Fluid delivery system

Abstract

Examples described herein provide a syringe that includes a barrel having a longitudinal passage extending through the barrel. The barrel has a distal end and a proximal end, the distal end configured to operably couple to a needle. The syringe further includes a mechanical separator disposed within the longitudinal passage. The mechanical separator is movable between the proximal end and the distal end. The syringe further includes a pressure sensor to monitor pressure of a fluid being injected from the syringe into a subject.

Description

FLUID DELIVERY SYSTEMCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is related to U.S. Provisional Application entitled “FLUID DELIVERY PRESSURE MONITORING AND CONTROL SYSTEM,” Attorney Docket Number KAD6020USPSP1 -138616-0601, filed April 24, 2024, and the contents of which are incorporated by reference herein in their entirety.TECHNICAL FIELD

[0002] The present disclosure relates to fluid delivery systems for use in medical injection systems.BACKGROUND

[0003] Pharmaceutical products (including large and small molecule pharmaceuticals, hereinafter “drugs”) are administered to patients using a variety of different drug delivery devices for the treatment of a variety of different medical indications. Drug delivery devices for delivering liquid drugs include, for example, syringes, manual injectors, pen injectors, autoinjectors, on-body delivery devices, and off-body delivery devices. These delivery devices commonly include an actuator, a drug container, and a needle or cannula. The drug container contains the liquid drug and the actuator drives the liquid drug from the drug container, and through the needle or cannula to the patient.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] FIG. 1A depicts an example of a fluid delivery system according to one or more embodiments described herein.

[0005] FIG. IB depicts the pressure sensor, the syringe, and the needle of the fluid delivery system of FIG. 1A according to one or more embodiments described herein.

[0006] FIGS. 2A and 2B depict examples of a fluid delivery system according to one or more embodiments described herein.

[0007] FIG. 2C depicts an example of a needle for measuring tip pressure according to one or more embodiments described herein.

[0008] FIG. 2D depicts a pressure sensor for measuring tip pressure according to one or more embodiments described herein.

[0009] FIGS. 3A-3C depict example environments for using a fluid delivery system according to one or more embodiments described herein.

[0010] FIG. 4 depicts a flow diagram of a method for operating a fluid delivery system according to one or more embodiments described herein.

[0011] FIG. 5 depicts an example of a fluid delivery system according to one or more embodiments described herein.

[0012] FIG. 6 depicts an example graph of real-time feedback information for pressure of a fluid delivery system according to one or more embodiments described herein.

[0013] FIG. 7 depicts an example of a fluid delivery system according to one or more embodiments described herein.

[0014] FIG. 8 depicts an example apparatus according to one or more embodiments described herein.

[0015] Various embodiments are described in detail below with reference to the accompanying drawings, wherein like reference numerals represent like elements. DESCRIPTION OF EMBODIMENTS

[0016] To treat certain tumors, drugs in fluid form are injected directly into the tumor. In some cases, it is desirable to inject contrast agents into a tumor to perform medical imaging.Currently clinicians have limited access to tumor quantitative data that describe the biomechanical properties of the tumor microenvironment. Furthermore, when a liquid-like contrast agent or drug is injected into tumor, the exact location of the fluid is unknown. That is, it is unknown whether the fluid will stay in place or leak out of the tumor. For example, chemotherapy is systemically delivered into a subject’s veins causing the drug to distribute throughout the subject’s body. However, there are some limitations to this approach. The drug may not penetrate the tumor because of the tumor’s microenvironment, which reduces the drug’s effectiveness. Also, the drug is exposed to the entire body system, which can harm healthy cells. Intra- tumoral drug delivery is the injection of a fluid drug directly into the target tumor through various routes of administration, such as through the subject’s chest wall or through a bronchoscopy procedure. This approach has several advantages including the tumor is treated with a higher concentration of drug, less volume of drug is used to treat the tumor, and the drug is less likely to reach surrounding healthy cells. However, there are limitations with this approach. Since the drug has a higher concentration, it must stay within the tumor. To maximize the drug effectiveness, the drug must be distributed throughout the tumor. These limitations result in a complex procedure. Furthermore, existing technology does not provide feedback to the clinician if the drug enters the tumor, if the drug leaks out of the tumor, if there is a blockage, etc.

[0017] As discovered by the inventors, a fluid delivery system that monitors pressure and collects real-time pressure data can be used to more accurately and precisely deliver fluids to subjects (e.g., to tumors of subjects). By using a fluid delivery system that collects, using one or more pressure sensors disposed in a syringe, real-time (or near real-time) pressure data to deliver fluids (e.g., drugs), quantitative data can be collected that describes the tumor material(biomechanical) properties and the drug injection process. One or more embodiments described herein provide for real-time pressure feedback, which enables drugs to be delivered efficiently and effectively which in turn provides for a safer, less expensive, more accurate, and more effective procedure.

