ABSTRACT
Abstract
The present disclosure relates to a medicament delivery device including a cartridge holder to which an injection needle holder can be fixed, the injection needle holder holding an injection needle having a proximal end and a distal end, the proximal end being protected by an inner injection needle cap detachably connected to the injection needle holder, the cartridge holder being mounted in a housing and configured to receive a cartridge of medicament, a cap assembly detachably connected to the housing, and
a gripping mechanism configured to remove the inner injection needle cap from the injection needle holder when the cap assembly is pulled away from the cartridge holder.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
The present application is a continuation of patent application Ser. No. 15/778,348, filed on May 23, 2018, which is the national stage entry of International Patent Application No. PCT/EP2016/078271, filed on Nov. 21, 2016, and claims priority to Application No. EP 15196705.6, filed on Nov. 27, 2015, the disclosures of which are expressly incorporated herein in entirety by reference thereto.
TECHNICAL FIELD
The present disclosure relates to a device for delivery of medicament to a patient.
BACKGROUND
Medicament injection devices such as auto-injectors are a common type of medicament delivery devices designed to deliver a medicament by injection. This type of devices are designed to be easy to use and intended for self-administration by patients, or administration by persons having no formal medical training.
In some circumstances, medicament injection devices are used by patients of impaired physical ability such as the elderly or physically impaired, and it may be harder for them to operate the device.
At least in certain embodiments, the present disclosure sets out to overcome or ameliorate at least some of the problems mentioned above. In particular, the present disclosure sets out to provide a device for delivery of medicament which is easy to use.
SUMMARY
Aspects of the present disclosure relate to a device for delivery of medicament to a patient.
According to a further aspect of the present disclosure, there is provided a medicament delivery device comprising:
a cartridge holder to which an injection needle holder can be fixed, the injection needle holder holding an injection needle having a proximal end and a distal end, the proximal end being protected by an inner injection needle cap detachably connected to the injection needle holder, the cartridge holder being mounted in a housing and configured to receive a cartridge of medicament; a cap assembly detachably connected to the housing; and a gripping mechanism configured to remove the inner injection needle cap from the injection needle holder when the cap assembly is pulled away from the cartridge holder. This may advantageously reduce the amount of steps a user must perform for a medicament injection procedure. Conventional medicament delivery devices require the user to remove the cap assembly and the inner needle cap separately to expose the needle in order to make the device ready for injection. It shall be appreciated that infirm patients such as the elderly or physically impaired may find removing the inner needle cap more difficult than removing the cap assembly due to the small size of the inner needle cap. According to the present disclosure, both the cap assembly and the inner needle cap are removed simultaneously in a single operation, which thereby makes the medicament delivery device easier to use.
The cap assembly may be configured to pull the inner injection needle cap away from the injection needle holder in an axial direction along a longitudinal axis of the housing when the cap assembly is pulled away from the cartridge holder. This may advantageously ensure that the inner needle cap is easily removable from the injection needle holder.
The gripping mechanism may comprise at least one gripping member movable from a retracted position towards an engaged position in which the or each gripping member engages the inner injection needle cap, and the or each gripping member may move from the retracted position towards the engaged position when the cap assembly is pulled away from the cartridge holder. In one embodiment, said at least one gripping member is moveable relative to the cap assembly from the retracted position towards the engaged position.
The gripping mechanism may comprise a catch configured to hold the inner injection needle cap and remove the inner injection needle cap from the injection needle holder while the cap assembly is pulled away from the cartridge holder. This may advantageously ensure that the inner injection needle cap is removed in a reliable way from the housing prior injection.
The gripping mechanism may comprise a plurality of spring arms each having a free end, and the spring arms may be configured such that the free ends fold on and clamp the inner injection needle cap when the cap assembly is pulled away from the cartridge holder. This may advantageously provide a medicament delivery device which is of simple construction.
In the retracted position, the free end of each spring arm may rest on the cartridge holder, and in the engaged position, the free end of each spring arm may clamp the inner injection needle cap.
The spring arms may biased towards each other.
The cap assembly may comprise an inner cap and an outer cap connected to the inner cap, the spring arms may have a first end opposed to the free end and each first end may be secured to the inner cap.
An outer needle cap may be located over the inner needle cap and the cap assembly may comprise a stop member, the stop member being configured to engage a distal section of the outer needle cap to remove the outer needle cap from the inner needle cap prior the removal of the inner needle cap from the injection needle holder when the cap assembly is pulled away from the cartridge holder. Both the inner needle cap and the outer needle cap are removed from the injection needle holder in a single operation, which thereby reduces the amount of steps a user must perform for a medicament injection procedure.
