Classifications

• • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
  • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
  • F04B—POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS
  • F04B51/00—Testing machines, pumps, or pumping installations
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
  • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
  • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
  • A61M5/1456—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/168—Means 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
  • A61M5/16804—Flow controllers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/168—Means 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
  • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/168—Means 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
  • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
  • A61M5/1684—Monitoring, detecting, signalling or eliminating infusion flow anomalies by detecting the amount of infusate remaining, e.g. signalling end of infusion
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M2205/00—General characteristics of the apparatus
  • A61M2205/33—Controlling, regulating or measuring
  • A61M2205/3379—Masses, volumes, levels of fluids in reservoirs, flow rates
  • A61M2205/3389—Continuous level detection
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES 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
  • A61M2209/00—Ancillary equipment
  • A61M2209/02—Equipment for testing the apparatus
• • G—PHYSICS
  • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
  • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
  • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
  • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
  • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation

Definitions

• This disclosure relates generally to medical devices. More particularly, this disclosure relates to devices for, and methods of, syringe characterization.
• syringe pump is intended to generally pertain to any device which acts on a syringe to controllably force fluid outwardly therefrom.
• syringes are characterized by manufacturers of syringes and/or syringe pumps according to pre-determined criteria, such as outer diameters. This characterization data may be electronically stored in a syringe database loaded into a syringe pump.
• determination of an outer diameter of a particular syringe may primarily serve a purpose of limiting or filtering a list of possible syringes from the pump database which have outer diameters that approximate an outer diameter of the particular syringe.
• various means and methods have also been proposed for characterization of syringes while installed in syringe pumps. These known means and methods of characterization, however, have often merely focused on determinations of outer diameters of syringe barrels by way of moveable measurement jaws, clamps, and the like provided on or in the pumps.
• Other known means and methods have employed conventional rulers or other linearly ruled components coupled to the pumps, with or without such syringe barrel outer diameter sensors.
• rudimentary ruled components have typically been provided in substantially parallel orientations along central longitudinal axes of syringes installed in the pumps.
• a health care practitioner would, for example, visually inspect the length of the syringe with respect to the ruled component for visually determining a volume or "length" of fluid contained within the syringe, a location of a tip of the plunger within the syringe, a distance of maximum possible linear travel of the plunger tip with the syringe barrel, and/or any other desired parameters. The user would then typically compare such metrics to a list or database of similar parameters of known syringe types, sizes, and brands, etc.
• a device for syringe characterization can include a syringe pump with a plunger driver, for a syringe containing a fluid, wherein the syringe includes a barrel and a plunger.
• the barrel and the plunger therewithin together define a central longitudinal axis of the syringe.
• the device can also include a barrel outer diameter sensor, and a linear position sensor in a substantially parallel orientation with the central longitudinal axis of the syringe when the syringe is installed in the syringe pump.
• At least one moveable marker can be in communication with the linear potentiometer, being capable of indicating a location along the linear potentiometer corresponding to a selected location on the barrel of the syringe when the syringe is installed in the syringe pump.
• the device can further include software for performing calculations that are indicative of syringe characterization, with respect to locations of selected ones of the at least one moveable marker and a diameter of the barrel that is sensed by the barrel outer diameter sensor.
• An electronic input and display component can be provided in a substantially parallel orientation with the central longitudinal axis of the syringe when installed in the syringe pump, with the electronic input and display component being substituted for the linear potentiometer and the at least one moveable marker.
• At least one moveable marker can be in communication with the linear potentiometer, being capable of indicating a location along the linear potentiometer corresponding to a selected location on the barrel of the syringe when the syringe is installed in the syringe pump.
• the device can further include software for performing calculations that are indicative of syringe characterization, with respect to locations of selected ones of the at least one moveable marker and a diameter of the barrel that is sensed by the barrel outer diameter sensor.
• the barrel outer diameter sensor, the at least one moveable marker, and the software together can function to provide syringe characterization for determination of a selected volume of fluid that is delivered from the syringe from a selected linear displacement of the plunger.
• a method of syringe characterization can comprise: providing a device for syringe characterization as aforedescribed; instructing a user of the device to engage the barrel outer diameter sensor, with the sensor thereby determining an outer diameter of a barrel of the syringe; calculating an approximate internal diameter of the barrel of the syringe; instructing the user to move a selected one of the at least one moveable marker to a first position corresponding to a particular volume location along the barrel of the syringe; calculating a second position corresponding to another volume location along the barrel of the syringe and instructing the user to move a selected one of the at least one moveable marker to the second position and provide feedback to the device upon completion thereof; calculating an apparent actual wall thickness of the barrel of the syringe; verifying whether the calculated wall thickness of the barrel of the syringe is within acceptable limits, and if the calculated thickness is not within acceptable limits, then returning to instructing the user to move a selected one of the at least
