WO2019191181A1 - Peristaltic pump nerve block injection system and related methods - Google Patents

Peristaltic pump nerve block injection system and related methods Download PDF

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Publication number
WO2019191181A1
WO2019191181A1 PCT/US2019/024208 US2019024208W WO2019191181A1 WO 2019191181 A1 WO2019191181 A1 WO 2019191181A1 US 2019024208 W US2019024208 W US 2019024208W WO 2019191181 A1 WO2019191181 A1 WO 2019191181A1
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WO
WIPO (PCT)
Prior art keywords
fluid
injection
conduit
needle
coupled
Prior art date
Application number
PCT/US2019/024208
Other languages
French (fr)
Inventor
Ryan Lefevre
Ryan Peterson
Original Assignee
Baylor Research Institute
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baylor Research Institute filed Critical Baylor Research Institute
Publication of WO2019191181A1 publication Critical patent/WO2019191181A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M19/00Local anaesthesia; Hypothermia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14212Pumping with an aspiration and an expulsion action
    • A61M5/14228Pumping with an aspiration and an expulsion action with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804Flow controllers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16854Monitoring, detecting, signalling or eliminating infusion flow anomalies by monitoring line pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/48Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for varying, regulating, indicating or limiting injection pressure
    • A61M5/484Regulating injection pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow

Definitions

  • This disclosure relates generally to an injection system, but not by way of limitation, to devices, systems and methods for peripheral nerve block injection.
  • PNBs Peripheral nerve blocks
  • the present disclosure describes systems, devices, and methods for a peripheral nerve injection system configured to enable administration of a liquid medication, such as a local anesthetic.
  • the peripheral nerve injection system may enable a single operator to administer the liquid medication, which eliminates the need to coordinate having two individuals present for administration of a peripheral nerve block and reduces a cost of operating the system.
  • the systems, devices and methods of the present disclosure significantly reduce the risk of high injection pressures, associated with the rare but serious consequence of intraneural injection, by using an embedded pressure monitor.
  • a solution e.g., a liquid medication
  • a solution may be directly withdrawn from a vial while maintaining sterility, thus eliminating the need to pre-draw medicine into large syringes and lowering the time required to prepare for a procedure.
  • the systems, devices and methods of the present disclosure may not only reduce needed personnel, but may advantageously simplify logistical problems of coordinating workers who are often busy in hospital setting.
  • a single anesthesia provider may have complete autonomy and freedom to perform a peripheral nerve block.
  • the peripheral nerve injection system disclosed herein may provide pressure monitoring, such as continuous pressure monitoring during a procedure, and can provide an alert or stop injection once a particular pressure is reached. This functionality may reduce the rare but potentially deleterious event from damage to nerves, since this has been shown to correlate with higher injection pressures.
  • Some embodiments of the present fluid injection/aspiration device comprise: a body configured to be coupled to a needle; and one or more switches coupled to the body.
  • the one or more switches in a first configuration provides a first control signal that indicates a first operating state in which a first flow direction from a conduit to the needle is established for providing a first fluid to an injection site via the needle
  • the one or more switches in a second configuration provides a second control signal that indicates a second operating state in which a second flow direction from the injection site via the needle to the conduit is established for aspirating a second fluid.
  • the injection/aspiration device further comprises the needle coupled to the body and/or the conduit coupled to the body and in fluid communication with the needle.
  • the injection site includes tissue.
  • the first operating state comprises a fluid injection state
  • the second operating state comprises an aspiration state
  • at least one switch of the one or more switches comprises a manually operated switch configured to be operated by a hand of a user.
  • the one or more switches comprise multiple switches, where the multiple switches comprise a first switch configured to provide the first control signal and a second switch configured to provide the second control signal.
  • At least one switch of the one or more switches comprises a push button switch and the one or more switches are configured to be electronically coupled to a control device.
  • the one or more switches in a third configuration indicates a third operating state in which no flow path is established between the needle and the conduit.
  • the body is configured to surround at least a portion of an outer perimeter of the conduit or to be clipped to the portion of the conduit.
  • Some embodiments of the present control device comprise at least one pump configured to be coupled to a first conduit and a second conduit; and at least one processor coupled to the at least one pump.
  • the at least one processor is configured to: monitor for control signals from one or more switches coupled to a body, the body coupled to the first conduit; receive a first control signal from the one or more switches; based on the first control signal, operate the at least one pump to withdraw a first fluid from a fluid source coupled via a fluid removal device to the second conduit and to provide the first fluid to an injection site via a needle coupled to the first conduit; receive a second control signal from the one or more switches; and based on the second control signal, operate the at least one pump to aspirate a second fluid from the injection site via the needle.
  • the at least one pump comprises at least one peristaltic pump.
  • the control device further comprises a display device coupled to the at least one processor.
  • the at least one processor is electronically coupled to a pressure sensor coupled to the first conduit and is configured to receive pressure data from the pressure sensor, the pressure data indicating a pressure within the first conduit.
  • the display device is configured to output an indication of the pressure, an indication of a volume of fluid withdrawn from the fluid source, or both.
  • the at least one processor is configured to determine whether the pressure satisfies a pressure threshold and the display device is further configured to output an alarm responsive to the pressure satisfying the pressure threshold.
  • the control device further comprises a pressure alarm device configured to output an alarm responsive to the pressure satisfying the pressure threshold.
  • the pressure alarm device comprises a visual indication device, an audio indication device, a tactile indication device, or a combination thereof.
  • the control device further comprises a pressure threshold setting control device configured to set the pressure threshold at one of multiple selectable values.
  • the at least one pump comprises a plurality of pumps, and the plurality of pumps comprises: a first pump configured to be coupled to the first conduit and the second conduit; and a second pump configured to be coupled to a third conduit and a fourth conduit, the fourth conduit coupled to a second fluid removal device.
  • the control device further comprises at least one fluid container size selector switch configured to select a fluid container size from a plurality of fluid container sizes, a fluid volume, or both.
  • the at least one processor is configured to operate the at least one pump to cease withdrawal of the first fluid from the fluid source responsive to a volume of fluid withdrawn from the fluid source satisfying a selected fluid container size.
  • the peripheral nerve block injection system comprise: a fluid injection/aspiration device; and a control device.
  • the fluid injection/aspiration device comprises a body configured to be coupled to a needle and to a first conduit; and one or more switches coupled to the body.
  • the one or more switches in a first configuration provides a first control signal to indicate a first operating state in which a first flow direction from the first conduit to the needle is established for providing a first fluid to an injection site via the needle.
  • the one or more switches in a second configuration provides a second control signal to indicate a second operating state in which a second flow direction from the injection site via the needle to the first conduit is established for aspirating a second fluid.
  • the control device comprises: at least one pump configured to be coupled to the first conduit and a second conduit; and at least one processor coupled to the at least one pump.
  • the at least one processor is configured to: monitor for control signals from the one or more switches; receive the first control signal from the one or more switches; based on the first control signal, operate the at least one pump to withdraw a first fluid from a first fluid source coupled via a fluid removal device to the second conduit and to provide the first fluid to the injection site via the needle; receive the second control signal; and based on the second control signal, operate the at least one pump to aspirate the second fluid from the injection site via the needle.
  • the system further comprises a pressure sensor coupled to the first conduit and configured to provide pressure data to the control device, the pressure data indicative of a pressure within the first conduit.
  • the fluid removal device comprises: a second needle including a distal end configured to be inserted in a fluid container and including a proximal end configured to be coupled to a second conduit, the second needle configured to enable withdrawal of a fluid from the fluid container to the second conduit; a vent tube coupled in a fixed positional relationship with respect to the second needle, the vent tube comprising a distal end and a proximal end and configured to enable fluid communication of air between the proximal end and the distal end, where the distal end of the vent tube is positioned along a longitudinal length of the second needle at a particular distance from the distal end of the second needle such that, when the distal end of the vent tube is positioned within the fluid container, the distal end of the second needle is positioned within the fluid container; and a pressure sensor coupled to the second needle or the vent tube and configured to measure a pressure within the fluid container when the distal end of the vent tube is positioned within the fluid container.
  • the fluid withdrawal device further comprises: a pressure release valve coupled to the vent tube and configured to maintain a pressure within the fluid container to be less than or equal to a threshold pressure when the distal end of the vent tube is positioned within the fluid container; and/or a fluid level sensor coupled to the second needle and/or the vent tube and configured to detect a fluid level in the fluid container.
  • Some embodiments of the present methods comprise: coupling a body comprising one or more switches to a conduit and/or a needle, where the conduit is coupled in fluid communication with the needle; transitioning the one or more switches into a first configuration to provide a first control signal to indicate a first operating state in which a first flow direction from the conduit to the needle is established for providing a first fluid to an injection site via the needle; and transitioning the one or more switches into a second configuration to provide a second control signal to indicate a second operating state in which a second flow direction from the injection site via the needle to the conduit is established for aspirating a second fluid.
  • the second fluid contains at least a portion of the first fluid.
  • the methods further comprise transitioning the one or more switches into a third configuration to indicate a third operating state in which no flow path is established between the needle and the conduit.
  • transitioning the one or more switches into the first configuration comprises transitioning from the third configuration to the first configuration
  • transitioning the one or more switches into the second configuration comprises transitioning from the third configuration to the second configuration.
  • the one or more switches comprise a three-way switch.
  • the first control signal is provided from the one or more switches to a control device communicatively coupled to the one or more switches.
  • a pressure sensor is coupled to the conduit and configured to measure a pressure within the conduit.
  • Some embodiments of the present methods comprise: monitoring, at a control device, for control signals from one or more switches coupled to a body, the body coupled to a first conduit coupled to at least one pump, the at least one pump coupled to the control device; receiving a first control signal at the control device from the one or more switches; operating the at least one pump to cause a first fluid to be withdrawn from a fluid source via a fluid removal device coupled to a second conduit coupled to the at least one pump and to provide the first fluid to an injection site via a needle coupled to the first conduit; receiving a second control signal at the control device from the one or more switches; and operating the at least one pump to aspirate a second fluid from the injection site via the needle.
  • the methods further comprise receiving pressure data from a pressure sensor coupled to the first conduit, the pressure data indicating a pressure within the first conduit. In some such embodiments, the methods further comprise initiating output of the pressure at a display device of the control device. In some such embodiments, the methods further comprise initiating an alarm at the control device based on determining that the pressure satisfies a pressure threshold. In some such embodiments, the methods further comprise setting the pressure threshold based on an input from a pressure setting control of the control device.
  • the methods further comprise setting a fluid container size, a maximum amount of fluid withdrawal, or both, based on an input from a fluid container size control of the control device.
  • the at least one pump comprises a plurality of pumps.
  • a first pump of the plurality of pumps is operated to withdraw the first fluid from the fluid source and to provide the first fluid to the needle.
  • the methods further comprise operating a second pump of the plurality of pumps to cause a third fluid to be withdrawn from a second fluid source via a second fluid removal device coupled to the second pump and to provide the third fluid to the needle.
  • the first fluid and the third fluid are the same type of fluid.
  • the first control signal indicates a first operating state of the one or more switches
  • a second control signal indicates a second operating state of the one or more switches.
  • the methods further comprise: receiving an indication of a third operating state of the one or more switches; and ceasing operation of the at least one pump to cause no flow path between the fluid source and the needle responsive to the indication of the third operating state.
  • Some embodiments of the present disclosure include a kit that comprises: a fluid aspiration/injection device, one or more electrical connectors configured to couple one or more switches to a control device; and a first conduit.
  • the fluid/injection aspiration device comprises: a body configured to be coupled to a needle and to the first conduit; and the one or more switches coupled to the body.
  • the one or more switches in a first configuration provides a first control signal to indicate a first operating state in which a first flow direction from the first conduit to the needle is established for providing a first fluid to an injection site via the needle
  • the one or more switches in a second configuration provides a second control signal to indicate a second operating state in which a second flow direction from the injection site via the needle to the first conduit is established for aspirating a second fluid.
  • the kit further comprises the needle configured to be coupled to a first end of the first conduit. Additionally, or alternatively, the kit further comprises a pressure sensor configured to be coupled to the first conduit. Additionally, or alternatively, the kit further comprises the control device configured to be coupled to the one or more switches via the one or more electrical connectors. In such embodiments, the control device comprises at least one pump configured to be coupled to the first conduit.
  • the kit further comprises a fluid withdrawal device.
  • the fluid withdrawal device comprises: a second needle including a distal end configured to be inserted in a fluid container and including a proximal end configured to be coupled to a second conduit, the second needle configured to enable withdrawal of fluid from the fluid container to the second conduit; and a vent tube coupled in a fixed positional relationship with respect to the second needle.
  • the vent tube comprises a distal end and a proximal end and is configured to enable fluid communication of air between the proximal end and the distal end.
  • the distal end of the vent tube is positioned along a longitudinal length of the second needle at a particular distance from the distal end of the second needle such that when the distal end of the vent tube is positioned within the fluid container the distal end of the second needle is positioned within the fluid container.
  • the kit further comprises: a pressure sensor coupled to the second needle or the vent tube and configured to measure a pressure within the fluid container; and the second conduit configured to be coupled to the second needle.
  • an ordinal term e.g.,“first,”“second,”“third,” etc.
  • an element such as a structure, a component, an operation, etc.
  • the term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically; two items that are“coupled” may be unitary with each other.
  • the terms“a” and “an” are defined as one or more unless this disclosure explicitly requires otherwise.
  • substantially is defined as largely but not necessarily wholly what is specified - and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel - as understood by a person of ordinary skill in the art.
  • the term“substantially” may be substituted with“within [a percentage] of’ what is specified, where the percentage includes 0.1, 1, 5, and 10 percent; and the term “approximately” may be substituted with“within 10 percent of’ what is specified.
  • the phrase “and/or” means and or.
  • A, B, and/or C includes: A alone, B alone, C alone, a combination of A and B, a combination of A and C, a combination of B and C, or a combination of A, B, and C.
  • “and/or” operates as an inclusive or.
  • any implementation of any of the apparatuses, systems, and methods can consist of or consist essentially of - rather than comprise/include/have - any of the described steps, elements, and/or features.
  • the term“consisting of’ or“consisting essentially of’ can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open- ended linking verb.
  • the term“wherein” may be used interchangeably with“where.”
  • a device or system that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described. Aspects of one example may be applied to other examples, even though not described or illustrated, unless expressly prohibited by this disclosure or the nature of a particular example. Some details associated with the aspects described above and others are described below.
  • FIGS. 1A-1B show views of an example of a peripheral nerve block injection system.
  • FIG. 2 shows a view of an example of a control device of the peripheral nerve block injection system shown in FIGS. 1A-1B.
  • FIGS. 3A-3B show various views of an example of a fluid injection device.
  • FIGS. 4A, 4B, and 4C show various views of an example of a fluid withdrawal device.
  • FIG. 5 is a flowchart of an example of a method of using a peripheral nerve block injection system.
  • FIG. 6 is a flowchart of an example of a method of monitoring a fluid injection pressure of a peripheral nerve block injection system.
  • FIG. 7 is a flowchart of another example of a method of using a peripheral nerve block injection system.
  • FIG. 8 is a flowchart of another example of a method of using a peripheral nerve block injection system.
  • FIG. 9 is a block diagram showing an example of the peripheral nerve block injection system shown in FIGS. 1A-1B.
  • FIG. 10 is a diagram of an example of a kit for peripheral nerve block injection systems.
  • FIG. 11 is a flowchart illustrating an example of a method of operating a fluid injection/aspiration device.
  • FIG. 12 is a flowchart illustrating an example of a method of operating a control device of a peripheral nerve block injection system.
  • an example of an injection system 100 such as a peripheral nerve block (PNB) injection system
  • Injection system 100 is configured to withdraw a certain volume of fluid (e.g., liquid medication), such as anesthesia, and administer the medication to a patient, such as during performance of a peripheral nerve block injection.
  • Injection system 100 is also configured to aspirate fluid from the patient.
  • Injection system 100 includes a control device 104, a body 107 (e.g., a housing), a fluid injection/aspiration device 108, and a fluid withdrawal device 112.
  • Control device 104 is configured to send and receive communication/control signals between control device 104 and the other elements of injection system 100.
  • control device 104 may send and/or receive one or more signals via wired and/or wireless communication.
  • control device 104 includes one or more processors.
  • the one or more processors may be coupled to a memory storing computer-executable instructions that, when executed by the one or more processors, cause the one or more processors to perform operations of control device 104 described herein, such as one or more operations described with reference to FIG. 9.
  • Fluid injection/aspiration device 108 includes body 107.
  • Body 107 has a first end 109 and a second end 110 and is a part of fluid injection/aspiration device 108.
  • fluid injection/aspiration device 108 is configured to be coupled to a needle, such as an injection needle 128.
  • fluid injection/aspiration device 108 further includes injection needle 128.
  • injection needle 128 is coupled to first end 109 of fluid injection/aspiration device 108.
  • Injection needle 128 is hollow (e.g., defines a through channel) and configured to be inserted into an injection site. For example, injection needle 128 may be inserted into a patient by a medical professional operating injection system 100.
  • injection site may include tissue, such as human tissue.
  • injection needle 128 is a spinal needle configured to perform a peripheral nerve block (PNB) injection.
  • PPB peripheral nerve block
  • fluid injection/aspiration device 108 is configured to be compatible with a variety of types of injection needles.
  • Fluid injection/aspiration device 108 may also be configured to be coupled to a conduit, such as a fluid injection conduit 148.
  • fluid injection/aspiration device 108 also includes fluid injection conduit 148 coupled to body 107.
  • the fluid injection conduit 148 in fluid communication with injection needle 128. For example, one or more flow paths may be established from the fluid injection conduit 148 to the injection needle 128.
  • the fluid injection conduit 148 is in fluid communication with the injection needle 128 through the body 107.
  • body 107 may be substantially hollow and may be configured to enable fluid to pass within.
  • injection needle 128 is coupled to first end 109 and fluid injection conduit 148 is coupled to second end 110, and fluid is permitted to flow through body 107 from fluid injection conduit 148 to injection needle 128 (or in the opposite direction).
  • the first end 109 may include a first connector configured to be coupled to a connector of injection needle 128, and the second end 110 may include a second connector configured to be coupled to a connector of fluid injection conduit 148.
  • injection needle 128 is coupled to fluid injection conduit 148, and body 107 is externally coupled to fluid injection conduit 148, injection needle 128, or both.
  • body 107 may be configured to surround at least a portion of an outer perimeter of fluid injection conduit 148.
  • body 107 may be configured to be clipped to a portion of fluid injection conduit 148.
  • body 107 may be coupled to fluid injection conduit 148, injection needle 128, or both, in other ways. In such alternate implementations, the fluid paths between injection needle 128 and fluid injection conduit 148 do not traverse body 107.
  • Fluid injection/aspiration device 108 includes one or more switches 116 (also referred to as a fluid control switch) coupled to body 107.
  • switches 116 may be configurable in multiple configurations. Configuring one or more switches 116 may provide control signals to control device 104 to operate in different operating states, as further described herein. For example, if one or more switches 116 are in a first configuration, one or more switches 116 provide a first control signal to control device 104 that indicates a first operating state in which a first flow direction from fluid injection conduit 148 to injection needle 128 is established for providing a first fluid to an injection site via injection needle 128.
  • the one or more switches provide a second control signal to control device 104 that indicates a second operating state in which a second flow direction from the injection site via injection needle 128 to fluid injection conduit 148 is established for aspirating a second fluid.
  • the third configuration indicates a third operating state in which no flow path is established between injection needle 128 and fluid injection conduit 148.
  • the first operating state includes a fluid injection state
  • the second operating state includes an aspiration state
  • the third operating state includes a standby state, as further described herein.
  • At least one switch of one or more switches 116 include a manually operated switch configured to be operated by a hand of a user.
  • at least one switch of one or more switches 116 may include a push button switch.
  • one or more switches 116 include a single switch.
  • the single switch may include a three-way switch.
  • the three-way switch may be configured in one of three positions, each position corresponding to one of the first, second, or third operating states.
  • one or more switches 116 include multiple switches.
  • the multiple switches may include a first switch configured to provide the first control signal and a second switch configured to provide the second control signal. In the implementation shown in FIGS.
  • one or more switches 116 include two switches: an injection button 120 for controlling an injection of fluid (e.g., a first switch for providing the first control signal) and an aspiration button 124 for controlling an aspiration of fluid (e.g., a second switch for providing the second control signal).
  • an injection button 120 for controlling an injection of fluid
  • an aspiration button 124 for controlling an aspiration of fluid
  • one or more switches 116 can include more than two switches or can include other elements for toggling between functions, such as a toggle switch, a knob, or other suitable switching elements, as illustrative, non-limiting examples.
  • Fluid withdrawal device 112 includes a fluid drawing needle 132 and a vent tube 136.
  • Fluid drawing needle 132 is configured to be inserted in a fluid container and includes a proximal end configured to be coupled to a fluid withdrawal conduit 144.
  • Fluid drawing needle 132 is configured to enable withdrawal of a fluid from the fluid container to fluid withdrawal conduit 144.
  • fluid drawing needle 132 is a hollow needle configured to be inserted into a sterile vial 140 that contains liquid medication (or another fluid).
  • fluid drawing needle 132 may be placed in another type of fluid container, such as a bag, a bladder, a bottle, or any other type of fluid container.
  • Fluid drawing needle 132 may have a gauge sufficient to enable withdrawal of a volume or amount of fluid from vial 140 into a hollow cavity of fluid drawing needle 132.
  • Vent tube 136 is coupled in a fixed relationship with respect to fluid drawing needle 132.
  • Vent tube 136 includes a distal end and a proximal end and is configured to enable fluid communication of air between the proximal end and the distal end.
  • the distal end of vent tube 136 is positioned along a longitudinal length of fluid drawing needle 132 at a particular distance from the distal end of fluid drawing needle 132 such that, when the distal end of vent tube 136 is positioned within the fluid container, the distal end of the of fluid drawing needle 132 is positioned within the fluid container.
  • vent tube 136 is a hollow needle configured to be inserted into vial 140.
  • vent tube 136 has a needle size or gauge (effective internal diameter) sufficient to enable a passage of gas (e.g., air) between vial 140 and an outer environmental atmosphere through the hollow cavity of vent tube 136.
  • vent tube 136 is a tube (e.g., is not a needle) and can be inserted into vial 140 via a hole in a lid formed by fluid drawing needle 132. Fluid withdrawal device 112 is further described with reference to FIGS. 4A-4C.
  • Fluid injection/aspiration device 108 and fluid withdrawal device 112 are coupled to fluid injection conduit 148 and fluid withdrawal conduit 144, respectively.
  • fluid withdrawal conduit 144 and fluid injection conduit 148 include tubing, such as sterile tubing.
  • fluid withdrawal conduit 144 and fluid injection conduit 148 include other components defining channels through which fluid is capable of flowing.
  • Fluid withdrawal conduit 144 is configured to connect fluid withdrawal device 112 to a pump 152 disposed on control device 104.
  • Fluid injection conduit 148 is configured to connect fluid injection/aspiration device 108 to the same pump 152 disposed on control device 104.
  • fluid injection conduit 148 is connected to fluid injection/aspiration device 108 at second end 110 to enable fluid communication between pump 152 and fluid injection/aspiration device 108 (e.g., to injection needle 128).
  • Pump 152 is configured to provide sufficient force to suction or withdraw fluid from a fluid source, such as vial 140, via fluid withdrawal device 112, through fluid withdrawal conduit 144, and into an input of pump 152.
  • Pump 152 is also configured to provide sufficient force to expel or inject fluid from an output of pump 152 into and through fluid injection conduit 148, and into fluid injection/aspiration device 108 (e.g., into and/or through injection needle 128).
