WO2016133635A1 - Occlusion sensor integrated within thixo magnesium plunger driver head - Google Patents

Occlusion sensor integrated within thixo magnesium plunger driver head Download PDF

Info

Publication number
WO2016133635A1
WO2016133635A1 PCT/US2016/014054 US2016014054W WO2016133635A1 WO 2016133635 A1 WO2016133635 A1 WO 2016133635A1 US 2016014054 W US2016014054 W US 2016014054W WO 2016133635 A1 WO2016133635 A1 WO 2016133635A1
Authority
WO
WIPO (PCT)
Prior art keywords
plunger
plunger driver
driver head
syringe
occlusion
Prior art date
Application number
PCT/US2016/014054
Other languages
French (fr)
Inventor
John Paul RUKAVINA
Jacob A. WANDER
Grant Alan ADAMS
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 WO2016133635A1 publication Critical patent/WO2016133635A1/en

Links

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
    • A61M5/142Pressure 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
    • A61M5/1458Means for capture of the plunger flange
    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M2005/16863Occlusion detection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/332Force measuring means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • A61M2205/3362Pressure; Flow with minimised length of fluid lines; Taking into account the elastic expansion of fluid lines to increase accuracy

Definitions

  • Embodiments disclosed herein generally relate to medical devices. More particularly, this disclosure relates to systems for, and methods of, occlusion detection using an integrated occlusion sensor. BACKGROUND
  • a pre-filled fluid syringe or reservoir is mechanically driven or controlled by a microprocessor to deliver a prescribed amount or dose of a drug, fluid, fluid-like substance, or medicament (hereinafter, collectively, an "infusate”) at a controlled rate to a patient through an infusion line fluidly connected to the syringe.
  • Infusates delivered to a patient by way of syringe pumps can include, but are not limited to: therapeutic agents; nutrients; drugs; medicaments such as antibiotics, blood clotting agents, and analgesics; and other fluids.
  • the devices can be used to introduce the infusates into patients' bodies utilizing any of several routes such as, for example, intravenously, subcutaneously, arterially, or epidurally.
  • occlusion typically refers to the blocking or restriction of a normally open passage or lumen.
  • an occlusion is desired such as when a catheter is pinched off or temporarily collapsed into a closed state intentionally by a practitioner during a medical procedure.
  • an unintended occlusion could result in a potentially harmful or even dangerous situation.
  • a syringe pump typically includes a motor that rotates a leadscrew.
  • the leadscrew in turn typically activates a plunger driver mechanism which pushes a thumb-press surface on the plunger of the syringe longitudinally, or approximately so, and forwardly within a barrel of the syringe.
  • Pushing the plunger forward thus forces the infusate outwardly from the syringe, into the infusion line, and to the patient intravenously.
  • an occlusion might occur when the intended and commanded forward progression of the plunger in the syringe barrel is blocked or otherwise impeded, as when for example the infusion line tubing is kinked or otherwise structurally blocked to some degree. If the occlusion is not noticed, the patient likely would not receive the intended infusate, which could lead to potentially serious consequences as aforementioned.
  • syringe pumps detect occlusions by use of a pressure sensor that senses a force exerted by the syringe thumb-press on a plunger driver head assembly of the plunger driver mechanism.
  • a processor connected to the pressure sensor generates a signal indicating that an occlusion has possibly occurred or is possibly occurring.
  • Known plunger driver head assemblies may comprise relatively complex parts or components and accordingly may be generally made from injection-molded plastic.
  • components of a typical plunger driver head assembly including one or more seals and pliable membranes, are often required to accommodate or support an incorporation of the pressure sensor(s) into the plunger driver head assembly. While this type of arrangement provides some occlusion sensing capabilities, an enhanced sensing design for syringe pumps providing improvement in terms of accuracy and manufacturability is desired.
  • This disclosure describes novel and inventive systems for, and methods of, occlusion detection using an integrated occlusion sensor.
  • This disclosure describes novel and inventive medical syringe pumps and devices that may be used for improved occlusion detection utilizing metal injection molding of thin wall plunger driver head structures as well as force sensors integrated on an interior side of these thin wall structures.
  • a system for occlusion detection includes a syringe pump for a syringe containing an infusate.
  • the syringe includes a plunger and a thumb-press.
  • the syringe pump includes a plunger driver mechanism.
  • the system further includes a plunger driver head of the plunger driver mechanism.
  • the plunger driver head includes an outer surface and an oppositely located inner surface, wherein the outer surface engages the thumb- press of the plunger of the syringe at a first location when selectively dispensing infusates.
  • the plunger driver head includes a thin walled metal injection molded structure (as described, for example, in the Detailed Description below) disposed between the outer surface and the inner surface proximate the first location.
  • the system further includes a force sensor integrally formed on the inner surface of the plunger driver head.
  • the thumb-press of the plunger of the syringe exerts a force against the outer surface of the plunger driver head of the plunger driver mechanism, thereby deflecting the outer surface.
  • Such a force also deflects the inner surface of the plunger driver head and the force sensor to generate a signal indicating the occurrence of the occlusion.
  • the thin walled metal injection molded structure is made of Thixo Magnesium (as described, for example, in the Detailed Description below) or similar material.
  • a system for occlusion detection includes a syringe pump for a syringe containing an infusate.
  • the syringe includes a plunger and a thumb-press.
  • the syringe pump includes a plunger driver mechanism.
  • the system further includes a plunger driver head of the plunger driver mechanism.
  • the plunger driver head includes an annular depression of thin wall thickness having an outer surface and an oppositely located inner surface, where the outer surface engages the thumb-press of the plunger of the syringe at a first location when selectively dispensing infusates.
  • the plunger driver head includes a Thixo Magnesium structure disposed between the outer surface and inner surface proximate the first location.
  • the system also includes a strain gauge integrally formed on the inner surface. Upon an occurrence of an occlusion, the thumb-press of the plunger exerts a force against the plunger driver head, thereby deflecting the inner surface and the strain gauge to generate a signal indicating the occurrence of the occlusion.
  • a system for occlusion detection includes a syringe pump for a syringe containing an infusate.
  • the syringe includes a plunger and a thumb-press.
  • the syringe pump includes a plunger driver mechanism.
  • the system further includes a plunger driver head of the plunger driver mechanism.
  • the plunger driver head includes an outer surface and an oppositely located inner surface, the outer surface engaging the thumb-press of the plunger of the syringe at a first location when selectively dispensing infusates.
  • the plunger driver head includes a thin walled metal injection molded structure disposed between the outer surface and the inner surface proximate the first location.
  • the system further includes a bendable element formed with the plunger driver head.
  • the bendable element extends downwardly from a top portion of the plunger driver head to extend partially across the inner surface.
  • the system further includes a force sensor integrally formed on the bendable element proximate the top portion.
  • the method includes providing a syringe pump for a syringe containing an infusate, wherein the syringe includes a plunger and a thumb-press.
