WO2017074599A1 - Systems and methods for securing infusion lines to syringe pumps - Google Patents

Systems and methods for securing infusion lines to syringe pumps Download PDF

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Publication number
WO2017074599A1
WO2017074599A1 PCT/US2016/052219 US2016052219W WO2017074599A1 WO 2017074599 A1 WO2017074599 A1 WO 2017074599A1 US 2016052219 W US2016052219 W US 2016052219W WO 2017074599 A1 WO2017074599 A1 WO 2017074599A1
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WO
WIPO (PCT)
Prior art keywords
receptacle
line
flap
syringe
infusion line
Prior art date
Application number
PCT/US2016/052219
Other languages
French (fr)
Inventor
Grant A. ADAMS
Christopher Allen Lacy
Original Assignee
Smiths Medical Asd, Inc.
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 Smiths Medical Asd, Inc. filed Critical Smiths Medical Asd, Inc.
Publication of WO2017074599A1 publication Critical patent/WO2017074599A1/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
    • 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
    • A61M5/1414Hanging-up devices
    • A61M5/1418Clips, separators or the like for supporting tubes or leads
    • 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
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/08Tubes; Storage means specially adapted therefor
    • A61M2039/087Tools for handling tubes, e.g. crimping tool for connecting tubes to a connector

Definitions

  • This disclosure relates to infusion pumps, and more particularly, to systems and methods for securing infusion lines to syringe pumps.
  • syringe infusion pumps have demonstrated their usefulness to medical practitioners.
  • some syringe pumps include a replaceable syringe to which an infusion tube, tubing, or line (collectively, "line") is attached.
  • Some syringe pumps include line holders through which the infusion line can be threaded downstream of the syringe. Such line holders can secure the infusion line to the pump and can provide a function of relieving or redirecting tension that may be present in the infusion line, before such tension might deleteriously reach the syringe to which the infusion line is attached.
  • Threading or otherwise routing an infusion line through line holders of an infusion pump can be a cumbersome task for a medical practitioner or other user of the syringe pump. Therefore, there is a need for improved systems and methods for securing infusion lines to syringe pumps.
  • This disclosure relates to infusion pumps, and more particularly, to systems and methods for securing infusion lines to syringe pumps.
  • the disclosure provides a syringe pump that can include a receptacle configured to receive a syringe and a receptacle flap attached to the pump.
  • the receptacle flap can move between an open mode and a closed mode. In the closed mode, the receptacle flap can be in a position that substantially inhibits access to the receptacle and to the syringe received by the receptacle. In the open mode, the receptacle flap can be in a position that enables access to the receptacle and to the syringe received by the receptacle.
  • the receptacle flap can include an engagement portion structured to engage an infusion line with the receptacle flap, the infusion line being fluidically coupled to the syringe.
  • the engagement portion can be structured to engage the infusion line via at least a clearance fit. In some cases, the engagement portion can include a slot structured to engage the infusion line. In some cases, the engagement portion can include a hook structured to engage the infusion line, In some examples, the engagement portion can be structured to engage the infusion line when the receptacle flap is in the open mode. In some such cases, if the infusion line is engaged with the engagement portion with the receptacle flap in the open mode, the engagement portion can be structured to maintain engagement of the infusion line when the receptacle flap moves between the open mode and the closed mode. In some cases, when the receptacle flap is in the closed mode, the infusion line can be constrained to remain in engagement with the engagement portion.
  • the syringe pump can further include a line securing mechanism that includes the engagement portion of the receptacle flap.
  • the line securing mechanism can engage the infusion line at a position substantially on or near a longitudinal axis of the syringe, away from a dispensing tip of the syringe at which the infusion line is attached.
  • the line securing mechanism can be structured such that, when engaging the infusion line, it can perform either or both of (a) bearing tension applied to the infusion line such that tension is reduced or relieved at the dispensing tip of the syringe; and (b) redirecting tension applied to the infusion line such that tension exerted on the dispensing tip of the syringe by the infusion line is substantially directed along the longitudinal axis of the syringe.
  • the syringe pump can further include line securing structures at or adjacent the receptacle. The line securing structures can function in cooperation with the engagement portion of the receptacle flap as part of the line securing mechanism when the receptacle flap is in the closed mode.
  • the infusion line when the receptacle flap is in the open mode and the infusion line is engaged by the engagement portion of the receptacle flap, the infusion line generally is not in contact with the line securing structures.
  • the line securing mechanism can be configured and structured such that the infusion line follows a tortuous path when engaged with the line securing mechanism with the receptacle flap in the closed mode.
  • a syringe pump that includes line securing structures can further include a selectively actuatable clamp mechanism that includes, at least part of the line securing mechanism.
  • the selectively actuatable clamp mechanism can be configured to responsively and reversibly compressively clamp the infusion line with sufficient force to temporarily and reversibly occlude the infusion line.
  • Some syringe pumps that include a selectively actuatable clamp mechanism can further include a flap latch configured to selectively constrain the receptacle flap to the closed mode.
  • the flap latch can further be configured to controllably position the receptacle flap within a pre-determined range of positions relative to the receptacle, thereby controllably positioning the engagement portion of the receptacle flap within a pre-determined range of positions relative to the line securing structures. At least one position in the pre-determined range of positions can correspond to an occluded condition for the infusion line.
  • a syringe pump includes a selectively actuatable clamp mechanism that further includes a flap latch configured to selectively constrain the receptacle flap to the closed mode
  • at least a portion of the line securing structures can be selectively positionable within a pre-determined range of positions relative to the engagement portion of the receptacle flap when the receptacle flap is constrained to the closed mode by the flap latch. At least one position in the pre-determined range of positions can correspond to an occluded condition for the infusion line.
  • the syringe pump can further include a flap latch configured to selectively constrain the receptacle flap to the closed mode, where the flap latch includes at least part of the engagement portion of the receptacle flap.
  • the infusion line includes an engagement structure structured to mate with the engagement portion.
  • the engagement structure can be configured to facilitate electrical and/or optical connectivity between the syringe pump and the infusion line by either providing electrical and/or optical connectivity via the engagement structure, or by positioning a connector that provides electrical and/or optical connectivity between the syringe pump and the infusion line.
  • the syringe pump can further include a power source configured to provide power to an optical element of the infusion line, with the engagement structure of the infusion line facilitating coupling of power from the power source to the optical element
  • Figure 1 is a schematic perspective view of a syringe pump
  • Figure 2 is a schematic perspective view of a syringe pump having a syringe receptacle and a receptacle flap in an open mode, with an infusion line engaged with an engagement portion of the receptacle flap;
  • Figure 3 is a schematic perspective view of the syringe pump of Figure 2, with the receptacle flap in a closed mode;
  • Figure 4 is a schematic perspective view of another syringe pump, showing line securing structures at its syringe receptacle;
  • Figure 5 is a schematic perspective view of aspects of another syringe pump, including components of a flap latch mechanism that is integrated with an engagement portion of a receptacle flap and a selective clamping mechanism;
  • Figure 6 is a schematic perspective view of another syringe pump, showing an infusion line having an engagement structure configured to mate with an engagement portion of a receptacle flap;
  • Figure 7 is a schematic perspective view of a receptacle flap having engagement portions that define a tortuous path.
  • FIG. 1 illustrates a syringe infusion pump 100, such as, for example, a MEDFUSION 4000 syringe infusion pump from Smiths Medical ASD, Inc.
  • syringe pump 100 can deliver various infusates, drug therapies and treatments to patients.
  • syringe pump 100 When in use, syringe pump 100 typically can include a removable and replaceable pharmaceutical container or syringe 110, which can be supported on and secured to housing 120 of pump 100 and can be secured thereto by clamp 130.
  • syringe 1 10 can be separately supplied from pump 100.
  • syringe 110 can be an integrated component of pump 100.
  • Syringe 110 can include a plunger 140 that can force fluid outwardly from syringe 110 via infusion line 150 that is connected to a patient (not illustrated).
  • Infusion line 150 can be fluidically and mechanically coupled to syringe 110 at an attachment point 155, typically at the tip of syringe 110 opposite plunger 140, from which infusate is dispensed.
  • a pusher or plunger driver mechanism 160 of pump 100 when in operation, can act to move plunger 140 of syringe 110.
  • Operation of mechanism 160 can be provided by way of, for example, cooperative action of a motor and lead screw arrangement internal to housing 120 of pump 100.
  • a sensor can be provided (not shown; typically internal to plunger driver mechanism 160) that can monitor force and/or a position of plunger 140 in syringe 110 according to system specifications.
  • Pump 100 typically can include a user interface 170 (that can include a display screen, keypad, and any other suitable user interface components) for relaying commands to a control system (not illustrated) of pump 100.
  • User interface 170 generally can allow a user to enter various parameters, including but not limited to names, drug information, limits, delivery shapes, information relating to hospital facilities, as well as various user-specific parameters (e.g., patient age and/or weight).
  • Infusion pump 100 can include any appropriate wired or wireless input/output (I/O) interface port and/or protocol (including, but not limited to, USB, Ethernet, WiFi, NFC, Bluetooth, and the like) for connecting pump 100 to a network or computer (not illustrated) having software designed to interface with pump 100.