  • pump 152 is configured to provide sufficient force to aspirate fluid from tissue via injection needle 128 into fluid injection/aspiration device 108 (and potentially into fluid injection conduit 148). This aspiration occurs in an opposite flow direction to the injection of the fluid.
  • Pump 152 is configured to enable a passage of fluid through pump 152 and to receive and expel fluid through each of a plurality of ports.
  • the injection system 100 includes a second pump 152 disposed on control device 104 to provide a dual pump configuration.
  • Each pump 152 can be configured to be connected to a separate fluid injection/aspiration device 108 and a separate fluid withdrawal device 112.
  • second pump 152 can be configured to be connected to the same fluid injection/aspiration device 108 (e.g., via a connector to couple fluid injection conduit 148 to a second fluid injection conduit coupled to the second pump 152).
  • the dual pump configuration enables a second vial to be connected to control device 104 and a second medication to be injected.
  • additional pumps e.g., more than two
  • control device 104 includes a single pump 152.
  • the injection system 100 also includes a pressure sensor 156 (e.g., a fluid injection pressure monitor) configured to monitor the fluid pressure within fluid injection conduit 148.
  • Pressure sensor 156 may be disposed on (e.g., coupled to) or in fluid injection conduit 148 inline between pump 152 and fluid injection/aspiration device 108. In other implementations, pressure sensor 156 can be disposed as a part of pump 152, fluid injection/aspiration device 108, and/or control device 104.
  • Pressure sensor 156 is configured to enable continuous monitoring of injection pressures. Monitoring of injection pressures is important, as high injection pressures have been associated with intraneural injections which can lead to complications such as nerve damage.
  • pressure sensor 156 is a transducer.
  • pressure sensor 156 may be any suitable pressure monitoring device having one or more pressure sensors. Pressure sensor 156 may be electrically coupled to control device 104 and can send and receive communication signals to and from control device 104. In this way, injection pressure data that is generated by pressure sensor 156 can be transmitted to control device 104 via a wired electrical connector. In some implementations the pressure data can be used to activate an audible, visual, and/or tactile alarm if the injection pressure satisfies (e.g., is greater than or equal to, or in other implementations is greater than) a specified pressure threshold.
  • control device 104 may include a pressure alarm device configured to output an alarm responsive to the pressure satisfying the pressure threshold.
  • the pressure alarm device may include a visual indication device, an audio indication device, a tactile indication device, or a combination thereof.
  • Control device 104 can also be programmed to slow or stop the injection fluid flow (e.g., by operating, or ceasing operation of, pump 152) if fluid pressures approaching or at the pressure threshold are detected.
  • control device 104 includes a display 160, a pressure threshold setting control device, such as an alarm pressure adjustment knob 164, and at least one fluid container size selector switch, such as one or more vial size selector switches 168.
  • the alarm pressure adjustment knob is configured to set the pressure threshold at one of multiple selectable values
  • the one or more vial size selector switches 168 are configured to select a fluid container size from a plurality of fluid container sizes, a fluid volume, or both.
  • control device 104 is connected to a power supply 172 configured to provide suitable and safe electrical power levels to control device 104 to enable control device 104 to perform the functions described herein.
  • Display 160 may be a liquid crystal display (LCD) or any other type of display.
  • Display 160 may be configured to display (e.g., output) various data to the user of injection system 100.
  • display 160 may be configured to output the fluid pressure within fluid injection conduit 148 sensed by pressure sensor 156 (e.g., based on pressure data received by control device 104 from pressure sensor 156). The fluid pressure can be adjusted and displayed in real time to the user as the fluid pressure within fluid injection conduit 148 fluctuates.
  • Display 160 can also be configured to output the alarm pressure threshold value so that the user can compare the current fluid pressure to the threshold pressure value.
  • display 160 is configured to output the fluid volume withdrawn from vial 140 and the fluid volume injected into the tissue via injection needle 128.
  • fluid volume values can be adjusted and displayed in real time to the user as the amount of fluid withdrawn from vial 140 into pump 152 and the amount of fluid expelled from pump 152 into fluid injection/aspiration device 108 fluctuates.
  • the fluid volumes may be measured by pump 152 or by a sensor coupled to the fluid withdrawal device, as further described with reference to FIG. 4C.
  • Alarm pressure adjustment knob 164 can be used by a user to manually modify and set a fluid pressure threshold value.
  • alarm pressure adjustment knob 164 toggles between various fluid pressure values and enables selection of a fluid pressure value as a threshold value for triggering an alarm.
  • the alarm pressure threshold can be pre-programmed into control device 104.
  • vial size selector switches 168 include multiple switches.
  • each pump 152 may have a corresponding vial size selector switch.
  • the vial size selector switches 168 can be used by a user to manually activate or deactivate a corresponding pump 152 and configure an active pump 152 to a particular vial size (or fluid volume). The forces applied by each activated pump 152 during fluid withdrawal, injection, and aspiration can thereby be adjusted for various vial sizes (or fluid volumes).
  • FIGS. 1A-1B illustrate alarm pressure adjustment knob 164 and vial size selector switches 168, these are optional.
  • display 160 is a touchscreen display that enables a user to provide user input to configure settings of control device 104. For example, the user may enter, via the touchscreen, the various thresholds, such as the alarm pressure threshold and/or the vial size (or fluid volumes).
  • alarm pressure adjustment knob 164 and the vial size selector switches 168 are not included in control device 104.
  • control device 104 may be powered on and fluid withdrawal device 112 may be inserted in vial 140, such as by piercing a lid of vial 140 with fluid drawing needle 132.
  • an operator e.g., an anesthesiologist
  • the operator may hold an ultrasound probe in a first hand and hold fluid injection/aspiration device 108 in a second hand.
  • the operator may use the ultrasound probe to identify an injection site (e.g., human tissue) and the user may insert injection needle 128 into the injection site.
  • the operator may manipulate one or more switches 116 to cause one or more switches 116 to transition into the first configuration to provide a first control signal to control device 104.
  • the operator may depress injection button 120.
  • one or more switches 116 are configured to enable or to provide the first control signal by completing a circuit with control device 104.
  • one or more switches 116 may be coupled to control device 104 by electrical connectors and, when one or more switches 116 are in the first configuration (e.g., when injection button 120 is depressed), a circuit may be established between one or more switches 116 and control device 104. Completing such a circuit may“provide” the first control signal to control device 104.
  • one or more switches 116 may be coupled to a power source, and one or more switches 116 may generate and transmit the first control signal when one or more switches 116 are in the first configuration (e.g., when injection button 120 is depressed).
  • the first control signal may be provided continuously or periodically in various implementations.
  • the first control signal indicates a first operating state in which a first flow direction from fluid injection conduit 148 to injection needle 128 is established for providing a first fluid to the injection site.
  • Control device 104 based on receipt of the first control signal, operates pump 152 to cause withdrawal of fluid (e.g., liquid medicine) from vial 140 via fluid withdrawal device 112. Due to force applied by pump 152, the fluid flows from fluid withdrawal device 112 through fluid withdrawal conduit 144 to an input of pump 152. The fluid then flows through an output of pump 152, through fluid injection conduit 148, and through injection needle 128 to the injection site.
  • fluid e.g., liquid medicine
  • control device 104 is configured to operate pump 152 to provide a preset or predetermined volume of the first fluid in the first flow direction based on receipt of the first control signal.
  • the user may configure the one or more switches in the third configuration (e.g., a standby configuration). For example, the user may not depress either injection button 120 or aspiration button 124. Transitioning the one or more switches to the third configuration causes control device 104 to cease operating pump 152 such that no flow path is established between injection needle 128 and fluid injection conduit 148.
  • the operator may also configure one or more switches 116 to cause one or more switches 116 to transition into the second configuration to provide a second control signal to control device 104.
  • the operator may depress aspiration button 124.
  • the second control signal indicates a second operating state in which a second flow direction from the injection site via injection needle 128 to fluid injection conduit 148 is established for aspirating a second fluid.
  • Control device 104 based on receipt of the second control signal, operates pump 152 to cause aspiration of the second fluid from the injection site via injection needle 128.
  • pump 152 operates in a reverse mode to establish a flow path that is in the opposite direction of the flow path established during the first operating state (e.g., the injection operating state).
  • the second fluid contains at least a portion of the first fluid.
  • a first fluid e.g., anesthetic
  • control device 104 is configured to operate pump 152 to aspirate a preset or predetermined volume of the second fluid in the second flow direction based on receipt of the second control signal.
  • the user may configure the one or more switches in the third configuration to cause the second fluid to be returned to the injection site and to cease operation of pump 152 such that no flow path is established between injection needle 128 and fluid injection conduit 148.
  • injection system 100 of FIG. 1A enables a single user to perform a peripheral nerve block injection procedure.
  • the user may use one hand to manipulate an ultrasound probe and another hand to control fluid injection/aspiration device 108 to perform injection and aspiration.
  • This is in contrast to conventional techniques, where a first user manipulates the ultrasound probe, and a second user uses a syringe to perform injection and aspiration. Reducing the number of personnel that perform the peripheral nerve block injection procedure enables some personnel to perform other tasks, thereby increasing revenue to a hospital or doctor’s office.
  • the injection and aspiration can be controlled by manipulation of one or more switches 116, which are disposed in a position where a user’s hand will be, the user can simply and quickly change operating modes without performing more complex actions or pausing or stopping the procedure to change operating modes. For example, the user can simply depress one of multiple buttons to activate a particular operating mode.
  • a fluid injection/aspiration device (e.g., fluid injection/aspiration device 108) includes a body (e.g., body 107) configured to be coupled to a needle (e.g., injection needle 128) and one or more switches (e.g., one or more switches 116) coupled to the body.
  • the one or more switches in a first configuration provides a first control signal that indicates a first operating state in which a first flow direction from a conduit (e.g., fluid injection conduit 148) to the needle is established for providing a first fluid to an injection site via the needle.
  • the one or more switches in a second configuration provides a second control signal that indicates a second operating state in which a second flow direction from the injection site via the needle to the conduit is established for aspirating a second fluid.
  • a fluid injection device (e.g., fluid injection/aspiration device 108) includes a housing (e.g., body 107) having a first end (e.g., first end 109) configured to couple with an injection needle (e.g., injection needle 128) and a second end (e.g., second end 110) configured for fluid communication with a fluid source.
  • the fluid injection device also includes a fluid control switch (e.g., one or more switches 116) configured to be selectable for automatically providing fluid to the injection needle from the fluid source or automatically aspirating fluid from an injection site.
  • the fluid injection device further includes an injection needle (e.g., injection needle 128) coupled to the fluid control switch and at least one fluid injection tube (e.g., fluid injection conduit 148) coupled to the fluid control switch.
  • the fluid control switch may be coupled to, disposed on, connected to, or secured to, the housing. In a particular implementation, the fluid control switch is in direct contact with the housing. Alternatively, in another particular implementation, the fluid control switch is separate from the housing.
  • the injection site may include tissue, such as human tissue.
  • the fluid control switch is configured to be selectable for automatically providing fluid in a first direction toward an injection site or in a second direction opposite the first direction for aspirating fluid from the injection site.
  • the fluid control switch may comprise an injection button (e.g., injection button 120) configured to automatically provide fluid in a first direction toward an injection site, an aspiration button (e.g., aspiration button 124) configured to automatically aspirate or withdraw fluid from an injection site, or both.
  • the first end includes a connector configured for removably coupling with the injection needle.
  • the fluid control switch includes an injection button (e.g., injection button 120) configured to be selectably activated or deactivated, such that activation of the injection button causes fluid to be automatically provided from the fluid source toward the injection site, and such that deactivation of the injection button ceases or prevents fluid from being automatically provided from the fluid source toward the injection site.
  • activation of the injection button causes a preset or predetermined volume of fluid from the fluid source to be provided to the injection site. Selectably activating the injection button may include depressing the injection button and/or selectably deactivating the injection button may include releasing or not depressing the injection button.
  • the fluid control switch includes an aspiration button (e.g., aspiration button 124) configured to be selectably activated or deactivated, where activation of the aspiration button causes fluid to be automatically aspirated or withdrawn from the injection site, and where deactivation of the aspiration button ceases or prevents fluid from being automatically aspirated or withdrawn from the injection site.
  • activation of the aspiration button causes a preset or predetermined volume of fluid from the injection site to be aspirated or withdrawn.
  • selectably activating the aspiration button may include depressing the aspiration button, and selectably deactivating the aspiration button may include releasing or not depressing the aspiration button.
  • the fluid control switch is electronically connected to a control device (e.g., control device 104) configured to operate at least one peristaltic pump (e.g., pump 152) configured to withdraw fluid from the fluid source and provide fluid to the fluid injection device.
  • a control device e.g., control device 104
  • at least one peristaltic pump e.g., pump 152
  • a peripheral nerve block injection system (e.g., injection system 100) includes at least one fluid injection device (e.g., fluid injection/aspiration device 108) including an injection needle (e.g., injection needle 128), at least one injection tube (e.g., fluid injection conduit 148), and a fluid control switch (e.g., one or more switches 116) coupled to the injection needle.
  • the system includes at least one fluid withdrawal device (e.g., fluid withdrawal device 118) including a needle (e.g., fluid drawing needle 132) and at least one fluid withdrawal tube (e.g., fluid withdrawal conduit 144).
  • the system includes at least one peristaltic pump (e.g., pump 152) coupled to the at least one fluid withdrawal tube and the at least one injection tube.
  • the system further includes a control device (e.g., control device 104) including at least one processor configured to operate the at least one peristaltic pump to enable the fluid withdrawal device to withdraw a fluid volume from a vial (e.g., vial 140) into the peristaltic pump, and operate the at least one peristaltic pump to enable the fluid injection device to dispense the fluid volume from the peristaltic pump.
  • the system includes a fluid injection pressure monitor (e.g., pressure sensor 156) coupled to the at least one fluid injection device and configured to monitor a fluid injection pressure inside the at least one injection tube.
  • the system includes a display device (e.g., display 160) configured to display at least one of the fluid volume and the fluid injection pressure. Additionally, or alternatively, the system further includes a fluid pressure alarm device configured to issue an alarm upon the fluid injection pressure approaching, meeting, and/or exceeding a fluid injection pressure threshold. Additionally, or alternatively, the system includes a fluid injection pressure threshold setting device (e.g., alarm pressure adjustment knob 164) configured to set the fluid injection pressure threshold at a predetermined value. Additionally, or alternatively, the system includes a plurality of peristaltic pumps (e.g., pumps 152) each configured to couple to a separate fluid injection device and a separate fluid withdrawal device. Additionally, or alternatively, the system includes at least one vial size selector switch (e.g., vial size selector switches 168) configured to select a vial size from a plurality of predetermined vial sizes.
  • a display device e.g., display 160
  • the system further includes a fluid pressure alarm device configured to issue an alarm upon the fluid injection pressure approaching,
  • the fluid control switch has an injection setting configured to, when the injection setting is activated, send an injection signal to the control device triggering the peristaltic pump to dispense the fluid volume into the fluid injection device.
  • the control device may be programmed to withdraw a preset fluid volume from the vial into the peristaltic pump.
  • the control device may be programmed to, when the injection setting is activated, dispense the preset fluid volume from the peristaltic pump into the fluid injection device.
  • the peristaltic pump dispenses the fluid volume into the fluid injection device when the injection setting is activated and ceases dispensing the fluid volume when the injection setting is deactivated.
  • the fluid control switch has an aspiration setting configured to, when the aspiration setting is activated, send an aspiration signal to the control device triggering the peristaltic pump to withdraw an aspiration fluid volume into the fluid injection device from a tissue.
  • the control device may be programmed to withdraw a preset aspiration fluid volume from the tissue into the peristaltic pump.
  • the control device may be programmed to, when the aspiration setting is activated, withdraw the preset aspiration fluid volume from the tissue into the peristaltic pump.
  • the peristaltic pump withdraws the aspiration fluid volume into the fluid injection device when the aspiration setting is activated and ceases withdrawing the fluid volume when the aspiration setting is deactivated.
  • the fluid control switch includes an injection button (e.g., injection button 120) and an aspiration button (e.g., aspiration button 124).
  • the injection button activates the injection setting when depressed and deactivates the injection setting when not depressed
  • the aspiration button activates the aspiration setting when depressed and deactivates the aspiration setting when not depressed.
  • the fluid control switch is coupled between the injection tube and the injection needle.
  • the needle includes a fluid drawing needle coupled to the fluid withdrawal tube and a venting needle (e.g., vent tube 136) coupled to the fluid drawing needle.
  • the fluid drawing needle is configured to pierce the vial of fluid; and withdraw the fluid volume from the vial. The venting needle may pierce the vial of fluid and enable a passage of gas between the vial and an outside atmosphere.
  • pumps 152 have input and outputs (e.g., input ports and output ports).
  • control device 104 has a pump 152 with an input of pump 152 coupled to one end of fluid withdrawal conduit 144 and an output of pump 152 coupled to one end of fluid injection conduit 148.
  • the opposite end of fluid withdrawal conduit 144 is coupled to fluid withdrawal device 112 and the opposite end of fluid injection conduit 148 is coupled to fluid injection/aspiration device 108.
  • Components of the injection system 100 may be electronically coupled to enable electronic communication.
  • one or more electrical connectors 176 electronically couple control device 104 to pressure sensor 156 and one or more switches 116.
  • the one or more electrical connectors 176 can be separate connectors/wires each coupled to separate system elements or can be a bundle of separate connectors/wires coupled to separate system elements.
  • one end of an electrical connector 176 is connected to pressure sensor 156 and one end of a separate electrical connector 176 is connected to one or more switches 116.
  • each of injection button 120 and aspiration button 124 has its own electrical connector 176 to enable coupling to control device 104.
  • electrical connectors 176 may be coupled to sensors coupled to fluid withdrawal device 112, as further described with reference to FIG. 4C.
  • electrical connector 176 To couple the components to control device 104, the opposite ends of electrical connectors 176 are coupled to control device 104 at an electrical port 180. Although illustrated as separate from the fluid injection conduit 148, in other implementations, electrical connector 176 can be disposed onto or within a portion of fluid injection conduit 148 so as to be essentially unitary with fluid injection conduit 148 along a length of the conduit.
  • the one or more electrical connectors 176 send and receive communication/control signals between control device 104 and the various system elements as well as provide power to one or more switches 116 and pressure sensor 156 from control device 104.
  • control device 104 is configured to wirelessly communicate with one or more switches 116, pressure sensor 156, and/or the sensors coupled to fluid withdrawal device 112. In this implementation, some or all of the one or more electrical connectors 176 are not included in the injection system 100.
  • pressure sensor 156 can be a separate component that is coupled between portions (e.g., pieces) of fluid injection conduit 148.
  • a first portion (e.g., piece) of fluid injection conduit 148 may be configured to be coupled between injection needle 128 and a first end of pressure sensor 156 and a second portion (e.g., piece) of fluid injection conduit 148 may be configured to be coupled between pump 152 and a second end of pressure sensor 156.
  • An electrical connector 176 may be configured to be coupled to a third end of pressure sensor 156 to provide a connection to control device 104.
  • FIG. 2 a view of control device 104 of FIGS. 1A-B is shown.
  • the implementation illustrated in FIG. 2 is a dual pump implementation in which, control device 104 can use two pumps 152 to perform fluid withdrawal, injection and aspiration functions.
  • the pumps 152 include at least one peristaltic pump.
  • Peristaltic pumps can be used for injection system 100 for a variety of reasons.
  • peristaltic pumps can utilize a short segment of sterile conduit, such as sterile tubing, which can be sequentially compressed by a series of rollers (not shown) to pump the medication. In this manner, the medication comes in contact with the sterile conduit and does not contact the rollers or other pump mechanical parts. This ensures sterility as the conduit can then be disposed of after each procedure and new sterile conduit can be attached.
  • peristaltic pumps are able to pump air in addition to fluid, which enables peristaltic pumps to be self-priming, thereby simplifying setup for each procedure.
  • Peristaltic pumps are also able to pump both in both forward and reverse directions, which allows for fluid withdrawal, injection and aspiration functions.
  • Peristaltic pumps can provide an accurate and repeatable volume for each turn of the pump which enables the injected volume to be measured and tracked by control device 104 without any additional flow meters.
  • control device 104 uses two pumps 152 which are coupled to a single injection conduit via a“Y” piece. To illustrate, the section of injection conduit protruding from the left section (in the orientation of FIG. 2) of the“Y” piece constitutes fluid withdrawal conduit 144 and the opposite section of injection conduit protruding from the right section of the“Y” piece constitutes fluid injection conduit 148.
  • a first pump e.g., pump 152 on the left of FIG. 2 is configured to be coupled to a first conduit (e.g., fluid injection conduit 148) and a second conduit (e.g., fluid withdrawal conduit 144).
  • a second pump e.g., pump 152 on the right of FIG. 2 is configured to be coupled to a third conduit (e.g., a second fluid injection conduit) and a fourth conduit (e.g., a second fluid withdrawal conduit).
  • the fourth conduit is configured to be coupled to a second fluid withdrawal device.
  • each of the first conduit (e.g., fluid injection conduit 148) and the third conduit (e.g., the second fluid injection conduit) is configured to be coupled to injection needle 128 via a coupler.
  • a coupler may couple the first conduit and the third conduit to a piece of conduit that is coupled to injection needle 128 (thereby combining the fluids provided by the first conduit and the third conduit).
  • the third conduit is configured to be coupled to a second fluid injection/aspiration device including a second injection needle, and the two injection needles are inserted in as close proximity as possible at the injection site (e.g., the human tissue).
  • each pump 152 has a separate vial size selector switch 168 which allows the user to choose which vial size is attached to each pump. Control device 104 can then proportion the amount of local anesthetic drawn from each vial as well as the withdrawal rate according to the vial size.
  • one pump can be configured to withdraw anesthetic from a 30mL vial, and the other pump can be configured to withdraw anesthetic from a lOmL vial.
  • control device 104 draws anesthetic from the 30mL vial at a faster flow rate than from the lOmL vial so that both vials are emptied at approximately the same time.
  • the dual pump configuration also allows for the mixing of multiple concentrations of local anesthetic, which is commonly performed for some peripheral nerve blocks.
  • each vial size selector switch 168 has three selection options: OFF, lOmL vial, and 30mL vial. A selection of OFF deactivates the corresponding pump 152 while a selection of lOmL vial and 30mL vial is used when the corresponding pump 152 is coupled to a particular vial size.
  • additional vial size selection options e.g., other than lOmL and 30 mL may be provided for the vial size selector switches 168.
  • alarm pressure adjustment knob 164 is configured to increase the alarm threshold pressure level by turning the knob in a clockwise direction (denoted by a“+“ sign) and to decrease the alarm threshold pressure level by turning the knob in a counterclockwise direction (denoted by a sign).
  • the alarm threshold pressure level can be adjusted in units of pounds per square inch (PSI) and displayed in real time via display 160.
  • control device 104 can automatically set the alarm pressure threshold level based on the sizes of the vials connected to the pumps 152 and the type of medication contained in the vials.
  • control device 104 may set the alarm threshold pressure level at one pressure value when a lOmL vial is attached and a different pressure value when a 30mL vial is attached. This may enable the pumps 152 to pump medication from the 30mL vial at a higher pressure than from the lOmL vial to enable proportional injection of the medication as discussed above.
  • FIGS. 3A-B show various views of an example of fluid injection/aspiration device 108 of FIGS. 1A-1B.
  • one or more switches 116 include two buttons (i.e., injection button 120 and aspiration button 124) located near injection needle 128.
  • body 107 (which includes one or more switches 116) can be removably coupled to injection needle 128 via connector 184.
  • fluid injection conduit 148 is configured to be coupled to injection needle 128 via the connector 184, and body 107 is external to fluid injection conduit 148.
  • Connector 184 can be threaded or can use other suitable means to securely attach injection needle 128 to the connector 184 and enable removal of injection needle 128 from the connector 184 after use.
