Patent Description:
In cancer treatments involving radiation therapy, inadvertent or excess exposure to radiation from radioactive therapeutic agents can be harmful and potentially lethal to patients or medical personnel. Accordingly, medical instruments for radiation therapies must be configured to localize the delivery of radioactive material to a particular area of the patient's body while shielding others from unnecessarily being exposed to radiation.

Transarterial radioembolization is a transcatheter intra-arterial procedure performed by interventional radiology and is commonly employed for the treatment of malignant tumors. During this medical procedure, a microcatheter is navigated into a patient's liver where radioembolizing microspheres loaded with a radioactive compound, such as yttrium-<NUM> (<NUM>Y), are delivered to the targeted tumors. The microspheres embolize blood vessels that supply the tumors while also delivering radiation to kill tumor cells.

Generally, medical devices for performing radioembolization procedures require multiple syringes, external tubing, a vial containing the radioactive compound, and a bulky shield assembly for containing and shielding the radioactive vial. Such devices typically involve time consuming and labor-intensive setup procedures. The complex devices are commonly stationary and thereby limit a physician's mobility in an operating room to within a certain proximity of the device.

Routine manipulation of a product container storing radioactive material during radioembolization procedures generally requires a Nuclear Medicine Technician, who handles the material with forceps or tweezers. This process involves further potential of exposing additional medical personnel to radioactivity, and contaminating the operating room. Syringes for manually administering the radioactive compound as an administered fluid are prone to inconsistent flow rates and pressures. Insufficient injection rates result in decreased bead dispersion, which may impact efficacy of the treatment.

Accordingly, a need exists for a medical device that is configured and operable to perform radioembolization that incorporates a simplistic design and consistent means for administering and monitoring constant flow rates and pressure of the radioactive compound to the patient's body. A simplified device provides a physician enhanced maneuverability in the operating room during the medical procedure, including an ability to reposition the device about the patient as desired. Additionally, a device with enhanced shielding of the radioactive material enables greater protection to a physician utilizing the medical device while treating a patient.

<CIT>relates to an apparatus having a syringe housing. A plunger has a shaft, wherein the plunger is slidably received within the syringe housing between a first and second position. A Hall sensor is disposed within the shaft and a magnet is fixed proximate the syringe housing.

<CIT>relates to a "Smart Microcatheter" (SMC) system comprising a device for controlled particle release and drug delivery into a blood vessel, hepatic artery or any patho-physiological target. This document further describes methods of using the micro-catheter system for optimal targeted delivery of therapeutic microspheres comprising using subject-specific computer simulations of particle-hemodynamics.

<CIT> relates to a controller for closed loop control of infusion devices. A variety of infusion systems are described that use the closed loop control architecture. In some examples, the closed loop control may be adapted to current commonly used infusion means such as a gravity feed intravenous system. Other examples describe infusion pump system that use biasing or drive mechanisms of springs, elastomers, rotary and linear motors.

The present invention provides a method and system for determination of flow parameters of administered fluid from a radioembolization delivery device as set out in claims <NUM> and <NUM>.

In one implementation, a method for determination of flow parameters of administered fluid from a radioembolization delivery device may include translationally moving a device delivery arm of the radioembolization delivery device in a translational direction. The device delivery arm may be coupled to a syringe holder such that movement in the translational direction one of proximally or distally advances the syringe holder. The method may further include sensing, via one or more pattern sensors, a corresponding movement of a pattern associated with the translational device delivery arm movement as a sensed pattern movement, generating, via the one or more pattern sensors, one or more output signals based on the sensed pattern movement, and generating, via a processor, at least one of a flow rate of the administered fluid, a flow amount of the administered fluid, or the translational direction of movement of the device delivery arm with respect to the syringe holder based on the one or more output signals.

In another implementation, a system for determination of flow parameters of administered fluid from a radioembolization delivery device may include a radioembolization delivery device including a device delivery arm coupled to a syringe holder, a pattern assembly, and one or more pattern sensors configured to detect the pattern assembly based on movement of the pattern assembly, and the device delivery arm configured to move in a translational direction to one of proximally or distally advance the syringe holder, and a processor communicatively coupled to the radioembolization delivery device and a non-transitory computer storage medium. The non-transitory computer storage medium stores instructions that, when executed by the processor, cause the processor to: monitor translational movement of the device delivery arm of the radioembolization delivery device in the translational direction; sense, via the one or more pattern sensors, a corresponding movement of the pattern assembly associated with the translational device delivery arm movement as a sensed pattern movement; generate, via the one or more pattern sensors, one or more output signals based on the sensed pattern movement; and generate at least one of a flow rate of the administered fluid, a flow amount of the administered fluid, or a direction of movement of the device delivery arm with respect to the syringe holder based on the one or more output signals.

These and additional features provided by the implementations described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.

Referring generally to the figures, embodiments of the present disclosure are directed to systems and methods for determination of flow parameters of administered fluid from radioembolization delivery devices as described herein. Various embodiments of such systems and methods are described in detail herein.

