WO2015105937A1 - Piston - Google Patents

Piston Download PDF

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Publication number
WO2015105937A1
WO2015105937A1 PCT/US2015/010564 US2015010564W WO2015105937A1 WO 2015105937 A1 WO2015105937 A1 WO 2015105937A1 US 2015010564 W US2015010564 W US 2015010564W WO 2015105937 A1 WO2015105937 A1 WO 2015105937A1
Authority
WO
WIPO (PCT)
Prior art keywords
piston
fluid
sealing feature
sealing
hydraulic
Prior art date
Application number
PCT/US2015/010564
Other languages
English (en)
Inventor
Steven Levesque
Robert Standley
Matthew P. Johnson
Original Assignee
Valeritas, 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 Valeritas, Inc. filed Critical Valeritas, Inc.
Publication of WO2015105937A1 publication Critical patent/WO2015105937A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding

Definitions

  • the present invention generally relates to a piston and, in some embodiments, to a piston for a fluid delivery device.
  • a piston for use with a fluid delivery device comprising: a body having a longitudinal axis; at least one sealing feature extending from the body and configured to have an interference fit with a fluid reservoir, the at least one sealing feature configured to radially deform to fit within the fluid reservoir at least partially through bending; and a protrusion that axially extends from an end of the body and forms an open undercut between the protrusion and the at least one sealing feature.
  • the at least one sealing feature is coated with a material.
  • the material includes one or more of silicone, silicone oil,
  • the at least one sealing feature extends from the body of the piston at an acute angle relative to the longitudinal axis of the body.
  • the at least one sealing feature includes two sealing features that extend from the body in opposite axial directions from one another.
  • the at least one sealing feature includes two sealing features that extend from the body in the same axial direction as one another.
  • the at least one sealing feature is proximate an end of the body.
  • a leading portion of the body is tapered and shaped to match the contours of a necking portion of a fluid reservoir.
  • the at least one sealing feature extends circumferentially around the body.
  • an end of the at least one sealing feature and an end of the protrusion are axially aligned.
  • a fluid delivery device comprising: a fluid reservoir; a piston slideably sealing an end of the fluid reservoir, the piston including at least one sealing feature configured to radially deform to fit within the fluid reservoir at least partially through bending; a hydraulic pump chamber having hydraulic fluid, the fluid reservoir being coupled to the hydraulic pump chamber and configured to contain a fluid deliverable to a patient; and an actuator coupled to the hydraulic pump chamber and configured to urge the hydraulic fluid to move the piston within the fluid reservoir.
  • the fluid delivery device comprises a hydraulic reservoir chamber having the hydraulic fluid and coupled between the actuator and the hydraulic pump chamber, the actuator configured to urge the hydraulic fluid from the hydraulic reservoir into the hydraulic pump chamber; and a flow restrictor fiuidly coupling the hydraulic reservoir chamber and the hydraulic pump chamber.
  • FIG. 1 is a trimetric view of a fluid delivery device in accordance with an exemplary embodiment of the present invention
  • FIG. 2 is a top cross sectional view of the fluid delivery device shown in Fig. 1 taken along a plane indicated by line 2-2;
  • FIG. 3 A is a front cross sectional view of the fluid delivery device shown in Fig. 1 taken along a plane indicated by line 3 A-3 A;
  • Fig. 3B is a front cross sectional view of the fluid delivery device of Fig. 3 A shown in the deployed position;
  • FIG. 4A is a trimetric view of a piston in accordance with an exemplary embodiment of the present invention.
  • Fig. 4B is a cross sectional trimetric view of the piston shown in Fig. 4A;
  • Fig. 4C is a side cross sectional view of the piston shown in Fig. 4A;
  • Fig. 4D is a side cross sectional view of the piston shown in Fig. 4A shown inside a vial;
  • FIG. 5A is a trimetric view of a piston in accordance with an exemplary embodiment of the present invention.
  • Fig. 5B is a side cross sectional view of the piston shown in Fig. 5A;
  • Fig. 5C is a side cross sectional view of a piston in accordance with an exemplary embodiment of the present invention.
  • Fig. 5D is a side cross sectional view of a piston in accordance with an exemplary embodiment of the present invention.
  • Fig. 6 is a side view of a conventional piston
  • Fig. 7A is a side view of a piston in accordance with an exemplary embodiment of the present invention.
  • Fig. 7B is a side cross sectional view of the piston shown in Fig. 7 A.
  • Fig. 7C is a side cross sectional view of the piston shown in Fig. 7A inside a vial. DETAILED DESCRIPTION OF THE INVENTION
  • Liquid pharmaceuticals for subcutaneous infusion are commonly packaged in generally cylindrical vials or fluid reservoirs with an outlet for dispending the fluid from one end and a piston sealing the opposite end.
