WO2021044055A1 - Device for receiving a container for a parenteral drug injection system and method for preheating injectable fluid - Google Patents

Device for receiving a container for a parenteral drug injection system and method for preheating injectable fluid Download PDF

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Publication number
WO2021044055A1
WO2021044055A1 PCT/EP2020/074936 EP2020074936W WO2021044055A1 WO 2021044055 A1 WO2021044055 A1 WO 2021044055A1 EP 2020074936 W EP2020074936 W EP 2020074936W WO 2021044055 A1 WO2021044055 A1 WO 2021044055A1
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WO
WIPO (PCT)
Prior art keywords
container
anyone
temperature
fluid
heating
Prior art date
Application number
PCT/EP2020/074936
Other languages
French (fr)
Inventor
Martin Vogt
Joachim Weber
Susanne JOERG
Hanns-Christian Mahler
Roman Mathaes
Original Assignee
Lonza Ltd
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 Lonza Ltd filed Critical Lonza Ltd
Publication of WO2021044055A1 publication Critical patent/WO2021044055A1/en

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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
    • A61M5/44—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 having means for cooling or heating the devices or media
    • A61M5/445—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 having means for cooling or heating the devices or media the media being heated in the reservoir, e.g. warming bloodbags
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • 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
    • A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • 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
    • A61M5/008—Racks for supporting syringes or needles