  • the syringe pump includes (i) a plunger driver mechanism (ii) a plunger driver head of the plunger driver mechanism and (iii) a force sensor integrally formed on the inner surface of the plunger driver head.
  • the plunger driver head includes an outer surface and an oppositely located inner surface, the outer surface engaging the thumb-press of the plunger of the syringe at a first location when selectively dispensing infusates.
  • the plunger driver head includes a thin walled metal injection molded structure located between the outer surface and the inner surface proximate the first location.
  • the thumb-press of the plunger exerts a force against the outer surface of the plunger driver head, thereby deflecting the inner surface of the plunger driver head and the force sensor to thereby generate a signal indicating the occurrence of the occlusion.
  • the method further includes administering infusates to patients by way of syringe pumps as well as sending signals generated by the force sensors to medical staff, upon occurrence of occlusions.
  • Figure 1 is an illustration of an example of a syringe pump providing a system for occlusion detection, according to an embodiment.
  • Figure 2 is a partial cross-sectional diagram of a system for occlusion detection, according to an embodiment.
  • Figure 3 is a partial cross-sectional diagram of a system for occlusion detection, according to an embodiment.
  • Figure 4 is a partial cross-sectional diagram of a system for occlusion detection, according to an embodiment.
  • Figures 5a-c depict examples of plunger driver head embodiments for a system for occlusion detection.
  • Occlusion detection systems and methods make novel and inventive use of an occlusion sensor integrated within a plunger driver head made of Thixo Magnesium or similar material.
  • an occlusion detection system that uses metal injection molding of complex parts with a "thin wall" structure, to sense strain on the back side of the structure which drives a syringe plunger.
  • Such a sensing arrangement advantageously results in a simplified unitary assembly that may advantageously reduce manufacturing costs and decrease occurrences of deleterious water ingress.
  • the arrangement further enables use of metal materials of desirable characteristics providing enhanced force response, strength, robustness, and rigidity of the plunger driver head, its housing, and drive train. Accordingly, a response by the occlusion sensor, to linear travel of the plunger within the syringe, may be improved in embodiments described herein as compared to known devices.
  • a system for occlusion detection 10 generally comprising a syringe pump 20 is depicted.
  • a syringe pump 20 includes a base unit 100 having a user interface comprising a display screen and input controls such as push-buttons and the like.
  • Syringe pump 20 also includes a cradle 110 for supporting a barrel 112 of a syringe 114, a clamp 116 for selectively securing barrel 112 in cradle 110, and a plunger driver mechanism 120 for removably coupling a plunger 122 of syringe 114 to syringe pump 20.
  • a syringe 114 containing a desired volume of a flowable substance, such as an infusate, is installed in pump 20 by way of placement of barrel 112 in cradle 110, with barrel 112 being removably and selectively secured therein by clamp 116.
  • Plunger driver mechanism 120 is removably coupled to a thumb-press of plunger 122 at a distal end thereof.
  • plunger driver mechanism 120 advances forwardly against the thumb-press of plunger 122 (to the left in the drawing) along drive rod 124 which causes plunger 122 to also move forwardly in barrel 112 of syringe 114 and thereby cause the flowable substance to be forced outwardly therefrom at outlet 126 of syringe 114.
  • the portion of the plunger driver mechanism 120 adjacent the plunger 122 is the plunger driver head 128.
  • Plunger driver head 128 further contains a force sensor 130 (depicted in Fig. 2) integrally formed on the interior (or inner) surface of the plunger driver head 128 opposite the outside (or outer) surface location generally in contact with the thumb-press of plunger 122.
  • Tubing 132 is connected at outlet 126 to serve as a conduit for the flowable substance from syringe 114 to a patient 134.
  • FIG. 2 a portion of an example of an embodiment of a system for occlusion detection 10 is depicted.
  • the portion of the system 10 depicted includes a partial cross-sectional view of the plunger 122 and plunger driver mechanism 120 including plunger driver head 128.
  • the juxtaposed engagement between the plunger 122 and the adjacent plunger driver head 128 can be seen as well in the drawing.
  • most of the internal mechanisms and components internal to the plunger driver head 128 that are not directly related to occlusion sensing are not depicted in the figures for simplicity.
  • Plunger driver head 128 generally comprises a circular, disc-like structure, sized to selectively exert force on thumb-press 140 of plunger 122.
  • the plunger driver head 128 is generally part of the larger plunger drive mechanism 120 responsible for initiating and carrying out this movement of plunger 122.
  • Plunger driver head 128 further includes a first location 142 in which its structure has a thin walled portion 143 of narrow cross-section.
  • the thin walled portion 143 of plunger driver head 128, accordingly, is a thin walled injection molded structure.
  • This first location 142 can be centrally located in various embodiments.
  • the thin walled portion 143 has an outer surface 144 and an inner surface 146.
  • Outer surface 144 generally faces thumb-press 140 of plunger 122 and provides an abutting surface structure of similar orientation to thumb-press 140.
  • the outer surface 144 can include a raised protrusion, referred to herein as a load point or load point protrusion 150.
  • Load point 150 can be advantageously used to centralize forces on outer surface 144 of thin walled portion 143 in plunger driver head 128, which may be exerted thereon by thumb-press 140 of plunger 122.
  • Inner surface 146 is oppositely located to outer surface 144, on a back side of outer surface 144. Further in this example of system 10, a force sensor 130 is integrally formed with plunger driver mechanism 120 on the inner surface 146 to sense strain.
  • Force sensor 130 may include any of a variety of strain sensitive elements of various configurations, shapes, or sizes. Accordingly, force sensor 130 on thin walled portion 143 may sense deflections occurring on one side of portion 143 based on pressure applied to an opposite surface by a syringe plunger 122. Thus, upon occurrence of an occlusion, plunger 122 would exert a force backwardly via its thumb-press 140 to cause deflection of outer surface 144 and corresponding inner surface 146 of plunger driver head 128. Such deflection causes the integrally formed force sensor 130 to thereby generate a signal indicating the occurrence of the occlusion. Deflection of thin walled portion 143, measured by a strain gauge or other force sensor, is proportional to force applied on outer surface 144 of thin walled portion 143 in plunger driver head 128.
  • Thixo Magnesium One type of relatively new material that enables this type of thin walled structure is referred to as Thixo Magnesium.
  • Thixo Magnesium One type of relatively new material that enables this type of thin walled structure is referred to as Thixo Magnesium.
  • Thixo Magnesium is a semi- solid (Thixotropic) molding process for magnesium somewhat analogous to plastic injection molding.
  • Thixo Magnesium is a semi- solid (Thixotropic) molding process for magnesium somewhat analogous to plastic injection molding.
  • one such process involves feeding magnesium chips at ambient temperature into a heated barrel with the chips being propelled forward by a rotating screw.
  • the combined heat from resistance type heater bands and the shearing force provided by the rotating screw create a slurry of spheroidal solid particles within a molten matrix. This slurry is forced into a pre-heated mold that can be used to produce high precision, ultra-thin walled parts.
  • a thixomolded magnesium type of injection molding process can deliver relatively thin walled, high stiffness, impact resistant components.
