Robotic system for localized drug delivery at a target within a patient

Abstract

A medical system including a needle, a fluidics pump, a pressure sensor, and a flow rate sensor. The fluidics pump is operable to force fluid out of a syringe and into the needle via a fluid line in fluid communication with the fluidics pump and the needle. The pressure sensor is arranged inline with the fluid conduit downstream from an outlet of the syringe and operable to measure a pressure of the fluid exiting the syringe. The flow rate sensor is arranged inline with the fluid conduit downstream from the outlet and operable to measure a flow rate of the fluid exiting the syringe.

Description

049450-000420ROBOTIC SYSTEM FOR LOCALIZED DRUG DELIVERY AT A TARGET WITHIN A PATIENTCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 707,737 filed October 15, 2024, and U.S. Provisional Application No. 63 / 740,872 filed December 31, 2024. Each of the aforementioned applications are incorporated by reference herein in their entirety.TECHNICAL FIELD

[0002] This disclosure relates generally to medical systems and, more specifically, to robotic systems for localized drug delivery into a target within a patient.DESCRIPTION OF RELATED ART

[0003] Cancer detection, staging, and treatment is a multistep process that can often span weeks or even months. In addition to the risk and expense of the clinical work up, the extra time necessitated by the process can cause significant patient anxiety and heightened risk of interval metastases. Accordingly, longer diagnoses to treatment times are often correlated with lower chances of survival. Moreover, many existing cancer treatments involve systemic delivery of immunotherapies, which can have severe immune-related side effects due to systemic exposure and high toxicities.

[0004] There is a need for less toxic, organ sparing, local treatment that can be administered at substantially the same time as cancer diagnosis and staging.BRIEF DESCRIPTION OF THE DRAWINGS

[0005] Various embodiments are depicted in the accompanying drawings for illustrative purposes and should in no way be interpreted as limiting the scope of the inventions. In addition, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. Throughout the drawings, reference numbers may be reused to indicate correspondence between reference elements.

[0006] FIG. 1 is an example medical system, according to some implementations.

[0007] FIG. 2 is another example medical system, according to some implementations.

[0008] FIG. 3 is a block diagram of an example localization system, according to some implementations.049450-000420

[0009] FIG. 4A is another example medical system, according to some implementations.

[0010] FIG. 4B is a different view of the example medical system of FIG. 4A, according to some implementations.

[0011] FIG. 4C is a schematic of an example sensor assembly of the medical assembly shown in FIG. 4A, according to some implementations.

[0012] FIG. 5 A is a perspective view of a fluidics pump that can be used to inject drugs intratumorally, according to some implementations.

[0013] FIG. 5B is a partial cross-sectional perspective view of the fluidics pump of FIG. 5A, according to some implementations.

[0014] FIG. 5C illustrates a partial cross-sectional side view of the fluidics pump of FIG. 5A, according to some implementations.

[0015] FIG. 5D illustrates a side view of the fluidics pump of FIG. 5A, according to some implementations.

[0016] FIG. 6 is a schematic diagram of an example drug delivery system that can be used to inject drugs intratumorally, according to some implementations.

[0017] FIG. 7 is an example peristaltic fluidics pump that can be used to inject drugs intratumorally, according to some implementations.

[0018] FIG. 8A is another example medical system, according to some implementations.

[0019] FIG. 8B is a schematic diagram of an inline flow control assembly of the medical system of FIG. 8A, according to some implementations.

[0020] FIG. 9A is a partial cross-sectional view of an example fluidics pump that can be used to inject drugs intratumorally, according to some implementations.

[0021] FIG. 9B is a partial cross-sectional view of the fluidics pump of FIG. 9A, according to some implementations.

[0022] FIG. 9C is a side view of the fluidics pump of FIG. 9A, according to some implementations.

[0023] FIG. 9D is a cross-sectional view of the fluidics pump of FIG. 9A with a syringe being loaded into the fluidics pump, according to some implementations.

[0024] FIG. 9E is a cross-sectional view of the fluidics pump of FIG. 9A after the syringe is loaded, according to some implementations.

[0025] FIG. 9F is a cross-sectional side view of the fluidics pump of FIG. 9A after medicant has been expelled from the syringe, according to some implementations.049450-000420

[0026] FIG. 9G is a perspective view of the fluidics pump of FIG. 9A and depicting example installation of a pump plunger and biasing member, according to some implementations.

[0027] FIG. 10A is a schematic block diagram of an example drug injection system, according to some implementations.

[0028] FIG. 10B is a detailed schematic block diagram of the drug injection system of FIG. 10A including electronic circuitry, according to some implementations.

[0029] FIG. 10C is a schematic diagram depicting an example flowchart of the drug injection system of FIG. 10A, according to some implementations.

[0030] FIG. 11A is a front view of an example controller, according to some implementations.

[0031] FIG. 1 IB is a side view of the controller of FIG. 11A, according to some implementations.

[0032] FIG. 12 is a schematic block diagram of an example medical system used for planning, staging, and treatment of tumors, according to some implementations.

[0033] FIG. 13 is an example graphical interface for planning access to a target within an anatomy, according to some implementations.

[0034] FIG. 14A is an example graphical interface for navigating a needle to a target within an anatomy, according to some implementations.

[0035] FIG. 14B is another example graphical interface for navigating a needle to a target within an anatomy, according to some implementations.

[0036] FIG. 15 is an example graphical interface for controlling and monitoring intratumoral drug delivery, according to some implementations.

[0037] FIG. 16 is another example graphical interface for controlling and monitoring intratumoral drug delivery, according to some implementations.

[0038] FIG. 17 is another example graphical interface for controlling and monitoring intratumoral drug delivery, according to some implementations.

[0039] FIG. 18A illustrates a schematic representation of using a scope and tool with EM elements to locate a desired location at a target, according to some implementations.

[0040] FIG. 18B is a CT scan overlaid with the scope and tool tip locations obtained using EM sensing, according to some implementations.

[0041] FIG. 19A is a tool coupled to a stylet that includes an EM element, according to some implementations.049450-000420

[0042] FIG. 19B is a tool including an EM element, according to some implementations.

[0043] FIG. 19C is a tool including an EM element, according to some implementations.

[0044] FIG. 20A is a tool including an EM element, according to some implementations.

[0045] FIG. 20B is a tool including an EM element, according to some implementations.

[0046] FIG. 21 is a schematic flowchart of an example method of real-time tool-in- lesion control and confirmation using EM, according to some implementations.DETAILED DESCRIPTION

[0047] Embodiments of the present disclosure will now be described in detail with reference to the accompanying Figures. Like elements in the various figures may be denoted by like reference numerals for consistency. Further, in the following detailed description of embodiments of the present disclosure, numerous specific details are set forth in order to provide a more thorough understanding of the claimed subject matter. However, it will be apparent to one of ordinary skill in the art that the embodiments disclosed herein may be practiced without these specific details. In other instances, well-known features have not been described in detail to avoid unnecessarily complicating the description. Additionally, it will be apparent to one of ordinary skill in the art that the scale of the elements presented in the accompanying Figures may vary without departing from the scope of the present disclosure.

[0048] Aspects of the present disclosure relate to actively delivering a prescribed volume of a medicant (e.g., drug) to a target (e.g., tumor, lesion, nodule) within a patient that has an inherent resistance (e.g., high internal pressure) to the delivery of the medicant. The prescribed volume may be a small volume, such as the volume of a syringe, compared to systemic drug delivery which delivers a large volume (e.g., one or more IV bags) of drug into the patient at a location of low drug delivery resistance (e.g., low internal pressure). Additionally, the small volume of medicant is introduced to the target slowly, in the order of milliliters over many minutes (e.g., 0.1 ml / min, 10 ml / min). For example, the present disclosure may relate to intratumoral therapy as a treatment that involves injecting drugs directly into a tumor to control tumor growth and stimulate an immune response. Compared to systemic drug delivery, intratumoral therapy can use lower doses of drugs to achieve greater efficacy, while minimizing toxicity, and even allow for combination therapies. In many existing intratumoral049450-000420 procedures, a physician manually injects the drug into the tumor, which can lead to variability in drug distribution and / or leakage beyond the tumor. In addition, intratumoral therapy involves a series of complex steps that require careful movement and positioning of medical tools or instruments inside a patient’s body.

[0049] Some medical procedures can now be performed, at least in part, by a robotic system or apparatus, which can aid a physician or technician in navigating or positioning such medical instruments. For example, during a robotically assisted bronchoscopy, a physician controls a robotic system to advance and navigate a medical instrument (such as a scope) down the patient’s trachea and lungs using precise articulation commands from the robotic system until reaching a target location (such as the location of a lesion or lung nodule). The instrument can be tracked inside the anatomy using various imaging and / or sensor modalities. A needle can be precisely deployed to the target site, via endoluminal or percutaneous access, by leveraging the same imaging and / or sensor modalities.

[0050] Robotic systems can provide fine motor controls for manipulating instruments, procedural consistency, and real-time feedback that can significantly improve the accuracy and efficacy of intratumoral drug delivery. For example, dose fractionation is a technique for delivering a drug in multiple doses that are distributed over a wider area. Robotic systems may be used for dose fractionation (and avoid leakage) by precisely positioning a needle at multiple locations within a tumor and robotically controlling drug delivery or injection. The robotic system may provide procedure guidance to minimize the complexity of the procedure and / or reduce cognitive load. Additionally, by leveraging the same robotic systems (and data) to perform cancer diagnosis, staging, and treatment, aspects of the present disclosure can significantly reduce diagnosis to treatment times and improve patient survival rates.

[0051] Aspects of the present disclosure may be used to perform robotic-assisted medical procedures, such as endoscopic access, percutaneous access, or treatment for a target anatomical site. For example, robotic tools may engage or control one or more medical instruments to access a target site within a patient’s anatomy and / or perform a treatment at the target site. In some implementations, the robotic tools may be guided or controlled by a user (such as a physician or a technician). In some other implementations, the robotic tools may operate in an autonomous or semi-autonomous manner. Although systems and techniques are described herein in the context of robotic-assisted medical procedures, the systems and techniques may be applicable to other types of medical procedures that utilize camera and / or sensor data (such as procedures that do not rely on robotic tools or only utilize robotic tools in a very limited capacity). For example, the systems and techniques described herein may be049450-000420 applicable to medical procedures that rely on manually operated medical instruments (such as a needle that is manually inserted by a physician). The systems and techniques described herein also may be applicable beyond the context of medical procedures (such as in simulated environments or laboratory settings, such as with models or simulators, among other examples).

[0052] FIG. 1 is an example medical system 100, according to some implementations. The medical system 100 may be used for endoscopic procedures, for example. Robotic medical solutions can provide relatively higher precision, superior control, and / or superior hand-eye coordination with respect to certain instruments compared to strictly manual procedures. For example, robotic-assisted endoscopic access to patient anatomy can advantageously enable an operator to articulate an endoscope, sheath, or other instrument, using robotically-controlled gears / drives coupled to a handle / base portion of the instrument.

[0053] The medical system 100 includes a robotic system 110 (e.g., mobile robotic cart) configured to engage with and / or control a first instrument 130 (e.g., endoscope), including a proximal base 131, and a second instrument 140 (e.g., sheath), including a proximal base 139. The instrument 130 is shown configured to perform a direct-entry procedure on a patient 107. The term “direct-entry” is used herein according to its broad and ordinary meaning and may refer to any entry of instrumentation through a natural or artificial opening in a patient’s body, such as the mouth. The instruments 130, 140 may be any type of shaft-based medical instrument, including an endoscope (such as a bronchoscope), catheter (such as a steerable or non-steerable catheter), ureteroscope, nephroscope, gastroscope, laparoscope, or other type of medical instrument. Although direct entry of the instrument 130 is shown, aspects of the present disclosure relate to other types of subject entry, such as percutaneous entry.

[0054] The medical system 100 includes a control system 111 configured to interface with the robotic system 110, provide information regarding a procedure, and / or perform a variety of other operations. For example, the control system 111 can include one or more display(s) 141 configured to present certain information to assist the physician 105 and / or other technician(s) or individual(s). The medical system 100 can include a table 115 configured to hold the patient 107. The robotic system 110 includes one or more robotic arms 112 (two shown). Although the robotic arms 112 are shown in certain positions (orientation) and coupled to certain instruments, such configurations are shown for convenience and illustration purposes, and the robotic arms may have different configurations over time and / or at different points during a medical procedure. Furthermore, the robotic arms 112 may be coupled to049450-000420 different device s / instruments than what is shown in FIG. 1, and in some cases or periods of time, one or more of the arms 112 may not be utilized or coupled to a medical instrument.

[0055] Articulation of one or both of the instruments 130, 140 may be controlled robotically, such as through operation of robotic manipulators associated with the robot arm(s) 112, wherein such operation may be controlled by the control system 111 and / or robotic system 110. The term “robotic manipulator” is used herein according to its broad and ordinary meaning and may refer to any type or configuration of one or more robotic end effectors, actuators, gears, drives, rails, interfaces, or the like. Additionally, the robotic system 110 may be used to move and / or control another instrument (e.g., a needle) inserted into the instrument 130.

[0056] For illustrative purposes, FIG. 1 shows the robotic system 110 arranged for diagnostic and / or therapeutic bronchoscopy. During a bronchoscopy procedure, the arm(s) 112 may be configured to drive one or both of the instruments 130, 140 through a natural orifice access point (e.g., the mouth of the patient 107 positioned on a table 115) to deliver diagnostic and / or therapeutic tools. As shown, the robotic system 110 (e.g., cart) may be positioned proximate to the patient’s upper torso in order to provide access to the access point. The arrangement in FIG. 1 may also be utilized when performing an upper gastrointestinal (GI) procedure with a gastroscope, a specialized endoscope for GI procedures. The robotic system 110 can include a display 116 for providing procedure-related information to the user.

[0057] The instrument 130 may be directed down the patient’s trachea 106 and lungs after insertion using precise articulation commands from the robotic system 110 until reaching the target operative site. For example, the instrument 130 may be directed to deliver a needle (such as a biopsy needle or a drug delivery needle) to a target, such as a lesion or nodule 189 within the lungs of the patient 107. The needle may be deployed down a working channel that runs the length of the instrument 130 to obtain a tissue sample to be analyzed by a pathologist. According to embodiments of the present disclosure, the needle may also be used to deliver a medicant into the target. In some embodiments, for example, the needle may be used to deliver a fractional dose into the target, such as delivering a first fraction at a first location within the target and then being moved to a second location within the target to deliver a second fraction. In some instances, diagnostic and therapeutic treatments can be delivered in separate procedures.

[0058] For reference, FIG. 1 shows details of certain respiratory anatomy in which the instrument(s) 130, 140 may be advanced and / or articulated. Generally, the respiratory system comprises certain passages, vessels, organs, and muscles that aid the body in the exchange of gases between the air and blood, and between the blood and the cells of the body. The049450-000420 respiratory system includes the upper respiratory tract, which comprises the nose / nasal cavity, the pharynx (i.e., throat), and the larynx (i.e., voice box). The respiratory system further includes the lower respiratory tract, which is shown in detail and comprises the trachea 106, the lungs 104, and the various segments of the bronchial tree 108, including the alveoli and alveolar ducts, which comprise clusters of small air sacs that are responsible for gas exchange between the lungs and the pulmonary blood vessels. The bronchial tree 108 includes primary bronchi 181, which branch off into smaller secondary 188 and tertiary 185 bronchi, and terminate in even smaller tubes called bronchioles 187. Each bronchiole tube is coupled to a cluster of alveoli.

[0059] Although aspects of the present disclosure are presented in the context of luminal networks including a bronchial network of airways (e.g., lumens, branches) of a patient’s lung, embodiments of the present disclosure can be implemented in other types of luminal networks, such as renal networks, cardiovascular networks (e.g., arteries and veins), gastrointestinal tracts, urinary tracts, etc. In some implementations, the techniques and systems described herein are discussed in the context of a percutaneous procedure, which can include any procedure where access is gained to a target location by making a puncture or incision in the skin, mucous membrane, or other body layer.

[0060] Lung cancer and other cancers generally involve abnormal cell growth (e.g., in the area of the lungs or other anatomy), which can have the potential to invade or spread to other parts of the body. For example, cancer can form in tissues of the lung, such as in the cells that line the various air passages. When not treated in an effective and / or timely manner, lung cancers can spread / metastasize to lymph nodes or other organs in the body, which can severely impact patient recovery prospects. In FIG. 1, the patient 107 is shown having a mass of tissue 189, referred to as a lung nodule, that has formed in the area of the lungs 104. Such lung nodules can be benign or cancerous. Robotically-controlled instrumentation can be implemented to perform a diagnostic biopsy procedure from within the bronchial network to determine whether a lung nodule 189 is cancerous, or to perform other treatment or therapy.

[0061] In the illustrated example, the first instrument 130 is an endoscope and the second instrument 140 is a sheath. The first instrument 130 may be slidably positioned within a working channel / lumen of the second instrument 140. The terms “lumen” and “channel” are used herein according to their broad and ordinary meanings and may refer to a physical structure forming a cavity, void, conduit, or other pathway, such as an at least partially rigid elongate tubular structure, or may refer to a cavity, void, pathway, or other channel that occupies a space within an elongate structure (e.g., a tubular structure). The telescopic049450-000420 arrangement of the instruments 130, 140 may allow for a relatively thin design of the first instrument 130 and may improve a bend radius of the instrument 130 while providing a structural support via the second instrument 140.

[0062] The terms “scope” and “endoscope” are used herein according to their broad and ordinary meanings and can refer to any type of elongate medical instrument having image generating, viewing, and / or capturing functionality and configured to be introduced into any type of organ, cavity, lumen, chamber, and / or space of a body. For example, references herein to scopes or endoscopes can refer to a ureteroscope (such as for accessing the urinary tract), a laparoscope, a nephroscope (such as for accessing the kidneys), a bronchoscope (such as for accessing an airway, such as the bronchus), a colonoscope (such as for accessing the colon), an arthroscope (such as for accessing a joint), a cystoscope (such as for accessing the bladder), or a borescope, among other examples.

[0063] A scope may comprise a tubular and / or flexible medical instrument that is configured to be inserted into the anatomy of a patient to capture images of the anatomy. In some implementations, a scope may accommodate wires and / or optical fibers to transfer signals to or from an optical assembly and a distal end of the scope, which can include an imaging device, such as an optical camera. The camera or imaging device can be used to capture images of an internal anatomical space, such as a calyx or papilla of a kidney. A scope can further accommodate optical fibers to carry light from proximately-located light sources, such as lightemitting diodes, to the distal end of the scope. The distal end of the scope can include ports for light sources to illuminate an anatomical space when using the camera or imaging device. In some implementations, the scope may be controlled by a robotic system, such as the robotic system 110. The imaging device can comprise an optical fiber, fiber array, and / or lens. The optical components can move along with the tip of the scope such that movement of the tip of the scope results in changes to the images captured by the imaging device. In such applications, the scope with the imaging device comprises a working channel tool.

[0064] A scope can be articulable with respect to at least a distal portion of the scope to enable the scope to be steered within the human anatomy. In some implementations, a scope may be articulated with, for example, five or six degrees of freedom, including X, Y, Z coordinate movement, as well as pitch, yaw, and roll. A position sensor(s) of the scope can likewise have similar degrees of freedom with respect to the position information they produce or provide. A scope can include telescoping parts, such as an inner leader portion and an outer sheath portion, which can be manipulated to telescopically extend the scope. A scope can also include a sheath in telescoping arrangement with a leader. In some aspects, a scope may049450-000420 comprise a rigid or flexible tube configured to be passed within an outer sheath, catheter, introducer, or other lumen-type device, or can be used without such devices. In some implementations, a scope may include a working channel for deploying medical instruments (such as lithotripters, basketing devices, or forceps), irrigation, and / or aspiration to an operative region at a distal end of the scope.

[0065] The control system 111 may include a control interface 143, which includes the display 141 and a controller 142. The display 141 may be a graphical user interface to display information, and may also be used to input instructions into the control system, such as by using a keyboard coupled to the display 141. The controller 142, shown as a handheld controller, may be used to control the medical system 100, such as controlling the robotic system 110 and the instruments 130, 140. The controller 142 may also be used to control other aspects of the medical system, such as controlling the insertion of a needle (e.g., needle 421 shown in FIG. 4A) and / or controlling medicant delivery through the needle, such as controlling a fluidics pump, as described in more detail herein. The control interface 143 may serve as a single point of control so that the physician 105 can perform an operation using the controller 142 and display 141. In some embodiments, the controller 142 may be configured to provide haptic feedback to the physician (see controller 1100 in FIGS. 11A-1 IB) as medicant is injected into the patient 107.

[0066] FIG. 2 shows another example medical system 200, according to some implementations. The medical system 200 may be one example of the medical system 100 of FIG. 1, and may thus include the robotic system 110 and the control system 111 of FIG. 1.

[0067] With reference to FIG. 2, the robotic system 110 includes an elongated support structure 114 (also referred to as a “column”), a robotic system base 125, and a console 116 (e.g., display) at the top of the column 114. The column 114 may include one or more arm supports 117 (also referred to as a “carriages”) for supporting the deployment of the robotic arms 112. The arm support 117 may include individually-configurable arm mounts that rotate along a perpendicular axis to adjust the base of the robotic arms 112 for better positioning relative to the patient. The robotic arms 112 are configured to engage with and / or control the scope 130 and / or needle to perform aspects of a medical procedure. For example, a scopeadvancement instrument coupling (such as an instrument device manipulator) can be attached to the distal portion of one of the arms 112, to facilitate robotic control or advancement of the scope 130, while another arm 112 may have associated therewith an instrument coupling configured to facilitate advancement of a needle.049450-000420

[0068] The arm support 117 also includes a column interface that allows the arm support 117 to vertically translate along the column 114. In some implementations, the column interface can be connected to the column 114 through slots that are positioned on opposite sides of the column 114 to guide the vertical translation of the arm support 117. The slot contains a vertical translation interface to position and hold the arm support 117 at various vertical heights relative to the robotic system base 125. Vertical translation of the arm support 117 allows the robotic system 110 to adjust the reach of the robotic arms 112 to meet a variety of table heights, patient sizes, and physician preferences. Similarly, the individually-configurable arm mounts on the arm support 117 can allow the robotic arm base 121 of the robotic arms 112 to be angled in a variety of configurations.

[0069] The robotic arms 112 include robotic arm bases 121 and end effectors 122, separated by a series of linkages 123 that are connected by a series of joints 124, each joint 124 comprising one or more independent actuators 217. Each actuator 217 may comprise an independently-controllable motor. Each independently-controllable joint 124 can provide an independent degree of freedom of movement to the robotic arm. In some implementations, each arm 112 has seven joints, and thus provides seven degrees of freedom, including “redundant” degrees of freedom. Redundant degrees of freedom allow the robotic arms 112 to position their respective end effectors 122 at a specific position, orientation, and trajectory in space using different linkage positions and joint angles. This allows for the system to position and direct a medical instrument from a desired point in space while allowing the physician to move the arm joints into a clinically advantageous position away from the patient to create greater access, while avoiding arm collisions.

[0070] The robotic system base 125 balances the weight of the column 114, arm support 117, and arms 112 over the floor. Accordingly, the robotic system base 125 may house certain relatively heavier components, such as electronics, motors, power supply, as well as components that selectively enable movement or immobilize the robotic system. For example, the robotic system base 125 can include wheel-shaped casters 128 that allow for the robotic system to easily move around the operating room prior to a procedure. After reaching the appropriate position, the casters 128 may be immobilized using wheel locks to hold the robotic system 110 in place during the procedure.

[0071] A console 116 is positioned at the upper end of the column 114 and provides one or more I / O components 218, such as a user interface for receiving user input and a display screen (or a dual-purpose device such as, for example, a touchscreen) to provide the physician or user with pre-operative and intra-operative data. Example pre-operative data may include049450-000420 pre-operative plans, navigation, and mapping data derived from pre-operative computed tomography (CT) scans, and / or notes from pre-operative patient interviews. Example intraoperative data may include optical information provided from the tool, sensor and coordinate information from sensors, as well as vital patient statistics, such as respiration, heart rate, and / or pulse. The console 116 may be positioned and tilted to allow a physician to view the console 116, robotic arms 112, and patient while operating the console 116 from behind the robotic system 110.

[0072] The end effector 122 of each of the robotic arms 112 may comprise an instrument device manipulator (IDM) 129, which may be attached using a mechanism changer interface (MCI). In some implementations, the IDM 129 can be removed and replaced with a different type of IDM, for example, a first type of IDM may manipulate a scope, while a second type of IDM may manipulate a needle. Another type of IDM may be configured to hold an electromagnetic (EM) field generator. An MCI can include connectors to transfer pneumatic pressure, electrical power, electrical signals, and / or optical signals from the robotic arm 112 to the IDM 129. The IDMs 129 may be configured to manipulate medical instruments, such as the scope 130, using techniques including, for example, direct drives, harmonic drives, geared drives, belts and pulleys, magnetic drives, and the like. In some implementations, the IDMs 129 can be attached to respective robotic arms 112, wherein the robotic arms 112 are configured to insert or retract the respective coupled medical instruments into or out of the treatment site. The robotic system 110 further includes power 219 and communication interfaces 214 (such as connectors) to transfer pneumatic pressure, electrical power, electrical signals, and / or optical signals from the robotic arms 112 to the IDMs 129.

[0073] In some implementations, a user can manually manipulate a robotic arm 112 of the robotic system 110 without using electronic user controls. For example, during setup in a surgical operating room, a user may move the robotic arms 112 and / or any other medical instruments to provide desired access to a patient. The robotic system 110 may rely on force feedback and inertia control from the user to determine appropriate configuration of the robotic arms 112 and associated instrumentation.