  • I/O input/output
  • Power to infusion pump 100 can be provided via an AC or DC power cord, from an internally provided battery source (not illustrated), or by any other suitable means.
  • Embodiments can also include a wireless power source (not illustrated).
  • User inputs to infusion pump 100 can be provided by programming from an authorized user, such as a patient, pharmacist, scientist, drug program designer, medical engineer, nurse, physician, or other authorized medical practitioner or healthcare provider.
  • User inputs may utilize direct interfacing (via, e.g., keyboards, touch screens, or other touch-based inputs) as shown, and/or user inputs may utilize indirect or "touchless" interfacing (i.e., gestures; voice commands; facial movements or expressions; finger, hand, head, body and arm movements; or other inputs that do not require physical contact such as cameras, sensors of electric field, capacitance, or sound).
  • User inputs generally can be interfaced, communicated, sensed, and/or received by operator input mechanisms of user interface 170.
  • Pump 100 can include line holders 180, for guiding and removably securing a portion of infusion line 150 to housing 120 of pump 100.
  • line holders 180 can include multiple hooks facing opposite directions into which infusion line 150 can be threaded, such threading generally being performed manually by a medical practitioner or user of pump 100.
  • Line holders 180 can provide an important safety function for pump 100. In usage, undesirable tension can be introduced in infusion line 150, when a force or forces are unintentionally, incidentally, unavoidably, accidentally, maliciously, or otherwise exerted on the line.
  • infusion line 150 could pull on infusion line 150; line 150 could snag or snare a moving object or (part of) a person; separation between pump 100 and a patient connected to line 150 could increase such that line 150 is pulled taut; and so on.
  • line holders 180 can help maintain proper securement of syringe 110 to pump 100.
  • Tension in line 150 can dislodge syringe 110 from its proper position secured to pump 100, particularly if a force resulting from the tension is applied to syringe 110 at attachment point 155 in a direction substantially away from longitudinal axis 190 of syringe 110.
  • line 150 can be routed to extend from attachment point 155 to line holders 180 (which are located substantially along longitudinal axis 190). In this way, line holders can, in effect, redirect tension applied to the infusion line such that tension exerted on the dispensing tip (attachment point 155) of the syringe 110 by the infusion line is substantially directed along the longitudinal axis of the syringe.
  • infusion line 150 extending away from pump 100 downstream of line holders 180 makes a significant angle relative to longitudinal axis 190 of syringe 110, but a portion of line 150 between attachment point 155 and line holders 180 is substantially aligned with longitudinal axis 190 of syringe 110.
  • an effect or effects of direction of tension in infusion line 150 upon stability of syringe 110 relative to pump 100 can be understood by consideration of geometry of syringe 110 relative to pump 100.
  • Syringe 110 can be supported in a trough or cradle extending along an upper side of housing 120 of pump 100 as shown in Figure 1, and held down in the cradle by clamp 130.
  • clamp 130 can be spring loaded.
  • Finger tabs 195 of syringe 110 can bear against a side of housing 120.
  • Plunger 140 of syringe 110 can abut plunger driver 160 of pump 100, and can also be clipped thereto, as illustrated.
  • syringe 110 may tend to rotate about a point of rotation around where finger tabs 195 contact the housing 120.
  • a relatively long lever arm from such a point of rotation to attachment point 155 as compared to the relatively short distance from the point of rotation of syringe 110 to clamp 130, may result in the off-axis tension overcoming the clamping force of clamp 130 on syringe 110 and dislodging syringe 110 from proper securement to pump 100.
  • line holders 180 can also bear tension applied to infusion line 150 such that tension is reduced or relieved at the dispensing tip (attachment point 155) of syringe 110.
  • tension relief can also be referred-to as "stress relief,” and can depend on dimensions and geometry of line holders 150 and/or infusion line 150.
  • Line holders 150 can provide other beneficial features and advantages as well, such as holding line 150 in an orderly manner.
  • co-pending U.S. Provisional Patent Application Serial No. 62/169,115 describes, in part, novel infusion line clamp systems that can include tubing holders as components cooperatively in or with syringe pumps.
  • New or improved syringe infusion pumps can introduce new challenges and opportunities for management of infusion lines.
  • Co-pending U.S. Provisional Patent Application Serial No. 62/086,551, "SYRINGE INFUSION PUMP SECURITY” describes, in part, novel syringe infusion pump systems that can include a syringe receptacle and a receptacle flap movable between a closed mode and an open mode, in which the flap can, respectively, substantially inhibit or clear access to the receptacle and to a syringe received by the receptacle.
  • the present disclosure teaches novel systems and methods for securing infusion lines in syringe infusion pump systems having syringe receptacles, receptacle flaps, and/or similar structures.
  • FIG 2 is a schematic perspective view of a syringe infusion pump 200 provided in accordance with novel and inventive subject matter of the present disclosure, having a syringe receptacle 205 structured and configured to receive a syringe 220.
  • pump 200 can include a receptacle flap 210 movable between an open mode and a closed mode.
  • receptacle flap 210 is illustrated as being positioned in an open mode. While receptacle flap 210 is illustrated in the Figures of the present disclosure as being pivotable between open and closed modes, examples of flaps in the present disclosure are not necessarily limited to pivoting motions in all instances.
  • a receptacle flap could be configured to extend and retract, and/or slide, when moving between open and closed modes.
  • receptacle flap 210 is illustrated as pivoting via an upper or top hinge 212, this is not limiting and flap 210 could be configured to pivot via a lower or bottom hinge, or any other suitable hinge location.
  • Infusion syringe pump 200 can include any feature or features similarly as described for syringe infusion pump 100 of Figure 1, to an extent that such feature or features are compatible with pump 200.
  • Figure 2 is a simplified schematic view of pump 200 that may omit illustration of some features that can be included therein, such as a pusher or plunger driver mechanism like feature 160 of pump 100. Any such omissions may be made purely for convenience and clarity of illustration. Those of skill in the art may readily recognize features of syringe pumps that are desirable, necessarily, or otherwise can be included in pump 200 and be compatible with novel features described herein.
  • infusion pump 200 of Figure 2 is not illustrated with line holders directly provided on its housing 215.
  • components such as line holders 180 shown in Figure 1 can be directly provided on housing 215 of infusion syringe pump 200.
  • line holders could be placed inside syringe receptacle 205 such that they would be disposed substantially along a longitudinal axis (not shown) of syringe 220 installed in pump 200, at a location effective for redirecting tension applied to infusion line 225 substantially along the longitudinal axis of the syringe (with infusion line 225 being mechanically coupled to syringe 220 and in fluidic communication therewith).
  • infusion line 225 being mechanically coupled to syringe 220 and in fluidic communication therewith.
  • systems and methods of the present disclosure may provide line securing solutions that are simple and easy to use and manipulate with infusion lines inside or adjacent to a component such as syringe receptacle 205.
  • receptacle flap 210 can include an engagement portion 230 structured and configured to engage infusion line 225 with receptacle flap 210.
  • Engagement portion 230 can include any suitable structure or structures and can be configured to engage infusion line 225 in any suitable manner to, for example, assist in alleviating an undesirable tension and off-axis force that might be experienced by line 225 and syringe 220 as aforementioned.
  • engagement portion 230 can include a slot 232 structured to engage infusion line 225.
  • engagement portion 230 structures of engagement portion 230 that define or border slot 232 can be in at least partial or intermittent contact with infusion line 225.
  • a slot narrower than a nominal width of infusion line 225 might continuously hold, squeeze, or "pinch" the line between opposing sides of the slot.
  • one side or portion of a slot that is wider than the nominal width of infusion line 225 might contact the line with another side or portion of the slot not being in contact with the line.
  • engagement portion 230 can include a hook structured to engage infusion line 225.
  • engagement portion 230 can be structured to engage infusion line 225 via at least a clearance fit.
  • engagement portion 230 can be structured to engage infusion line 225 via at least a friction fit.
  • infusion line 225 can include a feature or component that is configured specifically to engage with engagement portion 230.
  • Engagement portion 230 can be structured to engage infusion line 225 when receptacle flap 210 is in an open mode (as illustrated in Figure 2), and engagement portion 230 can be positioned on receptacle flap 210 such that infusion line 225 can be readily manipulated and engaged with engagement portion 230 when receptacle flap 210 is in an open mode.
  • the location of engagement portion 230 on receptacle flap 210 when the flap is in an open mode (when flap 210 generally may be extended away from housing 215 of pump 100), can be substantially easier to access manually as compared to locations within syringe receptacle 205, where line holders might otherwise have been placed in contingent or hypothetical designs lacking engagement portion 230 and/or other novel and inventive line securing features of the present disclosure.
  • engagement portion 230 can be structured such that if infusion line 225 is engaged with engagement portion 230, it generally will remain so engaged by itself (e.g., without a need for separately holding line 225 in engagement with the engagement portion), at least under nominal conditions. If infusion line 225 is engaged with engagement portion 230, with receptacle flap 210 in an open mode, engagement portion 230 can be structured to maintain engagement of infusion line 225 when receptacle flap 210 moves between the open mode and the closed mode, at least under nominal conditions.