[0018] FIG. 1A depicts an example of a fluid delivery system 100 according to one or more embodiments described herein. The fluid delivery system 100 may be used to monitor the pressure of a fluid (e.g., a drug) being injected into a subject. The fluid delivery system 100 may include a pressure sensor 102 fluidly disposed between a syringe 104 and a needle 106. The syringe 104 may cause the fluid to flow through or by the pressure sensor 102 and into the needle 106 for injection into the subject.

[0019] The pressure sensor 102 may sense the pressure of the fluid as it flows through or by the pressure sensor 102 and may send a first signal to a pressure monitoring system 110 via a cable 108. The cable 108 may be an electrical cable to form an electrical connection between the pressure sensor 102 and the pressure monitoring system 110, a fiber optical cable to form a fiber optical connection between the pressure sensor 102 and the pressure monitoring system 110, and / or the like including combinations and / or multiples thereof. It should be appreciated that the cable 108 can be omitted in an alternative embodiment in which the pressure sensor 102 sends the first signal to the pressure monitoring system 110 using a wireless link (e.g., Bluetooth, WiFi, radio frequency, and / or the like including combinations and / or multiples thereof).

[0020] The pressure monitoring system 110 may receive the first signal from the pressure sensor 102 and transmit a second signal indicative of the first signal to a computing device 112. For example, the first signal can be an analog signal, and the pressure monitoring system 110 can convert the analog signal (e.g., the first signal) into a digital signal (e.g., the second signal). Thedigital signal can then be sent to the computing device 112 (also referred to as a “processing system” or “computing apparatus”) for processing and / or display. For example, the computing device 112 can display a graphical representation of the pressure of the fluid as it flows through or by the pressure sensor 102 as detected by the pressure sensor 102.

[0021] According to one or more embodiments described herein, features and functions of the pressure monitoring system 110 can be implemented by the computing device 112. For example, the pressure sensor 102 can be communicatively coupled directly to the computing device 112. According to one or more embodiments described herein, features and functions of the computing device 112 can be implemented by the pressure monitoring system 110. For example, the pressure monitoring system 110 can include a display for displaying pressure data.

[0022] According to one or more embodiments described herein, the computing device 112 may receive pressure information from the pressure sensor 102 (either directly or via the pressure monitoring system 110) and generate real-time (or near-real time) feedback information based at least in part on the pressure information. For example, the computing device 112 can display a real-time (or near-real time) pressure reading, a chart / graph showing historical pressure readings (see, e.g., FIG. 6), and / or the like including combinations and / or multiples thereof.

[0023] FIG. IB depicts the pressure sensor 102, the syringe 104, and the needle 106 of the fluid delivery system 100 of FIG. 1A according to one or more embodiments described herein. In this embodiment, the pressure sensor 102 is an in-line pressure sensor to measure the pressure of a fluid as it flows from the syringe 104 to the needle 106.

[0024] The syringe 104 may include a barrel 120 having a longitudinal passage extending through the barrel 120. The barrel may have a distal end 120a and a proximal end 120b. The distal end 120a may be configured to couple to the needle 106. A mechanical separator 122 maybe disposed within the longitudinal passage of the syringe 104. The mechanical separator 122 may be moveable between the proximal end 120b and the distal end 120a. According to one or more embodiments described herein, the mechanical separator 122 may be a plunger. According to one or more embodiments described herein, the mechanical separator 122 may include a first gasket and a second gasket having an airspace disposed between the first gasket and the second gasket. The airspace may provide a visual indication if any liquid passes the first gasket or the second gasket, which may indicate a malfunction of the mechanical separator 122.

[0025] FIG. 2A depicts an example of a fluid delivery system 200 according to one or more embodiments described herein. The fluid delivery system 200 may include a syringe pump 202 that can deliver a fluid 204 (e.g., a drug, saline, and / or the like including combinations and / or multiples thereof) via a syringe 206 to a subject (not shown). The syringe 206 can be fluidly connected to a closed system transfer device (CSTD) 208 directly or via an extension 210. A pressure sensor 212 may be fluidly connected to the CSTD 208, the pressure sensor 212 monitoring a pressure of the fluid 204 (e.g., the drug or saline) as the fluid 204 flows from the CSTD 208 to a needle 214, which may be insertable into the subject. Fluid may flow from the syringe 206 through the extension 210, the CSTD 208, the pressure sensor 212, and the needle 214 into the subject. The syringe pump 202 may apply a force to the syringe 206 to cause the fluid to flow. According to one or more embodiments described herein, the needle 214 may be primed in a procedure room and / or once inserted in the subject (e.g., into a tumor of the subject) while the syringe 206, the CSTD 208, the extension 210, and the pressure sensor 212 may be primed in a pharmacy or other suitable location (e.g., before being transferred to the procedure room).

[0026] According to one or more embodiments described herein, a processing system (e.g., the computing device 112 of FIG. 1A) can control the syringe pump 202 that is exerting force on a proximal end of the mechanical separator 122 based at least in part on the pressure information.For example, if the pressure is too high (e.g., exceeds an upper pressure threshold), the processing system can cause the syringe pump 202 to decrease the force. Similarly, if the pressure is too low (e.g., drops below a lower pressure threshold), the processing system can cause the syringe pump 202 to increase the force.