[0074] The medical system 200 can include control circuitry configured to perform certain functionality described herein, including control circuitry 211 of the robotic system 110 and / or control circuitry 251 of the control system 111. That is, the control circuitry of the medical system 200 may be part of the robotic system 110, the control system 111, or some combination thereof. Therefore, any reference herein to control circuitry may refer to circuitry049450-000420 embodied in a robotic system, a control system, or any other component of a medical system, such as the medical system 100 shown in FIG. 1 or the medical system 200.

[0075] The control circuitry 211 and / or 251 may comprise a computer-readable medium storing, and / or configured to store, hard-coded and / or operational instructions corresponding to at least some of the steps and / or functions illustrated in one or more of the present figures and / or implementations described herein. Such computer-readable media can be included in an article of manufacture in some instances. The control circuitry 211, 251 may be locally maintained on the robotic system 110 or the control system 111 or may be remotely located at least in part (such as communicatively coupled indirectly via a local area network and / or a wide area network). Any of the control circuitry 211, 251 may be configured to perform any aspect(s) of the various processes disclosed herein.

[0076] With respect to the robotic system 110, at least a portion of the control circuitry 211 may be integrated with the base 125, column 114, and / or console 116 of the robotic system 110, and / or another system communicatively coupled to the robotic system 110. With respect to the control system 111, at least a portion of the control circuitry 251 may be integrated with a console base 151 and / or display 141 of the control system 111.

[0077] Still referring to FIG. 2, the control system 111 includes various I / O components 258 configured to assist the physician or others in performing a medical procedure. For example, the I / O components 258 can be configured to allow for user input to control or navigate the scope 130 and / or needle within the patient. In some implementations, the physician can provide input to the control system 111 and / or robotic system 110 via one or more input controls 255, wherein in response to such input, control signals can be sent to the robotic system 110 to manipulate the scope 130 and / or needle. Example suitable input controls 255 may include any type of user input devices or device interfaces, such as buttons, keys, joysticks, handheld controllers (such as video game-type controllers), computer mice, trackpads, trackballs, control pads, foot pedals, sensors (such as motion sensors or cameras) that capture hand or finger gestures, or touchscreens, among other examples. The input controls 255 are shown as a video game-type controller 142 in FIGS. 1 and 2. To facilitate the functionality of the control system 111, the control system can include various components (sometimes referred to as “subsystems”). For example, the control system 111 can include control electronics or circuitry 251, as well as one or more power supplies or supply interfaces 259, pneumatic devices, optical sources, actuators, data storage devices, and / or communication interfaces 254.049450-000420

[0078] The various components of the medical system 100 can be communicatively coupled to each other over a network, which can include a wireless and / or wired network. Example networks include one or more personal area networks (PANs), local area networks (LANs), wide area networks (WANs), Internet area networks (IANS), cellular networks, the Internet, body area network (BANs), etc. For example, the communication interfaces 214 and 254 of the robotic system 110 and the control system 111, respectively, can be configured to communicate with one or more devices, sensors, or systems, such as over a wireless and / or wired network connection. In some implementations, the various communication interfaces can implement a wireless technology such as Bluetooth, Wi-Fi, near field communication (NFC), or the like. Furthermore, in some implementations, the various components of the system 100 can be connected for data communication, fluid exchange, power exchange, and so on via one or more support cables, tubes, or the like.

[0079] With further reference to FIG. 1, the medical system 100 provides a variety of benefits, such as providing guidance to assist a physician in performing a procedure (such as instrument tracking or instrument alignment information), enabling a physician to perform a procedure from an ergonomic position without the need for awkward arm motions and / or positions, enabling a single physician to perform a procedure with one or more medical instruments, avoiding radiation exposure (such as associated with fluoroscopy techniques), enabling a procedure to be performed in a single-operative setting, or providing continuous suction to remove an object more efficiently (such as to remove a kidney stone), among other examples. For example, the medical system 100 can provide guidance information to assist a physician in using various medical instruments to access a target anatomical feature while minimizing bleeding and / or damage to anatomy (such as critical organs or blood vessels).

[0080] Further, the medical system 100 can provide non-radiation-based navigational and / or localization techniques and / or reduce the amount of equipment in the operating room. Moreover, the medical system 100 can provide functionality that is distributed between at least the control system 111 and the robotic system 110, which can be independently movable. Such distribution of functionality and / or mobility can enable the control system 111 and / or the robotic system 110 to be placed at locations that are optimal for a particular medical procedure, which can maximize working area around the patient and / or provide an optimized location for a physician to perform a procedure.

[0081] FIG. 3 is a schematic block diagram of an example localization system 300, according to some implementations. The localization system 300 includes various positioning or imaging systems or modalities 302-312 (also referred to as “subsystems”), which can be049450-000420 implemented to facilitate anatomical mapping, navigation, positioning, or visualization for procedures in accordance with one or more examples. For example, the various systems 302- 312 can be configured to provide data for generating an anatomical map, determining a location of an instrument, determining a location of a target, or performing other techniques.

[0082] Each of the systems 302-312 can be associated with a respective coordinate space (also referred to as a “position coordinate frame”) or can provide data or information relating to instrument or anatomy locations, wherein registering the various coordinate spaces to one another can allow for integration of the various systems to provide mapping, navigation, or instrument visualization. For example, registering a first modality to a second modality can allow for determined positions in the first modality to be tracked or superimposed on or in a reference frame associated with the second modality, thereby providing layers of positional information that can be combined to provide a robust localization system.

[0083] In some aspects, the system 300 may be configured to perform one or more localization or localizing techniques. In some implementations, the anatomical space in which a medical instrument can be localized (such as where a pose or shape of the instrument is determined or estimated) may be a 2D or 3D portion of a patient’s tracheobronchial airways, vasculature, urinary tract, gastrointestinal tract, or any organ or space accessed via lumens. Various modalities can be implemented to provide images, representations, or models of the anatomical space. For example, an imaging modality can be implemented, which can include, for example, X-ray, fluoroscopy, computed tomography (CT), positron emission tomography (PET), PET-CT, CT angiography, cone beam CT (CBCT), three-dimensional rotational angiography (3DRA), single-photon emission CT (SPECT), magnetic resonance imaging (MRI), optical coherence tomography (OCT), or ultrasound, among other examples. In some implementations, the imaging modality may be used to capture or acquire images of a patient’s anatomy during a preoperative phase of a medical procedure. In some other implementations, the imaging modality may be used to capture or acquire images of a patient’s anatomy during an intraoperative phase of the medical procedure.

[0084] The systems 302-312 can provide information for generating a graphical user interface 314 (also referred to as a “graphical interface (I / F)”) that includes navigation information for navigating an instrument to a target within an anatomy. For example, the navigation information may include an anatomical map, an estimated position, orientation, and / or shape of the instrument. The navigation information also may include a shape, boundary, eccentricity, texture, and / or position of the target. In some implementations, the graphical user interface 314 or other localization information may be displayed to a user, such049450-000420 as a physician, during a medical procedure to assist the user in performing the procedure. For example, a visualization of a tracked instrument can be superimposed on an anatomical map depicted by the graphical user interface 314 based on position or sensor data associated with the tracked medical instrument.

[0085] The system 300 can include a support structure 302, which is a surgical bed or other patient positioning or support platform. For example, the support structure 302 may be table 115. The support structure 302 includes a planar surface that contacts and supports the patient. In some implementations, the position of the support structure 302 may be known based on data maintained relating to the position of the support structure 302 within the surgical or procedure environment. In some other implementations, the position of the support structure 302 may be sensed or otherwise determined using one or more markers or an appropriate imaging or positioning modality. In other applications, the support structure 302 may be integrated with the robotic arms such that the table 302 and the robotic system 304 may be one unit.

[0086] The system 300 further includes a robotic system 304 (such as a robotic cart or other device or system including one or more robotic end effectors). The robotic system 304 may comprise, for example, the robotic system 110 of FIGS. 1 and 2. Data relating to the position or state of robotic arms, actuators, or other components of the robotic system 304 can be known or derived from robotic command data or other robotic data relative to a coordinate frame of the robotic system 304. In some examples, reference frame registration 316 occurs between the support structure 302 and the robotic system 304, which can be a relatively coarse registration, in some implementations, based on robotic system or cart-set-up procedure (which can have any suitable or desirable scheme).

[0087] The system 300 further includes an EM sensor system 306, which can include an EM field generator and one or more EM sensors (e.g., EM elements). An EM sensor can be associated with a portion of an instrument that is tracked or controlled, such as a distal end (or tip) of the instrument or along a length of the instrument or other elongate member (such as a working channel) disposed in a lumen of the instrument. The EM field generator can be mechanically coupled to the support structure 302 or the robotic system 304 such that registration or association 318 between such systems can be known or determined. In some implementations, the registration 318 between the EM sensor system 306 and the robotic system 304 can be determined through forward kinematics or field generator mount transform information. For example, the field generator can be mounted to the support structure 302 such that the position of the field generator can be known relative to the robotic system positioning049450-000420 frame based on a known relationship between the position of the support structure 302 and the robotic system 304. The EM sensor system 306 can provide instrument pose or path information based on sensor readings associated with the instrument.

[0088] The system 300 further includes an optical camera system 308 including one or more cameras or other imaging devices configured to generate images of patient anatomy within a visual field thereof (such as real-time image data) during a surgical procedure. Registration 320 between the optical camera system 308 and the EM sensor system 306 can be achieved through identification of features having EM sensor data associated therewith, such as a medical instrument tip, in images generated by the optical camera system 308. The registration 320 can further be based at least in part on hand-eye interaction of the physician when viewing real-time camera images while the EM-sensor-equipped endoscope is navigating in the patient anatomy.

[0089] The system 300 further includes a computed tomography (CT) imaging system 310 configured to generate CT images of the patient anatomy, which can be performed preoperatively or intraoperatively. The CT imaging system 310 is generally used for scanning a relatively large volume. In some implementations, image processing can be implemented for registration 322 of the CT image data with the camera image data generated by the optical camera system 308. For example, common features identified in both camera image data and CT image data can be identified to relate the CT image frame to the camera image frame in space. In some examples, the CT imaging system 310 can be used to generate preoperative imaging data for producing the graphical user interface 314 or for path navigation planning.

[0090] The CT imaging system 310 may be registered 326 to the EM sensor system 306 through various techniques. In some implementations, a mechanical structure of the CT imaging system 310 can have a known physical transform or relationship with respect to a mounting position of the EM field generator of the EM sensor system 306. Such known relationship can be used to register the CT image space to the EM sensor space, or vice versa. The connection 328 represents a mapping or relationship between the CT imaging system 310 and an anatomical map depicted by the graphical user interface 314.

[0091] The system 300 further includes a fluoroscopy imaging system 312 configured to generate tomographic images (such as real-time X-ray images) of the surgical site. The fluoroscopy imaging system 312 is generally used for scanning a smaller volume compared to the CT imaging system 310. For example, the fluoroscopy imaging system 312 may include a CBCT scanner 340 coupled to a C-arm 342. The fluoroscopy imaging system 312 may be used with a contrast agent introduced into the anatomy to generate image data representing patient049450-000420 anatomy or instrumentation. The fluoroscopy imaging system 312 may be registered 324 to the CT imaging system 310 using any image processing technique suitable for such registration.

[0092] The fluoroscopy imaging system 312 may be registered 332 to the EM sensor system 306 through various techniques. In some implementations, a mechanical structure of the fluoroscopy imaging system 312 (such as the C-arm instrumentation) can have a known physical transform or relationship with respect to a mounting position of the EM field generator of the EM sensor system 306. Such known relationship can be used to register the fluoroscopy image space to the EM sensor space. The connection 330 represents a mapping or relationship between the fluoroscopy imaging system 312 and an anatomical map depicted by the graphical user interface 314.

[0093] The CT imaging system 310 and fluoroscopy imaging system 312 are illustrated in FIG. 3 as separated systems. In other implementations, however, a single imaging system may perform the functions of both the CT imaging system 310 and fluoroscopy imaging system 312.

[0094] The position, shape, or orientation of an instrument, such as an endoscope, can be determined using any one or more of the systems 302-312, which can facilitate generation of graphical interface data representing the estimated position or shape of the instrument relative to an anatomical map depicted by the graphical user interface 314. The graphical user interface 314 can be displayed on a display device, such as via the control system 111 or robotic system 110, or another device. In some implementations, the graphical user interface 314 also may indicate a position of a target within the anatomy that has been designated for treatment. High Performance System for Fluid Delivery into Lesions

[0095] FIGS. 4A and 4B illustrate another example medical system 400, according to one or more embodiments of the present disclosure. The medical system 400 may be the same as or similar to the medical system 100 of FIG. 1, and may thus be best understood with reference thereto. For example, the medical system 400 includes the robotic system 110 and the control system 111 of FIG. 1. Additionally, the medical system 400 includes an imaging device 410, which can be integrated into a C-arm 342 (FIG. 3) or otherwise configured to provide imaging during a procedure, such as for a fluoroscopy-type procedure. It is noted that the imaging device 410 is but one example of the fluoroscopy imaging system 312 of FIG. 3.

[0096] The medical system 400 also includes a drug delivery system 420 configured to deliver a medicant (e.g., drug, treatment, etc.) to a target location within a patient’s body. For example, the drug delivery system 420 may be configured to deliver the medicant into a target tissue (e.g., lesion, nodule, tumor), such as delivering the drug intratumorally. The robotic049450-000420 system 110 may be used to help deliver a needle 421 (such as a drug delivery needle) to the target location. The needle 421 is shown to be inserted via endoluminal access (such as within a working channel of the scope 130), but could alternatively be percutaneously inserted into the anatomy.

[0097] The drug delivery system 420 includes a fluidics pump 422 in communication with the needle 421 via one or more fluid lines 423. The fluidics pump 422 is configured to pump the medicant from a medicant source 425 (shown as a syringe in FIG. 4B) through the needle 421 via the fluid line 423 (e.g., fluid conduit, tubing). The fluidics pump 422 may be mounted to a support structure 429, such as a moveable IV pole. In some embodiments, the drug delivery system 420 (e.g., medicant delivery system, fluid delivery system) also includes a sensor assembly 430 fluidly connecting the needle 421 to the fluid line 423. A communication cable 427 may place the fluidics pump 422 in communication with the sensor assembly 430, and the sensor assembly 430 may be mounted to a fluid delivery arm 440 operatively coupled to the support structure 429. The fluid delivery arm 440 may include one or more members coupled together (e.g., telescopically) so that the sensor assembly 430 can be positioned in a desired location relative to the scope 130. In some embodiments, the fluid delivery arm 440 has one degree of freedom. In other embodiments, the fluid delivery arm 440 has a plurality of degrees of freedom. For example, the fluid delivery arm 440 may facilitate translation and / or rotational degrees of freedom to facilitate coaxial location of the needle 421 within the working channel of the scope 130. One or more of the members forming the fluid delivery arm 440 may be locking to maintain position or may be spring loaded to present resistance from movement beyond the set point while still being compliant. In other embodiments, the members forming the fluid delivery arm 440 may be free to move without resistance to one another.

[0098] FIG. 4C illustrates a schematic representation of the sensor assembly 430, which can include a body 431 and an internal flow path 432 extending from an inlet 433 to an outlet 434. The fluid line 423 (FIG. 4B) is fluidly coupled to the inlet 433 while the needle 421 is fluidly coupled to the outlet 434. In at least one embodiment, the needle 421 may extend into the internal flow path 432 and may be axially movable therein and relative to the outlet 434, thereby enabling the needle 421 to axially advance or retract.

[0099] The sensor assembly 430 includes one or more inline sensors. For example, the sensor assembly 430 may include an inline pressure sensor 436, such as a microelectromechanical system (“MEMS”) based inline pressure sensor. The sensor assembly 430 may optionally include an inline flow rate sensor 438, such as an ultrasonic, optical,049450-000420 doppler, or other suitable type of flow rate sensor. The sensor assembly 430 may include an electrical connector 435 connectable to the cable 427 (FIG. 4B) to facilitate communication between the fluidics pump 422 and the sensor assembly 430, including the pressure sensor 436 and the flow rate sensor 438. In other embodiments, the sensor assembly 430 may be in wireless communication with the fluidics pump 422, such as being connected by Bluetooth, Wi-Fi (e.g., wireless network), optical connection, and / or ultrasonic technologies. In some embodiments, the sensor assembly 430 receives power wirelessly from the fluidics pump 422 such that the sensor assembly 430 does not include its own power source.

[0100] In some embodiments, the sensor assembly 430 may include a check valve to prevent back-flow of fluids. The check valve may be located, for example, at one of the inlet or outlet 433, 434, or within the internal flow path 432. The check valve may alternatively be located between the outlet of the medicant source 425 and the proximal end of the needle 421, such as being between the outlet of the medicant source 425 and the inlet 433. In some embodiments, the sensor assembly 430 may also include a shutoff valve to selectively stop flow of the medicant. In some embodiments, the sensors 436, 438, the check valve, and / or the shutoff valve may not be integrated into a single unit like the sensor assembly 430. Instead, one or more of the sensors 436, 438, the check valve, and the shutoff valve may instead be disposed downstream from the outlet of the medicant source 425, such as being coupled to or arranged within the fluid line 423 upstream of the inlet 433.

[0101] Referring again to FIGS. 4A-4B, in some embodiments, the fluid delivery arm 440 may be configured to move the sensor assembly 430 and the needle 421 relative to the scope 130 and the support structure 429. In other words, the fluid delivery arm 440 may move the sensor assembly 430 and the needle 421 independent of the robotic system 110. For example, the fluid delivery arm 440 may have one degree of freedom such that the sensor assembly 430 and needle 421 are moveable as shown by the doubled sided arrow in FIG. 4A to advance or retract the needle 421 within the scope 130. In some embodiments, the fluid delivery arm 440 may have one or more tracks, with the needle 421 and sensor assembly 430 being coupled to a carrier moveable to one or more positions along the tracks. Additionally, the sensor assembly 430 may be independently moveable relative to the fluid delivery arm 440, such as along the tracks 441 shown in FIG. 4B, to facilitate coupling the sensor assembly 430 to the needle 421 that is already partially disposed in the scope 130, such as being manually placed into the scope 130 prior to coupling the needle 421 to the sensor assembly 430. The sensor assembly 430 may be fixed into position relative to the fluid delivery arm 440 once the needle 421 has been operatively coupled to the sensor assembly 430.049450-000420

[0102] In some embodiments, the fluid delivery arm 440 structurally supports the sensor assembly 430 and needle 421, and the robotic system 110 operates to move the needle 421 relative to at least one of the sensor assembly 430 and the scope 130. For example, one of the robotic arms 112 may use the end effector 122 thereof to advance the needle 421 to one or more positions within the scope 130. The fluid delivery arm 440 may have a track that the sensor assembly 430 can slide along as the robotic arm 112 moves the needle 421. In other embodiments, however, the needle 421 may be manually moved relative to the sensor assembly 430 and the scope 130, without departing from the scope of the disclosure.

[0103] The fluid delivery arm 440 may include one or more line management elements to facilitate movement of the fluid line 423 and the cable 427 as the needle 421 and sensor assembly 430 are moved. For example, the line management elements may be hooks that hang and support the fluid line 423 and the cable 427. As another example, the line management elements may be a reel that facilitates reeling in and out the fluid line 423 and the cable 427.

[0104] In some embodiments, the medical system 400 includes a puncture force sensor to measure the force needed for the tip of the needle 421 to puncture the target. The force sensor may monitor the force acting on the needle 421 prior to and post puncturing of the target, with the differential being the force needed to puncture the target. In some embodiments, the force sensor may be included in the actuator that moves the needle 421 relative to the scope 130, such as being a load cell or other suitable sensor for evaluating the force applied by the actuator. For example, the load sensor may be coupled to the actuator of the fluid delivery arm 440. In other embodiments, however, the force sensor may be located at the tip of the needle 421 to achieve a more precise measurement of the puncture force. In such embodiments, the force sensor may be configured to communicate (either wired or wirelessly) with the control system 111. The calculated puncture force may be used to characterize the target tissue type, such as evaluating if the target is a tumor or necrotic.

[0105] In some embodiments, the fluidics pump 422 is electronically controlled by the control system 111 to ensure precise and accurate medicant delivery. The control system 111 may utilize feedback from the sensor assembly 430, such as the measured pressure or measured flow rate, to control the fluidics pump 422. The feedback may be used to ensure that an accurate and precise dose of the medicant is delivered at a particular location within the target so that the medicant does not leak out from the target. The control system 111 may also use feedback from a rotary encoder of the fluidics pump 422 to control and monitor pumping of the medicant, such as using the information obtained from the rotary encoder to calculate the flow rate and049450-000420 using the information obtained from the flow rate sensor 438 to validate the calculated flow rate.

[0106] The needle 421 may be moved to different locations within the target to support dose fractionation. For example, after a target dose has been delivered to a particular location, the robotic system 110, the fluid delivery arm 440, and / or a surgeon may move the needle 421 to another location at the target to distribute the drug more evenly throughout the target. As described with reference to FIGS. 1-3, the robotic system 110 may rely on various imaging and / or sensor modalities (such as the EM sensor system 306, the camera system 308, and / or the fluoroscopy imaging system 312 of FIG. 3) for guiding precision needle placement within the anatomy. For example, the image data and / or sensor data can be used for tool-in-lesion confirmation and can also be used to plan needle insertion to reach various drug delivery locations. The image data and sensor data (such as position and / or pressure data) also may indicate real-time changes to the anatomy and / or drug delivery process which can be used to update or modify the delivery plan.

[0107] As shown in FIG. 4A, the drug delivery system 420 may optionally include a tray 426 and a display 424 (e.g., monitor, laptop, table) coupled to the support structure 429. The display 424 may comprise a graphical user interface allowing for a person (e.g., surgeon, nurse) to view and control operational parameters of the drug delivery system 420, such as the fluidics pump 422. In some embodiments, the display 424 may be a touch screen allowing a user to control the fluidics pump 422. In some embodiments, however, the medical system 400 has a single point of control at the control system 111 (e.g., control interface 143), and the display 424 shows information about the current procedure, such as the current flow rate and / or pressure. In other embodiments, the display 424 may be part of a separate control system that works independently of or in cooperation with the control system 111.

[0108] In some embodiments, the medical system 400 may be used to evaluate if a leak path is present prior to or during the delivery of the medicant from the medicant source 425 to a target location. Once the tip of the needle 421 is located at a desired location, such as within the target, the fluidics pump 422 may pump a small volume (e.g., test volume) of fluid into the target to reach a target pressure to test for leaks. The fluid may comprise a small volume of the medicant or a neutral fluid, such as saline. In some applications, the medicant source 425 may have multiple fluids arranged in series, with saline being used to initially test for leaks and followed by the medicant once the saline is exhausted.

[0109] The fluid pressure at the target may be monitored with the inline pressure sensor 436 after delivering the small volume into the target, with further fluid flow being suspended049450-000420 for the duration of the leak test. If the fluid pressure at the target does not decay or decays imperceptibly, there are no leak paths in the drug delivery system 420 (e.g., fluidics pump 422, fluid line 423, sensor assembly 430) nor from (at) the target. Little or no pressure decay indicates that there is very little if any diffusion of the fluid into the tissue (e.g., the lesion), which may indicate that the needle tip is in necrotic tissue or perhaps that needle tip is fully occluded by lesion tissue or perhaps bone. If the fluid pressure drops slowly, such as within an expected range of rates, then no gross leak paths are present and the fluid is likely diffusing as expected into the target tissue of the appropriate type. Combined with concurrent imaging, leak paths may be ruled out and the diffusion rate, along with target tissue diffusion characteristics, may be used to identify or confirm the type of tissue that the needle tip is disposed within. If fluid pressure drops quickly or a target pressure never develops, there may be a gross leak path in the drug delivery system 420 or target (e.g., burst lesion). Additionally, a pressure drop or failure to develop the target pressure may indicate that the needle tip is not within the target but is instead delivering (dispensing) into an open space or that the needle tip is delivering into an internal void within the target.

[0110] In some embodiments, the needle 421, the fluidics pump 422, and the inline pressure sensor 436 may be used to conduct a pressure probe test at one or more locations within the target to identify and / or characterize the tissue type. The pressure probe test may be similar in some respects to the leak test, with a small volume of fluid being delivered into the target via the needle 421 until a target pressure is reached. The fluidics pump 422 continues to pump the fluid at a target flow rate while monitoring the fluid pressure. The pressure-flow rate curve of the fluid produced during the pressure probe test, such as by monitoring the outputs of the inline pressure and flow rate sensors 436, 438, may then be compared to a library of pressure-flow rate curves to evaluate what type of tissue is present at the needle tip.

[0111] Additionally, the pressure probe test may yield the fluid resistance and / or diffusion behavior of the target, which may be used to identify or characterize the tissue type. For example, the probe test may determine that the tissue within which the needle tip is currently located is necrotic due to extremely low diffusion and resistance to fluid flow (e.g., increasing pressure in response to added flow).

[0112] The pressure probe test may further evaluate if the flow resistance of the tissue is within the acceptable bounds for the procedure, such as evaluating if the target can handle the prescribed medicant pressure without bursting. In some embodiments, the pressure probing test may provide haptic feedback to the user, such as increasing the resistance felt by the surgeon when trying to increase the fluid flow. Such haptic feedback may be incorporated into049450-000420 a controller connected to the control system 111, such as the controller 1100 in FIGS. 11A and 1 IB. For example, the physician presses a control “trigger” or ”‘lever” to command a delivery flow rate, the flow proportional to the distance the trigger is depressed, and the degree of resistance (e.g., force) felt (e.g., haptic feedback) by the physician is proportional to the fluid pressure at the flow rate commanded.

[0113] Additionally, the fluidics pump 422 may modulate the flow rate and / or pressure based on reaching maximum flow rate or pressure limits rather than producing an occlusion alarm and suspending / terminating medicant delivery.