Radioembolization involves a combination of (<NUM>) radiation therapy using ionizing radiation to kill cancer cells and shrink tumors and (<NUM>) an embolization procedure to occlude blood vessels feeding a tumor and thus to treat, for example, cancer of the liver. Radioembolization is directed to placement of a radioactive material directly inside a patient body, which form of treatment is called internal rational therapy. In radioembolization, tiny glass or resin beads called microspheres (or spheres) are placed inside blood vessels feeding a tumor to block (e.g., occlude) the supply of blood to cancer cells. Once the microspheres filled with the radioactive isotope yttrium Y-<NUM> become lodged at a tumor site, the lodged microspheres deliver a high dose of radiation to the tumor and not to normal tissues. Delivery of microspheres including mixing of the microspheres with a diluent, which is injected as an administered fluid into a patient using a syringe-holder delivery apparatus, such as described in <CIT> and <CIT>. An administration flow rate that equals a vascular flow rate of a subject is generally desired, and a flow rate may be estimated by a clinician performing the radioembolization procedure. The clinician may further manually keep track of a number of boluses administered through the procedure to determine a total volume.

The embodiments described herein are directed to radioembolization delivery devices including pattern sensor assemblies to sense one or more patterns within the delivery devices to generate pattern signals from which to automatically generate and determine flow parameters such as flow rate of a therapeutic fluid, flow amount of the therapeutic fluid, and/or a direction of travel of a device delivery arm coupled to the syringe holder that administers the therapeutic fluid. Thus, the embodiments described herein aid in the therapeutic fluid delivery procedure by determining and displaying information of a volumetric flow rate an a total infused volume through use of non-invasive pattern sensors removed from a fluid path and configured to determine a syringe plunger position and actuation direction during the administration procedure, as described in greater detail further below. The device delivery arm may translate to advance the syringe to administer fluid, whether through a direct translation or through a rotation that effects a translation, where such translation and/or rotation may be monitored by the sensors and/or systems described herein. Further, corresponding direction and/or speed of travel of the delivery device arm based on the monitored information may be displayed through the systems described herein. The delivery device arm and/or pattern sensor embodiments described herein include one or more technical effects directed to high reliability, increased accuracy, and low energy consumption based on pattern detection from alternating set sequences to determine output parameters, such a measurement of a change of liquid volume in a syringe based on a sensed pattern indicating movement in a distal direction to advance the syringe, as described in one or more embodiments herein.

In embodiments, attachment of a gear to a threaded plunger (e.g., a device delivery arm) that also includes a ring portion having a plurality of spaced rings in a pattern assists to sense rotational direction and distance via a quadrature encoder to determine a stopper position and velocity to calculate flowrate. Referring to <FIG>, a radioembolization delivery device <NUM> with a translational and/or rotational plunger to administer therapeutic fluid, such as a radioactive compound for a radioembolization procedure, is shown. The radioembolization delivery device <NUM> includes a device delivery arm <NUM> configured to translationally (e.g., linearly) move in a direction of an arrow A or of an arrow B, opposite to the arrow A, along a longitudinal axis LA of the device delivery arm <NUM> of the radioembolization delivery device <NUM>. The device delivery arm <NUM> may be coupled to a syringe holder (not shown but disposed within a housing <NUM> of the radioembolization delivery device <NUM>) such that movement in the translational direction one of proximally or distally advances the syringe holder. The radioembolization delivery devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> described herein similarly may affect a translational motion in either the direction of the arrow A or the arrow B along the longitudinal axis LA of the respective device delivery arms <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, as well as a counter-clockwise or a clockwise rotation around the respective longitudinal axis LA. The radioembolization delivery devices <NUM>, <NUM>, <NUM>, <NUM> described herein similarly may affect a translational motion in either the direction of the arrow A or the arrow B along the longitudinal axis LA of the respective device delivery arms <NUM>, <NUM>, <NUM>, <NUM>, as will be described in greater detail further below.

The device delivery arm <NUM> of the radioembolization delivery device <NUM> may further be configured to rotate about the longitudinal axis LA. The device delivery arm <NUM> may include a handle <NUM>, a ring portion <NUM>, and a threaded portion <NUM>. In embodiments, the device delivery arm <NUM> may be approximately twice a length of the threaded portion <NUM>, and a housing may include a support board, sensors, as the like as described herein. Further, the device delivery arm <NUM> may include a button <NUM> configured to allow for direct translation movement without rotation of device delivery arm <NUM> upon being pressed. As a non-limiting example, pressure upon the button <NUM> may unlatch an internal feature from the threaded portion <NUM>, allowing the threaded portion <NUM> to glide past an internal surface of the housing <NUM> such the device delivery arm <NUM> does not require a rotation to affect a translational motion.

Referring to <FIG>, the ring portion <NUM> includes a ring pattern formed through a series of spaced apart ring features projecting from the device delivery arm <NUM> at a set pattern with a spacing distance width between adjacent rings. A gear assembly <NUM> is configured to detect the ring pattern of the ring portion <NUM> through a tooth connection of the gear assembly <NUM> with each projecting ring feature to turn a top gear 112A and effect a corresponding rotation of a rotary wheel encoder 112B coupled to the top gear 112A. The rotary wheel encoder 112B includes a pattern <NUM> that is sensed by a pattern sensor that may be disposed in a clamp <NUM> of a support board <NUM> configured to hold the gear assembly <NUM> in a position in the radioembolization delivery device <NUM>. Translation of the device delivery arm <NUM> in the direction of the arrow A turns the top gear 112A in a counter-clockwise direction, while translation of the device delivery arm <NUM> in the direction of the arrow B turns the top gear 112A in a clock-wise direction.

