300 intermittently actuates the second dispenser 104 to dispense contrast agent bolus 105 into catheter 130 to inject contrast agent 105 into the target area, which can also be accomplished using a feedback control process based on sensor signals from any one or more of sensors 134a-134e.

[0096] When contrast agent 105 is injected from catheter 130 at the target location, the user can track the contrast agent 105 as it is injected into the target area and spreads through the target area of ​​the tissue to observe and monitor the progression of embolism in the target area of ​​the tissue using a visualization system such as a fluorescence microscope or other suitable X-ray system adapted to detect contrast agents and anatomical structures in the patient and generate real-time images displayed on a monitor.

[0097] Turning Figure 6 and Figure 7 Two different control schemes for distributing the embolization particle mixture 103 and contrast agent 105 using the embolization system 300 are described. Figure 6 and Figure 7 The control scheme shown is similar to Figure 2 and 3 The control scheme shown, except Figure 6 and Figure 7The control scheme is used outside of the embolization system 300, which has separate dispensers for embolization particles 302 and delivery medium 304. Figure 6 A diagram depicts a balanced pressure scheme in which the dispensing / injection pressure is controlled and the flow rate is any flow rate derived from the controlled dispensing / injection pressure. Balanced pressure schemes can be used to ensure that a safe pressure is always maintained for injecting fluid into a specific anatomical structure within a target area. Figure 6 As shown, in the balanced pressure scheme, the dispensing of embolic particles 302 by the first sub-dispenser 306 and the dispensing of the delivery medium 304 (i.e., the dispensing of the embolic particle mixture 103) by the second sub-dispenser 308 are paused during the dispensing of the contrast agent bolus 105 by the second dispenser 104. This maintains a substantially constant injection pressure within the mixer 310, where only a small pressure increase is possible during the injection of the contrast agent bolus 105. The embolization system 300 can be configured to operate using a balanced pressure scheme that uses a pressure reducing valve and / or regulator 148 and / or is configured with a controller 136 to control the dispensing to maintain a set dispensing / injection pressure. For example, a pressure reducing valve and / or regulator 148 may be provided to control the distribution pressure, and / or controller 136 may control the actuation force of the power injector 108 (in the case that dispensers 104, 306, 308 are power injectors), for example by controlling the current on motor 134 to obtain the desired distribution pressure through the first sub-distributor 306, the second sub-distributor 308 and the second distributor 104.

[0098] Compared to the pressure balancing scheme, Figure 7 A diagram depicts a balanced flow rate scheme in which the dispensing / injection flow rate is controlled and the pressure is any pressure derived from the controlled dispensing / injection flow rate. This scheme may be preferred to ensure a desired flow rate (or the amount of embolic particle dispensing rate, which is proportional to the flow rate of the embolic particle mixture 103, assuming a relatively constant concentration) of the embolic particle mixture 103 during embolization using the embolization system 300. Figure 7 As shown, in the balanced flow rate scheme, the distribution of embolic particles 302 by the first sub-distributor 306 is continuous during the distribution of contrast agent injection 105 by the second distributor 104, in order to maintain the set flow rate of the embolic particle mixture 103 (the distribution of the delivery medium 304 by the second sub-distributor 308 is paused). Figure 7As shown, this results in an increase in injection pressure at the output of manifold 126 during the injection of contrast agent bolus 105. The embolization system 300 can be configured to balance flow rate operation by configuring controller 136 to control the dispensing flow rates of the first sub-dispenser 306, the second sub-dispenser 308, and the second dispenser 104, for example, by controlling the actuation speed of the respective first and second sub-dispensers 306, 308, and the second dispenser 104.

[0099] The embolization system 300 can also be constructed with Figure 4 The distributor configuration of the embolization system 200 shown herein. In this embolization system, the first and second sub-distributors 306, 308 and the second distributor 104 include components described herein and Figure 4 The pressure distributor 200 shown is the same as or similar to the pressure distributor. The embolization system also includes a pressure source 204 and a distribution valve 208 for each of the first and second sub-distributors 306, 308 and the second distributor 104. The use and operation of the embolization system 300 with the pressure distributor are the same as those described for the embolization system 300, except that the distribution is controlled by controlling the pressure distributor 202 instead of the electric syringe 108. Similarly, the use and operation of the embolization system 300 with the pressure distributor are the same as those of the embolization system 300 when performing embolization to embolize a target area of ​​tissue, except that the distribution is performed by controllably operating the pressure distributor 202.