  • the process combines the benefits of die casting and plastic injection molding; and it may be used as a design replacement for injection molded plastic and composite materials.
  • thixomolded magnesium allows for manufacture of parts with thin walls. Parts are routinely molded with nominal wall thickness providing high-strength, precise moldings. In some cases wall thicknesses may be as small as 0.020".
  • Thixomolded magnesium allows for new, intricate, space-efficient designs by combining the process versatility and tooling capabilities of injection molding with improved material flow.
  • Embodiments of this disclosure can utilize, but are not limited to use of, Thixo Magnesium to form the plunger driver head 128 and its associated thin wall structures.
  • Thin wall structures of magnesium metal may be in the 0.025" to 0.050" thickness range, for example.
  • Other similar substances and processes may be used to form this type of structure.
  • aluminum, zinc, copper, beryllium-copper, titanium, steels, or stainless steels can be used in some embodiments.
  • a die cast magnesium process can be used to make "thin walled" structures in certain embodiments.
  • Other embodiments may include use of Liquidmetal® Alloys such as LM001B (comprised of zirconium, titanium, copper, nickel, and beryllium elements), titanium alloys, or stainless steel alloys.
  • Figure 3 depicts another partial cross-sectional view of an embodiment of a system for occlusion detection and specifically, cross-sectional portions of a plunger 122 and plunger driver mechanism 120 including a plunger driver head 128.
  • Figure 3 generally resembles the arrangement depicted in Figure 2, but further depicts a pair of rotatable flipper members 150 that are used to help secure the plunger thumb-press in a proper position relative to head 128.
  • Rotatable flipper members 150 generally project perpendicularly outward from the plunger driver head 128 and contain rotatable arm members 151 at the end of the outwardly projecting portion 153.
  • Flipper members 150 are not necessarily present in all syringe pump embodiments.
  • FIG. 3 also depicts a cable 162 that carries signals from force sensor 130 back to base unit 100 and corresponding controls for syringe pump 20.
  • cable 162 extends into a space defined in part by plunger driver head 128 and extends through drive rod 124 around lead screw 164.
  • Figure 4 discloses an illustrative partial cross sectional view of an example of alignment of plunger 122 residing in cradle 110 of syringe pump 20. Specifically, the view illustrates these components from the viewpoint of one looking in a direction of a longitudinal axis of plunger 122.
  • plunger 122 resides directly above cradle 110 of syringe pump 20.
  • This figure demonstrates how thumb-press 140 of plunger 122 can be held down by flipper members 150 to provide better alignment with thin walled portion 143 of plunger driver head 128.
  • FIGS 5a-c illustrate of examples of embodiments for a plunger driver head 128.
  • Reference numerals for these plunger driver head embodiments are respectively labeled with an "a", “b” or “c” for each of the embodiments; however, the generalized teaching of the corresponding components should be applied where appropriate as well.
  • a plunger driver head 128a is depicted having a circular shape with a small annular depression 166a located at a center of plunger driver head 128a and corresponding to thin walled portion 143a thereof.
  • Inner surface 146a of plunger driver head 128a is generally visible in Figure 5a and the position of force sensor 130a is shown at a central location on inner surface 146a of thin walled portion 143a.
  • Flipper member apertures 160a are further depicted about the centrally located thin walled portion 143a.
  • Figure 5b depicts an example of an embodiment of a plunger driver head 128b having a relatively larger central annular thin walled portion 143b than the corresponding feature depicted in Figure 5a.
  • Two connecting portions 168b are depicted between the outer and inner annular portions which each serve as locations for force sensors 130b. These locations provide concentration points for strain that may be detected by sensors 130b to help recognize when occlusions are occurring in the system.
  • Flipper member apertures 160b are depicted within thin walled portion 143b in this embodiment.
  • Figure 5c depicts an embodiment of a plunger driver head 128c having an annular depression 169c located about its center corresponding to thin walled portion 143c of plunger driver head 128.
  • Annular depression 169c further includes a bendable element 170c.
  • Such a bendable element 170c is attached at a top portion 172c of a perimeter of annular depression 169c of thin walled portion 143c, and extends partially across a diameter of annular depression 169c and inner surface 146c of head 128c.
  • bendable element 170c is formed with plunger driver head 128c and extends downwardly from top portion 172c of plunger driver head 128c to extend partially across inner surface 146c.
  • Bendable element 170c serves to amplify forces from smaller syringe diameters or sizes. Accordingly, bendable element 170c compensates for relatively smaller sensed occlusion forces generated by syringes having, correspondingly, relatively smaller diameter sizes. In general, forces exerted on inner surface 146c against bendable element 170c advantageously increase in magnitude as syringe sizes decrease. This enables faster occlusion detection in relatively small syringes. In this example embodiment, force sensor 130c is located near top portion 172c of bendable member 170c. Similar uses of bendable members in syringe pumps for occlusion detection are described in greater detail in PCT Publication No. WO2013/177379A1, Int'l. Applic.
  • plunger driver head arrangements of varying shapes and locations for force sensors 130 are contemplated by this disclosure.
  • a single force sensor 130 or a plurality of force sensors 130 are contemplated by subject matter hereof.
  • thin walled structures for plunger driver heads can be formed of a range of materials including, but not limited to Thixo Magnesium. Aluminum, zinc, copper, beryllium-copper, titanium, steels, or stainless steels can be used in some embodiments. Further, a die cast magnesium process can be used to make "thin walled" structures in certain embodiments. Other embodiments may include use of Liquidmetal® Alloys such as LMOOIB (comprised of zirconium, titanium, copper, nickel, and beryllium elements), titanium alloys, or stainless steel alloys.
  • LMOOIB compact of zirconium, titanium, copper, nickel, and beryllium elements
  • the plunger tube can be insert-molded into the Thixo Magnesium component to increase the rigidity of the system.
  • use of metal injection molded parts will provide greater durability and part life compared to plastic parts that have been used in known syringe pumps.
  • a syringe pump 20 for a syringe 114 containing an infusate.
  • Syringe 1 14 includes a plunger 122 and the syringe pump 20 includes a plunger driver mechanism 120 with a plunger driver head 128, and a force sensor 130 integrally formed on inner surface 146 of plunger driver head 128.
  • Plunger driver head 128 includes an outer surface 144 and an oppositely located inner surface 144, the outer surface 144 engaging a thumb-press 140 of plunger 122 in syringe 114 at a first location 142 when selectively dispensing infusates.
  • Plunger driver head 128 includes a thin walled metal injection molded structure or thin walled portion 143 located between outer surface 144 and inner surface 146 proximate the first location 142.
  • thumb-press 140 of plunger 122 exerts a force against outer surface 144 of plunger driver head 128, thereby deflecting inner surface 146 of plunger driver head 128 and force sensor 130 to thereby generate a signal indicating occurrence of the occlusion.
  • Methods can also include administering the infusate to a patient 134 by way of syringe 114 in syringe pump 20 as well as sending the signal generated by force sensor 130 to medical staff, upon occurrence of an occlusion.
  • compositions, sizes, and strengths of various aforementioned components of systems for, and methods of, occlusion detection using an integrated occlusion sensor that are described by example or otherwise contemplated herein are all a matter of design choice depending upon intended uses thereof.