[0027] FIG. 2B depicts another example of a fluid delivery system 220 according to one or more embodiments described herein. In this example, the fluid delivery system 220 may use multiple pressure sensors to monitor pressure of a fluid being injected into a subject at two locations: in line (referred to as “in-line pressure”) and at a tip of a needle (referred to as “tip pressure”). More particularly, the fluid delivery system 220 may include a syringe pump 222 that can deliver a fluid (e.g., a drug, saline, and / or the like including combinations and / or multiples thereof) via a syringe 226 to a subject (not shown). The syringe 206 can be fluidly connected to a pressure sensor 232 that can measure the in-line pressure of the fluid as described with respect to FIGS. IB and 2A. The pressure sensor 232 can be fluidly connected to an injection line 230, which in turn can be fluidly connected to a needle 234. Fluid flows from the syringe 226 through the pressure sensor 232, the injection line 230, and the needle 234 into the subject. The syringe pump 222 may apply a force to the syringe 206 to cause the fluid to flow. The pressure of the fluid may also be measured at a distal end 234a of the needle 234 as the tip pressure.

[0028] FIG. 2C depicts an example of a needle 240 for measuring tip pressure according to one or more embodiments described herein. In this example, the needle 240 may include a first channel 251 for the fluid (e.g., the fluid 204) to flow from the barrel (e.g., the barrel 120) of thesyringe (e.g., the syringe 104) through the needle 240 and into a subject (not shown). The needle 240 may also include a second channel 252 for receiving a tip pressure sensor 242 to monitor the tip pressure. According to one or more embodiments described herein, the tip pressure sensor 242 may be a fiber optical sensor or other suitable sensor to monitor the tip pressure. According to one or more embodiments described herein, the tip pressure sensor 242 may be extendable and retractable within the second channel 252 of the needle 240 as shown by the arrow 246. According to one or more embodiments described herein, the second channel 252 may be extendable and retractable within the first channel 251 of the needle 240 as shown by the arrow 246.

[0029] FIG. 2D depicts an example of a needle 260 for measuring tip pressure according to one or more embodiments described herein. In this example, the needle 260 may include an optical fiber sensor 262 inside a needle tip 264 of the needle 260 (e.g., inside the second channel 252). An optical fiber cable 266 may extend from the optical fiber sensor 262 through the needle 260 to an optical connector 268. The optical connector 268 can operably connect to any suitable system and / or device for measuring tip pressure, such as the pressure monitoring system 110 of FIG. 1A, the computing device 112 of FIG. 1A, and / or the like including combinations and / or multiples thereof.

[0030] FIGS. 3A-3C depict example environments for using a fluid delivery system according to one or more embodiments described herein. In FIG. 3A, an environment 300 for a peripheral bronchoscopy procedure (robotic and non-robotic) is shown. In FIG. 3B, an environment 320 for a percutaneous procedure is shown. In FIG. 3C, an environment 340 for an endobronchial ultrasound procedure is shown. In each of the environments 300, 320, 340, an inline pressure sensor 302 is used as described herein. It should be appreciated that other types ofenvironments can be used and / or other configurations and arrangements of pressure sensors can be used in the environments 300, 320, 340 as described herein.

[0031] FIG. 4 depicts a flow diagram of a method 400 for operating a fluid delivery system according to one or more embodiments described herein. The method 400 can be implemented by any suitable device or apparatus, such as the computing device 112 of FIG. 1 A, the apparatus 800 of FIG. 8, and / or the like including combinations and / or multiples thereof.

[0032] At block 402, the method 400 includes initiating injecting a fluid (e.g., the fluid 204) from a syringe (e.g., the syringe 104, the syringe 206, the syringe 226) into a subject, the syringe including a pressure sensor (e.g., the pressure sensor 102, the pressure sensor 212, the pressure sensor 232, the tip pressure sensor 242, the optical fiber sensor 262, the in-line pressure sensor 302, and / or the like including combinations and / or multiples thereof).

[0033] At block 404, the method 400 includes monitoring, using pressure information from the pressure sensor, a pressure of the fluid being injected from the syringe into a subject.According to one or more embodiments described herein, the syringe (e.g., the syringe 104) may include a barrel (e.g., the barrel 120) having a longitudinal passage extending through the barrel, the barrel having a distal end (e.g., the distal end 120a) and a proximal end (e.g., the proximal end 120b), the distal end configured to operably couple to a needle (e.g., the needle 106).According to one or more embodiments described herein, the syringe may further include a plunger (e.g., the mechanical separator 122) disposed within the longitudinal passage, the plunger movable between the proximal end of the barrel and the distal end of the barrel.According to one or more embodiments described herein, the syringe may further include a pressure sensor (e.g., the pressure sensor 102) to monitor a pressure of a fluid being injected from the syringe into a subject. According to one or more embodiments described herein, thepressure sensor may be an in-line pressure sensor (e.g., the in-line pressure sensor 302) disposed between the distal end of the barrel and a proximal end of the needle. According to one or more embodiments described herein, the pressure sensor may be an optical pressure sensor. The fluid may flow from the barrel through the in-line pressure sensor and into the needle.