Definitions

  • the present invention relates to a handheld device for receiving a container for a parenteral drug injection system with heating means and to a method for preheating injectable fluid.
  • PDIS parenteral drug injection systems
  • PDIS include a container which is preferably prefilled with the injectable fluid.
  • WO 2019/096913 A1 discloses a mixing and/or reconstitution system.
  • the system comprises a device, for example a cartridge, a syringe or an autoinjector, containing a first material within a first chamber, a housing and a plunger, wherein the plunger comprises a second chamber, containing a second material.
  • the system further comprises a base unit comprising a recess for accommodation of the device, a control unit and an electromagnetic unit which is adapted to produce an electromagnetic field penetrating the recess. The user can activate the base unit for the control unit to operate the electromagnetic unit for moving an element in the second chamber.
  • GB 2 506918 A discloses an injector device, in particular an auto-injector device comprising a housing for receiving a syringe, internal heating means for heating the contents of the syringe prior to injection and operating means for expelling the contents of the syringe.
  • the heating means may be a resistive or dielectric heater and may surround the whole syringe barrel.
  • There may be a docking means to provide power to the heating means, either by means of wires or inductively.
  • EP 3437683 A1 discloses an injection system for micro-catheters and therapeutic suspension medicine temperature maintaining and injection system.
  • the system comprises an injector, a pump control device, a pump head portion, a small diameter syringe and an outer peripheral temperature-maintaining heater unit to be mounted on the outer periphery of the small diameter syringe and the outer peripheral temperature-maintaining heater unit is connected to a heat source output terminal provided on the pump head portion.
  • a PDIS is a syringe.
  • the syringe comprises a barrel with a needle cannula provided at the distal end of the barrel.
  • the syringe further comprises a plunger which is inserted into the proximal end of the barrel.
  • the injectable fluid is provided in the barrel. By advancing the plunger towards the distal end of the barrel, the injectable fluid is forced out of the barrel through the needle cannula, that means is dispensed.
  • the dispensing of the injectable fluid is referred to as injection or dispensing.
  • PDIS is a syringe with a safety system.
  • This PDIS can be a passive or an active safety guard syringe, SGS.
  • the SGS comprises a syringe with a barrel, a plunger and needle cannula.
  • This syringe is provided with a shield and an inner body.
  • the inner body encloses at least part of the barrel of the syringe and is attached to the syringe.
  • the shield has a proximal end with a grip. At the proximal side of the grip latches are provided and extend in proximal direction.
  • a spring is provided inside the shield. The spring can be compressed by the inner body or the syringe.
  • the needle cannula of the SGS is preferably inserted into the skin or tissue of the patient by the patient. Once the pressure on the plunger by the user, who will also be referred to as patient, is released, the syringe is withdrawn into the shield, until the needle cannula is covered by the shield. By withdrawing the syringe, the needle cannula can automatically be pulled out of the tissue of the patient. Alternatively, the needle cannula can also be withdrawn from the tissue by the patient and the covering of the needle cannula by the shield is only effected after the needle cannula has been removed from the tissue.
  • An Al is a PDIS where the injection, that is the dispensing of the fluid is automatically effected, once the plunger is moved by the user or by the force of a spring.
  • An Al is preferably a single use device, that means has to be discarded after use.
  • the dose of the injectable fluid to be injected can be adjusted.
  • a syringe is provided in a casing. Before usage, the needle cannula of the syringe is inside the casing, in particular behind a membrane.
  • a spring based mechanism is provided inside the casing. Once the Al is depressed on the tissue of the patient, the spring based mechanism is activated.
  • the needle is released from its original position and penetrates through the membrane and the skin or tissue of the patient and the fluid which is provided in the barrel of the syringe is injected. After injection, the needle cannula is extracted from the tissue of the patient by the patient.
  • a PDIS is a pen.
  • a pen a cartridge or vial is introduced into a casing.
  • the cartridge can be exchanged.
  • the needle cannula is also preferably exchangeable.
  • the injection can be triggered by the patient by pushing a plunger or by a spring.
  • the dose of the fluid to be injected can be adjusted before the injection is triggered.
  • the pen is preferably reusable. With a pen, the needle cannula of the PDIS is inserted into and extracted from the skin by the patient.
  • the container for the fluid to be injected.
  • the fluid will hereinafter also be referred to as injectable fluid, fluid, pharmaceutical or drug.
  • the container preferably is the barrel of a syringe.
  • the container is preferably a cartridge.
  • the prefilled containers have to be stored in such a manner that the injectable fluid is conserved, the prefilled containers normally have to be cooled. Injecting cold fluid can be uncomfortable or even painful for the patient. In addition, the viscosity of the injectable fluid is lower at low temperatures. This can make the injection of the fluid difficult as it may require stronger force for the injection.
  • the patient thus has to remove the container from the refrigerator prior to injection and wait a certain amount of time.
  • Subject of the invention is a device for receiving a container for a parenteral drug injection system.
  • the device is characterized in that the device is sized to be handheld and in that the device comprises at least a part of heating means for heating the injectable fluid, which is contained in the container.
  • the device for receiving a container for a PDIS can be a part of the PDIS or can be a device separate to the PDIS.
  • the device is sized to be handheld. This means that the dimensions of the device are configured to allow a patient to hold the device or the PDIS which includes the device preferably with one hand.
  • the diameter of the device is thus selected to be small enough for the patient to cover most of the outer surface of the circumference of the device of the PDIS with one hand.
  • the diameter of the device is thus preferably selected to be small enough for the patient to hold it firmly with one hand.
  • the device comprises at least a part of heating means, HM, for heating the injectable fluid, which contained in the container.
  • the HM according to the invention comprise at least one heating element, HE, and at least one energy source for supplying energy to the at least one HE.
  • the HM also comprise at least one contact means for contacting the HE to the energy source.
  • the part of the HM which is comprised by the device is at least the at least one HE.
  • the energy source is part of the device.
  • the at least one HE can be attached to the energy source for example by a cable.
  • the HEs are preferably electrical HEs, for example resistance elements or induction elements.
  • the HE works by chemical means, that is by means of a reaction between to substances that releases heat, and which can be initiated by the user.
  • the heating means can also comprise thermally conductive material.
  • the device comprises a receiving element, RE, for receiving at least a part of the container.
  • the RE can enclose at least part of the length of the circumference of the container.
  • the RE can receive the container such that the outside of the container is in direct contact with the inside of the RE.
  • the RE can receive a part of a shield or casing, wherein the container is held.
  • the RE can also be an integral part of a shield or casing, wherein the container is held.
  • the RE can serve for holding the container.
  • the container can be inserted into the RE.
  • the RE can be positioned around the container.
  • the HEs are preferably provided at the RE or form the RE.
  • the fluid which is prefilled into the container can be heated or tempered.
  • the fluid can be brought to a temperature at which injection of the fluid is desired, for example body temperature.
  • a separate oven is no longer required wherein the container needs to be stored in order for the injectable fluid to be heated to the desired temperature prior to injection.
  • the RE is a hollow element.
  • the space defined by RE at its inside is the receiving space, RS, where at least part of the container can be received.
  • the RE is preferably a hollow cylindrical element.
  • the RS can also have a circular cross section.
  • the diameter of the inner circumference of the RE is larger than or equal to the outer diameter of the container at the section where the container is to be received.
  • the diameter of the inner circumference of the RE is larger than or equal to the outer diameter of the container at the barrel or fluid containing section of a cartridge.
  • the container can be in direct contact with the RE. Alternatively, an air gap can be present between the outside of the container and the inside of the RE.
  • the RE is a stiff tube, in particular a metal tube.
  • the HEs can be attached to or inserted into holes of the RE.
  • the RE is a stiff tube made of solid heat transferring material, e.g. metal such as aluminum or stainless steel or another solid heat transferring material, is advantageous as the RE itself can serve as heating means, as the ferrous metal or non-ferrous metal can be chosen to have a high heat transfer coefficient.
  • the RE can hold the container and the patient can thus merely hold the RE with the container inserted.
  • the RE is a soft pipe or a sleeve.
  • the HEs can be attached to or inserted into the material of the RE.
  • the RE occupies less space, when the device is not used.
  • the sleeve or soft pipe can be folded to be stored.
  • the at least one HE is provided at the RE or forms the RE.
  • the HEs can be inserted into respective holes of the RE or can be attached to the RE.
  • heat can be provided to the container which is at least partially received in the RE from the outside of the container.
  • the HEs cover at least part of the circumference of the RE.
  • the HE can cover at least part of the inner circumference of the RE.
  • the HE can be a mat or a coating applied to the material of the RE or integrated into the material of the RE.
  • the at least one HE is a longitudinal element, in particular a rod.
  • the RE in this embodiment comprises several HEs.
  • the HEs can be distributed over the circumference of the RE and are preferably provided within the material of the RE.
  • holes can be provided in a RE, which is a stiff tube.
  • the holes preferably extend in an axial direction.
  • the rod shaped HEs also preferably extend in an axial direction. Thereby the sleeve or soft pipe can be wrapped around the outside of the container without bending the HE(s).
  • the HE is a metal mesh. This embodiment is in particular advantageous for a RE which is made of flexible or soft material.
  • the HE is a metal wire, which may have the form of a coil.