Abstract

A system for occlusion detection including a syringe pump for a syringe containing an infusate. The syringe includes a plunger and a thumb-press. The syringe pump includes a plunger driver mechanism having a plunger driver head. The plunger driver head includes an outer surface and an oppositely disposed inner surface, where the outer surface engages the thumb-press of the plunger of the syringe at a first location. The plunger driver head includes a thin walled metal injection molded structure (made of Thixo Magnesium, for example) located between the outer surface and the inner surface proximate the first location. A force sensor is integrally formed on the inner surface of the plunger driver head. Upon an occurrence of an occlusion, the thumb-press of the plunger exerts a force against the outer surface of the plunger driver head, thereby deflecting the inner surface and the force sensor to generate an occlusion signal.

Description

OCCLUSION SENSOR INTEGRATED WITHIN THTXO MAGNESIUM
PLUNGER DRIVER HEAD TECHNICAL FIELD
Embodiments disclosed herein generally relate to medical devices. More particularly, this disclosure relates to systems for, and methods of, occlusion detection using an integrated occlusion sensor. BACKGROUND
In the field of medical infusion devices, including so-called "syringe pumps", typically a pre-filled fluid syringe or reservoir is mechanically driven or controlled by a microprocessor to deliver a prescribed amount or dose of a drug, fluid, fluid-like substance, or medicament (hereinafter, collectively, an "infusate") at a controlled rate to a patient through an infusion line fluidly connected to the syringe. Infusates delivered to a patient by way of syringe pumps can include, but are not limited to: therapeutic agents; nutrients; drugs; medicaments such as antibiotics, blood clotting agents, and analgesics; and other fluids. The devices can be used to introduce the infusates into patients' bodies utilizing any of several routes such as, for example, intravenously, subcutaneously, arterially, or epidurally.
Examples of syringe pumps and related components are disclosed in U.S. Pat. No.
4,978,335 titled "Infusion Pump with Bar Code Input to Computer," U.S. Pat. No. 8, 182,461 titled "Syringe Pump Rapid Occlusion Detection System," and U.S. Pat. No. 8,209,060 titled "Updating Syringe Profiles for a Syringe Pump." Each of these publications is hereby incorporated by reference in its entirety. As used throughout this disclosure, the term "syringe pump" is intended to generally pertain to any device which acts on a syringe to controllably force an infusate or infusates outwardly therefrom.
In the medical arts, the term "occlusion" typically refers to the blocking or restriction of a normally open passage or lumen. In some instances, an occlusion is desired such as when a catheter is pinched off or temporarily collapsed into a closed state intentionally by a practitioner during a medical procedure. In other instances, an unintended occlusion could result in a potentially harmful or even dangerous situation. For example, a syringe pump typically includes a motor that rotates a leadscrew. The leadscrew in turn typically activates a plunger driver mechanism which pushes a thumb-press surface on the plunger of the syringe longitudinally, or approximately so, and forwardly within a barrel of the syringe. Pushing the plunger forward thus forces the infusate outwardly from the syringe, into the infusion line, and to the patient intravenously. In such devices, an occlusion might occur when the intended and commanded forward progression of the plunger in the syringe barrel is blocked or otherwise impeded, as when for example the infusion line tubing is kinked or otherwise structurally blocked to some degree. If the occlusion is not noticed, the patient likely would not receive the intended infusate, which could lead to potentially serious consequences as aforementioned.
Attempts to sense or detect occlusions in medical devices such as syringe pumps have therefore been made. For example, some syringe pumps detect occlusions by use of a pressure sensor that senses a force exerted by the syringe thumb-press on a plunger driver head assembly of the plunger driver mechanism. When the force experienced by the pressure sensor exceeds a predetermined threshold force, a processor connected to the pressure sensor generates a signal indicating that an occlusion has possibly occurred or is possibly occurring. Known plunger driver head assemblies may comprise relatively complex parts or components and accordingly may be generally made from injection-molded plastic. Therefore, components of a typical plunger driver head assembly, including one or more seals and pliable membranes, are often required to accommodate or support an incorporation of the pressure sensor(s) into the plunger driver head assembly. While this type of arrangement provides some occlusion sensing capabilities, an enhanced sensing design for syringe pumps providing improvement in terms of accuracy and manufacturability is desired.
Consequently, it would be useful and advantageous to provide systems for, and methods of, occlusion detection using an integrated occlusion sensor.
SUMMARY
This disclosure describes novel and inventive systems for, and methods of, occlusion detection using an integrated occlusion sensor. This disclosure describes novel and inventive medical syringe pumps and devices that may be used for improved occlusion detection utilizing metal injection molding of thin wall plunger driver head structures as well as force sensors integrated on an interior side of these thin wall structures.
In one embodiment, a system for occlusion detection includes a syringe pump for a syringe containing an infusate. The syringe includes a plunger and a thumb-press. The syringe pump includes a plunger driver mechanism. The system further includes a plunger driver head of the plunger driver mechanism. The plunger driver head includes an outer surface and an oppositely located inner surface, wherein the outer surface engages the thumb- press of the plunger of the syringe at a first location when selectively dispensing infusates. Accordingly, the plunger driver head includes a thin walled metal injection molded structure (as described, for example, in the Detailed Description below) disposed between the outer surface and the inner surface proximate the first location. The system further includes a force sensor integrally formed on the inner surface of the plunger driver head. Upon an occurrence of an occlusion, the thumb-press of the plunger of the syringe exerts a force against the outer surface of the plunger driver head of the plunger driver mechanism, thereby deflecting the outer surface. Such a force also deflects the inner surface of the plunger driver head and the force sensor to generate a signal indicating the occurrence of the occlusion. In various embodiments, the thin walled metal injection molded structure is made of Thixo Magnesium (as described, for example, in the Detailed Description below) or similar material.
In another embodiment, a system for occlusion detection includes a syringe pump for a syringe containing an infusate. The syringe includes a plunger and a thumb-press. The syringe pump includes a plunger driver mechanism. The system further includes a plunger driver head of the plunger driver mechanism. The plunger driver head includes an annular depression of thin wall thickness having an outer surface and an oppositely located inner surface, where the outer surface engages the thumb-press of the plunger of the syringe at a first location when selectively dispensing infusates. The plunger driver head includes a Thixo Magnesium structure disposed between the outer surface and inner surface proximate the first location. The system also includes a strain gauge integrally formed on the inner surface. Upon an occurrence of an occlusion, the thumb-press of the plunger exerts a force against the plunger driver head, thereby deflecting the inner surface and the strain gauge to generate a signal indicating the occurrence of the occlusion.
