CN215938602U

CN215938602U - Cap for medical device, medical pen needle assembly, accessory and assembly

Info

Publication number: CN215938602U
Application number: CN202121824319.8U
Authority: CN
Inventors: M·法姆; P·格吉斯; J·加特纳
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2020-08-07
Filing date: 2021-08-06
Publication date: 2022-03-04
Anticipated expiration: 2031-08-06
Also published as: EP4192549A1; CN116056748A; WO2022031574A1

Abstract

The utility model relates to a cap for a medical device, a medical pen needle assembly, an accessory and a combination. A cap for a medical device, the cap configured to disinfect a skin surface, the cap comprising: a power source that supplies power; a light emitting source that disinfects the skin surface using power received from the power source; and a switch configured to be operated by a user action; wherein upon activation of the switch, the power from the power source is received by the light emitting source to emit visible light and disinfect the skin surface.

Description

Cap for medical device, medical pen needle assembly, accessory and assembly

Technical Field

The present invention relates to medical devices that disinfect skin surfaces at injection sites prior to administration of a drug, and in particular to caps, drug pen needle assemblies, accessories, and assemblies for medical devices.

Background

Insulin and other injectable drugs are typically administered using a medical device such as a drug delivery device or drug delivery pen, in which a disposable pen needle is attached to facilitate passage of a drug container and allow fluid to flow from the container, through the needle and into the patient.

As technology and competition advance, the need for shorter, thinner, less painful and more efficient injections is driven, the design of drug delivery devices such as pen needles and their components becomes increasingly important. The design needs to actively address the ability to ergonomically improve injection technology, injection depth control and accuracy, safe use and transport for disposal, sterilization, disinfection and prevention of misuse, while maintaining the ability to be economically manufactured on a large production scale.

A drug delivery device, such as the exemplary drug delivery pen 10 shown in fig. 1 and 2, may be designed for subcutaneous and intradermal injections, and generally includes a dose knob/button 22, an outer cannula or housing 11, and a cap 50. The dose knob/button 22 allows the clinician or patient to set a dose of the drug to be injected. The housing 11 is gripped by a user when injecting the medicament. The user may use the cover 50 to securely hold the drug delivery pen 10 in a shirt pocket, purse, or other suitable location and provide coverage/protection from accidental needle stick injury. The cap 50 also serves to cover the septum 18 of the drug cartridge 16 in the drug delivery pen 10 before and after use. Otherwise, the diaphragm 18 will be exposed.

Fig. 2 is an exploded view of the drug delivery pen 10 of fig. 1. The dose knob/button 22 has a dual purpose and is used both to set a dose of the drug to be injected and to inject a metered dose of the drug through the drug cartridge 16 attached to the drug delivery pen 10 through the body 20 via the lead screw 12 and the plunger/stopper 14. In a standard medication delivery pen, both the dosing and delivery mechanisms are located within the housing 11 and will not be described in further detail herein, as will be appreciated by those skilled in the art.

To operate, the drug delivery pen 10 is attached to a pen needle that includes a needle/cannula 30, a septum-penetrating cannula 32, and a hub 34. Specifically, distal movement of the plunger or stopper 14 within the drug cartridge 16 causes the drug to be forced into the needle 30 of the hub 34. The drug cartridge 16 is sealed by a septum 18 that is pierced by a septum-penetrating needle cannula 32 located within a hub 34. The hub 34 is preferably threaded onto the body 20, but other attachment means may be used.

To protect the user from accidental needle sticks or anyone handling the pen needle, an outer cover 38 attached to the hub 34 covers the hub 34. The inner shield 36 covers the patient needle 30 within the outer cover 38. The inner shield 36 may be secured to the hub 34 by any suitable means, such as an interference fit or snap fit, to cover the patient needle 30. The outer cover 38 and the inner cover 36 are removed prior to use.

The drug cartridge 16 is typically a glass tube or vial sealed at one end with a septum 18 and at the other end with a stopper 14. The septum 18 may be pierced by the septum-penetrating cannula 32 in the hub 34, but does not move relative to the drug cartridge 16. The bung 14 may be axially displaced within the medicament cartridge 16 while maintaining a fluid tight seal.

Prior drug delivery pens are disclosed in us patent application publication No. 2006/0229562 to Marsh et al, published on 12.10.2006, and r.marsh 2007/0149924, published on 28.6.2007, both of which are incorporated herein by reference in their entirety for this purpose.

Medical devices such as drug delivery pen 10 are typically prepared for use by disinfecting septum 18 with an alcohol wipe prior to attachment of a pen needle for drug delivery and disinfecting the skin surface at the injection site with a disinfectant wipe prior to administration. However, consistent and accurate disinfection of the drug delivery pen 10 and the skin surface for safe patient care presents challenges. Carrying an alcohol wipe and/or sterile wet wipe with the drug delivery pen 10 can be a burden to the user. Furthermore, alcohol wipes and/or disinfectant wipes have a shelf life system and are typically intended for single use only. In some instances, septum 18 may not be properly sterilized prior to use. It is not always feasible and difficult to ensure that optimal disinfection practices are consistently followed. Accordingly, there is a need for improved sterilization devices and processes for use with medical devices, such as the drug delivery pen 10.

SUMMERY OF THE UTILITY MODEL

An aspect of the utility model provides a cap that is capable of disinfecting a skin surface at an injection site, either alone or in combination with disinfecting a medical device or a portion thereof, such as a septum surface. Such a configuration improves the workflow and convenience for a user to use various medical devices, such as drug delivery pens, syringes, patch pumps, safety pens, and insulin vials. Poor injection practices are minimized because the user is no longer relied upon to use alcohol wipes or disinfectant wipes to disinfect skin surfaces, membranes, or other exposed surfaces or portions of a medical device. Indeed, the cover may be configured to automatically sterilize the septum or other exposed surface or portion, thereby saving time. Furthermore, it is more convenient to disinfect the skin surface simultaneously or alternately with respect to disinfection of the membrane to improve workflow and optimize time. The use of caps to disinfect medical devices and skin surfaces is also more controllable or automated to meet high precision and performance requirements. Finally, the user no longer needs to carry an alcohol wipe and/or a sterile wipe for the medical device and/or the skin surface.