The first end of each spring arm may be secured to the stop member.
The medicament delivery device may comprise a pair of spring arms facing each other.
The medicament delivery device may comprise an injection needle holder to which an injection needle is fixed, the injection needle having a proximal end and a distal end, the proximal end being protected by an inner injection needle cap detachably connected to the injection needle holder.
The medicament delivery device may comprise a cartridge of medicament, the cartridge being received in the cartridge holder.
According to a further aspect of the present disclosure, there is provided a method of removing an inner injection needle cap from an injection needle holder holding an injection needle in a medicament delivery device, the injection needle having a proximal end and a distal end, the proximal end being protected by the inner injection needle cap, the medicament delivery device comprising:
a cartridge holder to which the injection needle holder can be fixed, the cartridge holder being mounted in a housing and configured to receive a cartridge of medicament; a cap assembly detachably connected to the housing; and a gripping mechanism;
wherein the method comprises pulling the cap assembly away from the cartridge holder to cause the gripping mechanism to remove the inner injection needle cap from the injection needle holder.
An outer needle cap may be located over the inner needle cap and the method may comprise pulling the cap assembly away from the cartridge holder to cause the outer needle cap to be pulled away from the inner injection needle cap.
According to a further aspect of the present disclosure, there is provided a method of removing an inner injection needle cap from an injection needle in a medicament delivery device, the method comprising moving a cap assembly of the medicament delivery device a predetermined distance in a proximal direction to remove the cap assembly and the inner injection needle cap from the device.
An outer needle cap may be located over the inner needle cap and moving the cap assembly the predetermined distance may cause the outer needle cap to be removed from the inner injection needle cap.
The terms âdrugâ or âmedicamentâ which are used interchangeably herein, mean a pharmaceutical formulation that includes at least one pharmaceutically active compound.
The term âmedicament delivery deviceâ shall be understood to encompass any type of device, system or apparatus designed to immediately dispense a drug to a human or non-human body (veterinary applications are clearly contemplated by the present disclosure). By âimmediately dispenseâ is meant an absence of any necessary intermediate manipulation of the drug by a user between discharge of the drug from the drug delivery device and administration to the human or non-human body. Without limitation, typical examples of drug delivery devices may be found in injection devices, inhalers, and stomach tube feeding systems. Again without limitation, exemplary injection devices may include, e.g., syringes, autoinjectors, injection pen devices and spinal injection systems.â
BRIEF DESCRIPTION OF THE DRAWINGS
Exemplary embodiments of the present disclosure are described with reference to the accompanying drawings, in which:
FIGS. 1 A and 1 B show schematic side views of a medicament delivery device according to an embodiment of the present disclosure;
FIG. 2 shows a cross-sectional view of a part of the medicament delivery device of FIG. 1 A , the needle being in a storage position;
FIG. 3 shows a cross-sectional view of a part of the medicament delivery device of FIG. 1 A , the needle being in a use position;
FIG. 4 shows a cross-sectional view of a part of the medicament delivery device of FIG. 1 A , the needle being in the use position, the shield arms being held in an inactive position by the inner cap;
FIG. 5 shows a cross-sectional view of a part of the medicament delivery device of FIG. 1 A , the needle being in the use position, the inner needle cap being removed from the needle and the shield arms being in a needle safe position;
FIG. 6 A shows a perspective view of a part of the medicament delivery device of FIG. 1 A showing in greater detail the shield arms in an inactive position;
FIG. 6 B shows a cross-sectional view of the part of the medicament delivery device of FIG. 6 A ;
FIG. 7 A shows a perspective view of a part of the medicament delivery device of FIG. 1 A showing in greater detail the shield arms in the needle safe position; and
FIG. 7 B shows a cross-sectional view of the part of the medicament delivery device of FIG. 7 A .
DETAILED DESCRIPTION
Embodiments of the disclosure provide a mechanism for removing the inner needle cap from an injection needle holder of a medicament delivery device when the cap assembly of the medicament delivery device is pulled away from the cartridge holder. Providing such a mechanism allows both the cap assembly and the inner needle cap to be removed simultaneously in a single operation, which thereby makes the medicament delivery device easier to use.
According to some embodiments of the present disclosure, an exemplary drug delivery device 10 , herein simply referred to as â device 10 â, is shown in FIGS. 1 A & 1 B .
The terms âproximalâ and âdistalâ herein respectively refer to as relatively closer to the patient and relatively further away from the patient.