In one embodiment, a system for occlusion detection includes a syringe pump for a syringe containing an infusate. The syringe includes a plunger and a thumb-press. The syringe pump includes a plunger driver mechanism. The system further includes a plunger driver head of the plunger driver mechanism. The plunger driver head includes an outer surface and an oppositely located inner surface, the outer surface engaging the thumb-press of the plunger of the syringe at a first location when selectively dispensing infusates. The plunger driver head includes a thin walled metal injection molded structure disposed between the outer surface and the inner surface proximate the first location. The system further includes a bendable element formed with the plunger driver head. The bendable element extends downwardly from a top portion of the plunger driver head to extend partially across the inner surface. The system further includes a force sensor integrally formed on the bendable element proximate the top portion. Upon an occurrence of an occlusion, the thumb- press of the plunger exerts a force against the outer surface of the plunger driver head, thereby deflecting the inner surface of the plunger driver head and the bendable element containing the force sensor to generate a signal indicating the occurrence of the occlusion. Further, forces exerted by the inner surface against the bendable element increase in magnitude as syringe sizes decrease.
Another embodiment is directed to a method of occlusion detection. The method includes providing a syringe pump for a syringe containing an infusate, wherein the syringe includes a plunger and a thumb-press. The syringe pump includes (i) a plunger driver mechanism (ii) a plunger driver head of the plunger driver mechanism and (iii) a force sensor integrally formed on the inner surface of the plunger driver head. The plunger driver head includes an outer surface and an oppositely located inner surface, the outer surface engaging the thumb-press of the plunger of the syringe at a first location when selectively dispensing infusates. The plunger driver head includes a thin walled metal injection molded structure located between the outer surface and the inner surface proximate the first location. Upon an occurrence of an occlusion, the thumb-press of the plunger exerts a force against the outer surface of the plunger driver head, thereby deflecting the inner surface of the plunger driver head and the force sensor to thereby generate a signal indicating the occurrence of the occlusion. The method further includes administering infusates to patients by way of syringe pumps as well as sending signals generated by the force sensors to medical staff, upon occurrence of occlusions. BRIEF DESCRIPTION OF THE DRAWINGS
Subject matter hereof may be more completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying drawings, in which:
Figure 1 is an illustration of an example of a syringe pump providing a system for occlusion detection, according to an embodiment.
Figure 2 is a partial cross-sectional diagram of a system for occlusion detection, according to an embodiment. Figure 3 is a partial cross-sectional diagram of a system for occlusion detection, according to an embodiment.
Figure 4 is a partial cross-sectional diagram of a system for occlusion detection, according to an embodiment.
Figures 5a-c depict examples of plunger driver head embodiments for a system for occlusion detection.
DETAILED DESCRIPTION
The various embodiments disclosed may be embodied in other specific forms without departing from the essential attributes thereof; therefore, the illustrated embodiments should be considered in all respects as illustrative and not restrictive.
Occlusion detection systems and methods, that are described in greater detail by way of examples herein, make novel and inventive use of an occlusion sensor integrated within a plunger driver head made of Thixo Magnesium or similar material. Specifically, disclosed herein is an example of an occlusion detection system that uses metal injection molding of complex parts with a "thin wall" structure, to sense strain on the back side of the structure which drives a syringe plunger. Such a sensing arrangement advantageously results in a simplified unitary assembly that may advantageously reduce manufacturing costs and decrease occurrences of deleterious water ingress. The arrangement further enables use of metal materials of desirable characteristics providing enhanced force response, strength, robustness, and rigidity of the plunger driver head, its housing, and drive train. Accordingly, a response by the occlusion sensor, to linear travel of the plunger within the syringe, may be improved in embodiments described herein as compared to known devices.
Referring to Figure 1, an example of an embodiment of a system for occlusion detection 10 generally comprising a syringe pump 20 is depicted. Typically, such a syringe pump 20 includes a base unit 100 having a user interface comprising a display screen and input controls such as push-buttons and the like. Syringe pump 20 also includes a cradle 110 for supporting a barrel 112 of a syringe 114, a clamp 116 for selectively securing barrel 112 in cradle 110, and a plunger driver mechanism 120 for removably coupling a plunger 122 of syringe 114 to syringe pump 20. In use of syringe pump 20, a syringe 114 containing a desired volume of a flowable substance, such as an infusate, is installed in pump 20 by way of placement of barrel 112 in cradle 110, with barrel 112 being removably and selectively secured therein by clamp 116. Plunger driver mechanism 120 is removably coupled to a thumb-press of plunger 122 at a distal end thereof. Upon activation of pump 20, plunger driver mechanism 120 advances forwardly against the thumb-press of plunger 122 (to the left in the drawing) along drive rod 124 which causes plunger 122 to also move forwardly in barrel 112 of syringe 114 and thereby cause the flowable substance to be forced outwardly therefrom at outlet 126 of syringe 114. The portion of the plunger driver mechanism 120 adjacent the plunger 122 is the plunger driver head 128. Plunger driver head 128 further contains a force sensor 130 (depicted in Fig. 2) integrally formed on the interior (or inner) surface of the plunger driver head 128 opposite the outside (or outer) surface location generally in contact with the thumb-press of plunger 122. Tubing 132 is connected at outlet 126 to serve as a conduit for the flowable substance from syringe 114 to a patient 134.
Referring now to Figure 2, a portion of an example of an embodiment of a system for occlusion detection 10 is depicted. The portion of the system 10 depicted includes a partial cross-sectional view of the plunger 122 and plunger driver mechanism 120 including plunger driver head 128. The juxtaposed engagement between the plunger 122 and the adjacent plunger driver head 128 can be seen as well in the drawing. In general, most of the internal mechanisms and components internal to the plunger driver head 128 that are not directly related to occlusion sensing are not depicted in the figures for simplicity.