In some aspects, a ferrous object is embedded in a plunger rod (e.g., the device delivery arm) and sensors are placed and configured to sense variations in volume of the ferrous object as the ferrous object translates, which changes a level of a signal response to track a corresponding pattern in the translating ferrous object. Based on the order and frequency of the signal level changes, a direction and linear velocity of the device delivery arm including the embedded ferrous object may be determined. Referring to <FIG>, a radioembolization delivery device <NUM> includes a device delivery arm <NUM> projecting from a housing <NUM>, disposed in an arm enclosure <NUM>, and held therein via a clamp <NUM>. The device delivery arm <NUM> includes a ring portion <NUM> embedded within a threaded portion <NUM>, as shown in <FIG>. Pattern sensors <NUM>, <NUM> configured to detect a pattern of the ring portion <NUM> are disposed to face the ring portion <NUM>.

The ring portion <NUM> may be made of a magnetic or ferrous object disposed within the device delivery arm <NUM> and configured to be sensed by the pattern sensors <NUM>, <NUM>. The ring portion <NUM> may include a ball bearing and/or pattern rode disposed in a center of the device delivery arm <NUM> with inductive sensors disposed on an exterior of the device delivery arm <NUM>. Additionally or alternatively, the pattern sensors may be Hall effect sensors configured to measure a magnitude of a magnetic field associated with sensed portions of the ring portion <NUM> to sense a detected pattern of the ring portion <NUM>. A pair of reflective sensor components may be disposed opposite the pattern sensors <NUM>, <NUM> to reflect back a transmitted signal. The pattern sensors <NUM>, <NUM> may be disposed on and coupled to a printed circuit board configured to sense output signals from the pattern sensors <NUM>, <NUM> with respect to the detected pattern of the ring portion <NUM>.

An output voltage of a Hall effect sensor is directly proportional to a magnetic field strength through the Hall effect sensor, and a proximal magnetic or ferrous material, such as a projecting ring of the ring portion <NUM>, would cause a different magnetic field detection by a Hall effect sensor than a gap between a pair of projection rings of the ring portion <NUM>. By the sensing of one of the pattern sensors <NUM>, <NUM> of a projecting ring and the sensing of the other of the pattern sensors <NUM>, <NUM> of a gap between projecting rings, where a spacing between the projecting rings of the ring portion <NUM> is known, a direction of travel and amount traveled may be generated and used to generate associated flow parameters for fluid administration by the radioembolization delivery device <NUM>. In contrast to inductive sensors, which respond to a dynamic magnetic field that induces a current in a coil of wire to produce a voltage output, Hall effect sensors detect static magnetic fields through a thin metal strip having an applied current such that, in the presence of a magnetic field, the electrons in the thin metal strip deflect to an edge and produce a voltage gradient perpendicular to a feed current.

While Hall effect sensors are described as an embodiment of the pattern sensors <NUM>, <NUM>, it is contemplated and within the scope of this disclosure that inductive sensors, optical sensors, switch-sensors, magnetic sensors, and the like may be used to sense the ring pattern of the ring portion <NUM> of <FIG>. By way of example, and not as a limitation, the pattern sensors <NUM>, <NUM> may be optical sensors configured to detect a different light reflectivity associated with each projecting ring and each gap between projecting rings of the ring portion <NUM>. In embodiments, an external placement of the ring portion <NUM> may also be detected by the pattern sensors <NUM>, <NUM> may be optical sensors as one or more optical sensors configured to detect an external pattern including a projecting and a gap and a predetermined distance disposed therebetween.

In an embodiment, an encoded wheel or one or more cylinders may engage with a device delivery arm surface to sense a rotational and translation motion of the device delivery arm, and both motions may be sensed through a single omni wheel assembly. Referring to <FIG>, a radioembolization delivery device <NUM> including an omni wheel assembly <NUM> is shown. The omni wheel assembly <NUM> is configured to engage with a surface of a threaded portion <NUM> of the device delivery arm <NUM> such that a translation motion the device delivery arm <NUM> rotate an omni wheel <NUM> of the omni wheel assembly <NUM>, which effects through connection via a rod <NUM> a corresponding rotation of an encoder wheel <NUM> including a pattern <NUM> that is sensed by at least one pattern sensor (not shown). In embodiments, the device delivery arm <NUM> is contained within a housing of the radioembolization delivery device <NUM> through a clamp <NUM>, and the omni wheel assembly <NUM> is contained within the housing through a clamp <NUM>. Rotation of the omni wheel assembly <NUM> effecting a rotation of the encoder wheel <NUM> in turned causes a rotation of the pattern <NUM> of the encoder wheel <NUM> that is sensed by at least one pattern sensor, which may be an optical wheel sensor, an inductive sensor, a capacitance sensor, and the like to detect the pattern <NUM> and generate a flow rate, flow amount, and direction of travel based on the detected pattern <NUM>.