[0034] At block 406, the method 400 includes providing real-time (or near real-time) feedback information regarding the pressure. The real-time feedback can a signal to indicate a possible blockage of the fluid, a possible leak of the fluid, a signal to initiate an alarm (e.g., emit an audible alarm, display a visual alert), a signal to cease movement of the mechanical separator 122, and / or the like including combinations and / or multiples thereof. For example, if the pressure exceeds an upper threshold, it may be determined that a blockage exists. As another example, if the pressure drops below a lower threshold, it may be determined that a leak exists.

[0035] According to one or more embodiments described herein, the method 400 may include controlling a syringe pump (e.g., the syringe pump 202, the syringe pump 222) exerting a force on a proximal end of a plunger (e.g., the mechanical separator 122) of the syringe (e.g., the syringe 104) based at least in part on the pressure information received from the pressure sensor (e.g., the pressure sensor 102, the pressure sensor 212, the pressure sensor 232, the tip pressure sensor 242, the optical fiber sensor 262, the in-line pressure sensor 302). Controlling the syringe pump may include adjusting (e.g., increasing or decreasing) the force of the syringe pump.

[0036] Additional processes also may be included, and it should be understood that the processes depicted in FIG. 4 represent illustrations, and that other processes may be added or existing processes may be removed, modified, or rearranged without departing from the scope of the present disclosure. It should also be understood that the processes depicted in FIG. 4 may be implemented as programmatic instructions stored on a non-transitory computer-readable storagemedium that, when executed by a processor (e.g., the one or more processors 802 of FIG. 8) of a computing system (e.g., the apparatus 800 of FIG. 8), cause the processor to perform the processes described herein.

[0037] FIG. 5 depicts an example of a portion of a fluid delivery system 500 according to one or more embodiments described herein. In this example, multiple pressure sensors are used. The fluid delivery system 500 may include a barrel 520 having a longitudinal passage extending through the barrel 520. The barrel 520 may have a proximal end 520a and a distal end 520b. The distal end 520b may be configured to operably couple to a needle (not shown). The fluid delivery system 500 may include a mechanical separator 522 within the barrel 520 movably positioned between the proximal end 520a and the distal end 520b. The mechanical separator 522 may separate a first fluid 531 (e.g., saline) and a second fluid 532 (e.g., a drug). The first fluid 531 may be within the barrel 520 between the proximal end 520a and the mechanical separator 522, and the second fluid 532 may be within the barrel 520 between the mechanical separator 522 and the distal end 520b. The fluid delivery system 500 may include multiple pressure sensors. For example, as shown in FIG. 5, the fluid delivery system 500 includes two pressure sensors: a first pressure sensor 502a to monitor a first pressure; and a second pressure sensor 502b to monitor a second pressure. According to one or more embodiments described herein, the mechanical separator 522 may include a first gasket and a second gasket having an airspace disposed between the first gasket and the second gasket. According to one or more embodiments described herein, the mechanical separator 522 may prevent a mixing of the first fluid 531 and the second fluid 532.

[0038] The first fluid 531 (e.g., saline) may be used to cause the second fluid 532 (e.g., a drug) to be injected into a subject. For example, a first force may be applied to the first fluid 531using a pump (e.g., the syringe pump 202), and a second force may be applied to the second fluid532 via the first fluid 531 and the mechanical separator 522.

[0039] In the example of FIG. 5, the first pressure sensor 502a may monitor the pressure of the first fluid 531 and the second pressure sensor 502b monitors the pressure of the second fluid 532. According to one or more embodiments described herein, the first pressure sensor 502a may be disposed on a proximal end of the mechanical separator 522, and the second pressure sensor 502b is disposed on a distal end of the mechanical separator 522. Additional pressure sensors can be used with the fluid delivery system 500, such as an in-line pressure sensor (e.g., the in-line pressure sensor 302) and / or a tip pressure sensor (e.g., the tip pressure sensor 242). For example, an in-line pressure sensor and / or a tip pressure sensor can be used to measure the pressure of the second fluid 532 in addition to the second pressure sensor 502b. According to one or more embodiments described herein, the fluid delivery system 500 can include a third pressure sensor (not shown) that is an in-line pressure sensor disposed between the distal end 520b of the barrel 520 and a proximal end of the needle that measures the pressure of the second fluid 532 as the second fluid 532 flows from the barrel 520 through the in-line pressure sensor and into the needle. According to one or more embodiments described herein, the fluid delivery system 500 can include a fourth pressure sensor (not shown) disposed at the distal end of the needle to measure the pressure of the second fluid 532 at the distal end of the needle.

