WO2023061545A1 - Ensemble seringue médicale durable - Google Patents

Ensemble seringue médicale durable Download PDF

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Publication number
WO2023061545A1
WO2023061545A1 PCT/DK2022/050216 DK2022050216W WO2023061545A1 WO 2023061545 A1 WO2023061545 A1 WO 2023061545A1 DK 2022050216 W DK2022050216 W DK 2022050216W WO 2023061545 A1 WO2023061545 A1 WO 2023061545A1
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WO
WIPO (PCT)
Prior art keywords
plunger
disposable
syringe barrel
stopper
barrel
Prior art date
Application number
PCT/DK2022/050216
Other languages
English (en)
Inventor
Mads JACOBSEN
Oliver SCHOLLERT
Trine FRANDSEN
Ida Jensen
Kristian KROGSGAARD
Lars Gyldenvang
Original Assignee
Sipho - Sustainable Medicare Aps
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 Sipho - Sustainable Medicare Aps filed Critical Sipho - Sustainable Medicare Aps
Publication of WO2023061545A1 publication Critical patent/WO2023061545A1/fr

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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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14566—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M2005/14573—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for quick connection/disconnection with a driving system
    • 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
    • A61M5/31515—Connection of piston with piston rod

Definitions

  • the present invention relates to the field of medical syringes and particularly medical syringe assemblies with increased sustainability compared to conventional disposable medical syringes.
  • medical syringes have been applied for injection of liquids to patients in need thereof with respect to various medical treatments and alleviation of medical conditions.
  • Some of the advantages of medical syringes include a more precise as well as a more controlled dosing of medical ingredients, such as propofol or remifentanil, compared to other available means. Since the injected medical ingredients surpass the natural bacterial defence system and biological membranes, there is a potential bacterial risk to the body if not handled correctly.
  • disposable medical syringes are provided as complete syringe sets where the plunger is already inserted in the barrel with the stopper positioned close to the liquid discharge orifice in an upper end of the barrel.
  • These kinds of syringe sets are inexpensive and intended for disposal after use, including the barrel, the stopper, and the plunger.
  • these systems may have a high negative environmental footprint.
  • various auxiliary equipment are applied in addition to the complete syringe set, including needles, glass ampoules, glass vials, sterile filters, alcohol wet-wipes and a range of other single-use remedies to extract the medical solution and assure that the patient receives a sterile dose of drug.
  • This workflow is often strenuous to the person handling the injection, each extra step of action and extra piece of equipment offering an increased risk of contamination to the patient.
  • plungers of disposable medical syringes are commonly made in a cross-shaped design. This design may serve to minimize the use of plastic material in the medical syringe product which in turn may keep the price point at a low level.
  • certain challenges are associated with this plunger shape, such as the risk of contamination during handling of the plunger due to the cross-shaped design, making the design unfit for re-use, as initial contamination of the plunger will complicate regular cleaning.
  • plungers of medical syringes applied in automatic dosing apparatus systems of active pharmaceutical ingredient liquids have been subject to less attention over the years. While it is considered that plungers of medical syringes with an appropriate configuration may be beneficial in combination with automatic dosing apparatus systems, focus has mainly been on disposable plungers, likely by virtue of the hygiene demands for these kind of systems.
  • WO 20087042299 discloses a disposable medical syringe where a cross-shaped disposable plunger may be attached/detached to/from the barrel by certain fastening means, for instance if the plunger may not easily be pre-positioned in the barrel due to size restrictions during transportation and storage.
  • the solution provided may not necessarily solve the risk of contamination during handling of the plunger, in some instances the solution may be relatively expensive for disposable syringes, and the solution may not solve the environmental issues.
  • a sustainable medical syringe assembly comprising: i) a reusable plunger (10) in a material and configuration suitable for multiple cycles of medical use, the plunger (10) comprising: a head portion (14) having a substantially elongated body and being adapted for engaging with a tail member (27) of a disposable liquid stopper (20) pre-positioned in a syringe barrel (30); and a tail portion (16) operable to provide a linear movement for expelling an active pharmaceutical ingredient liquid (44) contained in an upper part of said syringe barrel (30) through a liquid discharge orifice (40) in an upper end of said syringe barrel (30), and as a separate arrangement ii) a disposable cylindrical syringe barrel (30) comprising a disposable prepositioned liquid stopper (20), the stopper (20) comprising: a head member (25) sealing said barrel (30) during storage and upon linear sliding movement of said reusable plunger (10); and a tail member (27) with a substantially elongated
  • a sustainable medical syringe assembly comprising: i) a reusable plunger (10) in a material and configuration suitable for multiple cycles of medical use, the plunger (10) comprising: a cylindrical head portion (14) having a substantially elongated body and being adapted for engaging with a tail member (27) of a disposable liquid stopper (20) pre-positioned in a syringe barrel (30); and a tail portion (16) operable to provide a linear movement for expelling an active pharmaceutical ingredient liquid (44) contained in an upper part of said barrel (30) through a liquid discharge orifice (40) in an upper end of said syringe barrel (30), and as a separate arrangement ii) a disposable cylindrical syringe barrel (30) comprising a disposable prepositioned liquid stopper (20), the stopper (20) comprising: a head member (25) sealing said barrel (30) during storage and upon linear sliding movement of said reusable plunger (10); and a tail member (27) with a substantially elongated body
  • a sustainable medical syringe assembly comprising: i) a reusable plunger (10) in a material and configuration suitable for multiple cycles of medical use, the plunger (10) comprising: a cylindrical head portion (14) having a substantially elongated body with an outer diameter substantially fitting an inside diameter of a disposable cylindrical syringe barrel (30) and being adapted for engaging with a tail member (27) of a disposable liquid stopper (20) pre-positioned in said syringe barrel (30); and a cylindrical tail portion (16) operable to provide a linear movement for expelling an active pharmaceutical ingredient liquid (44) contained in an upper part of said barrel (30) through a liquid discharge orifice (40) in an upper end of said syringe barrel (30), and as a separate arrangement ii) a disposable cylindrical syringe barrel (30) comprising a disposable prepositioned liquid stopper (20), the stopper (20) comprising: a head member (25) sealing said barrel (30) during storage and upon linear sliding movement of said
  • a sustainable system for automatic injection of an active pharmaceutical ingredient liquid comprising a dosing apparatus (50) for automatic injection of an active pharmaceutical ingredient liquid (44) to patients in need thereof and a sustainable medical syringe assembly as outlined in the aspects above.