  • the piston typically moves through the vial due to a force applied to the piston forcing the fluid through the outlet.
  • Resistance to the piston moving through the vial comes from two sources. The first is the fluidic resistance of the fluid flowing out of the vial through whatever delivery system is connected to the outlet (e.g., a needle). This resistance is determined by the delivery system fluid path area, the fluid path length and the viscosity of the fluid as well as other factors.
  • the second source of resistance is the interaction between the piston and the vial's inner wall.
  • This glide force resistance is dominated by friction between the piston material and the wall and any adhesion between the piston and the wall. Once the piston is in motion, the glide force is dominated by the friction between the piston and the walls of the vial.
  • the frictional force is directly related to the normal force exerted by the piston on the walls of the vial.
  • the primary function of the piston is to create a moving seal to hold the fluid in the reservoir so there must be enough of this normal force to create an effective seal. This normal force is typically created by an interference fit between the piston and the reservoir inside dimension.
  • the piston is typically made of or has an outer layer of a compliant elastomer to accommodate microscopic variations in the vial's internal surface and create the seal.
  • the sealing features extend outward essentially perpendicular to the core axis.
  • typical tolerances in the inside diameter of production fabricated vials can result in large variations in the interference between the piston and the reservoir.
  • the consistency of the glide force is critical in maintaining proper performance in a predetermined delivery rate system. This is especially true in a force balance system where the rate of the piston motion is determined by resistance forces balancing against a nearly constant drive force such as a spring.
  • the resistance force could be the fluid medicament in the vial flowing through a restriction in the delivery path or a hydraulic fluid that passes through a flow limiting restriction before reaching the non-medicament side of the piston. In both these cases, the glide force of the piston becomes part of the resistance force and should be taken into account. If the glide force varies excessively from part to part, getting an accurate delivery rate puts an extra burden on the device design.
  • Embodiments of the piston described herein may be used with various fluid delivery devices 110 (see Figs. 1-3B) such as the fluid delivery devices disclosed in U.S. Patent Application Publication No. 2013/0046239, U.S. Patent Application Publication No. 2011/0306929, and U.S. Patent No. 7,481,792 that are hereby incorporated by reference in their entirety.
  • the fluid delivery device includes a bottom surface configured to be coupled to a skin surface in an engaged position.
  • a cartridge having a fluid reservoir is coupled to the housing and has a septum.
  • the septum seals one end of the fluid reservoir and a piston (see Fig. 2) seals the other end.
  • the patient inserts a pre-filled cartridge into the fluid delivery device prior to use.
  • the septum of the cartridge may have a pierceable portion, the portion of the septum pierced by the needle during use.
  • the cartridge is comprised of glass, or has an inner glass coating though other materials for the cartridge such as plastic may be used and can have a silicone coating on the glass or plastic.
  • a needle assembly having a needle may be used to fluidly couple the septum with the skin surface with the desired motion by the user or be configured to
  • the needle may have a delivery end and a fluid coupling end. Initially, fluid coupling end may be fluidly disengaged from the fluid reservoir, (e.g., an initial or pre-fluid delivery position). After the fluid delivery device is adhered to the skin surface in the engaged position, the delivery end of the needle may be extended past the bottom surface of the fluid delivery device and the fluid coupling end of the needle may be extended through the pierceable portion of the septum either simultaneously, at offset times or separately such that fluid reservoir is fluidly coupled with the patient during use (e.g., a deployed, in-use or fluid delivery position).
  • fluid reservoir e.g., an initial or pre-fluid delivery position
  • fluid delivery device 110 is a discrete ambulatory insulin delivery pump.
  • Fluid delivery device 110 may be single use, disposable and incapable of reuse.
  • Fluid delivery device 110 may provide therapeutic capability in a small, single use, disposable package and can be produced using high volume manufacturing fabrication (e.g., injection molding) and assembly processes, allowing for low cost-of goods.
  • Devices of the invention can be used for a broad range of applications, including, but not limited to, clinical applications (administration of medicaments, etc.) and biomedical research (e.g., microinjection into cells, nuclear or organelle transplantation, isolation of single cells or hybridomas, etc.).