  • engagement portion 230 can be structured such that its rotation as flap 210 pivots about hinge 212 does not result in disengagement of infusion line 225 therefrom.
  • at least under nominal conditions in relation to the infusion line 225 remaining in engagement with engagement portion 230, this can mean under many conditions that normally would be expected during use of pump 200, which would, for example, exclude intentional attempts to manipulate line 225 to disengage it from engagement portion 230.
  • Engagement portion 230 can be a component of a line securing mechanism of infusion pump 200.
  • a line securing mechanism can include an engagement portion such as engagement portion 230 as a primary component or, in some cases, sole component.
  • an engagement mechanism can include multiple components that may function in cooperation to provide a line securing function.
  • the line securing mechanism can be structured such that, when engaging infusion line 225 at this position, it can provide one or more functions that enhance infusion line and syringe security.
  • One function it can provide is to bear tension applied to infusion line 225 such that tension is reduced or relieved at dispensing tip 255 of syringe 220.
  • Another function it can provide is to redirect tension applied to infusion line 225 such that tension exerted on dispensing tip 255 of syringe 220 by line 225 is substantially directed along the longitudinal axis of syringe 220.
  • These functions can be the same or similar to functions provided by line holders 180 of infusion pump 100 of Figure 1. As provided for infusion pump 200, this line securing mechanism can possibly be easier to manipulate and engage with infusion line 225 than conventional line holders, if such conventional holders were provided for pump 200.
  • FIG 3 is a schematic perspective view of infusion pump 200 of Figure 2, with receptacle flap 210 in the closed mode.
  • Infusion pump 200 can be structured and configured such that when receptacle flap 210 is in the closed mode, infusion line 225 is constrained to remain in engagement with engagement portion 230. Such a constraint can be achieved in any suitable manner.
  • an opening 235 of engagement portion 230 can be obstructed or blocked by a region 237 of a wall portion of syringe receptacle 205 when receptacle flap 210 is moved into the closed mode, which can prevent infusion line 225 from exiting engagement portion 230 via the (obstructed) opening.
  • Region 237 of the wall portion of syringe receptacle 205 that obstructs opening 235 of engagement portion 230 can be, in an embodiment, smooth and similar to any other part of the wall or syringe-facing surface of receptacle 205, as illustrated in Figure 3.
  • an infusion pump can include, at or adjacent the syringe receptacle, line securing structures.
  • Line securing structures can be designed and configured to function in cooperation with an engagement portion of a receptacle flap as part of a line securing mechanism when the receptacle flap is in the closed mode.
  • Line securing structures can include one or more projections, recesses, or other shapes departing from the general surface of the wall of the syringe receptacle. Such structures could be formed integrally with the wall of the syringe receptacle, or could be attached to the wall.
  • Figure 4 is a schematic perspective view of certain components of an infusion pump 400, showing a line securing structure 440 at syringe receptacle 405.
  • Pump 400 can include various features similar to or the same as corresponding features of pump 200. To improve the visibility of line securing structure 440, some features associated with infusion pump 400 are not shown in Figure 4, such as a receptacle flap and an infusion line similar to or the same as the corresponding features of pump 200 of Figure 2.
  • a line securing mechanism of pump 400 including line securing structure 440 and an engagement portion of a receptacle flap (not shown in Figure 4), can be structured and configured such that when the receptacle flap is in the closed mode, the line securing mechanism constrains an infusion line (not shown in Figure 4) to follow a tortuous path.
  • the line securing mechanism of pump 400 can be structured and configured such that when the receptacle flap of the pump is in the open mode with an infusion line engaged with the engagement portion of the flap, the infusion line generally is not in contact with the securing structure 440.
  • the line securing mechanism of pump 400 can be structured and configured in some embodiments such that as the receptacle flap is moved to the closed mode, the infusion line remains engaged with the engagement portion of the flap and is moved into the tortuous path defined (at least in part) by line securing structures 440 and the engagement portion.
  • the infusion line can be manually placed into engagement with line securing structures 440 without necessarily being engaged with the engagement portion of the receptacle flap; and when the receptacle flap is subsequently moved to the closed mode, the infusion line is constrained to a tortuous path and can be engaged with the engagement portion.
  • Constraining the infusion line to a tortuous path can be part of a manner in which the line securing mechanism of pump 400 can provide stress relief for the infusion line, and reduce or relieve tension at dispensing tip 455 of the syringe 420 to which the infusion line (not shown in Figure 4) is coupled.
  • an infusion line can be constrained to a tortuous path in the system of pump 400 by the cooperative effect of line securing structures 440 and the engagement portion of a receptacle flap, other ways of constraining an infusion line to a tortuous path are contemplated.
  • Figure 7 is a schematic perspective view of a receptacle flap 710 similar to receptacle flap 210 of Figures 2 and 3.
  • Receptacle flap 710 can include multiple engagement portions 732, 734 through which a portion of an infusion line (not illustrated) can be threaded or placed. While two engagement portions 732, 734 are illustrated, any suitable number can be included. Threading the infusion line through the engagement portions 732, 734 can place that portion of the infusion line into a tortuous path that can be defined by engagement portions 732, 734, without the infusion line interacting with line securing structures of a syringe receptacle. Such threading can be performed readily when flap 710 is in an open mode, before flap 710 is moved to the closed mode.
  • receptacle flap 710 can be part of a pump that includes line securing structures at or adjacent the syringe receptacle that further define a tortuous path for the infusion line when the flap is moved to the closed mode, but this is not necessary, and in some embodiments, a tortuous path for the infusion line is defined by engagement portions 732, 734 without participation of line securing structures, when the receptacle flap is in the closed mode.
  • line securing mechanisms associated with receptacle flaps could participate in other functions in addition to (or perhaps in some embodiments, alternatively to) redirection or relief of tension of infusion lines, such as a selectively actuatable clamp mechanism configured to responsively and reversibly compressively clamp the infusion line with sufficient force to temporarily and reversibly occlude the infusion line.
  • a selectively actuatable clamp mechanism configured to responsively and reversibly compressively clamp the infusion line with sufficient force to temporarily and reversibly occlude the infusion line.
  • an infusion line could be selectively clamped, for example, between an engagement portion of a receptacle flap, and line securing structures at or adjacent the syringe receptacle.
  • the line securing structures could remain in a fixed position relative to the syringe receptacle, and the position of the engagement portion (or a sub-portion thereof) could be varied in order to achieve a variable gap between the two in which the infusion line could be clamped.
  • the position of the engagement portion could be held fixed relative to the syringe receptacle, and the position of the line securing structures (or a sub-portion thereof) could be varied, likewise to achieve a variable gap in which the infusion line could be clamped.
  • the positions of both the engagement portion and the line securing structures can be varied. The variation in the position of the engagement portion and/or line securing structure can be effected in any suitable manner.
  • Figure 5 is a schematic perspective view of aspects of an infusion pump 500 that can provide selective clamping of an infusion line between an engagement portion 530 of a receptacle flap 510 and line securing structure(s) 540 at or adjacent a syringe receptacle 505.
  • the position of engagement portion 530 can be varied by varying the position of receptacle flap 510 of which engagement portion 530 is a component.
  • Infusion pump 500 can include a flap latch mechanism configured to selectively constrain receptacle flap 510 to the closed mode and also to controllably position receptacle flap 510 within a pre-determined range of positions relative to receptacle 505, thereby controllably positioning engagement portion 530 of flap 510 within a pre-determined range of positions relative to line securing structures 540. At least one position in the pre-determined range of positions can correspond to an occluded (i.e., clamped) condition for an infusion line (not illustrated, for clarity) engaged by the line securing mechanism of pump 500 in a space 560 between engagement portion 530 and line securing structures 540.
  • a flap latch mechanism configured to selectively constrain receptacle flap 510 to the closed mode and also to controllably position receptacle flap 510 within a pre-determined range of positions relative to receptacle 505, thereby controllably positioning engagement portion 530 of flap 510 within a pre-determined range of positions relative to line securing
  • pump 500 can include a flap latch mechanism integrated with engagement portion 530 of receptacle flap 510.
  • Engagement portion 530 can include a mating structure 545 structured to selectively couple to another component of the flap latch mechanism of pump 500.
  • mating structure 545 can pass through an opening 550 in housing 515, where it can couple with an internal component (not shown) of the flap latch mechanism.
  • the internal component can be actuatable by a controller of pump 500 (for example, by electric motor) to controllably position engagement portion 530 and receptacle flap 510 closer to, or further away from, housing 515, receptacle 505, and line securing structures 540 of the pump, thereby varying dimensions of space 560 in which an infusion line can be selectively clamped.
  • a controller of pump 500 for example, by electric motor
  • an infusion pump can include a flap latch configured to selectively constrain its receptacle flap to the closed mode, but that is not necessarily configured to controllably position the receptacle flap within a range of positions relative to the receptacle.
  • line securing structures can be configured such that at least a portion of the line securing structures is controllably positionable within a pre-determined range of positions relative to the engagement portion of the receptacle flap when the receptacle flap is constrained to the closed mode by the flap latch.