  • the disposable cylindrical syringe barrel (30) is fixed during operation in the dosing apparatus (50) and the tail portion (16) of the reusable plunger (10) is fixed in a position that solely allows for linear sliding movement of said reusable plunger (10) during operation in the dosing apparatus (50).
  • the dosing apparatus (50) is configured to allow for linear sliding movement of said reusable plunger (10) at a constant velocity, thereby allowing for a constant flow of the active pharmaceutical ingredient liquid (44) to patients in need thereof.
  • the dosing apparatus (50) is programmable and operable to provide a constant flow of the active pharmaceutical ingredient liquid (44) to patients in need thereof.
  • the tail portion (16) of the reusable plunger (10) is fixed in a position with a deviation of less 2 mm, such as less than 1 mm, in a transverse direction relative to the linear sliding movement of said reusable plunger (10).
  • One of the advantages of the medical syringe assembly according to the invention is that the environmental footprint will be less pronounced and disposable materials may be kept at a minimum while still complying with the requirement of clinical handling practice. Since the plunger of a medical syringe may constitute a large part of the medical syringe set, a reusable plunger will improve the overall environmental footprint after only a few times of reuse and contribute with sustainability of hitherto known disposable medical syringes.
  • the meaning of “sustainable medical syringe” or similar wordings is intended to be understood as a comparison to conventional medical syringes completely for one-time-use. Accordingly, the wording is neither to be taken to mean that the complete syringe set is completely sustainable but that the sum of elements of the medical syringe is delivering an improved contribution to the overall environmental disposal issues.
  • reusable plunger By the wording “reusable plunger”, the intention is to highlight that the plunger is not disposable in a commonly known way, i.e., is not intended for one-time-use but is intended for use more than one time. In some embodiments of the invention, the “reusable plunger” is reusable multiple times, such as more than 10 times, such as more than 50 times, such as more than 100 times. The overall idea with the wording “reusable plunger” is that the plunger should be in a material and configuration suitable for multiple cycles of medical use.
  • the intended meaning is that the plunger should be able to withstand attachment/ detachment in a barrel for multiple time use and should be made in a material and configuration that may withstand multiple use cycles and multiple cleansing cycles that ensures that hygiene demands are undertaken.
  • a less attractive configuration is a plunger where the tail portion comprises a configuration of cross-fingers, which may be more demanding in terms of multiple cleansing cycles and hygiene.
  • the attachment/detachment should be robust.
  • a reusable plunger was suitable as a separate arrangement in a medical syringe assembly.
  • all substantial elements in a medical syringe are disposable and attention is usually directed to usability of one- time-use assemblies.
  • the inventors of the present invention found solutions hitherto unrevealed and they estimated that the contribution of a reusable plunger to the overall environmental footprint of medical syringes was adequate to significantly lower the sustainability of medical syringes.
  • the overall premise of the present invention is that the reusable plunger is attached/ detached to/from a stopper comprised in the barrel of the medical syringe. Accordingly, the stopper is always present in the barrel of the medical syringe according to the invention and as a critical aspect is not attached/detached to/from a stopper outside the barrel.
  • the advantage of this premise is that the stopper of the medical syringe in some embodiments may constitute a plug for pre-filled active pharmaceutical ingredient liquid in the barrel and in some embodiments may be kept inside the barrel in order to avoid or minimize contamination during use.
  • the reusable plunger does not necessarily need to be handled in compliance with clinical guidelines, the stopper of the medical syringe may require more strict clinical handling practice.
  • the reusable plunger is denoted a “separate arrangement” according to the invention
  • the disposable cylindrical syringe barrel comprising a disposable pre-positioned liquid stopper is also denoted a “separate arrangement”, highlighting that the two arrangements are to be separately connected upon use of the medical syringe or in advance of use of the medical syringe.
  • the plunger according to the invention is reusable, the stopper and barrel of the medical syringe is disposable according to the invention. It is contemplated that the stopper and barrel may not be reusable for practical reasons, including the risk of contamination and dosing issues. However, even despite this, the plunger may constitute a relatively large part of the medical syringe set and therefore may contribute to a major improvement of the environmental footprint if being reusable. Additionally, since the plunger may be used multiple times, it is possible to provide a quality of the reusable plunger that both gives a more reliable and predictable handling during use and a sense of more control to the personnel using the reusable plunger on a daily basis.