[0114] The fluidics pump 422 may be used to deliver a desired dose of the medicant at a commanded (predetermined) flow rate and / or pressure with precision and accuracy. In some embodiments, the fluidics pump 422 can be operated to deliver the medicant at relatively low flow rates over a specific period of time, which is advantageous for localized injection of the medicant in the target within the patient. For example, the fluidics pump 422 can be controlled to pump the medicant out of the medicant source 425 at flow rates of about 0.1 ml / min to about 10 ml / min. The fluidics pump 422 may also be controlled to deliver the medicant at low flow rates over an extended period of time, such as delivering the medicant over a 5 to 20 minute time span to allow the medicant to diffuse into the target.

[0115] The fluidics pump 422 may be controlled to deliver the medicant at a desired pressure. In some embodiments, the medicant can be pumped with a pressure up to about 1800 mmHg, which is significantly higher than the high end pressure of conventional intravenous infusion pumps which operate between 300-600 mmHg. Furthermore, the fluidics pump 422 can accommodate a variety of syringe sizes, allowing the fluidics pump 422 to be used to deliver a variety of medicant volumes into a patient. For example, the fluidics pump 422 can be used to pump volumes between about 1ml to about 100ml.

[0116] Additionally, the fluidics pump 422 may be operated to deliver the medicant over a desired delivery profile with varying flow rates and / or pressures, such as delivering a first portion of the dose at a first pressure and then delivering a second portion of the dose at a second pressure. Additionally, different fractional doses may be delivered at different pressures and / or flow rates.

[0117] FIGS. 5A-5D illustrate an example fluidics pump 500 that can be used to inject a medicant into a target, according to some implementations. The fluidics pump 500 may be the same as or similar to the fluidics pump 422 of FIGS. 4A-4B, and may thus be used in the drug delivery system 420 of FIGS. 4A-4B and may comprise a mechanical pump that can be electronically controlled and operated. The fluidics pump 500 can be used to dispense fluid049450-000420(such as a drug or “medicant”) from a syringe 590 into a fluid line fluidly coupled thereto, such as the fluid line 423 of FIG. 4B.

[0118] The fluidics pump 500 can be adapted to use both off-the-shelf (OTS) syringes or customized syringe designs. OTS syringes are produced in high volume and at low cost. Additionally, syringes that are disposable after one use are well suited for hospital pharmacy custom filling on demand, patient and procedure specific uses. Syringes can be used to deliver medications with short working life with low temperature maintenance requirements. Syringes can also be made from a wide range of materials (e.g., wetted surfaces) to ensure chemical compatibility with various medicants. Syringes can also be used to hold a variety of volumes (e.g., ImL, 3mL, 5mL, lOmL, 20mL, 30mL, 50mL, 60mL, etc.).

[0119] FIG. 5 A illustrates a perspective view of the fluidics pump 500. As illustrated, the fluidics pump 500 includes a housing 502 (shown as being transparent) and a displacement head 504 coupled to a motorized assembly 506 having control circuitry 508. The displacement head 504 is configured to be translated (e.g., axially moved) by operation of the motorized assembly 506 along axis 501 (FIG. 5C) so that a portion (e.g., an inner surface) of the displacement head 504 presses against (engages) a plunger 592 of the syringe 590 to expel fluid stored therein into a fluid line connected to an outlet of the syringe 590.

[0120] The fluidics pump 500 may optionally include a door 510 that can be moved to one or more positions relative to the housing 502. The door 510 may be used to shield the syringe 590 during use, such as protecting the syringe 590 from incidental contact by personnel.

[0121] The motorized assembly 506 is operable to drive the displacement head 504 along the axis 501 (FIG. 5C) in a direction toward or away from the housing 502. Driving the displacement head 504 toward the housing 502 causes the displacement head 504 to engage and depress the plunger 592. In some embodiments, driving the displacement head 504 away from the housing 502 retracts the plunger 592, but in other embodiments may simply move the displacement head 504 away from the plunger 592.

[0122] In some implementations, the rate and / or direction with which the motorized assembly 506 drives the displacement head 504 may be controlled, at least in part, by the control circuitry 508. In some implementations, the control circuitry 508 may receive and execute commands or instructions from a separate control system (such as the control system 111 of FIGS. 1 and 4A) to actuate the motorized assembly 506.

[0123] Referring specifically to FIGS. 5A-5C, the motorized assembly 506 includes a motor 531, a rotary encoder 532, a lead screw 533, and a power transfer system 534 that mechanically links the motor 531 to the lead screw 533 such that operating the motor 531049450-000420 correspondingly rotates the lead screw 533. Turning to FIG. 5B, a lead nut 541 (shown as a dashed box) is threaded onto the lead screw 533 and operatively coupled to a shaft 542 (shown in phantom) extending from the displacement head 504. The motor 531 causes the lead screw 533 to rotate about the axis 501 (FIG. 5C), which causes the lead nut 541 to translate along the lead screw 533, and translation of the lead nut 541 moves the shaft 542, which causes the displacement head 504 to move toward or away from the housing 502, depending on the rotational direction of the lead screw 533. The displacement head 504, the shaft 542, and the lead nut 541 are collectively referred to herein as the “pump plunger” of the fluidics pump 500 and which is translatable in response to operation of the motor 531 and thereby change the position of the plunger 592 of the syringe 590.

[0124] The lead screw 533 may be partially disposed in the shaft 542, and may be formed from a metal (e.g., stainless steel, aluminum, etc.), a metal alloy, or a plastic (e.g., an injection molded plastic with fillers). The lead nut 541 is shown schematically in FIG. 5B near the bottom end of the shaft 542. The lead nut 541 has internal threads that are complementary to external threads provided on the lead screw 533. For example, the lead nut 541 may have a 1.00mm pitch Vee thread. The lead nut 541 may be formed from a metal (e.g., stainless steel, aluminum, etc.), or a plastic.

[0125] Still referring to FIG. 5B, the motorized assembly 506 and the shaft 542 may be supported by a chassis 538 disposed within the housing 502. One or more lead nut guides 539 may be coupled to the chassis 538 to help guide movement of the shaft 542. Additionally, a bearing 545 may be mounted to the chassis 538 to help facilitate movement of the shaft 542 relative to the chassis 538.

[0126] In some embodiments, the motor 531 is a stepper motor that rotates in a series of small and discrete angular steps (movements). For example, the stepper motor may be a 1.8 degree full-step motor. In some embodiments, the motor may be an 8x or even a 16x microstepped motor for increased resolution and / or reduced minimum incremental fluid delivery volume with a modest torque reduction.

[0127] The rotary encoder 532 may correlate the rotation of the rotor of the motor 531 (e.g., tracking the number of commanded steps) to the current axial position of the displacement head 504. Additionally, the rotary encoder 532 may correlate the rotational speed of the rotor of the motor 531 to the linear speed of the displacement head 504. The rotary encoder 532 may include one or more opto-interrupt sensors, such as a pair of infrared sensors. In some embodiments, the rotary encoder 532 may include a four flag encoder wheel on the motor to track the number of steps and the rotational speed of the rotor of the motor. In some049450-000420 embodiments, the rotary encoder 532 uses quadrature position sensing to monitor the motor 531. In some embodiments, the rotary encoder 532 may monitor for missed steps to more accurately determine the axial position of the displacement head 504. For example, the rotary encoder 532 may include an opto-interrupt derived sensor position to detect missed steps by comparing the commanded motor steps (e.g., commanded by the control circuitry 508) to actual steps.

[0128] In some embodiments, the motorized assembly 506 may include a torque limiting device to prevent the displacement head 504 from exceeding a maximum pushing force against the plunger 592. The torque limiting device may be a clutch used to restrict the motion of the lead screw 533. For example, the clutch may be an over-running clutch including a leaf spring mounted to the lead screw 533 that engages a ring of detents integral to and concentric with the hub of the chassis 538.

[0129] In some embodiments, the power transfer system 534 may be a gear system, as shown in FIG. 5C, configured to drive rotation of the lead screw 533. For example, the power transfer system 534 may include a first gear 535 (e.g., a pinion gear) operatively coupled to the rotor of the motor 531, a second gear 536 (e.g., idler gear) engageable with the first gear 535, and a third gear 537 (e.g., drive gear) engageable with the second gear 536 and operatively coupled to the lead screw 533 such that rotation of the third gear 537 correspondingly rotates the lead screw 533. The gears 535, 536, 537 may have a speed reduction ratio of about 4:6: 1, but could exhibit different speed reduction ratios, without departing from the scope of the disclosure. The first gear 535 may be formed from a metal (e.g., brass) while the second and third gears 536, 537 may be formed from metal or a molded plastic. The power transfer system 534 may include more than three gears in some embodiments. In other embodiments, however, the second gear 536 may be omitted and the first gear 535 may be arranged to drive the third gear 537 and thereby rotate the lead screw 533. The power transfer system 534 may alternatively comprise a belt system, such as the rotor of the motor 531 and the lead screw 533 each having a belt pulley that a belt is looped around.

[0130] Driving the displacement head 504 using the motorized assembly 506 provides a consistent pressure and / or flow rate of the fluid exiting the syringe outlet 596. Additionally, the fluid is delivered in a non-pulsatile manner unlike linear or rotary peristaltic pumps. Furthermore, the motorized assembly 506 is capable of pumping force or shear-sensitive medicants, such as medicants that contain a suspension of particles or cellular bodies.

[0131] FIG. 5C illustrates a partially disassembled side view of the fluidics pump 500. The fluidics pump 500 includes a cradle 512 (shown schematically as a dashed box) configured049450-000420 to support a barrel 594 of the syringe 590, and center the syringe 590 while the displacement head 504 is translated to move the plunger 592. In some embodiments, the syringe 590 may be placed in the cradle 512 after the fluid line is secured to the syringe 590 at the syringe outlet 596. In other embodiments, the fluid line is secured to the syringe outlet 596 after the syringe 590 is placed in the cradle 512.

[0132] The cradle 512 may be integral with or separate from the housing 502. The cradle 512 may include an internal support surface that has a geometry that contours to (matches) a corresponding geometry of the barrel 594 of the syringe 590 but provides access for the fluid line connected to the syringe outlet 596 formed as part of the barrel 594. For example, the cradle 512 may be a cylindrical or V-shaped body with the internal support surface. In some embodiments, the internal support surface of the cradle 512 may include a profile, such as a groove, configured to trap the barrel flange 595 to hold the barrel 594 in a fixed axial position. In other embodiments, the cradle 512 may include a shoulder that the bottom surface of the barrel flange 595 abuts against.

[0133] In some embodiments, the cradle 512 may include one or more movable (manipulatable) securing means (e.g., spring-loaded claws, spring -loaded clamps, snap-fit engagement, etc.) to help facilitate securing the syringe 590 in place within the cradle 512. In other embodiments, the cradle 512 may be configured to have an interference fit with the barrel 594. The cradle 512 may be top-loading, where the syringe 590 is inserted into the cradle 512 from the top of the cradle 512 in a direction generally parallel to the axis 501. The cradle 512 may alternatively be side-loading, with the syringe 590 being inserted into the cradle 512 in a direction generally perpendicular to the axis 501. Alternatively, the cradle 512 may comprise two or more spring-loaded clamps (e.g., spring-loaded claws) axially spaced along the housing 502 and configured to grippingly engage the barrel 594 to lock (secure) the syringe 590 into place.

[0134] In some embodiments, the displacement head 504 may include a plunger retainer 514 configured to secure the end of the plunger 592 to the displacement head 504 such that the plunger 592 can be moved upwards relative to the barrel 594. The plunger retainer 514 may be one or more clamping elements that grip the end of the plunger 592, such as gripping the plunger end flange. In some embodiments, the plunger retainer 514 may comprise a slot defining a shoulder that traps the end of the plunger 592, such as a shoulder that is engaged against the underside of the plunger end flange. The plunger retainer 514 can be actuated to release the plunger 592 once the syringe 590 has been emptied or delivered the desired dose (e.g., volume).049450-000420

[0135] In some embodiments, the fluidics pump 500 may include a plunger brake 524 (shown as a dashed box) that is selectively used (actuated) to arrest or slow movement of the plunger 592. In some embodiments, the plunger brake 524 may be automatically activated when the fluidics pump 500 is not actively moving the plunger 592. The plunger brake 524 may also be used as an emergency brake to stop further displacement of the plunger 592. The plunger brake 524 may comprise one or more gripping members that can engage (e.g., bite into) the plunger 592. In at least one embodiment, the gripping members may comprise a claw with one or more biting elements. The plunger brake 524 may be attached to the housing 502 and may be located between the cradle 512 and the displacement head 504.

[0136] In some applications, the motor 531 may lose power due to system failures, operational errors, system power off, etc., such that the fluidics pump 500 can stop driving the plunger 592. The fluid may flow in an inverse direction potentially imposing safety risks, system contamination risks, etc. and altering the delivered medicant dose. To prevent the fluid from flowing in the inverse direction, the plunger brake 524 can be activated automatically once the motor 531 loses power. In some embodiments, to enhance reliability and safety, the plunger brake 524 is actively disabled (e.g., using electrical system power) when motion of the displacement head 504 is desired and is passively enabled when motion of the displacement head 504 is not desired (e.g., during power loss). For example, the plunger brake 524 may be biased toward an engaged position by a biasing element, the bias of which is selectively overcome by an electromechanical device (e.g., actuator). The electromechanical device moves the plunger brake 524 from the engaged position, where the plunger 592 is gripped, to a disengaged position, where the plunger 592 is free to move relative to the plunger brake 524. The biasing element engages the plunger brake 524 against the plunger 592 to stop motion of the plunger 592 when the electromechanical device becomes non-operational, such as during a power loss.

[0137] In some embodiments, the syringe 590 may include an identification element 599. In at least one embodiment, the identification element 599 may comprise a label fixed to the syringe 590, such as on the barrel 594. The label may include a readable mark, such as a bar code or QR code. In other embodiments, the identification element 599 may be an element with information stored within that is accessible once read by an appropriate reader 560, such as being a radio frequency identification (“RFID”) device attached to the barrel 594 or molded into the barrel 594. In some embodiments, the syringe 590 may include multiple identification elements 599, such as a first identification element that includes a readable mark and a second identification element that is an RFID device.049450-000420

[0138] The reader 560 (shown generally as a dashed box) for the identification element 599 may be integrated into the fluidics pump 500, such as being integral with or attached to the cradle 512, the door 510, or the housing 502. The reader 560 may be used to interrogate the syringe 590 prior to or after the syringe 590 is installed in the cradle 512. The reader 560 may be in communication with the control circuitry 508 and / or the control system 111.

[0139] The identification element 599 may include (or store) a variety of information, such as information about the patient, syringe specifications, and / or information about the medicant contained within the syringe 590. For example, the identification element 599 may allow the control system 111 to determine the patient identification, prescription identification, medicant identification, medicant specifications (e.g., concentration, working life, handling precautions), procedure parameters (e.g., prescribed number of fractional doses, prescribed fractional dose volume, prescribed plunger speed, prescribed flow rate, and / or prescribed pressure for each fractional dose), syringe technical specifications (e.g., syringe manufacturer, model, wetted material, chemical compatibility with medicant, syringe nominal volume, precise barrel inner diameter, barrel length, outlet fitting type), needle size and length for procedure, and / or tubing set lumen identification and lengths for procedure, and / or linear syringe plunger speed and validation of pump calculated plunger speed.

[0140] In some embodiments, the identification element 599 may cause the display 141 of the control system 111 to display a message detailing special biohazard precautions for the medicant after being interrogated (e.g., read) by the reader 560. Additionally, the identification element 599 may cause the control system 111 to set certain permissions, such as allowing or disallowing the user to override fluid delivery parameters. For example, the control system 111 may limit the user’s ability to override permissions based on the information obtained from the identification element 599, such as setting a “cannot exceed value” for certain parameters.

[0141] In some embodiments, the identification element 599 is used to confirm that the correct syringe 590 is loaded into the fluidics pump 500. For example, the identification element 599 may be used to allow the control system 111 to automatically check if the loaded syringe 590 contains the correct medicant for the patient, the correct dose, and that the syringe 590 has correct size and / or specifications to be used with the fluidics pump 500.

[0142] In some embodiments, the information obtained from the identification element 590 is input into the control system 111 automatically upon being read (detected) by the reader 560. In other words, the control system 111 may use the information obtained from the identification element 599 as an input used to control and monitor the pumping of the medicant out of the syringe 590 into the patient.049450-000420

[0143] The fluidics pump 500 may also include a syringe size sensor 562 operable to determine the outer diameter of the barrel 594. In at least one embodiment, the syringe size sensor 562 may comprise a mechanical device, such as a caliper, that is able to mechanically or structurally measure the diameter of the barrel 594. The control system 111 may use the outer diameter of the barrel 594 measured by the syringe size sensor 562 to validate the information obtained from the identification element 599, such as cross-referencing the outer diameter information obtained by reading the identification element 599 with the measured outer diameter. For example, the identification element 599 may cause the control system 111 to call up (locate, obtain) the syringe specifications from a library of syringe specifications based on the model number of the syringe. The syringe specifications are then compared to the measured outer diameter, and if the outer diameters do not match within a threshold, then the control system 111 may alert the user that the incorrect syringe 590 is within the cradle 512. Additionally, the syringe size sensor 562 may be used to validate manually input (uploaded) syringe identification information.

[0144] The outlet 596 of the syringe 590 fluidly communicates with an inline pressure sensor, such as the inline pressure sensor 436 (FIG. 4C), to monitor the pressure of the fluid. The inline pressure sensor is located between the syringe outlet 596 and a proximal end of the needle 421 (FIGS. 4A-4B). The pressure sensed by the pressure sensor is used to estimate the pressure at the needle tip. In other words, the inline pressure sensor may be used to estimate the pressure within a target, such as a lesion, tumor, or nodule. The pressure measurement may be used by the control circuitry 508 and / or the control system 111 to control the fluidics pump 500, such as using the feedback from the inline pressure sensor to cause the motor 531 to adjust the speed and / or position of the displacement head 504.

[0145] In some embodiments, the fluidics pump 500 may include a force sensor 522 (e.g., load cell) between the end of the plunger 592 and an inner surface of the displacement head 504. The force sensor 522 is schematically shown in FIG. 5C as a dashed box. The force sensor 522 may be used to estimate fluid pressure based on information obtained from the rotary encoder 532 and known specifications of the syringe 590 to validate the pressure obtained by the inline pressure sensor fluidly coupled to the syringe 590. The force measurements obtained from the force sensor 522 may be a useful indicator of a mechanical malfunction such as excessive friction issues with the lead screw 533, the motor 531, the power transfer system 534, the bearing 545, the lead nut 541, etc. that would not necessarily be apparent from a direct fluid pressure measurement from the inline pressure sensor.049450-000420

[0146] In some embodiments, the fluidics pump 500 includes a fluid level sensor 526 to monitor the height of the column of fluid remaining in the syringe 590 in real-time and over time. The fluid level within the syringe 590 is used to determine the static pressure head component of the pressure read by the inline pressure sensor. The static pressure head is the portion of the pressure due to the column of fluid within the syringe 590 and the fluid line connected to the needle. Additionally, there may be a static head pressure due to the height differential between the inline pressure sensor and the tip of the needle (e.g., needle 421 in FIG. 4B) in the patient. The control system 111 may increase the accuracy of the pressure estimation at the needle tip (e.g., pressure within the target) by accounting for the static head pressure due upstream of the inline pressure sensor (e.g., inline pressure sensor 436 in FIG. 4C) due to the height differential between the inline pressure sensor and the current fluid height in the syringe 590 and the static head pressure downstream of the inline pressure sensor due to the height differential between the inline pressure sensor and the tip of the needle. In other words, the control system 111 may be able to estimate the portion of the estimated pressure at the needle tip that is contributed by the fluid column between the needle tip and the current fluid height in the syringe 590.

[0147] The height position of the inline pressure sensor and the current fluid height obtained by the fluid level sensor 526 is input into the control system 111. The height position of the needle tip may be obtained using such various imaging and / or sensor modalities (such as the EM sensor system 306, the camera system 308, and / or the fluoroscopy imaging system 312 of FIG. 3). In some embodiments, the static head pressure component is accounted for in real-time. In other embodiments, the static head pressure component is determined at distinct intervals.

[0148] The fluid level sensor 526 may be an optical sensor that measures the current height of the fluid. In some embodiments, the fluid level sensor 526 may be a laser sensor that monitors the current position of the medicant end of the plunger 592 relative to the bottom end of the inner volume of the barrel 594. In some embodiments, the fluid level sensor 526 may be a manual sensor, such as a tape measure that is pulled down to measure the fluid level height and a user may manually input the measurement in the control system 111. The tape measure may also automatically input the read fluid height in the control system 111 based on an integrated position sensor within the tape measure.

[0149] Another approach to determining the static head component does not rely on the fluid level sensor 526. Instead, the height differential between the syringe 590 and needle tip is estimated using a laser distance measuring device coupled to the fluidics pump 500. The049450-000420 visible spectrum laser could be angled manually at the pump 500 by the user such that the laser dot appears on the patient (or the needle) at the estimated height position of the needle, and based on sensed distance along the laser beam path, and the sensed angle set by the user, the vertical component of the distance measurement can be calculated and incorporated into the calculation of needle tip pressure. The height differential measurement could also be estimated using manual measurement means.

[0150] The flow rate of the fluid out of the syringe outlet 596, and ultimately out of the needle through the tubing connection, is proportional to the speed of the plunger 592. The speed of the plunger 592 is determined by the linear speed of the displacement head 504 (e.g., linear speed of the lead nut 541 and shaft 542), which can be measured by the rotary encoder 532. The flow rate may be calculated by multiplying the linear speed of the displacement head 504 by the inner cross-sectional area of the barrel 594 (e.g., circular area defined by the inner barrel diameter). The inner cross-sectional area of the barrel 594 may be stored or accessed using the identification element 599. In some embodiments, the control circuitry 508 or the control system 111 may calculate the flow rate.

[0151] In some embodiments, the inline flow rate sensor 438 (FIG. 4C) may be used to validate the flow rate calculated based on the linear speed of the displacement head 504. The inline flow rate sensor 438 is disposed between the syringe outlet 596 and the proximal end of the needle, such as being incorporated into the sensor assembly 430 (FIG. 4C).

[0152] Still referring to FIG. 5C, in some embodiments, the fluidics pump 500 may include an optional graphical user interface 580 (shown schematically as a dashed box). The graphical user interface 580 may be disposed on the housing 502 or on the door 510. The graphical user interface 580 may display one or more operational parameters of the fluidics pump 500 and / or information obtained from the identification element 599 to a user. In some embodiments, the graphical user interface 580 is used to control one or more parameters of the fluidics pump 500. For example, the graphical user interface 500 may be a touch screen that allows a user to input control commands. In some embodiments, the graphical user interface 580 only displays information, with the control system 111 having a single point of control at the control system 111 (e.g., control interface 143). In some embodiments, the graphical user interface 580 may be a thin film display attached to the fluidics pump 500.

[0153] In some implementations, the control circuitry 508 may control the operation of the motorized assembly 506 based on sensor data or telemetry from one or more sensors associated with the fluidics pump 500. Example suitable sensors may include pressure sensors (e.g., the inline pressure sensor 436) that can detect the pressure of the drug or fluid in the fluid049450-000420 lines and the flow rate sensors (e.g., the flow rate sensor 438) that can detect the rate of fluid flow in the fluid lines. For example, the control circuitry 508 may control the motorized assembly 506 to ensure a constant or steady flow rate in the fluid lines and to ensure that pressure inside the lines (e.g., fluid line 423) does not exceed a threshold or maximum fluid pressure. In some implementations, the sensors may be disposed on the fluidics pump 500 (such as where the syringe 590 is coupled to the fluid lines). In some other implementations, the sensors may be disposed outside of the fluidics pump 500 (such as on a mounting structure or surface that supports the fluid line and the needle). In such implementations, the control circuitry 508 may receive telemetry from the sensors via one or more external communication paths (not shown for simplicity).

[0154] The control circuitry 508 may include one or more printed circuit boards with associated electrical components. The control circuitry 508 may be connected to various inputs. FIG. 5D illustrates a side view of the fluidics pump 500 that illustrates a communication interface 550 of the fluidics pump 500. The communications interface 550 includes a power input 551 (e.g., direct current input) that is used to supply electrical power to the fluidics pump 500, such as being used to power the control circuitry 508, the motor 531, and the rotary encoder 532. The communications interface 550 also includes a power switch 552 used to turn “on” or “off’ the fluidics pump 500. The communications interface 550 may further include one or more connectors to receive corresponding communications cables. For example, the communication interface 550 may include a first connector 553 that is connectable to a sensor cable in communication with the inline pressure sensor and / or inline flow sensor, such as the sensor cable 427. The first connector 553 may be a USB-A connector as shown in FIG. 5D, but could comprise other types of connectors. The communication interface 550 may include a second connector 554 to facilitate communication between the control circuitry 508 and the control system 111 via a cable. The second connector 554 may be a USB-C connector as shown in FIG. 5D, but could comprise other types of connectors. The first and second connectors 553, 554 may be any suitable connector, such as a USB connector or serial connector. Alternatively, the communications interface 550 may comprise any wireless modality.

[0155] In some embodiments, the control circuitry 508 may include a pump controller 509 (FIG. 5C) connected to the printed circuit board, such as an ARDUINO® controller. In some embodiments, the pump controller 509 is in communication with the control system 111. For example, the pump controller 509 may relay the information from the rotary encoder 532 and sensors connected to the fluidics pump 500 to the control system 111. The control system 111 may instruct the pump controller 509 to operate the fluidics pump 500, such as selectively049450-000420 changing a flow parameter of the medicant. In some embodiments, the control circuitry 508 may be configured to control the fluidics pump 500 independent from the control system 111, such as the pump controller 509 operating the fluidics pump 500 based on real-time sensor feedback.