[0100] Now for reference Figure 8 and Figure 9 Now, a flow rectifier 400 for use with any of the embolization systems described herein, including embolization systems 100, 200, 300, and any of the disclosed variants, will be described. Figure 8 As shown, the embolic particles 302 in the embolic particle mixture 103 can aggregate and block at physical barriers and obstructions in the flow path, such as at constricted flow outlets, vascular junctions, etc. This aggregation and blockage can also reduce the effectiveness of embolization because the disordered and disjointed distribution of the embolic particles 302 in the embolic particle mixture 103 makes them prone to aggregation and blockage when encountering obstacles and obstructions.

[0101] To help prevent such aggregation and blockage, the embolization system disclosed herein may include a flow rectifier 400 that regulates the flow patterns of the embolic particles 302 and the delivery medium 304 and combines the two flows to "mix" the embolic particles 302 and the delivery medium 304 in a regular, specific configuration. Figure 9As shown, the flow rectifier 400 has a first fluid passage 410 (inner tube 410) located at the center of the device and a second fluid passage 412 (outer tube 412) having an annular cross-section surrounding the first fluid passage, such that the first fluid passage 410 and the second fluid passage 412 are coaxial. The first fluid passage 410 has a first inlet 402, which is connected to and in fluid communication with the outlet of the first sub-distributor 306. The first fluid passage 410 has a tapered first outlet 414, which is located at the center of the tapered second outlet 416 of the second fluid passage 412.

[0102] The first fluid passage 410 is configured to rectify the flow of the embolic particles 302 as they flow through the first fluid passage 412, to produce a more uniform pattern and consistent flow velocity of the embolic particles 302 at the first outlet 414. This uniform pattern may be a single-row alignment of the embolic particles 302, or a flow with a very small number of embolic particles 302 spanning the diameter of the outlet 414, such as less than 5 embolic particles 302, less than 10 embolic particles, or less than 20 embolic particles.

[0103] The second fluid path 410 is configured to rectify the flow of the delivery medium 304 into a uniform laminar flow pattern at the second outlet 416. Therefore, when the rectified flow of embolic particles 302 and the rectified flow of the delivery medium 304 combine at the respective first outlet 414 and second outlet 416, an embolic particle mixture flow 103 is generated, which has a sheath flow 420 with a uniform and aligned flow pattern of the delivery medium 304 surrounding the embolic particles 302. Depending on the configuration of the flow rectifier 400, the sheath flow 420 surrounding the embolic particles 302 can be formed in a two-dimensional (2D), three-dimensional (3D), or cylindrical symmetrical form. The combination of the cylindrical shear flow 420 of the central flow of the embolic particle flow 420 surrounding the embolic particles 302 helps to prevent the embolic particles 302 from making corrective contact with the surrounding walls, cylindrical materials, and conduits in a single tandem or low particle count profile. This reduces interference from unrectified injection of the embolic particle mixture 103, thereby preventing or reducing the incidence of blockage by random clumps formed by the circulation and turbulence of the flow. Furthermore, due to the rectification and alignment of the embolic particles 302 by the flow rectifier 400, passive or active measurements can be applied to predict or count the number of embolic particles 302 being dispensed. The controller 136 can use this counting to control the dispensing of the embolic particle mixture 103, resulting in more predictable treatment control. Organized / rectified laminar flow not only reduces interference from uncontrolled mixing but also provides a uniform distribution of the embolic particles 302 throughout the delivery along the flow field or pressure gradient.

[0104] Flow rectifier 400 is not limited to Figure 9The illustrated embodiment could be replaced by other suitable types of rectifiers, such as those utilizing microchannels, fluid chips, microgrooves, or microstructures to provide a uniform distribution of embolic particles 302 within the flow of the dispensed embolic particle mixture 103. Fluid chips or fluid microchannels could also be used to mix and prepare the embolic particles 302, the embolic particle mixture 103, and / or the contrast agent 105, subsequently filling the dispenser of the embolization system and connecting the embolization system to a catheter for embolization.

