CN116056748A

CN116056748A - Medical device for disinfecting skin surfaces

Info

Publication number: CN116056748A
Application number: CN202180057056.9A
Authority: CN
Inventors: J·加特纳; M·法姆; P·格吉斯
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2020-08-07
Filing date: 2021-08-02
Publication date: 2023-05-02
Also published as: EP4192549A1; WO2022031574A1; CN215938602U

Abstract

A medical device (40) and method configured to disinfect a skin surface (80), the device comprising a power source (60) providing power, a light emitting source (68) disinfecting the skin surface using power received from the power source, and a switch (72) configured to be operated by a user action, wherein when the switch is activated, power from the power source is received by the light emitting source to emit visible light and disinfect the skin surface.

Description

Medical device for disinfecting skin surfaces

RELATED APPLICATIONS

This application is a continuation-in-part application of U.S. non-provisional application Ser. No.16/777,553, filed 1/30/2020, which claims the benefit of U.S. provisional patent application Ser. No.62/804,415, filed 2/12/2019, the contents of which are incorporated herein by reference in their entirety.

Technical Field

The present invention relates to medical devices for disinfecting the skin surface at an injection site prior to administration.

Background

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

As technology and competition advances, the design of drug delivery devices such as pen needles and their components has become increasingly important to drive the need for shorter, thinner, less painful, and more effective injections. The design requires active solutions to ergonomically improve injection technology, injection depth control and accuracy, the ability to be safely used and transported for disposal, sterilization, disinfection and prevention of misuse, while maintaining the ability to be manufactured in a large production scale economy.

Drug delivery devices, such as the exemplary drug delivery pen 10 shown in fig. 1 and 2, may be designed for subcutaneous as well as intradermal injection, and generally include a dose knob/button 22, an outer sleeve or housing 11, and a cap 50. The dose knob/button 22 allows the clinician or patient to set a dose of medication to be injected. The housing 11 is gripped by a user when injecting the medicament. The user may use the cap 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 sticks. 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 dual purposes and is used both to set a dose of medicament to be injected and to inject a dose of medicament through the cartridge 16 via the lead screw 12 and the plunger/stopper 14, which is attached to the medicament delivery pen 10 through the body 20. In a standard drug delivery pen, the dosing and delivery mechanism is located within the housing 11 and will not be described in more detail herein, as they will be understood by those familiar with the art.

For operation, the drug delivery pen 10 is attached to a pen needle comprising a needle/cannula 30, a septum-penetrating cannula 32 and a hub 34. Specifically, distal movement of plunger or stopper 14 within cartridge 16 causes medication to be forced into needle 30 of 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, although other attachment means may be used.

To protect the user or anyone manipulating the pen needle from accidental needle sticks, 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 to cover the patient needle 30 by any suitable means, such as an interference fit or a snap fit. The outer cover 38 and inner shroud 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. Stopper 14 is axially displaceable within drug cartridge 16 while maintaining a fluid-tight seal.

Existing drug delivery pens are disclosed in U.S. patent application publication No.2006/0229562 to Marsh et al published at 10/12 in 2006 and in R.Marsh No.2007/0149924 published at 28 in 6 in 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 sterilizing septum 18 with an alcohol wipe prior to attaching a pen needle for drug delivery and sterilizing the skin surface at the injection site with a sterile wet wipe prior to administration. However, it presents challenges to disinfect the drug delivery pen 10 and the skin surface consistently and accurately for safe patient care. Carrying alcohol wipes and/or sterile wipes with the drug delivery pen 10 can be a burden to the user. In addition, alcohol wipes and/or sterilized wet wipes have shelf life limitations and are typically only intended for single use. In some cases, the septum 18 may not be properly sterilized prior to use. Always following the best disinfection practices is not always feasible and difficult to ensure. Accordingly, there is a need for improved disinfection devices and procedures for use with medical devices such as drug delivery pen 10.

Disclosure of Invention

An aspect of the invention provides a cap that is capable of disinfecting a skin surface at an injection site, alone or in combination with disinfecting a medical device or a portion of a medical device, such as a septum surface. This configuration improves the workflow and convenience for the 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 disinfect the skin surface, septum, or other exposed surface or portion of the medical device using an alcohol wipe or disinfectant wet wipe. In fact, the cover may be configured to automatically sterilize the septum or other exposed surface or portion, thereby saving time. Furthermore, the skin surface is more conveniently disinfected simultaneously or alternately with respect to the disinfection of the membrane to improve the workflow and optimize the time. The use of the cap 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 alcohol wipes and/or sterile wipes for the medical device and/or skin surface.