[0156] Referring again to FIGS. 5A-5C, the fluidics pump 500 may be used to deliver a desired dose (e.g., volume) of the medicant at a commanded (predetermined) flow rate and / or pressure with precision and accuracy. In some embodiments, the motor 531 can be operated to deliver the medicant at relatively low flow rates over a known (predetermined) time period, which is advantageous for localized injection of the medicant in the target within the patient. For example, the motor 531 can be controlled to pump the medicant out of the syringe outlet 596 at flow rates of about 0.1 ml / min to about 10 ml / min. The motor 531 can also be controlled to deliver the medicant at low flow rates over an extended period of time, such a delivering the medicant over a 5 to 20 minute time span to allow the medicant to diffuse into the target.

[0157] The motor 531 can also be controlled to deliver the medicant at a desired pressure. In some embodiments, the medicant can be pumped with a pressure up to about 1800 mmHg, which is significantly higher than the high end pressure of conventional intravenous infusion pumps which operate between 300-600 mmHg. Furthermore, the fluidics pump 500 can accommodate a variety of syringe sizes, allowing the fluidics pump 500 to be used to deliver a variety of medicant volumes into a patient. For example, the fluidics pump 500 can be used to pump volumes between about 1ml to about 100ml.

[0158] Volume to linear conversion may be used to pump a desired fluid volume from the syringe 590 with the fluidics pump 500. In other words, the control system 111 may instruct the motor 531 to translate the plunger 592 a set axial distance that will cause the required volumetric dose to be pumped out of the syringe outlet 596 based on the known inner cross- sectional area of the syringe 590. Similarly, the liner displacement of the plunger 592 over a period of time may be used to determine the total volume medicant that was delivered over the time interval.

[0159] In some embodiments, the motor 531 is controlled based on real-time feedback from the inline pressure sensor (e.g., inline pressure sensor 436). For example, the motor 531 may be operated to move the plunger 592 to adjust the pressure. Additionally, the motor 531 may be slowed down and / or stopped if the pressure exceeds a maximum threshold. The motor 531 may be controlled to deliver the medicant over a desired delivery profile with varying pressures, such as delivering a first portion of the dose at a first pressure and then delivering a049450-000420 second portion of the dose at a second pressure. Additionally, different fractional doses may be delivered at different pressures.

[0160] In some embodiments, the motor 531 is controlled based on the real-time feedback of the flow rate, such as the flow rate calculated using the rotary encoder 532 and / or the inline flow sensor. The flow rate may be changed by controlling the motor 531 to adjust the linear speed of the plunger 592. The motor 531 may be controlled to deliver the medicant over a desired delivery profde with varying flow rates, such as delivering a first portion of the dose at a first flow rate and then delivering a second portion of the dose at a second flow rate. Additionally, different fractional doses may be delivered at different flow rates.

[0161] In some embodiments, the motor 531 is controlled based on the real-time flow rate and pressure feedback. This may allow the motor 531 to dynamically and selectively adjust the flow rate and / or pressure of the medicant by adjusting the axial position and / or liner speed of the plunger 592. The motor 531 may be controlled to deliver the medicant over a desired delivery profde with varying pressures and flow rates, such as delivering a first portion of the dose at a first flow rate and first pressure and then delivering a second portion of the dose at a second flow rate and second pressure. Additionally, different fractional doses may be delivered at different flow rates and pressures.

[0162] In some embodiments, the control system 111 or control circuitry 508 may perform (undertake) a pumping operation to deliver a desired dose (e.g., volumetric amount) of the medicant. The pumping operation may have one or more target operating objectives, such as a target position of the pump plunger (e.g., displacement head 504, shaft 542, lead nut 541), a target pump plunger velocity, and a target fluid pressure. The pumping operation may also have a maximum allowable pressure, a maximum allowable flow rate, and a maximum allowable pump plunger velocity. The pressure and / or flow rate feedback may be used to adjust the pump plunger position and / or pump plunger velocity if the pumping operating is deviating from the target objectives.

[0163] In some embodiments, the fluidics pump 500 can be operated in a flow rate controlled mode based on the real-time pressure and / or flow rate feedback. In the flow rate controlled mode, the flow rate may be adjusted to deviate from the commanded value if the pressure reaches a pre-set pressure threshold. However, the flow rate is adjusted to remain as close as possible to the commanded value without the pressure exceeding or dropping below the pre-set pressure threshold. For example, the flow rate may be reduced to less than the commanded value if the pressure reaches a pre-set maximum pressure limit value while049450-000420 maintaining the medicant delivery with flow rate as close as possible to the commanded value without exceeding the pre-set maximum pressure limit.

[0164] In some embodiments, the fluidics pump 500 can be operated in a pressure controlled mode based on the real-time pressure and / or flow rate feedback. In the pressure controlled mode, the pressure may be adjusted to deviate from the commanded value if the flow rate reaches a pre-set pressure threshold. However, the pressure is adjusted to remain as close as possible to the commanded value without the flow rate exceeding or dropping below the pre-set flow rate threshold. For example, the pressure may be reduced to less than the commanded value if flow rate reaches a pre-set maximum limit value while maintaining fluid delivery pressure as close as possible to the commanded pressure without exceeding the preset maximum flow rate limit.

[0165] In some embodiments, the fluidics pump 500 may be primed by activating the motor 531 to deliver a priming volume of fluid out of the syringe outlet 596 and into the tubing connected to the syringe outlet 596. The medicant itself or a non-drug fluid (e.g., saline) may be used to prime the fluidics pump 500. For example, the syringe 590 may include a plurality fluids in a fluid train, such as first fluid (e.g., saline) followed by a second fluid (e.g., the medicant). The first fluid may be used to prime the fluidics pump 500 and to perform one or more tests, such as a leak test or a pressure probe test, as generally described above. The second fluid exits the syringe outlet 590 once the saline is exhausted. In some embodiments, a release valve may be incorporated into the sensor assembly 430 or the line 423 to expel a residual portion of the saline without delivering the saline into the target. The first fluid may be selected based on non-toxicity, viscosity, and / or mixability with the second fluid. In some embodiments, the fluids in the fluid train may be separated by an element within the syringe 590, such as a membrane, that ruptures in response to a pressure increase to allow flow through the syringe outlet 596.

[0166] The force sensor 522 may be used to prepare the fluidics pump 500 for a pumping operation. For example, the force sensor 522 may monitor for engagement of the end of the plunger 592 and the displacement head 504. The pump controller 509 and / or control system 111 may cause the motor 531 to adjust the position of the displacement head 504 until the force sensor 522 detects the end of the plunger 592, which prepares the fluidics pump 500 for the pumping operation. The movement of the displacement head 504 is stopped once the end of the plunger 592 is detected. In some embodiments, the motor 531 may be operated to quickly change the position of the displacement head 504 until the plunger 592 is detected to decrease the delay between loading the syringe 590 and being in a pump ready state. In some049450-000420 embodiments, a user may load the syringe 590 into the cradle 512 and then press a button on the graphical interface 580 to cause the displacement head 504 to move until the force sensor 522 detects the end of the plunger 592.

[0167] In some embodiments, unloading the syringe 590 from the cradle 512 may include instructing the fluidics pump 500 to back drive the displacement head 504 until the force sensor 522 no longer detects the end of the plunger 592. For example, the user may interact with the graphical interface 580, such as pressing a button, to cause the displacement head 504 to move away from the plunger 592 until the displacement head 504 is no longer engaged with the plunger 592. In other embodiments, a clutch may be used to detach the pump plunger (e.g., displacement head 504, shaft 542, lead nut 541) from the motor 531 to allow the displacement head 504 to be disengaged from the syringe plunger 592.

[0168] FIG. 6 illustrates a schematic diagram of an example drug delivery system 600, according to one or more embodiments. In some cases, a user may need to deliver multiple medicants during a procedure, such as alternating medicants during the procedure. Additionally, the user may need to mix multiple medicants together on demand. The drug delivery system 600 may be able to accomplish these tasks and may include an array 601 of fluidics pumps 610 that all feed to a common outlet. While three fluidics pumps 610 are shown, the array 601 may include more or less than three fluidics pumps 610.

[0169] Each fluidics pump 610 is configured to pump fluid from a corresponding medicant source 620 connected thereto. Each fluidics pump 610 may be the same as or similar to the fluidics pump 500 of FIGS. 5A-5D and each medicant source 620 may comprise a syringe, such as the syringe 590. Each medicant source 620 may contain a different medicant, and one or more of the medicant sources 620 may contain a base fluid or inert fluid, such as saline.

[0170] The outlet of each medicant source 620 is in fluid communication with a common needle 630. The fluidics pumps 610 may be selectively actuated to deliver the fluid contained within the medicant source 620 to the needle 630. The timing and sequencing of the different fluidics pumps 610 may be controlled to deliver a desired sequence of medicants. For example, the fluidics pumps 610 may be selectively actuated to alternate which medicant is flowing to the needle 630. In some embodiments, the inert fluid, such as saline, may be dispensed between two medicants.

[0171] In some embodiments, the outlet of the medicant sources 620 are fluidly coupled to a common manifold 640 such as via tubing 622. The tubing 622 may include one or more valves 662, such as a shutoff-valve. In some embodiments, the manifold 640 may have one or049450-000420 more valves and / or mixers. For example, the manifold 640 may include one or more mixing valves that control the ratio of the different medicants flowing into the manifold 640 from the different medicant sources 620 to produce a medicant that is mixed on demand and then delivered to the needle via tubing 641. In some embodiments, a booster pump may be coupled to (arranged within) the tubing 641 to deliver the mixed medicant to the needle 630 at a desired flow rate and / or pressure.

[0172] In some embodiments, each set of tubing 622 may include one or more inline sensors 660, such as an inline pressure sensor and / or an inline flow rate sensor. Each fluidics pump 610 may be controlled based on the feedback from the corresponding inline sensor 660. The fluidics pump 610 may be controlled similar to the fluidics pump 500 of FIGS. 5A-5D, such as being controlled in a pressure -controlled mode or a flow rate-controlled mode.

[0173] Additionally, the drug delivery system 600 may be operated similar to the drug delivery system 420 of FIGS. 4A-4B. For example, the drug delivery system 600 may be used to perform a leak test and / or a pressure probe test, as generally described above.

[0174] In some embodiments, the tubing 641 may include one or more sensors 670, such as an inline flow and / or pressure sensor. The sensors 670 may be used to control one or more of the fluidics pumps 610 and thereby control the pressure and / or flow rate of the fluid flowing to the needle 630. For example, the sensors 670 may be used to control the fluidics pump 610 that is being used to pump the medicant through the tubing 641 and out of the needle 630. While not shown, there may be cables connecting the sensors 660, 670 to the fluidics pumps 610 or the control system, such as the control system 111.

[0175] In some embodiments, the drug delivery system 600 may be incorporated into the medical system 400 (FIGS. 4A-4B) in the place of the drug delivery system 420. For example, the fluidics pumps 610 and manifold 640 may be supported on the support structure 429 (FIGS. 4A-4B). The needle 630 may be supported by the drug delivery arm 440, and advanced into the scope 130 manually, such as being manually inserted and then moved by one of an actuator of the drug delivery arm 440 or the robotic system 110. In some embodiments, the needle 630 is advanced without manual intervention, such as being moved by the actuator of the drug delivery arm 440 or the robotic system 110.

[0176] FIG. 7 is a schematic side view of an example peristaltic fluidics pump 700 that may be used in one or more embodiments of the present disclosure. More specifically, a medical system may include a drug delivery assembly that includes the peristaltic fluidics pump 700 in conjunction with a medicant source 740, which may be installed in the place of the fluidics pump 422 and the medicant source 425 of the medical system 400 of FIG. 4.049450-000420

[0177] As illustrated, the peristaltic pump 700 includes a motor 710, a transmission 720, a cam shaft assembly 730, and an anvil plate 750. The motor 710 may comprise a stepper motor, and rotation of the stepper motor 710 may be monitored by a rotary encoder 712 to monitor the position of the rotor of the motor 710. The transmission 720 may include one or more reduction gears so that the rotation of the motor 710 correspondingly rotates the cam shaft assembly 730 and thereby dispense medicant from the medicant source 740 at a slow flow rate, such as a flow rate between 0. 1 mL / min to 10 ml / min.

[0178] The cam shaft assembly 730 includes a shaft 731 operatively coupled to the transmission 720, a plurality of cams 732 arranged in series, and a plurality of cam followers 733 arranged in series and aligned with the cams 732. Rotation of the shaft 731 due to operation of the transmission causes the cams 732 to interact with corresponding cam followers 733 to advance the fluid within the medicant source 740.

[0179] The medicant source 740 may be made of a flexible material and is placed between the cam shaft assembly 730 and the anvil plate 750. The profile of the cam followers 733 causes multiple pinched regions 741 to develop within the medicant source 740 as the shaft 731 rotates. Moreover, rotation of the cam shaft assembly 730 causes the pinched regions 741 to axially translate to eventually pump the medicant out of an outlet 742 to the medicant source 740. The outlet 742 may be fluidly coupled to the needle 421 (FIG. 4). Additionally, one or more inline sensors, such as a pressure and / or flow sensor, may monitor the flow rate and pressure of the fluid exiting the fluidics pump 700, and the fluidics pump 700 may be controlled based on feedback from the inline sensors.Spring Energized Pump for Controlled Fluid Delivery into Lesions

[0180] FIG. 8A illustrates another example medical system 800 in accordance with the principles of the present disclosure. The medical system 800 may be similar in some respects to the medical system 400 of FIGS . 4A-4B and therefore may be best understood with reference thereto, where like numerals will correspond to like components not described again in detail. Similar to the medical system 400, for example, the medical system 800 includes the robotic system 110, the control system 111, the scope 130, and the imaging system 410.

[0181] The medical system 800 also includes a drug delivery system 820, which may be similar in some respects to the drug delivery system 420 of FIGS. 4A-4B. However, unlike the drug delivery system 420, the drug delivery system 820 does not include a motorized fluidics pump. Rather, the drug delivery system 820 includes a fluidics pump 822 that includes a biasing member (e.g., spring) and operates based on stored spring force. As illustrated, the fluidics pump 822 may be used to pump a medicant from a medicant source 825 (e.g., the049450-000420 syringe 990 of FIG. 9A) into a fluid line 823 (e.g., fluid conduit) that is fluidly coupled to the proximal end of the needle 421 and the outlet of the medicant source 825. An inline flow control assembly 830 is fluidly coupled to the outlet of the medicant source 825 and can be used to control and / or monitor fluid flow out of the medicant source 825.

[0182] The fluidics pump 822 includes a pump plunger 826 that is driven by the expansion (i.e., stored spring force) of the biasing member (e.g., biasing member 902 in FIG. 9A) to pump the medicant out of the medicant source 825 and into the fluid line 823. In some embodiments, the pump plunger 826 may be disposed within the biasing member; e.g., biasing member comprises a coil spring and the pump plunger 826 extends within the multiple revolutions of the spring. The biasing member and the pump plunger 826 may be arranged within a housing 827 of the fluidics pump 822, and the medicant source 825 may comprise a syringe positioned in line with the pump plunger 826 and biasing member (see FIG. 9A).

[0183] In other embodiments, the biasing member is not disposed around (about) the pump plunger 826. Instead, the biasing member may be arranged serially inline (e.g., coaxial) with the pump plunger 826 and the medicant source 825. In such embodiments, the medicant source 825 may be loaded within a housing that is arranged coaxial with but axially offset from the biasing member. The separate housing that holds the medicant source 825 may make loading and unloading the medicant source 825 easier and also accommodate a wide size range of the medicant source 825, such as a variety of syringe sizes. As another example, a plurality of biasing members may be arranged around (about) the medicant source 825 and the pump plunger 826 in a planetary configuration.

[0184] In some embodiments, the fluidics pump 822 may comprise an elastomeric pump. For example, the fluidics pump 822 may include a moveable wall plunger that is driven by the biasing member to expel medicine from the medicant source 825, which is a flexible drug reservoir coupled to the pump plunger 826. The inline flow control assembly 830 may include inline flow rate and pressure sensors (e.g., analog flow rate and pressure sensors) to monitor the fluid flow out of the flexible drug reservoir.

[0185] In some applications, the pump plunger 826 may be dampened to limit the initial speed / impact of the pump plunger 826 on the medicant source 825, such as the plunger head of a syringe. The pump plunger 826 may also include a lock assembly (e.g., a release pin or lock assembly 940 of FIG. 9B) that axially locks the pump plunger 826 in a desired position. For example, the pump plunger 826 may be locked in a loading position to facilitate loading the medicant source 825 into the fluidics pump 822. The lock assembly can thereafter be unlocked (e.g., released) to allow the pump plunger 826 to travel in response to the expansion049450-000420 of the biasing member. In some embodiments, the fluidics pump 822 may include one or more brakes, such as a brake configured to arrest the motion of the pump plunger 826.

[0186] The inline flow control assembly 830 (schematically represented as a dashed box) may be integrated into the fluid line 823 and may include one or more inline valves and inline sensors to control and monitor the fluid flow. For example, the inline flow control assembly 830 may include one or more of a check valve to inhibit backflow, a flow control valve to control the medicant flow, a pressure sensor to monitor the pressure of the medicant, and a flow rate sensor to measure the fluid flow rate. The inline flow control assembly 830 may be in communication with the control system 111 or a controller (e.g., the controller 982 of FIG. 9C). The flow control valve may be controlled in response to feedback from the pressure and / or flow rate sensor. In some embodiments, the valves and sensors of the inline flow control assembly 830 may be integrated into a single unit / device as shown in FIG. 8B. In other embodiments, the inline flow control assembly 830 may comprise multiple devices (e.g., flow control valve, check valve, sensors) in fluid communication with the medicant source 825 outlet, such as being disposed at different positions along the fluid line 823.

[0187] FIG. 8B is schematic diagram of an example embodiment of the inline flow control assembly 830. As illustrated, the inline flow control assembly 830 can comprise a single, integrated unit that includes an inlet 831 and an outlet 832. The inlet 831 is in fluid communication with the outlet of the medicant source 825, while the outlet 832 is in fluid communication with the needle 421. In some embodiments, the inlet 831 may be coupled to a portion of the fluid line 823 or directly to the outlet of the medicant source 825. The inline flow control assembly 830 further includes an inline flow control valve 833 and an inline check valve 834. The inline flow control assembly 830 may optionally include an inline pressure sensor 835 and / or an inline flow rate sensor 836. The inline flow control valve 833, inline check valve 834, inline pressure sensor 835, and inline flow rate sensor 836 may be arranged in series and in any order.

[0188] The flow control valve 833 may be designed to provide laminar or turbulent flow. In some embodiments, the flow control valve 833 may be electronically controlled, such as including an actuator that allows a controller, such as the control system 111, to selectively cause the flow control valve 833 to adjust the flow rate. The control system 111 and / or integrated controller (see controller 982) may use real-time feedback from the flow rate and / or pressure sensors 835, 836 to adjust the flow control valve 833 and thereby achieve and maintain a desired pressure and / or flow rate. In some embodiments, the flow control valve 833 may049450-000420 instead have a manually controlled dial that allows the user to manually select the desired flow rate.

[0189] Additionally, the flow control valve 833 may selectively stop fluid flow, such as stopping flow when a desired volumetric amount (e.g., fractional dose) has been expelled from the needle 421. The delivered volumetric amount may be tracked by monitoring the flow rate over time and / or calculating the volume pumped out of the medicant source 825 based on the positional change of the pump plunger 826.

[0190] The flow control valve 833 may be operated to achieve a desired flow rate and / or pressure, such as being used to deliver the medicant along a desired delivery profile. The biasing member is used to drive the fluidics pump 822 and exhibits a predictable decay in spring force, which causes a predictable decay in the pressure and flow rate. The biasing member may be selected based on a known spring constant, with a lower spring constant causing less change between the starting and ending spring force over the course of the medicant delivery. The flow control valve 833 may be used to compensate for the decay, such as adjusting the flow rate to maintain a pressure. Additionally, the flow control valve 833 may be used to deliver the medicant over a desired delivery profile with varying pressures and / or flow rates, such as delivering a first portion of the dose at a first flow rate and first pressure and then delivering a second portion of the dose at a second flow rate and second pressure. In some embodiments, different fractional doses may be delivered at different flow rates and pressures.

[0191] In some embodiments, the inline flow control assembly 830 may include one or more batteries to power the flow control valve 833, pressure sensor 835, and flow rate sensor 836. The inline flow control assembly 830 may be in wired or wireless communication with the control system 111 or integrated controller. For example, a cable (e.g., cable 427 of FIG. 4B) may be connected to the inline flow control assembly 830 to facilitate communication and provide electrical power.

[0192] Referring again to FIG. 8A, in some embodiments of the medical system 800, a person may manually move the fluidics pump 822 to advance and retract the needle 421 connected thereto through the scope 130. The person may also support the fluidics pump 822 while the medicant is delivered through the needle 421 into the patient. The person holding the fluidics pump 822 and / or another person of the medical team may manually operate the flow control valve 833 to change one or more fluid parameters (e.g., flow rate, pressure) of the medicant. Alternatively, the flow control valve 833 may be controlled by the control system049450-000420111 and / or integrated controller (e.g., video game-type controller 142) while the fluidics pump 822 is supported by a person during delivery of the medicant.

[0193] In some embodiments, the fluidics pump 822 is not held by a person during positioning of the needle 421 and / or delivery of the medicant through the needle 421. Instead, the weight of the fluidics pump 822, inline flow control assembly 830, needle 421, and the fluid line 823 may be supported by a fluid delivery member, such as the fluid delivery arm 440 connected to the support structure 429 shown in FIGS. 4A-4B. The fluid delivery member may include one or more line management elements to facilitate the movement of the fluid line 823 and any cables. For example, the line management elements may comprise hooks that hang and support the fluid line 823 and any cables connected to the inline flow control assembly 830. As another example, the line management elements may comprise a reel that facilitates reeling in and out the fluid line 823.

[0194] In some embodiments, the needle 421 is moved into position by the robotic system 110, but could alternatively be moved (advanced or retracted) manually. The fluidics pump 822 and needle 421 may be moveable relative to the fluid delivery member, such as being coupled to a carriage moveable along a track of the fluid delivery member to allow the robotics system 110 to advance and / or retract the needle 421 within the scope 130. In other embodiments, the fluid delivery member may linearly translate the fluidics pump 822 and inline flow control assembly 830 independent of the robotics system to position the needle 421 within the scope 130 and similarly to the fluid delivery arm 440 (FIGS. 4A-4B). For example, the fluid delivery member may include an actuator with one degree of freedom that linearly translates the needle 421, fluidics pump 822, and inline flow control assembly 830.

[0195] In some implementations, the robotic system 110 or fluid delivery member (e.g., fluid delivery arm 440) may move the needle 421 to different locations within the target to support dose fractionation. For example, after a target dose has been delivered to a particular location, the robotic system 110 and / or fluid delivery support may move the needle 421 to another location to distribute the drug more evenly throughout the target. As described with reference to FIGS. 1-3, the robotic system 110 may rely on various imaging and / or sensor modalities (such as the EM sensor system 306, the camera system 308, and / or the fluoroscopy imaging system 312 of FIG. 3) for guiding precision needle placement within the anatomy. For example, the image data and / or sensor data can be used for tool -in-lesion confirmation and can also be used to plan needle insertion to reach various drug delivery locations. The image data and sensor data (such as position and / or pressure data) also may indicate real-time changes to049450-000420 the anatomy and / or drug delivery process which can be used to update or modify the delivery plan.

[0196] The fluidics pump 822 and inline flow control assembly 830 may be used to deliver a desired dose of the medicant at a desired flow rate and / or pressure with precision and accuracy. The fluidics pump 822 and inline flow control assembly 830 can deliver the medicant at relatively low flow rates over a predetermined period of time, which is advantageous for localized injection of the medicant in the target within the patient. For example, the medicant can be delivered at flow rates of about O. lml / min to about 10 ml / min. Additionally, the operating parameters (e.g., flow rate, pressure, etc.) of the fluidics pump 822 can be shifted by pre-loading the biasing member (e.g., changing the starting length of the biasing member). Additionally, the fluidics pump 822 can deliver the medicant at low flow rates over an extended period of time, such as delivering the medicant over a 5 to 20 minute time span to allow the medicant to diffuse into the target.

[0197] The fluidics pump 822 may be used to deliver the medicant at a desired pressure. In some embodiments, the medicant can be pumped with a pressure up to about 1800 mmHg, which is significantly higher than the high end pressure of conventional intravenous infusion pumps which operate between 300-600 mmHg. The decay in the medicant pressure is predictable over time due to the predictable decay in the spring force applied by the biasing member overtime. In some embodiments, the inline flow control assembly 830 may adjust the pressure by controlling the flow rate. Furthermore, the fluidics pump 822 can accommodate a variety of medicant source 825 (e.g., syringe) sizes, allowing the fluidics pump 822 to be used to deliver a variety of medicant volumes into a patient. For example, the fluidics pump 822 can be used to pump volumes between about 1ml to about 100ml.

[0198] In some embodiments, a pumping operation may be performed to deliver a desired dose (e.g., volumetric amount) of the medicant with the fluidics pump 822. The pumping operation may have one or more target operating objectives, such as a target flow rate and target fluid pressure. The pumping operation may also have a maximum allowable pressure and a maximum allowable flow rate. The pressure and / or flow rate feedback may be used to adjust the flow control valve 833 if the pumping operation is deviating from the target objectives.

[0199] In some embodiments, the fluidics pump 822 can be operated in a flow rate controlled mode based on the real-time pressure and / or flow rate feedback. In the flow rate controlled mode, the flow rate may be adjusted by the flow control valve 833 to deviate from the commanded value if the pressure reaches a pre-set pressure threshold. However, the flow049450-000420 rate is adjusted to remain as close as possible to the commanded value without the pressure exceeding or dropping below the pre-set pressure threshold. For example, the flow rate may be reduced to less than the commanded value if pressure reaches a pre-set maximum pressure limit value while maintaining the medicant delivery with flow rate as close as possible to the commanded value without exceeding the pre-set maximum pressure limit.