[0105] Turn now Figure 10The distal end of an embolization system 500 with different catheters for dispensing an embolic particle mixture 103 and a contrast agent 105 is shown. The embolization system 500 may be configured similarly to any of the embolization systems 100, 200, 300 and disclosed variants, except that the system 500 has a first catheter 502 for dispensing the embolic particle mixture 103 and a second catheter 504 for dispensing the contrast agent 105. The embolization system 500 may also include a catheter connector 506 and a first connector 510 and a second connector 512 for coaxially coupling and sealing the first catheter 502 and the second catheter 504 to the first dispenser 120 and the second dispenser 104. For example, the catheter connector 506 may be a rotary hemostatic valve (RHV) or a Touhy-Borst connector. In the illustrated embodiment, the first conduit 502 may be a microcatheter, and the second conduit 504 may be a guide conduit, configured such that the first conduit 502 can be inserted into the lumen of the second conduit 504, such that the first conduit 502 and the second conduit 504 are coaxial. A first connector 510 is disposed on the distal end of the first fluid conduit 514, which is in fluid communication with the first dispenser 102. The first connector 510 is configured to attach to the proximal end of the first conduit 502. A second connector 512 is disposed on the distal end of the second fluid conduit 516, which is in fluid communication with the second dispenser. The second connector 512 is configured to attach to a first connector 518 of a conduit connector 506. The conduit connector 506 has a second connector 520, which is configured to attach to the proximal end of the second conduit 504. The conduit connector 506 also has a compression connector 524, which is configured to receive the first conduit 502 to form a fluid seal around the first conduit 502. A first catheter 502 is inserted through a compression fitting 524 and into the lumen of a second catheter 504, thereby forming an annular flow path 522 between the first catheter 502 and the second catheter 504. A catheter fitting 506 has a fluid flow path 526 that fluidly connects a second fluid catheter 516 to the annular flow path 522. The first catheter 502 is connected to and in fluid communication with a first dispenser, and the second catheter 504 is connected to and in fluid communication with a second dispenser 102 via the annular flow path 522. Therefore, the first dispenser 102 can dispense the embolic particle mixture 103 through the lumen of the first catheter 502, and the second dispenser 104 can dispense contrast agent through the annular flow path 522 to corresponding outlets at the distal ends of the respective first catheter 502 and second catheter 504. The embolization system 500 may have any of the features and aspects described herein with respect to embolization systems 100, 200, and 300.

[0106] Aside from the placement and function of the first catheter 502 and the second catheter 504, the use and operation of the embolization system 500 in performing embolization to embolize a target area of ​​tissue are substantially the same as those of the corresponding embolization systems 100, 200, and 300. In one method, the second catheter 504 is used as a guide catheter 504 and is inserted and advanced through the vascular system to a target location near the target area of ​​the tissue to be embolized, as described herein. The second catheter 504 is connected to the catheter connector 506 by connecting its proximal end to a second connector 520. The first catheter 502 is then inserted into the lumen of the second catheter 504 via a compression fitting 524 of the catheter connector 506 and advanced through the lumen of the second catheter 504 to the target location. Alternatively, the first catheter 502 may be inserted first and advanced to the target location, and then used similarly to a guidewire. The second catheter 504 is then advanced over the first catheter 502, which is located within the lumen of the second catheter 504. Before or after advancing the second catheter 504 over the first catheter 502 to the target position, the proximal end of the second catheter 504 is connected to the second connector 520 of the catheter connector 506. The first connector 510 is connected to the proximal end of the first catheter 502, and the second connector 512 is connected to the first connector of the catheter connector 506 to connect the embolization system 500 to the first catheter 502 and the second catheter 504.

[0107] Then, the embolization system 500 is operated as described above for the respective embolization systems 100, 200 and 300 in manual mode, automatic mode or any other suitable manner.

[0108] Various aspects of this disclosure are described below with reference to the accompanying drawings. It should be noted that the drawings are not drawn to scale, and elements with similar structures or functions are indicated by the same reference numerals throughout the drawings. It should also be noted that the drawings are intended only to facilitate description and are not intended to be an exhaustive description of this disclosure or a limitation on the scope of this disclosure, which is defined only by the appended claims and their equivalents. Furthermore, each illustrated aspect does not need to possess all the features or advantages of the aspects described herein. Features or advantages described in connection with a particular aspect of this disclosure are not necessarily limited to that aspect and can be practiced with any other aspect, even if not stated otherwise.

Claims

1. A system for dispensing embolic particles into a catheter for delivery into a patient to embolize a target area, comprising: A first dispenser is used to dispense a mixture of embolic particles into a catheter, the mixture comprising embolic particles and a delivery medium, the first dispenser being electronically controllable to automatically control the dispensing of the embolic particle mixture; A second dispenser is used to dispense contrast agent into the catheter. The second dispenser is electronically controlled to automatically control the dispensing of the contrast agent. as well as A controller, operably coupled to the first dispenser and the second dispenser, is configured to automatically control the first dispenser and the second dispenser to controllably dispense the embolic mixture from the first dispenser and controllably dispense the contrast agent from the second dispenser.