Plunger driver head 128 generally comprises a circular, disc-like structure, sized to selectively exert force on thumb-press 140 of plunger 122. The plunger driver head 128 is generally part of the larger plunger drive mechanism 120 responsible for initiating and carrying out this movement of plunger 122. Plunger driver head 128 further includes a first location 142 in which its structure has a thin walled portion 143 of narrow cross-section. In this example of system 10, the thin walled portion 143 of plunger driver head 128, accordingly, is a thin walled injection molded structure. This first location 142 can be centrally located in various embodiments. The thin walled portion 143 has an outer surface 144 and an inner surface 146. Outer surface 144 generally faces thumb-press 140 of plunger 122 and provides an abutting surface structure of similar orientation to thumb-press 140. The outer surface 144 can include a raised protrusion, referred to herein as a load point or load point protrusion 150. Load point 150 can be advantageously used to centralize forces on outer surface 144 of thin walled portion 143 in plunger driver head 128, which may be exerted thereon by thumb-press 140 of plunger 122. Inner surface 146 is oppositely located to outer surface 144, on a back side of outer surface 144. Further in this example of system 10, a force sensor 130 is integrally formed with plunger driver mechanism 120 on the inner surface 146 to sense strain. Force sensor 130 may include any of a variety of strain sensitive elements of various configurations, shapes, or sizes. Accordingly, force sensor 130 on thin walled portion 143 may sense deflections occurring on one side of portion 143 based on pressure applied to an opposite surface by a syringe plunger 122. Thus, upon occurrence of an occlusion, plunger 122 would exert a force backwardly via its thumb-press 140 to cause deflection of outer surface 144 and corresponding inner surface 146 of plunger driver head 128. Such deflection causes the integrally formed force sensor 130 to thereby generate a signal indicating the occurrence of the occlusion. Deflection of thin walled portion 143, measured by a strain gauge or other force sensor, is proportional to force applied on outer surface 144 of thin walled portion 143 in plunger driver head 128.
It is to be appreciated and understood that construction of a strain sensitive plunger driver head 128 is made possible by thin walled metal injection molding. One type of relatively new material that enables this type of thin walled structure is referred to as Thixo Magnesium. Further, thixomolding, the process used to create Thixo Magnesium, is a semi- solid (Thixotropic) molding process for magnesium somewhat analogous to plastic injection molding. In general, one such process involves feeding magnesium chips at ambient temperature into a heated barrel with the chips being propelled forward by a rotating screw. The combined heat from resistance type heater bands and the shearing force provided by the rotating screw create a slurry of spheroidal solid particles within a molten matrix. This slurry is forced into a pre-heated mold that can be used to produce high precision, ultra-thin walled parts.
A thixomolded magnesium type of injection molding process can deliver relatively thin walled, high stiffness, impact resistant components. The process combines the benefits of die casting and plastic injection molding; and it may be used as a design replacement for injection molded plastic and composite materials. Further, thixomolded magnesium allows for manufacture of parts with thin walls. Parts are routinely molded with nominal wall thickness providing high-strength, precise moldings. In some cases wall thicknesses may be as small as 0.020". Thixomolded magnesium allows for new, intricate, space-efficient designs by combining the process versatility and tooling capabilities of injection molding with improved material flow.
Embodiments of this disclosure can utilize, but are not limited to use of, Thixo Magnesium to form the plunger driver head 128 and its associated thin wall structures. Thin wall structures of magnesium metal may be in the 0.025" to 0.050" thickness range, for example. Other similar substances and processes may be used to form this type of structure. For example, aluminum, zinc, copper, beryllium-copper, titanium, steels, or stainless steels can be used in some embodiments. Further, a die cast magnesium process can be used to make "thin walled" structures in certain embodiments. Other embodiments may include use of Liquidmetal® Alloys such as LM001B (comprised of zirconium, titanium, copper, nickel, and beryllium elements), titanium alloys, or stainless steel alloys.
Figure 3 depicts another partial cross-sectional view of an embodiment of a system for occlusion detection and specifically, cross-sectional portions of a plunger 122 and plunger driver mechanism 120 including a plunger driver head 128. Figure 3 generally resembles the arrangement depicted in Figure 2, but further depicts a pair of rotatable flipper members 150 that are used to help secure the plunger thumb-press in a proper position relative to head 128. Rotatable flipper members 150 generally project perpendicularly outward from the plunger driver head 128 and contain rotatable arm members 151 at the end of the outwardly projecting portion 153. Flipper members 150 are not necessarily present in all syringe pump embodiments. These flipper members 150 account for the apertures 160 present in the various plunger driver head embodiments in Figures 5a-c. Embodiments without such flipper members 150 would likely not require apertures 160 in plunger driver head 128. Figure 3 also depicts a cable 162 that carries signals from force sensor 130 back to base unit 100 and corresponding controls for syringe pump 20. In a particular embodiment, cable 162 extends into a space defined in part by plunger driver head 128 and extends through drive rod 124 around lead screw 164.
Figure 4 discloses an illustrative partial cross sectional view of an example of alignment of plunger 122 residing in cradle 110 of syringe pump 20. Specifically, the view illustrates these components from the viewpoint of one looking in a direction of a longitudinal axis of plunger 122. In this example, plunger 122 resides directly above cradle 110 of syringe pump 20. This figure demonstrates how thumb-press 140 of plunger 122 can be held down by flipper members 150 to provide better alignment with thin walled portion 143 of plunger driver head 128. The size of the syringe will impact the strain sensed; however, force sensor 130 on inner surface 146 of plunger driver head 128 will be able to sense strain to detect occlusions - even when thumb-press 140 of plunger 122 and first location 142 of plunger driver head 128 are not completely aligned.
Figures 5a-c illustrate of examples of embodiments for a plunger driver head 128. Reference numerals for these plunger driver head embodiments are respectively labeled with an "a", "b" or "c" for each of the embodiments; however, the generalized teaching of the corresponding components should be applied where appropriate as well. In the example of Figure 5a, a plunger driver head 128a is depicted having a circular shape with a small annular depression 166a located at a center of plunger driver head 128a and corresponding to thin walled portion 143a thereof. Inner surface 146a of plunger driver head 128a is generally visible in Figure 5a and the position of force sensor 130a is shown at a central location on inner surface 146a of thin walled portion 143a. Flipper member apertures 160a are further depicted about the centrally located thin walled portion 143a.