The drug delivery device, as described herein, may be configured to inject a medicament into a patient. For example, delivery could be sub-cutaneous, intra-muscular, or intravenous. Such a device could be operated by a patient or care-giver, such as a nurse or physician, and can include various types of safety syringe, pen-injector, or auto-injector. The device can include a cartridge-based system that requires piercing a sealed ampule before use. Volumes of medicament delivered with these various devices can range from about 0.5 ml to about 2 ml. Yet another device can include a large volume device (âLVDâ) or patch pump, configured to adhere to a patient's skin for a period of time (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a âlargeâ volume of medicament (typically about 2 ml to about 10 ml).
In combination with a specific medicament, the presently described devices may also be customized in order to operate within required specifications. For example, the device may be customized to inject a medicament within a certain time period (e.g., about 3 to about 20 seconds for auto-injectors, and about 10 minutes to about 60 minutes for an LVD). Other specifications can include a low or minimal level of discomfort, or to certain conditions related to human factors, shelf-life, expiry, biocompatibility, environmental considerations, etc. Such variations can arise due to various factors, such as, for example, a drug ranging in viscosity from about 3 cP to about 50 cP. Consequently, a drug delivery device will often include a hollow needle ranging from about 25 to about 31 Gauge in size. Common sizes are 27 and 29 Gauge.
The delivery devices described herein can also include one or more automated functions. For example, one or more of needle insertion, medicament injection, and needle retraction can be automated. Energy for one or more automation steps can be provided by one or more energy sources. Energy sources can include, for example, mechanical, pneumatic, chemical, or electrical energy. For example, mechanical energy sources can include springs, levers, elastomers, or other mechanical mechanisms to store or release energy. One or more energy sources can be combined into a single device. Devices can further include gears, valves, or other mechanisms to convert energy into movement of one or more components of a device.
The one or more automated functions of an auto-injector may each be activated via an activation mechanism. Such an activation mechanism can include one or more of a button, a lever, a needle sleeve, or other activation component. Activation of an automated function may be a one-step or multi-step process. That is, a user may need to activate one or more activation components in order to cause the automated function. For example, in a one-step process, a user may depress a needle sleeve against their body in order to cause injection of a medicament. Other devices may require a multi-step activation of an automated function. For example, a user may be required to depress a button and retract a needle shield in order to cause injection.
In addition, activation of one automated functi
CROSS REFERENCE TO RELATED APPLICATIONS
The present application is a continuation of patent application Ser. No. 15/778,348, filed on May 23, 2018, which is the national stage entry of International Patent Application No. PCT/EP2016/078271, filed on Nov. 21, 2016, and claims priority to Application No. EP 15196705.6, filed on Nov. 27, 2015, the disclosures of which are expressly incorporated herein in entirety by reference thereto.
TECHNICAL FIELD
The present disclosure relates to a device for delivery of medicament to a patient.
BACKGROUND
Medicament injection devices such as auto-injectors are a common type of medicament delivery devices designed to deliver a medicament by injection. This type of devices are designed to be easy to use and intended for self-administration by patients, or administration by persons having no formal medical training.
In some circumstances, medicament injection devices are used by patients of impaired physical ability such as the elderly or physically impaired, and it may be harder for them to operate the device.
At least in certain embodiments, the present disclosure sets out to overcome or ameliorate at least some of the problems mentioned above. In particular, the present disclosure sets out to provide a device for delivery of medicament which is easy to use.
SUMMARY
Aspects of the present disclosure relate to a device for delivery of medicament to a patient.
According to a further aspect of the present disclosure, there is provided a medicament delivery device comprising:
a cartridge holder to which an injection needle holder can be fixed, the injection needle holder holding an injection needle having a proximal end and a distal end, the proximal end being protected by an inner injection needle cap detachably connected to the injection needle holder, the cartridge holder being mounted in a housing and configured to receive a cartridge of medicament; a cap assembly detachably connected to the housing; and a gripping mechanism configured to remove the inner injection needle cap from the injection needle holder when the cap assembly is pulled away from the cartridge holder. This may advantageously reduce the amount of steps a user must perform for a medicament injection procedure. Conventional medicament delivery devices require the user to remove the cap assembly and the inner needle cap separately to expose the needle in order to make the device ready for injection. It shall be appreciated that infirm patients such as the elderly or physically impaired may find removing the inner needle cap more difficult than removing the cap assembly due to the small size of the inner needle cap. According to the present disclosure, both the cap assembly and the inner needle cap are removed simultaneously in a single operation, which thereby makes the medicament delivery device easier to use.