  • new and sterile fluid injection needles can be easily attached to connector 184 and used fluid injection needles can be easily detached from connector 184 for disposal.
  • injection button 120 and aspiration button 124 can control the injection and aspiration functions of fluid injection/aspiration device 108, respectively.
  • Such a configuration allows a single operator to control these functions while also positioning injection needle 128 into a tissue (e.g., an injection site) with one hand. The operator’s second hand is thus left free to control an ultrasound probe for imaging the tissue to determine the injection location, thereby allowing a peripheral nerve block injection to be performed and controlled by a single operator.
  • injection button 120 and aspiration button 124 are connected to fluid injection/aspiration device 108 with various electrical connectors 176 (e.g., wires) that run alongside fluid injection conduit 148.
  • injection button 120 When depressed by the user, injection button 120 causes fluid injection/aspiration device 108 to provide the first control signal to control device 104, and control device 104 causes injection of local anesthetic into the tissue through injection needle 128. Fluid injection/aspiration device 108 continues injecting fluid (e.g., providing the first control signal) as long as injection button 120 is depressed. The fluid injection rate and pressure is determined and controlled by control device 104 and pump 152. When injection button 120 is released, fluid injection/aspiration device 108 ceases fluid injection (e.g., one or more switches 116 transition into the third/standby operating state and the first control signal is no longer provided).
  • fluid injection/aspiration device 108 When depressed by the user, injection button 120 causes fluid injection/aspiration device 108 to provide the first control signal to control device 104, and control device 104 causes injection of local anesthetic into the tissue through injection needle 128. Fluid injection/aspiration device 108 continues injecting fluid (e.g., providing the first control signal) as
  • fluid injection/aspiration device 108 When aspiration button 124 is depressed, fluid injection/aspiration device 108 provides the second control signal to control device 104, and control device 104 causes withdrawal of a pre-specified volume of fluid from the tissue (for example, approximately lmL).
  • the aspiration function enables the user to determine that fluid injection needle 128 has been inserted into desired tissue location for the peripheral nerve block procedure (e.g., inserted into a nerve and not a blood vessel).
  • fluid injection/aspiration device 108 or the injection needle 128 and/or the fluid injection conduit 148) holds the aspiration fluid volume.
  • the aspiration fluid volume is returned to the tissue so that any negative pressure is released.
  • a first user would control an ultrasound probe and position an injection needle, and a second user would hold a syringe of local anesthetic connected to the injection needle. The second user would perform the injection and aspiration functions once the first user was satisfied with the injection needle location.
  • a single operator can now control the ultrasound probe, position the needle at the desired tissue site, and control injection and aspiration of fluid to and from the tissue site.
  • FIGS. 4A-C show various views of an example of fluid withdrawal device 112 of FIGS. 1A-1B.
  • Fluid withdrawal device 112 includes a fluid drawing needle 132 having a distal end 133 and a proximal end 135 and a vent tube 136 having a distal end 137 and a proximal end 139.
  • Distal end 133 of fluid drawing needle 132 is configured to be inserted in a fluid container (e.g., vial 140), and the proximal end 135 of fluid drawing needle 132 is configured to be coupled to fluid withdrawal conduit 144.
  • Fluid drawing needle 132 is configured to enable withdrawal of a fluid from vial 140 to fluid withdrawal conduit 144.
  • Vent tube 136 is coupled in a fixed positional relationship with respect to fluid drawing needle 132 and enables fluid communication of air (e.g., a gas) between proximal end 139 of vent tube 136 and distal end 137 of vent tube 136.
  • Distal end 137 is positioned along a longitudinal length of fluid drawing needle 132 such that, when distal end 137 of vent tube 136 is positioned within vial 140, distal end 133 of fluid drawing needle 132 is positioned within the vial.
  • fluid drawing needle 132 is used to access a vial 140 allowing the pumps 152 to draw the medication directly from vial 140 into fluid withdrawal conduit 144.
  • Distal end 133 of fluid drawing needle 132 distal to fluid withdrawal conduit 144 can be sharp and/or tapered and configured to pierce a top of vial 140 to provide a sterile boundary between the outer atmosphere and the medication within vial 140.
  • the proximal end 135 of fluid drawing needle 132 is configured to be removably coupled to fluid withdrawal conduit 144 via a connector or coupler, similar to the connector 184 of FIGS. 3 A and 3B.
  • fluid drawing needle 132 is coupled to vent tube 136.
  • vent tube 136 may be coupled to fluid drawing needle 132 via fastener 188.
  • Fastener 188 may include tape, a clip, a weld, an adhesive, or a combination thereof, as non limiting examples.
  • the proximal end 135 of fluid drawing needle 132 is coupled to vent tube 136 via a coupler configured to couple fluid drawing needle
  • vent tube 136 is integrally formed with fluid drawing needle 132.
  • a longitudinal length of vent tube 136 is disposed adjacent to a longitudinal length of fluid drawing needle 132 and extends along a portion of the longitudinal length of fluid drawing needle 132.
  • distal end 137 of vent tube 136 can be sharp and/or tapered and configured to pierce the top of vial 140 along with distal end 133 of fluid drawing needle 132.
  • distal end 137 of vent tube 136 may be rounded or flat and may enter vial 140 through a hole created by fluid drawing needle 132.
  • vent tube 136 has a longitudinal length shorter than fluid drawing needle 132 or vent tube 136 is positioned such that distal end 137 of vent tube 136 avoids insertion in the liquid contained within vial 140.
  • distal end 137 of vent tube 136 avoids insertion in the liquid contained within vial 140.
  • Distance d can be greater than or equal to, or substantially greater than, any of 0.5 centimeters (cm), 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm, 6.5 cm, 7 cm, 7.5 cm, 8 cm,
  • distance d is greater than or equal to 0 cm. Additionally, or alternatively, distance d can be less than or equal to, or substantially less than, any of 20 cm, 19.5 cm, 19 cm, 18.5 cm, 18 cm, 17.5 cm, 17 cm, 16.5 cm, 16 cm, 15.5 cm, 15 cm, 14.5 cm, 14 cm, 13.5 cm, 13 cm, 12.5 cm, 12 cm, 11.5 cm, 11 cm, 10.5 cm, 10 cm, 9.5 cm, 9 cm, 8.5 cm, 8 cm, 7.5 cm, 7 cm, 6.5 cm, 6 cm, 5.5 cm, 5 cm, 4.5 cm, 4 cm, 3.5 cm, 3 cm, 2.5 cm, 2 cm, 1.5 cm, and 1 cm.
  • the distance d is at least 0.5 cm and/or is less than or equal to 20 cm.
  • fluid drawing needle 132 and vent tube 136 can have the same longitudinal length and/or have different lengths but be configured to both be inserted into the liquid.
  • vent tube 136 is hollow and includes a vent port 192 (e.g., a vent) configured to protrude external to an interior of vial 140 when both distal end 133 of fluid drawing needle 132 and distal end 137 of vent tube 136 are disposed within vial 140.
  • the vent port 192 is configured to allow air or other gas(es) to pass through vent tube 136 into vial 140 while liquid is being withdrawn into fluid drawing needle 132, thereby preventing the formation of a vacuum inside vial 140. Allowing the liquid to be drawn directly from vial 140 greatly simplifies the setup prior to performing the peripheral nerve block.
  • fluid withdrawal device 112 includes a pressure sensor 194 coupled to fluid drawing needle 132 or vent tube 136.
  • Pressure sensor 194 is configured to measure a pressure within vial 140 when distal end 137 of vent tube 136 is positioned within vial 140.
  • Pressure sensor 194 may be electronically coupled to control device 104 (e.g., via an electrical connector 176) and configured to provide pressure data generated by pressure sensor 194 to control device 104.
  • Control device 104 may be configured to initiate output of the pressure within vial 140 via display 160. Additionally, or alternatively, control device 104 may be configured to operate the pumps 152 to cease (or slow down) withdrawal of fluid from vial 140 if the pressure within vial 140 satisfies (e.g., is greater than or equal to) a threshold.
  • fluid withdrawal device 112 includes a fluid level sensor 196 coupled to fluid drawing needle 132 and/or vent tube 136.
  • Fluid level sensor 196 is configured to detect a fluid level of the fluid in vial 140.
  • Fluid level sensor 196 may be electronically coupled to control device 104 (e.g., via an electrical connector 176) and configured to provide fluid level data generated by fluid level sensor 196 to control device 104.
  • Control device 104 may be configured to initiate output of the fluid level within vial 140 via display 160. Additionally, or alternatively, control device 104 may be configured to cease (or slow down) withdrawal of fluid from vial 140 if the fluid level within vial 140 satisfies (e.g., is less than or equal to) a threshold.
  • fluid withdrawal device 112 includes a pressure release valve 198 coupled to vent tube 136.
  • Pressure release valve 198 is configured to maintain a pressure within vial 140 to be less than or equal to a pressure threshold when distal end 137 of vent tube 136 is positioned within vial 140. If the pressure within vial 140 satisfies a particular threshold, pressure release valve 198 opens, allowing fluid to flow out pressure release valve 198 to reduce pressure within vial 140. Alternatively, pressure release valve 198 may enable air (or another gas) to enter vial 140 to reduce the pressure within vial 140.
  • fluid withdrawal device 112 also includes a second vent tube coupled in a fixed positional relationship with respect to fluid drawing needle 132.
  • the second vent tube includes a distal end and a proximal end and is configured to enable fluid communication of air (or other gasses) between the proximal and distal ends.
  • the distal end of the second vent tube is positioned along the longitudinal length of fluid drawing needle 132 at the particular distance (e.g., the distance d ) from distal end 133 of fluid drawing needle 132 such that when the distal end of the second vent tube is positioned within vial 140 distal end 133 of fluid drawing needle 132 is positioned within vial 140.
  • the second vent tube may provide additional pressure relief capabilities or act as a backup in case vent tube 136 becomes plugged up and unable to enable air to enter vial 140.
  • fluid drawing needle 132 (and in some implementations, vent tube 136) pierce a lid of vial 140 (e.g., a fluid container). Distal end 133 of fluid drawing needle 132 is inserted into a fluid within vial 140 without inserting distal end 137 of vent tube 136 into the fluid.
  • Control device 104 (responsive to a control signal from fluid injection/aspiration device 108) operates the pumps 152 to cause fluid to be removed from vial 140 via fluid drawing needle 132. Concurrently with removal of the fluid, air (or other gasses) is enabled to flow into vial 140 via vent tube 136. Additionally, a pressure within vial 140 is measured via pressure sensor 194 to generate pressure data that is provided to control device 104. In some implementations, a fluid level within vial 140 is measured via fluid level sensor 196 and fluid level data is provided to control device 104.
  • fluid withdrawal device 112 of FIGS. 4A-4C enables withdrawal of fluid without creating a vacuum within a fluid container, such as vial 140. Because the pressure in vial 140 is controlled, fluid (e.g., liquid medicine, such as anesthesia) can be withdrawn by pumps 152, which eliminates the need for a user to withdraw fluid from vial 140 using a syringe, which can inadvertently cause bubbles to be included in the withdrawn fluid.
  • fluid e.g., liquid medicine, such as anesthesia
  • a fluid withdrawal device (e.g., fluid withdrawal device 112) includes a needle (e.g., fluid drawing needle 132) including a distal end (e.g., distal end 133) configured to be inserted in a fluid container (e.g., vial 140) and including a proximal end (e.g., proximal end 135) configured to be coupled to a conduit (e.g., fluid withdrawal conduit 144).
  • the needle is configured to enable withdrawal of a fluid from the fluid container to the conduit.
  • the fluid withdrawal device includes a vent tube (e.g., vent tube 136) coupled in a fixed positional relationship with respect to the needle.
  • the vent tube includes a distal end (e.g., distal end 137) and a proximal end (e.g., proximal end 139) and is configured to enable fluid communication of air between the proximal end (e.g., proximal end 139) and the distal end (e.g., distal end 137).
  • the distal end (e.g., distal end 137) of the vent tube is positioned along a longitudinal length of the needle at a particular distance (e.g., distance d ) from the distal end (e.g., distal end 133) of the needle such that, when the distal end (e.g., distal end 137) of the vent tube is positioned within the fluid container, the distal end (e.g., distal end 133) of the needle is positioned within the fluid container.
  • the fluid withdrawal device also includes a pressure sensor (e.g., pressure sensor 194) coupled to the needle or the vent tube and configured to measure a pressure within the fluid container when the distal end of the vent tube is positioned within the fluid container.
  • a fluid withdrawal device (e.g., fluid withdrawal device 112) includes a drawing needle (e.g., fluid drawing needle 132) and a venting needle (e.g., vent tube 136) disposed adjacent to the drawing needle.
  • the venting needle includes a distal end (e.g., distal end 137) positioned along a longitudinal length of the drawing needle at a distance d from a distal end (e.g., distal end 133) of the drawing needle.
  • the distance d is 0 cm. In other implementations, the distance d is at least 0.5 cm. Additionally, or alternatively, the distance d is not greater than 20 cm.
  • the venting needle is coupled to the drawing needle.
  • the venting needle is coupled to the drawing needle by a fastener (e.g., fastener 188).
  • the fastener may include tape, a clip, a weld, an adhesive, or a combination thereof.
  • the venting needle is integrally formed with the drawing needle.
  • the drawing needle includes a proximal end (e.g., proximal end 135) opposite its distal end (e.g., distal end 133), and the proximal end of the drawing needle is attached, or configured for removable attachment, to a fluid withdrawal tube (e.g., fluid withdrawal conduit 144).
  • the venting needle includes a proximal end (e.g., proximal end 139) opposite its distal end (e.g., distal end 137).
  • the proximal end of the venting needle includes a vent, and the vent is configured to protrude external to an interior of a vial (e.g., vial 140) when both distal ends of the drawing needle and vent tube are disposed within the vial.
  • FIGS. 5-8 show examples of methods of operating an injection system, such as the injection system 100 of FIGS. 1A and 1B.
  • FIG. 5 is an example of a method of operating an injection system to dispense fluid.
  • FIG. 6 is an example of a method monitoring pressure in an injection system.
  • FIG. 7 is an example of a method of operating an injection system to dispense fluid.
  • FIG. 8 is an example of a method of operating an injection system to aspirate fluid.
  • FIG. 5 illustrates a method 500 of operating an injection system.
  • the method 500 may be performed by control device 104, pump 152, or a combination thereof, of the injection system 100 of FIGS. 1A-1B.
  • the method 500 includes receiving an injection control signal (e.g., a first control signal), at 502.
  • control device 104 may receive an injection control signal from one or more switches 116.
  • control device 104 receives the injection control signal from injection button 120 when depressed.
  • Method 500 includes sending a fluid withdrawal signal, at 504.
  • control device 104 may process the injection signal and provide a fluid withdrawal signal to a pump 152 coupled to fluid withdrawal device 112.
  • Method 500 includes withdrawing fluid volume with a peristaltic pump, at 506.
  • pump 152 may apply a force to withdraw a fluid volume or amount from vial 140 via fluid withdrawal device 112.
  • Method 500 further includes dispensing fluid volume with the peristaltic pump, at 508.
  • pump 152 may dispense the fluid volume to fluid injection/aspiration device 108.
  • FIG. 6 illustrates a method 600 of monitoring fluid injection pressure of an injection system.
  • method 600 may be performed by the pressure sensor 156, the control device 104 (including the display 160), or a combination thereof, of injection system 100 of FIGS. 1A-1B.
  • Method 600 includes monitoring a fluid injection pressure, at 602.
  • pressure sensor 156 may monitor the pressure within fluid injection conduit 148 using one or more pressure sensors.
  • Method 600 includes displaying fluid volume and/or fluid injection pressure, at 604.
  • control device 104 may receive pressure data indicating a fluid injection pressure value from pressure sensor 156, and control device 104 may initiate output of the fluid volume dispensed and/or the current fluid injection pressure via display 160.
  • Method 600 includes determining fluid pressure relative to a fluid threshold, at 606.
  • control device 104 may compare the current fluid injection pressure value to an alarm fluid pressure threshold.
  • Method 600 also includes issuing a fluid pressure alarm, at 608.
  • control device 104 may issue an alarm via display 160 or an alarm device when the current fluid injection pressure approaches and/or reaches the alarm fluid pressure threshold.
  • FIG. 7 illustrates a method 700 of operating an injection system.
  • method 700 may be performed by control device 104, pump 152, fluid injection/aspiration device 108, or a combination thereof, of injection system 100 of FIGS. 1A- 1B.
  • Method 700 includes determining that an injection setting is activated, at 702.
  • control device 104 may determine that an injection setting is activated.
  • control device 104 determines that an injection setting is activated when an injection control signal (e.g., a first control signal) is received from one or more switches 116.
  • the injection control signal is received when injection button 120 is depressed.
  • Method 700 includes dispensing fluid volume into a fluid injection device, at 704.
  • control device 104 may operate a pump 152 coupled to fluid injection/aspiration device 108 to dispense fluid volume into fluid injection/aspiration device 108 (or to fluid injection conduit 148 to which fluid injection/aspiration device 108 is coupled).
  • Method 700 includes determining that the injection setting is deactivated, at 706.
  • control device 104 may determine that an injection setting is deactivated, such as by determining that an injection control signal is not being continuously or periodically received.
  • control device 104 determines that an injection setting is deactivated when one or more switches 116 are disposed in a third configuration, such as when injection button 120 is released.
  • Method 700 further includes ceasing dispensing fluid volume into the fluid injection device, at 708.
  • control device 104 may cause pump 152 to cease to dispense the fluid volume into fluid injection/aspiration device 108 (or to fluid injection conduit 148 to which fluid injection/aspiration device 108 is coupled).
  • FIG. 8 illustrates method 800 of operating an injection system.
  • method 800 may be performed by control device 104, pump 152, fluid injection/aspiration device 108, or a combination thereof, of injection system 100 of FIGS. 1A- 1B.
  • Method 800 includes determining that an aspiration setting is activated, at 802.
  • control device 104 may determine that an aspiration setting is activated.
  • control device 104 may determine that an aspiration setting is activated when an aspiration control signal (e.g., a second control signal) is received from one or more switches 116.
  • an aspiration control signal e.g., a second control signal
  • the aspiration control signal is received when aspiration button 124 is depressed.
  • Method 800 includes withdrawing fluid volume from tissue, at 804.
  • control device 104 may operate a pump 152 coupled to fluid injection/aspiration device 108 to aspirate/withdraw a preset fluid volume from the tissue through injection needle 128 into fluid injection/aspiration device 108 (or into the injection needle 128 and/or the fluid injection conduit 148).
  • Method 800 includes determining that the aspiration setting is deactivated, at 806.
  • control device 104 may determine that an aspiration setting is deactivated.
  • control device 104 may determine that an aspiration setting is deactivated when an aspiration signal is not received continuously or periodically from one or more switches 116.
  • control device 104 determines that the aspiration setting is deactivated when aspiration button 124 is released and the preset aspiration fluid volume has been aspirated.
  • Method 800 includes ceasing withdrawing the fluid volume from the tissue, at 808.
  • control device 104 may cause pump 152 to cease to withdraw fluid volume from the tissue into fluid injection/aspiration device 108 (or into the injection needle 128 and/or the fluid injection conduit 148).
  • Method 800 further includes injecting the fluid volume back into the tissue, at 810.
  • control device 104 may operate pump 152 to inject the aspirated fluid volume from fluid injection/aspiration device 108 (or the injection needle 128 and/or the fluid injection conduit 148) back into the tissue.
  • FIGS. 5-8 provide methods of operating an injection system that allow a single operator to perform a procedure, such as a PNB injection, that includes injection and aspiration.
  • the methods 500-800 enable the operator to select operating states (e.g., injection or aspiration) through manipulation of one or more switches held in a hand that holds an injection needle.
  • the methods provide a simple and quick way to change between injection or aspirating fluids without stopping a procedure and without requiring a second operator.
  • the methods of FIGS. 5-8 enable the operator to monitor pressure in a conduit of the injection system and receive an alarm if the pressure reaches a threshold, thereby reducing or preventing damage to nerves that has been shown to correlate with higher injection pressures.
  • Injection system 100 includes control device 104, one or more switches 116, the pumps 152, pressure sensor 156, and fluid withdrawal device sensors 910.
  • Fluid withdrawal device sensors 910 include pressure sensor 194, fluid level sensor 196, pressure release valve 198 of FIG. 4C, or a combination thereof.
  • Control device 104 includes a processor 902 and a memory 904 coupled to processor 902. Processor 902 and the memory 904 may be coupled together via a bus or other interface.
  • the memory 904 includes a volatile memory, a non-volatile memory, or a combination thereof.
  • the memory 904 is configured to store computer-readable instructions that cause processor 902 to perform the operations described herein.
  • Control device 104 includes display 160 described with reference to FIGS. 1A, 1B, and 2. Display 160 is coupled to processor 902.
  • Control device 104 includes switches 906 coupled to processor 902. The switches 906 are configured to enable a user to set various values used by processor 902 to perform operations, such as various thresholds.
  • the switches 906 include the vial size selector switches 168 and alarm pressure adjustment knob 164 of FIGS.1A, 1B, and 2.
  • Control device 104 optionally includes an input/output (I/O) port 908.
  • the I/O port 908 may include or correspond to the electrical port 180 of FIG. 1B.
  • the I/O port 908 is configured to be coupled to electrical connectors that couple control device 104 (e.g., processor 902) to one or more switches 116, the pumps 152, pressure sensor 156, and fluid withdrawal device sensors 910 and to provide input signals and/or to receive output signals to/from one or more switches 116, the pumps 152, pressure sensor 156, and fluid withdrawal device sensors 910..
  • the I/O port 908 is replaced with a network interface, and control device 104 is configured to wirelessly communicate with one or more switches 116, the pumps 152, pressure sensor 156, and fluid withdrawal device sensors 910.
  • processor 902 is configured to monitor for control signals from one or more switches 116. As described with reference to FIGS. 1 A-1B, one or more switches 116 are coupled to body 107, and body 107 is coupled to fluid injection conduit 148. When one or more switches 116 are configured in a first configuration, processor 902 receives a first control signal 920 from one or more switches 116.
  • Processor 902 based on first control signal 920, operates the pumps 152 to withdraw a first fluid from a first fluid source (e.g., vial 140) coupled via a fluid removal device (e.g., fluid withdrawal device 112) to a second conduit (e.g., fluid withdrawal conduit 144) and to provide the first fluid to an injection site via a needle (e.g., injection needle 128) coupled to a first conduit (e.g., fluid injection conduit 148).
  • processor 902 may imitate transmission of one or more pump controls signals 924 to the pumps 152 to cause the pumps 152 to withdraw a first fluid (e.g., anesthetic) from vial 140 via fluid withdrawal device 112 and to provide the first fluid to the injection site via injection needle 128.
  • a first fluid e.g., anesthetic
  • one or more pump control signals 924 may correspond to a current that processor 902 causes to be provided to the pumps 152 to operate the pumps 152.
  • the processor receives a second control signal 922 from one or more switches 116.
  • Processor 902 based on second control signal 922, operates the pumps 152 to aspirate a second fluid from the injection site via the needle (e.g., injection needle 128).
  • processor 902 may provide a pump control signal 924 (or a particular current) that causes the pumps to operate in the opposite direction in order to aspirate the second fluid via injection needle 128.
  • processor 902 continuously or periodically receives first control signal 920 while one or more switches 122 are in the first configuration (or continuously or periodically receives second control signal 922 while the one or more switches are in the second configuration). If processor 902 does not receive either first control signal 920 or second control signal 922 for a particular duration of time, processor 902 determines that one or more switches 122 are configured in a third configuration. Based on the determination, processor 902 ceases operation of the pumps 152. For example, processor 902 ceases to provide one or more pump control signals 924 to the pumps 152.