Another aspect of the invention provides an accessory attachable to the device to disinfect a skin surface prior to injection. Such an accessory provides visible light to safely disinfect the skin surface prior to needle injection of the device. The accessory may also be adapted for use with a variety of products including medical devices and configured to attach and detach 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 electrical power; a light source for disinfecting 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.

The foregoing and/or other aspects of the present invention may also be achieved by providing a cap for a medical device, the cap being configured to disinfect a skin surface, the cap comprising: a power supply for powering a microcontroller, said microcontroller sensing and controlling operation of said cover; a light source emitting visible light under 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 may also be achieved by providing a method of sterilizing and injecting a drug to a skin surface using a medical device, the method comprising 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 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 initiate 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 may additionally be achieved by providing an accessory configured to be attached to a device to disinfect a skin surface, the accessory comprising 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 device.

The foregoing and/or other aspects of the present invention are also achieved by providing a method of disinfecting and injecting a drug substance using a medical device, the method comprising mounting an accessory to an outer surface of a cap of the medical device, the accessory comprising a light source that emits visible light to disinfect the skin surface; activating the light 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 medicine.

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

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 diagram 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; and

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

Fig. 3 shows a cap 50 for a medical device such as a 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 cap 50 is mounted to drug delivery pen 10, top wall 54 is positioned opposite septum 18 of 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 to a drug delivery pen 10 without the pen needle being present. However, with appropriate modification, other types of medical devices requiring 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 an externally accessible surface (such as a septum), cap 50 may be incorporated for sterilization purposes. Any surface or portion of the medical device housed within the cap 50 and exposed to the electromagnetic radiation source 68 may be sterilized.

With respect to the drug delivery pen 10, even if the pen needle is attached to the drug delivery pen 10 and covered by the cap 50, the operation of the 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 because repeated use of the pen needle is not recommended.

The cap 50 is configured to be indirectly connectable to the drug delivery pen 10 (shown in fig. 3-5) via the universal fitment 40, or directly connectable to the drug delivery pen (not shown) without the universal fitment 40. An exemplary embodiment of universal fitting 40 includes a ring that tightens the fit between the distal end of cap 50 and cartridge 16 of drug delivery pen 10. A rotating sleeve that reduces the inner diameter when rotated and acts like a telescoping rod is another common fitting 40 that tightens the fit between the cap 50 and the drug delivery pen 10. Further, the use of ribs, pleats, or graduations as universal fitting 40 provides an expandable, contractible, and/or friction surface at the interface between the distal end of cap 50 and 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 an applied force between the distal end of the cap 50 and the drug delivery pen 10.

The status of the use of the universal fitting 40 is provided as feedback to the microcontroller 62 as further described below and as 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 drug delivery pen 10 cartridge 16. 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 commands for emitting electromagnetic radiation 70 and/or visible light 170 based on status. For example, when the universal fitting 40 and the cover 50 are engaged, the microcontroller 62 issues commands 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 for emitting electromagnetic radiation 70 and/or visible light 170.

The cover 50 includes a power source 60 that provides power to the cover 50. The power source 60 is preferably a flexible battery wrapped along the inner surface of the sidewall 52. The power source 60 may also be a lithium battery. Finally, the power supply 60 may be a wired circuit that provides power (AC/DC current) to the cover 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 exhausted. 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 to the microcontroller 62 of the cover 50, or directly to the electromagnetic radiation source 68 (see fig. 6), in particular. Electromagnetic radiation source 68 (an 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 independently and/or uniquely emit visible light within a selected wavelength range relative to the electromagnetic radiation source 68. In other words, the embodiment shown in FIG. 7 may include both electromagnetic radiation source 68 and light emitting source 168, while another embodiment may include only light emitting source 168. The operation of electromagnetic radiation source 68 in connection with the remaining features of drug delivery pen 10 disclosed herein may be similarly configured and applied to light emitting source 168.

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

Electromagnetic radiation source 68 advantageously emits electromagnetic radiation 70 to disinfect septum 18 of drug delivery pen 10. Electromagnetic radiation 70 is also emitted onto other surfaces or portions of drug delivery pen 10 surrounded by cap 50. An electromagnetic radiation source 68 is disposed on an inner surface of top wall 54 of 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. The visible light 170 may also be applied to other medical devices and surfaces. However, this application is not as effective at disinfecting as the ultraviolet light emitted by the electromagnetic radiation source 68.

As shown in fig. 7, a light source 168 is disposed on the outer surface of the top wall 54 of the cap 50 to emit visible light 170 to disinfect the skin surface 80. However, the light emitting source 168 may also be provided on an outer surface of the side wall 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, electromagnetic radiation source 68 is disposed distally of power supply 60 such that electromagnetic radiation 70 may be emitted directly onto septum 18 of drug delivery pen 10 as well as onto other surfaces or portions of drug delivery pen 10.