The cap assembly may be configured to pull the inner injection needle cap away from the injection needle holder in an axial direction along a longitudinal axis of the housing when the cap assembly is pulled away from the cartridge holder. This may advantageously ensure that the inner needle cap is easily removable from the injection needle holder.
The gripping mechanism may comprise at least one gripping member movable from a retracted position towards an engaged position in which the or each gripping member engages the inner injection needle cap, and the or each gripping member may move from the retracted position towards the engaged position when the cap assembly is pulled away from the cartridge holder. In one embodiment, said at least one gripping member is moveable relative to the cap assembly from the retracted position towards the engaged position.
The gripping mechanism may comprise a catch configured to hold the inner injection needle cap and remove the inner injection needle cap from the injection needle holder while the cap assembly is pulled away from the cartridge holder. This may advantageously ensure that the inner injection needle cap is removed in a reliable way from the housing prior injection.
The gripping mechanism may comprise a plurality of spring arms each having a free end, and the spring arms may be configured such that the free ends fold on and clamp the inner injection needle cap when the cap assembly is pulled away from the cartridge holder. This may advantageously provide a medicament delivery device which is of simple construction.
In the retracted position, the free end of each spring arm may rest on the cartridge holder, and in the engaged position, the free end of each spring arm may clamp the inner injection needle cap.
The spring arms may biased towards each other.
The cap assembly may comprise an inner cap and an outer cap connected to the inner cap, the spring arms may have a first end opposed to the free end and each first end may be secured to the inner cap.
An outer needle cap may be located over the inner needle cap and the cap assembly may comprise a stop member, the stop member being configured to engage a distal section of the outer needle cap to remove the outer needle cap from the inner needle cap prior the removal of the inner needle cap from the injection needle holder when the cap assembly is pulled away from the cartridge holder. Both the inner needle cap and the outer needle cap are removed from the injection needle holder in a single operation, which thereby reduces the amount of steps a user must perform for a medicament injection procedure.
The first end of each spring arm may be secured to the stop member.
The medicament delivery device may comprise a pair of spring arms facing each other.
The medicament delivery device may comprise an injection needle holder to which an injection needle is fixed, the injection needle having a proximal end and a distal end, the proximal end being protected by an inner injection needle cap detachably connected to the injection needle holder.
The medicament delivery device may comprise a cartridge of medicament, the cartridge being received in the cartridge holder.
According to a further aspect of the present disclosure, there is provided a method of removing an inner injection needle cap from an injection needle holder holding an injection needle in a medicament delivery device, the injection needle having a proximal end and a distal end, the proximal end being protected by the inner injection needle cap, the medicament delivery device comprising:
a cartridge holder to which the injection needle holder can be fixed, the cartridge holder being mounted in a housing and configured to receive a cartridge of medicament; a cap assembly detachably connected to the housing; and a gripping mechanism;
wherein the method comprises pulling the cap assembly away from the cartridge holder to cause the gripping mechanism to remove the inner injection needle cap from the injection needle holder.
An outer needle cap may be located over the inner needle cap and the method may comprise pulling the cap assembly away from the cartridge holder to cause the outer needle cap to be pulled away from the inner injection needle cap.
According to a further aspect of the present disclosure, there is provided a method of removing an inner injection needle cap from an injection needle in a medicament delivery device, the method comprising moving a cap assembly of the medicament delivery device a predetermined distance in a proximal direction to remove the cap assembly and the inner injection needle cap from the device.
An outer needle cap may be located over the inner needle cap and moving the cap assembly the predetermined distance may cause the outer needle cap to be removed from the inner injection needle cap.
The terms âdrugâ or âmedicamentâ which are used interchangeably herein, mean a pharmaceutical formulation that includes at least one pharmaceutically active compound.