  • processor 902 receives pressure data 926 from pressure sensor 156.
  • pressure sensor 156 may measure a pressure within fluid injection conduit 148 and generate pressure data 926 that indicates the pressure.
  • Processor 902 receives pressure data 926 and processes pressure data 926 for output via display 160. For example, processor 902 may initiate output of an indication of the pressure via display 160.
  • Processor 902 may also compare the pressure to a pressure threshold and, if the pressure satisfies (e.g., is greater than or equal to) the pressure threshold, processor 902 imitates an alarm via display 160 and/or via an alarm device, such as a visual indication device, an audio indication device, a tactile indication device, or a combination thereof. Additionally, or alternatively, processor 902 may cease operation of the pumps 152 responsive to the pressure satisfying the pressure threshold.
  • the pressure threshold may be set based on an input from the switches 906 (e.g., alarm pressure adjustment knob 164).
  • processor 902 receives sensor data 928 from fluid withdrawal device sensors 910.
  • Sensor data 928 may include second pressure data from pressure sensor 194 or fluid level data from fluid level sensor 196 of FIG. 4C.
  • Processor 902 processes sensor data 928 and performs one or more operations based on sensor data 928. For example, processor 902 may initiate output of a volume of fluid withdrawn from vial 140 (or a volume of fluid remaining in vial 140) via display 160 based on the fluid level data. Additionally, or alternatively, processor 902 may cease operation of the pumps 152 (e.g., cease withdrawal of fluid) if the volume of fluid remaining (or withdrawn) satisfies a threshold (e.g., a selected fluid container size).
  • a threshold e.g., a selected fluid container size
  • processor 902 may initiate output of an alarm, via display 160 or an alarm device, based on a pressure indicated by the second pressure data satisfying a threshold. Additionally, or alternatively processor 902 may cease operations of the pumps 152, open pressure release valve 198 of FIG. 4C, or both, based on the pressure satisfying the threshold.
  • FIG. 9 describes operations performed by control device 104 to enable operation of the injection system 100.
  • the injection system 100 enables quick and easy selection of an operating state (e.g., injection, aspiration, etc.) and enables a complicated procedure, such as a peripheral nerve block, to be performed by a single operator.
  • an operating state e.g., injection, aspiration, etc.
  • a complicated procedure such as a peripheral nerve block
  • a peripheral nerve block injection system (e.g., injection system 100) includes a fluid injection/aspiration device (e.g., fluid injection/aspiration device 108) and a control device (e.g., control device 104).
  • the fluid injection/aspiration device includes a body (e.g., body 107) configured to be coupled to a needle (e.g., injection needle 128) and a first conduit (e.g., fluid injection conduit 148) and one or more switches (e.g., one or more switches 116) coupled to the body.
  • the one or more switches in a first configuration provides a first control signal (e.g., first control signal 920) to indicate a first operating state in which a first flow direction from the first conduit to the needle is established for providing a first fluid to an injection site via the needle.
  • the one or more switches in a second configuration provides a second control signal (e.g., second control signal 922) to indicate a second operating state in which a second flow direction from the injection site via the needle to the first conduit is established for aspirating a second fluid.
  • the control device includes at least one pump (e.g., pump 152) configured to be coupled to the first conduit and to a second conduit (e.g., fluid withdrawal conduit 144).
  • the control device also includes at least one processor (e.g., processor 902) coupled to the at least one pump.
  • the at least one processor is configured to monitor for control signals from the one or more switches, receive the first control signal from the one or more switches, based on the first control signal, operate the at least one pump to withdraw the first fluid from a first fluid source coupled via a fluid withdrawal device to the second conduit and to provide the first fluid to the injection site via the needle, receive the second control signal, and based on the second control signal, operate the at least one pump to aspirate the second fluid from the injection site via the needle.
  • a kit 1000 for peripheral nerve block injection systems such as injection system 100 of FIGS. 1A-1B, is shown.
  • the kit includes a fluid injection/aspiration device 1004, electrical connectors 1008, and a first conduit 1010.
  • Fluid injection/aspiration device 1004 includes one or more switches 1006.
  • fluid injection/aspiration device 1004, one or more switches 1006, electrical connectors 1008, and first conduit 1010 may include or correspond to fluid injection/aspiration device 108, one or more switches 116, the one or more electrical connectors 176, and fluid injection conduit 148 of FIGS. 1A-1B.
  • Fluid injection/aspiration device 1004 includes a body configured to be coupled to a needle and/or to first conduit 1010.
  • the body also includes one or more switches 1006 coupled to the body.
  • One or more switches 1006 in a first configuration provides a first control signal to indicate a first operating state in which a first flow direction from first conduit 1010 to the needle is established for providing a first fluid to an injection site via the needle.
  • One or more switches 1006 in a second configuration provides a second control signal to indicate a second operating state in which a second flow direction from the injection site via the needle to first conduit 1010 is established for aspirating a second fluid.
  • kit 1000 also includes the needle configured to be coupled to a first end of first conduit 1010.
  • kit 1000 may include a package 1002.
  • package 1002 may include a box, a bag, a container, or the like. Additionally, or alternatively, package 1002 may include a packaging medium (e.g., packaging material), such as foam, paper, or the like.
  • package 1002 may also include fluid injection/aspiration device 1004, electrical connectors 1008, and first conduit 1010.
  • package 1002 may also include one or more additional elements, as further described herein.
  • kit 1000 may include a pressure sensor 1012. The pressure sensor is configured to be coupled to first conduit 1010.
  • pressure sensor 1012 may include or correspond to pressure sensor 156 of FIGS. 1A-1B.
  • kit 1000 may include a fluid withdrawal device 1014.
  • Fluid withdrawal device 1014 may include or correspond to fluid withdrawal device 112 of FIGS. 1A-1B and 4A-4C.
  • Fluid withdrawal device 1014 includes a second needle including a distal end configured to be inserted in a fluid container and including a proximal end configured to be coupled to a second conduit 1018. The second needle is configured to enable withdrawal of fluid from the fluid container to second conduit 1018.
  • Fluid withdrawal device 1014 also includes a vent tube coupled in a fixed positional relationship with respect to the second needle. The vent tube includes a distal end and a proximal end and is configured to enable fluid communication of air between the proximal end and the distal end.
  • the distal end of the vent tube is positioned along a longitudinal length of the second needle at a particular distance from the distal end of the second needle such that when the distal end of the vent tube is positioned within the fluid container the distal end of the second needle is positioned within the fluid container.
  • kit 1000 may include second conduit 1018.
  • Kit 1000 may also include fluid withdrawal device sensor(s) 1016.
  • the fluid withdrawal device sensor(s) 1016 may include a pressure sensor configured to be coupled to the second needle or the vent tube and configured to measure a pressure within the fluid container, a pressure release valve configured to be coupled to the vent tube and configured to maintain a pressure within the fluid container to be less than or equal to a threshold pressure when the distal end of the vent tube is positioned within the fluid container, a fluid level sensor configured to be coupled to the second needle and/or the vent tube and configured to detect a fluid level of the fluid in the fluid container, or a combination thereof.
  • the fluid withdrawal device sensor(s) 1016 may include or correspond to pressure sensor 194, fluid level sensor 196, and/or pressure release valve 198 of FIG. 4C.
  • kit 1000 may include a control device 1020.
  • Control device 1020 is configured to be coupled to one or more switches 1006 via electrical connectors 1008.
  • Control device 1020 includes at least one pump 1022 that is configured to be coupled to first conduit 1010.
  • control device 1020 and the at least one pump 1022 may include or correspond to control device 104 and the pumps 152 of FIGS. 1A-1B and 2.
  • FIG. 10 describes a kit for a peripheral nerve block injection system that includes a fluid injection/aspiration device.
  • the fluid injection/aspiration device includes one or more switches that enable a user to select an operating mode with the same hand used to hold an injection needle.
  • the user may quickly and easily select an operation mode (e.g., by manipulating the one or more switches) without having to stop the procedure, and the user’s other hand is free to hold an ultrasound probe, thereby enabling a single person (e.g., the user) to perform a peripheral nerve block injection.
  • an operation mode e.g., by manipulating the one or more switches
  • the user’s other hand is free to hold an ultrasound probe, thereby enabling a single person (e.g., the user) to perform a peripheral nerve block injection.
  • FIG. 11 illustrates a method 1100 of operating a fluid injection/aspiration device.
  • the method 1100 may be performed at, by, or with a fluid injection/aspiration device, such as fluid injection/aspiration device 108 of FIGS. 1A-1B and 3A-3B.
  • the method 1100 includes coupling a body including one or more switches to a conduit and/or a needle, at 1102.
  • the conduit is coupled in fluid communication with the needle.
  • body 107 including one or more switches 116 may be coupled to injection needle 128 and/or fluid injection conduit 148.
  • the method 1100 includes transitioning the one or more switches into a first configuration to provide a first control signal to indicate a first operating state in which a first flow direction from the conduit to the needle is established for providing a first fluid to an injection site via the needle, at 1104.
  • one or more switches 116 transition into a first configuration to provide a first control signal (e.g., first control signal 620 of FIG. 9) to control device 104 to indicate a first operating state in which a first flow direction from fluid injection conduit 148 to injection needle 128 is established.
  • Control device 104 may operate the pumps 152 to cause fluid from vial 140 to be provided in the first flow direction to an injection site via injection needle 128, as described with reference to FIGS. 1A, 1B, 2, and 9.
  • the method 1100 further includes transitioning the one or more switches into a second configuration to provide a second control signal to indicate a second operating state in which a second flow direction from the injection site via the needle to the conduit is established for aspirating a second fluid.
  • one or more switches 116 transition into a second configuration to provide a second control signal (e.g., second control signal 622 of FIG. 9) to control device 104 to indicate a second operating state in which a second flow direction from the injection site via injection needle 128 to fluid injection conduit 148 is established for aspirating a second fluid.
  • the second fluid contains at least a portion of the first fluid.
  • a first fluid e.g., anesthetic
  • the method 1100 includes transitioning the one or more switches into a third configuration to indicate a third operating state in which no flow path is established between the needle and the conduit.
  • a third configuration to indicate a third operating state in which no flow path is established between injection needle 128 and fluid injection conduit 148 (e.g., neither an injection mode nor an aspiration mode is engaged).
  • Transitioning the one or more switches into the first configuration may include transitioning from the third configuration to the first configuration
  • transitioning the one or more switches into the second configuration may include transitioning from the third configuration to the second configuration.
  • one or more switches 116 may be in a third configuration, and responsive to manipulation of one or more switches 116, one or more switches 116 may transition from the third configuration to the first configuration or the second configuration.
  • the one or more switches may include a three-way switch.
  • configuring the various configurations of one or more switches 116 may include or correspond to positioning of a three-way switch.
  • the first control signal is provided from the one or more switches to a control device communicatively coupled to the one or more switches.
  • the first control signal (or the second control signal) may be provided from one or more switches 116 to control device 104, as described with reference to FIGS. 1A, 1B, 2, and 9.
  • a presser sensor may be coupled to the conduit and configured to measure a pressure within the conduit.
  • pressure sensors 156 may be coupled to or disposed within fluid injection conduit 148 and configured to provide pressure data to control device 104, the pressure data indicating a pressure within fluid injection conduit 148.
  • the method 1100 describes operation of a fluid injection/aspiration device.
  • the fluid injection/operation device may be coupled to a fluid injection conduit and/or an injection needle, which may enable a user to quickly and easily select operating modes for the fluid injection/aspiration device using the same hand that holds the injection needle.
  • a user’s other hand may be used to hold and guide an ultrasound device used to determine an injection site, which enables a single person to perform a peripheral nerve block injection.
  • the one or more switches are nearby where the user grips the injection needle, the user is able to easily select operating modes without performing complicated other gestures or stopping the procedure to select an operating mode.
  • FIG. 12 illustrates a method 1200 of operating a control device of a peripheral nerve block injection system.
  • the method 1200 may be performed at, by, or with a control device, such as control device 104 of FIGS. 1A-1B, 2, and 9.
  • the method 1200 includes monitoring, at a control device, for control signals from one or more switches coupled to a body, at 1202.
  • the body is coupled to a first conduit coupled to at least one pump, and the at least one pump is coupled to the control device.
  • control device 104 may monitor for signals from one or more switches 116 coupled to body 107.
  • the method 1200 includes receiving a first control signal at the control device from the one or more switches.
  • control device 104 may receive a first control signal (e.g., first control signal 620 of FIG. 9) from one or more switches 116.
  • the method 1200 includes operating the at least one pump to cause a first fluid to be withdrawn from a fluid source via a fluid removal device coupled to a second conduit coupled to the at least one pump and to provide the first fluid to an injection site via a needle coupled to the first conduit.
  • control device 104 may operate the pumps 152 to cause a first fluid to be withdrawn from vial 140 via fluid withdrawal device 112 and to cause the first flue to be provided to an injection site via injection needle 128.
  • the method 1200 includes receiving a second control signal at the control device from the one or more switches.
  • control device 104 may receive a second control signal (e.g., second control signal 622 of FIG. 9) from one or more switches 116.
  • the method 1200 further includes operating the at least one pump to aspirate a second fluid from the injection site via the needle.
  • control device 104 may operate the pumps 152 to cause aspiration of a second fluid from the injection site via injection needle 128.
  • the method 1200 includes receiving pressure data from a pressure sensor coupled to the first conduit, the pressure data indicating a pressure within the first conduit.
  • control device 104 may receive pressure data (e.g., pressure data 626 of FIG. 9) from pressure sensor 156.
  • the method 1200 includes initiating output of the pressure at a display device of the control device.
  • control device 104 may initiate output of the pressure at display 160.
  • the method 1200 includes initiating an alarm at the control device based on determining that the pressure satisfies a pressure threshold.
  • control device 104 may initiate output of an alarm via display 160 or via an alarm device based on determining that the pressure satisfies (e.g., is greater than or equal to) a pressure threshold.
  • the method 1200 includes setting the pressure threshold based on an input from a pressure setting control of the control device.
  • control device 104 may set the pressure threshold based on an input from alarm pressure adjustment knob 164.
  • the method 1200 includes setting a fluid container size, a maximum amount of fluid withdrawal, or both, based on an input from a fluid container size control of the control device.
  • control device 104 may set a fluid container size, a maximum amount of fluid withdrawal, or both, based on an input from the vial size selector switches 168.
  • the at least one pump includes a plurality of pumps.
  • the at least one pump may include the two pumps 152 (e.g., of the dual pump configuration).
  • a first pump of the plurality of pumps is operated to withdraw the first fluid from the fluid source and to provide the first fluid to the needle.
  • a first pump of the pumps 152 may be operated by control device 104 to withdraw the first fluid from vial 140 and to provide the first fluid to injection needle 128.
  • the method 1200 includes operating a second pump of the plurality of pumps to cause a third fluid to be withdrawn from a second fluid source via a second fluid removal device coupled to the second pump and to provide the third fluid to the needle.
  • control device 104 may operate a second pump of the pumps 152 to cause withdrawal of a third fluid from a second vial and to cause the third fluid to be provided to injection needle 128 (via a second injection conduit).
  • the first fluid and the third fluid may be the same type of fluid, such as the same type of anesthetic in differing concentrations.
  • a first control signal indicates a first operating state of the one or more switches and a second control signal indicates a second operating state of the one or more switches.
  • the first control signal may indicate an injection mode and the second control signal may indicate an aspiration mode.
  • the method 1200 includes receiving an indication of a third operating state of the one or more switches and ceasing operation of the at least one pump to cause no flow path between the fluid source and the needle responsive to the indication of the third operation state.
  • control device 104 may not receive a control signal from one or more switches 116, and control device 104 may cease operation of the pumps 152 to cause to flow path between the fluid source (e.g., vial 140) and injection needle 128.
  • the method 1200 describes operation of a control device of a peripheral nerve block injection system.
  • the method 1200 enables the system to operate in a variety of operating modes based on user input to one or more switches located proximate to a needle held by the user. This enables the user to quickly and easily select an operating state without stopping the procedure while allowing the user’s other hand to be free to operate an ultrasound probe.
  • one or more operations described above with reference to one of the methods of FIGS. 5-8 and 11-12 may be combined with one or more operations of another of FIGS. 5-8 and 11-12.
  • one or more operations of method 500 of FIG. 5 may be combined with one or more operations of method 600 of FIG. 6.
  • one or more operations of the methods of FIGS. 5-8 and 11-12 may be performed serially or concurrently.
  • one or more operations described above with reference FIGS. 1A, 1B, 2, 3A, 3B, 4A, 4B, 4C, 9, and 10 may be combined with one or more operations of FIGS. 5-8 and 11-12, or a combination of FIGS. 5-8 and 11-12.

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Abstract

In a particular aspect, a fluid injection/aspiration device includes a body configured to be coupled to a needle. The fluid injection/aspiration device further includes one or more switches coupled to the body. The one or more switches in a first configuration provides a first control signal that indicates a first operating state in which a first flow direction from a conduit to the needle is established for providing a first fluid to an injection site via the needle. The one or more switches in a second configuration provides a second control signal that indicates a second operating state in which a second flow direction from the injection site via the needle to the conduit is established for aspirating a second fluid.

Description

DESCRIPTION
PERISTALTIC PUMP NERVE BLOCK INJECTION SYSTEM AND RELATED METHODS
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims benefit of U.S. Provisional Patent Application No. 62/648,710, filed March 27, 2018, which is incorporated by reference herein in its entirety.
TECHNICAL FIELD
[0002] This disclosure relates generally to an injection system, but not by way of limitation, to devices, systems and methods for peripheral nerve block injection.
BACKGROUND
[0003] Peripheral nerve blocks (PNBs) are now ubiquitous at hospitals and outpatient surgical centers and thousands of these procedures are performed in the US each day. Continuous PNB catheters only make one fraction of this market, and alone this sector is growing quickly. Growth has been spurred by a combination of factors including better patient satisfaction, lower post-operative pain scores, decreased use of narcotics, and often by enabling surgeons to perform procedures with the patient being only under sedation, thus avoiding general anesthesia in some patients.
[0004] Traditionally a limiting factor in performing PNBs is the need for two operators to perform the block: an anesthesia provider trained in the procedure and additional personnel (another anesthesia provider or an available nurse) who injects medicine and aspirates at the request of the anesthesia provider. There is a need for a device that enables a single operator to perform a PNB and maintain sterility and safety.
SUMMARY
[0005] The present disclosure describes systems, devices, and methods for a peripheral nerve injection system configured to enable administration of a liquid medication, such as a local anesthetic. For example, the peripheral nerve injection system may enable a single operator to administer the liquid medication, which eliminates the need to coordinate having two individuals present for administration of a peripheral nerve block and reduces a cost of operating the system. In some implementations, the systems, devices and methods of the present disclosure significantly reduce the risk of high injection pressures, associated with the rare but serious consequence of intraneural injection, by using an embedded pressure monitor. Additionally, or alternatively, in some implementations, a solution (e.g., a liquid medication) may be directly withdrawn from a vial while maintaining sterility, thus eliminating the need to pre-draw medicine into large syringes and lowering the time required to prepare for a procedure.
[0006] Thus the systems, devices and methods of the present disclosure may not only reduce needed personnel, but may advantageously simplify logistical problems of coordinating workers who are often busy in hospital setting. To illustrate, a single anesthesia provider may have complete autonomy and freedom to perform a peripheral nerve block. Further, the peripheral nerve injection system disclosed herein may provide pressure monitoring, such as continuous pressure monitoring during a procedure, and can provide an alert or stop injection once a particular pressure is reached. This functionality may reduce the rare but potentially deleterious event from damage to nerves, since this has been shown to correlate with higher injection pressures.
[0007] Some embodiments of the present fluid injection/aspiration device comprise: a body configured to be coupled to a needle; and one or more switches coupled to the body. In such embodiments, the one or more switches in a first configuration provides a first control signal that indicates a first operating state in which a first flow direction from a conduit to the needle is established for providing a first fluid to an injection site via the needle, and the one or more switches in a second configuration provides a second control signal that indicates a second operating state in which a second flow direction from the injection site via the needle to the conduit is established for aspirating a second fluid. In some of the foregoing embodiments, the injection/aspiration device further comprises the needle coupled to the body and/or the conduit coupled to the body and in fluid communication with the needle. In some of the foregoing embodiments, the injection site includes tissue. In some of the foregoing embodiments, the first operating state comprises a fluid injection state, the second operating state comprises an aspiration state, and at least one switch of the one or more switches comprises a manually operated switch configured to be operated by a hand of a user. Additionally, or alternatively, the one or more switches comprise multiple switches, where the multiple switches comprise a first switch configured to provide the first control signal and a second switch configured to provide the second control signal. Additionally, or alternatively, at least one switch of the one or more switches comprises a push button switch and the one or more switches are configured to be electronically coupled to a control device. In some of the foregoing embodiments, the one or more switches in a third configuration indicates a third operating state in which no flow path is established between the needle and the conduit. In some of the foregoing embodiments, the body is configured to surround at least a portion of an outer perimeter of the conduit or to be clipped to the portion of the conduit.
[0008] Some embodiments of the present control device comprise at least one pump configured to be coupled to a first conduit and a second conduit; and at least one processor coupled to the at least one pump. In such embodiments, the at least one processor is configured to: monitor for control signals from one or more switches coupled to a body, the body coupled to the first conduit; receive a first control signal from the one or more switches; based on the first control signal, operate the at least one pump to withdraw a first fluid from a fluid source coupled via a fluid removal device to the second conduit and to provide the first fluid to an injection site via a needle coupled to the first conduit; receive a second control signal from the one or more switches; and based on the second control signal, operate the at least one pump to aspirate a second fluid from the injection site via the needle. In some of the foregoing embodiments, the at least one pump comprises at least one peristaltic pump.
[0009] In some of the foregoing embodiments, the control device further comprises a display device coupled to the at least one processor. In such embodiments, the at least one processor is electronically coupled to a pressure sensor coupled to the first conduit and is configured to receive pressure data from the pressure sensor, the pressure data indicating a pressure within the first conduit. The display device is configured to output an indication of the pressure, an indication of a volume of fluid withdrawn from the fluid source, or both. In some such embodiments, the at least one processor is configured to determine whether the pressure satisfies a pressure threshold and the display device is further configured to output an alarm responsive to the pressure satisfying the pressure threshold. In some such embodiments, the control device further comprises a pressure alarm device configured to output an alarm responsive to the pressure satisfying the pressure threshold. In such embodiments, the pressure alarm device comprises a visual indication device, an audio indication device, a tactile indication device, or a combination thereof. Additionally, or alternatively, the control device further comprises a pressure threshold setting control device configured to set the pressure threshold at one of multiple selectable values.
[0010] In some of the foregoing embodiments, the at least one pump comprises a plurality of pumps, and the plurality of pumps comprises: a first pump configured to be coupled to the first conduit and the second conduit; and a second pump configured to be coupled to a third conduit and a fourth conduit, the fourth conduit coupled to a second fluid removal device. In some of the foregoing embodiments, the control device further comprises at least one fluid container size selector switch configured to select a fluid container size from a plurality of fluid container sizes, a fluid volume, or both. In such embodiments, the at least one processor is configured to operate the at least one pump to cease withdrawal of the first fluid from the fluid source responsive to a volume of fluid withdrawn from the fluid source satisfying a selected fluid container size.