  • the RS of the RE has a seat at one end, preferably the distal end.
  • This seat can be shaped such that the shoulder of a barrel of a syringe or a shoulder of a cartridge rests on the seat, once the container is inserted into the RS of the RE.
  • the RE has an inner shape that corresponds to the outer shape of a casing or shield of a PDIS.
  • the inner shape of the RE in particular, the inner diameter can for example be equal to or larger than the outer diameter of an Al, a pen or a SGS.
  • the device comprises a housing for enclosing the RE.
  • the housing is preferably made of a thermally insolating material, such as plastic.
  • the comfort of the patient is increased as they do not have to touch or otherwise get in contact with the RE.
  • the RE is made of thermally conductive material this embodiment is advantageous.
  • the part of the HM which is comprised by the device is the energy source.
  • a part of the heating means which is comprised by the device is at least part of the contact means, in particular a contact element.
  • the at least one heating element of the HM can be attached to, inserted into or integrated in the container.
  • a temperature sensor can be attached to, inserted into or integrated in the container.
  • the HE(s) can be brought into contact with the contact element and can for example be inserted into the contact element.
  • both the device and the container have at least a part of the contact means, that is both the device and the container have a contact element and provide of the contact between the HE of the container and the energy source of the device.
  • these two contact elements fit to each other, that is they are complementary, for example in shape and/or in function, in order to provide a safe contact once the container is inserted into the device.
  • the device has a control unit for controlling at least the HM.
  • the control unit is a unit for at least initiating heating of the HEs.
  • the control unit can be a unit for setting the temperature of the HEs and thereby the temperature of the injectable fluid in the container.
  • the control unit can comprise or be connected to means for triggering injection, that means dispensing of the fluid, for example once the desired temperature has been reached.
  • the amount of substances in the HEs may be adjusted so that the desired amount of heat is released by the reaction once the reaction is initiated.
  • the device has an operating button for activating the heating means.
  • the operating button can be connected to the HEs.
  • the operating button can be a switch for providing electrical power to the HEs or for initiating the chemical reaction in the HE.
  • the operating button is connected to the control unit.
  • the device has means for measuring and /or for adjusting the temperature of the heating means.
  • the device preferably has at least one temperature sensor. By providing measuring means the temperature can be determined and can either be displayed or used for further purposes such as adjustment of the temperature.
  • the personal needs of the patient can be considered, i.e. the patient may set the temperature to a level which is comfortable for the patient.
  • the means for measuring and/or adjusting the temperature can be provided to monitor the temperature change during heating by the HEs. In particular, reaching a preset temperature can be monitored by the measuring and/or adjusting means.
  • Means for adjusting the temperature of the heating means may be realized preferably when the heating means are electrical HEs.
  • the temperature sensor is preferably located close to the container; it may also be located in the container and thereby in contact with the injectable fluid.
  • the latter embodiment, where the temperature sensor is in direct contact with the injectable fluid, is preferably realized in case of the PDIS being a SGS, an Al or a pen.
  • the device is integrated into a PDIS or is a PDIS.
  • the device can be provided within the casing or shield of an Al, a pen or a SGS.
  • the HE may be advantageously have the form of a wire or coil which may be wound around the container.
  • the HE can also be an integral part of the container.
  • the HE can be molded into the material of the container. In this case, this HE does not form part of the device but is part of the container.
  • the embodiment, where the HE is separate to the device and in particular part of the container, is preferably an embodiment, where the PDIS is a pen.
  • the container is exchangeable, that means the container can be detached from the PDIS and be replaced.
  • the HE which is part of the container will be brought into contact with a contact element of the device to provide power to the HE from an energy source of the device.
  • both the container and the device comprise at least one HE.
  • the device comprises a triggering unit.
  • the device also comprises a security unit connected to a triggering unit of the device.
  • the triggering unit can be a unit for manually triggering the injection, i.e. dispensing, or a unit for automatically triggering the injection, i.e. dispensing.
  • the triggering unit can comprise a push button for pushing a gliding element, in particular a plunger within the container and to thereby dispense the fluid from the container via a needle cannula.
  • the triggering unit can also comprise a push button.
  • the push button acts on a triggering mechanism which may comprise a spring to push a gliding element, in particular a plunger, within the container to dispense the fluid from the container via a needle cannula.
  • the triggering unit is connected to the security unit.
  • the security unit has means for suppressing the triggering of the injection, i.e. dispensing, if the preset temperature of the fluid has not been reached.
  • the security means can have an interruption element for interrupting an injection, i.e. dispensing, which has been activated by the triggering unit.
  • the interruption element can be a mechanical element, which interacts with the gliding element or triggering mechanism.
  • the interruption element can for example be a stopper, which is movably held in the device perpendicular to the direction of movement of the triggering mechanism or gliding element.
  • the interruption element can be an electronic component, which defers transmission of a triggering signal until the predetermined temperature of the fluid has been reached.
  • the device may comprise a display.
  • the display may for example visualize the actual and/or the target temperature within the container or close to the container, it may for example visualize the time between triggering the heating means and reaching the desired temperature, it may for example visualize warning signals for example in case the desired temperature has not been reached.
  • the device may comprise a loud speaker.
  • the loud speaker may by an acoustical signal for example notify the start of the heating and/or the reaching of the target temperature within the container or close to the container, it may for example give acoustical warning signals, for example in case the desired temperature has not been reached.
  • the device has a power unit.
  • the power unit can be a battery.
  • the battery can be a rechargeable battery.
  • the power unit is preferably the energy source for the at least one heating element.
  • the power unit also provides power to other units of the device, such as a triggering unit, a control unit, a security unit, a display or a loud speaker.
  • a device comprising a container, the device being a parenteral drug injection system, with the device and the container as described herein, also with all their embodiments.
  • a further subject of the invention is a method for preheating injectable fluid of a PDIS, characterized in that the method is carried out with a device according to the invention.
  • the method comprises the step of: a) activating heating means.
  • the method further comprises the step of b) inserting a container with prefilled fluid or a PDIS into the RE.
  • the method comprises the step of: c) monitoring the temperature of the fluid. In one embodiment, the method comprises the steps of: c) monitoring the temperature of the fluid; and d) outputting a signal, when the selected temperature is reached.
  • the method comprises the step of: e) interrupting triggering of injection, i.e. dispensing, until the selected temperature is reached.
  • a further subject of the invention is a method for assembling a device comprising a container, the device being a parenteral drug injection system, characterized in that the container is inserted into the device, with the device and the container as described herein, also with all their embodiments.
  • Figure 1 shows a perspective view of a first embodiment of the device according to the invention
  • Figure 2 shows a perspective bottom view of the first embodiment of the device
  • Figure 3 shows a perspective top view of the first embodiment of the device
  • Figure 4 shows another perspective top view of the first embodiment of the device
  • Figure 5 shows a perspective side view of the first embodiment of the device
  • Figure 6 shows a schematic sectional side view of the first embodiment of the device
  • Figure 7 shows a schematic sectional side view of a second embodiment of the device
  • Figure 8 shows a schematic view of the inside of a third embodiment of the device
  • Figure 9 shows a schematic view of the inside of a fourth embodiment of the device
  • Figure 10 shows a schematic block diagram of a fifth embodiment of the device
  • Figure 11 shows a schematic sectional view of a syringe
  • Figure 12 shows a schematic side view of a sixth embodiment of the device
  • Figure 13 shows a schematic sectional view of a seventh embodiment of the device
  • Figure 14 shows a schematic perspective view of an auto injector
  • Figure 15 shows a schematic sectional view of an eighth embodiment of the device.
  • FIGS 1 to 6 show different views of a first embodiment of the device 2 according to the invention.
  • the device 2 has a RE 20.
  • the RE 20 is a hollow cylindrical element made of metal.
  • the RE 20 has a RS 200 formed by a hole extending from the proximal end of the RE 20.
  • a seat 2001 is formed at the distal end of the RS 200.
  • the seat 2001 has a diameter which is smaller than the diameter of the RS 200 in the proximal section.
  • the seat has a curved surface at the transitional section between the larger diameter and the smaller diameter.
  • the curve has a convex curvature.
  • three insertion holes 211 are provided in the wall of the RE 20.
  • the insertion holes 211 each extend from the proximal end of the RE 20 and terminate in a distance to the distal end of the RE 20.
  • a HE 210 is inserted into one of the insertion holes 211 .
  • a temperature sensor element 212 is inserted into a second insertion hole .
  • the third insertion hole in Figure 3 is empty.
  • the HE 210 in this embodiment has a longitudinal shape and in particular is a rod.
  • the device 2 is separate to the PDIS 1.
  • the PDIS 1 in this embodiment is a syringe 10.
  • the container 3 of the PDIS 1 is therefore the barrel 30 of the syringe 10.
  • the syringe 10 comprises a barrel 30.
  • the barrel 30 has a flange 101 at the back end, which is also referred to as the proximal end.
  • the barrel 30 has a shoulder 31, where the diameter of the barrel 30 reduces.
  • the lumen of the barrel 30 extends between the proximal end and distal end.
  • a dispensing opening is provided at the distal end of the barrel 30 .