  • the head portion (14) is to have a substantially elongated body according to the invention.
  • “elongated body” is to be understood as a certain length in the barrel length direction in order to provide stability for attachm ent/ detachment to/from the tail member (27) of the disposable liquid stopper (20) pre-positioned in the syringe barrel (30), and also to provide stability during use of the medical syringe.
  • the reusable plunger may provide a flexing movement in the barrel during use. Potentially, a flexing movement may impact leakage of the liquid or may otherwise contribute to less optimal handling of the reusable plunger.
  • the length of the elongated body of the head member of the reusable plunger needs to be substantial.
  • the elongated body has a length of more than 0.5 cm. In some embodiments, the elongated body has a length of more than 0.7 cm. In some embodiments, the elongated body has a length of more than 1.0 cm.
  • the elongated body has a length of more than 1.2 cm. In some embodiments, the elongated body has a length of more than 1.5 cm. In some embodiments, the elongated body has a length of more than 2.0 cm. In some embodiments, the elongated body has a length of more than 2.5 cm. In some embodiments, the elongated body has a length of more than 3.0 cm.
  • the stopper (20) is to be pre-positioned in the barrel and would work to avoid liquid from leaking from the barrel during use.
  • liquid stopper is that the stopper is to keep liquid from leaking to the outside, i.e., that the stopper fits tightly to the inside surface of the barrel while still being operable for linear movement inside the barrel.
  • the stopper is made of an elastomeric material and in some other embodiments the stopper comprises an elastomeric material between the outside peripherical surface of the stopper exposed to the inside surface of the barrel.
  • the elastomeric material is allocated in separate rings outside the stopper, such as in one, two, three or four separate rings. In that case, the stopper would not need to be made of an elastomeric material and may preferably be made in the same material as the barrel.
  • the intended meaning is that “seal” or “sealing” is to avoid liquid leakage as previously mentioned.
  • the head member of the stopper is intended to seal the liquid and avoid leakage during storage as well as under operation of the medical syringe.
  • the head member of the stopper (20) is intended as the sealing member, but in some embodiments, also the tail member of the stopper may serve to provide a sealing contribution.
  • elongated body is to be understood as a certain length in the barrel length direction in order to provide stability for attachment/detachment to/from the head member of the reusable plunger, and also to provide stability during use of the medical syringe.
  • the reusable plunger may provide a flexing movement in the barrel during use. Potentially, a flexing movement may impact leakage of the liquid or may otherwise contribute to less optimal handling of the reusable plunger.
  • the length of the elongated body of the tail member of the stopper needs to be substantial.
  • the elongated body has a length of more than 0.5 cm. In some embodiments, the elongated body has a length of more than 0.7 cm. In some embodiments, the elongated body has a length of more than 1.0 cm.
  • the elongated body has a length of more than 1.2 cm. In some embodiments, the elongated body has a length of more than 1.5 cm. In some embodiments, the elongated body has a length of more than 2.0 cm. In some embodiments, the elongated body has a length of more than 2.5 cm. In some embodiments, the elongated body has a length of more than 3.0 cm.
  • the reusable plunger comprises a cylindrical head portion (14) having a substantially elongated body and being adapted for engaging with a tail member (27) of a disposable liquid stopper (20) pre-positioned in a syringe barrel (30). While a head portion (14) of the reusable plunger in any form may be applied according to some embodiments of the invention, a cylindrical head portion (14) may have several advantages. One of the advantages of a cylindrical head portion (14) of the reusable plunger is that various means for engagement with the head member (25) of the stopper (20) may be more easily applied, such as a screw engagement means, and a bayonet-type engagement means. Additionally, support for the reusable plunger may be more easily applied.
  • the outer diameter of the cylindrical head portion (14) may substantially fit the inside diameter of the barrel.
  • support may more easily be applied for the assembly thereby avoiding or minimizing flexing movements of the reusable plunger during operation in the barrel.
  • the head portion (14) of the reusable plunger is cylindrical with an outer diameter less than the inside diameter of the barrel but fitting substantially tight inside the barrel. In some embodiments, the head portion (14) of the reusable plunger is cylindrical with an outer diameter less than the inside diameter of the barrel but without fitting substantially tight inside the barrel. In some embodiments, the head portion (14) of the reusable plunger is cylindrical with an outer diameter substantially less than the inside diameter of the barrel.
  • a cylindrical head portion (14) Another advantage of a cylindrical head portion (14) is that the cleansing procedures for improved hygiene may be more effective in-between the use of the reusable plunger.
  • the presence of irregular protrusions and grooves may be avoided or minimized since the cylindrical shape may provide regular surfaces on the head portion of the reusable plunger. These irregular protrusions and grooves may be present in certain engagement means in conventional medical syringes.
  • Yet another advantage of a cylindrical head portion (14) is that a more precise and reliable engagement with the tail member of the stopper may be complied with.
  • the tail portion (16) of the reusable plunger is cylindrical.
  • further advantages of the reusable plunger is accommodated, including the aforementioned hygiene concerns appliable for the cylindrical head portion.
  • irregular protrusions and grooves are avoided or minimized whereby cleansing may be easier and/or daily contact contamination as a consequence of personnel handling may be less pronounced.