Another aspect of the utility model provides an accessory attachable to a device to disinfect a skin surface prior to injection. Such accessories provide visible light to safely disinfect the skin surface prior to injection of the needle of the device. The accessory may also be adapted for use with a variety of products including medical devices and configured to be attached and detached for general and convenient use.

The foregoing and/or other aspects of the present invention may be achieved by providing a medical device configured to disinfect a skin surface, the device including a power source to provide power; a light emitting source that disinfects the skin surface using power received from the power source; and a switch configured to be operated by user action, wherein upon activation of the switch, the power from the power source is received by the light emitting source to emit visible light and disinfect the skin surface.

The foregoing and/or other aspects of the present invention can also be achieved by providing a cap for a medical device, the cap configured to disinfect a skin surface, the cap including a power source to power a microcontroller, the microcontroller sensing and controlling operation of the cap; a light emitting source emitting visible light under the control of the microcontroller to disinfect the skin surface; and a switch that causes the microcontroller to activate and deactivate the light emitting source.

The foregoing and/or other aspects of the present invention can also be achieved by providing a method of sterilizing a skin surface and injecting a medicine using a medical device, the method including providing a light emitting source on an outer surface of a cap of the medical device; securing the cap to the medical device; activating the light emitting source to emit visible light to disinfect the skin surface; exposing the skin surface to the visible light from the light emitting source; removing the cap of the medical device to begin drug delivery; inserting a needle of the medical device into the skin surface; and injecting the drug.

The foregoing and/or other aspects of the present invention are additionally achieved by providing an accessory configured to be attached to a device to disinfect a skin surface, the accessory including a light emitting source that emits visible light to disinfect the skin surface; and a mounting mechanism configured to attach and detach the light emitting source and the device.

The foregoing and/or other aspects of the present invention are also achieved by providing a method of sterilizing a skin surface and injecting a drug using a medical device, the method including mounting an accessory to an outer surface of a cap of the medical device, the accessory including a light emitting source that emits visible light to sterilize the skin surface; activating the light emitting source to disinfect the skin surface; removing the cap of the medical device; inserting a needle of the medical device into the skin surface; and injecting the drug.

The foregoing and/or other aspects of the present invention provide a cap for a medical device, the cap configured to disinfect a skin surface, the cap comprising: a power source that supplies power; a light emitting source that disinfects the skin surface using power received from the power source; and a switch configured to be operated by a user action; wherein upon activation of the switch, the power from the power source is received by the light emitting source to emit visible light and disinfect the skin surface.

In the foregoing and/or other aspects of the present invention, the power source includes a battery.

In the foregoing and/or other aspects of the utility model, the cap further includes an electromagnetic radiation source that emits ultraviolet light using the power received from the power source to sterilize the medical device or a portion thereof.

In the foregoing and/or other aspects of the present invention, the electromagnetic radiation source radiates electromagnetic radiation to sterilize the medical device or a portion thereof.

In the foregoing and/or other aspects of the present invention, the electromagnetic radiation source is disposed inside the cover.

In the foregoing and/or other aspects of the present invention, the electromagnetic radiation source emits light at a bandwidth to sterilize the portion of the medical device; and the portion of the medical device is a surface of the medical device.

In the foregoing and/or other aspects of the present invention, the medical device comprises a vial; and the vial includes a septum to selectively seal the medicament therein.

In the foregoing and/or other aspects of the present invention, the light emitting source is disposed on an outer surface of the cover.

In the foregoing and/or other aspects of the present invention, the light-emitting source emits visible light in a wavelength range between 400nm and 410 nm.

In the foregoing and/or other aspects of the utility model, the light emitting source operates simultaneously with the electromagnetic radiation source.

In the foregoing and/or other aspects of the utility model, the light emitting source is operated alternately with respect to the electromagnetic radiation source.

In the foregoing and/or other aspects of the utility model, the wavelength of the emission from the light emitting source is different from the wavelength of the radiation from the electromagnetic radiation source.

The foregoing and/or other aspects of the present invention provide a medicine pen needle assembly including: a cover of a medical device according to the utility model; the medical device comprising a drug delivery pen; and a pen needle attached to the drug delivery pen, wherein power from the power source is applied to the electromagnetic radiation source to radiate electromagnetic radiation on the needle of the pen needle.

The foregoing and/or other aspects of the present invention provide a medicine pen needle assembly including: a cover of a medical device according to the utility model; the medical device comprising a drug delivery pen; and a universal fitting disposed between the cap and the drug delivery pen for securing the cap to the drug delivery pen.

The foregoing and/or other aspects of the present invention provide a cap for a medical device, the cap configured to disinfect a skin surface, the cap comprising: a power supply to power a microcontroller, the microcontroller sensing and controlling operation of the lid; a light emitting source emitting visible light under the control of the microcontroller to disinfect the skin surface; and a switch that causes the microcontroller to activate and deactivate the light emitting source.

In the foregoing and/or other aspects of the present invention, the cover further comprises: an electromagnetic radiation source that radiates electromagnetic radiation under control of the microcontroller to sterilize the medical device or a portion thereof; wherein the switch causes the microcontroller to activate and deactivate the electromagnetic radiation source.