• a syringe pump that includes an outer diameter syringe barrel sensor and a linear potentiometer as aforementioned. At least one moveable marker is provided in communication with the linear potentiometer. The at least one moveable marker can be moved to a location corresponding to a selected location on the syringe barrel when the syringe is installed in the pump.
• the pump includes software for performing calculations with respect to locations of the at least one moveable marker and a sensed outer diameter of the syringe barrel, which are indicative of selected syringe parameters.
• the pump further includes display means for communicating those parameters to a user, and, optionally, a database of a variety of syringes characterized by the selected parameters such as, for example, type, size, and/or brand of syringe.
• Device 10 includes a syringe pump 100 for a syringe S having a barrel B and a plunger P with a plunger tip PT.
• Syringe S is of a size or diameter (N) (e.g., a 30 ml syringe) configured to contain a medication or other fluid to be delivered to a patient from pump 100 acting on syringe S by way of a plunger driver (not illustrated in Figure 1) as known in the art.
• N size or diameter
• Barrel B, and plunger P therewithin, can define a central longitudinal axis of syringe S.
• Device 10 also includes software and display means (not depicted in Figure 1) that can, in an embodiment, be provided by way of suitable computing components and a display screen or graphical user interface within or on pump 100, respectively (not illustrated in Figure 1) for performing calculations with respect to locations of the at least one moveable marker and communicating those calculations to a user.
• the at least one moveable marker together with the linear position sensor and the software, enable determination of specific locations - and also measurement of distances between selected points - along the barrel of a syringe.
• the software can also contain a database of a variety of syringes characterized by selected parameters such as, for example, type, size, and brand as aforementioned, which could then in turn be communicated to the user by the software and display means.
• FIG. 2 therein illustrated is an example of an embodiment of a method of syringe characterization 20 - wherein parenthetical reference numerals herein correspond to the example of a method shown in Figure 2.
• device 10 as aforedescribed is provided and a particular syringe S is installed (200) in pump 100.
• a user of device 10 is instructed (200) by the aforementioned software and display (which hereinafter may also be simply referred to as "the software" - whether including or excluding the display according to a particular component or embodiment of device 10 and/or method 20) to engage outer diameter sensor 110 with barrel B of syringe S.
• the software which hereinafter may also be simply referred to as "the software" - whether including or excluding the display according to a particular component or embodiment of device 10 and/or method 20
• Sensor 110 determines the outer diameter of barrel B of syringe S (205).
• the software calculates or predicts an approximate internal diameter of barrel B of syringe S using the outer diameter so determined by sensor 110 and an estimate of a wall thickness of barrel B based upon typical barrel wall thicknesses of typical syringes (205).
• the software then instructs the user (210) to move a selected one of the at least one moveable marker (e.g., in Figure 1, 130A or 130B) to a first position along position sensor 120 corresponding to a particular syringe volume location along barrel B of syringe S.
• a selected one of the at least one moveable marker e.g., in Figure 1, 130A or 130B
• this can be with reference to a printed scale on barrel B corresponding to a zero volume location on barrel B and/or to a point where plunger tip PT could not further advance within syringe S (215).
• the software uses the previously calculated or predicted approximate internal diameter of barrel B of syringe S, the software then calculates or predicts (220) a second position along the printed scale of barrel B corresponding to another volume location of syringe S to which it would be possible to move a selected one of the at least one moveable marker.
• the software then instructs the user to move that selected moveable marker to the second position along the linear position sensor corresponding to the scale of syringe S, and provide feedback to device 10 when that has been completed (225) by way of, e.g., the software and display means.
• the software uses a distance measured between the first and second positions to calculate the apparent actual wall thickness of barrel B of syringe S (230).
• the software can then ask the user, or alternatively make a comparison to an associated database or other internal process, to verify whether the calculated wall thickness of barrel B is within acceptable limits (235).
• the method would return to the aforementioned (225)- (235) until the calculated wall thickness is within acceptable limits.
• a determination of whether the calculated wall thickness is within acceptable limits can be made by the user via user input to the software of device 10 and/or automatically by the software itself, depending upon a particular embodiment of a method of syringe characterization as described by example or otherwise contemplated herein. If the calculated wall thickness is within acceptable limits ("Yes” in Figure 2) then a determination is made whether accuracy of the wall thickness calculation needs to be improved (240) - again, by the user and/or the software.
• a volume of fluid within the barrel can be calculated as being the product of pi multiplied by the radius of the barrel, squared, and then multiplied by a "length" of the fluid 2
• any previous wall thickness calculations are grouped by the software with a most recent wall thickness calculation (250) and a determination is then made - again, by the user and/or the software - of whether the group of wall thickness calculations is sufficiently consistent (255). If the group of wall thickness calculations is not sufficiently consistent ("No” in Figure 2) then the method returns to (225); but if the group of wall thickness calculations is sufficiently consistent ("Yes” in Figure 2) then a determination is made of whether a required number of measurements or calculations have been made - again, by the user and/or the software (260). If the required number of measurements or calculations have not been made (“No” in Figure 2) then the method again returns to (225); but if the required number of measurements or calculations have been made (“Yes” in Figure 2) then the method proceeds to the aforementioned (245).