[0011] Some embodiments of the peripheral nerve block injection system comprise: a fluid injection/aspiration device; and a control device. In such embodiments, the fluid injection/aspiration device comprises a body configured to be coupled to a needle and to a first conduit; and one or more switches coupled to the body. In such embodiments, the one or more switches in a first configuration provides a first control signal to indicate a first operating state in which a first flow direction from the first conduit to the needle is established for providing a first fluid to an injection site via the needle. In such implementations, the one or more switches in a second configuration provides a second control signal to indicate a second operating state in which a second flow direction from the injection site via the needle to the first conduit is established for aspirating a second fluid. In such implementations, the control device comprises: at least one pump configured to be coupled to the first conduit and a second conduit; and at least one processor coupled to the at least one pump. In such implementations, the at least one processor is configured to: monitor for control signals from the one or more switches; receive the first control signal from the one or more switches; based on the first control signal, operate the at least one pump to withdraw a first fluid from a first fluid source coupled via a fluid removal device to the second conduit and to provide the first fluid to the injection site via the needle; receive the second control signal; and based on the second control signal, operate the at least one pump to aspirate the second fluid from the injection site via the needle. In at least some of the foregoing embodiments, the system further comprises a pressure sensor coupled to the first conduit and configured to provide pressure data to the control device, the pressure data indicative of a pressure within the first conduit.
[0012] In at least some of the foregoing embodiments, the fluid removal device comprises: a second needle including a distal end configured to be inserted in a fluid container and including a proximal end configured to be coupled to a second conduit, the second needle configured to enable withdrawal of a fluid from the fluid container to the second conduit; a vent tube coupled in a fixed positional relationship with respect to the second needle, the vent tube comprising a distal end and a proximal end and configured to enable fluid communication of air between the proximal end and the distal end, where the distal end of the vent tube is positioned along a longitudinal length of the second needle at a particular distance from the distal end of the second needle such that, when the distal end of the vent tube is positioned within the fluid container, the distal end of the second needle is positioned within the fluid container; and a pressure sensor coupled to the second needle or the vent tube and configured to measure a pressure within the fluid container when the distal end of the vent tube is positioned within the fluid container. In some such embodiments, the fluid withdrawal device further comprises: a pressure release valve coupled to the vent tube and configured to maintain a pressure within the fluid container to be less than or equal to a threshold pressure when the distal end of the vent tube is positioned within the fluid container; and/or a fluid level sensor coupled to the second needle and/or the vent tube and configured to detect a fluid level in the fluid container.
[0013] Some embodiments of the present methods comprise: coupling a body comprising one or more switches to a conduit and/or a needle, where the conduit is coupled in fluid communication with the needle; transitioning the one or more switches into a first configuration to provide a first control signal to indicate a first operating state in which a first flow direction from the conduit to the needle is established for providing a first fluid to an injection site via the needle; and transitioning the one or more switches into a second configuration to provide a second control signal to indicate a second operating state in which a second flow direction from the injection site via the needle to the conduit is established for aspirating a second fluid. In some such embodiments, the second fluid contains at least a portion of the first fluid.
[0014] In some of the foregoing embodiments, the methods further comprise transitioning the one or more switches into a third configuration to indicate a third operating state in which no flow path is established between the needle and the conduit. In some such implementations, transitioning the one or more switches into the first configuration comprises transitioning from the third configuration to the first configuration, and transitioning the one or more switches into the second configuration comprises transitioning from the third configuration to the second configuration. In some such embodiments, the one or more switches comprise a three-way switch. In some of the foregoing embodiments, the first control signal is provided from the one or more switches to a control device communicatively coupled to the one or more switches. Additionally, or alternatively, a pressure sensor is coupled to the conduit and configured to measure a pressure within the conduit. [0015] Some embodiments of the present methods comprise: monitoring, at a control device, for control signals from one or more switches coupled to a body, the body coupled to a first conduit coupled to at least one pump, the at least one pump coupled to the control device; receiving a first control signal at the control device from the one or more switches; operating the at least one pump to cause a first fluid to be withdrawn from a fluid source via a fluid removal device coupled to a second conduit coupled to the at least one pump and to provide the first fluid to an injection site via a needle coupled to the first conduit; receiving a second control signal at the control device from the one or more switches; and operating the at least one pump to aspirate a second fluid from the injection site via the needle.
[0016] In some of the foregoing embodiments, the methods further comprise receiving pressure data from a pressure sensor coupled to the first conduit, the pressure data indicating a pressure within the first conduit. In some such embodiments, the methods further comprise initiating output of the pressure at a display device of the control device. In some such embodiments, the methods further comprise initiating an alarm at the control device based on determining that the pressure satisfies a pressure threshold. In some such embodiments, the methods further comprise setting the pressure threshold based on an input from a pressure setting control of the control device.
[0017] In some of the foregoing embodiments, the methods further comprise setting a fluid container size, a maximum amount of fluid withdrawal, or both, based on an input from a fluid container size control of the control device. Additionally, or alternatively, the at least one pump comprises a plurality of pumps. In some such embodiments, a first pump of the plurality of pumps is operated to withdraw the first fluid from the fluid source and to provide the first fluid to the needle. In some such embodiments, the methods further comprise operating a second pump of the plurality of pumps to cause a third fluid to be withdrawn from a second fluid source via a second fluid removal device coupled to the second pump and to provide the third fluid to the needle. In some such embodiments, the first fluid and the third fluid are the same type of fluid.
[0018] In some of the foregoing embodiments, the first control signal indicates a first operating state of the one or more switches, and a second control signal indicates a second operating state of the one or more switches. In some such embodiments, the methods further comprise: receiving an indication of a third operating state of the one or more switches; and ceasing operation of the at least one pump to cause no flow path between the fluid source and the needle responsive to the indication of the third operating state. [0019] Some embodiments of the present disclosure include a kit that comprises: a fluid aspiration/injection device, one or more electrical connectors configured to couple one or more switches to a control device; and a first conduit. In such implementations, the fluid/injection aspiration device comprises: a body configured to be coupled to a needle and to the first conduit; and the one or more switches coupled to the body. In such implementations, the one or more switches in a first configuration provides a first control signal to indicate a first operating state in which a first flow direction from the first conduit to the needle is established for providing a first fluid to an injection site via the needle, and the one or more switches in a second configuration provides a second control signal to indicate a second operating state in which a second flow direction from the injection site via the needle to the first conduit is established for aspirating a second fluid.
[0020] In some of the foregoing embodiments, the kit further comprises the needle configured to be coupled to a first end of the first conduit. Additionally, or alternatively, the kit further comprises a pressure sensor configured to be coupled to the first conduit. Additionally, or alternatively, the kit further comprises the control device configured to be coupled to the one or more switches via the one or more electrical connectors. In such embodiments, the control device comprises at least one pump configured to be coupled to the first conduit.
[0021] In some of the foregoing embodiments, the kit further comprises a fluid withdrawal device. The fluid withdrawal device comprises: a second needle including a distal end configured to be inserted in a fluid container and including a proximal end configured to be coupled to a second conduit, the second needle configured to enable withdrawal of fluid from the fluid container to the second conduit; and a vent tube coupled in a fixed positional relationship with respect to the second needle. In such embodiments, the vent tube comprises a distal end and a proximal end and is configured to enable fluid communication of air between the proximal end and the distal end. In such embodiments, the distal end of the vent tube is positioned along a longitudinal length of the second needle at a particular distance from the distal end of the second needle such that when the distal end of the vent tube is positioned within the fluid container the distal end of the second needle is positioned within the fluid container. In some such embodiments, the kit further comprises: a pressure sensor coupled to the second needle or the vent tube and configured to measure a pressure within the fluid container; and the second conduit configured to be coupled to the second needle. [0022] As used herein, various terminology is for the purpose of describing particular implementations only and is not intended to be limiting of implementations. For example, as used herein, an ordinal term (e.g.,“first,”“second,”“third,” etc.) used to modify an element, such as a structure, a component, an operation, etc., does not by itself indicate any priority or order of the element with respect to another element, but rather merely distinguishes the element from another element having a same name (but for use of the ordinal term). The term “coupled” is defined as connected, although not necessarily directly, and not necessarily mechanically; two items that are“coupled” may be unitary with each other. The terms“a” and “an” are defined as one or more unless this disclosure explicitly requires otherwise. The term “substantially” is defined as largely but not necessarily wholly what is specified - and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel - as understood by a person of ordinary skill in the art. In any disclosed embodiment, the term“substantially” may be substituted with“within [a percentage] of’ what is specified, where the percentage includes 0.1, 1, 5, and 10 percent; and the term “approximately” may be substituted with“within 10 percent of’ what is specified. The phrase “and/or” means and or. To illustrate, A, B, and/or C includes: A alone, B alone, C alone, a combination of A and B, a combination of A and C, a combination of B and C, or a combination of A, B, and C. In other words,“and/or” operates as an inclusive or.
[0023] The terms“comprise” and any form thereof such as“comprises” and“comprising,” “have” and any form thereof such as“has” and“having,” and“include” and any form thereof such as“includes” and“including” are open-ended linking verbs. As a result, an apparatus that “comprises,”“has,” or“includes” one or more elements possesses those one or more elements, but is not limited to possessing only those elements. Likewise, a method that“comprises,” “has,” or“includes” one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps.
[0024] Any implementation of any of the apparatuses, systems, and methods can consist of or consist essentially of - rather than comprise/include/have - any of the described steps, elements, and/or features. Thus, in any of the claims, the term“consisting of’ or“consisting essentially of’ can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open- ended linking verb. Additionally, it will be understood that the term“wherein” may be used interchangeably with“where.” [0025] Further, a device or system that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described. Aspects of one example may be applied to other examples, even though not described or illustrated, unless expressly prohibited by this disclosure or the nature of a particular example. Some details associated with the aspects described above and others are described below.
[0026] Some details associated with the aspects are described above, and others are described below. Other implementations, advantages, and features of the present disclosure will become apparent after review of the entire application, including the following sections: Brief Description of the Drawings, Detailed Description, and the Claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The following drawings illustrate by way of example and not limitation. For the sake of brevity and clarity, every feature of a given structure is not always labeled in every figure in which that structure appears. Identical reference numbers do not necessarily indicate an identical structure. Rather, the same reference number may be used to indicate a similar feature or a feature with similar functionality, as may non-identical reference numbers. The figures are drawn to scale (unless otherwise noted), meaning the sizes of the depicted elements are accurate relative to each other for at least the embodiment depicted in the figures.
[0028] FIGS. 1A-1B show views of an example of a peripheral nerve block injection system.
[0029] FIG. 2 shows a view of an example of a control device of the peripheral nerve block injection system shown in FIGS. 1A-1B.
[0030] FIGS. 3A-3B show various views of an example of a fluid injection device.
[0031] FIGS. 4A, 4B, and 4C show various views of an example of a fluid withdrawal device.
[0032] FIG. 5 is a flowchart of an example of a method of using a peripheral nerve block injection system.
[0033] FIG. 6 is a flowchart of an example of a method of monitoring a fluid injection pressure of a peripheral nerve block injection system.
[0034] FIG. 7 is a flowchart of another example of a method of using a peripheral nerve block injection system. [0035] FIG. 8 is a flowchart of another example of a method of using a peripheral nerve block injection system.
[0036] FIG. 9 is a block diagram showing an example of the peripheral nerve block injection system shown in FIGS. 1A-1B.
[0037] FIG. 10 is a diagram of an example of a kit for peripheral nerve block injection systems.
[0038] FIG. 11 is a flowchart illustrating an example of a method of operating a fluid injection/aspiration device.
[0039] FIG. 12 is a flowchart illustrating an example of a method of operating a control device of a peripheral nerve block injection system.
DETAILED DESCRIPTION
[0040] Referring to FIGS. 1A-1B, an example of an injection system 100, such as a peripheral nerve block (PNB) injection system, is shown. Injection system 100 is configured to withdraw a certain volume of fluid (e.g., liquid medication), such as anesthesia, and administer the medication to a patient, such as during performance of a peripheral nerve block injection. Injection system 100 is also configured to aspirate fluid from the patient. Injection system 100 includes a control device 104, a body 107 (e.g., a housing), a fluid injection/aspiration device 108, and a fluid withdrawal device 112.
[0041] Control device 104 is configured to send and receive communication/control signals between control device 104 and the other elements of injection system 100. For example, control device 104 may send and/or receive one or more signals via wired and/or wireless communication. In some implementations, control device 104 includes one or more processors. The one or more processors may be coupled to a memory storing computer-executable instructions that, when executed by the one or more processors, cause the one or more processors to perform operations of control device 104 described herein, such as one or more operations described with reference to FIG. 9.
[0042] Fluid injection/aspiration device 108 includes body 107. Body 107 has a first end 109 and a second end 110 and is a part of fluid injection/aspiration device 108. In some implementations, fluid injection/aspiration device 108 is configured to be coupled to a needle, such as an injection needle 128. In some implementations, fluid injection/aspiration device 108 further includes injection needle 128. In some implementations, injection needle 128 is coupled to first end 109 of fluid injection/aspiration device 108. Injection needle 128 is hollow (e.g., defines a through channel) and configured to be inserted into an injection site. For example, injection needle 128 may be inserted into a patient by a medical professional operating injection system 100. The injection site may include tissue, such as human tissue. In a particular implementation, injection needle 128 is a spinal needle configured to perform a peripheral nerve block (PNB) injection. In other implementations, fluid injection/aspiration device 108 is configured to be compatible with a variety of types of injection needles.
[0043] Fluid injection/aspiration device 108 may also be configured to be coupled to a conduit, such as a fluid injection conduit 148. In some implementations, fluid injection/aspiration device 108 also includes fluid injection conduit 148 coupled to body 107. The fluid injection conduit 148 in fluid communication with injection needle 128. For example, one or more flow paths may be established from the fluid injection conduit 148 to the injection needle 128.
[0044] In a particular implementation, the fluid injection conduit 148 is in fluid communication with the injection needle 128 through the body 107. For example, body 107 may be substantially hollow and may be configured to enable fluid to pass within. In such an implementation, injection needle 128 is coupled to first end 109 and fluid injection conduit 148 is coupled to second end 110, and fluid is permitted to flow through body 107 from fluid injection conduit 148 to injection needle 128 (or in the opposite direction). The first end 109 may include a first connector configured to be coupled to a connector of injection needle 128, and the second end 110 may include a second connector configured to be coupled to a connector of fluid injection conduit 148. In an alternate implementation, injection needle 128 is coupled to fluid injection conduit 148, and body 107 is externally coupled to fluid injection conduit 148, injection needle 128, or both. As a particular example, body 107 may be configured to surround at least a portion of an outer perimeter of fluid injection conduit 148. As another particular example, body 107 may be configured to be clipped to a portion of fluid injection conduit 148. In other implementations, body 107 may be coupled to fluid injection conduit 148, injection needle 128, or both, in other ways. In such alternate implementations, the fluid paths between injection needle 128 and fluid injection conduit 148 do not traverse body 107.
[0045] Fluid injection/aspiration device 108 includes one or more switches 116 (also referred to as a fluid control switch) coupled to body 107. One or more switches 116 may be configurable in multiple configurations. Configuring one or more switches 116 may provide control signals to control device 104 to operate in different operating states, as further described herein. For example, if one or more switches 116 are in a first configuration, one or more switches 116 provide a first control signal to control device 104 that indicates a first operating state in which a first flow direction from fluid injection conduit 148 to injection needle 128 is established for providing a first fluid to an injection site via injection needle 128. As another example, if one or more switches 116 are in a second configuration, the one or more switches provide a second control signal to control device 104 that indicates a second operating state in which a second flow direction from the injection site via injection needle 128 to fluid injection conduit 148 is established for aspirating a second fluid. As another example, if one or more switches 116 are in a third configuration, the third configuration indicates a third operating state in which no flow path is established between injection needle 128 and fluid injection conduit 148. The first operating state includes a fluid injection state, the second operating state includes an aspiration state, and the third operating state includes a standby state, as further described herein.
[0046] In some implementations, at least one switch of one or more switches 116 include a manually operated switch configured to be operated by a hand of a user. For example, at least one switch of one or more switches 116 may include a push button switch. In some implementations, one or more switches 116 include a single switch. As an example, the single switch may include a three-way switch. To illustrate, the three-way switch may be configured in one of three positions, each position corresponding to one of the first, second, or third operating states. In alternate implementations, one or more switches 116 include multiple switches. For example, the multiple switches may include a first switch configured to provide the first control signal and a second switch configured to provide the second control signal. In the implementation shown in FIGS. 1A-1B, one or more switches 116 include two switches: an injection button 120 for controlling an injection of fluid (e.g., a first switch for providing the first control signal) and an aspiration button 124 for controlling an aspiration of fluid (e.g., a second switch for providing the second control signal). However, in other implementations, one or more switches 116 can include more than two switches or can include other elements for toggling between functions, such as a toggle switch, a knob, or other suitable switching elements, as illustrative, non-limiting examples.
[0047] Fluid withdrawal device 112 includes a fluid drawing needle 132 and a vent tube 136. Fluid drawing needle 132 is configured to be inserted in a fluid container and includes a proximal end configured to be coupled to a fluid withdrawal conduit 144. Fluid drawing needle 132 is configured to enable withdrawal of a fluid from the fluid container to fluid withdrawal conduit 144. In a particular implementation, fluid drawing needle 132 is a hollow needle configured to be inserted into a sterile vial 140 that contains liquid medication (or another fluid). Although described as a vial 140, in other implementations, fluid drawing needle 132 may be placed in another type of fluid container, such as a bag, a bladder, a bottle, or any other type of fluid container. Fluid drawing needle 132 may have a gauge sufficient to enable withdrawal of a volume or amount of fluid from vial 140 into a hollow cavity of fluid drawing needle 132.
[0048] Vent tube 136 is coupled in a fixed relationship with respect to fluid drawing needle 132. Vent tube 136 includes a distal end and a proximal end and is configured to enable fluid communication of air between the proximal end and the distal end. The distal end of vent tube 136 is positioned along a longitudinal length of fluid drawing needle 132 at a particular distance from the distal end of fluid drawing needle 132 such that, when the distal end of vent tube 136 is positioned within the fluid container, the distal end of the of fluid drawing needle 132 is positioned within the fluid container. In a particular implementation, vent tube 136 is a hollow needle configured to be inserted into vial 140. In this implementation, vent tube 136 has a needle size or gauge (effective internal diameter) sufficient to enable a passage of gas (e.g., air) between vial 140 and an outer environmental atmosphere through the hollow cavity of vent tube 136. In other implementations, vent tube 136 is a tube (e.g., is not a needle) and can be inserted into vial 140 via a hole in a lid formed by fluid drawing needle 132. Fluid withdrawal device 112 is further described with reference to FIGS. 4A-4C.
[0049] Fluid injection/aspiration device 108 and fluid withdrawal device 112 are coupled to fluid injection conduit 148 and fluid withdrawal conduit 144, respectively. In a particular implementation, fluid withdrawal conduit 144 and fluid injection conduit 148 include tubing, such as sterile tubing. In other implementations, fluid withdrawal conduit 144 and fluid injection conduit 148 include other components defining channels through which fluid is capable of flowing. Fluid withdrawal conduit 144 is configured to connect fluid withdrawal device 112 to a pump 152 disposed on control device 104. Fluid injection conduit 148 is configured to connect fluid injection/aspiration device 108 to the same pump 152 disposed on control device 104. For example, fluid injection conduit 148 is connected to fluid injection/aspiration device 108 at second end 110 to enable fluid communication between pump 152 and fluid injection/aspiration device 108 (e.g., to injection needle 128). Pump 152 is configured to provide sufficient force to suction or withdraw fluid from a fluid source, such as vial 140, via fluid withdrawal device 112, through fluid withdrawal conduit 144, and into an input of pump 152. Pump 152 is also configured to provide sufficient force to expel or inject fluid from an output of pump 152 into and through fluid injection conduit 148, and into fluid injection/aspiration device 108 (e.g., into and/or through injection needle 128). Additionally, or alternatively, pump 152 is configured to provide sufficient force to aspirate fluid from tissue via injection needle 128 into fluid injection/aspiration device 108 (and potentially into fluid injection conduit 148). This aspiration occurs in an opposite flow direction to the injection of the fluid.
[0050] Pump 152 is configured to enable a passage of fluid through pump 152 and to receive and expel fluid through each of a plurality of ports. In some implementations, the injection system 100 includes a second pump 152 disposed on control device 104 to provide a dual pump configuration. Each pump 152 can be configured to be connected to a separate fluid injection/aspiration device 108 and a separate fluid withdrawal device 112. Alternatively, second pump 152 can be configured to be connected to the same fluid injection/aspiration device 108 (e.g., via a connector to couple fluid injection conduit 148 to a second fluid injection conduit coupled to the second pump 152). The dual pump configuration enables a second vial to be connected to control device 104 and a second medication to be injected. In some implementations, additional pumps (e.g., more than two) can be provided on control device 104 to enable a plurality of medications to be injected into the tissue. In other implementations, control device 104 includes a single pump 152.
[0051] The injection system 100 also includes a pressure sensor 156 (e.g., a fluid injection pressure monitor) configured to monitor the fluid pressure within fluid injection conduit 148. Pressure sensor 156 may be disposed on (e.g., coupled to) or in fluid injection conduit 148 inline between pump 152 and fluid injection/aspiration device 108. In other implementations, pressure sensor 156 can be disposed as a part of pump 152, fluid injection/aspiration device 108, and/or control device 104. Pressure sensor 156 is configured to enable continuous monitoring of injection pressures. Monitoring of injection pressures is important, as high injection pressures have been associated with intraneural injections which can lead to complications such as nerve damage. In a particular implementation, pressure sensor 156 is a transducer. In other implementations, pressure sensor 156 may be any suitable pressure monitoring device having one or more pressure sensors. Pressure sensor 156 may be electrically coupled to control device 104 and can send and receive communication signals to and from control device 104. In this way, injection pressure data that is generated by pressure sensor 156 can be transmitted to control device 104 via a wired electrical connector. In some implementations the pressure data can be used to activate an audible, visual, and/or tactile alarm if the injection pressure satisfies (e.g., is greater than or equal to, or in other implementations is greater than) a specified pressure threshold. For example, control device 104 may include a pressure alarm device configured to output an alarm responsive to the pressure satisfying the pressure threshold. The pressure alarm device may include a visual indication device, an audio indication device, a tactile indication device, or a combination thereof. Control device 104 can also be programmed to slow or stop the injection fluid flow (e.g., by operating, or ceasing operation of, pump 152) if fluid pressures approaching or at the pressure threshold are detected.
[0052] In a particular implementation shown in FIGS. 1A-1B, control device 104 includes a display 160, a pressure threshold setting control device, such as an alarm pressure adjustment knob 164, and at least one fluid container size selector switch, such as one or more vial size selector switches 168. The alarm pressure adjustment knob is configured to set the pressure threshold at one of multiple selectable values, and the one or more vial size selector switches 168 are configured to select a fluid container size from a plurality of fluid container sizes, a fluid volume, or both. In a particular implementation, control device 104 is connected to a power supply 172 configured to provide suitable and safe electrical power levels to control device 104 to enable control device 104 to perform the functions described herein.
[0053] Display 160 may be a liquid crystal display (LCD) or any other type of display. Display 160 may be configured to display (e.g., output) various data to the user of injection system 100. For example, display 160 may be configured to output the fluid pressure within fluid injection conduit 148 sensed by pressure sensor 156 (e.g., based on pressure data received by control device 104 from pressure sensor 156). The fluid pressure can be adjusted and displayed in real time to the user as the fluid pressure within fluid injection conduit 148 fluctuates. Display 160 can also be configured to output the alarm pressure threshold value so that the user can compare the current fluid pressure to the threshold pressure value. Additionally, or alternatively, display 160 is configured to output the fluid volume withdrawn from vial 140 and the fluid volume injected into the tissue via injection needle 128. These fluid volume values can be adjusted and displayed in real time to the user as the amount of fluid withdrawn from vial 140 into pump 152 and the amount of fluid expelled from pump 152 into fluid injection/aspiration device 108 fluctuates. The fluid volumes may be measured by pump 152 or by a sensor coupled to the fluid withdrawal device, as further described with reference to FIG. 4C.