In the foregoing and/or other aspects of the present invention, the switch comprises a micro switch, a proximity sensor, a hall effect sensor, a photosensor, an optical sensor, or a force sensor.

In the foregoing and/or other aspects of the utility model, the cover further includes an indicator that indicates at least one of whether the electromagnetic radiation source is activated, whether the light emitting source is activated, whether any sterilization process is complete, and a remaining life of the power source.

In the foregoing and/or other aspects of the present invention, the cover further includes a timer that controls at least one of a time delay, a duration of the radiation, and a duration of the emitted visible light.

The foregoing and/or other aspects of the present invention provide an accessory configured to be attached to a device for disinfecting a skin surface, the accessory comprising: a light emitting source emitting visible light to disinfect the skin surface; and a mounting mechanism configured to attach and detach the light emitting source and the device.

In the foregoing and/or other aspects of the present invention, the device includes one of a drug delivery pen, a syringe, a patch pump, and a safety pen.

In the foregoing and/or other aspects of the present invention, the device includes one of a drug delivery pen having a pen cap and an injector having an injector shield; and the mounting mechanism is attached to one of the pen cap and the injector shield.

In the foregoing and/or other aspects of the present invention, the mounting mechanism includes one of a universal cap, a spring-loaded member, a press-fit, an adhesive, threads, and a button.

In the foregoing and/or other aspects of the present invention, the accessory further comprises: a power supply for supplying power to the light emitting source; and a switch for activating and deactivating the light emitting source.

In the foregoing and/or other aspects of the utility model, the accessory further comprises a receptacle for carrying the light emitting source.

The foregoing and/or other aspects of the present invention provide an assembly configured to disinfect a skin surface and a medical device or a portion of a medical device, the assembly comprising: a cover for the medical device, the cover comprising: a power source to provide power, an electromagnetic radiation source to emit electromagnetic radiation for disinfection using the power received from the power source, and a switch configured to be operated by user action; and an accessory according to the present invention, wherein said mounting mechanism is attached to an outer surface of said cover, and upon activation of said switch, said power from said power source is applied to at least one of said electromagnetic radiation source and said light emitting source for disinfection.

In the foregoing and/or other aspects of the present invention, the mounting mechanism includes electrical contacts; the cap of the medical device comprises an electrical contact; and the electrical contacts of the mounting mechanism engage the electrical contacts of the cover to provide power from the power source to the light-emitting source.

Additional and/or other aspects and advantages of the utility model will be set forth in the description which follows or will be obvious from the description, or may be learned by practice of the utility model.

Drawings

The above aspects and features of the present invention will become more apparent by describing exemplary embodiments thereof with reference to the attached drawings, in which:

FIG. 1 is a perspective view of a prior art assembled drug delivery pen;

FIG. 2 is an exploded perspective view of components of the drug delivery pen and pen needle of FIG. 1;

FIG. 3 is a cross-sectional view of an exemplary embodiment of a cap of a drug delivery pen;

FIG. 4 is a schematic view of electrical components within the cover of FIG. 3 without user input;

FIG. 5 is a schematic view of electrical components within the cover of FIG. 3 with user input;

FIG. 6 is a schematic diagram of the circuitry of another exemplary embodiment of a cover;

FIG. 7 is a cross-sectional view of an exemplary embodiment of a cap of the drug delivery pen of FIG. 3 with a light emitting source on an outer surface of the cap;

FIG. 8 is a cross-sectional view of an exemplary embodiment of an accessory attached to a drug delivery pen for disinfecting a skin surface.

Detailed Description

Related applications: this application is a continuation-in-part application of U.S. non-provisional application serial No. 16/777,553 filed on 30/1/2020, claiming the benefit of U.S. provisional patent application serial No. 62/804,415 filed on 12/2/2019, both of which are incorporated herein by reference in their entirety.

Fig. 3 shows a cap 50 for a medical device, such as the drug delivery pen 10, according to an embodiment of the present invention. The lid 50 includes side walls 52 and a top wall 54. The cap 50 is configured to enclose a distal portion of the drug delivery pen 10. Specifically, when the cap 50 is mounted to the drug delivery pen 10, the top wall 54 is positioned opposite the septum 18 of the drug delivery pen 10. Side wall 52 is connected to top wall 54 and surrounds body 20. In this configuration, the distal end of the cap 50 is disposed substantially centrally along the longitudinal axis of the drug delivery pen 10.

The embodiments of the cap 50 disclosed herein are most commonly configured to be mounted onto the drug delivery pen 10, while the pen needle is not present. However, with appropriate modification, other types of medical devices that require sterilization, such as needleless IV connectors, extension sets, IV sets, catheters, syringes (such as pre-filled syringes), drug (e.g., insulin) vials, and other devices having externally accessible surfaces, such as septa, may incorporate the cap 50 for sterilization purposes. Any surface or portion of the medical device contained within the cover 50 and exposed to the electromagnetic radiation source 68 may be sterilized.

With respect to drug delivery pen 10, even if the pen needle is attached to drug delivery pen 10 and covered by cap 50, operation of cap 50 may still occur. In this case, the pen needle may be sterilized instead of the septum 18. However, this is generally not preferred as repeated use of the pen needle is not recommended.

The cap 50 is configured to be indirectly connectable to the drug delivery pen 10 via the universal fitting 40 (shown in fig. 3-5) or directly connectable to the drug delivery pen without the universal fitting 40 (not shown). An exemplary embodiment of the universal fitting 40 includes a ring that tightens the fit between the distal end of the cap 50 and the cartridge 16 of the drug delivery pen 10. A rotating sleeve that reduces the inner diameter when rotated and acts like a telescoping rod is another universal fitting 40 that tightens the fit between the cap 50 and the drug delivery pen 10. In addition, the use of ribs, pleats, or graduations as a universal fitting 40 provides an expandable, collapsible, and/or frictional surface at the interface between the distal end of the cap 50 and the body 20. The universal fitting 40 may have prongs to provide mechanical engagement between the cap 50 and the body 20. Finally, another embodiment of the universal fitting 40 is a spring loaded member that provides a force to be applied between the distal end of the cap 50 and the drug delivery pen 10.