In embodiments, encoding of conductive rods that connect to a circuit and act as an electrical switch assist to determine a sensed pattern. The rods may be connected to a collar feature that is free to rotate about a center axis as the device delivery arm is rotated to keep the rods in a sensing area. As the device delivery arm translates either by a lead or axial load, the rods close the electrical circuit. Through the generated order and frequency of switching information, a direction and linear velocity of the device delivery arm may be determined. Referring to <FIG>, a radioembolization delivery device <NUM> includes a conductive rod assembly including a pair of conductive rods <NUM>, <NUM> projecting from a clip feature <NUM> disposed about the device delivery arm <NUM> extending from a housing <NUM> and disposed in an enclosure <NUM>. The clip feature <NUM> may be a slip ring or other fastening to attached the pair of conductive rods <NUM>, <NUM> to the device delivery arm <NUM> such that the pair of conductive rods <NUM>, <NUM> move together with the device delivery arm <NUM> while rotation of the delivery arm <NUM> does not cause a rotation of the clip feature <NUM> or the pair of conductive rods <NUM>, <NUM>. The device delivery arm <NUM> includes a threaded portion <NUM> and is configured for rotational and/or translational movement along and about a longitudinal axis of the device delivery arm <NUM>. The conductive rod <NUM> includes an alternating pattern <NUM>, and the conductive rod <NUM> includes an alternating pattern <NUM>.

Referring to <FIG>, the alternating pattern <NUM> includes a high feature 444A and a low feature 444B detected by lead switches <NUM>, <NUM> upon contact. Similar, the alternating pattern <NUM> includes a high feature 454A and a low feature 454B detected by lead switches <NUM>, <NUM>. The lead switches <NUM>, <NUM>, <NUM>, <NUM> may include electrical contacts such as metal plate switches configured to contact the alternating patterns to be switch on and off per high and low readings as described herein. The lead switch detection may result in an on/off wave form that follows a binary model and forms a step-like wave form. In embodiments, the alternating patterns <NUM>, <NUM> may be sensed by one or more other pattern sensors including, but not limited to, Hall effect sensors, magnetic sensors, optical sensors, and the like and may generate a range of non-binary signals to form a sine-like wave form. The pattern sensors may detect quadrature signals disposed <NUM> degrees apart from the alternating patterns <NUM>, <NUM>. As a non-limiting example, when the lead switch <NUM> contacts a low feature 444B of the alternating pattern <NUM> indicative of a closed switch, the opposing lead switch <NUM> contacts a high feature 454A of the alternating pattern <NUM> indicative of an open switch.

In an embodiment, an encoded rack and pinion assembly includes a pinion attached to a rotary quadrature encoder and a rack attached to a translating device delivery arm via a collar feature that is not constrained to the rotation of the device delivery arm. Thus, the collar feature prevents the rack and pinion assembly from rotating while allowing for a translation free as the device delivery arm is rotated and/or translated. Referring to <FIG>, a radioembolization delivery device <NUM> is shown that includes a rack and pinion rod assembly <NUM> that includes a pinion <NUM> rotatable by movement of a rack <NUM> in a translational direction and attached to a rotary encoder <NUM> including a pattern <NUM> configured for detection by a sensor (not shown). The radioembolization delivery device <NUM> includes a device delivery arm <NUM> extending from a housing <NUM> and enclosed in an enclosure <NUM> including clamps <NUM> to contain internal components. A pair of rack rods are disposed on opposite sides of the device delivery arm <NUM> and extend from a clip feature <NUM> disposed about the device delivery arm <NUM>. A rotation of the device delivery arm <NUM> does not effect a corresponding rotation of the clip feature <NUM> such that the rack rods <NUM>, <NUM> do not rotate but rather only translate along with the device delivery arm <NUM>. The projecting teeth of the rack rod <NUM> inserted into grooves of the pinion <NUM> may generate one of a high-low pattern, while the gaps between the projecting teeth of the rack rod <NUM> receiving teeth of the pinion <NUM> may generate the other of the high-low pattern to generate a flow rate, flow amount, and direction of motion of the device delivery arm <NUM>.

In an aspect, a linear encoded member is optically sensed while a device delivery arm is translated through an axial load or through a rotation. The linear encoded member is attached to a collar feature that is free to rotate about a center axis as the device delivery arm is rotated to keep the linear encoded member in a sensing area. Referring to <FIG>, a radioembolization delivery device <NUM> includes a device delivery arm <NUM> having a threaded portion <NUM> and disposed in an enclosure <NUM> and surrounded by pair of optical rods <NUM>, <NUM> of an optical conductive rod assembly including a pair of pattern sensors <NUM>, <NUM> to detect optical patterns from the pair of optical rods <NUM>, <NUM>, such as optical high-low, alternating pattern as described with respect to the radioembolization delivery devices <NUM> and <NUM> similarly attached to respective device delivery arms <NUM> and <NUM> through non-rotational, translational clip features. In embodiments, the pattern sensors <NUM>, <NUM> may be magnetic sensors configured to sense an alternating north-south pattern on the pair of rods <NUM>, <NUM>, and an input known start position is configured to assist the magnetic sensors from generating output signals from which to determine incremental advancement data and actual position data of the device delivery arm <NUM>.