  • At least one position in the pre- determined range of positions can correspond to an occluded (i.e., clamped) condition for an infusion line engaged by the line securing mechanism that includes the engagement portion and the line securing structures.
  • the line securing structures (or sub-portion thereof) can be configured to be controllably positionable in any suitable manner. They may be movable via, for example, motor, solenoid, or any other mechanical actuation technology that can be commanded by a controller of the pump.
  • a line securing mechanism could be integrated with, or otherwise operate in cooperation with, other infusion pump functions, such as sensors of the infusion pump.
  • an occlusion detector and/or an air-in-line detector could be located at or near line securing structures of a syringe receptacle, and an engagement portion of a receptacle flap could guide an infusion line to proper coupling with the detector or sensor.
  • a sensor or detector could be located at or integrated with an engagement portion of a receptacle flap. In such an example, the act of engaging an infusion line with an engagement portion could also couple the line with the sensor or detector.
  • line securing mechanisms include an engagement portion on a receptacle flap that is configured to engage an infusion line, where the infusion line can be a standard infusion line without special hardware or other provisions for engagement with the engagement portion.
  • systems of infusion pumps and infusion lines are contemplated where the infusion line can include a component or device particularly configured to mate with an engagement portion of a receptacle flap of an infusion pump.
  • Figure 6 is a schematic perspective view of an infusion pump 600 having a syringe receptacle 605 and a receptacle flap 610 having an engagement portion 630.
  • Infusion line 625 can include an engagement structure 655 that is configured to mate with the engagement portion 630 of the receptacle flap 610.
  • Engagement structure 655 can take any suitable form, and can be attached to or associated with infusion line 625 in any suitable manner.
  • engagement structure 655 could slidably encircle infusion line 625 and mate with engagement portion 630 in a grommet-like manner.
  • engagement structure 655 could be non-movingly adhered, bonded, integrated with, or otherwise fixedly attached to infusion line 625 such that when engagement structure 655 is mated with engagement portion 630 and receptacle flap 610 is in the closed mode, tension in infusion line 625 downstream of engagement structure 655 is substantially borne by the line securing mechanism and is substantially not passed on to syringe 620 by a portion of infusion line 625 upstream of engagement structure 655 (i.e., between structure 655 and a tip of syringe 620).
  • engagement structure 655 can provide or participate in additional functionality.
  • engagement structure 655 could be structured as a clamp (not specifically illustrated).
  • the clamp could be structured to permit manual manipulation for clamping/unclamping, and/or it could be structured such than a mechanism of pump 600 could actuate clamping/unclamping.
  • the aforementioned U.S. Provisional Patent Application Serial No. 62/199,718, "INFUSION LINE CLAMP SYSTEMS FOR INFUSION PUMPS,” describes infusion pump systems with pump-actuatable infusion line clamps.
  • an engagement structure of an infusion line can be configured to facilitate electrical and/or optical connectivity between the infusion pump and the infusion line by either providing electrical and/or optical connectivity via the engagement structure, or by positioning a connector that provides electrical and/or optical connectivity between the infusion pump and the infusion line.
  • the aforementioned U.S. Patent Application Publication No. 2013/0123579, "ILLUMINATED TUBING SET,” and U.S. Patent Application Publication No. 2013/0123743, "MEDICAL TUBING DETECTION AND MANAGEMENT” describe, in part, infusion lines that include optical elements that can provide illumination.
  • the present disclosure contemplates infusion syringe pumps that include power sources configured to provide power to such an optical element of an infusion line.
  • An engagement structure of an infusion line similar to structure 655 of Figure 6 could facilitate coupling of power from the power source to the optical element in any suitable manner.
  • an infusion pump could include one or more light emitters such as light emitting diodes (LEDs).
  • LEDs light emitting diodes
  • Figure 4 of the aforementioned U.S. Provisional Patent Application Serial No. 62/086,551 illustrates light emitters (129) that can inject or otherwise couple light into a receptacle flap (114).
  • pump 600 could include a light emitter (not shown) configured to provide light to flap 610.
  • Flap 610 could include a lightguide such as an optical fiber or fiber bundle that could transport the light to the engagement portion 630, which could be configured to deliver the light to engagement structure 655.
  • the light could be coupled to an optical element of infusion line 625, such as an optical fiber or fiber bundle, or other optical waveguide.
  • pump 600 could include an electrical power supply configured to supply electrical power to infusion line 625, with an electrical connection made via the receptacle flap 610, via engagement portion 630, to engagement structure 655.
  • electrical power Once electrical power is delivered to the infusion line 625 via engagement structure 655, it could be provided, for example, to light emitters attached to or otherwise integrated with the infusion line.
  • optical and/or electrical power could be provided to engagement structure 655 not via the engagement portion 630, but the engagement portion could position the engagement structure, as the flap is moved from the open to the closed mode, such that the engagement structure makes an optical and/or electrical connection with optical and/or electrical connectors disposed in, at, or near the syringe receptacle 605 of pump 600.
  • the present disclosure further contemplates that line securing mechanisms associated with receptacle flaps could provide or participate in any suitable connectivity features.
  • an infusion line may be to provide a fluid conduit
  • the infusion line could have associated or integrated functionalities, such as electronic or optical signal transmission, and line securing mechanisms could be configured to provide, or participate in providing, electrical and/or optical connectivity.

Abstract

A syringe pump can include a receptacle configured to receive a syringe and a receptacle flap attached to the pump. The receptacle flap can move between an open mode and a closed mode. In the closed mode, the receptacle flap can be in a position that substantially inhibits access to the receptacle and to the syringe received by the receptacle. In the open mode, the receptacle flap can be in a position that enables access to the receptacle and to the syringe received by the receptacle. The receptacle flap can include an engagement portion structured to engage an infusion line with the receptacle flap, the infusion line being fluidically coupled to the syringe.

Description

SYSTEMS AND METHODS FOR SECURING INFUSION LINES TO
SYRINGE PUMPS
TECHNICAL FIELD
This disclosure relates to infusion pumps, and more particularly, to systems and methods for securing infusion lines to syringe pumps.
BACKGROUND
Syringe infusion pumps (or, "syringe pumps") have demonstrated their usefulness to medical practitioners. When in use, some syringe pumps include a replaceable syringe to which an infusion tube, tubing, or line (collectively, "line") is attached. Some syringe pumps include line holders through which the infusion line can be threaded downstream of the syringe. Such line holders can secure the infusion line to the pump and can provide a function of relieving or redirecting tension that may be present in the infusion line, before such tension might deleteriously reach the syringe to which the infusion line is attached.
Threading or otherwise routing an infusion line through line holders of an infusion pump can be a cumbersome task for a medical practitioner or other user of the syringe pump. Therefore, there is a need for improved systems and methods for securing infusion lines to syringe pumps.
SUMMARY
This disclosure relates to infusion pumps, and more particularly, to systems and methods for securing infusion lines to syringe pumps.
In an illustrative but non-limiting example, the disclosure provides a syringe pump that can include a receptacle configured to receive a syringe and a receptacle flap attached to the pump. The receptacle flap can move between an open mode and a closed mode. In the closed mode, the receptacle flap can be in a position that substantially inhibits access to the receptacle and to the syringe received by the receptacle. In the open mode, the receptacle flap can be in a position that enables access to the receptacle and to the syringe received by the receptacle. The receptacle flap can include an engagement portion structured to engage an infusion line with the receptacle flap, the infusion line being fluidically coupled to the syringe.
In some cases, the engagement portion can be structured to engage the infusion line via at least a clearance fit. In some cases, the engagement portion can include a slot structured to engage the infusion line. In some cases, the engagement portion can include a hook structured to engage the infusion line, In some examples, the engagement portion can be structured to engage the infusion line when the receptacle flap is in the open mode. In some such cases, if the infusion line is engaged with the engagement portion with the receptacle flap in the open mode, the engagement portion can be structured to maintain engagement of the infusion line when the receptacle flap moves between the open mode and the closed mode. In some cases, when the receptacle flap is in the closed mode, the infusion line can be constrained to remain in engagement with the engagement portion.
In some examples, the syringe pump can further include a line securing mechanism that includes the engagement portion of the receptacle flap. The line securing mechanism can engage the infusion line at a position substantially on or near a longitudinal axis of the syringe, away from a dispensing tip of the syringe at which the infusion line is attached. The line securing mechanism can be structured such that, when engaging the infusion line, it can perform either or both of (a) bearing tension applied to the infusion line such that tension is reduced or relieved at the dispensing tip of the syringe; and (b) redirecting tension applied to the infusion line such that tension exerted on the dispensing tip of the syringe by the infusion line is substantially directed along the longitudinal axis of the syringe. In some cases, the syringe pump can further include line securing structures at or adjacent the receptacle. The line securing structures can function in cooperation with the engagement portion of the receptacle flap as part of the line securing mechanism when the receptacle flap is in the closed mode. In some of these cases, when the receptacle flap is in the open mode and the infusion line is engaged by the engagement portion of the receptacle flap, the infusion line generally is not in contact with the line securing structures. In some cases, the line securing mechanism can be configured and structured such that the infusion line follows a tortuous path when engaged with the line securing mechanism with the receptacle flap in the closed mode.