• the software and display means can optionally instruct the user to indicate a zero volume location on barrel B of syringe S (265) and/or the software can itself extrapolate the zero volume location from measurements and calculations of preceding (200)-(260).
• the software can then instruct the user (270) to move the at least one moveable marker to a location corresponding to plunger tip PT of syringe S.
• the software can then calculate (275) an actual volume of the fluid contained within that syringe S.
• a drive arm in the pump - which acts to advance the plunger in use of the pump - can include a position sensor to sense a present position of the drive arm. With a position of the drive arm thus known and the location of the plunger tip determined as aforementioned, the software can then calculate the length of the plunger arm.
• the software can also compare the aforedescribed characteristics of syringe S (e.g., outer diameter, inner diameter, volume of fluid that is deliverable per linear distance advanced by plunger tip PT, etc.) to a database of previously characterized and known syringes, and through the display means communicate to the user any correspondence between syringe S and a known syringe in the database.
• a device and method of syringe characterization can also be utilized for quality control verification and patient safety with known syringes.
• a known syringe can be installed in a device 10 and the method of syringe characterization as aforedescribed can be performed to verify an expected syringe brand and size. If the displayed syringe characterization parameters do not match with what was expected by the user, then the user can have an indication that the particular syringe is non-conforming or non-standard and should not be used.
• suitable push-buttons can be provided with the at least one moveable marker to enable a user to more positively confirm locations associated therewith.
• an electronic input and display component can be provided in a substantially parallel orientation with the central longitudinal axis of the syringe when installed in the syringe pump. In such an embodiment, the electronic input and display component can be substituted for the linear potentiometer and the at least one moveable marker. For a given display component, the pitch of the rows and/or columns is known by the software.
• the software can determine the number of rows and/or columns between indicators on the display or from an edge of the display and from that calculate a position of a marker and/or a distance between two markers or distances between three or more markers.
• the display and user interface of the device thus can perform the function of one or more linear position sensors.
• the electronic input and display component can comprise, for example, suitable touch screen or LCD technology. Examples of touch screen devices generally are disclosed in U.S. Pat. Applic. Pub. Nos. 2006/0097991 titled "Multipoint Touchscreen” and in 2011/0193788 titled "Graphical Objects that Respond to Touch or Motion Input.” Examples of novel and inventive infusion pump technologies employing touch screen devices are disclosed in U.S. Pat. No.
• a user can mark and measure distances along the syringe, on screen, in performance of a method of syringe characterization as described by example or otherwise contemplated herein.
• a user can move graphical icons - including representations of all or part of a scale on a syringe barrel - on screen, or zoom in or out or otherwise scale a screen image of the syringe, in performance of the method.
• a syringe barrel outer diameter sensor can comprise a "syringe size sensor” that is commercially available in a Medfusion® 3500 Series infusion pump from Smiths Medical ASD, Inc.
• the position sensor is a precision potentiometer that produces a voltage (resistance) which is, in turn, proportional to an outside diameter of a barrel of a syringe that is installed in the pump.
• the at least one moveable marker communicating with a linear position sensor, and the software together function to provide syringe characterization for determination of a selected volume of fluid that is delivered from the syringe from a selected linear displacement of the syringe's plunger.
• novel and inventive devices for and methods of calculating or predicting inner diameters of syringe barrels enable such characterizations of unknown syringes as also aforedescribed.
• devices and methods of syringe characterization that have been described by example or otherwise contemplated herein, for syringes that might have been previously unknown, can advantageously enhance accuracy - and thus safety and efficacy - in fluid delivery to patients.
• devices for, and methods of, syringe characterization such as have been described by example or otherwise contemplated herein, can be able, for a particular linear displacement or travel of a particular plunger, to determine with increased accuracy how much fluid is ultimately delivered. For example, for a particular syringe one millimeter (1 mm) of plunger travel could result in ten milliliters (10 ml) of fluid delivered to the patient.
• compositions, sizes, and strengths of various aforementioned components of devices for, and methods of, syringe characterization described by example or otherwise contemplated herein are all a matter of design choice depending upon intended uses thereof.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Hematology (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Mechanical Engineering (AREA)
• General Engineering & Computer Science (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Priority Applications (8)

Applications Claiming Priority (2)

Publications (2)

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Cited By (4)

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• 2013
  • 2013-12-03 EP EP13859917.0A patent/EP2928525A4/en not_active Withdrawn
  • 2013-12-03 CN CN201380064092.3A patent/CN105307708B/zh not_active Expired - Fee Related
  • 2013-12-03 SG SG11201503265QA patent/SG11201503265QA/en unknown
  • 2013-12-03 AU AU2013356289A patent/AU2013356289A1/en not_active Abandoned
  • 2013-12-03 CA CA2891993A patent/CA2891993A1/en not_active Abandoned
  • 2013-12-03 US US14/443,928 patent/US9976551B2/en not_active Expired - Fee Related
  • 2013-12-03 JP JP2015546545A patent/JP6401179B2/ja not_active Expired - Fee Related
  • 2013-12-03 KR KR1020157017718A patent/KR20150093197A/ko not_active Withdrawn
  • 2013-12-03 WO PCT/US2013/072751 patent/WO2014089008A2/en not_active Ceased

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