The term âmedicament delivery deviceâ shall be understood to encompass any type of device, system or apparatus designed to immediately dispense a drug to a human or non-human body (veterinary applications are clearly contemplated by the present disclosure). By âimmediately dispenseâ is meant an absence of any necessary intermediate manipulation of the drug by a user between discharge of the drug from the drug delivery device and administration to the human or non-human body. Without limitation, typical examples of drug delivery devices may be found in injection devices, inhalers, and stomach tube feeding systems. Again without limitation, exemplary injection devices may include, e.g., syringes, autoinjectors, injection pen devices and spinal injection systems.â
BRIEF DESCRIPTION OF THE DRAWINGS
Exemplary embodiments of the present disclosure are described with reference to the accompanying drawings, in which:
FIGS. 1 A and 1 B show schematic side views of a medicament delivery device according to an embodiment of the present disclosure;
FIG. 2 shows a cross-sectional view of a part of the medicament delivery device of FIG. 1 A , the needle being in a storage position;
FIG. 3 shows a cross-sectional view of a part of the medicament delivery device of FIG. 1 A , the needle being in a use position;
FIG. 4 shows a cross-sectional view of a part of the medicament delivery device of FIG. 1 A , the needle being in the use position, the shield arms being held in an inactive position by the inner cap;
FIG. 5 shows a cross-sectional view of a part of the medicament delivery device of FIG. 1 A , the needle being in the use position, the inner needle cap being removed from the needle and the shield arms being in a needle safe position;
FIG. 6 A shows a perspective view of a part of the medicament delivery device of FIG. 1 A showing in greater detail the shield arms in an inactive position;
FIG. 6 B shows a cross-sectional view of the part of the medicament delivery device of FIG. 6 A ;
FIG. 7 A shows a perspective view of a part of the medicament delivery device of FIG. 1 A showing in greater detail the shield arms in the needle safe position; and
FIG. 7 B shows a cross-sectional view of the part of the medicament delivery device of FIG. 7 A .
DETAILED DESCRIPTION
Embodiments of the disclosure provide a mechanism for removing the inner needle cap from an injection needle holder of a medicament delivery device when the cap assembly of the medicament delivery device is pulled away from the cartridge holder. Providing such a mechanism allows both the cap assembly and the inner needle cap to be removed simultaneously in a single operation, which thereby makes the medicament delivery device easier to use.
According to some embodiments of the present disclosure, an exemplary drug delivery device 10 , herein simply referred to as â device 10 â, is shown in FIGS. 1 A & 1 B .
The terms âproximalâ and âdistalâ herein respectively refer to as relatively closer to the patient and relatively further away from the patient.
The drug delivery device, as described herein, may be configured to inject a medicament into a patient. For example, delivery could be sub-cutaneous, intra-muscular, or intravenous. Such a device could be operated by a patient or care-giver, such as a nurse or physician, and can include various types of safety syringe, pen-injector, or auto-injector. The device can include a cartridge-based system that requires piercing a sealed ampule before use. Volumes of medicament delivered with these various devices can range from about 0.5 ml to about 2 ml. Yet another device can include a large volume device (âLVDâ) or patch pump, configured to adhere to a patient's skin for a period of time (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a âlargeâ volume of medicament (typically about 2 ml to about 10 ml).
In combination with a specific medicament, the presently described devices may also be customized in order to operate within required specifications. For example, the device may be customized to inject a medicament within a certain time period (e.g., about 3 to about 20 seconds for auto-injectors, and about 10 minutes to about 60 minutes for an LVD). Other specifications can include a low or minimal level of discomfort, or to certain conditions related to human factors, shelf-life, expiry, biocompatibility, environmental considerations, etc. Such variations can arise due to various factors, such as, for example, a drug ranging in viscosity from about 3 cP to about 50 cP. Consequently, a drug delivery device will often include a hollow needle ranging from about 25 to about 31 Gauge in size. Common sizes are 27 and 29 Gauge.
The delivery devices described herein can also include one or more automated functions. For example, one or more of needle insertion, medicament injection, and needle retraction can be automated. Energy for one or more automation steps can be provided by one or more energy sources. Energy sources can include, for example, mechanical, pneumatic, chemical, or electrical energy. For example, mechanical energy sources can include springs, levers, elastomers, or other mechanical mechanisms to store or release energy. One or more energy sources can be combined into a single device. Devices can further include gears, valves, or other mechanisms to convert energy into movement of one or more components of a device.
The one or more automated functions of an auto-injector may each be activated via an activation mechanism. Such an activation mechanism can include one or more of a button, a lever, a needle sleeve, or other activation component. Activation of an automated function may be a one-step or multi-step process. That is, a user may need to activate one or more activation components in order to cause the automated function. For example, in a one-step process, a user may depress a needle sleeve against their body in order to cause injection of a medicament. Other devices may require a multi-step activation of an automated function. For example, a user may be required to depress a button and retract a needle shield in order to cause injection.
In addition, activation of one automated function may activate one or more subsequent automated functions, thereby forming an activation sequence. For example, activation of a first automated function may activate at least two of needle insertion, medicament injection, and needle retraction. Some devices may also require a specific sequence of steps to cause the one or more automated functions to occur. Other devices may operate with a sequence of independent steps.