[0040] According to one or more embodiments described herein, at least one of the first pressure sensor 502a and second pressure sensor 502b can be communicatively connected to a processing system (e.g., the computing device 112 of FIG. 1A). The computing device 112 can include a memory having computer readable instructions and a processing device (e.g., a processor or multiple processors) for executing the computer readable instructions. The computerreadable instructions control the processing device to perform operations, including receiving first pressure information from the first pressure sensor 502a, receiving second pressure information from the second pressure sensor 502b, and generating real-time feedback information based at least in part on the first pressure information and the second pressure information. The first pressure sensor 502a and the second pressure sensor 502b can be coupled to the processing system via any suitable technique, such as wired (e.g., electrical connection, fiber optical connection), and / or wireless connection as described herein.

[0041] The processing system can receive pressure information from the first pressure sensor 502a and the second pressure sensor 502b to determine whether a blockage exists and / or whether a leak exists at an injection site of the subject. For example, the processing system can compare a first pressure value for first pressure information received from the first pressure sensor 502a to a second pressure value for the second pressure information received from the second pressure sensor 502b and can determine that a blockage exists responsive to determining that the second pressure value is greater than the first pressure value. As another example, the processing system can compare the first pressure value for the first pressure information received from the first pressure sensor 502a to the second pressure value for the second pressure information received from the second pressure sensor 502b and can determine that the leak exists responsive to determining that the first pressure value is greater than the second pressure value. According to one or more embodiments described herein, the processing system can generate an alert responsive to determining that the first pressure value for the first pressure information differs from the second pressure value for the second pressure information by at least a threshold difference (e.g., a difference in an amount of pressure, a percent difference, etc.).

[0042] FIG. 6 depicts an example graph 600 of real-time feedback information for pressure of a fluid delivery system according to one or more embodiments described herein. In this example, a fluid delivery system (e.g., the fluid delivery system 500) with two pressure sensors is used. A first pressure sensor (e.g., the first pressure sensor 502a) may generate first pressure information 602a, and a second pressure sensor (e.g., the second pressure sensor 502b) may generate second pressure information 602b. A difference 604 can be determined from the first pressure information 602a and the second pressure information 602b. The difference 604 can be used to determine whether a leak exists if the difference is greater than a threshold amount, for example. In some embodiments, when a leak is detected, a syringe pump can be automatically shut off and / or an alert can be issued.

[0043] FIG. 7 depicts a flow diagram of a method 700 for operating a fluid delivery system according to one or more embodiments described herein. The method 700 can be implemented by any suitable device or apparatus, such as the computing device 112 of FIG. 1 A, the apparatus 800 of FIG. 8, and / or the like including combinations and / or multiples thereof.

[0044] At block 702, the method 700 includes initiating injecting a drug in fluid form from a syringe into a subject. According to one or more embodiments described herein, the syringe may include a first pressure sensor (e.g., the second pressure sensor 502b) to monitor a pressure of the drug and a second pressure sensor to monitor a pressure of a pumping fluid (e.g., the first pressure sensor 502a). The pumping fluid (e.g., saline) may be used to apply a force to the drug to cause the drug to be injected into the subject. The drug may be separated from the pumping fluid by a mechanical separator (e.g., the mechanical separator 522) disposed within a barrel (e.g., the barrel 520) of the syringe.

[0045] At block 704, the method 700 includes monitoring, using the first pressure sensor, a pressure of the drug being injected from the syringe into a subject.

[0046] At block 706, the method 700 includes monitoring, using the second pressure sensor, a pressure of the pumping fluid used to apply the force to the drug.

[0047] At block 708, the method 700 includes providing real-time feedback information regarding the pressure of the drug and the pressure of the pumping fluid.

[0048] According to one or more embodiments described herein, the method 700 may further include determining whether a blockage exists by comparing the pressure of the drug to the pressure of the pumping fluid. In this example, the real-time feedback information may indicate the blockage exists responsive to determining that the pressure of the drug is greater than the pressure of the pumping fluid.

[0049] According to one or more embodiments described herein, the method 700 may further include determining whether a leak exists by comparing the pressure of the drug to the pressure of the pumping fluid. In this example, the real-time feedback information may indicate the leak exists responsive to determining that the pressure of the drug is less than the pressure of the pumping fluid.

[0050] According to one or more embodiments described herein, the method 700 can include, based on the real-time feedback information, at least one of ceasing injecting the drug into the subject or initiating an alarm.

[0051] According to one or more embodiments described herein, the method 700 can include, when the real-time feedback information indicates at least one of a blockage of the drug or a leak of the drug, at least one of ceasing injecting the drug into the subject or initiating an alarm.

[0052] According to one or more embodiments described herein, the method 700 can include, when the pressure of the drug and the pressure of the pumping fluid diverge, at least one of ceasing injecting the drug into the subject or initiating an alarm.