2. The system of claim 1, wherein the first dispenser includes a first power injector configured to controllably dispense a pressurized flow of the embolic particle mixture from the first dispenser, and the second dispenser includes a second power injector configured to controllably dispense a pressurized flow of the contrast agent from the second dispenser.

3. The system according to claim 2, wherein, The first dispenser includes a first power injection cartridge, and the second power injector includes a second power injection cartridge.

4. The system of claim 1, wherein the first dispenser comprises a first sub-dispenser for dispensing embolic particles into the mixer and a second sub-dispenser for dispensing the delivery medium into the mixer; and The system further includes a mixer in fluid communication with the first sub-distributor and the second sub-distributor, the mixer being configured to mix the embolic particles and the delivery medium and output the embolic particle mixture.

5. The system of claim 4, wherein the first sub-dispenser includes a first powered injector configured to controllably dispense a pressurized flow of embolic particles into the mixer, the second sub-dispenser includes a second powered injector configured to controllably dispense a pressurized flow of a delivery medium into the mixer, and the second dispenser includes a third electric injector configured to controllably dispense a pressurized flow of contrast agent from the second dispenser.

6. The system of claim 1, wherein the controller is optionally programmed to control one of dispensing the embolic particle mixture via the first dispenser and dispensing the contrast agent via the second dispenser.

7. The system according to claim 6, wherein, The distribution characteristics of the first distributor and the second distributor are at least one of the following: the distribution flow rate, the distribution pressure, and the distribution volume.

8. The system of claim 6, further comprising a first sensor operatively connected to the controller and configured to detect an attribute of the allocation via at least one of the first and second allocators and output a first sensor signal associated with the attribute, wherein the controller is configured to use a feedback control process that utilizes the first sensor signal to control the allocation of at least one of the first and second allocators.

9. The system according to claim 8, in, The first sensor includes one of a flow rate sensor, a pressure sensor, a force sensor, a torque sensor, and a current sensor. The allocated attribute is one of the injection flow rate and injection pressure allocated to the catheter by at least one of the first and second dispensers, and the controller uses the feedback control process to control at least one of the first and second dispensers to achieve predetermined characteristics allocated to the catheter. The predetermined characteristics assigned to the catheter include one or more of the flow rate, pressure, and concentration of the assigned mixture of embolic particles or contrast agent.

10. The system according to any one of claims 1-9, wherein, The controller is configured to automatically perform the following processes, including: Dispensing the embolic particle mixture at a predetermined flow rate controlled by the controller; and The contrast agent is intermittently injected at a predetermined flow rate controlled by the controller.

11. The system according to any one of claims 1-10, further comprising a flow rectifier having an inlet and a rectifier outlet, the inlet being connected to and in fluid communication with the outlet of the manifold, the flow rectifier being configured to adjust the flow pattern of the embolic particle mixture as it flows through the rectifier to produce a more uniform flow of the embolic particles within the delivery medium.

12. The system of claim 11, wherein the rectifier is configured to generate a laminar flow of the embolic particle mixture, wherein the embolic particles are aligned at the outlet of the rectifier adjacent to the centerline of the flow of the embolic particle mixture.

13. The system according to any one of claims 1-12, further comprising a manifold fluidly connected to both the first distributor and the second distributor, such that the first distributor and the second distributor dispense into the manifold, the manifold having an outlet for dispensing from the manifold.

14. The system according to any one of claims 1-13, further comprising: A first conduit, which is in fluid communication with the first distributor; as well as The second conduit is in fluid communication with the second distributor. The first catheter can be inserted into the lumen of the second catheter, such that the first dispenser is configured to dispense the mixture of embolic particles into the first catheter, and the second catheter is configured to dispense the contrast agent into the annular flow path formed between the first catheter and the second catheter.

15. The system of claim 14, further comprising: A first connector, the first connector being used to connect to the proximal end of the first catheter to fluidly connect the first dispenser to the first catheter; and A second connector is used to connect to a conduit connector to connect the second distributor fluid to the annular flow path. in, The catheter connector includes a first connector for connecting to the second connector, a second connector for connecting to the proximal end of the second catheter, and a compression connector for receiving the first catheter and forming a fluid seal around the first catheter. The conduit connector includes a fluid flow path that fluidly connects the first connector to the annular flow path.

16. The system according to any one of claims 1-15, wherein, The embolic particle mixture has a low concentration of embolic particles relative to the embolic particle mixture, ranging from 2.0% to 0.05% by volume.