  • fluid delivery device 110 is a device for dispensing, delivering, or administering the fluid or agent to the user or patient.
  • the fluid may be a low viscosity gel agent and or a therapeutic agent.
  • the fluid is an analgesic agent.
  • the fluid is insulin.
  • the fluid is a U100 insulin.
  • the fluid is a U200 insulin.
  • the fluid is a U300 insulin.
  • the fluid is a U500 insulin.
  • the fluid is any insulin concentration.
  • the fluid is Glucagon- like peptide- 1 (GLP-1).
  • the fluid may be, but is not limited to, opiates and/or other palliatives or analgesics, hormones, psychotropic therapeutic compositions, or any other drug or chemical whose continuous dosing is desirable or efficacious for use in treating patients.
  • Single fluids and combinations of two or more fluids may be delivered using fluid delivery device 110.
  • patients or “user” can be human or non-human animals; the use of fluid delivery device 1 10 is not confined solely to human medicine, but can be equally applied to veterinarian medicine.
  • Fluid delivery device 110 may dispense the fluid over a sustained period of time (i.e., basal delivery). In one embodiment, the fluid delivery rate is continuously or near continuously delivered to the user over the sustained period of time. Fluid delivery device 110 may also be capable of dispensing a supplementary amount of fluid, in addition to the basal amount, on demand, under patient control (i.e., bolus delivery). In one embodiment, the bolus amount delivered in a single, selectable administration is pre-determined. In preferred embodiments, fluid delivery device 110 is hydraulically actuated and comprises one or more reservoirs or chambers containing hydraulic fluid of a suitable viscosity for transferring power from one or more actuators to the fluid and controlling the delivery rate as discussed further below.
  • the fluid delivery device 110 shown includes a housing 112 and an adhesive bottom surface 114 such as a foam pad.
  • fluid delivery device 110 includes a cartridge 222 having a fluid reservoir 220 containing the medicament.
  • the fluid delivery device 110 may include one or more actuators 226 (such as a basal actuator), 228 (such as a bolus actuator) that act on piston 224 within cartridge 222.
  • actuators 226 such as a basal actuator
  • 228 such as a bolus actuator
  • a needle 330 may be deployed to fluidly couple fluid reservoir 220 and the patient. Needle 330 may be coupled to a button 332 and the needle 330 may be bent such that a translation of button 332 toward the patient causes a fluid coupling end 330a to be fluidly coupled to fluid reservoir 220 and a delivery end 330b to extend from bottom surface 114.
  • a side view of a typical piston 601 is shown.
  • the piston 601 has an interference fit with the surrounding cylinder (also referred to as a vial, fluid reservoir or cartridge).
  • the interference fit results in a reduction of the piston 601 diameter through the compression of a portion, such as sealing features 610, of the piston 601 resulting in a seal between the piston 601 and the vial wall.
  • the force required to reduce the diameter of a conventional piston 601 results in pure compression as the sealing feature 610 is backed by solid material of the remainder of the piston 601.
  • the force of compression of the sealing feature 610 is transmitted radially to the core 600 of the piston 601.
  • the piston 601 is comprised of an elastomer, the compression results in a significant change in force normal to the axis and vial when the fluid reservoir inside diameter is at the smaller end of its tolerance range.
  • the raised sealing features 410 circumscribe the piston core 400 and extend axially and radially at an acute angle i relative to the axis 400a of the piston 401.
  • the sealing feature 410 forms a flap or skirt that to seal the piston 401 to the inner surface of the vial.
  • the sealing features 410 are configured to be the only part of the piston 401 in contact with the vial 419.
  • the acute angle i is sufficiently acute and the length of the sealing feature 410 sufficiently long such that at least a portion of the sealing area, along the radial extreme of sealing feature 410, extends axially past the base of the sealing feature 410 where it joins the piston core 400.
  • the sealing feature 410 significantly bends rather than compresses when being forced to radially deform by the surrounding vial. This is shown in Fig. 4D with the piston 401 disposed in the vial 419 and the piston sealing features 410 deforming to accommodate the inside diameter of the vial 419. After inserting the piston 401 in the vial 419, the inserted angle a 2 is less than the angle i prior to inserting the piston 401 into the vial 419 (see Figs. 4A-4C). This bending of the sealing features 410 may absorb much of the deformation required for the piston 401 to fit inside of the vial 419 where if the sealing features 410 projected with a generally perpendicular orientation as in a conventional piston (see Fig. 6), the deformation of the sealing features 410 would be pure compression with essentially no bending. Bending of an object typically requires less force than compression to achieve a similar deflection, thus proving the sealing features 410 at an acute angle reduces the normal forces.