[0054] Alarm pressure adjustment knob 164 can be used by a user to manually modify and set a fluid pressure threshold value. In a particular implementation, alarm pressure adjustment knob 164 toggles between various fluid pressure values and enables selection of a fluid pressure value as a threshold value for triggering an alarm. In other implementations, the alarm pressure threshold can be pre-programmed into control device 104.
[0055] In some implementations, such as the one shown in FIGS. 1A-1B, vial size selector switches 168 include multiple switches. For example,, each pump 152 may have a corresponding vial size selector switch. The vial size selector switches 168 can be used by a user to manually activate or deactivate a corresponding pump 152 and configure an active pump 152 to a particular vial size (or fluid volume). The forces applied by each activated pump 152 during fluid withdrawal, injection, and aspiration can thereby be adjusted for various vial sizes (or fluid volumes).
[0056] Although FIGS. 1A-1B illustrate alarm pressure adjustment knob 164 and vial size selector switches 168, these are optional. In other implementations, display 160 is a touchscreen display that enables a user to provide user input to configure settings of control device 104. For example, the user may enter, via the touchscreen, the various thresholds, such as the alarm pressure threshold and/or the vial size (or fluid volumes). In these implementations, alarm pressure adjustment knob 164 and the vial size selector switches 168 are not included in control device 104.
[0057] During operation, control device 104 may be powered on and fluid withdrawal device 112 may be inserted in vial 140, such as by piercing a lid of vial 140 with fluid drawing needle 132. After inserting fluid withdrawal device 112 into vial 140, an operator (e.g., an anesthesiologist) may hold an ultrasound probe in a first hand and hold fluid injection/aspiration device 108 in a second hand. The operator may use the ultrasound probe to identify an injection site (e.g., human tissue) and the user may insert injection needle 128 into the injection site. The operator may manipulate one or more switches 116 to cause one or more switches 116 to transition into the first configuration to provide a first control signal to control device 104. As a particular example, the operator may depress injection button 120.
[0058] In a particular implementation, one or more switches 116 are configured to enable or to provide the first control signal by completing a circuit with control device 104. For example, one or more switches 116 may be coupled to control device 104 by electrical connectors and, when one or more switches 116 are in the first configuration (e.g., when injection button 120 is depressed), a circuit may be established between one or more switches 116 and control device 104. Completing such a circuit may“provide” the first control signal to control device 104. In an alternate implementation, one or more switches 116 may be coupled to a power source, and one or more switches 116 may generate and transmit the first control signal when one or more switches 116 are in the first configuration (e.g., when injection button 120 is depressed). The first control signal may be provided continuously or periodically in various implementations.
[0059] The first control signal indicates a first operating state in which a first flow direction from fluid injection conduit 148 to injection needle 128 is established for providing a first fluid to the injection site. Control device 104, based on receipt of the first control signal, operates pump 152 to cause withdrawal of fluid (e.g., liquid medicine) from vial 140 via fluid withdrawal device 112. Due to force applied by pump 152, the fluid flows from fluid withdrawal device 112 through fluid withdrawal conduit 144 to an input of pump 152. The fluid then flows through an output of pump 152, through fluid injection conduit 148, and through injection needle 128 to the injection site. In a particular implementation, control device 104 is configured to operate pump 152 to provide a preset or predetermined volume of the first fluid in the first flow direction based on receipt of the first control signal. After the injection is completed, the user may configure the one or more switches in the third configuration (e.g., a standby configuration). For example, the user may not depress either injection button 120 or aspiration button 124. Transitioning the one or more switches to the third configuration causes control device 104 to cease operating pump 152 such that no flow path is established between injection needle 128 and fluid injection conduit 148.
[0060] The operator may also configure one or more switches 116 to cause one or more switches 116 to transition into the second configuration to provide a second control signal to control device 104. As a particular example, the operator may depress aspiration button 124. The second control signal indicates a second operating state in which a second flow direction from the injection site via injection needle 128 to fluid injection conduit 148 is established for aspirating a second fluid. Control device 104, based on receipt of the second control signal, operates pump 152 to cause aspiration of the second fluid from the injection site via injection needle 128. For example, pump 152 operates in a reverse mode to establish a flow path that is in the opposite direction of the flow path established during the first operating state (e.g., the injection operating state). In a particular implementation, the second fluid contains at least a portion of the first fluid. For example, a first fluid (e.g., anesthetic) may be aspirated from the injection site to confirm that the injection site is a nerve and not a blood vessel (as indicated by aspiration of blood). In a particular implementation, control device 104 is configured to operate pump 152 to aspirate a preset or predetermined volume of the second fluid in the second flow direction based on receipt of the second control signal. After the aspiration is completed, the user may configure the one or more switches in the third configuration to cause the second fluid to be returned to the injection site and to cease operation of pump 152 such that no flow path is established between injection needle 128 and fluid injection conduit 148.
[0061] Thus, injection system 100 of FIG. 1A enables a single user to perform a peripheral nerve block injection procedure. For example, the user may use one hand to manipulate an ultrasound probe and another hand to control fluid injection/aspiration device 108 to perform injection and aspiration. This is in contrast to conventional techniques, where a first user manipulates the ultrasound probe, and a second user uses a syringe to perform injection and aspiration. Reducing the number of personnel that perform the peripheral nerve block injection procedure enables some personnel to perform other tasks, thereby increasing revenue to a hospital or doctor’s office. Additionally, because the injection and aspiration can be controlled by manipulation of one or more switches 116, which are disposed in a position where a user’s hand will be, the user can simply and quickly change operating modes without performing more complex actions or pausing or stopping the procedure to change operating modes. For example, the user can simply depress one of multiple buttons to activate a particular operating mode.
[0062] In a particular implementation, a fluid injection/aspiration device (e.g., fluid injection/aspiration device 108) includes a body (e.g., body 107) configured to be coupled to a needle (e.g., injection needle 128) and one or more switches (e.g., one or more switches 116) coupled to the body. The one or more switches in a first configuration provides a first control signal that indicates a first operating state in which a first flow direction from a conduit (e.g., fluid injection conduit 148) to the needle is established for providing a first fluid to an injection site via the needle. The one or more switches in a second configuration provides a second control signal that indicates a second operating state in which a second flow direction from the injection site via the needle to the conduit is established for aspirating a second fluid.
[0063] In another particular implementation, a fluid injection device (e.g., fluid injection/aspiration device 108) includes a housing (e.g., body 107) having a first end (e.g., first end 109) configured to couple with an injection needle (e.g., injection needle 128) and a second end (e.g., second end 110) configured for fluid communication with a fluid source. The fluid injection device also includes a fluid control switch (e.g., one or more switches 116) configured to be selectable for automatically providing fluid to the injection needle from the fluid source or automatically aspirating fluid from an injection site. In some implementations, the fluid injection device further includes an injection needle (e.g., injection needle 128) coupled to the fluid control switch and at least one fluid injection tube (e.g., fluid injection conduit 148) coupled to the fluid control switch. The fluid control switch may be coupled to, disposed on, connected to, or secured to, the housing. In a particular implementation, the fluid control switch is in direct contact with the housing. Alternatively, in another particular implementation, the fluid control switch is separate from the housing. The injection site may include tissue, such as human tissue. In some implementations, the fluid control switch is configured to be selectable for automatically providing fluid in a first direction toward an injection site or in a second direction opposite the first direction for aspirating fluid from the injection site. For example, the fluid control switch may comprise an injection button (e.g., injection button 120) configured to automatically provide fluid in a first direction toward an injection site, an aspiration button (e.g., aspiration button 124) configured to automatically aspirate or withdraw fluid from an injection site, or both. In some implementations, the first end includes a connector configured for removably coupling with the injection needle.
[0064] In some implementations, the fluid control switch includes an injection button (e.g., injection button 120) configured to be selectably activated or deactivated, such that activation of the injection button causes fluid to be automatically provided from the fluid source toward the injection site, and such that deactivation of the injection button ceases or prevents fluid from being automatically provided from the fluid source toward the injection site. In some implementations, activation of the injection button causes a preset or predetermined volume of fluid from the fluid source to be provided to the injection site. Selectably activating the injection button may include depressing the injection button and/or selectably deactivating the injection button may include releasing or not depressing the injection button. In some implementations, the fluid control switch includes an aspiration button (e.g., aspiration button 124) configured to be selectably activated or deactivated, where activation of the aspiration button causes fluid to be automatically aspirated or withdrawn from the injection site, and where deactivation of the aspiration button ceases or prevents fluid from being automatically aspirated or withdrawn from the injection site. In some such implementations, activation of the aspiration button causes a preset or predetermined volume of fluid from the injection site to be aspirated or withdrawn. As an illustrative, non-limiting example, selectably activating the aspiration button may include depressing the aspiration button, and selectably deactivating the aspiration button may include releasing or not depressing the aspiration button. In some implementations, the fluid control switch is electronically connected to a control device (e.g., control device 104) configured to operate at least one peristaltic pump (e.g., pump 152) configured to withdraw fluid from the fluid source and provide fluid to the fluid injection device.
[0065] In another aspect particular implementation, a peripheral nerve block injection system (e.g., injection system 100) includes at least one fluid injection device (e.g., fluid injection/aspiration device 108) including an injection needle (e.g., injection needle 128), at least one injection tube (e.g., fluid injection conduit 148), and a fluid control switch (e.g., one or more switches 116) coupled to the injection needle. The system includes at least one fluid withdrawal device (e.g., fluid withdrawal device 118) including a needle (e.g., fluid drawing needle 132) and at least one fluid withdrawal tube (e.g., fluid withdrawal conduit 144). The system includes at least one peristaltic pump (e.g., pump 152) coupled to the at least one fluid withdrawal tube and the at least one injection tube. The system further includes a control device (e.g., control device 104) including at least one processor configured to operate the at least one peristaltic pump to enable the fluid withdrawal device to withdraw a fluid volume from a vial (e.g., vial 140) into the peristaltic pump, and operate the at least one peristaltic pump to enable the fluid injection device to dispense the fluid volume from the peristaltic pump. In some implementations, the system includes a fluid injection pressure monitor (e.g., pressure sensor 156) coupled to the at least one fluid injection device and configured to monitor a fluid injection pressure inside the at least one injection tube. Additionally, or alternatively, the system includes a display device (e.g., display 160) configured to display at least one of the fluid volume and the fluid injection pressure. Additionally, or alternatively, the system further includes a fluid pressure alarm device configured to issue an alarm upon the fluid injection pressure approaching, meeting, and/or exceeding a fluid injection pressure threshold. Additionally, or alternatively, the system includes a fluid injection pressure threshold setting device (e.g., alarm pressure adjustment knob 164) configured to set the fluid injection pressure threshold at a predetermined value. Additionally, or alternatively, the system includes a plurality of peristaltic pumps (e.g., pumps 152) each configured to couple to a separate fluid injection device and a separate fluid withdrawal device. Additionally, or alternatively, the system includes at least one vial size selector switch (e.g., vial size selector switches 168) configured to select a vial size from a plurality of predetermined vial sizes.
[0066] In some such implementations, the fluid control switch has an injection setting configured to, when the injection setting is activated, send an injection signal to the control device triggering the peristaltic pump to dispense the fluid volume into the fluid injection device. For example, the control device may be programmed to withdraw a preset fluid volume from the vial into the peristaltic pump. To further illustrate, the control device may be programmed to, when the injection setting is activated, dispense the preset fluid volume from the peristaltic pump into the fluid injection device. In some implementations, the peristaltic pump dispenses the fluid volume into the fluid injection device when the injection setting is activated and ceases dispensing the fluid volume when the injection setting is deactivated. In some implementations, the fluid control switch has an aspiration setting configured to, when the aspiration setting is activated, send an aspiration signal to the control device triggering the peristaltic pump to withdraw an aspiration fluid volume into the fluid injection device from a tissue. For example, the control device may be programmed to withdraw a preset aspiration fluid volume from the tissue into the peristaltic pump. To further illustrate, the control device may be programmed to, when the aspiration setting is activated, withdraw the preset aspiration fluid volume from the tissue into the peristaltic pump. In some implementations, the peristaltic pump withdraws the aspiration fluid volume into the fluid injection device when the aspiration setting is activated and ceases withdrawing the fluid volume when the aspiration setting is deactivated. In some implementations, the fluid control switch includes an injection button (e.g., injection button 120) and an aspiration button (e.g., aspiration button 124). In such implementations, the injection button activates the injection setting when depressed and deactivates the injection setting when not depressed, and the aspiration button activates the aspiration setting when depressed and deactivates the aspiration setting when not depressed. In some implementations, the fluid control switch is coupled between the injection tube and the injection needle. In some implementations, the needle includes a fluid drawing needle coupled to the fluid withdrawal tube and a venting needle (e.g., vent tube 136) coupled to the fluid drawing needle. In some implementations, the fluid drawing needle is configured to pierce the vial of fluid; and withdraw the fluid volume from the vial. The venting needle may pierce the vial of fluid and enable a passage of gas between the vial and an outside atmosphere.
[0067] Referring to FIG. 1B, view showing how the various elements of injection system 100 are connected to each other is shown. In some implementations, pumps 152 have input and outputs (e.g., input ports and output ports). For example, as illustrated in FIG. 1B, control device 104 has a pump 152 with an input of pump 152 coupled to one end of fluid withdrawal conduit 144 and an output of pump 152 coupled to one end of fluid injection conduit 148. The opposite end of fluid withdrawal conduit 144 is coupled to fluid withdrawal device 112 and the opposite end of fluid injection conduit 148 is coupled to fluid injection/aspiration device 108.
[0068] Components of the injection system 100 may be electronically coupled to enable electronic communication. In some implementations, one or more electrical connectors 176 electronically couple control device 104 to pressure sensor 156 and one or more switches 116. The one or more electrical connectors 176 can be separate connectors/wires each coupled to separate system elements or can be a bundle of separate connectors/wires coupled to separate system elements. In a particular implementation, one end of an electrical connector 176 is connected to pressure sensor 156 and one end of a separate electrical connector 176 is connected to one or more switches 116. In some such implementations, each of injection button 120 and aspiration button 124 has its own electrical connector 176 to enable coupling to control device 104. Additionally, or alternatively, electrical connectors 176 may be coupled to sensors coupled to fluid withdrawal device 112, as further described with reference to FIG. 4C.
[0069] To couple the components to control device 104, the opposite ends of electrical connectors 176 are coupled to control device 104 at an electrical port 180. Although illustrated as separate from the fluid injection conduit 148, in other implementations, electrical connector 176 can be disposed onto or within a portion of fluid injection conduit 148 so as to be essentially unitary with fluid injection conduit 148 along a length of the conduit. The one or more electrical connectors 176 send and receive communication/control signals between control device 104 and the various system elements as well as provide power to one or more switches 116 and pressure sensor 156 from control device 104. In an alternate implementation, control device 104 is configured to wirelessly communicate with one or more switches 116, pressure sensor 156, and/or the sensors coupled to fluid withdrawal device 112. In this implementation, some or all of the one or more electrical connectors 176 are not included in the injection system 100.
[0070] Additionally, or alternatively, as illustrated in FIG. 1B, pressure sensor 156 can be a separate component that is coupled between portions (e.g., pieces) of fluid injection conduit 148. For example, a first portion (e.g., piece) of fluid injection conduit 148 may be configured to be coupled between injection needle 128 and a first end of pressure sensor 156 and a second portion (e.g., piece) of fluid injection conduit 148 may be configured to be coupled between pump 152 and a second end of pressure sensor 156. An electrical connector 176 may be configured to be coupled to a third end of pressure sensor 156 to provide a connection to control device 104. [0071] Referring to FIG. 2, a view of control device 104 of FIGS. 1A-B is shown. The implementation illustrated in FIG. 2 is a dual pump implementation in which, control device 104 can use two pumps 152 to perform fluid withdrawal, injection and aspiration functions. In a particular implementation, the pumps 152 include at least one peristaltic pump. Peristaltic pumps can be used for injection system 100 for a variety of reasons. For example, peristaltic pumps can utilize a short segment of sterile conduit, such as sterile tubing, which can be sequentially compressed by a series of rollers (not shown) to pump the medication. In this manner, the medication comes in contact with the sterile conduit and does not contact the rollers or other pump mechanical parts. This ensures sterility as the conduit can then be disposed of after each procedure and new sterile conduit can be attached. In addition, peristaltic pumps are able to pump air in addition to fluid, which enables peristaltic pumps to be self-priming, thereby simplifying setup for each procedure. Peristaltic pumps are also able to pump both in both forward and reverse directions, which allows for fluid withdrawal, injection and aspiration functions. Peristaltic pumps can provide an accurate and repeatable volume for each turn of the pump which enables the injected volume to be measured and tracked by control device 104 without any additional flow meters. In the implementation of FIG. 2, control device 104 uses two pumps 152 which are coupled to a single injection conduit via a“Y” piece. To illustrate, the section of injection conduit protruding from the left section (in the orientation of FIG. 2) of the“Y” piece constitutes fluid withdrawal conduit 144 and the opposite section of injection conduit protruding from the right section of the“Y” piece constitutes fluid injection conduit 148.
[0072] In a particular implementation in which the pumps 152 include two pumps (e.g., a plurality of pumps), a first pump (e.g., pump 152 on the left of FIG. 2) is configured to be coupled to a first conduit (e.g., fluid injection conduit 148) and a second conduit (e.g., fluid withdrawal conduit 144). In this implementation, a second pump (e.g., pump 152 on the right of FIG. 2) is configured to be coupled to a third conduit (e.g., a second fluid injection conduit) and a fourth conduit (e.g., a second fluid withdrawal conduit). In this implementation, the fourth conduit is configured to be coupled to a second fluid withdrawal device. In some implementations, each of the first conduit (e.g., fluid injection conduit 148) and the third conduit (e.g., the second fluid injection conduit) is configured to be coupled to injection needle 128 via a coupler. For example, a coupler may couple the first conduit and the third conduit to a piece of conduit that is coupled to injection needle 128 (thereby combining the fluids provided by the first conduit and the third conduit). In an alternate implementation, the third conduit is configured to be coupled to a second fluid injection/aspiration device including a second injection needle, and the two injection needles are inserted in as close proximity as possible at the injection site (e.g., the human tissue).
[0073] Use of two or more pumps 152 may enable procedures using different volumes or concentrations of medicine. To illustrate, local anesthetic is commonly available in 10 milliliter (mL) and 30mL vials. Some peripheral nerve blocks use greater than 30 mLs of local anesthetic. If greater than 30 mLs are to be used, two vials can be used concurrently, which eliminates the need to stop or pause the procedure to attach a new vial. In a particular implementation, shown, each pump 152 has a separate vial size selector switch 168 which allows the user to choose which vial size is attached to each pump. Control device 104 can then proportion the amount of local anesthetic drawn from each vial as well as the withdrawal rate according to the vial size. For example, if 40mL of anesthetic is to be used for a peripheral nerve block, one pump can be configured to withdraw anesthetic from a 30mL vial, and the other pump can be configured to withdraw anesthetic from a lOmL vial. In this example, control device 104 draws anesthetic from the 30mL vial at a faster flow rate than from the lOmL vial so that both vials are emptied at approximately the same time. The dual pump configuration also allows for the mixing of multiple concentrations of local anesthetic, which is commonly performed for some peripheral nerve blocks. For example, a commonly used concentration of bupivacaine is 0.375% which is obtained via a 50/50 mix of 0.5% bupivacaine and 0.25% bupivacaine as 0.375% bupivacaine is not commercially available. These various fluid withdrawal amounts and flow rates may be programmed and stored in control device 104 and set to correspond to selections of the vial size selector switches 168. In a particular implementation, each vial size selector switch 168 has three selection options: OFF, lOmL vial, and 30mL vial. A selection of OFF deactivates the corresponding pump 152 while a selection of lOmL vial and 30mL vial is used when the corresponding pump 152 is coupled to a particular vial size. In other implementations, additional vial size selection options (e.g., other than lOmL and 30 mL) may be provided for the vial size selector switches 168.
[0074] In a particular implementation, alarm pressure adjustment knob 164 is configured to increase the alarm threshold pressure level by turning the knob in a clockwise direction (denoted by a“+“ sign) and to decrease the alarm threshold pressure level by turning the knob in a counterclockwise direction (denoted by a sign). The alarm threshold pressure level can be adjusted in units of pounds per square inch (PSI) and displayed in real time via display 160. In some implementations, control device 104 can automatically set the alarm pressure threshold level based on the sizes of the vials connected to the pumps 152 and the type of medication contained in the vials. For example, control device 104 may set the alarm threshold pressure level at one pressure value when a lOmL vial is attached and a different pressure value when a 30mL vial is attached. This may enable the pumps 152 to pump medication from the 30mL vial at a higher pressure than from the lOmL vial to enable proportional injection of the medication as discussed above.
[0075] FIGS. 3A-B show various views of an example of fluid injection/aspiration device 108 of FIGS. 1A-1B. In a particular implementation shown in FIGS. 3A-3B, one or more switches 116 include two buttons (i.e., injection button 120 and aspiration button 124) located near injection needle 128. Additionally, or alternatively, body 107 (which includes one or more switches 116) can be removably coupled to injection needle 128 via connector 184. In an alternate implementation, fluid injection conduit 148 is configured to be coupled to injection needle 128 via the connector 184, and body 107 is external to fluid injection conduit 148. Connector 184 can be threaded or can use other suitable means to securely attach injection needle 128 to the connector 184 and enable removal of injection needle 128 from the connector 184 after use. Thus, new and sterile fluid injection needles can be easily attached to connector 184 and used fluid injection needles can be easily detached from connector 184 for disposal.
[0076] As described above, injection button 120 and aspiration button 124 can control the injection and aspiration functions of fluid injection/aspiration device 108, respectively. Such a configuration allows a single operator to control these functions while also positioning injection needle 128 into a tissue (e.g., an injection site) with one hand. The operator’s second hand is thus left free to control an ultrasound probe for imaging the tissue to determine the injection location, thereby allowing a peripheral nerve block injection to be performed and controlled by a single operator. In the implementation illustrated in FIGS. 3A-3B, injection button 120 and aspiration button 124 are connected to fluid injection/aspiration device 108 with various electrical connectors 176 (e.g., wires) that run alongside fluid injection conduit 148. When depressed by the user, injection button 120 causes fluid injection/aspiration device 108 to provide the first control signal to control device 104, and control device 104 causes injection of local anesthetic into the tissue through injection needle 128. Fluid injection/aspiration device 108 continues injecting fluid (e.g., providing the first control signal) as long as injection button 120 is depressed. The fluid injection rate and pressure is determined and controlled by control device 104 and pump 152. When injection button 120 is released, fluid injection/aspiration device 108 ceases fluid injection (e.g., one or more switches 116 transition into the third/standby operating state and the first control signal is no longer provided).
[0077] When aspiration button 124 is depressed, fluid injection/aspiration device 108 provides the second control signal to control device 104, and control device 104 causes withdrawal of a pre-specified volume of fluid from the tissue (for example, approximately lmL). The aspiration function enables the user to determine that fluid injection needle 128 has been inserted into desired tissue location for the peripheral nerve block procedure (e.g., inserted into a nerve and not a blood vessel). As long as aspiration button 124 is depressed, fluid injection/aspiration device 108 (or the injection needle 128 and/or the fluid injection conduit 148) holds the aspiration fluid volume. When aspiration button 124 is released, the aspiration fluid volume is returned to the tissue so that any negative pressure is released. Traditionally, a first user would control an ultrasound probe and position an injection needle, and a second user would hold a syringe of local anesthetic connected to the injection needle. The second user would perform the injection and aspiration functions once the first user was satisfied with the injection needle location. Using the disclosed implementations, a single operator can now control the ultrasound probe, position the needle at the desired tissue site, and control injection and aspiration of fluid to and from the tissue site.