[0200] In some embodiments, the fluidics pump 822 can be operated in a pressure controlled mode based on the real-time pressure and / or flow rate feedback. In the pressure controlled mode, the pressure may be adjusted by operating the flow control valve 833 to deviate from the commanded value if the flow rate reaches a pre-set pressure threshold. However, the pressure is adjusted to remain as close as possible to the commanded value without the flow rate exceeding or dropping below the pre-set flow rate threshold. For example, the pressure may be reduced to less than the commanded value if flow rate reaches a pre-set maximum limit value while maintaining fluid delivery pressure as close as possible to the commanded pressure without exceeding the pre-set maximum flow rate limit.

[0201] In some embodiments, the medical system 800 may be used to evaluate if a leak path is present prior to or during delivery of the medicant from the medicant source 825. Once the tip of the needle 421 is located at a desired location, such as within the target, as generally described above, the fluidics pump 822 may pump a small volume (e.g., test volume) of fluid into the target to reach a target pressure to test for leaks. The small volume may be pumped by opening the flow control valve 833 of the inline flow control assembly 830 for a set period of time and at a desired flow rate. The fluidics pump 822 may pump a small volume of the medicant or a neutral fluid, such as saline, to evaluate for a leak path. For example, the medicant source 825 may have multiple fluids arranged in a train (in series) with saline being used to initially test for leaks and followed by the medicant once the saline is exhausted. The pressure is monitored by the inline pressure sensor 835 after delivering the small volume into the target, with further fluid flow being suspended for the duration of the leak test. If the fluid pressure does not decay or decays imperceptibly, there are no leak paths in the drug delivery system 820 (e.g., fluidics pump 822, fluid line 823, inline flow control assembly 830) nor from the target. However, little to no pressure decay indicates that there is very little if any diffusion of the fluid into tissue, which may indicate that the needle tip is in necrotic tissue or perhaps that the needle tip is fully occluded by lesion tissue or perhaps bone. If fluid pressure drops slowly, such as within an expected range of rates, then no gross leak paths are present and the fluid is likely diffusing as expected into the target tissue of the appropriate type. Combined with concurrent imaging, leak paths may be ruled out and the diffusion rate, along with target tissue049450-000420 diffusion characteristics, may be used to identify or confirm the tissue that the needle tip is disposed within. If fluid pressure drops quickly or a target pressure never develops, that may be an indication that there is a gross leak path in the drug delivery system 820 or the target (e.g., burst lesion). Additionally, a pressure drop or failure to develop the target pressure may indicate that the needle tip is not within the target but is instead delivering into an open space or that the needle tip is delivering into an internal void within the target.

[0202] In some embodiments, the needle 421, fluidics pump 822, and inline pressure sensor 835 may be used to pressure probe test one or more locations within the target to identify and / or characterize the tissue type. The pressure probe test may be similar in some respects to the leak test, with a small volume being delivered into the target via the needle and until a target pressure is reached. However, the fluidics pump 822 continues to pump the fluid at a target flow rate while monitoring the fluid pressure. The pressure-flow rate curve of the fluid produced during the pressure probe test, such as by monitoring the outputs of the inline pressure and flow rate sensors 835, 836, may then be compared to a library of pressure-flow rate curves to evaluate what type of tissue is present at the needle tip. Additionally, the pressure probe test may yield the fluid resistance and / or diffusion behavior of the target, which may be used to identify or characterize the tissue type. For example, the probe test may determine that the tissue where the needle tip is currently located is necrotic due to extremely low diffusion and resistance to fluid flow (e.g., increasing pressure in response to added flow). Additionally, the pressure probe test may evaluate if the flow resistance of the tissue is within the acceptable bounds for the procedure, such as evaluating if the target can handle the prescribed medicant pressure without bursting.

[0203] In some embodiments, the pressure probing test may provide haptic feedback to the user, such as increasing the resistance felt by the surgeon when trying to increase or otherwise change the fluid flow (e.g., changing position of the flow control valve 833). The haptic feedback may be incorporated into a controller (e.g., the controller 1100 of FIG. 10) connected to the control system 111. For example, the physician depresses a control “trigger” or “lever” to command a delivery flow rate by moving the flow control valve 833 to one or more open positions, the flow proportional to the distance the trigger is depressed, and the degree of resistance (e.g., force) felt (e.g., haptic feedback) by the physician is proportional to the fluid pressure at the flow rate commanded.

[0204] Additionally, the fluidics pump 822 and inline flow control assembly 830 may be controlled to modulate the flow rate and / or pressure based on reaching maximum flow rate049450-000420 or pressure limits rather than producing an occlusion alarm and suspending / terminating medicant delivery.

[0205] The fluidics pump 822 may be primed by causing the flow control valve 833 to allow a known volume of a priming fluid out of the medicant source 825 and into the fluid line 823. The priming fluid may be the medicant itself or a non-medicant, such as saline. The residual saline may be expelled by a release valve, which may be incorporated into the flow control assembly 830. In some embodiments, the medicant source 825 may include a plurality of fluids arranged in series or a train. Each fluid in the fluid train may be separated by a rupturable membrane.

[0206] In some embodiments, the medicant source 825 may include the identification elements 599 (FIG. 5C) described above with respect to the syringe 590 of FIGS. 5A-5D. For example, the identification element can be used to determine the patient identification, prescription identification, medicant identification, medicant specifications (e.g., concentration, working life, handling precautions), procedure parameters (e.g., prescribed number of fractional doses, prescribed fractional dose volume, prescribed flow rate, and / or prescribed pressure for each fractional dose), syringe technical specifications (e.g., syringe manufacturer, model, wetted material, chemical compatibility with medicant, syringe nominal volume, precise barrel inner diameter, barrel length, outlet fitting type), needle size and length for procedure, and / or tubing set lumen identification and lengths for procedure. The inline flow control assembly may be controlled based on the information obtained from the identification element 599.

[0207] Additionally, data obtained during the procedure (e.g., flow rate, pressure) may be captured and analyzed in real-time, which is not currently done with spring-driven medical pumps. For example, the data may be collected by the control system 111.

[0208] FIGS. 9A-9G are various views of an example fluidics pump 900 according to one or more embodiments of the present disclosure. The fluidics pump 900 may be the same as or similar to the fluidics pump 822 of FIG. 8A, and is depicted as a hand pump that can be manually operated by a physician or technician. More specifically, the fluidics pump 900 can be used to dispense fluid (such as a drug) from a syringe 990 into a fluid line coupled thereto (such as the fluid line 823 of FIG. 8A). The fluidics pump 900 may be adapted to use both off- the-shelf (OTS) syringes or customized syringe designs. Furthermore, the fluidics pump 900 is capable of pumping force / shear-sensitive medicants from the syringe 990, such as medicants that contain a suspension of particles or cellular bodies. In some embodiments, the syringe 990 may include the identification element 599 (FIG. 5C), which can be used in a similar manner049450-000420 as described above with respect to the syringe 590 (FIG. 5C), such as being used to control a flow control valve (e.g., flow control valve 833) fluidly coupled to the syringe outlet 996.

[0209] Referring first to FIG. 9A, the fluidics pump 900 includes a pump plunger 901, a biasing member 902, a housing 904, a cradle 920, and a finger retention mechanism 924. The syringe 990 is loaded into the cradle 920, and the biasing member 902 is configured to drive the pump plunger 901 relative to the housing 904 to thereby depress a plunger 992 of the syringe 990 to pump (e.g., expel) a medicant stored within the barrel 994 of the syringe 990 out of the syringe outlet 996.

[0210] In some implementations, the housing 904 may include a grip 905 engageable by a user (e.g., fingers) to help set the pump 900 for operation. For example, the user may engage the grip 905 and pull back on the pump plunger 901 to compress the biasing member 902, and the grip 905 may prevent the user’s hand from slipping on the surface of the housing 904 while manipulating the pump plunger 901 with the other hand. In some implementations, the grip 905 may further include an anti-roll feature 907 that protrudes from a portion of the grip 905 to prevent the housing 904 from rolling when placed on a flat surface. In some embodiments, the anti-roll feature 907 includes three points at different locations along the housing 904 that are contactable with a surface to prevent the housing 904 from rolling when placed on the surface. In some embodiments, the housing 904 may comprise a clamshell housing with two or more pieces connected together by one or more fasteners and / or by welds (e.g., ultrasonic welding, RF welding).

[0211] FIG. 9B is an enlarged, cross-sectional view of the pump 900 to better illustrate the pump plunger 901. The pump plunger 901 includes a handle 910 and a push member 930 attached to or otherwise forming part of the handle 910, and engageable with the plunger 992. The handle 910 is manually pulled back to compress (e.g., charge, build spring force) the biasing member 902. The handle 910 defines an internal channel 911 and an exterior surface 912 that defines an external channel 913 and a key 914. The external channel 913 includes a longitudinal slot 915 that extends between the internal and external channels 911, 913. The key 914 interfaces with a keyway 909 defined in the housing 904 to inhibit the handle 910 from rotating as it is pulled and retracts. The proximal end of the handle 910 may include finger grooves that substantially match the curvature and ergonomics of folded human fingers to provide enhanced grip comfort.

[0212] Referring again to FIG. 9A, the push member 930 is disposed within the housing 904 and interfaces with the plunger 992 and the biasing member 902. In some embodiments, as illustrated, the push member 930 is arranged within the turns of the biasing member 902 and049450-000420 includes an inner surface 931 and an opposing outer surface 932. The inner surface 931 is engageable with the plunger 992, and the outer surface 932 is engageable with a distal end of the biasing member 902. For example, the outer surface 932 may define a shoulder 933 (e.g., annular shoulder) engageable with the end of the biasing member 902. In some embodiments, the push member 930 is formed integrally with the handle 910, but could alternatively comprise a separate component operatively coupled (e.g., threaded) to the handle 910.

[0213] The proximal end of the biasing member 902 is engaged with a shoulder 908 formed on the inner surface of the housing 904. The biasing member 902 is shown as a round wire, helical compression spring. The biasing member 902, however, may be any suitable spring, such as an interlaced wave spring, a wave spring, a wave spring with shim ends, or a machined spring. In some embodiments, the biasing member 902 may be formed from titanium wire, steel, or a Titanium Beta-C alloy.

[0214] In some embodiments, the pump plunger 901 may be locked in a loading position (see FIGS. 9A and 9D) by a lock assembly 940, which helps facilitate loading (and unloading) the syringe 990 into the cradle 920. The lock assembly 940 may be subsequently unlocked (disengaged) to allow the biasing member 902 to expand and thereby cause the pump plunger 901 to depress the plunger 992.

[0215] Referring again to FIG. 9B, the lock assembly 940 includes a plunger shaft 941 arranged within the internal channel 911 and including a button 942 at a proximal end and a lock profile 943 provided at a distal end and protruding into the slot 915. The button 942 is pressed by a user to move the plunger shaft 941 from a first position (FIG. 9D) to a second position (FIG. 9B), which changes the axial position of the lock profile 943 within the slot 915. The plunger shaft 941 may be naturally biased toward the first position by a biasing member 944 engaged with the distal end of the plunger shaft 941.

[0216] The lock assembly 940 further includes an actuatable pawl 945 that is pivotally coupled to a support 948 disposed in the housing 904. The handle 910 extends through an aperture 949 defined in the support 948, and the support 948 helps to limit the axial movement of the pump plunger 901 relative to the housing 904. The pawl 945 pivots between an unlocked position, as shown in FIG. 9B, and a locked position, as shown in FIG. 9E. When the pawl 945 is in the locked position, the pump plunger 901 is prevented from advancing past the loading position to facilitate loading the syringe 990 into the cradle 920. The pawl 945 is moved to the unlocked position by pressing the plunger shaft 941 and thereby allowing the biasing member 902 to advance the pump plunger 901 and cause the plunger 992 to move. The pawl 945 is biased toward the locked position by a biasing member 947. The pawl 945 may include a049450-000420 bailout feature 946 that allows a user to manually move the pawl 945 to the unlocked position as needed.

[0217] The pawl 945 is forced against the lock profde 943 by the biasing member 947 when the plunger shaft 941 is in the first position. Interaction of the pawl 945 and the lock profile 943 prevents the biasing member 902 from advancing the pump plunger 901 past the loading position. Depressing the plunger shaft 941, however, causes the pawl 945 to move away from the locked position as the pawl 945 rides along a first profile portion 943a of the lock profile 943 and until the pawl 945 reaches the unlocked position shown in FIG. 9B, thereby allowing the lock profile 943 to slip past the pawl 945 to allow for continued advancement of the pump plunger 901. The lock profile 943 has a second profile portion 943b configured to retract the pawl 945 to facilitate moving the pump plunger 901 back to the loading position when the plunger 901 is pulled back to recharge the biasing member 902.

[0218] FIGS. 9C-9D illustrate example loading of the syringe 990 after moving the pump plunger 901 to the loading position. In the illustrated embodiment, the fluidics pump 900 comprises a side-loading pump with the housing 904 including a loading aperture 906 formed in the sidewall thereof and aligned with the cradle 920 disposed within the housing 904. A portion of the loading aperture 906 may define a distal end 903 (FIG. 9A) of the housing 904. The portion of the loading aperture 906 defining the distal end 903, however, may be contoured to the outer diameter of the barrel 994 and may exhibit a smaller diameter than a flange 995 of the barrel 994.

[0219] The cradle 920 has a syringe channel 921 sized to receive the syringe 990 and configured to align the syringe 990 within the pump 900. In some embodiments, the shape of the syringe channel 921 is complementary to the shape of the barrel 994. The syringe channel 921 may be shaped to receive a wide variety of syringe sizes. The cradle 920 may include a loading profile 922 (e.g., a groove) configured to receive the flange 995 of the barrel 994 as the syringe 990 is inserted into the cradle 920 through the loading aperture 906. For example, the loading profile 922 may be shaped to accommodate tilting the syringe 990 at an angle during loading, as shown in FIG. 9D. The loading profile 922 also provides a shoulder that the flange 995 seats against (engages) to facilitate moving the plunger 992 relative to the barrel 994, as shown in FIGS. 9E-9F.

[0220] As shown in FIGS. 9A and 9C-9D, the cradle 920 may also have at least one retention mechanism 924 pivotally coupled thereto. The retention mechanism 924 may be a spring loaded claw or clamp (e.g., geared clamp) configured to lock the barrel 994 in position once received within the cradle 920. The retention mechanism 924 may also be depressed by049450-000420 the user to unlock (e.g., release) the syringe 990. In some embodiments, the retention mechanism 924 may eject the syringe 990 once the desired amount of medicant has been dispensed from the syringe 990. The retention mechanism 924 may have a curvature that substantially matches the curvature of a human fingertip to provide a more ergonomic or natural mechanism for releasing the syringe 990 from the pump 900. In some embodiments, the cradle 920 may include multiple releases 924, such as two releases 924 at different axial locations within the cradle 920 to facilitate securing and releasing the syringe 990 within the cradle 920.

[0221] FIG. 9E is a cross-sectional view of the pump 900 with the syringe 990 loaded and aligned within the cradle 920. As illustrated, the cradle 920 may also provide or otherwise define a stop shoulder 926 that limits downward travel (e.g., stroke) of the push member 930. In some embodiments, the stop shoulder 926 may be formed partially by the housing 904 and the cradle 920, but could alternatively be provided solely by the housing 904.

[0222] As discussed above, the lock assembly 940 (FIGS. 9A-9B) is operated to release the pump plunger 901 from the loading position, following which the push member 930 can be translated axially due to the expansion of the biasing member 902, which depresses the plunger 992 to pump fluid out of the syringe outlet 996. FIG. 9F shows the pump 900 with the syringe 990 being empty after the biasing member 902 fully expands and causes the pump plunger 901 to translate axially from the loading position (e.g., fully retracted position) to a fully advanced position. The push member 930 may occlude the loading aperture 906 when the pump plunger 901 is in the fully advanced position.

[0223] FIG. 9E illustrates the biasing member 902 in a fully compressed state (e.g., minimum length) prior to activating the lock assembly 940 to release the pump plunger 901, and FIG. 9F illustrates the biasing member 902 in a fully expanded state (e.g., maximum length) after the push member 930 has engaged the stop shoulder 926. Expansion of the biasing member 902 pumps (e.g., expels) medicant out of the syringe outlet 996. Unlike a peristaltic pump, the biasing member 902 provides non-pulsatile (smooth) flow. Additionally, the fluidics pump 900 has a predictable decay in flow rate and / or pressure due to the spring constant of the biasing member 902. The spring rate of the biasing member 902 may be selected based on a desired application. However, a low spring rate decreases the difference in force applied by the biasing member when in the fully compressed and fully expanded states. In other words, the decay in the flow rate and / or pressure may be reduced by lowering the spring rate . Additionally, lowering the spring rate decreases the syringe fluid pressure contribution to flow rate variation over time as the medicant is pumped out of the syringe outlet 996. The spring rate may be049450-000420 decreased by a high spring index (e.g., mean spring diameter / wire diameter) and by increasing the coil count.

[0224] The biasing member 902 may be selected to provide a spring force to achieve a high pressure delivery (e.g., up to or greater than about 1800mmHg) while having a low spring rate. For example, the biasing member 902 may be selected to achieve a pressure between 1800mmHg and 2700mmHg. Forming the biasing member 902 from high strength materials like work hardened austenitic Stainless Steel (302 / 304 SS) and high strength, low elastic modulus materials like titanium alloys such as Ti Beta-C yields low spring rates while providing a high spring force. For example, the biasing member 902 may be formed from a high strength material and have a high coil count while having a small wire diameter to increase the force applied. Additionally, a wave spring may provide a low spring rate with high spring force and may also be implemented with a lower overall spring length to allow the fluidics pump 900 to be made shorter. For example, the wave spring may be in a multi-turn flat wire configuration.

[0225] In one or more embodiments, the biasing member 902 may be made of work hardened austenitic stainless steel (302 / 304 SS) spring wire with 13.3 total coils having closed and ground ends, a free length of 279mm, an inside diameter of 44.9mm, an outside diameter of 50.8mm, a spring rate of 0.122 Ibf / mm (3.10 Ibf / in), a solid length of 39.1mm, a max deflection of 191mm, a max load of 231bf, a wire diameter of 2.95mm, a mean diameter of 47.85mm, and a spring index of 16.24.

[0226] As compared to conventional spring-driven syringe pumps, the fluidics pump 900 allows a biasing member with a longer spring length and lower spring rate to be used to pump the medicant out of a syringe without increasing the overall length of the delivery device. This is achieved by loading the syringe 990 into the cradle 920 when the biasing member 902 is at its shortest length (FIG. 9E), and then enveloping the syringe 990 within the biasing member 902 over the course of the medicant delivery as the biasing member 902 approaches its maximum length (FIG. 9F). The biasing member 902 is shown having a large enough spring diameter to accommodate (receive) the push member 930. In addition to lowering the spring rate, the spring diameter allows the overall length of the fluidics pump 900 to be compact since the push member 930 is enveloped by the biasing member 902.

[0227] FIG. 9G illustrates loading the biasing member 902 into the housing 904, according to one or more embodiments. As shown, plunger 901, cradle 920, and the support 948, are each first installed in one half of the clamshell-design housing 904. The biasing member 902 is placed around the plunger 901 before installing the plunger 901 into one half049450-000420 of the clamshell housing 904. To install the plunger 901, the distal end of the biasing member 902 is engaged with the shoulder 933 while the proximal end is engaged with a loading tool 979. The loading tool 979 can be used to compress the biasing member 902 and thereby allow the biasing member 902 to be received within the housing 904. Once the biasing member 902 is installed in one half of the clamshell housing 904, the loading tool 979 is removed which allows the biasing member 902 to expand and contact the shoulder 908. The second half of the clamshell housing 904 can then be attached to the first half, such as by using one or more fasteners and / or welds.

[0228] The medicant pressure within the syringe barrel 994 (e.g., syringe barrel fluid pressure) is estimated based on the spring force applied over the inner cross-sectional area (e.g., area calculated based on the inner diameter) barrel 994. The spring force is a function of the spring constant and the spring deformation (e.g., change in spring length). Thus, the length of the biasing member 902 relative to the spring free length may be used to estimate the medicant pressure within the syringe 990. The starting spring force may be calculated based on the difference between the spring free length and the spring length at delivery start (e.g., minimum spring length). The ending spring force may be calculated based on the difference between the spring free length and the spring length at delivery end (e.g., maximum spring length). The syringe barrel fluid pressure may also be estimated based on the plunger seal frictional force, which can be characterized for specific syringes and incorporated in the pressure calculation to produce a more accurate estimate of the pressure. The inner-cross sectional area and plunger seal frictional force may be determined by reading the identification element 599.

[0229] The needle exit pressure is calculated based on one or more of the syringe barrel fluid pressure, medicant viscosity, static pressure head, resistance of the inline flow control assembly, and the resistance of the fluid line (e.g., tubing, conduit) and needle.

[0230] The flow rate out of the syringe outlet 996 is proportional to the pressure differential between the syringe barrel fluid pressure and the internal pressure of the target (e.g., intra-tumoral pressure) at the needle tip and the total fluid delivery path hydraulic resistance (e.g., inline flow control valve, tubing, needle).

[0231] The flow rate and / or pressure of the medicant can be selectively adjusted by the inline flow control assembly (e.g., inline flow control assembly 830 of FIG. 8C). For example, the inline flow control assembly may selectively change the flow rate based on a desired medicant delivery profde. The inline flow control valve (e.g., flow control valve 833) of the inline flow control assembly may be manually controlled or controlled by the control system 111, which may use feedback from one or more sensors (e.g., the pressure and flow rate sensors049450-000420835, 836). Additionally, the inline flow control assembly may be used to compensate for the decay in the syringe barrel fluid pressure due to expansion of the biasing member 902, such as by adjusting the flow rate to maintain a desired delivery pressure of the medicant. Additionally, the inline flow control assembly can stop fluid flow when desired (e.g., close the flow control valve 833), which arrests continued motion of the plunger 992 and the pump plunger 901. The inline flow control valve may also be used to deliver a desired volumetric amount to the target. For example, the inline flow control assembly may be operated to stop fluid flow once the desired amount (e.g., fractional dose) has been delivered to the target. The control system 111 may track the delivered volumetric amount exiting the needle by monitoring the flow rate over time with a flow rate sensor (e.g., flow rate sensor 836). Additionally, the control system 111 may monitor the change in position of the handle 910 using a sensor (e.g., optical sensor). The change in position of the handle 910 due to the biasing member 902 is equivalent to the change in position of the plunger 992, and the change in position of the plunger 992 is correlated with a delivered volumetric amount. In some embodiments, the fluidics pump 900 may include linear potentiometer or linear magnetic encoder sensing the position and velocity of the plunger 992 which can be used to calculate the flow rate and volumetric amount pumped out the syringe outlet 996.

[0232] Still referring to FIG. 9E, in some embodiments, the fluidics pump 900 may include a pre-load element 960 (shown as a dashed box) within the housing 904 that the proximal end of the biasing member 902 engages (e.g., is shouldered against). The axial position of the pre-load element 960 may be changed to selectively change the length of the spring over its travel range (e.g., change the length at both its longest and fully compressed minimum length states). For example, the pre-load element 960 may be rotated about internal threads formed on the inner surface of the housing 904 to increase or decrease the minimum spring length. Decreasing the minimum spring length is referred to as “pre-loading,” and the biasing member can be “pre-loaded” to shift the pressure capacity of the pump over the range of travel of the biasing member 902 and the operating point on the pressure-flow curve based on the fluid resistance (e.g., hydraulic resistance of the inline flow control assembly, tubing, and needle). Pre-loading allows for a shift in the target pressure for a given flow rate or a shift in the flow rate for a given target pressure. Thus, pre-loading allows for the flow rate and pressure output by the fluidics pump 900 to be adjusted based on the specific medicant and / or target application. For example, the biasing member 902 may be pre-loaded to increase the medicant pressure.049450-000420

[0233] As another example, pre-load element 960 may include an external element, such as ring or collar, engaged with the threads on the exterior of the housing 904. The preload element 960 may further include an internal element, such as a yoke, engaged with the end of the biasing member 902. The internal element and external element may be connected together, such as by pins extending through slots formed in the housing 904. Rotating the preload element 960 relative to the housing 904 about the threads changes an axial position of the internal element which correspondingly adjusts the length of the biasing member 902.

[0234] In some embodiments, the fluidics pump 900 may include a plunger brake that is selectively used to arrest (stop or slow) pumping fluid out of the syringe 990, such as being used as an emergency brake. The plunger brake may be configured to arrest the motion of the pump plunger 901 or the plunger 992. The plunger brake may comprise, for example, one or more gripping members that can engage (e.g., bite into) the plunger 992, such as being a claw with one or more biting elements. The plunger brake may be controlled automatically by the control system 111, which may command the plunger brake to engage (actuate) when the desired volumetric amount of the medicant (e.g., dose) has been delivered. Alternatively, the plunger brake may otherwise be engaged manually.

[0235] FIG. 9E illustrates various schematic placements of a plunger brake. In some embodiments, a first plunger brake 950a (shown schematically as a dashed box) is configured to arrest the motion of the pump plunger 901 and is positioned at the handle 910 to selectively grip the handle 910 to arrest movement of the pump plunger 901. The first plunger brake 950a may be arranged exterior to the housing 904 or disposed within the housing 904, such as being incorporated into the support 948 (FIG. 9B). A second plunger brake 950b (shown as a dashed box) may be configured to selectively arrest the plunger 992 and may be positioned within the push member 930. The second plunger brake 950b may be used to selectively grip the plunger 992 or used to prevent further movement of the push member 930 relative to the cradle 920. A third plunger brake 950c (shown as a dashed box) may be coupled to or incorporated with the cradle 920 to selectively arrest the movement of the plunger 992. In some embodiments, the fluidics pump 900 may have one or more brakes, such as only one of the brakes 950a-c or any combination of the brakes 950a-c, such as the first and third brakes 950a, 950c.