  • the dispensing opening is provided by a needle cannula 32.
  • the barrel 30 is filled with an injectable fluid (not shown).
  • the needle cannula 32 is covered by a needle shield 102.
  • a plunger 100 is inserted into the proximal end of the barrel 30.
  • the injectable fluid can be dispensed from the needle cannula 32.
  • the injectable fluid With the needle cannula 32 inserted into the tissue of the patient, the injectable fluid thereby can be injected into the patient’s body.
  • distal denotes the direction from the back end of the syringe to the front end of the syringe with the dispensing opening
  • proximal denotes the opposite direction
  • the syringe 10 is inserted into the RE 20.
  • the barrel 30 of the syringe 10 is inserted into the RS 200 of the device 2.
  • At least the needle cannula 32 extends over the distal end of the RE 20.
  • the inner diameter of the RS 200 is equal to or larger than the outer diameter of the barrel 30.
  • the inner diameter of the RS 200 is smaller than the outer diameter of the flange 101 of the barrel 30.
  • the syringe 10 can be held in the RE 20, when the plunger 100 of the syringe 10 is pushed towards the distal end of the barrel 30.
  • the shoulder 31 rests on the seat 2001.
  • the length of the RE 20 can be shorter than the length of the barrel 30.
  • the device 2 comprises a power unit 23, which can be a battery or rechargeable battery.
  • the HEs 210 can be connected to the power unit 23 by wires, a shown in Figure 3.
  • the HEs 210 can be activated, i.e. switched on, by pressing an operating button 22 (see Figure 6).
  • the operating button 22 is preferably arranged on the outside of the device 2, so that it can be operated by the patient with one hand.
  • the RE 20 is covered at the outside and distal end with a cover 202.
  • the cover surrounds the RE 20 at its outer circumference and the distal end.
  • the distal end has an opening extending to the RS 200 of the RE 20.
  • the proximal end of the cover 202 is preferably covered by a lid 203.
  • the lid 203 can be screwed onto the cover 202.
  • the lid 203 covers the insertion holes 211 and any cable that may be provided for supplying electrical power to the HEs 210 inserted into the insertion holes 211.
  • the patient can insert a cooled, prefilled syringe 10 into the device 2.
  • the barrel 30 of the syringe 10 is inserted into the RS 200 of the RE 20.
  • the outer circumference of the barrel 30 is preferably in contact with the inner circumference of the RS 200.
  • a second embodiment of the device 2 is shown. Also in the second embodiment the device 2 is a separate component to the PDIS 1.
  • the PDIS1 in Figure 7 is a syringe 10 and the prefilled container 3 is the barrel 30 of the syringe.
  • the RE 20 of the device 2 is a thin walled hollow cylindrical element, in particular a soft pipe or sleeve.
  • the HEs 210 is a coating at the inside of the RE 20.
  • the RE 20 can be made of plastic.
  • the coating which forms the HE 210 can be made of ferrous metal or non- ferrous metal.
  • the coating can be supplied with power for a power unit 23. For example, the coating can be heated by resistance of the coating.
  • the inner diameter of the RE 20 equals to or is slightly larger than the outer diameter of the barrel 30 of the syringe 10.
  • the syringe 10 can be inserted into the RE 20 of the device 2 or the RE 20 can be slid onto or wrapped around the barrel 30 of the syringe 1.
  • the length of the RE 20 corresponds to the length of the barrel 30 between the flange 101 and the shoulder 31.
  • the working of the device 2 of the second embodiment corresponds to the working of the device 2 of the first embodiment.
  • a third and fourth embodiment of the device 2 are shown.
  • the two embodiments only differ by the shape of the HE 210.
  • the RE 20 is a sleeve made of a soft plastic, which has the shape of a mat.
  • fastening elements 201 are provided at one side edge of the mat.
  • the fastening elements 201 are tabs or flaps, which can be made for example of Velcro.
  • a plurality of HEs 210 is provided and the HEs 210 are parallel to each other.
  • a power unit 23 is provided in the mat and an operating button 22 is provided on the outside of the RE 20, i.e. in Figure 8 and 9 the side facing away.
  • the HEs 210 are longitudinal elements which extend over most of the length of the RE 20, i.e. the mat.
  • the HEs 210 can be integrated into the material of the RE 20 by molding.
  • the HEs 210 can be at the inner side of the RE 20, i.e. the side visible in Figure 8.
  • the HE 210 is an areal element such as a mesh.
  • the HE 210 extends over most of the width and most of the length of the mat.
  • the third and fourth embodiment can be used by placing the container (not shown) on the mat, wrapping the RE 20 around the container and closing the RE 20 by means of the fastening elements 201. Thereby the RS 200 is formed and the RE 20 is tightly wrapped around the container.
  • the working of the device 2 of the third and fourth embodiment corresponds to the working of the first embodiment.
  • the device comprises a RE (not shown), an operating button 22, a power unit 23, a control unit 24, a temperature sensor 25, a triggering unit 26, a security unit 27 and at least one HE 210.
  • the operating button 22 can serve for activating the control unit 24, which may be a micro computer.
  • the control unit 24 can serve for activating the at least one HE 210.
  • the control unit 24 can serve for activating the triggering unit 26.
  • the triggering unit 26 may comprise a spring mechanism or other forcing element for forcing a plunger within the container 30 to dispense the injectable fluid.
  • the activation of the HE 210 and of the triggering unit 26 can be made in a time delayed fashion.
  • control unit 24 can first activate the HE 210 and subsequently after a predetermined period of time can activate the triggering unit 26.
  • the temperature sensor 25 is preferably provided at the RE 20 close to the RS 200 formed therein. The temperature sensor 25 serves for monitoring the temperature of the container 3, thereby, the control unit 24 or a separate unit can determine the temperature of the fluid within the container 3.
  • a temperature which the fluid should reach is preset by the patient or user, this temperature can be preset in the control unit 24. Once this temperature is reached by the fluid, a signal can be output by the device 2 via an output unit (not shown).
  • the signal can be an optical or acoustical signal.
  • the activation of the HE 210 and of the triggering unit 26 can also be controlled by temperature, for example the control unit 24 can first activate the HE 210 and monitor the temperature change induced by the HE 210, and after reaching a preset temperature can activate the triggering unit 26.
  • the operating button 22 can be directly connected to the HE 210 and a separate operating button (not shown) can be provided to activate the triggering unit 26.
  • the control unit 24 in this embodiment can be activated by either of the operating buttons 22. Once the signal has been output the patient or user can activate the triggering unit 26.
  • the reaching of a preset temperature of the fluid can be monitored by the security unit 27. If the temperature of the fluid is below the preset temperature, the security unit 27 can block the activation of the triggering unit 26 in the central unit. Alternatively, the security unit 27 can block the triggering unit 26 itself, for example, by a mechanical stopper, until the preset temperature has been reached.
  • FIG 12 a sixth embodiment of the device 2 is shown.
  • device is integrated into a PDIS 1 , which is an Al 11.
  • the Al 11 has a tubular casing 111.
  • an operating button 22 is provided at the proximal end of the casing 111 .
  • a movable cap 110 is provided at the distal end of the casing 111 .
  • a window 112 is provided in the side wall of the casing 111 .
  • the window 112 is formed in a protrusion extending from the outer circumference of the casing 111.
  • the RE 20 of the device 20 is part of the casing 111.
  • the HEs 210 are provided within the casing 111 and extend in a longitudinal direction parallel to the container 3, which is held in the casing 111.
  • the HEs 210 can be activated by the control button 22.
  • an additional control button at the side of the casing can be provided for activating the HEs 210.
  • a seventh embodiment of the device 2 is shown.
  • the device 2 is separate to a PDIS 1.
  • the seventh embodiment is designed to be used with an Al 11.
  • the device 2 has a design similar to the first embodiment of the device 2. The difference being, that the RS 200 does not have a circular cross section.
  • the RS 200 has a lateral recess 2000 on the otherwise circular cross section.
  • the lateral recess 2000 can serve for receiving the protrusion of a casing of an Al, for example a protrusion where a window is provided.
  • the RS 200 thus not only receives the container 3 of the PDIS 1 but the casing of the PDIS 1 , wherein the container 3 is held, is inserted into the RS 200.
  • FIG 15 shows an eighths embodiment of the device 2.
  • This embodiment differs from the seventh embodiment by the cross section of the RS 200 of the RE 20.
  • the RS 200 has a circular cross section with two lateral recesses 2000.
  • This embodiment can serve for receiving a SGS 12.
  • a SGS 12 is shown in Figure 14.
  • the SGS 12 has a container 3, which is the barrel of a syringe.
  • a plunger 100 is provided within the container 3 and extends over the proximal end thereof.
  • a needle cannula is provided at the distal end of the container 3 .
  • the needle cannula is covered in Figure 14 by a needle shield 102.
  • the SGS 12 comprises a shield 120, which has two poles extending parallel at opposite sides of the container 3 parallel to the container 3.
  • a spring 260 is provided inside the shield 120 at the distal end of the shield 120.
  • a grip 122 is provided at the proximal end of the shield 120.
  • This SGS 12 can be inserted into the RE 20 of the eighth embodiment of the device 2.
  • the poles of the shield 120 can be received in the lateral recesses 2000 of the RS 200.
  • heating elements (not shown) inserted into the insertion holes 211 in the RE 20, the fluid in the container 3 of the SGS 12 can be tempered to the desired temperature.
  • the device can also be integrated into an SGS 12.
  • the heating elements of the device can be provided for example in the gap 121 (see Figure 14) between the outside of the container and the pole of the shield.
  • the PDIS is a pen.
  • the container is preferably a cartridge.
  • the container comprises a HE.
  • the HE can be integrated into the material of the wall of the container.
  • One embodiment of the HE is a coiled wire.
  • the coiled wire can be integrated into the material of the wall of the container.
  • the ends of the HE will come in contact with the contact element of the device when the container, preferably the cartridge, is inserted into the device, preferably the pen.
  • the HE is connected to the energy source of the device
  • one end of the coiled wire can be provided in form of a contact element of the container.
  • the contact element of the container When the container is inserted into the pen, the contact element of the container will come in contact with the contact element of the device and the HE will thereby be connected to the energy source of the device.
  • the other components of the device which have been described with respect to figure 10 can be provided at the device and can have the respective functions.