  • the tail portion (16) of the reusable plunger is cylindrical with an outer diameter less than the inside diameter of the barrel but fitting substantially tight inside the barrel. In some embodiments, the tail portion (16) of the reusable plunger is cylindrical with an outer diameter less than the inside diameter of the barrel but without fitting substantially tight inside the barrel. In some embodiments, the tail portion (16) of the reusable plunger is cylindrical with an outer diameter substantially less than the inside diameter of the barrel.
  • both the head portion (14) and the tail portion (16) of the reusable plunger is cylindrical.
  • One of the advantages of these embodiments is that further improved hygiene may be achieved, and a more reliable and predictable sense may be achieved by the personnel operating the medical syringe.
  • a cylindrical tail portion problems with appropriate support for the fingers by the operating personnel may be avoided or minimized. In turn, this may provide a more reliable and predictable operation of the medical syringe.
  • the reusable plunger comprises a cylindrical head portion (14) having a substantially elongated body with an outer diameter substantially fitting an inside diameter of a disposable cylindrical syringe barrel (30) and being adapted for engaging with a tail member (27) of a disposable liquid stopper (20) pre-positioned in said syringe barrel (30).
  • further improved support may be provided, especially when the elongated body has a substantial length.
  • This particular embodiment may be directed to the head portion of the reusable plunger being a female engaging portion, where the tail member of the stopper is a male member.
  • a presently preferred embodiment encompasses this construction of the medical syringe assembly.
  • the head portion (14) of the reusable plunger is connected with the tail portion (16) of the stopper through an inwardly shaped connecting member (15) made as a cylindrical connecting member.
  • the reusable plunger may be substantially without protrusions, fissures, and groves, and thereby substantially avoiding or minimizing contamination and/or improving hygiene.
  • the diameter of the tail portion is substantially smaller than the diameter of the head portion.
  • the head portion of the reusable plunger preferably comprises a female screw engagement means and the tail member of the stopper comprises a male screw engagement means. In some embodiments, the head portion of the reusable plunger comprises a male screw engagement means and the tail member of the stopper comprises a female screw engagement means. In some embodiments, the head portion of the reusable plunger comprises a bayonet-type engagement means and the tail member of the stopper comprises a bayonet-type engagement means. In some embodiments, the head portion of the reusable plunger comprises a male engagement means and the tail member of the stopper comprises a female engagement means. In some embodiments, the head portion of the reusable plunger comprises a female engagement means and the tail member of the stopper comprises a male engagement means.
  • the disposable cylindrical syringe barrel (30) comprises a pre-filled active pharmaceutical ingredient liquid (44) in an upper part of said syringe barrel (30) and a disposable pre-positioned liquid stopper (20) enclosing said liquid (44) in a lower part of said syringe barrel (30).
  • One of the advantages of a pre-filled active pharmaceutical ingredient liquid (44) in an upper part of said syringe barrel (30) and a disposable pre-positioned liquid stopper (20) enclosing said liquid (44) in a lower part of said syringe barrel (30) is that various utensils and other auxiliary vials and equipment will be minimized, contributing to the overall sustainability of the invention.
  • the overall environmental footprint will be substantially minimized according to these embodiments of the invention.
  • the stopper may have several functions, including a plug function for the liquid and a ready -to-use function for direct engagement with the reusable plunger.
  • a ready -to-use barrel containing an active pharmaceutical ingredient liquid (44) and a disposable liquid stopper (20) pre-positioned in said syringe barrel (30) may be provided.
  • the reusable plunger may be directly engaged with the separate arrangement and directly applied to a patient in need thereof.
  • the time used for preparing a barrel of an active pharmaceutical ingredient liquid (44) by medical personnel is substantial, and the pre-filled barrel with a stopper according to the invention will save a substantial amount of time in the preparations by the personnel. Also, mistakes may be avoided by appropriately marking the pre-filled barrel with the correct information, concentration and ingredients contained in the barrel.
  • anesthetics such as propofol or remifentanil
  • use of anesthetics may be more easily applied to patients in need thereof with a more reliable procedure and less risk of mistakes by the personnel preparing the medical syringes before use.
  • the barrel is a 10 ml barrel. In some embodiments, the barrel is a 20 ml barrel. In some embodiments, the barrel is a 30 ml barrel. In some embodiments, the barrel is a 50 ml barrel. In some embodiments, the barrel is a 100 ml barrel.
  • the stopper does not comprise silicone coating in order to avoid contamination with the active ingredient during operation or storage.
  • the material of the reusable plunger (10) suitable for multiple cycles of medical use comprises a material that may withstand multiple cycles of a washing procedure at above 75 degree Celsius. In some embodiments, the material of the reusable plunger (10) suitable for multiple cycles of medical use comprises a material that may withstand multiple cycles of a washing procedure at above 80 degree Celsius.
  • the material of the reusable plunger (10) suitable for multiple cycles of medical use comprises a material that remains chemically stable or otherwise keeps the reusable plunger (10) consistent in form during multiple cycles of a washing procedure at above 75 degree Celsius. In some embodiments, the material of the reusable plunger (10) suitable for multiple cycles of medical use comprises a material that remains chemically stable or otherwise keeps the reusable plunger (10) consistent in form during multiple cycles of a washing procedure at above 80 degree Celsius.
  • the material of the reusable plunger (10) suitable for multiple cycles of medical use comprises a thermoplastic.