Figure 5b depicts an example of an embodiment of a plunger driver head 128b having a relatively larger central annular thin walled portion 143b than the corresponding feature depicted in Figure 5a. Two connecting portions 168b are depicted between the outer and inner annular portions which each serve as locations for force sensors 130b. These locations provide concentration points for strain that may be detected by sensors 130b to help recognize when occlusions are occurring in the system. Flipper member apertures 160b are depicted within thin walled portion 143b in this embodiment.
Figure 5c depicts an embodiment of a plunger driver head 128c having an annular depression 169c located about its center corresponding to thin walled portion 143c of plunger driver head 128. Annular depression 169c further includes a bendable element 170c. Such a bendable element 170c is attached at a top portion 172c of a perimeter of annular depression 169c of thin walled portion 143c, and extends partially across a diameter of annular depression 169c and inner surface 146c of head 128c. In general, bendable element 170c is formed with plunger driver head 128c and extends downwardly from top portion 172c of plunger driver head 128c to extend partially across inner surface 146c. Bendable element 170c serves to amplify forces from smaller syringe diameters or sizes. Accordingly, bendable element 170c compensates for relatively smaller sensed occlusion forces generated by syringes having, correspondingly, relatively smaller diameter sizes. In general, forces exerted on inner surface 146c against bendable element 170c advantageously increase in magnitude as syringe sizes decrease. This enables faster occlusion detection in relatively small syringes. In this example embodiment, force sensor 130c is located near top portion 172c of bendable member 170c. Similar uses of bendable members in syringe pumps for occlusion detection are described in greater detail in PCT Publication No. WO2013/177379A1, Int'l. Applic. No. PCT/US2013/042388, which is hereby incorporated by reference. Various other plunger driver head arrangements of varying shapes and locations for force sensors 130 are contemplated by this disclosure. A single force sensor 130 or a plurality of force sensors 130 are contemplated by subject matter hereof. Likewise, thin walled structures for plunger driver heads can be formed of a range of materials including, but not limited to Thixo Magnesium. Aluminum, zinc, copper, beryllium-copper, titanium, steels, or stainless steels can be used in some embodiments. Further, a die cast magnesium process can be used to make "thin walled" structures in certain embodiments. Other embodiments may include use of Liquidmetal® Alloys such as LMOOIB (comprised of zirconium, titanium, copper, nickel, and beryllium elements), titanium alloys, or stainless steel alloys.
Advantageous features are accordingly provided by the above-noted example embodiments since no rubber membranes or seals are required by metal injection molded components (such as a Thixo Magnesium component as aforedescribed) around the occlusion sensing components; and accordingly, embodiments described by example or otherwise contemplated herein have greater resistance to water ingress than known sensor assemblies. Elimination of membranes or seals also provides for faster responses to forces applied, and the metal structure of the plunger driver head 128 can be significantly stronger than a plastic structure. Further, the rigidity of the entire drive train system can be improved from use of metal components; and accordingly, linear travel response of the plunger driver head 128 can be improved. In some embodiments, the plunger tube can be insert-molded into the Thixo Magnesium component to increase the rigidity of the system. In general, use of metal injection molded parts will provide greater durability and part life compared to plastic parts that have been used in known syringe pumps.
Methods of occlusion detection can accordingly be carried out using the aforementioned system description. In general, this includes providing a syringe pump 20 for a syringe 114 containing an infusate. Syringe 1 14 includes a plunger 122 and the syringe pump 20 includes a plunger driver mechanism 120 with a plunger driver head 128, and a force sensor 130 integrally formed on inner surface 146 of plunger driver head 128. Plunger driver head 128 includes an outer surface 144 and an oppositely located inner surface 144, the outer surface 144 engaging a thumb-press 140 of plunger 122 in syringe 114 at a first location 142 when selectively dispensing infusates. Plunger driver head 128 includes a thin walled metal injection molded structure or thin walled portion 143 located between outer surface 144 and inner surface 146 proximate the first location 142. Upon an occurrence of an occlusion, thumb-press 140 of plunger 122 exerts a force against outer surface 144 of plunger driver head 128, thereby deflecting inner surface 146 of plunger driver head 128 and force sensor 130 to thereby generate a signal indicating occurrence of the occlusion. Methods can also include administering the infusate to a patient 134 by way of syringe 114 in syringe pump 20 as well as sending the signal generated by force sensor 130 to medical staff, upon occurrence of an occlusion.
It is also to be appreciated and understood that types, components, dimensions, fabrication processes, and other particulars and parameters of aforedescribed example embodiments can be substituted for others as desired, or that accessories can be added thereto.
Lastly, compositions, sizes, and strengths of various aforementioned components of systems for, and methods of, occlusion detection using an integrated occlusion sensor that are described by example or otherwise contemplated herein are all a matter of design choice depending upon intended uses thereof.
Accordingly, these and other various changes or modifications in form and detail may also be made, without departing from the true spirit and scope of systems for, and methods of, occlusion detection using an integrated occlusion sensor that may be defined by the appended claims.
It should also be appreciated that embodiments described herein are only examples, and are not intended to limit the scope, applicability, or configuration of subject matter hereof in any way. Rather, the foregoing detailed description will provide those skilled in the art with an enabling disclosure for implementing embodiments that have been described by example or which are otherwise contemplated herein. It should be understood that various changes can be made in the function and arrangement of elements without departing from the scope of subject matter hereof, which may be set forth in the appended claims and the legal equivalents thereof.
The embodiments above are intended to be illustrative and not limiting. Additional embodiments are within the claims. Although subject matter hereof has been described with reference to particular embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the subject matter.
Various modifications may be apparent to one of skill in the art upon reading this disclosure. For example, persons of ordinary skill in the relevant art will recognize that the various features described for various embodiments can be suitably combined, un-combined, and re-combined with other features, alone, or in various combinations, within the spirit and scope hereof. Likewise, the various features described above should all be regarded as example embodiments, rather than limitations to the scope or spirit of the subject matter hereof. Therefore, the foregoing is not contemplated to be limiting.