The use status of the universal accessory 40 is provided as feedback to the microcontroller 62 as further described below and shown in fig. 4 and 5. The use state of the universal fitting 40 includes, for example, a capped position when the outer surface of the universal fitting 40 is engaged to the inner surface of the cap 50 and when the inner surface of the universal fitting 40 is engaged to the outer surface of the cartridge 16 of the drug delivery pen 10. The use state of the universal fitting 40 also includes an uncapped position, for example, when one or both of these connections are disconnected. Alternatively, the universal accessory 40 may be used without the cooperation of the microcontroller 62, as further described in fig. 6.

The universal accessory 40 may also cooperate with the microcontroller 62 to change the command for emitting electromagnetic radiation 70 and/or visible light 170 based on the status. For example, when the universal accessory 40 and the cover 50 are engaged, the microcontroller 62 issues a command for emitting electromagnetic radiation 70 and/or visible light 170. On the other hand, if one or both of the connections are disconnected, the microcontroller 62 does not issue a command to emit electromagnetic radiation 70 and/or visible light 170.

The lid 50 includes a power source 60 that provides power to the lid 50. The power source 60 is preferably a flexible battery wrapped along the inner surface of the sidewall 52. The power supply 60 may also be a lithium battery. Finally, the power source 60 may be a wired circuit that provides power (AC/DC current) to the lid 50.

If the power source 60 is a battery, the battery 60 may be rechargeable via solar energy, motion, or electricity (wired or wireless). Alternatively or additionally, the battery 60 may be discarded and replaced. In addition, the cover 50 may be replaced when the battery 60 is depleted. The power source 60 may be disposed on an inner or outer surface of the side wall 52 or the top wall 54.

As shown in fig. 3-5, the power supply 60 is configured to provide power, particularly to the microcontroller 62 of the lid 50 or directly to the electromagnetic radiation source 68 (see fig. 6). The electromagnetic radiation source 68 (internal light source) may emit electromagnetic radiation in a selected wavelength range, including Ultraviolet (UV) light 70.

In another embodiment, as described below, the light emitting source 168 (external light source) may optionally emit visible light within a selected wavelength range independently and/or uniquely relative to the electromagnetic radiation source 68. In other words, the embodiment shown in fig. 7 may include both the electromagnetic radiation source 68 and the light emitting source 168, while another embodiment may include only the light emitting source 168. The operation of the electromagnetic radiation source 68 in relation to the remaining features of the medication delivery pen 10 disclosed herein may be similarly configured and applied to the light emitting source 168.

The microcontroller 62 is programmed to sense and control the operation of the lid 50 as is commonly understood by those skilled in the art. Specifically, the microcontroller 62 receives feedback and issues commands to the various components of the lid 50, including, for example, the universal accessory 40 (as described above), the timer 64, the indicator 66, the electromagnetic radiation source 68, the light emitting source 168, and the switch 72.

Electromagnetic radiation source 68 advantageously emits electromagnetic radiation 70 to sterilize septum 18 of drug delivery pen 10. Electromagnetic radiation 70 is also emitted onto other surfaces or portions of drug delivery pen 10 enclosed by cap 50. A source of electromagnetic radiation 68 is provided on the inner surface of the top wall 54 of the lid 50.

In another embodiment, the light emitting source 168 advantageously emits visible light 170 for disinfecting the skin surface 80 at the injection site prior to needle insertion. Visible light 170 may also be applied to other medical devices and surfaces. However, such applications are not as effective at sterilizing as the ultraviolet light emitted by the electromagnetic radiation source 68.

As shown in fig. 7, a light emitting source 168 is disposed on the outer surface of the top wall 54 of the cover 50 to emit visible light 170 to disinfect the skin surface 80. However, the light emitting source 168 may also be disposed on an outer surface of the sidewall 52 of the cap 50, on a longitudinal side surface of the housing 11 of the drug delivery pen 10, or on any other outer surface of any other medical device 10.

In yet another embodiment, both the power source 60 and the electromagnetic radiation source 68 are stacked on the inner surface of the top wall 54 of the lid 50. Thus, the electromagnetic radiation source 68 is disposed distal to the power source 60 such that the electromagnetic radiation 70 may be emitted directly onto the septum 18 of the drug delivery pen 10 and onto other surfaces or portions of the drug delivery pen 10.

In another embodiment, the electromagnetic radiation source 68 is positioned such that the electromagnetic radiation 70 does not directly impinge on the diaphragm 18. While it is more efficient to radiate electromagnetic radiation 70 directly on the diaphragm 18, this configuration is not critical to efficient operation and sterilization.

Commands to control the operation of the electromagnetic radiation source 68 and the light emitting source 168 are received from the microcontroller 62 or directly from the switch 72 (see fig. 6). The electromagnetic radiation source 68 and the light emitting source 168 are preferably a plurality of Light Emitting Diodes (LEDs) that are commercially known and available. LEDs have advantages in emitting light at optimal wavelengths for improved disinfection, have a small footprint, and consume much less energy due to their instant on/off capability. However, any source of energy for sterilization may be used.

A variety of wavelength ranges from the electromagnetic spectrum may be used for disinfection. For example, the relative effectiveness of ultraviolet light wavelengths for this process is known as the germicidal action spectrum, with a peak at a maximum wavelength of 265nm (UV-C). Thus, the preferred wavelength range of the ultraviolet light 70 is between 250nm and 280 nm. Many applications require an exposure range of 10mJ/cm²And 100mJ/cm²In the meantime.