Some delivery devices can include one or more functions of a safety syringe, pen-injector, or auto-injector. For example, a delivery device could include a mechanical energy source configured to automatically inject a medicament (as typically found in an auto-injector) and a dose setting mechanism (as typically found in a pen-injector).
Device 10 , as described above, is configured to inject a medicament, e.g. a liquid medicament, into a patient's body. Device 10 includes a body or housing 11 which typically contains a reservoir containing the medicament to be injected (e.g., a syringe) and the components required to facilitate one or more steps of the delivery process. Device 10 can also include a cap assembly 12 that can be detachably mounted to the housing 11 . Typically a user must remove the cap assembly 12 from the housing 11 before the device 10 can be operated.
The device 10 includes a cartridge 15 pre-filled with liquid medicament, and a pen needle or needle assembly 16 (visible in FIG. 2 ) comprising an injection needle 17 for injecting medicament from the cartridge 15 to a patient's body. The housing 11 includes a window 11 a , through which the contents of the cartridge 15 can be viewed. As shown in FIG. 2 , the device 10 also comprises a coupling mechanism 18 connecting the cap assembly 12 to the needle assembly 16 , and shield elements 19 for occluding access to the needle 17 when the device 10 is in use.
As shown, the housing 11 is substantially cylindrical and has a substantially constant diameter along the longitudinal axis X. The housing 11 has a proximal region 20 and a distal region 21 . The term âproximalâ refers to a location that is relatively closer to a site of injection, and the term âdistalâ refers to a location that is relatively further away from the injection site.
The device 10 can also include a needle sleeve 13 coupled to housing 11 to permit movement of sleeve 13 relative to housing 11 . The sleeve 13 is retractably mounted in the housing 11 . For example, sleeve 13 can move in a longitudinal direction parallel to longitudinal axis X. Specifically, movement of the sleeve 13 in a distal direction can permit the needle 17 to extend from the proximal region 20 of the housing 11 .
Insertion of the needle 17 can occur via several mechanisms. For example, needle 17 may be fixedly located relative to housing 11 and initially be located within an extended needle sleeve 13 . Distal movement of the sleeve 13 by placing a proximal end of the sleeve 13 against a patient's body and moving the housing 11 in a proximal direction will uncover the proximal end of the needle 17 . Such relative movement allows the proximal end of the needle 17 to extend into the patient's body. Such insertion is termed âmanualâ insertion as needle 17 is manually inserted via the patient's manual movement of the housing 11 relative to the sleeve 13 .
Another form of insertion is âautomated,â whereby needle 17 moves relative to housing 11 . Such insertion can be triggered by movement of sleeve 13 or by another form of activation, such as, for example, a button 22 . As shown in FIGS. 1 A & 1 B , button 22 is located at a distal end of housing 11 . However, in other embodiments, button 22 could be located on a side of housing 11 .
Other manual or automated features can include drug injection or needle retraction, or both. Injection is the process by which a bung or piston 23 is moved from a distal location within a cartridge to a more proximal location within the cartridge in order to force a medicament from the cartridge through needle 17 . In some embodiments, a drive spring (not shown) is under compression before device 10 is activated. A distal end of the drive spring can be fixed within distal region 21 of housing 11 , and a proximal end of the drive spring can be configured to apply a compressive force to a distal surface of piston 23 . Following activation, at least part of the energy stored in the drive spring can be applied to the distal surface of piston 23 . This compressive force can act on piston 23 to move it in a proximal direction. Such proximal movement acts to compress the liquid medicament within the cartridge, forcing it out of needle 17 .
Following injection, needle 17 can be retracted within sleeve 13 or housing 11 . Retraction can occur when sleeve 13 moves proximally as a user removes device 10 from a patient's body. This can occur as needle 17 remains fixedly located relative to housing 11 . Once a proximal end of sleeve 13 has moved past a proximal end of needle 17 , and needle 17 is covered, sleeve 13 can be locked. Such locking can include locking any distal movement of sleeve 13 relative to housing 11 .
Another form of needle retraction can occur if needle 17 is moved relative to housing 11 . Such movement can occur if the cartridge within housing 11 is moved in a distal direction relative to housing 11 . This distal movement can be achieved by using a retraction spring (not shown), located in proximal region 20 . A compressed retraction spring, when activated, can supply sufficient force to the cartridge to move it in a distal direction. Following sufficient retraction, any relative movement between needle 17 and housing 11 can be locked with a locking mechanism. In addition, button 22 or other components of device 10 can be locked as required.