  • the material of the reusable plunger (10) suitable for multiple cycles of medical use comprises a material selected from the group consisting of acrylonitrile butadiene styrene (ABS), polysulfone (PSU), poly ethersulfone (PES), polyphenylene sulfone (PPSU), polyethylene (PE), polypropylene (PP), polyethylene terephthalate (PET), cyclic olefin polymer (COP), polyvinyl chloride (PVC), and combinations thereof.
  • ABS acrylonitrile butadiene styrene
  • PSU polysulfone
  • PES poly ethersulfone
  • PPSU polyphenylene sulfone
  • PE polyethylene
  • PE polypropylene
  • PET polyethylene terephthalate
  • COP cyclic olefin polymer
  • PVC polyvinyl chloride
  • the material of the reusable plunger (10) suitable for multiple cycles of medical use comprises a material selected from the group consisting of acrylonitrile butadiene styrene (ABS), polysulfone (PSU), poly ethersulfone (PES), polyphenylene sulfone (PPSU), polyethylene (PE), polypropylene (PP), and combinations thereof.
  • the material of the reusable plunger (10) suitable for multiple cycles of medical use comprises acrylonitrile butadiene styrene (ABS).
  • the material of the reusable plunger (10) suitable for multiple cycles of medical use comprises stainless steel.
  • the barrel comprises a material selected from the group consisting of acrylonitrile butadiene styrene (ABS), polysulfone (PSU), polyethersulfone (PES), polyphenylene sulfone (PPSU), polyethylene (PE), polypropylene (PP), and combinations thereof.
  • ABS acrylonitrile butadiene styrene
  • PSU polysulfone
  • PES polyethersulfone
  • PPSU polyphenylene sulfone
  • PE polyethylene
  • PP polypropylene
  • the stopper comprises a material selected from the group consisting of acrylonitrile butadiene styrene (ABS), polysulfone (PSU), polyethersulfone (PES), polyphenylene sulfone (PPSU), polyethylene (PE), polypropylene (PP), and combinations thereof.
  • ABS acrylonitrile butadiene styrene
  • PSU polysulfone
  • PES polyethersulfone
  • PPSU polyphenylene sulfone
  • PE polyethylene
  • PP polypropylene
  • the barrel and the stopper comprises the same material. In some embodiments, the barrel and the stopper is made of the same material. In some embodiments, the barrel and the stopper is made of the same material, except for optional elastomeric rings on the outside of the head of the stopper. In some embodiments, the stopper comprises an elastomeric material. In some embodiments, the stopper is made of an elastomeric material. In some embodiments, the stopper is made of an elastomeric material, and optional elastomeric rings are not present on the outside of the head of the stopper.
  • the configuration of the reusable plunger (10) suitable for multiple cycles of medical use does not comprise a tail portion (16) including longitudinal cross-fingers angled at about 90 degrees or less, such as a longitudinal cross-shaped tail portion (16) including four fingers.
  • the configuration of the reusable plunger (10) suitable for multiple cycles of medical use comprises a tail portion (16) including longitudinal cross-fingers angled at more than 90 degrees, including three fingers.
  • the intended meaning is typically directed to a tail portion of plungers with a cross-like configuration where walls extend from a longitudinal centre of the tail portion to an outer periphery of the tail portion, typically with the walls being angled in 90 degrees relative to each other.
  • the walls typically have the same thickness from the centre to the outer periphery of the rail portion.
  • the substantially elongated body of the head portion (14) of the reusable plunger (10) is suitable for stabilizing the reusable plunger (10) during operation in the disposable cylindrical syringe barrel (30).
  • the head portion (14) of the reusable plunger (10) having a substantially elongated body and being adapted for engaging with a tail member (27) of a disposable liquid stopper (20) pre-positioned in said syringe barrel (30) comprises a female engaging arrangement (11,12,13) and the tail member (27) of the stopper (20) with a substantially elongated body adapted for engaging with said head portion (14) of said reusable plunger (10) comprises a male engaging arrangement (28).
  • the head portion (14) of the reusable plunger (10) having a substantially elongated body and being adapted for engaging with a tail member (27) of a disposable liquid stopper (20) pre-positioned in said syringe barrel (30) comprises a male engaging arrangement (12a) and the tail member (27) of the stopper (20) with a substantially elongated body adapted for engaging with said head portion (14) of said reusable plunger (10) comprises a female engaging arrangement (28a).
  • the head portion (14) of the reusable plunger (10) having a substantially elongated body and being adapted for engaging with a tail member (27) of a disposable liquid stopper (20) pre-positioned in said syringe barrel (30) comprises a bayonet-type engaging arrangement (11) and the tail member (27) of the stopper (20) with a substantially elongated body adapted for engaging with said head portion (14) of said reusable plunger (10) comprises a bayonet-type engaging arrangement (21).
  • the disposable cylindrical syringe barrel (30) is made of the same material as the disposable pre-positioned liquid stopper (20), except for any optional sealing members (29), such as elastomeric sealing members (29).
  • the disposable cylindrical syringe barrel (30) is made of polypropylene (PP).
  • the active pharmaceutical ingredient liquid (44) comprises any active pharmaceutical ingredient for injection.