Referring to <FIG>, a radioembolization delivery device <NUM> may include a lever arm assembly <NUM> and a flow parameter display <NUM> to monitor and display flow parameter information associated with sensed movement of a device delivery arm as determined and described herein. The radioembolization delivery device assembly <NUM> may be a delivery device as described in <CIT> and may include a syringe holder within a housing <NUM> of the radioembolization delivery device <NUM> to administer fluid as described in <CIT>. The flow parameter display <NUM> may be configured to display a flow rate of administered fluid (e.g., in ml/min), an amount of flow of administered fluid (e.g., as an infused volume in ml), and a direction of travel of the device delivery arm <NUM> (e.g., proximally or distally, wherein a distance advancement administers fluid from a syringe holder in the housing <NUM>.

In an embodiment, a rotary quadrature encoder may be attached to a pivot point of a lever of a delivery device such that an angular displacement and direction of the lever may be sensed and the angular displacement may be converted into a linear displacement of the device delivery arm. Referring to <FIG>, a radioembolization delivery device <NUM> includes a lever arm assembly <NUM>. The lever arm assembly <NUM> includes a handle <NUM> coupled to a lever arm <NUM> via a pivot point <NUM>, the lever arm <NUM> coupled to a base stand <NUM> via a pivot point <NUM>, a link <NUM> coupled to the lever arm <NUM> via a pivot point <NUM>, and the link <NUM> coupled to a device delivery arm <NUM> via a pivot point <NUM>. The device delivery arm <NUM> is configured to proximally and distally project with respect to a housing <NUM> that includes a syringe holder (not shown) to administer fluid. Application of a distal, downward force on the handle <NUM> causes a rotation of the lever arm <NUM> about the pivot point <NUM> in a counter-clock wise direction, a distal motion of the link <NUM> about the pivot point <NUM> to drive the device delivery arm <NUM> distally about the pivot point <NUM>, and a rotation of the lever arm about the pivot point <NUM> in a counter-clockwise direction, causing a rotation of a quadrature rotary encoder <NUM> including a pattern <NUM>. A pattern sensor (not shown) is configured to sense the pattern <NUM> corresponding to the motion of the device delivery arm <NUM> in one of a distal or proximal direction with respect to the lever arm <NUM>. An angle defined between horizontal from a center of the quadrature rotary encoder <NUM> and horizontal and a longitudinal axis of the lever arm <NUM> is used to define a distance of vertical displacement of the lever arm <NUM> that is associated with a translational displacement of the device delivery arm <NUM> with respect to the housing <NUM>. The pattern <NUM> of the quadrature rotary encoder <NUM> may be an alternating black and white pattern to present a high-low pattern to a pattern sensor from which flow amount, flow rate, and direction of travel of the device delivery arm <NUM> may be generated. The radioembolization delivery device <NUM> including the quadrature rotary encoder <NUM> is thus configured to sense an angular displacement and a direction of the lever arm <NUM>. The angular displacement may be converted to a linear displacement of the device delivery arm <NUM>. Given a predetermined syringe diameter, a dispensed volume and flow rate may be determined based on the sensed linear displacement of the device delivery arm <NUM>.

According to an aspect, optical sensors may be disposed and configured proximate to the device delivery arm to act as a linear quadrature encoded to sense linear displacement and direction of the device delivery arm. Referring to <FIG>, a radioembolization delivery device <NUM> includes a lever arm assembly in which a link <NUM> is coupled to a device delivery arm <NUM>, similar to the lever arm assembly <NUM> of the radioembolization delivery device <NUM>, to direct translational movement of the device delivery arm <NUM> with respect to a housing <NUM> within which a syringe to administered fluid is contained and may administer fluid based on a distal translation of the device delivery arm <NUM>. The device delivery arm <NUM> includes a pattern <NUM> with an alternating high-low sequence configured for detection by an optical quadrature linear encoder <NUM> including an optical transmitter sensor and an optical receive sensor. The optical transmitter sensor is configured to transmit an optical signal to reflect from the pattern <NUM>, and the optical receptor sensor is configured to receive the reflected pattern signal. It is contemplated within the scope of this disclosure that other sensors for the linear encoder <NUM> may be used to detect the high-low pattern <NUM> of the device delivery arm <NUM>. By way of example, and not as a limitation, a Hall effect sensor, a magnetic sensor, or an electrical switch sensor as described herein may be used. The linear encoder <NUM> as a pattern sensor is configured to sense the pattern <NUM> and linear displacement and direction of the device delivery arm <NUM>. Given a diameter of the syringe holder, a dispensed volume and flow rate of the administered fluid may be calculated based on the sensed displacement of the device delivery arm <NUM>.

According to another aspect, a quadrature rotary encoder may be attached to a device delivery arm via a wheel, and a sensed angular displacement of the wheel may be converted to a linear displacement of the device delivery arm. Referring to <FIG>, a radioembolization delivery device <NUM> operates similar to the radioembolization delivery devices <NUM>, <NUM> to move a link <NUM> to cause a device delivery arm <NUM> to rotate about a pivot point <NUM> and translate in a translational direction with respect to a housing <NUM> containing a syringe holder. A pattern sensor <NUM> including a wheel <NUM> is configured to contact a surface of the device delivery arm <NUM> at a wheel contact point 1022P such that the wheel <NUM> rotates clockwise in a direction of an arrow R corresponding to a distal translation of the device delivery arm <NUM> toward the housing <NUM>. The wheel <NUM> rotates counter-clock wise in a direction opposite the arrow R corresponding to a proximal translation of the device delivery arm <NUM> away from the housing <NUM>. The wheel <NUM> may include a pattern configured to be sensed by the pattern sensor <NUM>, which may be a quadrature rotary encoder that includes an optical, Hall effect, magnetic, or other like sensor to sense the pattern of the rotating wheel <NUM>. The pattern sensor <NUM> is configured to thus sense the linear displacement and direction of the device delivery arm <NUM>. Further, given a diameter of the syringe holder, a dispensed volume and flow rate of the administered fluid from the syringe holder may be calculated based on the linear displacement and direction information of the device delivery arm <NUM>.