Abstract

The present invention relates to a handheld device for receiving a container for a parenteral drug injection system with heating means and to a method for preheating injectable fluid.

Description

Device for Receiving a Container for a Parenteral Drug Injection System and Method for
Preheating Injectable Fluid
FIELD OF THE INVENTION
The present invention relates to a handheld device for receiving a container for a parenteral drug injection system with heating means and to a method for preheating injectable fluid.
TECHNOLOGICAL BACKGROUND
For administration of pharmaceuticals, the use of parenteral drug injection systems, PDIS, are known. PDIS include a container which is preferably prefilled with the injectable fluid.
WO 2019/096913 A1 discloses a mixing and/or reconstitution system. The system comprises a device, for example a cartridge, a syringe or an autoinjector, containing a first material within a first chamber, a housing and a plunger, wherein the plunger comprises a second chamber, containing a second material. The system further comprises a base unit comprising a recess for accommodation of the device, a control unit and an electromagnetic unit which is adapted to produce an electromagnetic field penetrating the recess. The user can activate the base unit for the control unit to operate the electromagnetic unit for moving an element in the second chamber.
GB 2 506918 A discloses an injector device, in particular an auto-injector device comprising a housing for receiving a syringe, internal heating means for heating the contents of the syringe prior to injection and operating means for expelling the contents of the syringe. The heating means may be a resistive or dielectric heater and may surround the whole syringe barrel. There may be a docking means to provide power to the heating means, either by means of wires or inductively.
EP 3437683 A1 discloses an injection system for micro-catheters and therapeutic suspension medicine temperature maintaining and injection system. The system comprises an injector, a pump control device, a pump head portion, a small diameter syringe and an outer peripheral temperature-maintaining heater unit to be mounted on the outer periphery of the small diameter syringe and the outer peripheral temperature-maintaining heater unit is connected to a heat source output terminal provided on the pump head portion.
D4 (US 2006/271014 A1) discloses a heat retention device for a syringe.
One example of a PDIS is a syringe. The syringe comprises a barrel with a needle cannula provided at the distal end of the barrel. The syringe further comprises a plunger which is inserted into the proximal end of the barrel. The injectable fluid is provided in the barrel. By advancing the plunger towards the distal end of the barrel, the injectable fluid is forced out of the barrel through the needle cannula, that means is dispensed. Hereinafter the dispensing of the injectable fluid is referred to as injection or dispensing.
Another example of a PDIS is a syringe with a safety system. This PDIS can be a passive or an active safety guard syringe, SGS. The SGS comprises a syringe with a barrel, a plunger and needle cannula. This syringe is provided with a shield and an inner body. The inner body encloses at least part of the barrel of the syringe and is attached to the syringe. The shield has a proximal end with a grip. At the proximal side of the grip latches are provided and extend in proximal direction. At the distal end of the shield a spring is provided inside the shield. The spring can be compressed by the inner body or the syringe. The needle cannula of the SGS is preferably inserted into the skin or tissue of the patient by the patient. Once the pressure on the plunger by the user, who will also be referred to as patient, is released, the syringe is withdrawn into the shield, until the needle cannula is covered by the shield. By withdrawing the syringe, the needle cannula can automatically be pulled out of the tissue of the patient. Alternatively, the needle cannula can also be withdrawn from the tissue by the patient and the covering of the needle cannula by the shield is only effected after the needle cannula has been removed from the tissue.
Another example of a PDIS is an auto injector, Al. An Al is a PDIS where the injection, that is the dispensing of the fluid is automatically effected, once the plunger is moved by the user or by the force of a spring. An Al is preferably a single use device, that means has to be discarded after use. In some embodiments, the dose of the injectable fluid to be injected can be adjusted. In an Al, a syringe is provided in a casing. Before usage, the needle cannula of the syringe is inside the casing, in particular behind a membrane. A spring based mechanism is provided inside the casing. Once the Al is depressed on the tissue of the patient, the spring based mechanism is activated. Thereby the needle is released from its original position and penetrates through the membrane and the skin or tissue of the patient and the fluid which is provided in the barrel of the syringe is injected. After injection, the needle cannula is extracted from the tissue of the patient by the patient.
Another example of a PDIS is a pen. In a pen a cartridge or vial is introduced into a casing. The cartridge can be exchanged. The needle cannula is also preferably exchangeable. The injection can be triggered by the patient by pushing a plunger or by a spring. The dose of the fluid to be injected can be adjusted before the injection is triggered. The pen is preferably reusable. With a pen, the needle cannula of the PDIS is inserted into and extracted from the skin by the patient.
All of these PDIS have a container for the fluid to be injected. The fluid will hereinafter also be referred to as injectable fluid, fluid, pharmaceutical or drug. In case of a syringe, a SGS and an Al, the container preferably is the barrel of a syringe. In case of a pen, the container is preferably a cartridge.
As the prefilled containers have to be stored in such a manner that the injectable fluid is conserved, the prefilled containers normally have to be cooled. Injecting cold fluid can be uncomfortable or even painful for the patient. In addition, the viscosity of the injectable fluid is lower at low temperatures. This can make the injection of the fluid difficult as it may require stronger force for the injection.
The patient thus has to remove the container from the refrigerator prior to injection and wait a certain amount of time.
It may also be desirable to be able to inject the injectable fluid with a temperature above ambient temperature.
Therefore, there was a need for a solution to allow an instant and secure usage of a PDIS.
Surprisingly, the problem was solved by providing a device which allows the patient to adjust the temperature of the injectable fluid before injection, that means before dispensing from the device. ABBREVIATIONS
PDIS parenteral drug injection system
SGS safety guard syringe Al auto injector
RE receiving element RS receiving space HE heating element HM heating means
SUMMARY OF THE INVENTION
Subject of the invention is a device for receiving a container for a parenteral drug injection system. The device is characterized in that the device is sized to be handheld and in that the device comprises at least a part of heating means for heating the injectable fluid, which is contained in the container.
DETAILED DESCRIPTION OF THE INVENTION
The device for receiving a container for a PDIS can be a part of the PDIS or can be a device separate to the PDIS. The device is sized to be handheld. This means that the dimensions of the device are configured to allow a patient to hold the device or the PDIS which includes the device preferably with one hand. Especially, the diameter of the device is thus selected to be small enough for the patient to cover most of the outer surface of the circumference of the device of the PDIS with one hand. The diameter of the device is thus preferably selected to be small enough for the patient to hold it firmly with one hand. The device comprises at least a part of heating means, HM, for heating the injectable fluid, which contained in the container. The HM according to the invention comprise at least one heating element, HE, and at least one energy source for supplying energy to the at least one HE. According to one embodiment, the HM also comprise at least one contact means for contacting the HE to the energy source. By providing at least part of the HM at the device, the fluid in the prefilled container can be heated, when the prefilled container is in contact with the device.
According to one embodiment, the part of the HM which is comprised by the device is at least the at least one HE. In this embodiment also the energy source is part of the device. The at least one HE can be attached to the energy source for example by a cable.
The HEs are preferably electrical HEs, for example resistance elements or induction elements. In another embodiment, the HE works by chemical means, that is by means of a reaction between to substances that releases heat, and which can be initiated by the user. The heating means can also comprise thermally conductive material.
According to one embodiment, the device comprises a receiving element, RE, for receiving at least a part of the container. In particular, the RE can enclose at least part of the length of the circumference of the container. The RE can receive the container such that the outside of the container is in direct contact with the inside of the RE. Alternatively, the RE can receive a part of a shield or casing, wherein the container is held. The RE can also be an integral part of a shield or casing, wherein the container is held. The RE can serve for holding the container. According to one embodiment, the container can be inserted into the RE. Alternatively, the RE can be positioned around the container.
According to one embodiment, the HEs are preferably provided at the RE or form the RE. By providing HEs in the device for receiving the container, the fluid which is prefilled into the container, can be heated or tempered. Thereby, the fluid can be brought to a temperature at which injection of the fluid is desired, for example body temperature. By providing HEs the time between taking the container from a refrigerator and injection can be minimized. Furthermore a separate oven is no longer required wherein the container needs to be stored in order for the injectable fluid to be heated to the desired temperature prior to injection.
According to one embodiment, the RE is a hollow element. The space defined by RE at its inside is the receiving space, RS, where at least part of the container can be received. The RE is preferably a hollow cylindrical element. As a container of the PDIS preferably has a circular cross section, the RS can also have a circular cross section. The diameter of the inner circumference of the RE is larger than or equal to the outer diameter of the container at the section where the container is to be received. In particular, the diameter of the inner circumference of the RE is larger than or equal to the outer diameter of the container at the barrel or fluid containing section of a cartridge. The container can be in direct contact with the RE. Alternatively, an air gap can be present between the outside of the container and the inside of the RE.
According to one embodiment, the RE is a stiff tube, in particular a metal tube. The HEs can be attached to or inserted into holes of the RE. This embodiment, where the RE is a stiff tube made of solid heat transferring material, e.g. metal such as aluminum or stainless steel or another solid heat transferring material, is advantageous as the RE itself can serve as heating means, as the ferrous metal or non-ferrous metal can be chosen to have a high heat transfer coefficient. In addition, the RE can hold the container and the patient can thus merely hold the RE with the container inserted.
According to one embodiment, the RE is a soft pipe or a sleeve. The HEs can be attached to or inserted into the material of the RE. By providing an RE, which is made of soft material, e.g. plastic, the RE occupies less space, when the device is not used. In particular, the sleeve or soft pipe can be folded to be stored.
According to a preferred embodiment, the at least one HE is provided at the RE or forms the RE. The HEs can be inserted into respective holes of the RE or can be attached to the RE. By providing the HEs at the RE, heat can be provided to the container which is at least partially received in the RE from the outside of the container.
According to one embodiment, the HEs cover at least part of the circumference of the RE. In particular, the HE can cover at least part of the inner circumference of the RE. In this embodiment, the HE can be a mat or a coating applied to the material of the RE or integrated into the material of the RE.
According to a preferred embodiment, the at least one HE is a longitudinal element, in particular a rod. Preferably, the RE in this embodiment comprises several HEs. The HEs can be distributed over the circumference of the RE and are preferably provided within the material of the RE. In this embodiment, holes can be provided in a RE, which is a stiff tube. The holes preferably extend in an axial direction. In case of a soft pipe or sleeve, the rod shaped HEs also preferably extend in an axial direction. Thereby the sleeve or soft pipe can be wrapped around the outside of the container without bending the HE(s).
According to one embodiment, the HE is a metal mesh. This embodiment is in particular advantageous for a RE which is made of flexible or soft material.
According to one embodiment, the HE is a metal wire, which may have the form of a coil.