In view of the above, alternative wavelengths may be used. All uv wavelengths shorter than 300nm are effective at disinfecting and killing microorganisms. The main principle of operation is based on ultraviolet germicidal irradiation (UVGI). This disinfection method uses short-wave ultraviolet light to kill or inactivate microorganisms by destroying nucleic acids and destroying their DNA or causing photodegradation of their DNA. Thus, such disinfection methods may be harmful to humans and inorganic materials, such that, for example, exposure to these wavelengths may severely damage skin and eyes.

UVGI is commonly used to disinfect equipment such as safety glasses, instruments, pipettes, and other devices. Laboratory personnel also disinfect glassware and plastic ware in this manner. The microbiological laboratory uses UVGI to disinfect surfaces within a biosafety cabinet ("hood") between uses (see the following link, incorporated herein by reference for this purpose: https:// www.medicaldesignandoutsourcing.com/uvc-leds-energizing-new-generationally-enabled-machinery-devices /). Therefore, it is preferable to perform ultraviolet sterilization in the absence of human and inorganic materials. However, the limitations of uv disinfection have reduced its usefulness in some situations.

Longer wavelengths may be equally effective given sufficient energy and time. However, disinfection at each location should be managed individually for best results. White light is understood to be a mixture of all wavelengths in the visible spectrum. Visible light is understood to be typically in the range of 400-700 nm. Light in the wavelength range of 400-410nm, also known as violet light, has in particular the ability to disinfect bacterial cells, but does not have all the same effects of ultraviolet light on mammalian cells. Such visible light applications may preferably be mixed wavelength applications, although monochromatic light is also possible. Human cells can be exposed to visible light without causing harm to the human cells and without losing cell activity. For example, visible light has been shown in the literature to kill gram negative and gram positive bacteria, bacterial endospores, yeasts, molds, and fungi. This is because both mammalian and bacterial cells have porphyrin molecules, but mammalian cells have a more complex approach to dealing with oxidative damage than bacterial cells, making bacterial cells more primitive and less resistant to visible light.

The destruction of microorganisms by the ultraviolet light 70 is an exponential process. The higher the given exposure, the higher the proportion of microorganisms that are destroyed. Thus, the exposure required to break 99% is twice the value of 90% break. Thus, the exposure required to kill 99.9% is three times the value of 90% destruction, and the exposure required to kill 99.99% is four times the value of 90% destruction.

Although the preferred wavelength ranges of the ultraviolet light 70 and visible light 170 are desired, the duration of the emission of the ultraviolet light 70 and visible light 170 required for disinfection is a function of distance, power, time, and wavelength. The required exposure (i.e., UV dose, visible dose, or energy) can be calculated using the following formula:

dose (J/m2) ═ irradiance (W/m2) x exposure time (seconds)

The necessary wavelength and exposure time may be calculated based on the desired dose of UV light 70 as set forth in the following table:

bacterial-uv dose correlation table:

alternatively, the target wavelength may be used to calculate the energy consumption by the following equation:

e ═ hc/λ Joule

Wherein:

h-planck constant (6.626x 10)^-34Js)

C-speed of light (2.998x 10)⁸ms^-1)

λ is the wavelength in m

Once the target energy is determined, the energy consumption (i.e., power) can be calculated using the following equation:

when calculating the power P (in watts), an appropriate power supply 60 may be selected to provide the required energy for the desired duration. For example, assume the size of the pen cap (about 3.14 cm)²) In the region of (1) within 100mJ/cm²Exposure to UV for 10 seconds (based on patient comfort) (depending on the exposure necessary for UV disinfection) requires about 0.0314 watts of energy. Given that visible (violet) light has a longer wavelength, it consumes more energy under the same conditions. This analysis shows that basic button cells or similar small power sources are suitable for operating uv and visible light for multiple exposures over the life of the cell. The amount of time required for disinfection is related to the distance from the light source, the light dose, the wavelength and the microorganisms.

The cover 50 also includes a switch 72 that causes the microcontroller 62 to generate commands that activate and deactivate the electromagnetic radiation source 68 and the light-emitting source 168. Alternatively, as shown in FIG. 6, the switch 72 itself connects and disconnects the power supply 60 to the electromagnetic radiation source 68 and the light emitting source 168 to control the illumination of the electromagnetic radiation source 68. As shown in fig. 3, the switch 72 is provided on the inner surface of the side wall 52 of the cover 50. However, the switch 72 may be disposed on any interior or exterior surface of the cover 50. The switch 72 may be an actuation switch, such as a microswitch, a spring loaded switch or a push button switch. In another embodiment, the switch 72 includes a first switch and a second switch to individually activate and deactivate the electromagnetic radiation source 68 and the light emitting source 168, respectively.

In particular, the micro-switch and/or spring loaded switch may be activated based on pressure from the user prior to injection (manual) or force applied between the cap 50 and the drug delivery pen 10 during assembly (automatic). As shown in fig. 4, upon sensing increased pressure, the microswitch 72 sends a signal to the microcontroller 62 to activate the electromagnetic radiation source 68 and the light emitting source 168 (capping, depressed position). When the user releases the pressure or when the cap 50 and drug delivery pen 10 are removed, the pressure decreases and the micro switch 72 sends a signal to the microcontroller 62 to deactivate the electromagnetic radiation source 68 and the light emitting source 168 (uncapped, relaxed position).