Referring to <FIG>, a flow chart of a process <NUM> is shown that utilizes the radioembolization delivery devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of <FIG> to determine flow rate of administered fluid, flow amount, and a direction of travel of a respective device delivery arm as described herein. The process <NUM> for determination of flow parameters of administered fluid from a radioembolization delivery device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may include, in block <NUM>, translationally moving a respective device delivery arm <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> of the radioembolization delivery device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> in a translational direction. The respective device delivery arm <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be coupled to a syringe holder such that movement in the translational direction one of proximally or distally advances the syringe holder. A distal advancement, for example, may cause the syringe holder to administer the therapeutic fluid. Thus, a distal advancement of the syringe holder may be configured to administer the fluid from the radioembolization delivery device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> into a blood vessel.

In embodiments, the translational direction is one of a first direction along a longitudinal axis LA of the device delivery arm <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or a second direction that is opposite the first direction. The first direction may be one of a proximal advancement and a distal advancement along the longitudinal axis LA corresponding to a proximal or distance advancement of the syringe holder, and the second direction may be the other of the proximal advancement or the distal advancement. Further, the device delivery arm <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be rotated about the longitudinal axis LA of the device delivery arm <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> when translationally moving the device delivery arm <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> in the translational direction along the longitudinal axis LA.

In block <NUM>, a corresponding movement of a pattern associated with the translational device delivery arm movement is sensed, via one or more pattern sensors as described herein with respect to <FIG>, as a sensed pattern movement. In embodiments, and as described herein, the one or more pattern sensors may include at least one of an optical sensor, a Hall effect sensor, a magnetic sensor, or a switch-based sensor configured to sense a corresponding alternating high-low pattern associated with the device delivery arm <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> and including a corresponding optical, electromagnetic, magnetic, or switch pattern.

In block <NUM>, one or more output signals are generated, via the one or more pattern sensors, based on the sensed pattern movement. Referring to <FIG>, as described herein and above, the one or more pattern sensors are configured to detect a pattern associated with a translational motion of a respective device delivery arm. By way of example, and not as a limitation, and referring to <FIG>, the one or more pattern sensors may include a gear assembly <NUM> configured to detect a ring pattern of a ring portion <NUM> on the device delivery arm <NUM> of a radioembolization delivery device <NUM>. Referring to <FIG>, the one or more pattern sensors <NUM>, <NUM> may include a ring assembly configured to detect the pattern comprising a ring pattern of a ring portion <NUM> on the device delivery arm <NUM>. The ring assembly may include a pair of Hall effect sensors, and the ring pattern may include one of magnets or ferrous objects embedded in the device delivery arm. Alternatively, the ring assembly may include a pair of optical sensors, and the ring pattern may include at least two different reflective surface types for detection by the pair of optical sensors.

Referring to <FIG>, the one or more pattern sensors may include an omni wheel assembly <NUM> configured to detect the pattern including a thread pattern of a threaded portion <NUM> on the device delivery arm <NUM>. Referring to <FIG>, the one or more pattern sensors may include a conductive rod assembly including a pair of conductive rods <NUM>, <NUM> and configured to detect the pattern based on alternating switch patterns <NUM>, <NUM> disposed on the pair of conductive rods <NUM>, <NUM> attached to the device delivery arm <NUM>. Referring to <FIG>, the one or more pattern sensors may include a rack and pinion rod assembly <NUM> configured to detect the pattern based on a rack pattern on at least one rack rod <NUM> attached to the device delivery arm <NUM>. Referring to <FIG>, the one or more pattern sensors may include an optical conductive rod assembly including a pair of pattern sensors <NUM>, <NUM> configured to detect the pattern based on an optical pattern of at least one conductive optical rod <NUM>, <NUM> attached to the device delivery arm <NUM>.

Referring to <FIG>, the one or more pattern sensors may include a rotary encoder assembly configured to detect the pattern <NUM> from a rotation of a quadrature rotary encoder <NUM> based on a pivot around a pivot joint <NUM> corresponding to a translation of the device delivery arm <NUM>. Referring to <FIG>, the one or more pattern sensors may include an optical linear encoder assembly including the optical quadrature linear encoder <NUM> configured to detect the pattern <NUM> as an alternating optical high-low pattern disposed on the device delivery arm <NUM>. Referring to <FIG>, the one or more pattern sensors <NUM> may include a rotary encoder assembly including a wheel <NUM>. The rotary encoder assembly may include a wheel encoder as the wheel <NUM> configured to contact a surface of the device delivery arm <NUM>. When the device delivery moves in a translation in the translational direction, the wheel encoder including the pattern is configured to rotate, and the one or more pattern sensors <NUM> are configured to detect the pattern on the wheel encoder (e.g., the wheel <NUM>) corresponding to the translation of the device delivery arm <NUM>.