17. The system according to any one of claims 1-16, wherein, The controller is configured to be triggered by manual input from the user to actuate the second dispenser to dispense the contrast agent.

18. The system according to any one of claims 1-16, wherein, The controller is configured to automatically initiate the dispensing of the contrast agent by the second dispenser.

19. A method for embolizing a target region of tissue within the body, the method comprising: An embolic particle mixture, comprising embolic particles and a delivery medium, is injected into a target area of ​​the tissue via a catheter. The injection of the embolic particle mixture is automatically controlled by a controller. Contrast agent is intermittently injected into the target blood vessel via the catheter to monitor the progression of embolism in the target area of ​​the tissue on a visualization system, the injection of the contrast agent being automatically controlled by a controller.

20. The method of claim 19, wherein the injection of the embolic particle mixture is paused during the injection of the contrast agent bolus.

21. The method according to claim 19 or 20, wherein, The embolic particle mixture is a premixture of embolic particles and a delivery medium disposed in the first dispenser.

22. The method according to any one of claims 19-21, wherein the embolic particle mixture is dispensed by a first dispenser configured to dispense the embolic particle mixture into the catheter, and the contrast agent is dispensed by a second dispenser configured to dispense the contrast agent into the catheter.

23. The method of claim 22, wherein the first dispenser comprises a first power injector configured to controllably dispense a pressurized flow of the embolic particle mixture from the first power injector, and the second dispenser comprises a second power injector configured to controllably dispense a pressurized flow of the contrast agent from the second power injector.

24. The method of claim 23, wherein the first dispenser comprises a first power injection cartridge, and the second power injector comprises a second power injection cartridge.

25. The method according to claim 19 or 20, wherein, The first dispenser includes a first sub-dispenser for dispensing the embolic particles into a mixer and a second sub-dispenser for dispensing the delivery medium into the mixer, wherein the mixer is configured to mix the embolic particles and the delivery medium and output the embolic particle mixture into the catheter.

26. The method of claim 25, wherein, The second dispenser is configured to dispense the contrast agent into the mixer, and the second sub-dispenser dispenses the delivery medium into the mixer, the second dispenser dispensing the contrast agent into the mixer to produce a contrast agent mixture.

27. The method according to claim 25, wherein, The first sub-dispenser includes a first powered injector configured to controllably dispense a pressurized flow of embolic particles into the mixer; the second sub-dispenser includes a second powered injector configured to controllably dispense a pressurized flow of delivery medium into the mixer; and the second dispenser includes a third powered injector configured to controllably dispense a pressurized flow of contrast agent from the second dispenser.

28. The method according to any one of claims 22-27, wherein, The first dispenser is an automatic controller configured to controllably dispense the embolic particle mixture into the catheter, and the second dispenser is an automatic dispenser configured to controllably dispense the contrast agent into the catheter.

29. The method of claim 28, wherein the controller is triggered by manual input from the user to actuate the second dispenser to dispense the contrast agent into the catheter.

30. The method of claim 28, wherein the controller automatically initiates the dispensing of the contrast agent by the second dispenser.

31. The method according to any one of claims 28-30, in, The controller is programmable to control the dispensing of the embolic particle mixture via the first dispenser and the dispensing of the contrast agent via the second dispenser, and The feature of the distribution through the first distributor and the second distributor is at least one of the distribution flow rate, the distribution pressure, and the distribution volume.

32. The method of claim 31, further comprising: The controller receives a first sensor signal from a first sensor, the first sensor signal being related to attributes allocated through the first distributor and the second distributor; and The controller uses a feedback control process based on the first sensor signal to control the allocation of the first distributor and the second distributor. in, The first sensor includes one of a flow rate sensor, a pressure sensor, a force sensor, a torque sensor, and a current sensor.

33. The method of claim 32, wherein the attribute of the dispensing is one of the injection flow rate and injection pressure dispensed into the catheter by the first dispenser and the second dispenser, and the controller uses the feedback control process to control the first dispenser and the second dispenser to achieve predetermined characteristics of dispensing into the catheter.

34. The method of claim 33, wherein the predetermined characteristics dispensed into the catheter include one or more of the flow rate, pressure, and concentration of the dispensed mixture of embolic particles or contrast agent.

35. The method according to any one of claims 19-34, wherein the embolic particle mixture has a low concentration of embolic particles relative to the embolic particle mixture in the range of 2.0%-0.05% by volume.

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