Thus, the spring force provides a single activation of the electromagnetic radiation source 68 and the light emitting source 168. After a predetermined period of time, the electromagnetic radiation source 68 and the light emitting source 168 are deactivated. Alternatively, a manual switch may be implemented to trigger activation of the electromagnetic radiation source 68 and the light-emitting source 168 for a desired duration prior to each use. In this regard, the activation and deactivation of the electromagnetic radiation source 68 and the light-emitting source 168 may be automatic, instantaneous, simultaneous, or alternating based on a programmed signal from the microcontroller 62 or the engagement and disengagement of the micro-switch 72.

If provided as a spring loaded switch, the switch 72 may release the spring force upon receiving increased pressure during assembly of the cap 50 to the drug delivery pen 10. The spring force provides for one activation of the electromagnetic radiation source 68 and the light emitting source 168. After a predetermined period of time, the electromagnetic radiation source 68 and the light emitting source 168 are deactivated.

The timer 64 may be incorporated into the spring-loaded switch 72, for example, to provide a predetermined period of time for the emission of electromagnetic radiation and visible light or a time delay before the emission of electromagnetic radiation and visible light is initiated. When the switch 72 is engaged, the timer 64 may be activated. For example, when the distance between the electromagnetic radiation source 68 and the septum 18 of the drug delivery pen 10 is two inches, the timer 64 may cause the electromagnetic radiation source 68 to emit electromagnetic radiation 70 at a wavelength of 265nm for up to 120 seconds. In a similar manner, the timer 64 may cause the light emitting source 168 to emit visible light 170 at a wavelength of 405nm for a particular amount of time at a particular distance between the light source 168 and the skin surface 80. The timer 64 may also cooperate with the microcontroller 62 to vary the commands for activating and deactivating the electromagnetic radiation source 68 and the light-emitting source 168.

As shown in fig. 5, when provided as a push button switch, the switch 72 may deflect, release force and/or establish electrical contact with the microcontroller 62 based on, for example, manipulation (such as pressing) by a user, such as a clinician or patient. In this manner, the user can control the activation and deactivation of the electromagnetic radiation source 68 and the light emitting source 168.

The switch 72 may also be a proximity sensor, a hall effect sensor, a photosensor, an optical sensor, and a force sensor. The operation of these sensors is generally understood by those skilled in the art. The proximity sensor may sense that the cap 50 is disposed on the drug delivery pen 10 and indicate this to the microcontroller 62. Subsequently, microcontroller 62 can command electromagnetic radiation source 68 to emit electromagnetic radiation 70 and command light emitting source 168 to emit visible light 170. When the cap 50 is removed from the drug delivery pen 10, the proximity sensor notifies the microcontroller 62 of this and the microcontroller commands the electromagnetic radiation source 68 to stop emitting electromagnetic radiation 70 and commands the light emitting source 168 to stop emitting visible light 170.

The cover 50 also includes an indicator 66 that displays a number of conditions, such as indicating when the electromagnetic radiation source 68 is activated or deactivated, when the light emitting source 168 is activated or deactivated, when the disinfection/sterilization process of the medical device 10 or the skin surface 80 is complete, and the remaining life of the power source 60. Indicator 66 communicates with microcontroller 62 to receive the status of one or more of these conditions prior to display. Indicator 66 displays these conditions through a number of mediums known to those skilled in the art, such as, for example, colors, symbols, and text.

The above-described cover 50 provides advantages not realized in the prior art. The cap 50 improves the workflow and convenience of a user (such as a clinician or patient) using the drug delivery pen 10. In particular, the user no longer needs to clean the skin surface 80, the septum 18, or other surfaces or portions of a medical device, such as the drug delivery pen 10, with an alcohol wipe or disinfectant wipe. This is because the cap 50 alone can use the electromagnetic radiation 70 and visible light 170 to sterilize the skin surface 80, the septum 18, and other surfaces or portions of the drug delivery pen 10. Thus, the user does not need to carry a separate alcohol wipe package or sterile wipe with the drug delivery pen 10 and manage additional steps in sterilizing the skin surface 80, septum 18, or other surface or portion. In addition, the skin surface 80, the septum 18, and other surfaces or portions are more reliably sterilized without user error such as ineffective sterilization or non-sterilization.

To operate the cap 50 with the drug delivery pen 10, the user simply attaches the cap 50 to the drug delivery pen 10 with or without the universal fitting 40 as described above. The electromagnetic radiation source 68 and the light emitting source 168 are then activated either automatically or manually by the user. Electromagnetic radiation source 68 emits electromagnetic radiation 70 on exposed septum 18 of drug delivery pen 10 to sterilize septum 18. Other surfaces or portions of the drug delivery pen 10 are also sterilized. Prior to needle insertion, light emitting source 168 emits visible light 170 toward skin surface 80. After sterilization is complete, the cap 50 is then removed. Next, the pen needle is attached to the cartridge 16 of the drug delivery pen 10. The drug delivery pen 10 is now ready to deliver a drug into the sterilized skin surface 80. The needle of the pen needle is then inserted into the skin surface 80 to dispense the drug to the patient.

After the drug delivery is complete, the pen needle will be removed from the cartridge 16 and discarded. The septum 18 of the cartridge 16 in the drug delivery pen 10 is now exposed. Next, the user returns and attaches the cap 50 to the drug delivery pen 10. Sterilization of the septum 18 and other surfaces or portions of the drug delivery pen 10 is resumed similarly as described above. If another dose of medicament is to be dispensed, the other skin surface 80 may also be disinfected by the light emitting source 168 in a manner similar to that described above. This sterilization process may be repeated between multiple injections of the drug delivery pen 10.