[0078] FIGS. 4A-C show various views of an example of fluid withdrawal device 112 of FIGS. 1A-1B. Fluid withdrawal device 112 includes a fluid drawing needle 132 having a distal end 133 and a proximal end 135 and a vent tube 136 having a distal end 137 and a proximal end 139. Distal end 133 of fluid drawing needle 132 is configured to be inserted in a fluid container (e.g., vial 140), and the proximal end 135 of fluid drawing needle 132 is configured to be coupled to fluid withdrawal conduit 144. Fluid drawing needle 132 is configured to enable withdrawal of a fluid from vial 140 to fluid withdrawal conduit 144. Vent tube 136 is coupled in a fixed positional relationship with respect to fluid drawing needle 132 and enables fluid communication of air (e.g., a gas) between proximal end 139 of vent tube 136 and distal end 137 of vent tube 136. Distal end 137 is positioned along a longitudinal length of fluid drawing needle 132 such that, when distal end 137 of vent tube 136 is positioned within vial 140, distal end 133 of fluid drawing needle 132 is positioned within the vial.
[0079] As illustrated in FIG. 4B, fluid drawing needle 132 is used to access a vial 140 allowing the pumps 152 to draw the medication directly from vial 140 into fluid withdrawal conduit 144. Distal end 133 of fluid drawing needle 132 distal to fluid withdrawal conduit 144 can be sharp and/or tapered and configured to pierce a top of vial 140 to provide a sterile boundary between the outer atmosphere and the medication within vial 140. In a particular implementation, the proximal end 135 of fluid drawing needle 132 is configured to be removably coupled to fluid withdrawal conduit 144 via a connector or coupler, similar to the connector 184 of FIGS. 3 A and 3B.
[0080] In some implementations, fluid drawing needle 132 is coupled to vent tube 136. For example, vent tube 136 may be coupled to fluid drawing needle 132 via fastener 188. Fastener 188 may include tape, a clip, a weld, an adhesive, or a combination thereof, as non limiting examples. In another particular implementation, the proximal end 135 of fluid drawing needle 132 is coupled to vent tube 136 via a coupler configured to couple fluid drawing needle
132 to fluid withdrawal conduit 144. In alternate implementations, vent tube 136 is integrally formed with fluid drawing needle 132.
[0081] As illustrated in FIG. 4C, a longitudinal length of vent tube 136 is disposed adjacent to a longitudinal length of fluid drawing needle 132 and extends along a portion of the longitudinal length of fluid drawing needle 132. In a particular implementation, distal end 137 of vent tube 136 can be sharp and/or tapered and configured to pierce the top of vial 140 along with distal end 133 of fluid drawing needle 132. Alternatively, distal end 137 of vent tube 136 may be rounded or flat and may enter vial 140 through a hole created by fluid drawing needle 132. In some implementations,, vent tube 136 has a longitudinal length shorter than fluid drawing needle 132 or vent tube 136 is positioned such that distal end 137 of vent tube 136 avoids insertion in the liquid contained within vial 140. In some implementations, distal end
133 is separated or offset from distal end 137 by a particular distance d. Distance d can be greater than or equal to, or substantially greater than, any of 0.5 centimeters (cm), 1 cm, 1.5 cm, 2 cm, 2.5 cm, 3 cm, 3.5 cm, 4 cm, 4.5 cm, 5 cm, 5.5 cm, 6 cm, 6.5 cm, 7 cm, 7.5 cm, 8 cm,
8.5 cm, 9 cm, 9.5 cm, 10 cm, 10.5 cm, 11 cm, 11.5 cm, 12 cm, 12.5 cm, 13 cm, 13.5 cm, 14 cm, 14.5 cm, 15 cm, 15.5 cm, 16 cm, 16.5 cm, 17 cm, 17.5 cm, 18 cm, 18.5 cm, 19 cm, and
19.5 cm. In a particular implementation, the distance d is greater than or equal to 0 cm. Additionally, or alternatively, distance d can be less than or equal to, or substantially less than, any of 20 cm, 19.5 cm, 19 cm, 18.5 cm, 18 cm, 17.5 cm, 17 cm, 16.5 cm, 16 cm, 15.5 cm, 15 cm, 14.5 cm, 14 cm, 13.5 cm, 13 cm, 12.5 cm, 12 cm, 11.5 cm, 11 cm, 10.5 cm, 10 cm, 9.5 cm, 9 cm, 8.5 cm, 8 cm, 7.5 cm, 7 cm, 6.5 cm, 6 cm, 5.5 cm, 5 cm, 4.5 cm, 4 cm, 3.5 cm, 3 cm, 2.5 cm, 2 cm, 1.5 cm, and 1 cm. In a particular implementation, the distance d is at least 0.5 cm and/or is less than or equal to 20 cm. In some implementations, fluid drawing needle 132 and vent tube 136 can have the same longitudinal length and/or have different lengths but be configured to both be inserted into the liquid.
[0082] In a particular implementation, vent tube 136 is hollow and includes a vent port 192 (e.g., a vent) configured to protrude external to an interior of vial 140 when both distal end 133 of fluid drawing needle 132 and distal end 137 of vent tube 136 are disposed within vial 140. The vent port 192 is configured to allow air or other gas(es) to pass through vent tube 136 into vial 140 while liquid is being withdrawn into fluid drawing needle 132, thereby preventing the formation of a vacuum inside vial 140. Allowing the liquid to be drawn directly from vial 140 greatly simplifies the setup prior to performing the peripheral nerve block. Traditionally, the local anesthetic was drawn into a large 60 mL syringe which was then used to perform the peripheral nerve block. Drawing a large volume of local anesthetic into a syringe is a time- consuming process and also a process that can introduce small bubbles into the local anesthetic solution. These small bubbles can then cause distortion of the ultrasound imaging when injected into the tissue site. Enabling direct drawing from vial 140 eliminates this step and the associated risk of bubbles in the local anesthetic solution.
[0083] In a particular implementation, fluid withdrawal device 112 includes a pressure sensor 194 coupled to fluid drawing needle 132 or vent tube 136. Pressure sensor 194 is configured to measure a pressure within vial 140 when distal end 137 of vent tube 136 is positioned within vial 140. Pressure sensor 194 may be electronically coupled to control device 104 (e.g., via an electrical connector 176) and configured to provide pressure data generated by pressure sensor 194 to control device 104. Control device 104 may be configured to initiate output of the pressure within vial 140 via display 160. Additionally, or alternatively, control device 104 may be configured to operate the pumps 152 to cease (or slow down) withdrawal of fluid from vial 140 if the pressure within vial 140 satisfies (e.g., is greater than or equal to) a threshold.
[0084] In some implementations, fluid withdrawal device 112 includes a fluid level sensor 196 coupled to fluid drawing needle 132 and/or vent tube 136. Fluid level sensor 196 is configured to detect a fluid level of the fluid in vial 140. Fluid level sensor 196 may be electronically coupled to control device 104 (e.g., via an electrical connector 176) and configured to provide fluid level data generated by fluid level sensor 196 to control device 104. Control device 104 may be configured to initiate output of the fluid level within vial 140 via display 160. Additionally, or alternatively, control device 104 may be configured to cease (or slow down) withdrawal of fluid from vial 140 if the fluid level within vial 140 satisfies (e.g., is less than or equal to) a threshold.
[0085] In some implementations, fluid withdrawal device 112 includes a pressure release valve 198 coupled to vent tube 136. Pressure release valve 198 is configured to maintain a pressure within vial 140 to be less than or equal to a pressure threshold when distal end 137 of vent tube 136 is positioned within vial 140. If the pressure within vial 140 satisfies a particular threshold, pressure release valve 198 opens, allowing fluid to flow out pressure release valve 198 to reduce pressure within vial 140. Alternatively, pressure release valve 198 may enable air (or another gas) to enter vial 140 to reduce the pressure within vial 140.
[0086] In a particular implementation, fluid withdrawal device 112 also includes a second vent tube coupled in a fixed positional relationship with respect to fluid drawing needle 132. The second vent tube includes a distal end and a proximal end and is configured to enable fluid communication of air (or other gasses) between the proximal and distal ends. The distal end of the second vent tube is positioned along the longitudinal length of fluid drawing needle 132 at the particular distance (e.g., the distance d ) from distal end 133 of fluid drawing needle 132 such that when the distal end of the second vent tube is positioned within vial 140 distal end 133 of fluid drawing needle 132 is positioned within vial 140. The second vent tube may provide additional pressure relief capabilities or act as a backup in case vent tube 136 becomes plugged up and unable to enable air to enter vial 140.
[0087] During operation of injection system 100, fluid drawing needle 132 (and in some implementations, vent tube 136) pierce a lid of vial 140 (e.g., a fluid container). Distal end 133 of fluid drawing needle 132 is inserted into a fluid within vial 140 without inserting distal end 137 of vent tube 136 into the fluid. Control device 104 (responsive to a control signal from fluid injection/aspiration device 108) operates the pumps 152 to cause fluid to be removed from vial 140 via fluid drawing needle 132. Concurrently with removal of the fluid, air (or other gasses) is enabled to flow into vial 140 via vent tube 136. Additionally, a pressure within vial 140 is measured via pressure sensor 194 to generate pressure data that is provided to control device 104. In some implementations, a fluid level within vial 140 is measured via fluid level sensor 196 and fluid level data is provided to control device 104.
[0088] Thus, fluid withdrawal device 112 of FIGS. 4A-4C enables withdrawal of fluid without creating a vacuum within a fluid container, such as vial 140. Because the pressure in vial 140 is controlled, fluid (e.g., liquid medicine, such as anesthesia) can be withdrawn by pumps 152, which eliminates the need for a user to withdraw fluid from vial 140 using a syringe, which can inadvertently cause bubbles to be included in the withdrawn fluid.
[0089] In a particular implementation of the present disclosure, a fluid withdrawal device (e.g., fluid withdrawal device 112) includes a needle (e.g., fluid drawing needle 132) including a distal end (e.g., distal end 133) configured to be inserted in a fluid container (e.g., vial 140) and including a proximal end (e.g., proximal end 135) configured to be coupled to a conduit (e.g., fluid withdrawal conduit 144). The needle is configured to enable withdrawal of a fluid from the fluid container to the conduit. The fluid withdrawal device includes a vent tube (e.g., vent tube 136) coupled in a fixed positional relationship with respect to the needle. The vent tube includes a distal end (e.g., distal end 137) and a proximal end (e.g., proximal end 139) and is configured to enable fluid communication of air between the proximal end (e.g., proximal end 139) and the distal end (e.g., distal end 137). The distal end (e.g., distal end 137) of the vent tube is positioned along a longitudinal length of the needle at a particular distance (e.g., distance d ) from the distal end (e.g., distal end 133) of the needle such that, when the distal end (e.g., distal end 137) of the vent tube is positioned within the fluid container, the distal end (e.g., distal end 133) of the needle is positioned within the fluid container. The fluid withdrawal device also includes a pressure sensor (e.g., pressure sensor 194) coupled to the needle or the vent tube and configured to measure a pressure within the fluid container when the distal end of the vent tube is positioned within the fluid container.
[0090] In another particular implementation of the present disclosure, a fluid withdrawal device (e.g., fluid withdrawal device 112) includes a drawing needle (e.g., fluid drawing needle 132) and a venting needle (e.g., vent tube 136) disposed adjacent to the drawing needle. The venting needle includes a distal end (e.g., distal end 137) positioned along a longitudinal length of the drawing needle at a distance d from a distal end (e.g., distal end 133) of the drawing needle. In some implementations, the distance d is 0 cm. In other implementations, the distance d is at least 0.5 cm. Additionally, or alternatively, the distance d is not greater than 20 cm. In some implementations, the venting needle is coupled to the drawing needle. In some such implementations, the venting needle is coupled to the drawing needle by a fastener (e.g., fastener 188). The fastener may include tape, a clip, a weld, an adhesive, or a combination thereof. In some alternate implementations, the venting needle is integrally formed with the drawing needle. In some implementations, the drawing needle includes a proximal end (e.g., proximal end 135) opposite its distal end (e.g., distal end 133), and the proximal end of the drawing needle is attached, or configured for removable attachment, to a fluid withdrawal tube (e.g., fluid withdrawal conduit 144). Additionally, or alternatively, the venting needle includes a proximal end (e.g., proximal end 139) opposite its distal end (e.g., distal end 137). The proximal end of the venting needle includes a vent, and the vent is configured to protrude external to an interior of a vial (e.g., vial 140) when both distal ends of the drawing needle and vent tube are disposed within the vial.
[0091] FIGS. 5-8 show examples of methods of operating an injection system, such as the injection system 100 of FIGS. 1A and 1B. FIG. 5 is an example of a method of operating an injection system to dispense fluid. FIG. 6 is an example of a method monitoring pressure in an injection system. FIG. 7 is an example of a method of operating an injection system to dispense fluid. FIG. 8 is an example of a method of operating an injection system to aspirate fluid.
[0092] FIG. 5 illustrates a method 500 of operating an injection system. In a particular implementation, the method 500 may be performed by control device 104, pump 152, or a combination thereof, of the injection system 100 of FIGS. 1A-1B.
[0093] The method 500 includes receiving an injection control signal (e.g., a first control signal), at 502. For example, control device 104 may receive an injection control signal from one or more switches 116. In a particular implementation, control device 104 receives the injection control signal from injection button 120 when depressed. Method 500 includes sending a fluid withdrawal signal, at 504. For example, control device 104 may process the injection signal and provide a fluid withdrawal signal to a pump 152 coupled to fluid withdrawal device 112. Method 500 includes withdrawing fluid volume with a peristaltic pump, at 506. For example, upon receipt of the fluid withdrawal signal from control device 104, pump 152 may apply a force to withdraw a fluid volume or amount from vial 140 via fluid withdrawal device 112. Method 500 further includes dispensing fluid volume with the peristaltic pump, at 508. For example, pump 152 may dispense the fluid volume to fluid injection/aspiration device 108.
[0094] FIG. 6 illustrates a method 600 of monitoring fluid injection pressure of an injection system. In a particular implementation, method 600 may be performed by the pressure sensor 156, the control device 104 (including the display 160), or a combination thereof, of injection system 100 of FIGS. 1A-1B.
[0095] Method 600 includes monitoring a fluid injection pressure, at 602. For example, pressure sensor 156 may monitor the pressure within fluid injection conduit 148 using one or more pressure sensors. Method 600 includes displaying fluid volume and/or fluid injection pressure, at 604. For example, control device 104 may receive pressure data indicating a fluid injection pressure value from pressure sensor 156, and control device 104 may initiate output of the fluid volume dispensed and/or the current fluid injection pressure via display 160. Method 600 includes determining fluid pressure relative to a fluid threshold, at 606. For example, control device 104 may compare the current fluid injection pressure value to an alarm fluid pressure threshold. Method 600 also includes issuing a fluid pressure alarm, at 608. For example, control device 104 may issue an alarm via display 160 or an alarm device when the current fluid injection pressure approaches and/or reaches the alarm fluid pressure threshold.
[0096] FIG. 7 illustrates a method 700 of operating an injection system. In a particular implementation, method 700 may be performed by control device 104, pump 152, fluid injection/aspiration device 108, or a combination thereof, of injection system 100 of FIGS. 1A- 1B.
[0097] Method 700 includes determining that an injection setting is activated, at 702. For example, control device 104 may determine that an injection setting is activated. In a particular implementation, control device 104 determines that an injection setting is activated when an injection control signal (e.g., a first control signal) is received from one or more switches 116. In some implementations, the injection control signal is received when injection button 120 is depressed. Method 700 includes dispensing fluid volume into a fluid injection device, at 704. For example, control device 104 may operate a pump 152 coupled to fluid injection/aspiration device 108 to dispense fluid volume into fluid injection/aspiration device 108 (or to fluid injection conduit 148 to which fluid injection/aspiration device 108 is coupled). Method 700 includes determining that the injection setting is deactivated, at 706. For example, control device 104 may determine that an injection setting is deactivated, such as by determining that an injection control signal is not being continuously or periodically received. In a particular implementation, control device 104 determines that an injection setting is deactivated when one or more switches 116 are disposed in a third configuration, such as when injection button 120 is released. Method 700 further includes ceasing dispensing fluid volume into the fluid injection device, at 708. For example, control device 104 may cause pump 152 to cease to dispense the fluid volume into fluid injection/aspiration device 108 (or to fluid injection conduit 148 to which fluid injection/aspiration device 108 is coupled).
[0098] FIG. 8 illustrates method 800 of operating an injection system. In a particular implementation, method 800 may be performed by control device 104, pump 152, fluid injection/aspiration device 108, or a combination thereof, of injection system 100 of FIGS. 1A- 1B.
[0099] Method 800 includes determining that an aspiration setting is activated, at 802. For example, control device 104 may determine that an aspiration setting is activated. To illustrate,, control device 104 may determine that an aspiration setting is activated when an aspiration control signal (e.g., a second control signal) is received from one or more switches 116. In a particular implementation, the aspiration control signal is received when aspiration button 124 is depressed. Method 800 includes withdrawing fluid volume from tissue, at 804. For example, control device 104 may operate a pump 152 coupled to fluid injection/aspiration device 108 to aspirate/withdraw a preset fluid volume from the tissue through injection needle 128 into fluid injection/aspiration device 108 (or into the injection needle 128 and/or the fluid injection conduit 148). Method 800 includes determining that the aspiration setting is deactivated, at 806. For example, control device 104 may determine that an aspiration setting is deactivated. To illustrate, control device 104 may determine that an aspiration setting is deactivated when an aspiration signal is not received continuously or periodically from one or more switches 116. In a particular implementation, control device 104 determines that the aspiration setting is deactivated when aspiration button 124 is released and the preset aspiration fluid volume has been aspirated. Method 800 includes ceasing withdrawing the fluid volume from the tissue, at 808. For example, control device 104 may cause pump 152 to cease to withdraw fluid volume from the tissue into fluid injection/aspiration device 108 (or into the injection needle 128 and/or the fluid injection conduit 148). Method 800 further includes injecting the fluid volume back into the tissue, at 810. For example, control device 104 may operate pump 152 to inject the aspirated fluid volume from fluid injection/aspiration device 108 (or the injection needle 128 and/or the fluid injection conduit 148) back into the tissue.
[0100] Thus, FIGS. 5-8 provide methods of operating an injection system that allow a single operator to perform a procedure, such as a PNB injection, that includes injection and aspiration. For example, the methods 500-800 enable the operator to select operating states (e.g., injection or aspiration) through manipulation of one or more switches held in a hand that holds an injection needle. Thus, the methods provide a simple and quick way to change between injection or aspirating fluids without stopping a procedure and without requiring a second operator. Additionally, the methods of FIGS. 5-8 enable the operator to monitor pressure in a conduit of the injection system and receive an alarm if the pressure reaches a threshold, thereby reducing or preventing damage to nerves that has been shown to correlate with higher injection pressures.
[0101] Referring to FIG. 9, a block diagram of the automated peripheral nerve block injection system 100 of FIGS. 1A-1B is shown. Injection system 100 includes control device 104, one or more switches 116, the pumps 152, pressure sensor 156, and fluid withdrawal device sensors 910. Fluid withdrawal device sensors 910 include pressure sensor 194, fluid level sensor 196, pressure release valve 198 of FIG. 4C, or a combination thereof.
[0102] Control device 104 includes a processor 902 and a memory 904 coupled to processor 902. Processor 902 and the memory 904 may be coupled together via a bus or other interface. The memory 904 includes a volatile memory, a non-volatile memory, or a combination thereof. The memory 904 is configured to store computer-readable instructions that cause processor 902 to perform the operations described herein. Control device 104 includes display 160 described with reference to FIGS. 1A, 1B, and 2. Display 160 is coupled to processor 902. Control device 104 includes switches 906 coupled to processor 902. The switches 906 are configured to enable a user to set various values used by processor 902 to perform operations, such as various thresholds. For example, the switches 906 include the vial size selector switches 168 and alarm pressure adjustment knob 164 of FIGS.1A, 1B, and 2. Control device 104 optionally includes an input/output (I/O) port 908. The I/O port 908 may include or correspond to the electrical port 180 of FIG. 1B. The I/O port 908 is configured to be coupled to electrical connectors that couple control device 104 (e.g., processor 902) to one or more switches 116, the pumps 152, pressure sensor 156, and fluid withdrawal device sensors 910 and to provide input signals and/or to receive output signals to/from one or more switches 116, the pumps 152, pressure sensor 156, and fluid withdrawal device sensors 910.. In an alternate implementation, the I/O port 908 is replaced with a network interface, and control device 104 is configured to wirelessly communicate with one or more switches 116, the pumps 152, pressure sensor 156, and fluid withdrawal device sensors 910.
[0103] During operation, processor 902 is configured to monitor for control signals from one or more switches 116. As described with reference to FIGS. 1 A-1B, one or more switches 116 are coupled to body 107, and body 107 is coupled to fluid injection conduit 148. When one or more switches 116 are configured in a first configuration, processor 902 receives a first control signal 920 from one or more switches 116. Processor 902, based on first control signal 920, operates the pumps 152 to withdraw a first fluid from a first fluid source (e.g., vial 140) coupled via a fluid removal device (e.g., fluid withdrawal device 112) to a second conduit (e.g., fluid withdrawal conduit 144) and to provide the first fluid to an injection site via a needle (e.g., injection needle 128) coupled to a first conduit (e.g., fluid injection conduit 148). For example, processor 902 may imitate transmission of one or more pump controls signals 924 to the pumps 152 to cause the pumps 152 to withdraw a first fluid (e.g., anesthetic) from vial 140 via fluid withdrawal device 112 and to provide the first fluid to the injection site via injection needle 128. Although described as sending one or more pump control signals 924, one or more pump control signals 924 may correspond to a current that processor 902 causes to be provided to the pumps 152 to operate the pumps 152.
[0104] When one or more switches 116 are configured in a second configuration, the processor receives a second control signal 922 from one or more switches 116. Processor 902, based on second control signal 922, operates the pumps 152 to aspirate a second fluid from the injection site via the needle (e.g., injection needle 128). For example, processor 902 may provide a pump control signal 924 (or a particular current) that causes the pumps to operate in the opposite direction in order to aspirate the second fluid via injection needle 128.
[0105] In some implementations, processor 902 continuously or periodically receives first control signal 920 while one or more switches 122 are in the first configuration (or continuously or periodically receives second control signal 922 while the one or more switches are in the second configuration). If processor 902 does not receive either first control signal 920 or second control signal 922 for a particular duration of time, processor 902 determines that one or more switches 122 are configured in a third configuration. Based on the determination, processor 902 ceases operation of the pumps 152. For example, processor 902 ceases to provide one or more pump control signals 924 to the pumps 152.
[0106] In some implementations, processor 902 receives pressure data 926 from pressure sensor 156. To illustrate, pressure sensor 156 may measure a pressure within fluid injection conduit 148 and generate pressure data 926 that indicates the pressure. Processor 902 receives pressure data 926 and processes pressure data 926 for output via display 160. For example, processor 902 may initiate output of an indication of the pressure via display 160. Processor 902 may also compare the pressure to a pressure threshold and, if the pressure satisfies (e.g., is greater than or equal to) the pressure threshold, processor 902 imitates an alarm via display 160 and/or via an alarm device, such as a visual indication device, an audio indication device, a tactile indication device, or a combination thereof. Additionally, or alternatively, processor 902 may cease operation of the pumps 152 responsive to the pressure satisfying the pressure threshold. The pressure threshold may be set based on an input from the switches 906 (e.g., alarm pressure adjustment knob 164).