[0236] The fluidics pump 900 may be packaged in a relatively compact and light weight envelope (e.g., the housing 904) which improves handling. The fluidics pump 900 may beneficially be formed from relatively low-cost materials. Additionally, the fluidics pump 900 can be adapted to pump medicant from off the shelf syringes 990 that may be fillable with medicant by pharmacies within or near to clinical site where medicant is delivered into target.049450-000420

[0237] The fluidics pump 900 may be characterized as a positive displacement pump that delivers a desired dose (e.g., volume) of the medicant at a desired flow rate and / or pressure with precision and accuracy. The fluidics pump 900, and the inline flow control assembly coupled thereto, may be controlled or utilized as described with respect to medical system 800. For example, the fluidics pump 900 may be controlled in a pressure controlled mode or a flow rate controlled mode. As another example, the fluidics pump 900 may be used in a pressure probe test and / or a leak test.

[0238] The fluidics pump 900 facilitates delivering the medicant at relatively low flow rates over a time period, which is advantageous for localized injection of the medicant in the target within the patient. For example, fluidics pump 900 and inline flow control assembly (e.g., inline flow control assembly 830) coupled thereto may achieve flow rates between about 0.1 ml / min to about 10 ml / min. The flow rate may be selectively adjusted by manipulating the flow control valve. Additionally, the flow rate and pressure can be adjusted by pre-loading the biasing member 902 with the pre-load element 960. Additionally, the fluidics pump 900 can deliver the medicant at low flow rates over an extended period of time, such a delivering the medicant over a 5 to 20 minute time span to allow the medicant to diffuse into the target.

[0239] The fluidics pump 900 may be used to deliver the medicant at a desired pressure. In some embodiments, the medicant can be pumped with a pressure up to about 1800 mmHg, which is significantly higher than the high end pressure of conventional intravenous infusion pumps which operate between 300-600 mmHg. The decay in the medicant pressure is predictable over time due to the predictable decay in the spring force applied by the biasing member 902 overtime. In some embodiments, the inline flow control assembly may adjust the pressure by controlling the flow rate. Furthermore, the fluidics pump 900 can accommodate a variety of syringes 990, allowing the fluidics pump 900 to be used to deliver a variety of medicant volumes into a patient. For example, the fluidics pump 900 can be used to pump volumes between about 1ml to about 100ml.

[0240] The fluidics pump 900 provides superior ranges of pressure and flow rate and facilitates a targeted delivery of a small volume of medicant into the patient as compared to conventional IV bags hung on an IV pole. IV bags are not a suitable medicant source for delivery of small volumes of medicant and pharmacy filling. Additionally, IV bags are not filled to customized, precise delivery volumes like syringes.

[0241] The spring-driven fluidics pump 900 may perform better than an electromechanical pump (intended for ambulatory infusion applications), which does not provide adequate pressure and flow rates to deliver medicant to a target within the patient.049450-000420Additionally, pressurizing an elastomeric pump is an additional burden on the user, requiring special attention and may not be done properly or consistently.

[0242] Conventional spring-powered syringe pumps substitute tubing sets with various resistances to achieve a specified flow rate. The fluidics pump 900 described herein, however, performs better than conventional spring-powered syringe pumps since the flow out of the syringe outlet 996 is selectively regulated with an inline flow control assembly fluidly coupled thereto.

[0243] The fluidics pump 900 provides a more consistent flow rate and pressure as compared to the conventional practice of user applied force to the syringe. The fluidics pump 900 also avoids the fatigue associated with manually depressing the syringe plunger over the course of an extended manual dose delivery.

[0244] The fluidics pump 900 may perform better than a tension-based fluid delivery device based on a back-to-back pair of constant force springs. Constant force springs are tension-based mechanisms, and creating a tension-based device for pumping medicant out of a syringe would involve designs with the constant force springs astride the syringe 990 since the use of direction reversing idler pulleys is problematic and not best practice. Such configurations yield a cumbersome and unwieldly packaging, as well as spring mounting and bearing challenges.

[0245] In some embodiments, the fluidics pump 900 and inline flow control assembly coupled thereto may not have any electronic parts, such as having a manually controlled flow control valve. However, the fluidics pump 900 and inline flow control assembly may be hybridized to include one or more electronically controlled parts that facilitate control by the control system 111. For example, the fluidics pump 900 may not include a user interface / display, except for power-on indication and perhaps an indicator for an error condition internal to the fluidics pump 900 if used with an auxiliary device. At some point, enough electronic parts are incorporated into the fluidics pump and inline flow control device that renders the instrument non-disposable. Additionally, the controllability and capabilities of a motor driven fluidics pump (e.g., fluidics pump 500) may be better suited for the needs of the medical team.

[0246] In some embodiments, a “mild” hybridized version comprises the fluidics pump 900 with a user interface 980 (FIG. 9C) and an inline flow control assembly that includes one or more electronically controlled parts and / or sensors. In some embodiments, the user interface 980 is merely for display purposes, such as displaying the pressure and / or flow rate. In other embodiments, the user interface 980 may be used to control the fluid output, such as being used049450-000420 to control the flow control valve. In some embodiments, the user interface 980 may be a flexible, curved LED display.

[0247] In some embodiments of the “mild” hybridized version, the flow control device may also have a battery powered electronic flow control valve (e.g., MEMS flow control valve) that facilitates suspending or interrupting fluid flow in response to a command from the control system 111 or user interface 980. Alternatively, the inline flow control assembly may include a manually settable flow control valve that allows the user to select the desired flow rate. For example, the inline flow control assembly may include a dial, knob, or slider that can be used to set the flow rate.

[0248] In some embodiments, the fluidics pump 900 may form part of a “substantial” hybridized version that includes the graphical interface 980, an electronic flow control valve (e.g., flow control valve 833), an electronic flow rate sensor (e.g., flow rate sensor 836), and a controller 982 (e.g., microprocessor) (see FIG. 9C). In some embodiments, the electronic flow rate sensor is fluidly coupled to the syringe outlet 996, but may instead comprise a battery powered linear potentiometer or linear magnetic encoder sensing the position and velocity of the plunger 992, which can be used to calculate the volumetric amount pumped out of the syringe outlet 996. The flow rate and the running total of the amount of medicant expensed may be displayed on the user interface 980. The sensed flow rate may be used to modulate the electric flow control valve to achieve a desired flow rate. The controller 982 may be in communication with the flow rate sensor and the electronic flow control valve and may be used to selectively actuate the flow control valve based on feedback from the flow rate sensor to achieve a target flow rate. The target flow rate may be pre-programmed into the controller 982 or input into the controller 982 using the user interface 980. The controller 982 may be battery powered or connectable to a power source. In some embodiments, the controller 982 and battery thereof may be attached to the exterior of the housing 904, as shown schematically in FIG. 9C. In some embodiments, the controller 982 facilitates pumping fractional doses.

[0249] The controller 982 may be in communication with the control system 111, such as via a wired or wireless connection. Thus, the target flow rate may be input into the controller 982 via the control system 111. However, the controller 982 may not communicate with the control system 111 in some embodiments. Moreover, the graphical interface 980 may be omitted in some embodiments of the “substantial” hybridized version. The controller 982 may instead be configured to communicate with an auxiliary user interface / display, such as a computer, tablet, and / or smartphone with wired or wireless connectivity.049450-000420

[0250] In some embodiments, the fluidics pump 900 may form part of a “substantial” hybridized version, which comprises an inline pressure sensor (e.g., pressure sensor 835) fluidly coupled to the syringe outlet 996. The pressure sensor may be integrated into the same unit as the electronic flow control valve (e.g., flow control valve 833) or may alternatively be a separate component from the electronic flow control valve. The pressure sensor may be a battery powered MEMS based pressure sensor. The pressure sensor may be connected directly to the syringe outlet 996. The pressure readings from the pressure sensor may be displayed on the user interface 980 or on the auxiliary user interface / display. The feedback from the pressure sensor may be used by the controller 982 to adjust the flow control valve. The pressure sensor also allows the controller 982 to operate the fluidics pump 900 in the pressure controlled mode and the flow rate controlled mode. Additionally, the controller 982 may also use the pressure sensor to help perform the leak test and / or pressure probe test.

[0251] In some embodiments, the fluidics pump 900 may be part of a “full” hybridized version, which includes an electronic inline flow control valve (e.g., flow control valve 833), an inline pressure sensor (e.g., pressure sensor 835), an inline flow rate sensor (e.g., flow rate sensor 836), the graphical interface 980, and the controller 982. The graphical interface 980 and controller 982 are integrated into the fluidics pump 900 while the inline electronic flow control valve, inline pressure sensor, and inline flow rate sensor are coupled to the syringe outlet 996. The “full” hybridized version has functionality similar to the “substantial” hybridized version. The syringe 990 may include the identification element 599. The identification element 599 can be used as described with respect to fluidics pump 500. For example, the identification element can be used to determine the patient identification, prescription identification, medicant identification, medicant specifications (e.g., concentration, working life, handling precautions), procedure parameters (e.g., prescribed number of fractional doses, prescribed fractional dose volume, prescribed flow rate, and / or prescribed pressure for each fractional dose), syringe technical specifications (e.g., syringe manufacturer, model, wetted material, chemical compatibility with medicant, syringe nominal volume, precise barrel inner diameter, barrel length, outlet fitting type), needle size and length for procedure, and / or tubing set lumen identification and lengths for procedure. The controller 982 or control system 111 may operate the inline electronic flow control valve based on the information obtained from the identification element 599.

[0252] In some embodiments, the plunger 901 may include a frictional element, such as an O-ring around the outside of the shoulder 933, to provide resistance (e.g., drag) to movement of the plunger 901 in response to the expansion of the biasing member 902.049450-000420

[0253] In some embodiments, a customized IV bag assembly may be used to deliver a medicant at a satisfactory flow rate and / or pressure. However, gravity alone will be insufficient to create the flow rate and / or pressure necessary for injecting fluid into a target within the patient. The IV bag may instead be energized, such as by counter rotating squeezer rollers or sequence plates to generate the desired flow rate and / or pressure. In some embodiments, a motor or biasing members are used to energize the IV bag.Closed Loop Control

[0254] In some aspects, the medical systems described herein may use a closed loop control system or algorithm to deliver a medicant from the medicant source intratumorally to a target within the patient at a desired drug delivery profile. The closed loop control can be used to deliver precise and accurate volumetric quantities of the medicant into the patient at desired pressures and / or flow rates. The closed loop control may use real-time sensor feedback (e.g., flow rate, pressure) to adjust the medicant delivery as necessary to meet the desired drug delivery profile. For example, the closed loop control may adjust the flow rate and / or pressure if the sensors detect a deviation from a desired set point or threshold.

[0255] The medical system 400 of FIGS. 4A-4B, for example, may be controlled using closed loop control, such as controlling the fluidics pump 422 (or fluidics pump 500) based on sensor feedback. Similarly, the medical system 800 of FIGS. 8A-8B may also be controlled using closed loop control, such as adjusting the flow control valve 833 to achieve a desired flow rate and / or pressure.

[0256] The closed loop control can also monitor sensor data for critical issues, such as occlusions (e.g., kinks, air bubbles, etc.) in the fluid line (e.g., fluid conduit) connected to the needle or reaching and / or exceeding a maximum pressure. The closed loop control can also monitor for discontinuities or anomalies in the data (e.g., implausibly high pressure, low pressure, low flow, missing data, etc.), which may indicate a leak. The closed loop control may issue an alarm if a critical issue is detected and may also issue an alarm or alert if discontinuities or anomalies in the data are detected. Additionally, using closed loop control reduces instances of false alarms or missed critical issues.

[0257] FIG. 10A is a schematic block diagram of an example drug injection system 1000 (e.g., drug delivery system) that uses closed loop control to inject a drug into a target (e.g., tumor, lesion, etc.) using a needle. The drug injection system 1000 is described in relation to a motor-driven fluidics pump (e.g., fluidics pumps 422, 500). However, aspects of the drug injection system 1000 may also be applicable to a spring-biased fluidics pump (e.g., fluidics pumps 822, 900), without departing from the scope of the disclosure.049450-000420

[0258] As shown in FIG. 10A, the drug injection system 1000 includes a user interface (e.g., input device) 1010, a signal processing and control system 1020, and fluidics pump hardware 1030. The physician may interact with the user interface 1010 to provide various inputs, such as a desired drug delivery profde, which is used by the signal processing and control system 1020 to operate the fluidics pump hardware 1030 based on sensor feedback. FIG. 10B is a more detailed block diagram of the drug injection system 1000 showing various aspects of the signal processing and control system 1020 and fluidics pump hardware 1030, including showing the user interface 1010 as a laptop.

[0259] The user interface 1010 may be the same as or similar to the control interface 143 of FIG. 1. The signal processing and control system 1020 may be the same as or similar to the control system 111, or otherwise integrated into the control system 111. The fluidics pump hardware 1030 may include the drug delivery system 420 of FIGS. 4A-4B, such as including the fluidics pump 422 (or fluidics pump 500), the fluid line 423, the sensor assembly 430, and the needle 421.

[0260] Users can interact with the drug injection system 1000 via the user interface 1010, which can be used to register patient information, set parameters of the medicant injection, define the medicant delivery profile (e.g., drug delivery profile), monitor the realtime flow rate and / or pressure data, and view displayed medicant delivery information. The user interface 1010 may be connected to an input port (e.g., port 554 of FIG. 5D), such as a serial port, of the signal processing and control system 1020.

[0261] The signal processing and control system 1020 comprises a memory 1021, a power management system 1022, one or more microcontroller, one or more audio alarms devices, and an emergency stop button (e.g., Estop button). In some embodiments, the signal processing and control system 1020 may include a first microcontroller 1023 and a second microcontroller 1024. One or both of the first or second microcontrollers 1023, 1024, such as the second microcontroller 1024, may be a proportional-integral-derivative (“PID”) controller that is used to control the fluidics hardware 1030 to deliver a desired volumetric amount of medicant at a desired flow rate and / or pressure. An output port of the signal processing and control system 1020 is connected to the fluidics pump hardware 1030.

[0262] The fluidics pump hardware 1030 may comprise a stepper motor (e.g., motor 531 of FIG. 5B), a motor driver, a leadscrew assembly (e.g., lead screw 533, lead nut 541 of FIG. 5B), one or more rotary encoders (e.g., encoder 532 of FIG. 5B), a pressure sensor (e.g., pressure sensor 436 of FIG. 4C), a force sensor (e.g., force sensor 522 of FIG. 5C), a position sensor, and a leak detection system. The lead screw assembly, which is mechanically linked to049450-000420 the syringe, such as by a pump plunger, is engaged with the plunger of the syringe. Medicant is pumped out of the syringe in response to the stepper motor driving the leadscrew assembly. The fluidics pump hardware 1030 may include a monitoring system that includes different types of sensors at different stages to facilitate the detection of abnormalities and / or divergence from a set point or threshold. In some embodiments, the pressure sensor at the output of the syringe can monitor occlusion. The force sensor at the end of the syringe plunger may be used to measure the resistance to further fluid flow. The position sensor at the leadscrew can be used to measure the flow rate to reduce volumetric errors when injecting a dose. The leak detection system monitors drug leakage, which enhances accuracy in determining the volumetric amount of medicant that reaches the target. The leak detection system may be implemented as a leak test. Additionally, the motor current is monitored with a current monitoring circuit to check status. The audio alarm devices are used to inform the medical and nursing staff of abnormal states. The Estop button can be activated at any emergency event detected using the monitoring system, such as in response to the alarm. In some embodiments, the motor current is monitored for over-current protection.

[0263] The power management system controls the system power “on” and “off,” provides power to the stepper motor and other electrical circuits, and disables the system power if voltage or current faults are detected. The power management system may also be equipped with a battery backup. In some embodiments, the power management system receives +12V input voltage and regulates the input voltage to 5V or 3.3V.

[0264] The microcontroller generates a pulse width modulation (“PWM’j signal with variable frequency and duty cycle based on the user defined flow rate. This PWM signal is applied to the gate of metal-oxide-semiconductor field-effect transistors (MOSFETs) in the motor driver. The output current of the MOSFETs drives the motor at the commanded rotational speed. The rotary encoder signals are sampled by the microcontroller and used to calculate the motor rotation speed. The volume of medicant and the flow rate can be further derived using the syringe dimension and leadscrew parameters. With the PID control, the desired flow rate and injection volume can be precisely controlled. Additionally, the PID control can resolve inaccuracy of infusion dose, such improper flow rates, by instructing the stepper motor to adjust its rotational speed, thereby controlling the flow rate.

[0265] In some embodiments, the stepper motor has a minimal step angle of 7.5°. The step of the motor is programmable by using a microstepping driver, which can be operated in full, half, quarter, eighth, and sixteenth step modes. A smaller motor step helps to reduce motor049450-000420 noise and to achieve low flow rate. For example, the smallest step angle may be 0.9375° if eighth step mode is implemented.

[0266] FIG. 10C is a schematic flowchart depicting an example of the drug injection system 1000 using Matlab / Simulink. The flowchart includes a PWM I / O block 1050, which has frequency and duty cycle to the inputs of the PWM block that drives the digital output pin in microcontroller to generate desired PWM signal.

[0267] The schematic shown in FIG. 10C includes two closed loops for controlling different user defined inputs. Control loop stability is adjusted and PID control is optimized. Example Loop 1 is a primary control loop. A user predefined drug delivery profile can be uploaded to the system through the user interface 1010 and executed by the signal processing and control system 1020. Loop 1 may include adjusting the stepper motor to output medicant at a desired flow rate and / or pressure profile. For example, the stepper motor may be operated at a desired rotational speed (e.g., RPM) to follow the desired flow rate and / or pressure profile.

[0268] Example Loop 2 is for changing the flow rate of medicant delivery to a lower flow rate over a period of time in response to reaching a threshold based on real-time pressure feedback, such as decreasing the flow rate to a fixed flow rate. For example, once the pressure reaches a threshold, the stepper motor is operated to reduce the flow rate.Controlled Medicant Delivery Using Pressure Feedback

[0269] As explained above, the medical systems described herein can adjust flow parameters of the medicant based on real-time pressure feedback from one or more inline pressure sensors (e.g., pressure sensors 436, 835) fluidly coupled to (in fluid communication with) the medicant source (e.g., syringe 590). The pressure may be used to deliver the medicant in accordance with a desired medicant delivery profile with one or more desired pressures. Additionally, the fluidics pumps described herein can be operated in a pressure and / or flow rate controlled mode using feedback obtained by the pressure sensor(s).

[0270] In some embodiments, a fluidics pump may include a single stepper motor (e.g., motor 531) that drives a lead screw (e.g., lead screw 533) to depresses the plunger (e.g., plunger 592) of the syringe (e.g., syringe 590). The motor is driven by a controller, such as a microcontroller, which determines the desired motor velocity (and therefore the plunger velocity) to achieve a desired flow rate and / or pressure. The controller actuates the stepper motor via a motor driver by activating the appropriate coils in the motor and thereby resulting in output shaft motion. In some embodiments, the frequency of coil activation is dictated by one of the digital output pins of the controller. In some embodiments, the output pin alternates between high and low with a period that is proportional to the desired motor velocity. The049450-000420 direction that the motor driver drives the stepper motor is dictated by a separate digital output pin, where low corresponds to one direction and high corresponds to the other. The controller may be any suitable controller, such as a proportional controller or a proportional-integral- derivative controller.

[0271] One or more rotary encoders (e.g., rotary encoder 532) can be used to monitor the steps and position of the lead nut (e.g., lead nut 541). The rotary encoder(s) can be used to calculate the velocity and axial displacement of the syringe plunger based on the information recorded by the rotary encoder(s) (e.g., number of steps counted over time). The axial displacement of the syringe plunger may be correlated to a volumetric amount based on the internal cross-sectional area of the syringe. Additionally, the rotary encoder(s) can be used to calculate the flow rate based on the internal cross-sectional area of the syringe and the change in axial position of the syringe plunger over time. In other words, the controller can convert the desired volumetric amount and flow rate to a syringe plunger position and velocity, respectively. The controller can be used, therefore, to selectively dispense a desired fractional dose by moving the syringe plunger a set axial distance. Additionally, the controller is able to calculate and control the time duration to deliver each volumetric amount. The controller may also output an estimated remaining completion time for the current input medicant delivery (e.g., injection) operation.

[0272] In some embodiments, the controller causes the fluidics pump (e.g., fluidics pumps 422, 500) to drive the syringe plunger while taking into account the syringe plunger position, the syringe plunger velocity, and the fluid pressure. The controller may require input from a user to determine the target operating objectives. The target operating objectives may include any combination of the following: desired plunger position, desired plunger velocity, and desired fluid pressure. The fluidics system is also able to detect and relay fault conditions resulting from but not limited to faulty target operating parameters or unacceptable signals during operation.

[0273] In some embodiments, the fluidics pump has a local controller (e.g., low level controller) in communication with a high level control system (e.g. control system 111). The high level control system may interact with the local controller of the fluidics pump by sending and receiving data packets via universal asynchronous receiver-transmitter (“UART”) serial communication. The sent data packets include the operating objectives mentioned above and a signal to start operation, to pause operation, or to clear fault. The received data packets include feedback information including actual plunger position, actual line pressure, and fault status.049450-000420

[0274] In some embodiments, the high level control system may send a single command to the local controller to deliver each dose . In other embodiments, the local controller may be tuned to simply follow the desired position command coming from the high level control system. The high level control system then would be responsible for trajectory planning of the plunger, allowing for more fine control and more sophisticated trajectories. This introduces more flexibility since this would allow the high level control system to adaptively modify the commands while monitoring the delivery metrics or analyzing the tissue response obtained by the sensors monitoring the fluidics pump. In some embodiments, the high level control system may also plan the trajectory of the needle.

[0275] The controller may also have an input max pressure threshold and max plunger velocity. The controller will endeavor to avoid exceeding the max pressure threshold and max plunger velocity. In some cases, the controller may operate the fluid pump in the flow rate controlled mode if the sensed pressure reaches or approaches the max pressure. In other cases, the controller may throttle the fluid pump flow rate based on the detected pressure to adjust the pressure. Additionally, the user is able to plan a delivery volume at a target delivery rate with maximum pressure being optional.

[0276] The controller further controls the velocity (e.g., RPMs) of the stepper motor. The output velocity is proportional to the error in the actual plunger position compared to the desired position. This relationship may be used to determine the plunger position and velocity. In some embodiments, the output velocity may be capped at the minimum value of the stepper motor and / or the user input velocity limit. In some embodiments, a dead zone value may be applied to the plunger position.

[0277] In some embodiments, the desired pressure is achieved by modifying the plunger position error inversely proportional to a margin between the actual pressure and the minimum value of the built-in hardware limit of the stepper motor, and taking into consideration the user desired pressure limit. The error modification is only applied if the desired plunger position intends to deliver fluid. The error modification cannot modify the error to deliver more fluid. However, the error modification can retract the plunger if the actual pressure exceeds the desired max pressure.

[0278] Plunger position, plunger velocity, and line pressure are objectives that may conflict with one another because they are all dependent on input from the stepper motor. The controller treats the plunger position and line pressure with higher priority than the plunger velocity. For example, if the plunger is at the desired position, then the fluidics pump will not cause further motion of the plunger even if the plunger velocity mismatches the desired049450-000420 velocity. If the pressure is equal to the max pressure, then the fluidics pump will not cause further motion of the syringe plunger. Additionally, if there is both sufficient error in the plunger position and sufficient margin in the line pressure, the system will operate at max plunger velocity. Therefore, by sending the appropriate command parameters, the user is able to command the fluidics system to prioritize any combination of the three operation objectives or alternatively a single objective.

[0279] Additionally, pressure feedback can be used to probe the pressure resistance of the target. For example, the pressure feedback may be used during a pressure probe test to evaluate what kind of tissue that the needle tip is disposed within (penetrating). In some embodiments, the target is probed by controlling the fluidics pump to deliver a small volume of fluid at a safe rate and safe max pressure.

[0280] In some embodiments, the pressure and / or flow rate feedback may be used to automate the fluidics pump. For example, the user may input a desired volumetric dose and desired medicant delivery profde, and the controller may use the pressure and / or flow rate feedback to automatically deliver the desired dose. Automatic medicant delivery eliminates errors associated with manual delivery, resulting in more consistent medicant delivery.

[0281] In some embodiments, the pressure sensed by the pressure sensor may be used to facilitate haptic feedback to the user. For example, the pressure detected by the pressure sensor may be correlated into resistance physically felt by the surgeon, such as by increasing the resistance on a handheld controller when trying to increase the fluid flow, as described in more detail below with reference to the controller 1100 in FIGS. 11A and 1 IB.

[0282] Additionally, the pressure and / or flow rate feedback may be used to dynamically adjust the medicant delivery. The control system is able to operate up to the limits specified by the user and notify the user that a limit has been reached or prompt them to make adjustments to the delivery plan. Additionally, the pressure and flow rate data obtained during the medicant delivery can be recorded for post-operative analysis.

[0283] In some embodiments, the pressure may be indirectly measured by using a force sensor (see e.g., force sensor 522) located at or engaged with the end of the syringe plunger. The force sensor may be used to validate the inline pressure sensor or in lieu of the inline pressure sensor.

[0284] Additionally, the sensed pressure and / or flow rate may be used to minimize the slowdown in the syringe plunger velocity as the syringe plunger reaches a desired axial position.049450-000420

[0285] In some embodiments, a drug delivery system may include a separate actuator specifically for influencing the in-line pressure. This would allow the fluidics pump to inject medicant while relying on the pressure relief to stay within the acceptable pressure bounds. Haptic Feedback for Intra-tumoral Medicant Injection

[0286] Surgeons lose the ability to access real-time feedback through tactile sensation when performing an intratumoral injection using a fluidics pump, such as a syringe pump. Sensory feedback, however, can be crucial for evaluating the tumor’s consistency and for manually adjusting the flow rate of the medicant. For example, sensation felt by the surgeon changes with tissue consistency, which can vary significantly within a tumor. Tissue consistency can be an important decision trigger during injection. This limitation restricts the surgeon’s ability to adjust the injection rate on the spot, risking the rupture of tumor tissue or indicating that the injection is being performed in the wrong location (necrotic area with different consistency for example), which may impact the effectiveness of the treatment and potentially damage surrounding tissues (in the case of leakage for example).