In some examples, a syringe pump that includes line securing structures can further include a selectively actuatable clamp mechanism that includes, at least part of the line securing mechanism. The selectively actuatable clamp mechanism can be configured to responsively and reversibly compressively clamp the infusion line with sufficient force to temporarily and reversibly occlude the infusion line.
Some syringe pumps that include a selectively actuatable clamp mechanism can further include a flap latch configured to selectively constrain the receptacle flap to the closed mode. In some cases, the flap latch can further be configured to controllably position the receptacle flap within a pre-determined range of positions relative to the receptacle, thereby controllably positioning the engagement portion of the receptacle flap within a pre-determined range of positions relative to the line securing structures. At least one position in the pre-determined range of positions can correspond to an occluded condition for the infusion line.
In some cases where a syringe pump includes a selectively actuatable clamp mechanism that further includes a flap latch configured to selectively constrain the receptacle flap to the closed mode, at least a portion of the line securing structures can be selectively positionable within a pre-determined range of positions relative to the engagement portion of the receptacle flap when the receptacle flap is constrained to the closed mode by the flap latch. At least one position in the pre-determined range of positions can correspond to an occluded condition for the infusion line.
In some examples, the syringe pump can further include a flap latch configured to selectively constrain the receptacle flap to the closed mode, where the flap latch includes at least part of the engagement portion of the receptacle flap.
In some examples, the infusion line includes an engagement structure structured to mate with the engagement portion. In some such cases, the engagement structure can be configured to facilitate electrical and/or optical connectivity between the syringe pump and the infusion line by either providing electrical and/or optical connectivity via the engagement structure, or by positioning a connector that provides electrical and/or optical connectivity between the syringe pump and the infusion line. In some of these cases, the syringe pump can further include a power source configured to provide power to an optical element of the infusion line, with the engagement structure of the infusion line facilitating coupling of power from the power source to the optical element
The above summary is not intended to describe each and every example or every implementation of the disclosure. The Description that follows more particularly exemplifies various illustrative embodiments.
BRIEF DESCRIPTION OF THE FIGURES
The following description should be read with reference to the drawings. The drawings, which are not necessarily to scale, depict several examples and are not intended to limit the scope of the disclosure. The disclosure may be more completely understood in consideration of the following description with respect to various examples in connection with the accompanying drawings, in which:
Figure 1 is a schematic perspective view of a syringe pump; Figure 2 is a schematic perspective view of a syringe pump having a syringe receptacle and a receptacle flap in an open mode, with an infusion line engaged with an engagement portion of the receptacle flap;
Figure 3 is a schematic perspective view of the syringe pump of Figure 2, with the receptacle flap in a closed mode;
Figure 4 is a schematic perspective view of another syringe pump, showing line securing structures at its syringe receptacle;
Figure 5 is a schematic perspective view of aspects of another syringe pump, including components of a flap latch mechanism that is integrated with an engagement portion of a receptacle flap and a selective clamping mechanism;
Figure 6 is a schematic perspective view of another syringe pump, showing an infusion line having an engagement structure configured to mate with an engagement portion of a receptacle flap; and
Figure 7 is a schematic perspective view of a receptacle flap having engagement portions that define a tortuous path.
DESCRIPTION
The present disclosure is related to U.S. Patent Application Publication No.
2013/0123579, "ILLUMINATED TUBING SET," U.S. Patent Application Publication No. 2013/0123743, "MEDICAL TUBING DETECTION AND MANAGEMENT," U.S. Provisional
Patent Application Serial No. 62/086,551, "SYRINGE INFUSION PUMP SECURITY," U.S.
Provisional Patent Application Serial No. 62/153,203, "SYSTEMS AND METHODS FOR
PROVIDING NOTE-TAKING SURFACES ON INFUSION PUMPS," U.S. Provisional Patent
Application Serial No. 62/169,115, "INFUSATE TUBING CLAMP SYSTEMS FOR INFUSION PUMPS," and U.S. Provisional Patent Application Serial No. 62/199,718,
"INFUSION LINE CLAMP SYSTEMS FOR INFUSION PUMPS," all of which are hereby incorporated by reference in their entireties.
The following description should be read with reference to the drawings, in which like elements in different drawings may be numbered in like fashion. The drawings, which are not necessarily to scale, depict selected examples and are not intended to limit the scope of the disclosure. Although examples of construction, dimensions, and materials may be illustrated for the various elements, those skilled in the art will recognize that many of the examples provided have suitable alternatives that may be utilized. Figure 1 illustrates a syringe infusion pump 100, such as, for example, a MEDFUSION 4000 syringe infusion pump from Smiths Medical ASD, Inc. In general, syringe pump 100 can deliver various infusates, drug therapies and treatments to patients. When in use, syringe pump 100 typically can include a removable and replaceable pharmaceutical container or syringe 110, which can be supported on and secured to housing 120 of pump 100 and can be secured thereto by clamp 130. In some embodiments, syringe 1 10 can be separately supplied from pump 100. In other embodiments, syringe 110 can be an integrated component of pump 100. Syringe 110 can include a plunger 140 that can force fluid outwardly from syringe 110 via infusion line 150 that is connected to a patient (not illustrated). Infusion line 150 can be fluidically and mechanically coupled to syringe 110 at an attachment point 155, typically at the tip of syringe 110 opposite plunger 140, from which infusate is dispensed. A pusher or plunger driver mechanism 160 of pump 100, when in operation, can act to move plunger 140 of syringe 110. Operation of mechanism 160 can be provided by way of, for example, cooperative action of a motor and lead screw arrangement internal to housing 120 of pump 100. In some embodiments, a sensor can be provided (not shown; typically internal to plunger driver mechanism 160) that can monitor force and/or a position of plunger 140 in syringe 110 according to system specifications.
Pump 100 typically can include a user interface 170 (that can include a display screen, keypad, and any other suitable user interface components) for relaying commands to a control system (not illustrated) of pump 100. User interface 170 generally can allow a user to enter various parameters, including but not limited to names, drug information, limits, delivery shapes, information relating to hospital facilities, as well as various user-specific parameters (e.g., patient age and/or weight). Infusion pump 100 can include any appropriate wired or wireless input/output (I/O) interface port and/or protocol (including, but not limited to, USB, Ethernet, WiFi, NFC, Bluetooth, and the like) for connecting pump 100 to a network or computer (not illustrated) having software designed to interface with pump 100. Power to infusion pump 100 can be provided via an AC or DC power cord, from an internally provided battery source (not illustrated), or by any other suitable means. Embodiments can also include a wireless power source (not illustrated). User inputs to infusion pump 100 can be provided by programming from an authorized user, such as a patient, pharmacist, scientist, drug program designer, medical engineer, nurse, physician, or other authorized medical practitioner or healthcare provider. User inputs may utilize direct interfacing (via, e.g., keyboards, touch screens, or other touch-based inputs) as shown, and/or user inputs may utilize indirect or "touchless" interfacing (i.e., gestures; voice commands; facial movements or expressions; finger, hand, head, body and arm movements; or other inputs that do not require physical contact such as cameras, sensors of electric field, capacitance, or sound). User inputs generally can be interfaced, communicated, sensed, and/or received by operator input mechanisms of user interface 170.
Pump 100 can include line holders 180, for guiding and removably securing a portion of infusion line 150 to housing 120 of pump 100. In some embodiments, and as illustrated, line holders 180 can include multiple hooks facing opposite directions into which infusion line 150 can be threaded, such threading generally being performed manually by a medical practitioner or user of pump 100. Line holders 180 can provide an important safety function for pump 100. In usage, undesirable tension can be introduced in infusion line 150, when a force or forces are unintentionally, incidentally, unavoidably, accidentally, maliciously, or otherwise exerted on the line. Merely as non-limiting examples: a practitioner, patient, or other person could pull on infusion line 150; line 150 could snag or snare a moving object or (part of) a person; separation between pump 100 and a patient connected to line 150 could increase such that line 150 is pulled taut; and so on. In such situations, line holders 180 can help maintain proper securement of syringe 110 to pump 100. Tension in line 150 can dislodge syringe 110 from its proper position secured to pump 100, particularly if a force resulting from the tension is applied to syringe 110 at attachment point 155 in a direction substantially away from longitudinal axis 190 of syringe 110. When the force is applied to syringe 110 at attachment point 155 along longitudinal axis 190, syringe 110 may be able to withstand considerably greater force and remain properly secured to pump 100. In the system of pump 100, line 150 can be routed to extend from attachment point 155 to line holders 180 (which are located substantially along longitudinal axis 190). In this way, line holders can, in effect, redirect tension applied to the infusion line such that tension exerted on the dispensing tip (attachment point 155) of the syringe 110 by the infusion line is substantially directed along the longitudinal axis of the syringe. In Figure 1, a portion of infusion line 150 extending away from pump 100 downstream of line holders 180 makes a significant angle relative to longitudinal axis 190 of syringe 110, but a portion of line 150 between attachment point 155 and line holders 180 is substantially aligned with longitudinal axis 190 of syringe 110.