In block <NUM>, a flow rate of the administered fluid, a flow amount of the administered fluid, and the translational direction of movement of the device delivery arm <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> with respect to the syringe holder, for a which a diameter is known, is generated, via processor, based on the one or more output signals. In embodiments, at least one of the flow rate of the administered fluid, the flow amount of the administered fluid, or the direction of movement of the device delivery arm <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be displayed on a display <NUM> communicatively coupled to the radioembolization delivery device <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>.

Referring to <FIG>, a system <NUM> for implementing a computer and software-based method to utilize the delivery device embodiments described herein to determine flow parameters of administered fluid from such radioembolization delivery devices <NUM> is illustrated as being implemented along with using a graphical user interface (GUI) <NUM> communicatively coupled to radioembolization delivery devices <NUM> to display the one or more flow parameters, for example. The system <NUM> includes a communication path <NUM>, one or more processors <NUM>, a memory component <NUM>, a pattern tool <NUM>, a storage or database <NUM>, a pattern sensor <NUM> configured to sense a pattern from the pattern tool <NUM> as described herein, a network interface hardware <NUM>, a network <NUM>, a server <NUM> that may include a cloud-based server, and a radioembolization delivery device <NUM>. The radioembolization delivery device <NUM> may be any of the embodiments of devices <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> described herein and/or the delivery devices described in <CIT> or <CIT>. The various components of the system <NUM> and the interaction thereof will be described in detail below. The pattern sensor <NUM> may be, for example, one or more of an optical sensor, a Hall effect sensor, a magnetic sensor, a switch-based sensor, an inductive sensor, a capacitive sensor, a wireless Bluetooth® sensor, and/or the like as described herein.

In some embodiments, the system <NUM> is implemented using a wide area network (WAN) or network <NUM>, such as an intranet or the Internet. The radioembolization delivery device <NUM> may include digital systems and other devices permitting connection to and navigation of the network. The lines depicted in <FIG> indicate communication rather than physical connections between the various components.

As noted above, the system <NUM> includes the communication path <NUM>. The communication path <NUM> may be formed from any medium that is capable of transmitting a signal such as, for example, conductive wires, conductive traces, optical waveguides, or the like, or from a combination of mediums capable of transmitting signals. The communication path <NUM> communicatively couples the various components of the system <NUM>. As used herein, the term "communicatively coupled" means that coupled components are capable of exchanging data signals with one another such as, for example, electrical signals via conductive medium, electromagnetic signals via air, optical signals via optical waveguides, and the like.

As noted above, the system <NUM> includes the processor <NUM>. The processor <NUM> can be any device capable of executing machine readable instructions. Accordingly, the processor <NUM> may be a controller, an integrated circuit, a microchip, a computer, or any other computing device. The processor <NUM> is communicatively coupled to the other components of the system <NUM> by the communication path <NUM>. Accordingly, the communication path <NUM> may communicatively couple any number of processors with one another, and allow the modules coupled to the communication path <NUM> to operate in a distributed computing environment. Specifically, each of the modules can operate as a node that may send and/or receive data.

As noted above, the system <NUM> includes the memory component <NUM> which is coupled to the communication path <NUM> and communicatively coupled to the processor <NUM>. The memory component <NUM> may be a non-transitory computer readable medium or non-transitory computer readable memory and may be configured as a nonvolatile computer readable medium. The memory component <NUM> may comprise RAM, ROM, flash memories, hard drives, or any device capable of storing machine readable instructions such that the machine readable instructions can be accessed and executed by the processor <NUM>. The machine readable instructions may comprise logic or algorithm(s) written in any programming language such as, for example, machine language that may be directly executed by the processor, or assembly language, object-oriented programming (OOP), scripting languages, microcode, etc., that may be compiled or assembled into machine readable instructions and stored on the memory component <NUM>. Alternatively, the machine readable instructions may be written in a hardware description language (HDL), such as logic implemented via either a field-programmable gate array (FPGA) configuration or an application-specific integrated circuit (ASIC), or their equivalents. Accordingly, the methods described herein may be implemented in any conventional computer programming language, as preprogrammed hardware elements, or as a combination of hardware and software components.

Still referring to <FIG>, as noted above, the system <NUM> comprises the display such as a GUI <NUM> on a screen communicatively coupled to the one or more radioembolization delivery devices <NUM> for providing visual output such as, for example, information, graphical reports, messages, or a combination thereof. The display on the screen is coupled to the communication path <NUM> and communicatively coupled to the processor <NUM>. Accordingly, the communication path <NUM> communicatively couples the display to other modules of the system <NUM>. The display can include any medium capable of transmitting an optical output such as, for example, a cathode ray tube, light emitting diodes, a liquid crystal display, a plasma display, or the like. Additionally, it is noted that the display can include at least one of the processor <NUM> and the memory component <NUM>. While the system <NUM> is illustrated as a single, integrated system in <FIG>, in other embodiments, the systems can be independent systems.