According to one embodiment, the RS of the RE has a seat at one end, preferably the distal end. This seat can be shaped such that the shoulder of a barrel of a syringe or a shoulder of a cartridge rests on the seat, once the container is inserted into the RS of the RE.
According to one embodiment, the RE has an inner shape that corresponds to the outer shape of a casing or shield of a PDIS. In this case the inner shape of the RE, in particular, the inner diameter can for example be equal to or larger than the outer diameter of an Al, a pen or a SGS.
According to one embodiment, the device comprises a housing for enclosing the RE. The housing is preferably made of a thermally insolating material, such as plastic. In this case, the comfort of the patient is increased as they do not have to touch or otherwise get in contact with the RE. Especially in the embodiment, where the RE is made of thermally conductive material this embodiment is advantageous.
According to the invention, the part of the HM which is comprised by the device is the energy source. According to one embodiment, a part of the heating means which is comprised by the device is at least part of the contact means, in particular a contact element. In this embodiment, the at least one heating element of the HM can be attached to, inserted into or integrated in the container. Also a temperature sensor can be attached to, inserted into or integrated in the container. The HE(s) can be brought into contact with the contact element and can for example be inserted into the contact element.
In one embodiment, both the device and the container have at least a part of the contact means, that is both the device and the container have a contact element and provide of the contact between the HE of the container and the energy source of the device. In one embodiment these two contact elements fit to each other, that is they are complementary, for example in shape and/or in function, in order to provide a safe contact once the container is inserted into the device. According to one embodiment, the device has a control unit for controlling at least the HM.
The control unit is a unit for at least initiating heating of the HEs. In addition, the control unit can be a unit for setting the temperature of the HEs and thereby the temperature of the injectable fluid in the container. Furthermore, the control unit can comprise or be connected to means for triggering injection, that means dispensing of the fluid, for example once the desired temperature has been reached. In case that the HE works by chemical means, then the amount of substances in the HEs may be adjusted so that the desired amount of heat is released by the reaction once the reaction is initiated.
According to one embodiment, the device has an operating button for activating the heating means. The operating button can be connected to the HEs. The operating button can be a switch for providing electrical power to the HEs or for initiating the chemical reaction in the HE. Preferably, the operating button is connected to the control unit. By providing an operating button at the device, the patient can start and may even stop the heating of the fluid.
According to one embodiment, the device has means for measuring and /or for adjusting the temperature of the heating means. In this embodiment, the device preferably has at least one temperature sensor. By providing measuring means the temperature can be determined and can either be displayed or used for further purposes such as adjustment of the temperature.
By providing adjusting means the personal needs of the patient can be considered, i.e. the patient may set the temperature to a level which is comfortable for the patient. Additionally, the means for measuring and/or adjusting the temperature can be provided to monitor the temperature change during heating by the HEs. In particular, reaching a preset temperature can be monitored by the measuring and/or adjusting means. Means for adjusting the temperature of the heating means may be realized preferably when the heating means are electrical HEs.
The temperature sensor is preferably located close to the container; it may also be located in the container and thereby in contact with the injectable fluid. The latter embodiment, where the temperature sensor is in direct contact with the injectable fluid, is preferably realized in case of the PDIS being a SGS, an Al or a pen.
According to the invention, the device is integrated into a PDIS or is a PDIS. In particular, the device can be provided within the casing or shield of an Al, a pen or a SGS. In this case the HE may be advantageously have the form of a wire or coil which may be wound around the container. The HE can also be an integral part of the container. In particular, the HE can be molded into the material of the container. In this case, this HE does not form part of the device but is part of the container.
The embodiment, where the HE is separate to the device and in particular part of the container, is preferably an embodiment, where the PDIS is a pen. In this case the container is exchangeable, that means the container can be detached from the PDIS and be replaced. In this case, the HE which is part of the container will be brought into contact with a contact element of the device to provide power to the HE from an energy source of the device.
In one embodiment, both the container and the device comprise at least one HE.
According to one embodiment, the device comprises a triggering unit. Preferably, the device also comprises a security unit connected to a triggering unit of the device.
In this embodiment, the triggering unit can be a unit for manually triggering the injection, i.e. dispensing, or a unit for automatically triggering the injection, i.e. dispensing. In case of a unit for manually triggering the injection, the triggering unit can comprise a push button for pushing a gliding element, in particular a plunger within the container and to thereby dispense the fluid from the container via a needle cannula. In case of automatic triggering, the triggering unit can also comprise a push button. In that case, the push button acts on a triggering mechanism which may comprise a spring to push a gliding element, in particular a plunger, within the container to dispense the fluid from the container via a needle cannula.
According to one embodiment, the triggering unit is connected to the security unit. The security unit has means for suppressing the triggering of the injection, i.e. dispensing, if the preset temperature of the fluid has not been reached. The security means can have an interruption element for interrupting an injection, i.e. dispensing, which has been activated by the triggering unit. The interruption element can be a mechanical element, which interacts with the gliding element or triggering mechanism. The interruption element can for example be a stopper, which is movably held in the device perpendicular to the direction of movement of the triggering mechanism or gliding element. According to one embodiment, the interruption element can be an electronic component, which defers transmission of a triggering signal until the predetermined temperature of the fluid has been reached.
The device may comprise a display. The display may for example visualize the actual and/or the target temperature within the container or close to the container, it may for example visualize the time between triggering the heating means and reaching the desired temperature, it may for example visualize warning signals for example in case the desired temperature has not been reached.
The device may comprise a loud speaker. The loud speaker may by an acoustical signal for example notify the start of the heating and/or the reaching of the target temperature within the container or close to the container, it may for example give acoustical warning signals, for example in case the desired temperature has not been reached.
According to a preferred embodiment, the device has a power unit. The power unit can be a battery. The battery can be a rechargeable battery. The power unit is preferably the energy source for the at least one heating element. By providing a power unit in the device, the patient can use the PDIS even if no power supply is available. Preferably, the power unit also provides power to other units of the device, such as a triggering unit, a control unit, a security unit, a display or a loud speaker.
Further subject of the invention is a device comprising a container, the device being a parenteral drug injection system, with the device and the container as described herein, also with all their embodiments.
A further subject of the invention is a method for preheating injectable fluid of a PDIS, characterized in that the method is carried out with a device according to the invention.
Features and advantages which have been described for the device - as far as applicable - also relate to the method and vice versa and will therefore only be described once.
In one embodiment, the method comprises the step of: a) activating heating means.
In one embodiment, the method further comprises the step of b) inserting a container with prefilled fluid or a PDIS into the RE.
In one embodiment, the method comprises the step of: c) monitoring the temperature of the fluid. In one embodiment, the method comprises the steps of: c) monitoring the temperature of the fluid; and d) outputting a signal, when the selected temperature is reached.
In one embodiment, the method comprises the step of: e) interrupting triggering of injection, i.e. dispensing, until the selected temperature is reached.
A further subject of the invention is a method for assembling a device comprising a container, the device being a parenteral drug injection system, characterized in that the container is inserted into the device, with the device and the container as described herein, also with all their embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be described again with reference to the enclosed drawings, wherein:
Figure 1 : shows a perspective view of a first embodiment of the device according to the invention; Figure 2: shows a perspective bottom view of the first embodiment of the device;
Figure 3: shows a perspective top view of the first embodiment of the device;
Figure 4: shows another perspective top view of the first embodiment of the device;
Figure 5: shows a perspective side view of the first embodiment of the device;
Figure 6: shows a schematic sectional side view of the first embodiment of the device; Figure 7: shows a schematic sectional side view of a second embodiment of the device;
Figure 8: shows a schematic view of the inside of a third embodiment of the device; Figure 9: shows a schematic view of the inside of a fourth embodiment of the device; Figure 10: shows a schematic block diagram of a fifth embodiment of the device; Figure 11: shows a schematic sectional view of a syringe; Figure 12: shows a schematic side view of a sixth embodiment of the device; Figure 13: shows a schematic sectional view of a seventh embodiment of the device; Figure 14: shows a schematic perspective view of an auto injector; and
Figure 15: shows a schematic sectional view of an eighth embodiment of the device.
DETAILLED DESCRIPTION OF PREFERRED EMBODIMENTS
The present invention will now be described in more detail with reference to the enclosed figures. Same components and arrangements are denoted in the figures by the same reference numerals and the respective description may be omitted in order to avoid redundancies.
Figures 1 to 6 show different views of a first embodiment of the device 2 according to the invention. The device 2 has a RE 20. In the depicted embodiment the RE 20 is a hollow cylindrical element made of metal. The RE 20 has a RS 200 formed by a hole extending from the proximal end of the RE 20. In the RS 200 a seat 2001 is formed at the distal end of the RS 200. The seat 2001 has a diameter which is smaller than the diameter of the RS 200 in the proximal section. In the depicted embodiment, the seat has a curved surface at the transitional section between the larger diameter and the smaller diameter. The curve has a convex curvature. In the wall of the RE 20 three insertion holes 211 are provided. The insertion holes 211 each extend from the proximal end of the RE 20 and terminate in a distance to the distal end of the RE 20. Into one of the insertion holes 211 a HE 210 is inserted. Into a second insertion hole a temperature sensor element 212 is inserted. The third insertion hole in Figure 3 is empty. The HE 210 in this embodiment has a longitudinal shape and in particular is a rod. In the first embodiment the device 2 is separate to the PDIS 1. The PDIS 1 in this embodiment is a syringe 10. The container 3 of the PDIS 1 is therefore the barrel 30 of the syringe 10.
One embodiment of a PDIS 1 which is a syringe 10 is shown in Figure 11. As can be derived from Figure 11, the syringe 10 comprises a barrel 30. The barrel 30 has a flange 101 at the back end, which is also referred to as the proximal end. At the front end, which is also referred to as the distal end, the barrel 30 has a shoulder 31, where the diameter of the barrel 30 reduces. The lumen of the barrel 30 extends between the proximal end and distal end. At the distal end of the barrel 30 a dispensing opening is provided. In the type of PDIS 1 shown in Figure 11 the dispensing opening is provided by a needle cannula 32. In the prefilled state of the syringe 10, the barrel 30 is filled with an injectable fluid (not shown). Before use and in particular before injection of the injectable fluid, the needle cannula 32 is covered by a needle shield 102. A plunger 100 is inserted into the proximal end of the barrel 30. By advancing the plunger 100 in the barrel 30 in the distal direction, the injectable fluid can be dispensed from the needle cannula 32. With the needle cannula 32 inserted into the tissue of the patient, the injectable fluid thereby can be injected into the patient’s body.