Without necessarily relying upon any particular theory of syringe to pump securement, an effect or effects of direction of tension in infusion line 150 upon stability of syringe 110 relative to pump 100 can be understood by consideration of geometry of syringe 110 relative to pump 100. Syringe 110 can be supported in a trough or cradle extending along an upper side of housing 120 of pump 100 as shown in Figure 1, and held down in the cradle by clamp 130. In some embodiments, clamp 130 can be spring loaded. Finger tabs 195 of syringe 110 can bear against a side of housing 120. Plunger 140 of syringe 110 can abut plunger driver 160 of pump 100, and can also be clipped thereto, as illustrated. Considering first an off-axis force applied to attachment point 155 of syringe 110 from tension in infusion line 150, syringe 110 may tend to rotate about a point of rotation around where finger tabs 195 contact the housing 120. A relatively long lever arm from such a point of rotation to attachment point 155, as compared to the relatively short distance from the point of rotation of syringe 110 to clamp 130, may result in the off-axis tension overcoming the clamping force of clamp 130 on syringe 110 and dislodging syringe 110 from proper securement to pump 100. Considering now an on-axis (or nearly on- axis) force applied by tension in infusion line 150 at attachment point 155, without a significant off-axis component there may be insufficient torque to rotate syringe 110 out of securement to pump 100, and constraints resulting from finger tabs 195 bearing against housing 120 may be sufficiently robust to withstand likely forces resulting from on-axis tension in line 150.
In some embodiments, line holders 180 can also bear tension applied to infusion line 150 such that tension is reduced or relieved at the dispensing tip (attachment point 155) of syringe 110. Such a feature can also be referred-to as "stress relief," and can depend on dimensions and geometry of line holders 150 and/or infusion line 150. Line holders 150 can provide other beneficial features and advantages as well, such as holding line 150 in an orderly manner. In another example of additional features, co-pending U.S. Provisional Patent Application Serial No. 62/169,115, "INFUSATE TUBING CLAMP SYSTEMS FOR INFUSION PUMPS," describes, in part, novel infusion line clamp systems that can include tubing holders as components cooperatively in or with syringe pumps.
New or improved syringe infusion pumps can introduce new challenges and opportunities for management of infusion lines. Co-pending U.S. Provisional Patent Application Serial No. 62/086,551, "SYRINGE INFUSION PUMP SECURITY," describes, in part, novel syringe infusion pump systems that can include a syringe receptacle and a receptacle flap movable between a closed mode and an open mode, in which the flap can, respectively, substantially inhibit or clear access to the receptacle and to a syringe received by the receptacle. The present disclosure teaches novel systems and methods for securing infusion lines in syringe infusion pump systems having syringe receptacles, receptacle flaps, and/or similar structures.
Figure 2 is a schematic perspective view of a syringe infusion pump 200 provided in accordance with novel and inventive subject matter of the present disclosure, having a syringe receptacle 205 structured and configured to receive a syringe 220. Associated with syringe receptacle 205, pump 200 can include a receptacle flap 210 movable between an open mode and a closed mode. In Figure 2, receptacle flap 210 is illustrated as being positioned in an open mode. While receptacle flap 210 is illustrated in the Figures of the present disclosure as being pivotable between open and closed modes, examples of flaps in the present disclosure are not necessarily limited to pivoting motions in all instances. In some embodiments, for example, a receptacle flap could be configured to extend and retract, and/or slide, when moving between open and closed modes. Further, while receptacle flap 210 is illustrated as pivoting via an upper or top hinge 212, this is not limiting and flap 210 could be configured to pivot via a lower or bottom hinge, or any other suitable hinge location.
Infusion syringe pump 200 can include any feature or features similarly as described for syringe infusion pump 100 of Figure 1, to an extent that such feature or features are compatible with pump 200. Figure 2 is a simplified schematic view of pump 200 that may omit illustration of some features that can be included therein, such as a pusher or plunger driver mechanism like feature 160 of pump 100. Any such omissions may be made purely for convenience and clarity of illustration. Those of skill in the art may readily recognize features of syringe pumps that are desirable, necessarily, or otherwise can be included in pump 200 and be compatible with novel features described herein.
Unlike infusion pump 100, which is illustrated in Figure 1 as including line holders 180 attached or integral to, or otherwise directly provided on, housing 120, infusion pump 200 of Figure 2 is not illustrated with line holders directly provided on its housing 215. However, in some embodiments (not illustrated), components such as line holders 180 shown in Figure 1 can be directly provided on housing 215 of infusion syringe pump 200. In some such embodiments, line holders could be placed inside syringe receptacle 205 such that they would be disposed substantially along a longitudinal axis (not shown) of syringe 220 installed in pump 200, at a location effective for redirecting tension applied to infusion line 225 substantially along the longitudinal axis of the syringe (with infusion line 225 being mechanically coupled to syringe 220 and in fluidic communication therewith). However, it could be difficult to thread line 225 into or through components similar to line holders 180 shown in Figure 1 if such components are placed inside syringe receptacle 205. Among other benefits, therefore, systems and methods of the present disclosure may provide line securing solutions that are simple and easy to use and manipulate with infusion lines inside or adjacent to a component such as syringe receptacle 205.
As part of a system and method for securing infusion line 225 to syringe pump 200, receptacle flap 210 can include an engagement portion 230 structured and configured to engage infusion line 225 with receptacle flap 210. Engagement portion 230 can include any suitable structure or structures and can be configured to engage infusion line 225 in any suitable manner to, for example, assist in alleviating an undesirable tension and off-axis force that might be experienced by line 225 and syringe 220 as aforementioned. In some embodiments, engagement portion 230 can include a slot 232 structured to engage infusion line 225. In such a slotted construction of engagement portion 230, structures of engagement portion 230 that define or border slot 232 can be in at least partial or intermittent contact with infusion line 225. For example, a slot narrower than a nominal width of infusion line 225 might continuously hold, squeeze, or "pinch" the line between opposing sides of the slot. In comparison, one side or portion of a slot that is wider than the nominal width of infusion line 225 might contact the line with another side or portion of the slot not being in contact with the line. In some embodiments, engagement portion 230 can include a hook structured to engage infusion line 225. In some embodiments, engagement portion 230 can be structured to engage infusion line 225 via at least a clearance fit. In some embodiments, engagement portion 230 can be structured to engage infusion line 225 via at least a friction fit. In some embodiments, some of which are discussed elsewhere herein, infusion line 225 can include a feature or component that is configured specifically to engage with engagement portion 230.
Engagement portion 230 can be structured to engage infusion line 225 when receptacle flap 210 is in an open mode (as illustrated in Figure 2), and engagement portion 230 can be positioned on receptacle flap 210 such that infusion line 225 can be readily manipulated and engaged with engagement portion 230 when receptacle flap 210 is in an open mode. The location of engagement portion 230 on receptacle flap 210 when the flap is in an open mode (when flap 210 generally may be extended away from housing 215 of pump 100), can be substantially easier to access manually as compared to locations within syringe receptacle 205, where line holders might otherwise have been placed in contingent or hypothetical designs lacking engagement portion 230 and/or other novel and inventive line securing features of the present disclosure. With receptacle flap 210 in an open mode, engagement portion 230 can be structured such that if infusion line 225 is engaged with engagement portion 230, it generally will remain so engaged by itself (e.g., without a need for separately holding line 225 in engagement with the engagement portion), at least under nominal conditions. If infusion line 225 is engaged with engagement portion 230, with receptacle flap 210 in an open mode, engagement portion 230 can be structured to maintain engagement of infusion line 225 when receptacle flap 210 moves between the open mode and the closed mode, at least under nominal conditions. For example, if receptacle flap 210 pivots between open and closed modes, engagement portion 230 can be structured such that its rotation as flap 210 pivots about hinge 212 does not result in disengagement of infusion line 225 therefrom. With regard to the description above "at least under nominal conditions" in relation to the infusion line 225 remaining in engagement with engagement portion 230, this can mean under many conditions that normally would be expected during use of pump 200, which would, for example, exclude intentional attempts to manipulate line 225 to disengage it from engagement portion 230.
Engagement portion 230 can be a component of a line securing mechanism of infusion pump 200. In some embodiments, a line securing mechanism can include an engagement portion such as engagement portion 230 as a primary component or, in some cases, sole component. In some embodiments, an engagement mechanism can include multiple components that may function in cooperation to provide a line securing function. When receptacle flap 210 is closed (and possibly in other modes), the line securing mechanism can engage infusion line 225 at a position substantially on or near a longitudinal axis (not illustrated in Figure 2) of syringe 220, away (downstream) from the dispensing tip (attachment point 255) of syringe 220 at which line 225 is attached. The line securing mechanism can be structured such that, when engaging infusion line 225 at this position, it can provide one or more functions that enhance infusion line and syringe security. One function it can provide is to bear tension applied to infusion line 225 such that tension is reduced or relieved at dispensing tip 255 of syringe 220. Another function it can provide is to redirect tension applied to infusion line 225 such that tension exerted on dispensing tip 255 of syringe 220 by line 225 is substantially directed along the longitudinal axis of syringe 220. These functions can be the same or similar to functions provided by line holders 180 of infusion pump 100 of Figure 1. As provided for infusion pump 200, this line securing mechanism can possibly be easier to manipulate and engage with infusion line 225 than conventional line holders, if such conventional holders were provided for pump 200.