[0053] According to one or more embodiments described herein, the method 700 can include, when an absolute value of a difference between the pressure of the drug and the pressure of the pumping fluid diverge exceeds a predetermined threshold, at least one of ceasing injecting the drug into the subject or initiating an alarm.

[0054] According to one or more embodiments described herein, the method 700 can include based on a comparison of a moving average of the pressure of the drug and a moving average of the pressure of the pumping fluid diverge, at least one of ceasing injecting the drug into the subject or initiating an alarm.

[0055] According to one or more embodiments described herein, the method 700 can include based on at least one of a calculation of the pressure of the drug or a calculation of the pressure of the pumping fluid diverge, at least one of ceasing injecting the drug into the subject or initiating an alarm. In this example, the calculation may be a moving average, a first derivative over time, or a second derivative over time.

[0056] Additional processes also may be included, and it should be understood that the processes depicted in FIG. 7 represent illustrations, and that other processes may be added or existing processes may be removed, modified, or rearranged without departing from the scope of the present disclosure. It should also be understood that the processes depicted in FIG. 7 may be implemented as programmatic instructions stored on a non-transitory computer-readable storage medium that, when executed by a processor (e.g., the one or more processors 802 of FIG. 8) of acomputing system (e.g., the apparatus 800 of FIG. 8), cause the processor to perform the processes described herein.

[0057] FIG. 8 depicts an example computer apparatus 800 (also referred to as “apparatus 800”) for use with the embodiments herein. As an example, the apparatus 800 may be a computer to implement certain inventive techniques disclosed herein, such as operating a fluid delivery system. As an example, method 400 of FIG. 4 and or the method 700 of FIG. 7 may be performed by a computer, such as the apparatus 800. As an example, the blocks 404 and / 406 of FIG. 4 and / or the blocks 704 to 708 of FIG. 7 may be performed by a computer, such as apparatus 800. The apparatus 800 may include one or more processors 802, memory 803, one or more input devices (not shown), and one or more output devices 805.

[0058] In some embodiments, based on input 801, the one or more processors 802 may generate control signals to control and / or monitor a fluid delivery system according to one or more embodiments described herein. As an example, input 801 may be user input. As an example, input 801 may be from another computer or device (e.g., a pressure sensor) in communication with the apparatus 800. The input 801 may be received in conjunction with one or more input devices (not shown) of the apparatus 800.

[0059] The memory 803 may be accessible by the one or more processors 802 (e.g., via a link 804) so that the one or more processors 802 may read information from and write information to the memory 803. The memory 803 may store instructions that, when executed by the one or more processors 802, implement one or more embodiments described herein. The memory 803 may be a non-transitory computer readable medium (or a non-transitory processor readable medium) containing a set of instructions thereon for controlling and / or monitoring fluiddelivery systems, wherein when executed by a processor (such as one or more processors 802), the instructions cause the processor to perform one or more methods discussed herein.

[0060] The one or more output devices 805 may provide the status of the operation of embodiments of the fluid delivery system described herein. The output device(s) 805 may provide visualization data according to some embodiments described herein.

[0061] The apparatus 800 may be an apparatus for controlling and / or monitoring a fluid delivery system, the apparatus including: one or more processors (such as one or more processors 802); and memory (such as memory 803) accessible by the one or more processors, the memory storing instructions that when executed by the one or more processors, cause the apparatus to perform one or more methods described herein.

[0062] The memory 803 may be a non-transitory processor readable medium containing a set of instructions thereon for controlling and / or monitoring a fluid delivery system, wherein when executed by a processor (such as the one or more processors 802), the instructions cause the processor to perform one or more methods described herein.

[0063] Embodiments illustrated under any heading or in any portion of the disclosure may be combined with embodiments illustrated under the same or any other heading or other portion of the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context. For example, and without limitation, embodiments described in dependent claim format for a given embodiment (e.g., the given embodiment described in independent claim format) may be combined with other embodiments (described in independent claim format or dependent claim format).

[0064] Numerous modifications, alterations, and changes to the described embodiments are possible without departing from the scope of the present invention defined in the claims. It isintended that the present invention need not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims, and equivalents thereof.

Claims

CLAIMSWhat is claimed is:

1. A syringe comprising: a barrel having a longitudinal passage extending through the barrel, the barrel having a distal end and a proximal end, the distal end configured to operably couple to a needle; a mechanical separator disposed within the longitudinal passage, the mechanical separator movable between the proximal end and the distal end; and a pressure sensor to monitor pressure of a fluid being injected from the syringe into a subject.

2. The syringe of claim 1 , wherein the pressure sensor is communicatively coupled to a processing system, the processing system comprising: a memory comprising computer readable instructions; and a processing device for executing the computer readable instructions, the computer readable instructions controlling the processing device to perform operations comprising: receiving pressure information from the pressure sensor; and generating real-time feedback information based at least in part on the pressure information.

3. The syringe of claim 2, wherein the pressure sensor is communicatively coupled to the processing system via an electrical connection.

4. The syringe of claim 2, wherein the pressure sensor is communicatively coupled to theprocessing system via a fiber optic connection.