Claims

1. A system for occlusion detection, comprising:
a syringe pump for a syringe containing an infusate, wherein the syringe includes a plunger and a thumb-press, and the syringe pump includes a plunger driver mechanism;
a plunger driver head of the plunger driver mechanism, wherein the plunger driver head includes an outer surface and an oppositely located inner surface, the outer surface engaging the thumb-press of the plunger of the syringe at a first location when selectively dispensing an infusate, the plunger driver head comprising a thin walled metal injection molded structure located between the outer surface and the inner surface proximate the first location; and
a force sensor integrally formed on the inner surface of the plunger driver head, wherein upon an occurrence of an occlusion, the thumb-press of the plunger exerts a force against the outer surface of the plunger driver head, thereby deflecting the outer surface as well as the inner surface and the force sensor to generate a signal indicating the occurrence of the occlusion.
2. The system of claim 1, wherein the thin walled metal injection molded structure is made of Thixo Magnesium.
3. The system of claim 1, wherein the force sensor is a strain gauge.
4. The system of claim 1, wherein the plunger driver head includes a load point protrusion for engagement with the thumb-press of the plunger.
5. The system of claim 1, wherein the thin walled metal injection molded structure has an annular depression.
6. The system of claim 1, wherein the thin walled metal injection molded structure has a bendable element.
7. A system for occlusion detection, comprising:
a syringe pump for a syringe containing an infusate, wherein the syringe includes a plunger and a thumb-press, and the syringe pump includes a plunger driver mechanism; a plunger driver head of the plunger driver mechanism, wherein the plunger driver head includes an annular depression of thin wall thickness having an outer surface and an oppositely located inner surface, the outer surface engaging the thumb-press of the plunger of the syringe at a first location when selectively dispensing an infusate, the plunger driver head comprising a Thixo Magnesium structure located between the outer surface and the inner surface proximate the first location; and
a strain gauge integrally formed on the inner surface of the plunger driver head, wherein upon an occurrence of an occlusion, the thumb-press of the plunger exerts a force against the plunger driver head, thereby deflecting the inner surface and the strain gauge to generate a signal indicating the occurrence of the occlusion.
8. A system for occlusion detection, comprising:
a syringe pump for a syringe containing an infustate, wherein the syringe includes a plunger and a thumb-press, and the syringe pump includes a plunger driver mechanism;
a plunger driver head of the plunger driver mechanism, wherein the plunger driver head includes an outer surface and an oppositely located inner surface, the outer surface engaging the thumb-press of the plunger of the syringe at a first location when selectively dispensing an infusate, the plunger driver head comprising a thin walled metal injection molded structure located between the outer surface and the inner surface proximate the first location;
a bendable element formed with the plunger driver head and extending downwardly from a top portion of the plunger driver head to extend partially across the inner surface; a force sensor integrally formed on the bendable element proximate the top portion, wherein upon an occurrence of an occlusion, the thumb-press of the plunger exerts a force against the outer surface of the plunger driver head, thereby deflecting the inner surface of the plunger driver head and the bendable element including the force sensor to generate a signal indicating the occurrence of the occlusion; and
wherein forces exerted by the inner surface against the bendable element increase in magnitude as syringe sizes decrease.
9. A method of occlusion detection, comprising:
providing a syringe pump for a syringe containing an infusate, wherein the syringe includes a plunger and a thumb-press, and the syringe pump includes (i) a plunger driver mechanism (ii) a plunger driver head of the plunger driver mechanism and (iii) a force sensor integrally formed on the inner surface of the plunger driver head,
wherein the plunger driver head includes an outer surface and an oppositely located inner surface, the outer surface engaging the thumb-press of the plunger of the syringe at a first location when selectively dispensing an infusate, the plunger driver head comprising a thin walled metal injection molded structure located between the outer surface and the inner surface proximate the first location; wherein upon an occurrence of an occlusion, the thumb-press of the plunger exerts a force against the outer surface of the plunger driver head, thereby deflecting the inner surface of the plunger driver head and the force sensor to generate a signal indicating the occurrence of the occlusion;
administering the infusate to a patient by way of the syringe pump; and
sending the signal generated by the force sensor to medical staff, upon occurrence of an occlusion.
10. The apparatuses as described herein.
11. The components and systems described herein.
12. The methods described herein.
13. The individual steps and combinations of steps described herein.
PCT/US2016/014054 2015-02-18 2016-01-20 Occlusion sensor integrated within thixo magnesium plunger driver head WO2016133635A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201562117726P 2015-02-18 2015-02-18
US62/117,726 2015-02-18

Publications (1)

Publication Number Publication Date
WO2016133635A1 true WO2016133635A1 (en) 2016-08-25

Family

ID=56689280

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2016/014054 WO2016133635A1 (en) 2015-02-18 2016-01-20 Occlusion sensor integrated within thixo magnesium plunger driver head

Country Status (1)

Country Link
WO (1) WO2016133635A1 (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10345175B2 (en) 2011-05-31 2019-07-09 Nxstage Medical, Inc. Pressure measurement devices, methods, and systems
US10864312B2 (en) 2005-11-09 2020-12-15 B. Braun Medical Inc. Diaphragm pressure pod for medical fluids

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6485465B2 (en) * 2000-03-29 2002-11-26 Medtronic Minimed, Inc. Methods, apparatuses, and uses for infusion pump fluid pressure and force detection
US20070100281A1 (en) * 2002-06-05 2007-05-03 Morris Matthew G Syringe plunger driver system
US7635349B2 (en) * 2000-08-16 2009-12-22 Smiths Group Plc Syringe pumps
US20100211002A1 (en) * 2009-02-18 2010-08-19 Davis David L Electromagnetic infusion pump with integral flow monitor
WO2013177379A1 (en) * 2012-05-25 2013-11-28 Smiths Medical Asd, Inc. Occlusion detection

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6485465B2 (en) * 2000-03-29 2002-11-26 Medtronic Minimed, Inc. Methods, apparatuses, and uses for infusion pump fluid pressure and force detection
US7635349B2 (en) * 2000-08-16 2009-12-22 Smiths Group Plc Syringe pumps
US20070100281A1 (en) * 2002-06-05 2007-05-03 Morris Matthew G Syringe plunger driver system
US20100211002A1 (en) * 2009-02-18 2010-08-19 Davis David L Electromagnetic infusion pump with integral flow monitor
WO2013177379A1 (en) * 2012-05-25 2013-11-28 Smiths Medical Asd, Inc. Occlusion detection

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10864312B2 (en) 2005-11-09 2020-12-15 B. Braun Medical Inc. Diaphragm pressure pod for medical fluids
US10345175B2 (en) 2011-05-31 2019-07-09 Nxstage Medical, Inc. Pressure measurement devices, methods, and systems
US11529448B2 (en) 2011-05-31 2022-12-20 Nxstage Medical, Inc. Pressure measurement devices, methods, and systems

Similar Documents

Publication Publication Date Title
EP2854625B1 (en) Occlusion detection
CN108348677B (en) Drive mechanism for a perfusion pump
US8016790B2 (en) Infusion status indicator
RU2325927C2 (en) Infusion pump
JP4242544B2 (en) Syringe pump
US6854620B2 (en) Drive system for an infusion pump
JP7385555B2 (en) Reservoir with low liquid level sensor
EP2783718B1 (en) Syringe pump and drive system thereof
CN106943642B (en) Liquid circuit set for medical use and liquid circuit system using the same
US9539384B2 (en) Telescoping piston drive for medical infusion device
JP6367193B2 (en) Modular infusion pump, method for controlling the delivery of medication, infusion pump, and method for measuring the level of medication
US20230097237A1 (en) Piezoelectric membrane pump for the infusion of liquids
EP2808046B1 (en) A releasable connecting mechanism
EP3017836B1 (en) Pulseless rotary peristaltic pump
JP6336401B2 (en) Dose end indicator
WO2016133635A1 (en) Occlusion sensor integrated within thixo magnesium plunger driver head
EP2579917B1 (en) A device for simultaneous infusion of drugs into multiple infusion sites
WO2018104028A1 (en) Infusion device suitable to test for extravasation
EP2825223A1 (en) Filling device and controller for filling an administration container
EP2394682B1 (en) A driving unit for a portable drug infusion device
WO2018104027A1 (en) Infusion device constituted to detect an abnormal condition during bolus injection
JP2005296142A (en) Liquid supply line for medical purpose
WO2014049657A1 (en) Medical-use pump

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 16752766

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 16752766

Country of ref document: EP

Kind code of ref document: A1