  • the active pharmaceutical ingredient liquid (44) comprises anesthetics, such as propofol or remifentanil. In some embodiments, the active pharmaceutical ingredient liquid (44) comprises propofol. In some embodiments, the active pharmaceutical ingredient liquid (44) comprises remifentanil. In some embodiments, the active pharmaceutical ingredient liquid (44) comprises insulin. In some embodiments, the active pharmaceutical ingredient liquid (44) comprises potassium chloride. In some embodiments, the active pharmaceutical ingredient liquid (44) comprises noradrenaline.
  • a system comprising the sustainable medical syringe assembly according to any one of the previous embodiments in combination with a dosing apparatus (50) for automatic injection of the active pharmaceutical ingredient liquid (44) to patients in need thereof, such as propofol or remifentanil.
  • a dosing apparatus for automatic injection of the active pharmaceutical ingredient liquid (44) to patients in need thereof, such as propofol or remifentanil.
  • Various dosing apparatus suitable for the purpose are available, such as Agilia® SP TIVA, Agilia® SP TIVA Wi-Fi, and Perfusor® Space (Braun).
  • the nurse then adjusts the automatic dosing apparatus.
  • the nurse uses guidance to determine the rate at which the medication is to be dosed and programs this in the machine.
  • the speed can be adjusted with arrow keys on the equipment.
  • the syringe assembly is place in the automatic dosing apparatus, i.e., the disposable syringe barrel is fixed and the reusable plunger is fixed in a position that solely allows for linear sliding movement of the reusable plunger during operation in the dosing apparatus.
  • the nurse connects a disposable tube tip of the syringe and to the patient drop.
  • the syringe according to the invention may be 'ready -to-use' and may be inserted into the syringe pump ready in a few seconds. This means that the nurses may avoid using excess time to refill the barrels.
  • a label may be pre-mounted on the pre-filled syringe barrels. This may avoid having to make handwritten labels for each individual syringe with the insecurity this involves.
  • the pre-filled syringe may also be color-coded from the factory, stating the drug type, concentration, production time and expiration date. In that way, the nurses may quickly decode what's inside and just have to write the time when the syringe is taken out of the packaging. This may increase the patient safety.
  • Another option is to apply a barcode, QR code or the like on the label in order for the dosing device to be able to preset itself. This would also reduce human error and increase patient safety.
  • a reusable plunger (10) in a material and configuration suitable for multiple cycles of medical use comprising: a cylindrical head portion (14) having a substantially elongated body with an outer diameter substantially fitting an inside diameter of a disposable cylindrical syringe barrel (30) and being adapted for engaging with a tail member (27) of a disposable liquid stopper (20) pre-positioned in said syringe barrel (30); and a cylindrical tail portion (16) operable to provide a linear movement for expelling an active pharmaceutical ingredient liquid (44) contained in an upper part of said barrel (30) through a liquid discharge orifice (40) in an upper end of said syringe barrel (30).
  • a reusable plunger (10) in a material and configuration suitable for multiple cycles of medical use comprising: a head portion (14) having a substantially elongated body with an outer diameter substantially fitting an inside diameter of a disposable cylindrical syringe barrel (30) and being adapted for engaging with a tail member (27) of a disposable liquid stopper (20) pre-positioned in said syringe barrel (30); and a tail portion (16) operable to provide a linear movement for expelling an active pharmaceutical ingredient liquid (44) contained in an upper part of said barrel (30) through a liquid discharge orifice (40) in an upper end of said syringe barrel (30).
  • a reusable plunger (10) in a material and configuration suitable for multiple cycles of medical use comprising: a head portion (14) having a substantially elongated body and being adapted for engaging with a tail member (27) of a disposable liquid stopper (20) pre-positioned in said syringe barrel (30); and a tail portion (16) operable to provide a linear movement for expelling an active pharmaceutical ingredient liquid (44) contained in an upper part of said barrel (30) through a liquid discharge orifice (40) in an upper end of said syringe barrel (30).
  • Fig. la illustrates a reusable plunger having a cylindrical head portion with a female bayonet-type engagement means and a cylindrical tail portion.
  • Fig. lb illustrates a stopper with a head member comprising an elastomeric ring member and a male bayonet-type tail member.
  • Fig. 1c illustrates a reusable plunger having a cylindrical head portion with a female bayonet-type engagement means and a cylindrical tail portion inserted into a stopper with a head member comprising an elastomeric ring member and a male bayonettype tail member.
  • Fig. 2a illustrates a reusable plunger having a cylindrical head portion with a female screw engagement means and a cylindrical tail portion.
  • Fig. 2b illustrates a stopper with a head member comprising an elastomeric ring member and a male screw tail member.
  • Fig. 2c illustrates a reusable plunger having a cylindrical head portion with a female screw engagement means and a cylindrical tail portion inserted into a stopper with a head member comprising an elastomeric ring member and a male screw tail member.
  • Fig. 3a illustrates a reusable plunger having a cylindrical head portion with a female engagement means and a cylindrical tail portion.
  • Fig. 3b illustrates a stopper with a head member comprising an elastomeric ring member and a male tail member.
  • Fig. 3c illustrates a reusable plunger having a cylindrical head portion with a female engagement means and a cylindrical tail portion inserted into a stopper with a head member comprising an elastomeric ring member and a male tail member.
  • Fig. 4a illustrates a reusable plunger having a cylindrical head portion with a male screw engagement means and a cylindrical tail portion.
  • Fig. 4b illustrates a stopper with a head member comprising an elastomeric ring member and a female screw tail member.