[0107] In some implementations, processor 902 receives sensor data 928 from fluid withdrawal device sensors 910. Sensor data 928 may include second pressure data from pressure sensor 194 or fluid level data from fluid level sensor 196 of FIG. 4C. Processor 902 processes sensor data 928 and performs one or more operations based on sensor data 928. For example, processor 902 may initiate output of a volume of fluid withdrawn from vial 140 (or a volume of fluid remaining in vial 140) via display 160 based on the fluid level data. Additionally, or alternatively, processor 902 may cease operation of the pumps 152 (e.g., cease withdrawal of fluid) if the volume of fluid remaining (or withdrawn) satisfies a threshold (e.g., a selected fluid container size). Additionally, or alternatively, processor 902 may initiate output of an alarm, via display 160 or an alarm device, based on a pressure indicated by the second pressure data satisfying a threshold. Additionally, or alternatively processor 902 may cease operations of the pumps 152, open pressure release valve 198 of FIG. 4C, or both, based on the pressure satisfying the threshold.
[0108] Thus, FIG. 9 describes operations performed by control device 104 to enable operation of the injection system 100. As previously described, the injection system 100 enables quick and easy selection of an operating state (e.g., injection, aspiration, etc.) and enables a complicated procedure, such as a peripheral nerve block, to be performed by a single operator.
[0109] In a particular implementation, a peripheral nerve block injection system (e.g., injection system 100) includes a fluid injection/aspiration device (e.g., fluid injection/aspiration device 108) and a control device (e.g., control device 104). The fluid injection/aspiration device includes a body (e.g., body 107) configured to be coupled to a needle (e.g., injection needle 128) and a first conduit (e.g., fluid injection conduit 148) and one or more switches (e.g., one or more switches 116) coupled to the body. The one or more switches in a first configuration provides a first control signal (e.g., first control signal 920) to indicate a first operating state in which a first flow direction from the first conduit to the needle is established for providing a first fluid to an injection site via the needle. The one or more switches in a second configuration provides a second control signal (e.g., second control signal 922) to indicate a second operating state in which a second flow direction from the injection site via the needle to the first conduit is established for aspirating a second fluid. The control device includes at least one pump (e.g., pump 152) configured to be coupled to the first conduit and to a second conduit (e.g., fluid withdrawal conduit 144). The control device also includes at least one processor (e.g., processor 902) coupled to the at least one pump. The at least one processor is configured to monitor for control signals from the one or more switches, receive the first control signal from the one or more switches, based on the first control signal, operate the at least one pump to withdraw the first fluid from a first fluid source coupled via a fluid withdrawal device to the second conduit and to provide the first fluid to the injection site via the needle, receive the second control signal, and based on the second control signal, operate the at least one pump to aspirate the second fluid from the injection site via the needle.
[0110] Referring to FIG. 10, a kit 1000 for peripheral nerve block injection systems, such as injection system 100 of FIGS. 1A-1B, is shown. The kit includes a fluid injection/aspiration device 1004, electrical connectors 1008, and a first conduit 1010. Fluid injection/aspiration device 1004 includes one or more switches 1006. For example, fluid injection/aspiration device 1004, one or more switches 1006, electrical connectors 1008, and first conduit 1010 may include or correspond to fluid injection/aspiration device 108, one or more switches 116, the one or more electrical connectors 176, and fluid injection conduit 148 of FIGS. 1A-1B.
[0111] Fluid injection/aspiration device 1004 includes a body configured to be coupled to a needle and/or to first conduit 1010. The body also includes one or more switches 1006 coupled to the body. One or more switches 1006 in a first configuration provides a first control signal to indicate a first operating state in which a first flow direction from first conduit 1010 to the needle is established for providing a first fluid to an injection site via the needle. One or more switches 1006 in a second configuration provides a second control signal to indicate a second operating state in which a second flow direction from the injection site via the needle to first conduit 1010 is established for aspirating a second fluid. In a particular implementation, kit 1000 also includes the needle configured to be coupled to a first end of first conduit 1010.
[0112] In some implementations, kit 1000 may include a package 1002. For example, package 1002 may include a box, a bag, a container, or the like. Additionally, or alternatively, package 1002 may include a packaging medium (e.g., packaging material), such as foam, paper, or the like. Package 1002 may also include fluid injection/aspiration device 1004, electrical connectors 1008, and first conduit 1010. In some implementations, package 1002 may also include one or more additional elements, as further described herein. [0113] In some implementations, kit 1000 may include a pressure sensor 1012. The pressure sensor is configured to be coupled to first conduit 1010. For example, pressure sensor 1012 may include or correspond to pressure sensor 156 of FIGS. 1A-1B.
[0114] In some implementations, kit 1000 may include a fluid withdrawal device 1014. Fluid withdrawal device 1014 may include or correspond to fluid withdrawal device 112 of FIGS. 1A-1B and 4A-4C. Fluid withdrawal device 1014 includes a second needle including a distal end configured to be inserted in a fluid container and including a proximal end configured to be coupled to a second conduit 1018. The second needle is configured to enable withdrawal of fluid from the fluid container to second conduit 1018. Fluid withdrawal device 1014 also includes a vent tube coupled in a fixed positional relationship with respect to the second needle. The vent tube includes a distal end and a proximal end and is configured to enable fluid communication of air between the proximal end and the distal end. The distal end of the vent tube is positioned along a longitudinal length of the second needle at a particular distance from the distal end of the second needle such that when the distal end of the vent tube is positioned within the fluid container the distal end of the second needle is positioned within the fluid container.
[0115] In some implementations, kit 1000 may include second conduit 1018. Kit 1000 may also include fluid withdrawal device sensor(s) 1016. The fluid withdrawal device sensor(s) 1016 may include a pressure sensor configured to be coupled to the second needle or the vent tube and configured to measure a pressure within the fluid container, a pressure release valve configured to be coupled to the vent tube and configured to maintain a pressure within the fluid container to be less than or equal to a threshold pressure when the distal end of the vent tube is positioned within the fluid container, a fluid level sensor configured to be coupled to the second needle and/or the vent tube and configured to detect a fluid level of the fluid in the fluid container, or a combination thereof. For example, the fluid withdrawal device sensor(s) 1016 may include or correspond to pressure sensor 194, fluid level sensor 196, and/or pressure release valve 198 of FIG. 4C.
[0116] In some implementations, kit 1000 may include a control device 1020. Control device 1020 is configured to be coupled to one or more switches 1006 via electrical connectors 1008. Control device 1020 includes at least one pump 1022 that is configured to be coupled to first conduit 1010. For example, control device 1020 and the at least one pump 1022 may include or correspond to control device 104 and the pumps 152 of FIGS. 1A-1B and 2. [0117] Thus, FIG. 10 describes a kit for a peripheral nerve block injection system that includes a fluid injection/aspiration device. The fluid injection/aspiration device includes one or more switches that enable a user to select an operating mode with the same hand used to hold an injection needle. Thus, the user may quickly and easily select an operation mode (e.g., by manipulating the one or more switches) without having to stop the procedure, and the user’s other hand is free to hold an ultrasound probe, thereby enabling a single person (e.g., the user) to perform a peripheral nerve block injection.
[0118] FIG. 11 illustrates a method 1100 of operating a fluid injection/aspiration device. The method 1100 may be performed at, by, or with a fluid injection/aspiration device, such as fluid injection/aspiration device 108 of FIGS. 1A-1B and 3A-3B.
[0119] The method 1100 includes coupling a body including one or more switches to a conduit and/or a needle, at 1102. The conduit is coupled in fluid communication with the needle. For example, body 107 (including one or more switches 116) may be coupled to injection needle 128 and/or fluid injection conduit 148.
[0120] The method 1100 includes transitioning the one or more switches into a first configuration to provide a first control signal to indicate a first operating state in which a first flow direction from the conduit to the needle is established for providing a first fluid to an injection site via the needle, at 1104. For example, responsive to a user input, one or more switches 116 transition into a first configuration to provide a first control signal (e.g., first control signal 620 of FIG. 9) to control device 104 to indicate a first operating state in which a first flow direction from fluid injection conduit 148 to injection needle 128 is established. Control device 104 may operate the pumps 152 to cause fluid from vial 140 to be provided in the first flow direction to an injection site via injection needle 128, as described with reference to FIGS. 1A, 1B, 2, and 9.
[0121] The method 1100 further includes transitioning the one or more switches into a second configuration to provide a second control signal to indicate a second operating state in which a second flow direction from the injection site via the needle to the conduit is established for aspirating a second fluid. For example, responsive to a user input, one or more switches 116 transition into a second configuration to provide a second control signal (e.g., second control signal 622 of FIG. 9) to control device 104 to indicate a second operating state in which a second flow direction from the injection site via injection needle 128 to fluid injection conduit 148 is established for aspirating a second fluid. In a particular implementation, the second fluid contains at least a portion of the first fluid. For example, a first fluid (e.g., anesthetic) may be aspirated from the injection site to confirm that the injection site is a nerve and not a blood vessel (as indicated by aspiration of blood).
[0122] In a particular implementation, the method 1100 includes transitioning the one or more switches into a third configuration to indicate a third operating state in which no flow path is established between the needle and the conduit. For example, in response to user input (or lack of user input), one or more switches 116 transition into a third configuration to indicate a third operating state in which no flow path is established between injection needle 128 and fluid injection conduit 148 (e.g., neither an injection mode nor an aspiration mode is engaged). Transitioning the one or more switches into the first configuration may include transitioning from the third configuration to the first configuration, and transitioning the one or more switches into the second configuration may include transitioning from the third configuration to the second configuration. For example, prior to a user manipulating one or more switches 116, one or more switches 116 may be in a third configuration, and responsive to manipulation of one or more switches 116, one or more switches 116 may transition from the third configuration to the first configuration or the second configuration. Additionally, or alternatively, the one or more switches may include a three-way switch. For example, configuring the various configurations of one or more switches 116 may include or correspond to positioning of a three-way switch.
[0123] In a particular implementation, the first control signal is provided from the one or more switches to a control device communicatively coupled to the one or more switches. For example, the first control signal (or the second control signal) may be provided from one or more switches 116 to control device 104, as described with reference to FIGS. 1A, 1B, 2, and 9. Additionally, or alternatively, a presser sensor may be coupled to the conduit and configured to measure a pressure within the conduit. For example, pressure sensors 156 may be coupled to or disposed within fluid injection conduit 148 and configured to provide pressure data to control device 104, the pressure data indicating a pressure within fluid injection conduit 148.
[0124] Thus, the method 1100 describes operation of a fluid injection/aspiration device. The fluid injection/operation device may be coupled to a fluid injection conduit and/or an injection needle, which may enable a user to quickly and easily select operating modes for the fluid injection/aspiration device using the same hand that holds the injection needle. Thus, a user’s other hand may be used to hold and guide an ultrasound device used to determine an injection site, which enables a single person to perform a peripheral nerve block injection. Additionally, because the one or more switches are nearby where the user grips the injection needle, the user is able to easily select operating modes without performing complicated other gestures or stopping the procedure to select an operating mode.
[0125] FIG. 12 illustrates a method 1200 of operating a control device of a peripheral nerve block injection system. The method 1200 may be performed at, by, or with a control device, such as control device 104 of FIGS. 1A-1B, 2, and 9.
[0126] The method 1200 includes monitoring, at a control device, for control signals from one or more switches coupled to a body, at 1202. The body is coupled to a first conduit coupled to at least one pump, and the at least one pump is coupled to the control device. For example, control device 104 may monitor for signals from one or more switches 116 coupled to body 107.
[0127] The method 1200 includes receiving a first control signal at the control device from the one or more switches. For example, control device 104 may receive a first control signal (e.g., first control signal 620 of FIG. 9) from one or more switches 116.
[0128] The method 1200 includes operating the at least one pump to cause a first fluid to be withdrawn from a fluid source via a fluid removal device coupled to a second conduit coupled to the at least one pump and to provide the first fluid to an injection site via a needle coupled to the first conduit. For example, control device 104 may operate the pumps 152 to cause a first fluid to be withdrawn from vial 140 via fluid withdrawal device 112 and to cause the first flue to be provided to an injection site via injection needle 128.
[0129] The method 1200 includes receiving a second control signal at the control device from the one or more switches. For example, control device 104 may receive a second control signal (e.g., second control signal 622 of FIG. 9) from one or more switches 116.
[0130] The method 1200 further includes operating the at least one pump to aspirate a second fluid from the injection site via the needle. For example, control device 104 may operate the pumps 152 to cause aspiration of a second fluid from the injection site via injection needle 128.
[0131] In a particular implementation, the method 1200 includes receiving pressure data from a pressure sensor coupled to the first conduit, the pressure data indicating a pressure within the first conduit. For example, control device 104 may receive pressure data (e.g., pressure data 626 of FIG. 9) from pressure sensor 156. In some implementations, the method 1200 includes initiating output of the pressure at a display device of the control device. For example, control device 104 may initiate output of the pressure at display 160. In some implementations, the method 1200 includes initiating an alarm at the control device based on determining that the pressure satisfies a pressure threshold. For example, control device 104 may initiate output of an alarm via display 160 or via an alarm device based on determining that the pressure satisfies (e.g., is greater than or equal to) a pressure threshold. In some implementations, the method 1200 includes setting the pressure threshold based on an input from a pressure setting control of the control device. For example, control device 104 may set the pressure threshold based on an input from alarm pressure adjustment knob 164.
[0132] In a particular implementation, the method 1200 includes setting a fluid container size, a maximum amount of fluid withdrawal, or both, based on an input from a fluid container size control of the control device. For example, control device 104 may set a fluid container size, a maximum amount of fluid withdrawal, or both, based on an input from the vial size selector switches 168.
[0133] In a particular implementation, the at least one pump includes a plurality of pumps. For example, the at least one pump may include the two pumps 152 (e.g., of the dual pump configuration). In some implementations, a first pump of the plurality of pumps is operated to withdraw the first fluid from the fluid source and to provide the first fluid to the needle. For example, a first pump of the pumps 152 may be operated by control device 104 to withdraw the first fluid from vial 140 and to provide the first fluid to injection needle 128. In some implementations, the method 1200 includes operating a second pump of the plurality of pumps to cause a third fluid to be withdrawn from a second fluid source via a second fluid removal device coupled to the second pump and to provide the third fluid to the needle. For example, control device 104 may operate a second pump of the pumps 152 to cause withdrawal of a third fluid from a second vial and to cause the third fluid to be provided to injection needle 128 (via a second injection conduit). The first fluid and the third fluid may be the same type of fluid, such as the same type of anesthetic in differing concentrations.
[0134] In a particular implementation, a first control signal indicates a first operating state of the one or more switches and a second control signal indicates a second operating state of the one or more switches. For example, the first control signal may indicate an injection mode and the second control signal may indicate an aspiration mode. In some implementations, the method 1200 includes receiving an indication of a third operating state of the one or more switches and ceasing operation of the at least one pump to cause no flow path between the fluid source and the needle responsive to the indication of the third operation state. For example, control device 104 may not receive a control signal from one or more switches 116, and control device 104 may cease operation of the pumps 152 to cause to flow path between the fluid source (e.g., vial 140) and injection needle 128.
[0135] Thus, the method 1200 describes operation of a control device of a peripheral nerve block injection system. The method 1200 enables the system to operate in a variety of operating modes based on user input to one or more switches located proximate to a needle held by the user. This enables the user to quickly and easily select an operating state without stopping the procedure while allowing the user’s other hand to be free to operate an ultrasound probe.
[0136] It is noted that one or more operations described above with reference to one of the methods of FIGS. 5-8 and 11-12 may be combined with one or more operations of another of FIGS. 5-8 and 11-12. For example, one or more operations of method 500 of FIG. 5 may be combined with one or more operations of method 600 of FIG. 6. Additionally, or alternatively, one or more operations of the methods of FIGS. 5-8 and 11-12 may be performed serially or concurrently. Additionally, or alternatively, one or more operations described above with reference FIGS. 1A, 1B, 2, 3A, 3B, 4A, 4B, 4C, 9, and 10 may be combined with one or more operations of FIGS. 5-8 and 11-12, or a combination of FIGS. 5-8 and 11-12.
[0137] The above specification and examples provide a complete description of the structure and use of illustrative examples. Although certain aspects have been described above with a certain degree of particularity, or with reference to one or more individual examples, those skilled in the art could make numerous alterations to aspects of the present disclosure without departing from the scope of the present disclosure. As such, the various illustrative examples of the methods and systems are not intended to be limited to the particular forms disclosed. Rather, they include all modifications and alternatives falling within the scope of the claims, and implementations other than the one shown may include some or all of the features of the depicted examples. For example, elements may be omitted or combined as a unitary structure, and/or connections may be substituted. Further, where appropriate, aspects of any of the examples described above may be combined with aspects of any of the other examples described to form further examples having comparable or different properties and/or functions, and addressing the same or different problems. Similarly, it will be understood that the benefits and advantages described above may relate to one example or may relate to several examples. Accordingly, no single implementation described herein should be construed as limiting and implementations of the disclosure may be suitably combined without departing from the teachings of the disclosure.
[0138] The previous description of the disclosed implementations is provided to enable a person skilled in the art to make or use the disclosed implementations. Various modifications to these implementations will be readily apparent to those skilled in the art, and the principles defined herein may be applied to other implementations without departing from the scope of the disclosure. Thus, the present disclosure is not intended to be limited to the implementations shown herein but is to be accorded the widest scope possible consistent with the principles and novel features as defined by the following claims. The claims are not intended to include, and should not be interpreted to include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s)“means for” or“step for,” respectively

Claims

1. A fluid injection/aspiration device comprising:
a body configured to be coupled to a needle; and
one or more switches coupled to the body; and
where:
the one or more switches in a first configuration provides a first control signal that indicates a first operating state in which a first flow direction from a conduit to the needle is established for providing a first fluid to an injection site via the needle; and
the one or more switches in a second configuration provides a second control signal that indicates a second operating state in which a second flow direction from the injection site via the needle to the conduit is established for aspirating a second fluid.
2. The fluid injection/aspiration device of claim 1, further comprising:
the needle coupled to the body; and/or
the conduit coupled to the body and in fluid communication with the needle.
3. The fluid injection/aspiration device of any of claims 1-2, where the injection site includes tissue.
4. The fluid injection/aspiration device of any of claims 1-3, where:
the first operating state comprises a fluid injection state, and where the second operating state comprises an aspiration state; and
at least one switch of the one or more switches comprises a manually operated switch configured to be operated by a hand of a user.
5. The fluid injection/aspiration device of any of claims 1-4, where the one or more switches comprise multiple switches, where the multiple switches comprise:
a first switch configured to provide the first control signal; and
a second switch configured to provide the second control signal.
6. The fluid injection/aspiration device of any of claims 1-4, where:
at least one switch of the one or more switches comprises a push button switch; and the one or more switches are configured to be electronically coupled to a control device.
7. The fluid injection/aspiration device of any of claims 1-6, where the one or more switches in a third configuration indicates a third operating state in which no flow path is established between the needle to the conduit.
8. The fluid injection/aspiration device of any of claims 1-7, where the body is configured to surround at least a portion of an outer perimeter of the conduit or to be clipped to the portion of the conduit.
9. A control device for a peripheral nerve block injection system, the control device comprising:
at least one pump configured to be coupled to a first conduit and a second conduit; and at least one processor coupled to the at least one pump, where the at least one processor is configured to:
monitor for control signals from one or more switches coupled to a body, the body coupled to the first conduit,
receive a first control signal from the one or more switches,
based on the first control signal, operate the at least one pump to withdraw a first fluid from a fluid source coupled via a fluid removal device to the second conduit and to provide the first fluid to an injection site via a needle coupled to the first conduit,
receive a second control signal from the one or more switches, and based on the second control signal, operate the at least one pump to aspirate a second fluid from the injection site via the needle.
10. The control device of claim 9, where the at least one pump comprises at least one peristaltic pump.
11. The control device of any of claims 9-10, further comprising:
a display device coupled to the at least one processor; and
where:
the at least one processor is electronically coupled to a pressure sensor coupled to the first conduit and is configured to receive pressure data from the pressure sensor, the pressure data indicating a pressure within the first conduit; and the display device is configured to output an indication of the pressure, an indication of a volume of fluid withdrawn from the fluid source, or both.
12. The control device of claim 11, where:
the at least one processor is configured to determine whether the pressure satisfies a pressure threshold; and
the display device is further configured to output an alarm responsive to the pressure satisfying the pressure threshold.
13. The control device of claim 12, further comprising a pressure alarm device configured to output an alarm responsive to the pressure satisfying the pressure threshold, where the pressure alarm device comprises a visual indication device, an audio indication device, a tactile indication device, or a combination thereof.
14. The control device of any of claims 12-13, further comprising a pressure threshold setting control device configured to set the pressure threshold at one of multiple selectable values.
15. The control device of any of claims 9-14, where the at least one pump comprises a plurality of pumps, and where the plurality of pumps comprises;
a first pump configured to be coupled to the first conduit and the second conduit; and a second pump configured to be coupled to a third conduit and a fourth conduit, the fourth conduit coupled to a second fluid removal device.
16. The control device of any of claims 9-15, further comprising at least one fluid container size selector switch configured to select a fluid container size from a plurality of fluid container sizes, a fluid volume, or both, where the at least one processor is configured to operate the at least one pump to cease withdrawal of the first fluid from the fluid source responsive to a volume of fluid withdrawn from the fluid source satisfying a selected fluid container size.
17. A peripheral nerve block injection system, the system comprising:
a fluid injection/aspiration device comprising:
a body configured to be coupled to a needle and to a first conduit; and one or more switches coupled to the body;
where: the one or more switches in a first configuration provides a first control signal to indicate a first operating state in which a first flow direction from the first conduit to the needle is established for providing a first fluid to an injection site via the needle; and the one or more switches in a second configuration provides a second control signal to indicate a second operating state in which a second flow direction from the injection site via the needle to the first conduit is established for aspirating a second fluid; and a control device comprising:
at least one pump configured to be coupled to the first conduit and a second conduit; and
at least one processor coupled to the at least one pump, where the at least one processor is configured to:
monitor for control signals from the one or more switches;
receive the first control signal from the one or more switches;
based on the first control signal, operate the at least one pump to withdraw the first fluid from a first fluid source coupled via a fluid withdrawal device to the second conduit and to provide the first fluid to the injection site via the needle;
receive the second control signal; and
based on the second control signal, operate the at least one pump to aspirate the second fluid from the injection site via the needle.
18. The peripheral nerve block injection system of claim 17, further comprising a pressure sensor coupled to the first conduit and configured to provide pressure data to the control device, the pressure data indicative of a pressure within the first conduit.
19. The peripheral nerve block injection system of any of claims 17-18, where the fluid withdrawal device comprises:
a second needle including a distal end configured to be inserted in a fluid container and including a proximal end configured to be coupled to the second conduit, the second needle configured to enable withdrawal of a fluid from the fluid container to the second conduit; a vent tube coupled in a fixed positional relationship with respect to the second needle, the vent tube comprising a distal end and a proximal end and configured to enable fluid communication of air between the proximal end and the distal end, where the distal end of the vent tube is positioned along a longitudinal length of the second needle at a particular distance from the distal end of the second needle such that, when the distal end of the vent tube is positioned within the fluid container, the distal end of the second needle is positioned within the fluid container; and
a pressure sensor coupled to the second needle or the vent tube and configured to measure a pressure within the fluid container when the distal end of the vent tube is positioned within the fluid container.
20. The peripheral nerve block injection system of claim 19, where the fluid withdrawal device further comprises:
a pressure release valve coupled to the vent tube and configured to maintain the pressure within the fluid container to be less than or equal to a threshold pressure when the distal end of the vent tube is positioned within the fluid container; and/or a fluid level sensor coupled to the second needle and/or the vent tube and configured to detect a fluid level of the fluid in the fluid container.
PCT/US2019/024208 2018-03-27 2019-03-27 Peristaltic pump nerve block injection system and related methods WO2019191181A1 (en)

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