As shown in FIG. 2 , the cartridge holder 14 is securely mounted to the housing 11 . The cartridge holder 14 comprises a wall 24 which defines a cavity 25 for receiving the cartridge 15 . The cartridge holder 14 comprises a main portion 26 and a proximal portion 27 . The main portion 26 is substantially cylindrical and has a substantially constant diameter along the longitudinal axis X. The proximal portion 27 is substantially cylindrical and has a diameter which is less than the diameter of the main portion 26 . The proximal portion 27 includes an external thread 28 . A rib 29 projects inwardly from the wall 24 at an end 30 of the proximal portion 27 and extends around the entire circumference of the proximal portion 27 . The rib 29 defines an opening 31 through which the needle 17 locates during injection. A seal- cutter 32 is fixed to the rib 29 . The seal- cutter 32 is in the form of a pair of cutting blades protruding from the rib 29 and distributed around the opening 31 .
The cartridge 15 is in the form of a tubular container 33 which stores the liquid medicament to be injected to the patient's body. The container 33 is fitted securely within the cavity 25 of the cartridge holder 14 . The container 33 includes an aperture 34 which faces the opening 31 of the cartridge holder 14 and which is sealed by means of a septum 35 .
The sleeve 13 has a generally tubular shape and extends along the longitudinal axis X, between the housing 11 and the cartridge holder 14 . The sleeve 13 is slidable along the longitudinal axis X between a deployed position in which the sleeve 13 protrudes from the proximal region 20 of the housing 11 and a retracted position in which the sleeve 13 is retracted within the housing 11 . A circumferential notch 36 is provided on an internal surface of the sleeve 13 at a proximal extremity 38 of the sleeve 13 . Rotation of the sleeve 13 relative to the housing 11 is prevented by a splined arrangement (not shown).
The needle assembly 16 comprises the injection needle 17 , an injection needle holder 39 to which the needle 17 is fixed, an inner needle shield or inner needle cap 40 and an outer needle shield or outer needle cap 41 .
The injection needle 17 is in the form of a hollow needle 17 comprising a proximal end 42 , a distal end 43 , and an intermediate section 44 joining the proximal end 42 and the distal end 43 together. The needle 17 is moveable from a storage position ( FIG. 2 ) towards a use position ( FIGS. 3 to 5 ). In the storage position, the distal end 43 of the needle 17 is spaced from the cartridge 15 so that medicament cannot be delivered. In the use position, the distal end 43 of the needle 17 is inserted in the cartridge 15 so that medicament can flow from the cartridge 15 through the needle 17 to be injected to a patient's body.
The needle holder 39 comprises a needle supporting portion 45 and a flange 46 extending from the needle supporting portion 45 . The needle supporting portion 45 is secured to the intermediate section 44 of the needle 17 and supports the needle 17 in a position substantially parallel to the longitudinal axis X. The needle 17 locates in the needle holder 39 such that the flange 46 surrounds the distal end 43 of the needle 17 . The flange 46 has an inner surface and an outer surface. The inner surface of the flange 46 has an internal thread 49 which is configured to mesh with the external thread 28 of the proximal portion 27 of the cartridge holder 14 . The flange 46 comprises a sealing film or sealing membrane 50 which extends in the flange 46 transversally to the longitudinal axis X. The sealing membrane 50 seals the distal end 43 of the needle 17 in the flange 46 when the needle 17 is in the storage position. As will be explained in more detail below, the sealing membrane 50 is configured to be sliced by the cutting blades 32 of the cartridge holder 14 to expose the distal end 43 of the needle 17 when the needle 17 moves towards the use position.
The <figure-callout id="40" label="inner needle cap"
CLAIMS
Claims ( 19 )
The invention claimed is:
1. A medicament delivery device comprising:
a cartridge holder configured for an injection needle holder to be fixed thereto, the injection needle holder being configured to hold an injection needle having a proximal end and a distal end, the proximal end being protected by an inner injection needle cap detachably connected to the injection needle holder, the cartridge holder being mounted in a housing and configured to receive a cartridge of medicament;
a cap assembly detachably connected to the housing; and
a gripping mechanism configured to remove the inner injection needle cap from the injection needle holder when the cap assembly is pulled away from the cartridge holder,
wherein an outer injection needle cap is located over the inner injection needle cap, the outer injection needle cap comprising a proximal section and a distal section, wherein the proximal section is relatively closer to a site of injection than the distal section,
wherein the cap assembly comprises a stop member, the stop member being configured to engage the distal section of the outer injection needle cap to remove the outer injection needle cap from the inner injection needle cap prior to the removal of the inner injection needle cap from the injection needle holder when the cap assembly is pulled away from the cartridge holder; and
wherein the stop member is configured to engage the distal section of the outer injection needle cap at a location distal of a proximal end of the injection needle.