  • the preferred angle i of the sealing feature is in a range from approximately 10° to approximately 45°. Angles greater than 45° may result in more compressive deformation and reduce the compliance due to bending. Angles less than 10° may result in requiring the sealing feature to be excessively thick to create sufficient sealing force.
  • i is approximately 10°. In one embodiment, i is approximately 15°. In one embodiment, i is approximately 20°. In one embodiment, i is approximately 25°. In one embodiment, i is approximately 30°. In one embodiment, i is approximately 35°. In one embodiment, i is approximately 40°. In one embodiment, i is approximately 45°. [0043] If examined in only two dimension, the sealing features 410 deformation is mostly in flexing or bending but since the piston 401 is three dimensional and inside of a three dimensional reservoir, the deformation is not pure bending. There will be circumferential compression of the piston material due to the hoop stress imposed on the sealing features 410.
  • the force required to create this compression can be limited through the narrowing of the thickness of the sealing feature 410 resulting the bending action providing the majority of the compliance required.
  • the preferred limit on the amount of deflection is approximately 0.5 mm to account for the combined tolerance of the piston and vial.
  • piston 401 may vary in size due to the size of the vial and
  • piston 401 is comprised of a compliant elastomeric material with a preferred embodiment such as of butyl rubber with a hardness range of Shore A 35 to Shore A 80.
  • piston 401 includes a core comprised of a more rigid material than the elastomeric outer cover.
  • the piston 401 is injection molded.
  • the piston 401 may be comprised of any material or materials and be manufactured using any preferred method.
  • the performance of the piston 401 is further enhanced through the application of a lubricious coating on the piston 401 and/or the wall of the vial 419.
  • exemplary coatings may include silicone oil, bonded silicone layers, Parylene, diamond-like carbon coatings, graphene, or Teflon® such as polytetrafluoroethylene (PTFE).
  • Piston 501 is similar to piston 401 discussed above except that the piston core 500 includes an axially extending protrusion 520 extending from one or both ends of the piston core 500.
  • the region radially inside of the sealing feature 510 is at least partially filled by the protrusion 520 to minimize the volume of the recessed space at the end of piston 501.
  • the filling of the recessed space may help to minimize the volume of medicament that cannot be delivered as the sealing features 510 without the protrusion would prevent the piston core 500 from reaching the end of the vial.
  • minimizing the hollow space within the sealing features 510 also minimizes any potentially trapped air when a vial with a compliant piston 501 is used.
  • the protrusion 520 is configured to fill all the space radially within the sealing feature 510 except the space required for the sealing feature 510 to flex in the case of the smallest vial anticipated. Because the resulting undercuts 530 (see Fig. 5C) may be difficult to manufacture, a protrusion 520 shape that minimizes the undercut 530 space while still filling a majority of the volume radially within the sealing features 510. An example is shown in Fig. 5B.
  • the sealing features 510 may extend in opposite directions (e.g., axially outward from each other). See Fig. 5C. In one embodiment, both sealing features 510 extend axially in the same direction. See Fig. 5D (piston 501 '). The travel direction of the piston 501 in the vial can be in the same or opposite direction as the axial direction of the sealing features 510. In one embodiment, the sealing features 510 both extend axially in the opposite direction of the travel of the piston relative to the vial to minimize variations in glide force between the piston 501 and the vial.
  • FIG. 7A-7C there is shown a third exemplary embodiment of the piston
  • the piston 701 is similar to pistons 401 and 501 except that the leading end includes a leading portion 750 that axially projects from the end of piston 701.
  • the leading portion 750 may be configured to extend from piston 701 and take up additional space in the vial 719 so that
  • leading portion 750 is shaped to substantially fill the delivery end of the vial 719 in the final position. In one embodiment, leading portion 750 is tapered. In one embodiment, leading portion 750 has a diameter that is smaller than a diameter of the piston core 720. In one embodiment, leading portion 750 extends from piston 701 in a direction opposite the axial direction the sealing features 710 extend. In one embodiment, the leading portion 750 is configured to extend further into the necked portion 765 of the vial 719, reducing the volume of medicament that remains once the piston 701 reaches its final position.