  • Fig. 4c illustrates a reusable plunger having a cylindrical head portion with a male screw engagement means and a cylindrical tail portion inserted into a stopper with a head member comprising an elastomeric ring member and a female screw tail member.
  • Fig. 5 illustrates a dosing apparatus for automatic injection of an active pharmaceutical ingredient liquid comprised in a medical syringe assembly according to the invention.
  • Fig. 6 illustrates a disposable cylindrical syringe barrel comprising a disposable prepositioned liquid stopper for engagement with a reusable plunger according to the invention.
  • a reusable plunger (10) in a material and configuration suitable for multiple cycles of medical use comprising a cylindrical head portion (14) having a substantially elongated body and being adapted for engaging with a tail member (27) of a disposable liquid stopper (20) pre-positioned in a syringe barrel (30); and a tail portion (16) operable to provide a linear movement for expelling an active pharmaceutical ingredient liquid (44) contained in an upper part of said barrel (30) through a liquid discharge orifice (40) in an upper end of said syringe barrel (30).
  • the reusable plunger illustrated in Fig. la, 2a, and 3a comprises a cylindrical tail portion (16) with a diameter that is smaller than the diameter of the head portion (14), where the head portion (14) has a diameter substantially fitting an inside diameter of a disposable cylindrical syringe barrel (30).
  • the elongated body of the head portion (14) may serve to support the reusable plunger in the barrel. This may for instance help on the stability of the plunger during operation, such as avoiding a flexing movement of the plunger in the barrel.
  • the reusable plunger is made of acrylonitrile butadiene styrene (ABS) but other materials may be applied, such as materials that is also suitable for multiple cycles of medical use.
  • the reusable plunger may comprise a bayonet-type engagement means (11).
  • This engagement means may both be provided as a female version (19) as illustrated but also be in a male version.
  • a female bayonet-type version (11) is preferred.
  • a female screw version (12) may be provided, and as illustrated in Fig. 3a, a straight version (13) may also be provided.
  • an upper surface (18) may interact directly with a neck portion (26) of a stopper (20) according to the invention, i.e., a portion (26) below the head member (25) of the stopper (20).
  • the reusable plunger (10) contains an attachment member (17) that may be applied when the syringe assembly is to be used in an automatic dosing apparatus (50). This serves to keep the plunger in place during operation in the apparatus.
  • a disposable pre-positioned liquid stopper (20) comprising a head member (25) sealing said barrel (30) during storage and upon linear sliding movement of said reusable plunger (10); and a tail member (27) with a substantially elongated body adapted for engaging with said head portion (14) of said reusable plunger (10).
  • the head (25) of the stopper (20) as illustrated in Fig. lb, 2b, and 3b is formed as a cylindrical pyramid (24) and comprises one or more sealing rings (29) made of an elastomeric material, such as butyl rubber.
  • the one or more elastomeric rings (29) serve to avoid leakage between the inside of the barrel (30) and the outside of the head member (25) of the stopper (20).
  • the stopper (20) in itself is made of a material to avoid leakage (shown in Fig. 5).
  • a bayonet-type (21) engagement means for engaging with the bayonet-type (11) engagement means of the head (14) of the plunger (10).
  • This is the presently preferred engagement type.
  • a screw (22) engagement means for engaging with the screw (12) engagement means of the head (14) of the plunger (10).
  • a straight (23) engagement means for engaging with the straight (13) engagement means of the head (14) of the plunger (10).
  • the neck member (26), as illustrated in Fig. lb, 2b, and 3b may be absent in certain embodiments, and the stopper (20) may comprise a hollow structure or may comprise a solid structure.
  • the stopper (20) is made of polypropylene (PP), except for the elastomeric ring element (29), and the syringe barrel (30) is made of the same material.
  • PP polypropylene
  • the syringe barrel (30) is made of the same material.
  • the two parts may be connected by at least 1/4 turn of the reusable plunger, such as at least 1/5 turn of the reusable plunger, such as at least 1/6 turn of the reusable plunger. It is contemplated that at least 1/6 turn may be adequate to safely lock the connecting parts.
  • Fig. 1c, 2c, and 3c the connecting parts are assembled, i.e., the reusable plunger (10) is inserted into the disposable liquid stopper (20).
  • the disposable liquid stopper (20) is pre-positioned in the disposable cylindrical syringe barrel (30) according to the invention, and therefore Fig. 1c, 2c, and 3c solely illustrates how the parts are connected.
  • the connection takes place inside the disposable cylindrical syringe barrel (30) according to the invention (shown in Fig. 5 and 6).
  • a head portion (14) of the reusable plunger (10) having a substantially elongated body (here illustrated as 14a) and being adapted for engaging with a tail member (27) of a disposable liquid stopper (20) pre-positioned in said syringe barrel (30).
  • the elongated body (14a) comprises a male engaging arrangement (19a) and the tail member (27) of the stopper (20) with a substantially elongated body adapted for engaging with said head portion (14) of said reusable plunger (10) comprises a female engaging arrangement (28a).
  • the reusable plunger may comprise a screw-type engagement means (12a).
  • a male bayonet-type version may be provided, and a straight version may also be provided (not illustrated).
  • the tail member (27) comprises a screw-type engagement means (22a), and the outer diameter of the tail member (27) may be substantially fitting on the inside of the surface of the barrel for stability reasons.
  • an upper surface (18a) of the reusable plunger may fit inside the stopper (20).