[0287] According to embodiments of the present disclosure, the control system 111 includes a controller (e.g., controller 142) that provides haptic (tactile) feedback to the surgeon when injecting the medicant with a fluidics pump. This haptic feedback may be in the form of resistance felt by the surgeon when trying to introduce medicant by pressing or pulling a trigger forming part of the controller. An actuator or brake coupled to the trigger may be used to selectively change the resistance felt by the surgeon based on flow rate and / or pressure feedback from inline sensors coupled to the fluidics pump. In some embodiments, the resistance is proportional to the tissue resistance during injection. Creating resistance in response to pressure allows the trigger to reflect the tumor's consistency during injection. In some embodiments, the measured fluid flow rate for a given applied force to the trigger is correlated to the pressure at the syringe outlet.

[0288] The trigger (e.g., button) mounted to the controller functions as the injection control: the more pressure applied to the trigger, the more force is exerted, thereby increasing the flow rate. For example, the motor (e.g., motor 531) of the fluidics pump (e.g., fluidics pump 500) may be operated in response to pulling (pushing on) the trigger to increase or decrease the flow rate. As another example, a control valve (e.g., flow control valve 833) coupled to a biasing member driven fluidics pump (e.g., fluidics pump 900) may be operated in response to pulling the trigger to increase or decrease the flow rate.

[0289] Providing haptic feedback allows the surgeon to physically feel the variations in tumor consistency and adjust the injection rate dynamically. Mimicking the natural feedback049450-000420 provides a safer, more precise method for intratumoral injections, thereby enhancing control during delivery and reducing risks associated with leakage or adjustments based on non-real- time feedback.

[0290] FIGS. 11A and 11B are top and side views, respectively of an example controller 1100 that may be used in conjunction with the medical drug delivery systems disclosed herein. The controller 1100 may be the same as or similar to the controller 142 of FIGS. 1 and 2, and may be somewhat similar to a gaming controller. The controller 1100 may include various inputs (e.g., buttons, triggers, bumpers, switches, toggle members, etc.) that can be used to input and / or control one or more medical instruments, such as being used to control the medical systems 100, 400, or 800 described herein. One of the inputs, shown as trigger 1110, is used to control delivery of a medicant pumped from the fluidics pump (e.g., fluidics pumps 500, 900) into the patient through a needle disposed within (penetrating) a target (e.g., tumor). The trigger 1110 is provided with haptic feedback to mimic the sensation associated with delivering the medicant directly by pressing on a plunger of a syringe.

[0291] The haptic feedback is provided by a resistance device 1120 (shown as a dashed box) incorporated into the controller 1100. The resistance device 1120 may be configured to selectively change the force (e.g., resistance) required to pull the trigger 1110 to provide haptic feedback to the surgeon. The resistance force applied by the resistance device 1120 may be based on feedback from one or more sensors fluidly coupled to a medicant source loaded into a fluidics pump, such as an inline pressure sensor and / or inline flow rate sensor. In some embodiments, the resistance force applied to the trigger 1110 by the resistance device 1120 is proportional to the tissue resistance during injection.

[0292] In some embodiments, the resistance device 1120 may be an actuator, such as an electric actuator (e.g., lead screw driven actuator), a hydraulic actuator, a pneumatic actuator, an electromechanical actuator, or any combination thereof. In some embodiments, the resistance device 1120 may be a brake, such as a magnetic or electromagnetic brake with an electromagnet that interacts with a permanent magnet coupled to the trigger 1110. The strength of the electromagnet may be adjusted (varies) based on the feedback derived from the sensors to adjust the brake force applied to the trigger 1110.

[0293] In some embodiments, the trigger 1110 is a finger trigger pivotally coupled to the controller 1100. In other embodiments, the trigger 1110 may be a depressible member, such as the bumper 1100a.

[0294] In some embodiments, the surgeon may rely on non-haptic feedback during injection. For example, the pressure and / or flow rate may be displayed to the surgeon, such as049450-000420 displaying a graph of the pressure and / or flow rate over time. The surgeon may use the pressure and / or flow rate feedback to make real-time adjustments during the injection operation, such as stopping injection or manipulating the fluidics pump and / or one or more valves coupled to the fluidics pump to change a flow parameter.

[0295] FIG. 12 shows a block diagram of an example medical system 1200 that can be used for planning, staging, and treatment of tumors, according to some implementations. The medical system 1200 may be one example of the medical system 400 of FIG. 4A or the medical system 800 of FIG. 8A. More specifically, the medical system 1200 may provide for planning, staging, and treatment of targets, such as tumors, in a way that reduces or minimizes time between diagnosis and treatment. In some implementations, various components of the medical system 1200 may be implemented into the control system 111, such as being implemented by any of the control circuitry 211 or 251 of FIG. 2.

[0296] The medical system includes a planning component 1210, a navigation component 1220, and a treatment component 1230. The planning component 1210 is configured to generate an access plan 1204 for accessing a target (such as a tumor, lesion, or nodule) within an anatomy based at least in part on image data 1202 representing images of the anatomy captured by an imaging device external to the anatomy. Example suitable imaging technologies include CT, X-ray, fluoroscopy, PET, PET-CT, CT angiography, CBCT, three- dimensional rotational angiography, single-photon emission CT, MRI, optical coherence tomography, and ultrasound, among other examples.

[0297] In some implementations, the planning component 1210 may generate a three- dimensional (3D) model of the anatomy (such as the anatomical model depicted by the graphical interface 314 of FIG. 3) based on the image data 1202. For example, the planning component 1210 may use various image processing techniques to reconstruct a 3D model of a luminal network within the anatomy. Example suitable image processing techniques include segmentation, machine learning, and statistical analysis, among other examples. As used herein, the term “segmentation” refers to various techniques for partitioning a digital image into groups of voxels (or “image segments”) based on related characteristics or identifying features. In some implementations, the anatomical model may further include the position or location of the target (or multiple targets). For example, the planning component 1210 may determine the position of the target using one or more image processing or segmentation techniques.049450-000420

[0298] The planning component 1210 may further determine a path for accessing the target based on the target location and the entry location for a medical instrument (e.g., scope, needle). For example, the medical instrument may be scope 130 that is used in combination with the needle 421 as shown in FIGS. 4 and 8. In some implementations, the planning component 1210 may map or plan an optimal or recommended path through the anatomy based on the topology of a luminal network depicted by the anatomical model. In some other implementations, the planning component 1210 may allow a user to select or refine the access path via one or more user inputs 1201. For example, the planning component 1210 may display a graphical user interface (GUI) 1203 (such as on the display 141 or 116 of FIG. 2) that includes the anatomical map and allows the user to draw or modify an access path on the anatomical map via the user inputs 1201. In some implementations, the planning component 1210 may further determine a path to a number of drug delivery locations (such as for dose fractionation) based on the position, size (e.g., dimensions), volume (e.g., gross tumor volume) and / or shape of the target. The access plan 1204 may include the anatomical map (e.g., airway tree) having the recommended access path and / or drug delivery locations overlaid thereon.

[0299] The planning component 1210 may also include inputting a desired medicant delivery profile for each dose, such as a different delivery profile and volumetric amount for each fractional dose. Additionally, the number of doses and / or information about the drug may be obtained by reading an identification element (e.g., identification element 599) coupled to medicant source (e.g., syringes 590, 990) input into the fluidics pump (e.g., fluidics pumps 500, 900).

[0300] Additionally, the planning component 1210 may include determining what areas of the target can be reached for treatment. For example, some parts of the target may not be accessible by the instrument due to the anatomy, target size, and / or movement limitations of the instrument. The physician can use the identified non-accessible areas to plan one or more locations to deliver the desired dose of the medicant.

[0301] Additionally, the planning component 1210 may be used to determine an access path 1204 directly to one or more locations that the physician wants to inject a desired fractional dose. For example, each location for a fractional dose may have its own independent access path 1204.

[0302] The navigation component 1220 is configured to guide or assist the user in navigating the instrument (such as scope 130 and needle 421) to the target with the robotics system 110 according to the access plan 1204. In some implementations, the navigation component 1220 may determine a pose (such as a position and / or orientation) of the instrument049450-000420 within the anatomy based on sensor data 1205 received via one or more sensors disposed on the instrument. Example suitable sensors include EM sensors and camera sensors, among other examples. In some other implementations, the navigation component 1220 may determine the instrument pose based on robotic telemetry associated with the robotic arms 112 used to manipulate the instrument (e.g., scope 130). Still further, in some implementations, the navigation component 1220 may implement a “fusion” navigation model that combines multiple sensing modalities (such as EM, robotic telemetry, and vision) to determine the instrument pose and / or compensate for any distortions in the sensor data 1205. It will be appreciated that the telemetry data can include both robotic and non-robotic sensor data.

[0303] In some aspects, the navigation component 1220 may display a GUI 1206 (such as on the displays 116, 141 of FIG. 2) that includes the anatomical model having the instrument pose projected thereon. For example, the navigation component 1220 may determine the pose of the instrument in relation to the anatomy based on the sensor data 1205 and a mapping between the sensor space and the image space (such as the registration 326 or 332 of FIG. 3). More specifically, the navigation component 1220 may use the mapping to transform the pose of the instrument from the sensor space (as indicated by the sensor data 1205) to a corresponding pose in the image space. The navigation component 1220 may continuously track any changes in the pose or movement of the instrument based on the sensor data 1205 and update the GUI 1206 to include spatial information 1207 reflecting the real-time pose of the instrument in relation to the anatomy.

[0304] After a needle has been guided to a desired location within the target (as indicated by the spatial information 1207), the treatment component 1230 may control intratumoral drug delivery via the needle. In some implementations, the treatment component 1230 may control the drug delivery based on telemetry data 1208 (e.g., feedback) received via one or more sensors associated with the drug delivery system (e.g., drug delivery system 420 of FIG. 4A, drug delivery system 820 of FIG. 8A). Example suitable sensors may include pressure sensors (e.g., inline pressure sensor 436, 835) that can detect the pressure of the drug or fluid in the fluid lines and flow rate sensors (e.g., inline flow rate sensors 438, 836) that can detect the rate of fluid flow in the fluid line(s).

[0305] The telemetry data 1208 may be used to monitor the medicant delivery and / or to dynamically change one or more fluid parameters of the medicant during the drug delivery. The telemetry data 1208 may be used to ensure that the medicant is delivered at the desired medicant delivery profile, such as being delivered at a desired pressure and / or flow rate over a period of time. As one example, the treatment component 1230 may dynamically adjust the049450-000420 rate at which fluidics pump 500 (FIGS. 5A-5D) expels fluid from the syringe 590 to ensure a constant or steady flow rate in the fluid lines and / or to ensure that pressure inside the lines does not exceed a threshold or maximum fluid pressure. As another example, treatment component may dynamically control a flow control valve (e.g., flow control valve 833 in FIG. 8B) to control the rate at which fluid is expelled from the syringe 990 loaded into fluidics pump 900 (FIGS. 9A-9G) to ensure a constant or steady flow rate and / or to ensure that the pressure does not exceed a threshold or maximum fluid pressure.

[0306] The treatment component 1230 may also be used to perform a pressure probe test and / or a leak test. For example, the treatment component 1230 may cause the robotic system 110 to change the position of the needle tip if the pressure probe test determines that the needle tip is currently in undesirable tissue (e.g., necrotic tissue). The treatment component 1230 may also operate the fluidics pump in a pressure controlled mode or a flow rate controlled mode.

[0307] Additionally, if the pressure and / or flow rate decreases suddenly, the user has the ability to stop medicant delivery immediately. For example, the motor 531 of the fluidics pump 500 can be turned off to stop fluid flow. After drug delivery, the physician has the ability to quantify how much of the mediant was delivered inside the intended fraction. Once satisfied with the concentration of the medicant delivered, the user can use the instrument and access plan to navigate to the next delivery location of the target to deliver the next fraction and repeat the drug delivery process.

[0308] In some aspects, the treatment component 1230 may display a GUI 1209 (such as on the displays 116, 141 in FIG. 2) that includes information related to the drug delivery. In some implementations, the GUI 1209 may display the spatial information 1207 depicting the position of the instrument in relation to the anatomy so that the user can view the current drug delivery location. In some other implementations, the GUI 1209 may display the telemetry data 1208 indicating the flow rate, pressure, and / or amount of drug delivered at the current drug delivery location. In some other implementations, the GUI 1209 may allow the user to manually adjust various drug delivery parameters (such as flow rate). Still further, in some implementations, the treatment component 1230 may dynamically adjust one or more drug delivery parameters based on changes detected in the sensor data 1205 and / or telemetry data 1208.

[0309] Additionally, the physician will be able to see the analytics and measurements from the procedure, such as on the display 141 shown in FIG. 2. The physician can track the volumetric amount for each dose, the gross tumor volume coverage, locations of drug delivery,049450-000420 and images (e.g., CT images) from the procedure. Additionally, the physician can use the information obtained during the procedure during post-operation analysis.

[0310] The medical system 1200 allows for an instrument (e.g., scope) to access the target for diagnosis and treatment during the same procedure.

[0311] FIG. 13 shows an example graphical interface 1300 for planning access to a target within an anatomy, according to some implementations. In some implementations, the graphical interface 1300 may be one example of the GUI 1203 of FIG. 12.

[0312] The graphical interface 1300 shows a tomogram of a lung (on the right) and a 3D model of the lung (on the left). With reference for example to FIG. 12, the planning component 1210 detects a tumor (labeled “A”) in the tomogram and maps the tumor to a corresponding position in the 3D anatomical model. In some aspects, the planning component 1210 also may determine a size of the tumor (shown as having a density equal to 8 cm3) and an appropriate drug dosage (shown as 4.2 mb) given the size of the tumor. In some implementations, the planning component 1210 may further select a number of drug delivery locations within the tumor. In the example of FIG. 13, three drug delivery locations (A, B, and C) are selected. However, in actual implementations, a drug may be distributed among any number of locations and in any amount at each location.

[0313] The graphical interface 1300 also shows two “optimal” paths for accessing the site of the tumor, including an indicating that the access paths are clear (or unobstructed). More specifically, the graphical interface 1300 depicts an endoluminal access path (labeled “Bronch” and having a length of 23 cm) and a percutaneous access path (labeled “Perc” and having a length of 10 cm). In some implementations, the planning component 1210 may generate the access paths using various image processing or segmentation techniques. In some other implementations, a user may draw or modify the access paths via one or more user inputs and / or controls associated with the graphical interface 1300 (not shown for simplicity).

[0314] FIG. 14A shows an example graphical interface 1400 for navigating a needle to a target within an anatomy, according to some implementations. In some implementations, the graphical interface 1400 may be one example of the GUI 1206 of FIG. 12.

[0315] The graphical interface 1400 shows an anatomical model depicting a spatial relationship between the needle and the target, including the recommended access path (shown as a dotted line that intersects the needle and the target). In the example of FIG. 14A, the access path is a percutaneous access path. Spatial information is depicted on the left of the graphical interface 1400 showing the depth of insertion of the needle in relation to the skin and three (3) drug delivery locations (depicted as circles or dots). In the example of FIG. 14A, three drug049450-000420 delivery locations are selected. However, in actual implementations, a drug may be distributed among any number of locations and in any amount at each location. As shown in FIG. 14A, the current pose or trajectory of the needle is not aligned with the recommended access path. Thus, the graphical interface 1400 displays a warning (“Needle Off Track”) to indicate to the user that needle may fail to reach the drug delivery locations if it continues along its current trajectory.

[0316] FIG. 14B shows another example graphical interface 1410 for navigating a needle to a target within an anatomy, according to some implementations. In some implementations, the graphical interface 1410 may be one example of the GUI 1206 of FIG. 12.

[0317] The graphical interface 1410 shows an anatomical model depicting a spatial relationship between the needle and the target, including the recommended access path (shown as a series of dotted lines that intersect the needle and the target at 3 drug delivery locations). In the example of FIG. 14B, the access path is an endoluminal access path. The graphical interface 1410 also shows a camera view in the upper-right comer that displays real-time images captured by a camera disposed on a scope within the anatomy. Spatial information is depicted on the left of the graphical interface 1410 showing the depth of insertion of the needle in relation to the scope (or working channel) and the nearest delivery location (depicted as circles or dots). As shown in FIG. 14B, the current pose or trajectory of the needle is aligned with the recommended access path (dotted lines for at least one of the drug delivery locations.

[0318] FIG. 15 shows an example graphical interface 1500 for controlling and monitoring intratumoral drug delivery, according to some implementations. In some implementations, the graphical interface 1500 may be one example of the GUI 1209 of FIG. 12.

[0319] The graphical interface 1500 shows an anatomical model bordered by three cross-sectional views (or “slices”) of the anatomy that depict the spatial relationship between a needle and a target (labeled “Uesion-01”), including three drug delivery locations (labeled “Fl,” “F2,” and “F3”). In the example of FIG. 15, three drug delivery locations are selected. However, in actual implementations, a drug may be distributed among any number of locations and in any amount at each location. Drug delivery telemetry is displayed to the left of the anatomical model as indicated by reference sign 1502. In the example of FIG. 15, the displayed telemetry includes the total amount of drug delivered compared to a planned injection volume (shown as 2.6 mU out of 8.0 mU) and also includes a dosage amount inside the target (shown as 2.3 mU) compared to a dosage amount outside the target (shown as 0.3 m ). The anatomical049450-000420 map may be color-coded with the drug delivery telemetry to show the distribution of the drug inside the target and the leakage of the drug outside the target. The graphical interface 1500 also shows a number of “Advanced Metrics” include the percentage of the tumor adjacent to the drug (shown as 32%), the extended tumor coverage (shown as 45%), and the radial dispersion of the drug (shown as 32%).

[0320] FIG. 16 shows another example graphical interface 1600 for controlling and monitoring intratumoral drug delivery, according to some implementations. In some implementations, the graphical interface 1600 may be one example of the GUI 1209 of FIG. 12.

[0321] The graphical interface 1600 shows an input feature (labeled “Pump Settings”) that allows a user to set a pump flow rate for drug delivery. For example, the user may input a desired pump flow rate (shown as “X” mL / Hour) and select whether the entire dose or a per fraction dose is to be delivered (via corresponding radio buttons). The graphical interface 1600 is also configured to display drug delivery telemetry (labeled “Real-time Pump Dashboard”) once the pump is started (such as after the user clicks or taps on the “Start Pump”) button. In the example of FIG. 16, the drug delivery telemetry is shown to include the pressure of the drug inside the fluid lines (in mmHg), the real-time flow rate of the pump (in mL / Hr), and the volume of drug delivered (including total volume and volume per fractional dose).

[0322] FIG. 17 shows another example graphical interface 1700 for controlling and monitoring intratumoral drug delivery, according to some implementations. In some implementations, the graphical interface 1700 may be one example of the GUI 1209 of FIG. 12.

[0323] The graphical interface 1700 shows an anatomical model depicting three drug delivery locations (shown as dots or circles) with respect to a target (shown as an outline around all three dots). In the example of FIG. 17, three drug delivery locations are selected. However, in actual implementations, a drug may be distributed among any number of locations and in any amount at each location. As shown in FIG. 17, all three doses of the drug have been intratumorally delivered (representing a total of 4.2 m ). The graphical interface 1700 also displays drug delivery telemetry, including the pressure inside the fluid lines (shown as 1.1 bar) and the flow rate of the drug (which is a null value since all three doses have been delivered), and the time in which the drug has been retained. A physician may monitor the graphical interface 1700 to ensure that the drug is retained within the target and / or detect changes to the anatomy or drug delivery that may necessitate modification to the drug delivery plan.049450-000420Real-time Tool-in-Lesion Control and Confirmation using EM

[0324] Intratumoral tool targeting is critical for procedures such as precision biopsy, therapy, and drug delivery. Typical intratumoral targeting methods do not have real-time closed-loop control of the tool trajectory and rely on limited radiation-based external imaging exposures taken periodically to confirm trajectory after the tool has been moved. These radiation-based external imaging methodologies (e.g., 2D, 3D fluoroscopy) expose the patient and staff to additional radiation.

[0325] In real-time 2D fluoroscopy, imaging is limited to planar position making it difficult for the user to confirm position in 3D space and to correct for that position. In 3D fluoroscopy, imaging is performed after the tool has been advanced to confirm position and is therefore retrospective, and the tool is advanced using open loop control. Additionally, the tool tip can be difficult to identify under fluoroscopy due to low radiopacity as a result of small tool size and / or chemical composition of the tool. Moreover, the tool tip can be difficult to identify under fluoroscopy when surrounded by other similar radiopaque materials such as dense tumor tissue, anatomy, and radiopaque or contrast enhanced drugs.

[0326] Additionally, there is a discontinuity between the directional articulatable driver (such as a scope) and the actual targeting tool making it difficult to correct for tool insertion (e.g., needle insertion) into the target when tool correction is controlled by the driver that is remote to the distal tip of the tool. There is also lack of positional data on the actual tool tip position relative to the defined target and regions of interest in a CT scan.

[0327] Electromagnetic (EM) sensing of tool position overcomes challenges in radiopacity and CT segmentation of the tool and confusion with drug, tumor and other anatomical features. EM sensing, therefore, provides more accurate positional and leakage information relating to drug delivery. EM sensing described herein can be used to precisely define tool tip position and enable real-time closed-loop positional driving control to target and provide positional confirmation. Additionally, EM sensing can be used without exposing the patient and personnel in the operating room to dangerous radiation.

[0328] According to embodiments of the present disclosure, EM sensing can be used to identify the distal tip of a scope (e.g., scope 130) and a distal tip of a tool (e.g., needle). The distal tip of the scope and distal tip of the tool may each include one or more EM elements to identify the scope and tool in EM space. The EM elements may be wired or non-wired EM elements, and may be part of an EM system, such as the EM sensor system 306 (FIG. 3). The EM system may be used in conjunction with the CT imaging system 310 (FIG. 3) and / or the049450-000420 fluoroscopy imaging system 312 (FIG. 3). Accordingly, in some embodiments, the EM system may be integrated into the localization system 300 (FIG. 3).

[0329] The location of the scope and distal tip of the tool may be correlated with another space, such as being calibrated and / or superimposed into the fluoroscopic space (e.g., fluoro space), CT space (e.g., superimposing the locations of the scope and tool tip on a CT scan), or other suitable imaging space. The EM elements may be used to track the scope and tool location in real-time in the EM space. Additionally, the EM elements may be used to show the locations of the scope and tool in real-time in 2D fluoroscopy or the location of the scope and tool in 3D fluoroscopy.

[0330] Once the tool tip is identified in EM space, the control system, such as control system 111, can identify the tool tip in another space. For example, the tool tip may be difficult to identify in fluoro space due to radiopacity as described above. The EM system is used to identify the location of the tool tip in EM space, which is then used to identify the tip in fluoro space. Additionally, the segmentation algorithms may use the identified location of the tool tip for precise volumetric measurements and identification of the location within the tumor that is being treated.

[0331] FIG. 18A is a schematic diagram illustrating the use of EM sensing, according to one or more embodiments of the disclosure. As illustrated, a scope 1810 is navigated near a tumor 1801. The scope 1810 may be maneuvered using a robotics system, such as the robotics system 110. A distal end 1811 (e.g., distal tip) of the scope 1810 includes one or more EM elements 1812 positioned at a known location (e.g., fixed location) on the scope 1810. The EM elements 1812 can be identified in EM space in real-time using a field generator, similar to the EM sensor system 306 (FIG. 3) described above. Consequently, the EM elements 1812 can be used to identify where the distal end 1811 is positioned in space. The EM elements 1812 may be disposed at a particular angle or orientation in order to identify the precise location and / or pose of the distal end 1811 in real-time . The EM space may be registered (e.g., correlated) with another space, such as CT space or fluoro space.

[0332] The scope 1810 may be used to deploy a tool 1820, such as a needle or other instrument, into the tumor 1801. The tool 1820 is deployed through a working channel 1813 of the scope 1810, and the tool 1820 includes one or more EM elements 1822 arranged in a fixed relationship to a distal tip 1821 of the tool 1820. The EM elements 1822 are used to identify the position of the distal tip 1821 in real-time in the EM space. In some embodiments, the tool 1820 may be made from a small gauge metal and / or nitinol to reduce radiopacity to enhance identification of the distal tip 1821 in fluoro or CT space.049450-000420

[0333] The tool 1820 is advanced at a trajectory that is defined by the pose of the scope 1810. Additionally, the location of the distal tip 1821 relative to a desired location 1802 at the tumor 1801 may be monitored. The real-time location of the distal end 1811 of the scope 1810 and the distal tip 1821 of the tool 1820 may be used by the control system to dynamically adjust the pose of the scope 1810 and advancement of the tool 1820 to hit the desired location 1802 with the distal tip 1821. The scope 1810 may also be manipulated based on information obtained by the optical camera system 308, the driving control, or other imaging systems (e.g., fluoroscopy). The robotic system may manipulate the scope 1810 and the tool 1820 to reach the desired location 1802 by closed loop control provided by the control system, such as the control system 111. In some embodiments, the scope 1810 and the tool 1820 may be manually manipulated to reach the desired location 1802 using the real-time location in EM space. In some embodiments, the scope 1810 and tool 1820 may be manipulated independent of one another. For example, the tool 1820 may be independently steerable, either manually or robotically, relative to the scope 1810. In some embodiments, the tool 1820 may be coaxial with the scope 1810. In other embodiments, the tool 1820 may be non-coaxial with the scope 1810, such as having a longitudinal axis that is eccentric to the longitudinal axis of the scope 1810.