In a simpler embodiment as described above and shown in fig. 6, the push button switch 72 and current limiting resistor 74 can control power directly from the power supply 60 to the electromagnetic radiation source 68 and the light emitting source 168 without the microcontroller 62. In this case, the user controls the duration of the sterilization, for example, by the length of time that the push button switch 72 is operated, activated, or depressed. That is, when the switch 72 is operated or depressed, the electromagnetic radiation source 68 and the light emitting source 168 use power from the power source 60 to illuminate the electromagnetic radiation source 68 and the light emitting source 168. When the switch 72 is not in operation or is not depressed, the electromagnetic radiation source 68 and the light emitting source 168 do not use power from the power supply 60. Therefore, no sterilization is performed.

As mentioned above, FIG. 7 shows an embodiment of the drug delivery pen 10 covered by a cap 50 that includes the electromagnetic radiation source 68 and the light emitting source 168 to sterilize the septum 18 and the skin surface 80, respectively, of the drug delivery pen 10. The features of the above-described embodiment may be equally applied to this embodiment as long as the operation of the features does not contradict the operation of this embodiment.

This embodiment advantageously allows for disinfection at the frequency allowed by the power supply. As described above with respect to the feasibility study, a basic coin cell battery or similar small power source may operate the electromagnetic radiation source 68 and the light emitting source 168 for multiple exposures over the life of the battery. This configuration has minimal limitations on shelf life and efficacy due to its long-term use.

In addition, the dual sterilization technique disclosed in the present embodiment saves time and improves the workflow and convenience of a user (such as a clinician or patient) using the drug delivery pen 10. Another advantage is that the user no longer needs to rely on an alcohol wipe or disinfectant wipe to disinfect the skin surface 80, the septum 18, or other exposed surface or portion of the drug delivery pen 10. Indeed, the cap 50 may be configured to automatically sterilize the septum 18 or other exposed surface or portion of the drug delivery pen 10, thereby saving time. In addition, it is more convenient to disinfect the skin surface 80 simultaneously or alternately with respect to disinfection of the septum 18 to improve workflow and optimize time. Sterilization of the drug delivery pen 10 with the cap 50 is also advantageously more controlled or automated to meet high precision and performance requirements. Finally, the user no longer needs to carry an alcohol wipe and/or a sterile wipe for the medical device and/or the skin surface 80. Thus, the disclosed embodiments provide such a solution for a drug delivery pen 10 for safe skin disinfection using light within the visible spectrum.

Fig. 8 illustrates another embodiment of providing an accessory 240 configured to be mounted to the drug delivery pen 10 to disinfect the skin surface 80 at the injection site. The features of the above-described embodiment may be equally applied to this embodiment as long as the operation of these features does not contradict the operation of this embodiment. Specifically, the accessory 240 may be used with any device, including any of the medical devices 10 described above, as well as syringes with or without syringe shields and drug delivery pens with or without caps. At least the power supply 260, timer 264, light emitting source 268, and switch 272 disclosed in this embodiment are the same or similar to the corresponding components in the embodiments described above.

Instead of integrating the light emitting source 268 into the drug delivery pen 10 as described in the above embodiment, this embodiment provides the light emitting source 268 through an attachment 240 that is attached to the drug delivery pen 10. Accessory 240 is attachable to and detachable from drug delivery pen 10, such as drug delivery pen 10 shown in FIG. 8. Specifically, the cap 50 of the drug delivery pen 10 is configured to engage the accessory 240.

In one embodiment, the attachment 240 includes an optional receptacle 250 carrying the light emitting source 268. The receptacle 250 is a cylindrical cavity sized to store and hold the light emitting source 268. For example, the light emitting source 268 is held in the container 250 by an adhesive, although other holding means are also contemplated.

The accessory 240 also includes a mounting mechanism 252 that attaches the accessory to the drug delivery pen 10. FIG. 8 illustrates the mounting mechanism 252 as including a mechanical clamp. However, other exemplary mounting mechanisms 252 may include, for example, a universal cover, a spring-loaded locking mechanism, a press-fit piece, an adhesive, a hook-and-loop fastener (Velcro), a threaded member, a spring clip, and a button similar to the universal fittings described above. The mounting mechanism 252 is advantageously selected based on the particular device 10 being used.

The mechanical clamp 252 resiliently compresses the cap 50 of the drug delivery pen 10 to secure the accessory to the drug delivery pen 10. In one embodiment, the proximal portion of the mechanical clamp 252 includes electrical contacts 254 that engage electrical contacts 256 of the drug delivery pen 10 at the compressed portion. In this manner, power is transmitted from the power source 60 through the

electrical contacts

254, 256 and through the wires disposed in the hollow mechanical clamp 252 to electrically connect to the power source 260 and provide energy to the power source.

In another embodiment, the power supply 260 is a separate, stand-alone battery, such as the battery commonly used in watches or a rechargeable battery. Thus, the power supply 260 provides power to the timer 264, the light emitting source 268, and the switch 272. In another embodiment, the accessory 240 is configured to be attached to a drug delivery pen 10 comprising a cap 50 having a source of electromagnetic radiation 68, as similarly described in the previous embodiments.

For use of medical products, the embodiment of the attachment 240 disclosed in fig. 8 advantageously provides visible light 270 to safely disinfect the skin application surface 80. The accessory 240 is advantageously adaptable to a variety of medical devices 10 and is configured to be attached and detached for general and convenient use. For ease of use, the accessory 240 may also be advantageously attached to and detached from the non-medical device 10 (an accessory such as a phone or wallet). Finally, accessory 240 also provides similar advantages as described above.

The foregoing detailed description of certain exemplary embodiments has been provided for the purpose of illustrating the principles of the present invention and its practical application, thereby enabling others skilled in the art to understand the present invention for various embodiments and with various modifications as are suited to the particular use contemplated. This description is not necessarily intended to be exhaustive or to limit the utility model to the precise embodiments disclosed. Any embodiments and/or elements disclosed herein may be combined with each other to form various additional embodiments not specifically disclosed, so long as they are not mutually inconsistent. Accordingly, additional embodiments are possible and are intended to be included within the scope of this description and the utility model. The specification describes specific examples for achieving a more general objective that may be achieved in another way.