If not defined differently, the term distal denotes the direction from the back end of the syringe to the front end of the syringe with the dispensing opening, and the term proximal denotes the opposite direction.
In the first embodiment of the device 2, the syringe 10 is inserted into the RE 20. In particular, the barrel 30 of the syringe 10 is inserted into the RS 200 of the device 2. At least the needle cannula 32 extends over the distal end of the RE 20. The inner diameter of the RS 200 is equal to or larger than the outer diameter of the barrel 30. Preferably, the inner diameter of the RS 200 is smaller than the outer diameter of the flange 101 of the barrel 30. Thereby, the syringe 10 can be held in the RE 20, when the plunger 100 of the syringe 10 is pushed towards the distal end of the barrel 30. In the embodiment shown in Figures 1 to 6, the shoulder 31 rests on the seat 2001. In this embodiment, the length of the RE 20 can be shorter than the length of the barrel 30.
As can be derived from Figure 6, the device 2 comprises a power unit 23, which can be a battery or rechargeable battery. The HEs 210 can be connected to the power unit 23 by wires, a shown in Figure 3. The HEs 210 can be activated, i.e. switched on, by pressing an operating button 22 (see Figure 6). The operating button 22 is preferably arranged on the outside of the device 2, so that it can be operated by the patient with one hand. In the first embodiment, the RE 20 is covered at the outside and distal end with a cover 202.
In particular, the cover surrounds the RE 20 at its outer circumference and the distal end. The distal end has an opening extending to the RS 200 of the RE 20. As can be derived from Figure 6, the proximal end of the cover 202 is preferably covered by a lid 203. The lid 203 can be screwed onto the cover 202. In particular, the lid 203 covers the insertion holes 211 and any cable that may be provided for supplying electrical power to the HEs 210 inserted into the insertion holes 211.
For operation of the first embodiment of the device 2, the patient can insert a cooled, prefilled syringe 10 into the device 2. In particular, the barrel 30 of the syringe 10 is inserted into the RS 200 of the RE 20. The outer circumference of the barrel 30 is preferably in contact with the inner circumference of the RS 200. Once the patient activated the HEs 210 which are disposed in the RE 20, the material of the RE 20 will transmit the heat of the HEs 210 to the barrel 30 and thereby to the fluid which is prefilled into the barrel 30. If the patient then pushes the plunger 100 in the distal direction, the fluid will be dispensed and thereby administered by injection into the body of the patient at the desired temperature.
In Figure 7 a second embodiment of the device 2 is shown. Also in the second embodiment the device 2 is a separate component to the PDIS 1. The PDIS1 in Figure 7 is a syringe 10 and the prefilled container 3 is the barrel 30 of the syringe. In the second embodiment, the RE 20 of the device 2 is a thin walled hollow cylindrical element, in particular a soft pipe or sleeve. In this embodiment, the HEs 210 is a coating at the inside of the RE 20. The RE 20 can be made of plastic. The coating which forms the HE 210 can be made of ferrous metal or non- ferrous metal. By pushing the operating button 22, the coating can be supplied with power for a power unit 23. For example, the coating can be heated by resistance of the coating. The inner diameter of the RE 20 equals to or is slightly larger than the outer diameter of the barrel 30 of the syringe 10. The syringe 10 can be inserted into the RE 20 of the device 2 or the RE 20 can be slid onto or wrapped around the barrel 30 of the syringe 1. In the depicted second embodiment, the length of the RE 20 corresponds to the length of the barrel 30 between the flange 101 and the shoulder 31. The working of the device 2 of the second embodiment corresponds to the working of the device 2 of the first embodiment.
In Figures 8 and 9 a third and fourth embodiment of the device 2 are shown. The two embodiments only differ by the shape of the HE 210. In both embodiments, the RE 20 is a sleeve made of a soft plastic, which has the shape of a mat. At one side edge of the mat fastening elements 201 are provided. In the depicted embodiment, the fastening elements 201 are tabs or flaps, which can be made for example of Velcro. A plurality of HEs 210 is provided and the HEs 210 are parallel to each other. A power unit 23 is provided in the mat and an operating button 22 is provided on the outside of the RE 20, i.e. in Figure 8 and 9 the side facing away.
In the third embodiment of Figure 8 the HEs 210 are longitudinal elements which extend over most of the length of the RE 20, i.e. the mat. The HEs 210 can be integrated into the material of the RE 20 by molding. The HEs 210 can be at the inner side of the RE 20, i.e. the side visible in Figure 8. In the fourth embodiment of the device 2 of Figure 9 the HE 210 is an areal element such as a mesh. The HE 210 extends over most of the width and most of the length of the mat.
The third and fourth embodiment can be used by placing the container (not shown) on the mat, wrapping the RE 20 around the container and closing the RE 20 by means of the fastening elements 201. Thereby the RS 200 is formed and the RE 20 is tightly wrapped around the container. The working of the device 2 of the third and fourth embodiment corresponds to the working of the first embodiment.
In Figure 10 a schematic block diagram of a fifth embodiment of the device 2 is shown. In this embodiment, the device comprises a RE (not shown), an operating button 22, a power unit 23, a control unit 24, a temperature sensor 25, a triggering unit 26, a security unit 27 and at least one HE 210. The operating button 22 can serve for activating the control unit 24, which may be a micro computer. The control unit 24 can serve for activating the at least one HE 210. In addition, the control unit 24 can serve for activating the triggering unit 26. The triggering unit 26 may comprise a spring mechanism or other forcing element for forcing a plunger within the container 30 to dispense the injectable fluid. The activation of the HE 210 and of the triggering unit 26 can be made in a time delayed fashion. In particular, the control unit 24 can first activate the HE 210 and subsequently after a predetermined period of time can activate the triggering unit 26. The temperature sensor 25 is preferably provided at the RE 20 close to the RS 200 formed therein. The temperature sensor 25 serves for monitoring the temperature of the container 3, thereby, the control unit 24 or a separate unit can determine the temperature of the fluid within the container 3.
If a temperature which the fluid should reach is preset by the patient or user, this temperature can be preset in the control unit 24. Once this temperature is reached by the fluid, a signal can be output by the device 2 via an output unit (not shown). The signal can be an optical or acoustical signal.
The activation of the HE 210 and of the triggering unit 26 can also be controlled by temperature, for example the control unit 24 can first activate the HE 210 and monitor the temperature change induced by the HE 210, and after reaching a preset temperature can activate the triggering unit 26.
In an alternative embodiment (not shown) the operating button 22 can be directly connected to the HE 210 and a separate operating button (not shown) can be provided to activate the triggering unit 26. The control unit 24 in this embodiment can be activated by either of the operating buttons 22. Once the signal has been output the patient or user can activate the triggering unit 26.
In the fifth embodiment shown in Figure 10, where the triggering unit 26 and the heating element 210 are both activated by the control unit 24, the reaching of a preset temperature of the fluid can be monitored by the security unit 27. If the temperature of the fluid is below the preset temperature, the security unit 27 can block the activation of the triggering unit 26 in the central unit. Alternatively, the security unit 27 can block the triggering unit 26 itself, for example, by a mechanical stopper, until the preset temperature has been reached.
In Figure 12 a sixth embodiment of the device 2 is shown. In this embodiment, device is integrated into a PDIS 1 , which is an Al 11. The Al 11 has a tubular casing 111. At the proximal end of the casing 111 , an operating button 22 is provided. At the distal end of the casing 111 a movable cap 110 is provided. In the side wall of the casing 111 a window 112 is provided. The window 112 is formed in a protrusion extending from the outer circumference of the casing 111. In this embodiment, the RE 20 of the device 20 is part of the casing 111. The HEs 210 are provided within the casing 111 and extend in a longitudinal direction parallel to the container 3, which is held in the casing 111. In this embodiment, the HEs 210 can be activated by the control button 22. Alternatively, an additional control button at the side of the casing can be provided for activating the HEs 210. Once the fluid in the container 3 has reached the required temperature, the patient can place the cap 110 on the skin whereby the cap 110 can be pushed into the casing. Once the needle cannula 32 has entered the tissue, the patient can push the operating button 22 at the proximal end of the casing 111 and can thereby initiate the injection of the fluid. In another embodiment, the HEs 210 provided within the casing 111 can be provided in form of a coil around the container 3, which is held in the casing 111.
In Figure 13 a seventh embodiment of the device 2 is shown. In this embodiment, the device 2 is separate to a PDIS 1. The seventh embodiment is designed to be used with an Al 11. As can be derived from Figure 13, the device 2 has a design similar to the first embodiment of the device 2. The difference being, that the RS 200 does not have a circular cross section. The RS 200 has a lateral recess 2000 on the otherwise circular cross section. The lateral recess 2000 can serve for receiving the protrusion of a casing of an Al, for example a protrusion where a window is provided. In the seventh embodiment, the RS 200 thus not only receives the container 3 of the PDIS 1 but the casing of the PDIS 1 , wherein the container 3 is held, is inserted into the RS 200.
Figure 15 shows an eighths embodiment of the device 2. This embodiment differs from the seventh embodiment by the cross section of the RS 200 of the RE 20. In the eighth embodiment the RS 200 has a circular cross section with two lateral recesses 2000. This embodiment can serve for receiving a SGS 12. One example of a SGS 12 is shown in Figure 14. The SGS 12 has a container 3, which is the barrel of a syringe. A plunger 100 is provided within the container 3 and extends over the proximal end thereof. At the distal end of the container 3 a needle cannula is provided. The needle cannula is covered in Figure 14 by a needle shield 102. The SGS 12 comprises a shield 120, which has two poles extending parallel at opposite sides of the container 3 parallel to the container 3. Inside the shield 120 a spring 260 is provided at the distal end of the shield 120. At the proximal end of the shield 120 a grip 122 is provided. This SGS 12 can be inserted into the RE 20 of the eighth embodiment of the device 2. In particular, the poles of the shield 120 can be received in the lateral recesses 2000 of the RS 200. With heating elements (not shown) inserted into the insertion holes 211 in the RE 20, the fluid in the container 3 of the SGS 12 can be tempered to the desired temperature.
In a further embodiment, which is not shown, the device can also be integrated into an SGS 12. In this case, the heating elements of the device can be provided for example in the gap 121 (see Figure 14) between the outside of the container and the pole of the shield.
In a further embodiment, which is not shown in the figures, the PDIS is a pen. In this embodiment, the container is preferably a cartridge. In this embodiment, the container comprises a HE. The HE can be integrated into the material of the wall of the container. One embodiment of the HE is a coiled wire. The coiled wire can be integrated into the material of the wall of the container. Preferably, the ends of the HE will come in contact with the contact element of the device when the container, preferably the cartridge, is inserted into the device, preferably the pen. Thereby the HE is connected to the energy source of the device For example, one end of the coiled wire can be provided in form of a contact element of the container. When the container is inserted into the pen, the contact element of the container will come in contact with the contact element of the device and the HE will thereby be connected to the energy source of the device. Also in this embodiment, the other components of the device, which have been described with respect to figure 10 can be provided at the device and can have the respective functions.
The invention is not limited to the embodiments described above. Individual features of one embodiment can be combined with a different embodiment.
LIST OF REFERENCE NUMERALS
1 parenteral drug injection system
10 syringe 100 plunger
101 flange
102 needle shield
11 auto injector
110 cap 111 casing
112 window
12 safety guard syringe
120 shield
121 gap 122 grip
2 device
20 receiving element
200 receiving space 2000 lateral recess
2001 seat
201 fastening means
202 cover
203 lid
210 heating element 211 insertion hole
212 temperature sensor element
22 operating button
23 power unit 24 control unit
25 temperature sensor
26 triggering unit
260 spring
27 security unit
3 container
30 barrel
31 shoulder
32 needle cannula