  • Fig. 4c there is provided an assembly of the connecting parts of this alternative embodiment.
  • the disposable liquid stopper (20) is pre-positioned in the disposable cylindrical syringe barrel (30) according to this alternative embodiment of the invention, and therefore Fig. 4c solely illustrates how the parts are connected. Importantly, connection takes place inside the disposable cylindrical syringe barrel (30) according to the invention (shown in Fig. 5 and 6).
  • a system comprising the sustainable medical syringe assembly according to any of the aforementioned embodiments in combination with a dosing apparatus (50) for automatic injection of the active pharmaceutical ingredient liquid (44) to patients in need thereof.
  • the illustrated apparatus is commonly used in connection with anesthetics, such as propofol or remifentanil.
  • anesthetics such as propofol or remifentanil.
  • the invention may be applied in connection with any medical ingredient for injection.
  • propofol or remifentanil is presently preferred.
  • a sustainable medical syringe assembly according to the invention inserted into a dosing apparatus (50) for automatic injection of the active pharmaceutical ingredient liquid (44) to patients in need thereof.
  • the syringe comprises an attachment member (17) for use to keeping the plunger in place during operation in the apparatus.
  • a locking mechanism (52) may be used for securing the plunger (10) whereafter a pressing means (54) of the apparatus (50) is applied for steadily injecting the active pharmaceutical ingredient liquid (44) through an orifice (58) of the barrel (30).
  • a further mechanism (56) is applied for keeping the barrel (30) in place during operation, specifically an end portion (34) of the barrel (30).
  • Fig. 6 the separate arrangement ii) of the sustainable medical syringe assembly is illustrated (without the reusable plunger) in an embodiment where the syringe is pre-filled.
  • the stopper (20) is applied as a plug keeping the active pharmaceutical ingredient liquid (44) in place in an upper part of said syringe barrel (30).
  • the stopper (20) is of a bayonet-type engagement type (21) and contains a sealing member (29) on the outside of the head member (25).
  • a plunger (10) Upon insertion of a plunger (10) according to the invention through the open end (32) of the syringe barrel (30) and attachment to the stopper (20), the active pharmaceutical ingredient liquid (44) is expelled through a liquid discharge orifice (40) in an upper end of said syringe barrel (30).
  • a luer lock may be provided and attached to an upper part (38) of the barrel (30), here illustrated with a cylindrical pyramid form (36).
  • the syringe barrel (30) may be provided with a label (42), clearly indicating the concentration and type of medical ingredient used to patients in need thereof.

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 ensemble seringue médicale durable, l'ensemble comprenant i) un piston réutilisable (10) dans un matériau et une configuration appropriés pour de multiples cycles d'utilisation médicale. Le piston (10) comprend une partie tête (14) ayant un corps sensiblement allongé et étant conçue pour venir en prise avec un élément queue (27) d'un bouchon de liquide jetable (20) pré-positionné dans un cylindre de seringue (30). Le piston (10) comprend en outre une partie queue (16) actionnable pour fournir un mouvement linéaire pour expulser un liquide d'ingrédient pharmaceutique actif (44) contenu dans une partie supérieure dudit cylindre de seringue (30) à travers un orifice d'évacuation de liquide (40) dans une extrémité supérieure dudit cylindre de seringue (30). En tant qu'agencement séparé, l'ensemble seringue médicale comprend ii) un corps de seringue cylindrique jetable (30) comprenant un bouchon de liquide pré-positionné jetable (20), le bouchon (20) comprend un élément tête (25) scellant ledit cylindre (30) pendant le stockage et lors du mouvement coulissant linéaire dudit piston réutilisable (10) ; et un élément queue (27) ayant un corps sensiblement allongé conçu pour venir en prise avec ladite partie tête (14) dudit piston réutilisable (10).
PCT/DK2022/050216 2021-10-14 2022-10-12 Ensemble seringue médicale durable WO2023061545A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DKPA202170510 2021-10-14
DKPA202170510 2021-10-14

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WO2023061545A1 true WO2023061545A1 (fr) 2023-04-20

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008042299A2 (fr) 2006-09-29 2008-04-10 Tyco Healthcare Group Lp Seringue à tige de piston démontable
US20090216190A1 (en) * 2002-12-20 2009-08-27 Medrad, Inc. Syringe having a proximal end with an outward extending lip
US20140243746A1 (en) * 2000-02-07 2014-08-28 Bayer Medical Care Inc. Front-Loading Medical Injector Adapted to Releasably Engage A Syringe Regardless of the Orientation of the Syringe With Respect to the Injector
EP3851139A1 (fr) * 2018-09-13 2021-07-21 Circulus Inc. Système d'injection, seringue et joint d'étanchéité

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140243746A1 (en) * 2000-02-07 2014-08-28 Bayer Medical Care Inc. Front-Loading Medical Injector Adapted to Releasably Engage A Syringe Regardless of the Orientation of the Syringe With Respect to the Injector
US20090216190A1 (en) * 2002-12-20 2009-08-27 Medrad, Inc. Syringe having a proximal end with an outward extending lip
WO2008042299A2 (fr) 2006-09-29 2008-04-10 Tyco Healthcare Group Lp Seringue à tige de piston démontable
EP3851139A1 (fr) * 2018-09-13 2021-07-21 Circulus Inc. Système d'injection, seringue et joint d'étanchéité

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