As used in this application, the terms "front," "back," "upper," "lower," "upward," "downward," and other orientation descriptors are intended to facilitate the description of exemplary embodiments of the utility model and are not intended to limit the structure of exemplary embodiments of the utility model to any particular position or orientation. Terms of degree such as "substantially" or "approximately" are understood by those of ordinary skill to refer to a reasonable range outside of the given value, e.g., the general tolerances associated with manufacturing, assembly, and use of the described embodiments.

Claims

1. A cap for a medical device, the cap configured to disinfect a skin surface, the cap comprising:

a power source that supplies power;

a light emitting source that disinfects the skin surface using power received from the power source; and

a switch configured to be operated by a user action; wherein

Upon activation of the switch, the power from the power source is received by the light emitting source to emit visible light and disinfect the skin surface.

2. The cover for a medical device of claim 1, wherein the power source comprises a battery.

3. The cover for a medical device of claim 1, further comprising an electromagnetic radiation source that emits ultraviolet light using the power received from the power source to sterilize the medical device or a portion thereof.

4. The cover for a medical device of claim 3, wherein the electromagnetic radiation source radiates electromagnetic radiation to sterilize the medical device or a portion thereof.

5. The cover of a medical device according to claim 3, wherein the electromagnetic radiation source is disposed inside the cover.

6. The cap for a medical device according to claim 3,

the electromagnetic radiation source emits light at a bandwidth to disinfect the portion of the medical device; and is

The portion of the medical device is a surface of the medical device.

7. The cap for a medical device according to claim 1,

the medical device comprises a vial; and is

The vial includes a septum to selectively seal the medicament therein.

8. The cover of the medical device of claim 1, wherein the light emitting source is disposed on an outer surface of the cover.

9. The cover of a medical device according to claim 1, wherein the light emitting source emits visible light in a wavelength range between 400nm and 410 nm.

10. The cover for a medical device according to claim 3, wherein said light emitting source operates simultaneously with said electromagnetic radiation source.

11. The cover of a medical device according to claim 3, wherein the light emitting source is operated alternately with respect to the electromagnetic radiation source.

12. The cover of a medical device according to claim 4, wherein the emission from the light emitting source is of a different wavelength than the radiation from the electromagnetic radiation source.

13. A medication pen needle assembly, comprising:

a cap for a medical device according to claim 3;

the medical device comprising a drug delivery pen; and

a pen needle attached to the drug delivery pen, wherein

Power from the power source is applied to the electromagnetic radiation source to radiate electromagnetic radiation on the needle of the pen needle.

14. A medication pen needle assembly, comprising:

a cap for a medical device according to claim 1;

the medical device comprising a drug delivery pen; and

a universal fitting disposed between the cap and the drug delivery pen for securing the cap to the drug delivery pen.

15. A cap for a medical device, the cap configured to disinfect a skin surface, the cap comprising:

a power supply to power a microcontroller, the microcontroller sensing and controlling operation of the lid;

a light emitting source emitting visible light under the control of the microcontroller to disinfect the skin surface; and

causing the microcontroller to activate and deactivate the switch of the light emitting source.

16. The cover for a medical device of claim 15, further comprising:

an electromagnetic radiation source that radiates electromagnetic radiation under control of the microcontroller to sterilize the medical device or a portion thereof; wherein

The switch causes the microcontroller to activate and deactivate the electromagnetic radiation source.

17. The medical device cover of claim 15, wherein the switch comprises a micro-switch, a proximity sensor, a hall effect sensor, a photosensor, an optical sensor, or a force sensor.

18. The medical device cover of claim 16, further comprising an indicator that indicates at least one of whether the electromagnetic radiation source is activated, whether the light emitting source is activated, whether any sterilization process is complete, and the remaining life of the power source.

19. The cover of the medical device of claim 16, further comprising a timer that controls at least one of a time delay, a duration of radiation, and a duration of emitted visible light.

20. An accessory configured to be attached to a device for disinfecting a skin surface, the accessory comprising:

a light emitting source emitting visible light to disinfect the skin surface; and

a mounting mechanism configured to attach and detach the light emitting source and the device.

21. The accessory of claim 20, wherein the device comprises one of a drug delivery pen, a syringe, a patch pump, and a safety pen.

22. The accessory of claim 20,

the device comprises one of a drug delivery pen having a pen cap and an injector having an injector shield; and is

The mounting mechanism is attached to one of the pen cap and the injector shield.

23. The accessory of claim 20, wherein the mounting mechanism comprises one of a universal cap, a spring-loaded member, a press-fit, an adhesive, threads, and a button.

24. The accessory of claim 20, further comprising:

a power supply for supplying power to the light emitting source; and

a switch for activating and deactivating the light emitting source.

25. The accessory according to claim 20, further comprising a container for carrying said light emitting source.

26. An assembly configured to disinfect a skin surface and a medical device or a portion of a medical device, the assembly comprising:

a cover for the medical device, the cover comprising:

a power source for supplying electric power to the electric motor,

an electromagnetic radiation source for emitting electromagnetic radiation for disinfection using the power received from the power source, and

a switch configured to be operated by a user action; and

the accessory according to claim 20,

the mounting mechanism is attached to an outer surface of the cap, and

upon activation of the switch, the power from the power source is applied to at least one of the electromagnetic radiation source and the light emitting source for disinfection.

27. The combination of claim 26,

the mounting mechanism includes electrical contacts;

the cap of the medical device comprises an electrical contact; and is

The electrical contacts of the mounting mechanism engage the electrical contacts of the cover to provide power from the power source to the light-emitting source.