Claims

1. Device for receiving a container (3) for a parenteral drug injection system (1), characterized in that the device (2) is sized to be handheld and in that the device (2) is a parenteral drug injection system (1) and comprises at least a part of heating means for heating the injectable fluid, which is contained in the container (3) and in that the part of the heating means which is comprised by the device (2) comprises an energy source (23).
2. Device according to claim 1 , wherein the part of the heating means which is comprised by the device is at least one heating element (210).
3. Device according to anyone of claim 1 or 2, wherein the device comprises a receiving element (20) for receiving at least a part of the container (3).
4. Device according to claim 3, wherein the at least one heating element (210) is provided at the receiving element (20) or forms the receiving element (20).
5. Device according to anyone of claims 3 or 4, wherein the receiving element (20) is a hollow element, preferably a stiff tube or soft pipe.
6. Device according to anyone of claims 2 to 5, wherein the heating element (210) is a longitudinal element, a metal mesh or a mat.
7. Device according to anyone of claims 1 or 2, wherein the part of the heating means which is comprised by the device (2) is at least part of contact means for contacting a heating element (210) with the energy source (23).
8. Device according to anyone of claims 1 to 7, wherein the device (2) has a control unit (24) for controlling at least the heating means.
9. Device according to anyone of claims 1 to 8, wherein the device (2) has an operating button (22) for at least activating the heating means.
10. Device according to anyone of claims 1 to 9, wherein the device (2) has means for measuring and /or for adjusting the temperature of the heating means and the means for measuring and/or adjusting the temperature preferably comprises at least one temperature sensor (25, 212).
11. Device according to anyone of claims 1 to 10, wherein the device (12) comprises a triggering unit (26) for triggering the dispensing of the injectable fluid and optionally, wherein the device (2) comprises a security unit (27) for suppressing the triggering of the injectable fluid.
12. Device according to claim 11 , wherein the heating element (210) is an integral part of the container (3) and preferably a coiled wire.
13. Method for preheating injectable fluid for a parenteral drug injection system (1), characterized in that the method is carried out with a device (2) according to anyone of claims 1 to 12.
14. Method according to claim 13, wherein the method comprises the step of a) activating heating means.
15. Method according to anyone of claims 13 or 14, wherein the method comprises the step of b) inserting a container (3) with prefilled fluid for a parenteral drug injection system (1) into the receiving element (20).
16. Method according to anyone of claims 13 to 15, wherein the method comprises the step of c) monitoring the temperature of the fluid and optionally the step of d) outputting a signal, when a preselected temperature is reached.
17. Method according to anyone of claims 13 to 16, wherein the method comprises the step of e) interrupting triggering of injection, until the selected temperature is reached.
18. Method for assembling a device according to anyone of claims 13 to 17, characterized in that a container (3) is inserted into a device according to anyone of claims 1 to 12.
PCT/EP2020/074936 2019-09-05 2020-09-07 Device for receiving a container for a parenteral drug injection system and method for preheating injectable fluid WO2021044055A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP19195638 2019-09-05
EP19195638.2 2019-09-05

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023192095A1 (en) * 2022-04-01 2023-10-05 Bayer Healthcare Llc Warming device and method
US11927465B2 (en) 2022-04-19 2024-03-12 Alcor Scientific, Inc. Flow sensor system and method for using same

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US20060271014A1 (en) 2005-05-31 2006-11-30 Mallinckrodt Inc. Heat retention device for a syringe and methods of use
GB2506918A (en) 2012-10-12 2014-04-16 Cambridge Consultants Injector device
EP3437683A1 (en) 2016-04-01 2019-02-06 Atsushi Hori Contrast medium temperature-maintaining and injecting system for microcatheter, and therapeutic suspension medicine temperature-maintaining and injecting system
WO2019096913A1 (en) 2017-11-17 2019-05-23 Sanofi Mixing and/or reconstitution system and respective method

Patent Citations (4)

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Publication number Priority date Publication date Assignee Title
US20060271014A1 (en) 2005-05-31 2006-11-30 Mallinckrodt Inc. Heat retention device for a syringe and methods of use
GB2506918A (en) 2012-10-12 2014-04-16 Cambridge Consultants Injector device
EP3437683A1 (en) 2016-04-01 2019-02-06 Atsushi Hori Contrast medium temperature-maintaining and injecting system for microcatheter, and therapeutic suspension medicine temperature-maintaining and injecting system
WO2019096913A1 (en) 2017-11-17 2019-05-23 Sanofi Mixing and/or reconstitution system and respective method

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023192095A1 (en) * 2022-04-01 2023-10-05 Bayer Healthcare Llc Warming device and method
US11927465B2 (en) 2022-04-19 2024-03-12 Alcor Scientific, Inc. Flow sensor system and method for using same

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