The system <NUM> may comprise the pattern sensor <NUM> to sense a pattern from the pattern tool <NUM>, as per one or more of the embodiments described herein, to transmit pattern signal information used to compute one or more flow parameters based on the pattern signal information. As will be described in further detail below, the processor <NUM> may process the input signals received from the system modules and/or extract information from such signals. For example, in embodiments, the processor <NUM> may execute instructions stored in the memory component <NUM> to implement the processes described herein.

The system <NUM> includes the network interface hardware <NUM> for communicatively coupling the system <NUM> with a computer network such as network <NUM>. The network interface hardware <NUM> is coupled to the communication path <NUM> such that the communication path <NUM> communicatively couples the network interface hardware <NUM> to other modules of the system <NUM>. The network interface hardware <NUM> can be any device capable of transmitting and/or receiving data via a wireless network. Accordingly, the network interface hardware <NUM> can include a communication transceiver for sending and/or receiving data according to any wireless communication standard. For example, the network interface hardware <NUM> can include a chipset (e.g., antenna, processors, machine readable instructions, etc.) to communicate over wired and/or wireless computer networks such as, for example, wireless fidelity (Wi-Fi), WiMax, Bluetooth®, IrDA, Wireless USB, Z-Wave, ZigBee, or the like.

Still referring to <FIG>, data from various applications running on programs associated with the radioembolization delivery devices <NUM> can be provided to the system <NUM> via the network interface hardware <NUM>. The radioembolization delivery devices <NUM> can be any device having hardware (e.g., chipsets, processors, memory, etc.) for communicatively coupling with the network interface hardware <NUM> and a network <NUM>.

The network <NUM> can include any wired and/or wireless network such as, for example, wide area networks, metropolitan area networks, the Internet, an Intranet, satellite networks, or the like. Accordingly, the network <NUM> can be utilized as a wireless access point to access one or more servers (e.g., a server <NUM>). The server <NUM> and any additional servers generally include processors, memory, and chipset for delivering resources via the network <NUM>. Resources can include providing, for example, processing, storage, software, and information from the server <NUM> to the system <NUM> via the network <NUM>. Additionally, it is noted that the server <NUM> and any additional servers can share resources with one another over the network <NUM> such as, for example, via the wired portion of the network, the wireless portion of the network, or combinations thereof.

In embodiments described herein, one or more pattern sensors in radioembolization delivery devices disposed away from a fluid administration path are used to record position of a device delivery arm and motion to continuously calculate and determine an infused volume and flow rate of a therapeutic fluid with sub-mL/min resolution and to dynamically display the information in real-time. The clinical may then be able to use the displayed information to dynamically tune the administration rate and keep the rate within a desired range throughout the procedure and to keep track of the total infused volume, all of which provide for a more efficient and safe procedure. Indeed, the systems and methods described herein allow for a recordation of flow rate and infused volume of therapeutic fluid and displaying of both parameters dynamically during a procedure. The pattern sensors described herein may be reusable sensors including accompanying electronics and a display integrated with a delivery device and disposed away from a fluid delivery path for the therapeutic fluid. In embodiments, an electro-mechanically driven administration procedure may involve an automatic determination of flow rate and infused volume based on driving and sensing information related to motor speed, direction, and frequency to control the device delivery arm coupled to the syringe holder to deliver the therapeutic fluid. A system to control the delivery devices described herein may be automatically, partially automatically, or manual controlled by a clinician through, for example, a joystick or button to control start, pause, and/or stop injection operations.

The embodiments described herein employ one or more pattern sensors to sense an angular or linear displacement of one or more components used to delivery Y90 microspheres during a radioembolization procedure. The sensed information may then be used to determine volumetric flow and flow rate of administered therapeutic fluid during the procedure. Different methods to sense relative displacement may be used with respect to the pattern sensors, including, but not limited to, angular and linear encoders, inductive proximity sensors, optical proximity sensors, capacitive proximity sensors, ultrasonic proximity sensor, and/or mechanical switches. Further, in addition to use of pattern sensors to sense flow as described herein, other sensors may be used such as a radioactive dosimeter to monitor bead concentration and potential leakage, a pressure sensor to monitor and report fluid pressure, and a temperature sensor to monitor and report fluid or ambient temperature during the procedure.

While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

It is noted that the terms "substantially" and "about" and "approximately" may be utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

Claim 1:
A method for determination of flow parameters of administered fluid from a fluid delivery device (<NUM>), the method comprising:
translationally moving a device delivery arm (<NUM>) of the fluid delivery device (<NUM>) in a translational direction, wherein the device delivery arm (<NUM>) is coupled to a syringe holder such that movement in the translational direction one of proximally or distally advances the syringe holder;
sensing, via one or more pattern sensors (<NUM>), a corresponding movement of a pattern associated with the translational device delivery arm movement as a sensed pattern movement;
generating, via the one or more pattern sensors (<NUM>), one or more output signals based on the sensed pattern movement; and
generating, via a processor (<NUM>), at least one of a flow rate of the administered fluid, a flow amount of the administered fluid, or the translational direction of movement of the device delivery arm (<NUM>) with respect to the syringe holder based on the one or more output signals, characterised in that said device is a radioembolisation device, and said pattern sensors are axially aligned with the device delivery arm and remote from the delivery path of the fluid.