Landscapes

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

Abstract

La présente invention concerne un piston à utiliser avec un dispositif d'administration de fluide, comprenant un corps qui présente un axe longitudinal. Au moins un élément d'étanchéité s'étend depuis le corps et est conçu pour présenter un ajustement serré avec un réservoir de fluide. Le ou les éléments d'étanchéité sont conçus pour se déformer radialement afin de s'ajuster à l'intérieur du réservoir de fluide au moins partiellement par flexiont. Une saillie s'étend axialement depuis une extrémité du corps et forme un dégagement ouvert entre la saillie et le ou les éléments d'étanchéité.
PCT/US2015/010564 2014-01-09 2015-01-08 Piston WO2015105937A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201461925286P 2014-01-09 2014-01-09
US61/925,286 2014-01-09

Publications (1)

Publication Number Publication Date
WO2015105937A1 true WO2015105937A1 (fr) 2015-07-16

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ID=53524321

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2015/010564 WO2015105937A1 (fr) 2014-01-09 2015-01-08 Piston

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Country Link
WO (1) WO2015105937A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018157097A1 (fr) * 2017-02-27 2018-08-30 W.L. Gore & Associates, Inc. Dispositifs d'administration médicaux comprenant des cylindres de seringue à faible teneur en lubrifiant
WO2022211638A1 (fr) * 2021-04-02 2022-10-06 Witteman Amber Helene Tamara Récipient de médicament comprenant une enceinte pourvue d'un revêtement de graphène ou une enceinte en un matériau comprenant du graphène

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4543093A (en) * 1982-12-20 1985-09-24 Becton, Dickinson And Company Variable sealing pressure plunger rod assembly
CA2152559A1 (fr) * 1994-07-01 1996-01-02 Lennox O. Watts Dispositif pour seringue
US20080083789A1 (en) * 2006-10-06 2008-04-10 Nikolaus Brugner Cartridge piston
US20080281271A1 (en) * 2007-05-09 2008-11-13 Griffiths Steven M Drug delivery system with a small amount of a therapeutic agent
US20110270167A1 (en) * 2009-01-13 2011-11-03 Rudolf Matusch Injector having a displaceable stopper part
US20110306929A1 (en) * 2010-06-09 2011-12-15 Valeritas, Inc. Fluid Delivery Device Needle Retraction Mechanisms, Cartridges and Expandable Hydraulic Fluid Seals

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4543093A (en) * 1982-12-20 1985-09-24 Becton, Dickinson And Company Variable sealing pressure plunger rod assembly
CA2152559A1 (fr) * 1994-07-01 1996-01-02 Lennox O. Watts Dispositif pour seringue
US20080083789A1 (en) * 2006-10-06 2008-04-10 Nikolaus Brugner Cartridge piston
US20080281271A1 (en) * 2007-05-09 2008-11-13 Griffiths Steven M Drug delivery system with a small amount of a therapeutic agent
US20110270167A1 (en) * 2009-01-13 2011-11-03 Rudolf Matusch Injector having a displaceable stopper part
US20110306929A1 (en) * 2010-06-09 2011-12-15 Valeritas, Inc. Fluid Delivery Device Needle Retraction Mechanisms, Cartridges and Expandable Hydraulic Fluid Seals

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018157097A1 (fr) * 2017-02-27 2018-08-30 W.L. Gore & Associates, Inc. Dispositifs d'administration médicaux comprenant des cylindres de seringue à faible teneur en lubrifiant
US10493207B2 (en) 2017-02-27 2019-12-03 W. L. Gore & Associates, Inc. Medical delivery devices having low lubricant syringe barrels
EP3597243A1 (fr) * 2017-02-27 2020-01-22 W. L. Gore & Associates Inc Dispositifs d'administration médicaux comprenant des cylindres de seringue à faible teneur en lubrifiant
AU2018224299B2 (en) * 2017-02-27 2020-04-16 W.L. Gore & Associates, Inc. Medical delivery devices having low lubricant syringe barrels
AU2020202193B2 (en) * 2017-02-27 2020-11-05 W.L. Gore & Associates, Inc. Medical delivery devices having low lubricant syringe barrels
AU2020205288B2 (en) * 2017-02-27 2021-10-14 W.L. Gore & Associates, Inc. Medical delivery devices having low lubricant syringe barrels
AU2022200248B2 (en) * 2017-02-27 2023-08-03 W. L. Gore & Associates, Inc. Medical delivery devices having low lubricant syringe barrels
EP4252788A3 (fr) * 2017-02-27 2023-12-06 W. L. Gore & Associates, Inc. Dispositifs d'administration médicaux comprenant des cylindres de seringue à faible teneur en lubrifiant
US11931553B2 (en) 2017-02-27 2024-03-19 W. L. Gore & Associates, Inc. Medical delivery devices having low lubricant syringe barrels
WO2022211638A1 (fr) * 2021-04-02 2022-10-06 Witteman Amber Helene Tamara Récipient de médicament comprenant une enceinte pourvue d'un revêtement de graphène ou une enceinte en un matériau comprenant du graphène

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