[0334] In some embodiments, the tool insertion distance is controlled independently in relation to the scope 1810 and the desired location 1802. In some embodiments, EM sensing of the distal tip 1821 location is used to update the position of the distal end 1811 of the scope 1810, and vice versa.

[0335] FIG. 18B shows the real-time location of the distal end 1811 of the scope 1810 and the distal tip 1821 of the tool 1820 obtained by EM sensing superimposed on a CT image 1840. The distal tip 1821 is shown within and otherwise penetrating the tumor 1801 due to the detection of the EM element 1822. Different segments (e.g., circle 1841, circle 1842) in the tumor 1801 can be identified in the CT image 1840 in relation to the distal tip 1821. Identification of the distal tip 1821 enables discrete segmentation of the drug and the tumor.

[0336] FIGS. 19A-19C illustrate various embodiments of a tool, such as tool 1820, with a working channel that can be inserted into a target (e.g., tumor) through a scope (e.g., scope 1810). The working channel of the tool can be used to deliver a medicant into the target or to take a biopsy of the target. The tools may be formed from a high mu material (e.g., nickel-iron soft ferromagnetic alloy).

[0337] FIG. 19A illustrates a schematic cross-sectional view of a first tool 1900a (e.g., needle 421) that includes a working channel 1901 defined by an interior surface 1902 (e.g.,049450-000420 internal surface) that is opposite an exterior surface 1903. A stylet 1920 is coupled to or forms part of the first tool 1900a and is disposed within the working channel 1901. The stylet 1920 includes an EM element 1930 coupled to a distal end thereof. The EM element 1930 is shown as a wire coil, which may be disposed around the exterior of the stylet 1920, or could alternatively be embedded into the stylet 1920. The EM element 1930 is connected to a power detector by wires 1931 coupled to the stylet 1920, such as being embedded in the stylet 1920. The power detector is configured to detect a parameter of a current induced within the EM element 1930 by the magnetic field generated by the filed generator of the EM sensor system 306. In some embodiments, the parameter is a voltage. For example, the power detector may include an analog to digital converter that samples the voltage. In other embodiments, the parameter may be the amperage.

[0338] The EM element 1930 may be a copper coil deposited by thick or thin film deposition on a flexible material that is wrapped around the exterior surface 1903. The coils may also be formed from a wire that is wrapped around the exterior surface 1903. In some embodiments, the coils may be deposited (e.g., thick or thin film deposition) directly onto the exterior surface 1903.

[0339] The relative lengths of the first tool 1900a and the stylet 1920 are known, which informs the location of the EM element 1930 to a distal tip 1905 of the first tool 1900a. The stylet 1920 is released and withdrawn from the first tool 1900a once the distal tip 1905 is placed in the desired location within the patient, such as within the tumor 1801, to facilitate injecting a medicant or taking a biopsy sample.

[0340] FIGS. 19B and 19C illustrate the tool with an integrated EM element rather than a stylet. More specifically, FIG. 19B illustrates a schematic partial cross-sectional view second tool 1900b with the EM element 1930 (e.g., wire coil) disposed about the exterior surface 1903. In some embodiments, the EM element 1930 may be wrapped around a groove 1906 (e.g., circumferential groove) defined by the exterior surface 1903 to minimize the overall outer diameter of the second tool 1900b. The groove 1906 may be sized so that the EM element 1930 is flush with the exterior surface 1903. The wires 1931 are shown as running within the second tool 1900b, such as being disposed within the working channel 1901. In some embodiments, however, the wires 1931 may be at least partially embedded into the wall of the second tool 1900b, adhered to the interior surface 1902, or run along the exterior surface 1903.

[0341] FIG. 19C illustrates a schematic partial cross-sectional view a third tool 1900c with the EM element 1930 disposed about the exterior surface 1903. The wires 1931, however, run along the exterior surface 1903.049450-000420

[0342] FIGS. 20A and 20B illustrate example tools with an EM element that can be inserted into a target. The tool, however, does not have a working channel that allows for the injection of a medicant or taking a biopsy sample. Similar to the tools in FIGS. 19A-19C, the tools shown in FIGS. 20A-20B may be formed from a high mu material.

[0343] FIG. 20A illustrates a first tool 2000a that includes a blind internal channel 2001 that does not extend completely through to a distal tip 2005 of the first tool 2000a; e.g., the tool 2000a has a blind or obstructed end. An EM element 2030 (e.g., wire coil) is shown disposed within the blind internal channel 2001 at or near the distal tip 2005. The EM element 2030 has a known relationship (distance) with the distal tip 2005, which can be used to locate the distal tip 2005 in EM space. The wires 2031 connecting the EM element 2030 to a power detector are shown as being disposed within the blind internal channel 2001.

[0344] The EM element 2030 may be a copper coil deposited by thick or thin film deposition on a flexible material that is wrapped around the exterior surface 2003. The coils may alternatively be formed from a wire that is wrapped around the exterior surface 2003. In some embodiments, the coils may be deposited (e.g., thick or thin film deposition) directly onto the exterior surface 2003.

[0345] FIG. 20B illustrates a second tool 2000b, shown as a solid tool without an internal channel. The second tool 2000b includes an EM element 2030 disposed around an exterior surface 2003 of the second tool 2000b at or near its distal end. The wires 2031 connecting the EM element 2030 to a power detector are shown as running along the exterior surface 2003. In some embodiments, the exterior surface 2003 may have or otherwise define a groove that receives the EM element 2030. The groove may be sized so that the EM element 2030 is mounted flush with the exterior surface 2003. In some embodiments, the wires 2031 may also be flush with the exterior surface 2003.

[0346] FIG. 21 illustrates an example method 2100 of real-time tool-in-lesion control and confirmation using EM. The method 2100 may be used in connection with a CT imaging device, a robotic system (e.g., robotic system 110), and a scope (e.g., scope 130). Moreover, the method 2100 may be implemented using control system 111 and using any of the medical systems or drug delivery systems described herein.

[0347] At operation 2101, a desired location of a target (e.g., tumor, lesion, nodule) is identified during pre-operation planning using a pre-operation CT scan. At operation 2102, an access path to the desired location using a robotic system is planned. Operation 2102 may be similar to planning component 1210 shown in FIG. 12. At operation 2103, a user drives the scope along the planned access path, and at operation 2104, the target registration is updated,049450-000420 such as by using a 3D CBCT. At operation 2105, the final scope path is updated and the distal end of the scope is identified in the updated scan using EM elements included in the scope.

[0348] At operation 2106, the user extends a tool (e.g., tool 1820) within a working channel of the scope beyond the distal tip of the scope. The tool includes one or more EM elements at a known location relative to a distal tip of the tool to facilitate identifying the position of the distal tip of the tool. At operation 2107, the EM system monitors the real-time location of the distal tip of the tool. The real-time location of the distal tip and trajectory thereof is used to update the pose of the scope and position of the distal tip to maintain and correct the current tool trajectory in order to hit the desired location at the target.

[0349] Operation 2107 creates several decision points. At operation 2108, a decision is made if the tool tip is on the correct trajectory. If the trajectory is correct, then the method 2100 advances to operation 2109. If the trajectory is incorrect, then the method 2100 advances to operation 2110. At operation 2112, the user can observe the tool position and trajectory and position in real-time using the EM sensors. Operation 2112 leads to operation 2110.

[0350] At operation 2109, the user (or robot) advances the tool along the expected trajectory to hit the desired location at the target. Operation 2109 leads to operation 2111. At operation 2111, the tool-in-lesion (e.g., distal tip hit the desired location) is confirmed when the tool tip in the real-time EM space is confirmed to hit the desired location in the co-registered EM space and CT space (see FIG. 18B). Medicant may be injected into the lesion after confirming the tool is in the desired location within the lesion.

[0351] At operation 2110, the robot adjusts the pose of the scope in real-time and updates the tool trajectory to attempt to hit the desired location at the target. Operation 2110 leads back to operation 2107.

[0352] Embodiments disclosed herein include:

[0353] A. A medical system including a needle, a fluidics pump, a pressure sensor, and a flow rate sensor. The fluidics pump is operable to force fluid out of a syringe and into the needle via a fluid line in fluid communication with the fluidics pump and the needle. The pressure sensor is arranged inline with the fluid conduit downstream from an outlet of the syringe and operable to measure a pressure of the fluid exiting the syringe . The flow rate sensor is arranged inline with the fluid conduit downstream from the outlet and operable to measure a flow rate of the fluid exiting the syringe.

[0354] B. A fluidics pump includes a housing; a cradle arranged within the housing and sized to receive a syringe; a stepper motor arranged within the housing and operable to rotate a lead screw; a displacement head engageable with a plunger of the syringe and including049450-000420 a shaft extending into the housing and operatively coupled to a lead nut, the lead nut being threaded to the lead screw such that rotation of the lead screw causes the shaft to move axially relative to the housing and thereby correspondingly move the displacement head to act on the plunger; and a rotary encoder arranged within the housing and operable to monitor operation of the stepper motor.

[0355] C. A fluidics pump including a housing that defines a loading aperture; a cradle arranged within the housing and providing a channel aligned with the loading aperture; a pump plunger partially disposed in the housing and including a handle extending from the housing and a push member arranged within the housing, the push member providing a first shoulder; and a biasing member arranged within the housing and engaged with the first shoulder and a second shoulder disposed within the housing, the biasing member being transitionable between a compressed state and an expanded state to move the pump plunger relative to the cradle.

[0356] D. A method for probing a lesion including inserting a tip of a needle into a lesion. The method further includes pumping a liquid with a pump into the lesion through the needle. The method further includes determining when a pressure within the lesion reaches a target pressure using a pressure sensor fluidly interposing the pump and needle. The method further includes pumping the liquid at a target flow rate after reaching the target pressure. The method further includes monitoring the pressure within the lesion with the pressure sensor while pumping the fluid at the target flow rate. The method further includes evaluating a characteristic of the lesion based on the pressure obtained while pumping the fluid at the target flow rate.

[0357] E. A method of performing a medical operation includes identifying a target in an anatomy using an imaging system external to the anatomy. The method further includes planning a path for an instrument to access the target within the anatomy based at least in part on image data of the anatomy obtained by the imaging system. The method further includes inserting the instrument into the anatomy along the path, the instrument including an electromagnetic sensor having a fixed relationship with a distal tip of the instrument. The method further includes registering a position of the distal tip of the instrument in the anatomy in real time by identifying the electromagnetic sensor in an electromagnetic space using an electromagnetic sensor system. The method further includes adjusting a trajectory of the instrument through the anatomy based on the real-time position of the instrument to reach the target.

[0358] F. A medical system including a fluidics pump operable to pump fluid from a syringe; a pressure sensor in fluid communication with the syringe; and a controller. The049450-000420 controller includes a trigger manually engageable by a user and operable to selectively change the flow rate of a fluid exiting the syringe when engaged by the user; and a resistance device operable to selectively change a resistance to the trigger based on feedback from the pressure sensor and thereby provide haptic feedback to the user.

[0359] Element 1: further comprising a controller configured to operate the fluidics pump based on feedback from at least one of the pressure sensor and the flow rate sensor. Element 2: further comprising a fluid delivery arm that selectively moves the pressure sensor, the flow rate sensor, and the needle relative to the fluidics pump. Element 3 : further comprising a fluid delivery arm that structurally supports the pressure sensor, the flow rate sensor, and the needle, wherein the pressure sensor, the flow rate sensor, and the needle are moveable relative to the fluid delivery arm. Element 4: wherein the fluidics pump is a motor driven pump. Element 5 : wherein the fluidics pump is driven by a biasing element, and wherein expansion of the biasing element moves a pump plunger included within the fluidics pump to depress a plunger of the syringe and thereby force the fluid out of the syringe. Element 6: further comprising a control valve arranged inline with the fluid conduit downstream of the outlet, the control valve being moveable between an open position, where fluid flow through the fluid line is permitted, and a closed position, where fluid flow through the fluid line is blocked and movement of the pump plunger is arrested. Element 7: further comprising a brake configured to arrest movement of the plunger. Element 8: further comprising a force sensor arranged between an end of the plunger and the displacement head. Element 9: further comprising a plunger retainer that secures the end of the plunger of the syringe to the displacement head. Element 10: further comprising a fluid level sensor configured to obtain a height of the column of a fluid within the syringe. Element 11: wherein the syringe includes an identification element. Element 12: further comprising a reader coupled to the housing and configured to interrogate the identification element to obtain information about at least one of the syringe or a fluid within the syringe. Element 13: further comprising a finger release coupled to the cradle to selectively secure and release a syringe from the cradle. Element 14: further comprising a lock assembly to selectively lock an axial position of the pump plunger. Element 15: wherein the push member occludes the loading aperture when the biasing member transitions to the expanded state. Element 16: further comprising a brake to selectively arrest movement of the pump plunger. Element 17: further comprising a pre-load member comprising the second shoulder disposed within the housing, the pre-load member being moveable to selectively change a length of the biasing member. Element 18: wherein the characteristic is a fluid resistance of the lesion or a diffusion behavior of the lesion. Element 19: wherein evaluating049450-000420 the characteristic includes comparing the pressure and the flow rate against a library of pressure and flow rates to determine a tissue type of the lesion. Element 20: further comprising confirming that the distal tip of the instrument is within the target; and delivering a drug intratumorally to the target via the instrument inserted in the target, wherein a flow parameter of the drug is adjusted based on feedback from at least one sensor fluidly coupled to the instrument. Element 21: wherein the adjusting the trajectory of the instrument includes articulating a scope that the instrument is disposed within to change a position of the distal tip relative to the anatomy. Element 22: wherein the real-time position of the distal tip registered in electromagnetic space is co-registered with a space of the imaging system. Element 23: wherein the imaging system is a three-dimensional cone beam computed tomography system and the space is computed tomography space.

[0360] By way of non-limiting example, exemplary combinations applicable to A, B, C, D, E, and F include: Element 1 with Element 4, Element 5 with Element 6, Element 7 with Element 8, Element 11 with Element 12, Element 14 with Element 15, Element 16 with Element 17, and Element 22 with Element 23.

[0361] In the foregoing description, numerous specific details are set forth such as examples of specific components, circuits, and processes to provide a thorough understanding of the present disclosure. The term “coupled” as used herein means connected directly to or connected through one or more intervening components or circuits. The terms “electronic system” and “electronic device” may be used interchangeably to refer to any system capable of electronically processing information. Also, in the foregoing description and for purposes of explanation, specific nomenclature is set forth to provide a thorough understanding of the aspects of the disclosure . However, it will be apparent to one skilled in the art that these specific details may not be required to practice the example implementations. In other instances, well- known circuits and devices are shown in block diagram form to avoid obscuring the present disclosure. Some portions of the detailed descriptions which follow are presented in terms of procedures, logic blocks, processing and other symbolic representations of operations on data bits within a computer memory.

[0362] The various illustrative logics, logical blocks, modules, circuits and algorithm processes described in connection with the implementations disclosed herein may be implemented as electronic hardware, computer software, or combinations of both. The interchangeability of hardware and software has been described generally, in terms of functionality, and illustrated in the various illustrative components, blocks, modules, circuits and processes described herein. Whether such functionality is implemented in hardware or049450-000420 software depends upon the particular application and design constraints imposed on the overall system.

[0363] Those of skill in the art will appreciate that information and signals may be represented using any of a variety of different technologies and techniques. For example, data, instructions, commands, information, signals, bits, symbols, and chips that may be referenced throughout the above description may be represented by voltages, currents, electromagnetic waves, magnetic fields or particles, optical fields or particles, or any combination thereof.

[0364] These descriptions and representations are the means used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. In the present disclosure, a procedure, logic block, process, or the like, is conceived to be a self-consistent sequence of steps or instructions leading to a desired result. The steps are those requiring physical manipulations of physical quantities. Usually, although not necessarily, these quantities take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated in a computer system. It should be borne in mind, however, that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities.

[0365] In the figures, a single block may be described as performing a function or functions; however, in actual practice, the function or functions performed by that block may be performed in a single component or across multiple components, or may be performed using hardware, using software, or using a combination of hardware and software. To clearly illustrate this interchangeability of hardware and software, various illustrative components, blocks, modules, circuits, and steps have been described below generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present disclosure. Also, the example systems or devices may include components other than those shown, including well-known components such as a processor, memory and the like.

[0366] The techniques described herein may be implemented in hardware, software, firmware, or any combination thereof, unless specifically described as being implemented in a specific manner. Any features described as modules or components may also be implemented together in an integrated logic device or separately as discrete but interoperable logic devices. If implemented in software, the techniques may be realized at least in part by a non-transitory049450-000420 processor-readable storage medium including instructions that, when executed, performs one or more of the methods described herein. The non-transitory processor-readable data storage medium may form part of a computer program product, which may include packaging materials.

[0367] The non-transitory processor-readable storage medium may comprise random access memory (RAM) such as synchronous dynamic random-access memory (SDRAM), read only memory (ROM), non-volatile random access memory (NVRAM), electrically erasable programmable read-only memory (EEPROM), FLASH memory, other known storage media, and the like. The techniques additionally, or alternatively, may be realized at least in part by a processor-readable communication medium that carries or communicates code in the form of instructions or data structures and that can be accessed, read, or executed by a computer or other processor.

[0368] The various illustrative logical blocks, modules, circuits and instructions described in connection with the implementations disclosed herein may be executed by one or more processors (or a processing system). The term “processor,” as used herein may refer to any general-purpose processor, special-purpose processor, conventional processor, controller, microcontroller, or state machine capable of executing scripts or instructions of one or more software programs stored in memory.

[0369] Unless specifically stated otherwise as apparent from the following discussions, it is appreciated that throughout the present application, discussions utilizing the terms such as “accessing,” “receiving,” “sending,” “using,” “selecting,” “determining,” “normalizing,” “multiplying,” “averaging,” “monitoring,” “comparing,” “applying,” “updating,” “measuring,” “deriving” or the like, refer to the actions and processes of a computer system, or similar electronic computing device, that manipulates and transforms data represented as physical (electronic) quantities within the computer system’s registers and memories into other data similarly represented as physical quantities within the computer system memories or registers or other such information storage, transmission or display devices.

[0370] Certain standard anatomical terms of location may be used herein to refer to the anatomy of animals, and namely humans, with respect to the example implementations. Although certain spatially relative terms, such as “outer,” “inner,” “upper,” “lower,” “below,” “above,” “vertical,” “horizontal,” “top,” “bottom,” and similar terms, are used herein to describe a spatial relationship of one element, device, or anatomical structure to another device, element, or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between elements and structures, as049450-000420 illustrated in the drawings. It should be understood that spatially relative terms are intended to encompass different orientations of the elements or structures, in use or operation, in addition to the orientations depicted in the drawings. For example, an element or structure described as “above” another element or structure may represent a position that is below or beside such other element or structure with respect to alternate orientations of the subject patient, element, or structure, and vice-versa. As used herein, the term “patient” may generally refer to humans, anatomical models, simulators, cadavers, and other living or non-living objects.

[0371] In the foregoing specification, implementations have been described with reference to specific examples thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader scope of the disclosure as set forth in the appended claims. The specification and drawings are, accordingly, to be regarded in an illustrative sense rather than a restrictive sense.

[0372] As used herein, a phrase referring to “at least one of’ a list of items refers to any combination of those items, including single members. As an example, “at least one of: a, b, or c” is intended to cover: a, b, c, a-b, a-c, b-c, and a-b-c.

[0373] Various modifications to the implementations described in this disclosure may be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other implementations without departing from the spirit or scope of this disclosure. Thus, the claims are not intended to be limited to the implementations shown herein, but are to be accorded the widest scope consistent with this disclosure, the principles and the novel features disclosed herein.

Claims

049450-000420CLAIMSWhat is claimed is:

1. A medical system, comprising: a needle; a fluidics pump operable to force fluid out of a syringe and into the needle via a fluid line in fluid communication with the fluidics pump and the needle; a pressure sensor arranged inline with the fluid conduit downstream from an outlet of the syringe and operable to measure a pressure of the fluid exiting the syringe; and a flow rate sensor arranged inline with the fluid conduit downstream from the outlet and operable to measure a flow rate of the fluid exiting the syringe.

2. The medical system of claim 1, further comprising a controller configured to operate the fluidics pump based on feedback from at least one of the pressure sensor and the flow rate sensor.

3. The medical system of claim 1, further comprising a fluid delivery arm that selectively moves the pressure sensor, the flow rate sensor, and the needle relative to the fluidics pump.

4. The medical system of claim 1, further comprising a fluid delivery arm that structurally supports the pressure sensor, the flow rate sensor, and the needle, wherein the pressure sensor, the flow rate sensor, and the needle are moveable relative to the fluid delivery arm.

5. The medical system of claim 1, wherein the fluidics pump is a motor driven pump.

6. The medical system of claim 1, wherein the fluidics pump is driven by a biasing element, and wherein expansion of the biasing element moves a pump plunger included within the fluidics pump to depress a plunger of the syringe and thereby force the fluid out of the syringe.049450-0004207. The medical system of claim 7, further comprising a control valve arranged inline with the fluid conduit downstream of the outlet, the control valve being moveable between an open position, where fluid flow through the fluid line is permitted, and a closed position, where fluid flow through the fluid line is blocked and movement of the pump plunger is arrested.

8. A fluidics pump, comprising: a housing; a cradle arranged within the housing and sized to receive a syringe; a stepper motor arranged within the housing and operable to rotate a lead screw; a displacement head engageable with a plunger of the syringe and including a shaft extending into the housing and operatively coupled to a lead nut, the lead nut being threaded to the lead screw such that rotation of the lead screw causes the shaft to move axially relative to the housing and thereby correspondingly move the displacement head to act on the plunger; and a rotary encoder arranged within the housing and operable to monitor operation of the stepper motor.

9. The fluidics pump of claim 8, further comprising a brake configured to arrest movement of the plunger.

10. The fluidics pump of claim 8, further comprising a force sensor arranged between an end of the plunger and the displacement head.

11. The fluidics pump of claim 8, further comprising a plunger retainer that secures the end of the plunger of the syringe to the displacement head.

12. The fluidics pump of claim 8, further comprising a fluid level sensor configured to obtain a height of the column of a fluid within the syringe.

13. The fluidics pump of claim 8, wherein the syringe includes an identification element.049450-00042014. The fluidics pump of claim 13, further comprising a reader coupled to the housing and configured to interrogate the identification element to obtain information about at least one of the syringe or a fluid within the syringe.

15. A fluidics pump, comprising: a housing that defines a loading aperture; a cradle arranged within the housing and providing a channel aligned with the loading aperture; a pump plunger partially disposed in the housing and including a handle extending from the housing and a push member arranged within the housing, the push member providing a first shoulder; and a biasing member arranged within the housing and engaged with the first shoulder and a second shoulder disposed within the housing, the biasing member being transitionable between a compressed state and an expanded state to move the pump plunger relative to the cradle.

16. The fluidics pump of claim 15, further comprising a finger release coupled to the cradle to selectively secure and release a syringe from the cradle.

17. The fluidics pump of claim 15, further comprising a lock assembly to selectively lock an axial position of the pump plunger.

18. The fluidics pump of claim 15, wherein the push member occludes the loading aperture when the biasing member transitions to the expanded state.

19. The fluidics pump of claim 15, further comprising a brake to selectively arrest movement of the pump plunger.

20. The fluidics pump of claim 15, further comprising a pre-load member comprising the second shoulder disposed within the housing, the pre-load member being moveable to selectively change a length of the biasing member.

21. A method for probing a lesion, comprising: inserting a tip of a needle into a lesion;049450-000420 pumping a liquid with a pump into the lesion through the needle; determining when a pressure within the lesion reaches a target pressure using a pressure sensor fluidly interposing the pump and needle; pumping the liquid at a target flow rate after reaching the target pressure; monitoring the pressure within the lesion with the pressure sensor while pumping the fluid at the target flow rate; and evaluating a characteristic of the lesion based on the pressure obtained while pumping the fluid at the target flow rate.

22. The method of claim 21, wherein the characteristic is a fluid resistance of the lesion or a diffusion behavior of the lesion.

23. The method of claim 21, wherein evaluating the characteristic includes comparing the pressure and the flow rate against a library of pressure and flow rates to determine a tissue type of the lesion.

24. A method of performing a medical operation, comprising: identifying a target in an anatomy using an imaging system external to the anatomy; planning a path for an instrument to access the target within the anatomy based at least in part on image data of the anatomy obtained by the imaging system; inserting the instrument into the anatomy along the path, the instrument including an electromagnetic sensor having a fixed relationship with a distal tip of the instrument; registering a position of the distal tip of the instrument in the anatomy in real time by identifying the electromagnetic sensor in an electromagnetic space using an electromagnetic sensor system; and adjusting a trajectory of the instrument through the anatomy based on the real-time position of the instrument to reach the target.

25. The method of claim 24, further comprising: confirming that the distal tip of the instrument is within the target; and delivering a drug intratumorally to the target via the instrument inserted in the target, wherein a flow parameter of the drug is adjusted based on feedback from at least one sensor fluidly coupled to the instrument.049450-00042026. The method of claim 24, wherein the adjusting the trajectory of the instrument includes articulating a scope that the instrument is disposed within to change a position of the distal tip relative to the anatomy.

27. The method of claim 24, wherein the real-time position of the distal tip registered in electromagnetic space is co-registered with a space of the imaging system.

28. The method of claim 27, wherein the imaging system is a three-dimensional cone beam computed tomography system and the space is computed tomography space.

29. A medical system, comprising: a fluidics pump operable to pump fluid from a syringe; a pressure sensor in fluid communication with the syringe; and a controller, comprising: a trigger manually engageable by a user and operable to selectively change the flow rate of a fluid exiting the syringe when engaged by the user; and a resistance device operable to selectively change a resistance to the trigger based on feedback from the pressure sensor and thereby provide haptic feedback to the user.

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