Figure 3 is a schematic perspective view of infusion pump 200 of Figure 2, with receptacle flap 210 in the closed mode. Infusion pump 200 can be structured and configured such that when receptacle flap 210 is in the closed mode, infusion line 225 is constrained to remain in engagement with engagement portion 230. Such a constraint can be achieved in any suitable manner. As illustrated in Figure 3, an opening 235 of engagement portion 230 can be obstructed or blocked by a region 237 of a wall portion of syringe receptacle 205 when receptacle flap 210 is moved into the closed mode, which can prevent infusion line 225 from exiting engagement portion 230 via the (obstructed) opening. Region 237 of the wall portion of syringe receptacle 205 that obstructs opening 235 of engagement portion 230 can be, in an embodiment, smooth and similar to any other part of the wall or syringe-facing surface of receptacle 205, as illustrated in Figure 3.
In other embodiments, an infusion pump can include, at or adjacent the syringe receptacle, line securing structures. Line securing structures can be designed and configured to function in cooperation with an engagement portion of a receptacle flap as part of a line securing mechanism when the receptacle flap is in the closed mode. Line securing structures can include one or more projections, recesses, or other shapes departing from the general surface of the wall of the syringe receptacle. Such structures could be formed integrally with the wall of the syringe receptacle, or could be attached to the wall. Figure 4 is a schematic perspective view of certain components of an infusion pump 400, showing a line securing structure 440 at syringe receptacle 405. Pump 400 can include various features similar to or the same as corresponding features of pump 200. To improve the visibility of line securing structure 440, some features associated with infusion pump 400 are not shown in Figure 4, such as a receptacle flap and an infusion line similar to or the same as the corresponding features of pump 200 of Figure 2. A line securing mechanism of pump 400, including line securing structure 440 and an engagement portion of a receptacle flap (not shown in Figure 4), can be structured and configured such that when the receptacle flap is in the closed mode, the line securing mechanism constrains an infusion line (not shown in Figure 4) to follow a tortuous path. The line securing mechanism of pump 400 can be structured and configured such that when the receptacle flap of the pump is in the open mode with an infusion line engaged with the engagement portion of the flap, the infusion line generally is not in contact with the securing structure 440. Starting from such a state, the line securing mechanism of pump 400 can be structured and configured in some embodiments such that as the receptacle flap is moved to the closed mode, the infusion line remains engaged with the engagement portion of the flap and is moved into the tortuous path defined (at least in part) by line securing structures 440 and the engagement portion. In some embodiments, with the receptacle flap in the open mode, the infusion line can be manually placed into engagement with line securing structures 440 without necessarily being engaged with the engagement portion of the receptacle flap; and when the receptacle flap is subsequently moved to the closed mode, the infusion line is constrained to a tortuous path and can be engaged with the engagement portion.
Constraining the infusion line to a tortuous path can be part of a manner in which the line securing mechanism of pump 400 can provide stress relief for the infusion line, and reduce or relieve tension at dispensing tip 455 of the syringe 420 to which the infusion line (not shown in Figure 4) is coupled. Whereas an infusion line can be constrained to a tortuous path in the system of pump 400 by the cooperative effect of line securing structures 440 and the engagement portion of a receptacle flap, other ways of constraining an infusion line to a tortuous path are contemplated. Figure 7 is a schematic perspective view of a receptacle flap 710 similar to receptacle flap 210 of Figures 2 and 3. Receptacle flap 710 can include multiple engagement portions 732, 734 through which a portion of an infusion line (not illustrated) can be threaded or placed. While two engagement portions 732, 734 are illustrated, any suitable number can be included. Threading the infusion line through the engagement portions 732, 734 can place that portion of the infusion line into a tortuous path that can be defined by engagement portions 732, 734, without the infusion line interacting with line securing structures of a syringe receptacle. Such threading can be performed readily when flap 710 is in an open mode, before flap 710 is moved to the closed mode. In some embodiments, receptacle flap 710 can be part of a pump that includes line securing structures at or adjacent the syringe receptacle that further define a tortuous path for the infusion line when the flap is moved to the closed mode, but this is not necessary, and in some embodiments, a tortuous path for the infusion line is defined by engagement portions 732, 734 without participation of line securing structures, when the receptacle flap is in the closed mode.
In the present disclosure, it is anticipated that line securing mechanisms associated with receptacle flaps could participate in other functions in addition to (or perhaps in some embodiments, alternatively to) redirection or relief of tension of infusion lines, such as a selectively actuatable clamp mechanism configured to responsively and reversibly compressively clamp the infusion line with sufficient force to temporarily and reversibly occlude the infusion line. Co-pending U.S. Provisional Patent Application Serial No. 62/169, 115, "INFUSATE TUBING CLAMP SYSTEMS FOR INFUSION PUMPS," describes some selectively actuatable clamp mechanisms for infusion lines in other infusion pump configurations. In infusion syringe pump configurations of the present disclosure, an infusion line could be selectively clamped, for example, between an engagement portion of a receptacle flap, and line securing structures at or adjacent the syringe receptacle.
To achieve such selective clamping, in some embodiments the line securing structures could remain in a fixed position relative to the syringe receptacle, and the position of the engagement portion (or a sub-portion thereof) could be varied in order to achieve a variable gap between the two in which the infusion line could be clamped. In some other embodiments, the position of the engagement portion could be held fixed relative to the syringe receptacle, and the position of the line securing structures (or a sub-portion thereof) could be varied, likewise to achieve a variable gap in which the infusion line could be clamped. In still other embodiments, the positions of both the engagement portion and the line securing structures can be varied. The variation in the position of the engagement portion and/or line securing structure can be effected in any suitable manner.
Figure 5 is a schematic perspective view of aspects of an infusion pump 500 that can provide selective clamping of an infusion line between an engagement portion 530 of a receptacle flap 510 and line securing structure(s) 540 at or adjacent a syringe receptacle 505. In this embodiment, the position of engagement portion 530 can be varied by varying the position of receptacle flap 510 of which engagement portion 530 is a component. Infusion pump 500 can include a flap latch mechanism configured to selectively constrain receptacle flap 510 to the closed mode and also to controllably position receptacle flap 510 within a pre-determined range of positions relative to receptacle 505, thereby controllably positioning engagement portion 530 of flap 510 within a pre-determined range of positions relative to line securing structures 540. At least one position in the pre-determined range of positions can correspond to an occluded (i.e., clamped) condition for an infusion line (not illustrated, for clarity) engaged by the line securing mechanism of pump 500 in a space 560 between engagement portion 530 and line securing structures 540. Any suitable flap latch mechanism capable of selectively constraining and controllably positioning receptacle flap 510 as described can be used. As illustrated in Figure 5, pump 500 can include a flap latch mechanism integrated with engagement portion 530 of receptacle flap 510. Engagement portion 530 can include a mating structure 545 structured to selectively couple to another component of the flap latch mechanism of pump 500. As illustrated, mating structure 545 can pass through an opening 550 in housing 515, where it can couple with an internal component (not shown) of the flap latch mechanism. In this embodiment, the internal component can be actuatable by a controller of pump 500 (for example, by electric motor) to controllably position engagement portion 530 and receptacle flap 510 closer to, or further away from, housing 515, receptacle 505, and line securing structures 540 of the pump, thereby varying dimensions of space 560 in which an infusion line can be selectively clamped.
Alternately, in some embodiments an infusion pump can include a flap latch configured to selectively constrain its receptacle flap to the closed mode, but that is not necessarily configured to controllably position the receptacle flap within a range of positions relative to the receptacle. In some such embodiments, line securing structures can be configured such that at least a portion of the line securing structures is controllably positionable within a pre-determined range of positions relative to the engagement portion of the receptacle flap when the receptacle flap is constrained to the closed mode by the flap latch. At least one position in the pre- determined range of positions can correspond to an occluded (i.e., clamped) condition for an infusion line engaged by the line securing mechanism that includes the engagement portion and the line securing structures. The line securing structures (or sub-portion thereof) can be configured to be controllably positionable in any suitable manner. They may be movable via, for example, motor, solenoid, or any other mechanical actuation technology that can be commanded by a controller of the pump.
In some embodiments, a line securing mechanism could be integrated with, or otherwise operate in cooperation with, other infusion pump functions, such as sensors of the infusion pump. For example, an occlusion detector and/or an air-in-line detector could be located at or near line securing structures of a syringe receptacle, and an engagement portion of a receptacle flap could guide an infusion line to proper coupling with the detector or sensor. In another example, a sensor or detector could be located at or integrated with an engagement portion of a receptacle flap. In such an example, the act of engaging an infusion line with an engagement portion could also couple the line with the sensor or detector.