5. The syringe of claim 2, wherein the operations further comprise controlling a syringe pump exerting a force on a proximal end of the mechanical separator based at least in part on the pressure information, wherein controlling the syringe pump comprises adjusting the force exerted by the syringe pump.

6. The syringe of claim 2, wherein the real-time feedback information comprises at least one of a signal to indicate a possible blockage of the fluid, a signal to indicate a possible leak of the fluid, a signal to initiate an alarm, or a signal to cease movement of the mechanical separator.

7. The syringe of claim 1 , wherein the pressure sensor is an in-line pressure sensor disposed between the distal end of the barrel and a proximal end of the needle, wherein the fluid flows from the barrel through the in-line pressure sensor and into the needle.

8. The syringe of claim 1 , wherein the needle comprises a first channel for the fluid to flow from the barrel into the subject and a second channel to receive a second pressure sensor, the second channel disposed within the first channel.

9. The syringe of claim 8, wherein the pressure sensor is extendable and retractable within the second channel relative to the first channel.

10. The syringe of claim 8, wherein the second channel is extendable and retractable withinthe first channel.

11. A computer- implemented method comprising: initiating injecting a fluid from a syringe into a subject, the syringe comprising a pressure sensor; monitoring, using pressure information from the pressure sensor, a pressure of the fluid being injected from the syringe into the subject; and providing real-time feedback information regarding the pressure.

12. The computer-implemented method of claim 11, further comprising: controlling a syringe pump exerting a force on a proximal end of a plunger of the syringe based at least in part on the pressure information received from the pressure sensor, wherein controlling the syringe pump comprises adjusting the force of the syringe pump.

13. The computer-implemented method of claim 11, wherein the syringe comprises: a barrel having a longitudinal passage extending through the barrel, the barrel having a distal end and a proximal end, the distal end configured to operably couple to a needle; and a plunger disposed within the longitudinal passage, the plunger movable between the proximal end and the distal end.

14. The syringe of claim 13, wherein the pressure sensor is an in-line pressure sensor disposed between the distal end of the barrel and a proximal end of the needle, wherein the fluid flows from the barrel through the in-line pressure sensor and into the needle.

15. A syringe comprising: a barrel having a longitudinal passage extending through the barrel, the barrel having a distal end and a proximal end, the distal end configured to operably couple to a needle; a mechanical separator within the barrel movably positioned between the distal end and the proximal end, the mechanical separator separating a first fluid and a second fluid, the first fluid being within the barrel between the proximal end and the mechanical separator, the second fluid being within the barrel between the mechanical separator and the distal end; a first pressure sensor to monitor a first pressure; and a second pressure sensor to monitor a second pressure.

16. The syringe of claim 15, wherein the first pressure sensor and the second pressure sensor monitor the pressure of the second fluid.

17. The syringe of claim 15, wherein the first pressure sensor monitors the pressure of the first fluid and the second pressure sensor monitors the pressure of the second fluid.

18. The syringe of claim 15, further comprising a third pressure sensor to monitor a third pressure, wherein the first pressure sensor and the second pressure sensor monitor the pressure of the second fluid, and the third pressure sensor monitors the pressure of the first fluid.

19. The syringe of claim 15, wherein the first pressure sensor is an in-line pressure sensor disposed between the distal end of the barrel and a proximal end of the needle that measures anin-line pressure of the fluid as the fluid flows from the barrel through the in-line pressure sensor and into the needle, wherein the second pressure sensor measures a tip pressure of the fluid at a distal end of the needle.

20. The syringe of claim 15, wherein the first fluid is a drug to be injected to a subject, and wherein the second fluid is saline.

21. The syringe of claim 15, wherein the first pressure sensor and the second pressure sensor are communicatively coupled to a processing system, the processing system comprising: a memory comprising computer readable instructions; and a processing device for executing the computer readable instructions, the computer readable instructions controlling the processing device to perform operations comprising: receiving first pressure information from the first pressure sensor; receiving second pressure information from the second pressure sensor; and generating real-time feedback information based at least in part on the first pressure information and the second pressure information.

22. The syringe of claim 21, wherein the first pressure sensor is communicatively coupled to the processing system via a first electrical connection and the second pressure sensor is communicatively coupled to the processing system via a second electrical connection.

23. The syringe of claim 21, wherein the first pressure sensor is communicatively coupled to the processing system via a first fiber optic connection and the second pressure sensor iscommunicatively coupled to the processing system via a second fiber optic connection.

24. The syringe of claim 21, wherein the first pressure sensor is communicatively coupled to the processing system via an electrical connection and the second pressure sensor is communicatively coupled to the processing system via a fiber optic electrical connection.

25. The syringe of claim 21, wherein the first pressure sensor is communicatively coupled to the processing system via a fiber optic connection and the second pressure sensor is communicatively coupled to the processing system via an electrical connection.

26. The syringe of claim 21, wherein at least one of the first pressure sensor and the second pressure sensor is communicatively coupled to the processing via a wired link.