2. The medicament delivery device according to claim 1 , wherein the cap assembly is configured to pull the inner injection needle cap away from the injection needle holder in an axial direction along a longitudinal axis of the housing when the cap assembly is pulled away from the cartridge holder.
3. The medicament delivery device according to claim 1 , wherein the gripping mechanism comprises at least one gripping member configured to be movable from a retracted position towards an engaged position in which the at least one gripping member engages the inner injection needle cap, and wherein the at least one gripping member is configured to move from the retracted position towards the engaged position when the cap assembly is pulled away from the cartridge holder.
4. The medicament delivery device according to claim 3 , wherein the at least one gripping member is configured to move relative to the cap assembly from the retracted position towards the engaged position.
5. The medicament delivery device according to claim 3 , wherein the at least one gripping member comprises multiple gripping members, wherein each gripping member of the multiple gripping members comprises a spring arm having a free end, wherein the spring arms of the gripping members are configured such that the free ends of the spring arms fold on and clamp the inner injection needle cap when the cap assembly is pulled away from the cartridge holder.
6. The medicament delivery device according to claim 5 , wherein in the retracted position, the free end of each spring arm of the spring arms is configured to rest on the cartridge holder, and wherein in the engaged position, the free end of each spring arm of the spring arms is configured to clamp the inner injection needle cap.
7. The medicament delivery device according to claim 5 , wherein the spring arms are biased towards each other.
8. The medicament delivery device according to claim 3 , wherein a first end of the at least one gripping member is secured to the stop member.
9. The medicament delivery device according to claim 1 , wherein the cap assembly comprises the inner injection needle cap and the outer injection needle cap connected to the inner injection needle cap.
10. The medicament delivery device according to claim 1 , wherein the gripping mechanism comprises a catch configured to hold the inner injection needle cap and remove the inner injection needle cap from the injection needle holder when the cap assembly is pulled away from the cartridge holder.
11. The medicament delivery device according to claim 1 , further comprising the cartridge of medicament, the cartridge of medicament being received in the cartridge holder.
12. The medicament delivery device according to claim 1 , wherein the outer injection needle cap comprises an external shoulder, and wherein the stop member is configured to engage the external shoulder.
13. The medicament delivery device according to claim 1 , wherein the outer injection needle cap is configured to tightly abut a part of the injection needle holder.
14. The medicament delivery device according to claim 1 , wherein the injection needle holder comprises a flange and wherein the outer injection needle cap is configured to locate over the flange.
15. The medicament delivery device according to claim 1 , wherein the inner injection needle cap and the injection needle holder are configured to locate in the outer injection needle cap.
16. The medicament delivery device according to claim 1 , wherein the injection needle is movable from a storage position to a use position, wherein in the storage position, the distal end of the injection needle is spaced from the cartridge of medicament and, in the use position, the distal end of the injection needle is inserted in the cartridge of medicament.
17. A method of removing an inner injection needle cap from an injection needle in a medicament delivery device, the method comprising:
moving a cap assembly of the medicament delivery device a predetermined distance in a proximal direction to remove the cap assembly and the inner injection needle cap from the medicament delivery device, wherein an outer injection needle cap is located over the inner injection needle cap, the outer injection needle cap comprising a proximal section and a distal section, wherein the proximal section is relatively closer to a site of injection than the distal section, and wherein the cap assembly comprises a stop member configured to engage a distal section of the outer injection needle cap at a location distal of a proximal end of the injection needle to remove the outer injection needle cap from the inner injection needle cap prior to the removal of the inner injection needle cap from an injection needle holder when the cap assembly is moved in the proximal direction.
18. The method according to claim 17 , wherein moving the cap assembly the predetermined distance causes the outer injection needle cap to be removed from the inner injection needle cap.
19. The method according to claim 17 , wherein the method further comprises moving the injection needle from a storage position to a use position, wherein in the storage position, the distal end of the injection needle is spaced from a cartridge of medicament and, in the use position, the distal end of the injection needle is inserted in the cartridge of medicament.
US17/401,573
2015-11-27
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Medicament delivery device
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Medicament delivery device
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2015-11-27
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WO2017089281A1
( en )
2015-11-27
2016-11-21
Medicament delivery device
US201815778348A
2018-05-23
2018-05-23
US17/401,573
US12251542B2
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Medicament delivery device
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