In embodiments of the present disclosure, line securing mechanisms are provided that include an engagement portion on a receptacle flap that is configured to engage an infusion line, where the infusion line can be a standard infusion line without special hardware or other provisions for engagement with the engagement portion. In some other embodiments, systems of infusion pumps and infusion lines are contemplated where the infusion line can include a component or device particularly configured to mate with an engagement portion of a receptacle flap of an infusion pump. Figure 6 is a schematic perspective view of an infusion pump 600 having a syringe receptacle 605 and a receptacle flap 610 having an engagement portion 630. Infusion line 625 can include an engagement structure 655 that is configured to mate with the engagement portion 630 of the receptacle flap 610. Engagement structure 655 can take any suitable form, and can be attached to or associated with infusion line 625 in any suitable manner. For example, engagement structure 655 could slidably encircle infusion line 625 and mate with engagement portion 630 in a grommet-like manner. In another example, engagement structure 655 could be non-movingly adhered, bonded, integrated with, or otherwise fixedly attached to infusion line 625 such that when engagement structure 655 is mated with engagement portion 630 and receptacle flap 610 is in the closed mode, tension in infusion line 625 downstream of engagement structure 655 is substantially borne by the line securing mechanism and is substantially not passed on to syringe 620 by a portion of infusion line 625 upstream of engagement structure 655 (i.e., between structure 655 and a tip of syringe 620).
In some embodiments, engagement structure 655 can provide or participate in additional functionality. For example, engagement structure 655 could be structured as a clamp (not specifically illustrated). The clamp could be structured to permit manual manipulation for clamping/unclamping, and/or it could be structured such than a mechanism of pump 600 could actuate clamping/unclamping. The aforementioned U.S. Provisional Patent Application Serial No. 62/199,718, "INFUSION LINE CLAMP SYSTEMS FOR INFUSION PUMPS," describes infusion pump systems with pump-actuatable infusion line clamps.
In some embodiments, an engagement structure of an infusion line can be configured to facilitate electrical and/or optical connectivity between the infusion pump and the infusion line by either providing electrical and/or optical connectivity via the engagement structure, or by positioning a connector that provides electrical and/or optical connectivity between the infusion pump and the infusion line. The aforementioned U.S. Patent Application Publication No. 2013/0123579, "ILLUMINATED TUBING SET," and U.S. Patent Application Publication No. 2013/0123743, "MEDICAL TUBING DETECTION AND MANAGEMENT" describe, in part, infusion lines that include optical elements that can provide illumination. The present disclosure contemplates infusion syringe pumps that include power sources configured to provide power to such an optical element of an infusion line. An engagement structure of an infusion line similar to structure 655 of Figure 6 could facilitate coupling of power from the power source to the optical element in any suitable manner.
In some embodiments, an infusion pump could include one or more light emitters such as light emitting diodes (LEDs). Figure 4 of the aforementioned U.S. Provisional Patent Application Serial No. 62/086,551 illustrates light emitters (129) that can inject or otherwise couple light into a receptacle flap (114). Similarly, or in other configurations having similar effect, pump 600 could include a light emitter (not shown) configured to provide light to flap 610. Flap 610 could include a lightguide such as an optical fiber or fiber bundle that could transport the light to the engagement portion 630, which could be configured to deliver the light to engagement structure 655. From engagement structure 655, the light could be coupled to an optical element of infusion line 625, such as an optical fiber or fiber bundle, or other optical waveguide. Alternatively or in addition, in some embodiments pump 600 could include an electrical power supply configured to supply electrical power to infusion line 625, with an electrical connection made via the receptacle flap 610, via engagement portion 630, to engagement structure 655. Once electrical power is delivered to the infusion line 625 via engagement structure 655, it could be provided, for example, to light emitters attached to or otherwise integrated with the infusion line. In other embodiments, optical and/or electrical power could be provided to engagement structure 655 not via the engagement portion 630, but the engagement portion could position the engagement structure, as the flap is moved from the open to the closed mode, such that the engagement structure makes an optical and/or electrical connection with optical and/or electrical connectors disposed in, at, or near the syringe receptacle 605 of pump 600. The present disclosure further contemplates that line securing mechanisms associated with receptacle flaps could provide or participate in any suitable connectivity features. For example, while the primary function of an infusion line may be to provide a fluid conduit, the infusion line could have associated or integrated functionalities, such as electronic or optical signal transmission, and line securing mechanisms could be configured to provide, or participate in providing, electrical and/or optical connectivity.
This disclosure is to be understood to be not limited to the particular examples described herein, but rather should be understood to cover all aspects of the disclosure and equivalents thereof. Various modifications, processes, and components, as well as numerous structures to which the disclosure can be applicable, will be readily apparent to those of skill in the art upon review of the instant specification.

Claims

1. An syringe pump, comprising:
a receptacle configured to receive a syringe; and
a receptacle flap attached to the pump, the receptacle flap movable between an open mode and a closed mode, wherein in the closed mode, the receptacle flap is in a position that substantially inhibits access to the receptacle and to the syringe received by the receptacle, and in the open mode, the receptacle flap is in a position that enables access to the receptacle and to the syringe received by the receptacle, the receptacle flap including an engagement portion structured to engage an infusion line with the receptacle flap, the infusion line being fluidically coupled to the syringe.
2. The syringe pump of claim 1, wherein the engagement portion is structured to engage the infusion line via at least a clearance fit.
3. The syringe pump of claim 1, wherein the engagement portion includes a slot structured to engage the infusion line.
4. The syringe pump of claim 1, wherein the engagement portion includes a hook structured to engage the infusion line,
5. The syringe pump of claim 1, wherein the engagement portion is structured to engage the infusion line when the receptacle flap is in the open mode.
6. The syringe pump of claim 5, wherein, if the infusion line is engaged with the engagement portion with the receptacle flap in the open mode, the engagement portion is structured to maintain engagement of the infusion line when the receptacle flap moves between the open mode and the closed mode.
7. The syringe pump of claim 6, wherein when the receptacle flap is in the closed mode, the infusion line is constrained to remain in engagement with the engagement portion.
8. The syringe pump of claim 1, further comprising a line securing mechanism that includes the engagement portion of the receptacle flap, wherein: the line securing mechanism engages the infusion line at a position substantially on or near a longitudinal axis of the syringe, away from a dispensing tip of the syringe at which the infusion line is attached; and
the line securing mechanism is structured such that, when engaging the infusion line, it performs either or both of:
bearing tension applied to the infusion line such that tension is reduced or relieved at the dispensing tip of the syringe; and
redirecting tension applied to the infusion line such that tension exerted on the dispensing tip of the syringe by the infusion line is substantially directed along the longitudinal axis of the syringe.
9. The syringe pump of claim 8, wherein the line securing mechanism is configured and structured such that the infusion line follows a tortuous path when engaged with the line securing mechanism with the receptacle flap in the closed mode.
10. The syringe pump of claim 8, further comprising line securing structures at or adjacent the receptacle, the line securing structures functioning in cooperation with the engagement portion of the receptacle flap as part of the line securing mechanism when the receptacle flap is in the closed mode.
11. The syringe pump of claim 10, wherein when the receptacle flap is in the open mode and the infusion line is engaged by the engagement portion of the receptacle flap, the infusion line generally is not in contact with the line securing structures.
12. The syringe pump of claim 10, further comprising a selectively actuatable clamp mechanism configured to responsively and reversibly compressively clamp the infusion line with sufficient force to temporarily and reversibly occlude the infusion line, wherein the selectively actuatable clamp mechanism comprises at least part of the line securing mechanism.
13. The syringe pump of claim 12, further comprising a flap latch configured to selectively constrain the receptacle flap to the closed mode, wherein the flap latch is further configured to controllably position the receptacle flap within a pre-determined range of positions relative to the receptacle, thereby controllably positioning the engagement portion of the receptacle flap within a pre-determined range of positions relative to the line securing structures, wherein at least one position in the pre-determined range of positions corresponds to an occluded condition for the infusion line.
14. The syringe pump of claim 12, further comprising a flap latch configured to selectively constrain the receptacle flap to the closed mode, wherein at least a portion of the line securing structures is selectively positionable within a pre-determined range of positions relative to the engagement portion of the receptacle flap when the receptacle flap is constrained to the closed mode by the flap latch, wherein at least one position in the pre-determined range of positions corresponds to an occluded condition for the infusion line.
15. The syringe pump of claim 1, further comprising a flap latch configured to selectively constrain the receptacle flap to the closed mode, wherein the flap latch includes at least part of the engagement portion of the receptacle flap.
16. The syringe pump of claim 1, wherein the infusion line includes an engagement structure structured to mate with the engagement portion.
17. The syringe pump of claim 16, wherein the engagement structure is configured to facilitate electrical and/or optical connectivity between the infusion pump and the infusion line by either providing electrical and/or optical connectivity via the engagement structure, or by positioning a connector that provides electrical and/or optical connectivity between the infusion pump and the infusion line.
18. The syringe pump of claim 17, further comprising a power source configured to provide power to an optical element of the infusion line, wherein the engagement structure of the infusion line facilitates coupling of power from the power source to the optical element.
PCT/US2016/052219 2015-10-28 2016-09-16 Systems and methods for securing infusion lines to syringe pumps WO2017074599A1 (en)

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US62/247,444 2015-10-28

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