27. The syringe of claim 21, wherein at least one of the first pressure sensor and the second pressure sensor is communicatively coupled to the processing via a wireless link.

28. The syringe of claim 21, wherein the real-time feedback information is able to indicate a blockage associated with at least one of the first fluid or the second fluid.

29. The syringe of claim 28, wherein the operations further comprise: comparing a first pressure value for the first pressure information to a second pressure value for the second pressure information; and determining that the blockage exists responsive to determining that the second pressurevalue is greater than the first pressure value.

30. The syringe of claim 21, wherein the real-time feedback information is able to indicate a leak at an injection site of a subject.

31. The syringe of claim 30, wherein the operations further comprise: comparing a first pressure value for the first pressure information to a second pressure value for the second pressure information; and determining that the leak exists responsive to determining that the first pressure value is greater than the second pressure value.

32. The syringe of claim 15, wherein a first force is applied to the first fluid using a pump, and wherein a second force is applied to the second fluid via the first fluid and the mechanical separator.

33. The syringe of claim 15, wherein generating the real-time feedback information comprises generating an alert responsive to determining that a first pressure value for the first pressure information differs from a second pressure value for the second pressure information by at least a threshold difference.

34. The syringe of claim 33, wherein the threshold difference is a percent difference.

35. The syringe of claim 33, wherein the threshold difference is a difference in pressure.

36. The syringe of claim 19, wherein the mechanical separator comprises a first gasket and a second gasket having an airspace disposed between the first gasket and the second gasket.

37. The syringe of claim 15, wherein the mechanical separator prevents a mixing of the first fluid and the second fluid.

38. The syringe of claim 19, further comprising a third pressure sensor, the third pressure sensor being an in-line pressure sensor disposed between the distal end of the barrel and a proximal end of the needle that measures the pressure of the second fluid as the second fluid flows from the barrel through the in-line pressure sensor and into the needle.

39. The syringe of claim 32, further comprising a fourth pressure sensor disposed at the distal end of the needle to measure the pressure of the second fluid at the distal end of the needle.

40. The syringe of claim 15, wherein the first pressure sensor is disposed on the proximal end of the mechanical separator, and wherein the second pressure sensor is disposed on the distal end of the mechanical separator.

41. A computer- implemented method comprising: initiating injecting a drug in fluid form from a syringe into a subject, the syringe comprising a first pressure sensor to monitor a pressure of the drug and a second pressure sensor to monitor a pressure of a pumping fluid, the pumping fluid being used to apply a force to thedrug to cause the drug to be injected into the subject, wherein the drug is separated from the pumping fluid by a mechanical separator disposed within a barrel of the syringe; monitoring, using the first pressure sensor, a pressure of the drug being injected from the syringe into the subject; monitoring, using the second pressure sensor, a pressure of the pumping fluid used to apply the force to the drug; and providing real-time feedback information regarding the pressure of the drug and the pressure of the pumping fluid.

42. The computer-implemented method of claim 41, further comprising determining whether a blockage exists by comparing the pressure of the drug to the pressure of the pumping fluid, wherein the real-time feedback information indicates the blockage exists responsive to determining that the pressure of the drug is greater than the pressure of the pumping fluid.

43. The computer-implemented method of claim 41, further comprising determining whether a leak exists by comparing the pressure of the drug to the pressure of the pumping fluid, wherein the real-time feedback information indicates the leak exists responsive to determining that the pressure of the drug is less than the pressure of the pumping fluid.

44. The computer-implemented method of claim 41, further comprising, based on the realtime feedback information, at least one of ceasing injecting the drug into the subject or initiating an alarm.

45. The computer-implemented method of claim 41, further comprising when the real-time feedback information indicates at least one of a blockage of the drug or a leak of the drug, at least one of ceasing injecting the drug into the subject or initiating an alarm.

46. The computer-implemented method of claim 41, further comprising when the pressure of the drug and the pressure of the pumping fluid diverge, at least one of ceasing injecting the drug into the subject or initiating an alarm.

47. The computer-implemented method of claim 41, further comprising when an absolute value of a difference between the pressure of the drug and the pressure of the pumping fluid diverge exceeds a predetermined threshold, at least one of ceasing injecting the drug into the subject or initiating an alarm.

48. The computer-implemented method of claim 41, further comprising based on a comparison of a moving average of the pressure of the drug and a moving average of the pressure of the pumping fluid diverge, at least one of ceasing injecting the drug into the subject or initiating an alarm.

49. The computer-implemented method of claim 41, further comprising based on at least one of a calculation of the pressure of the drug or a calculation of the pressure of the pumping fluid diverge, at least one of ceasing injecting the drug into the subject or initiating an alarm, wherein the calculation is a moving average, a first derivative over time, or a second derivative over time.

50. The computer-implemented method of claim 41, wherein the pumping fluid is saline.

51. A method, machine, manufacture, and / or system substantially as shown and described.

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