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

Commands that control the operation of electromagnetic radiation source 68 and light emitting source 168 are received from microcontroller 62 or directly from 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 one or more optimal wavelengths for improved disinfection, have a small footprint, and consume significantly less energy due to their instant on/off capability. However, any energy source that performs sterilization may be used.

A variety of wavelength ranges from the electromagnetic spectrum may be used for disinfection. For example, the relative effectiveness of UV light wavelengths for this process is known as the bactericidal spectrum, which peaks at a maximum wavelength of 265nm (UV-C). Thus, the preferred wavelength range of UV light 70 is between 250nm and 280 nm. The exposure range required for many applications is 10mJ/cm ² And 100mJ/cm ² Between them.

In view of the above, alternative wavelengths may be used. All ultraviolet wavelengths shorter than 300nm are effective for 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 the human body and inorganic materials, such that, for example, exposure to these wavelengths may severely damage the skin and eyes.

UVGI is commonly used to disinfect instruments such as goggles, equipment, pipettes, and other devices. Laboratory personnel also disinfect glassware and plastic ware in this manner. The microbiological laboratory uses UVGI to disinfect surfaces within biosafety cabinets ("hoods") between uses (see links for this purpose: https:// www.medicaldesignandoutsourcing.com/uvc-leds-engineering-new-manufacturing-healthcare-devices /). Therefore, it is preferable to perform ultraviolet sterilization in the absence of human and inorganic materials. However, the limitations of uv disinfection reduce their utility in certain situations.

Longer wavelengths may be equally effective given sufficient energy and time. However, disinfection at each location should be managed individually for optimal results. White light is understood to be a mixture of all wavelengths in the visible spectrum. Visible light is understood to be generally in the range 400-700 nm. Light in the wavelength range 400-410nm, also known as violet light, has in particular a sterilizing power for bacterial cells, but ultraviolet light does not have all the same effect 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 human cells or 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 more complex methods of dealing with oxidative damage than bacterial cells, making bacterial cells more primitive and less resistant to visible light.

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

Although the preferred wavelength ranges of the ultraviolet light 70 and the visible light 170 are required, the duration of the emission of the ultraviolet light 70 and the visible light 170 required for sterilization 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 equation:

light dose (J/m 2) =irradiance (W/m 2) 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 formula:

e=hc/λjoule

Wherein:

h=planck constant (6.626x10 ^-34 Js)

c=speed of light (2.998 ×10 ⁸ ms ^-1 )

λ=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), a suitable power supply 60 may be selected to provide the required energy for the desired duration. For example, assume that the pen cap size (about 3.14cm ² ) Is 100mJ/cm within a region of (2) ² Exposure for 10 seconds (based on patient comfort) (based 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 supplies are suitable for operating with multiple exposures of ultraviolet and visible light over the life of the cell. The amount of time required for sterilization is related to the distance of 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 to 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 irradiation of the electromagnetic radiation source 68. As shown in fig. 3, a 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 inner or outer surface of the cover 50. The switch 72 may be an actuated switch such as a micro switch, 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 the spring-loaded switch may be activated based on pressure from the user prior to injection (manually) or force applied between the cap 50 and the drug delivery pen 10 during assembly (automatically). As shown in fig. 4, upon sensing the increased pressure, the micro-switch 72 sends a signal to the microcontroller 62 to activate the electromagnetic radiation source 68 and the light emitting source 168 (capped, depressed position). When the user releases pressure or when the cap 50 and drug delivery pen 10 are removed, the pressure is reduced 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 for one activation of the electromagnetic radiation source 68 and the light emitting source 168. After a predetermined period of time, electromagnetic radiation source 68 and 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, activation and deactivation of the electromagnetic radiation source 68 and the light emitting source 168 may be automatic, instantaneous, simultaneous or alternating based on programming signals from the microcontroller 62 or engagement and disengagement of the micro-switch 72.

If provided as a spring-loaded switch, the switch 72 may release the spring force when 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, electromagnetic radiation source 68 and 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 electromagnetic radiation emission and visible light emission or a time delay before the electromagnetic radiation emission and visible light emission are 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 commands for activating and deactivating the electromagnetic radiation source 68 and the light emitting source 168.

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

The switch 72 may also be a proximity sensor, hall effect sensor, photosensor, optical sensor, and 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, the microcontroller 62 may instruct the electromagnetic radiation source 68 to emit electromagnetic radiation 70 and instruct the light emitting source 168 to emit visible light 170. When the cap 50 is removed from the drug delivery pen 10, the proximity sensor informs the microcontroller 62 of this and the microcontroller commands the electromagnetic radiation source 68 to cease emitting electromagnetic radiation 70 and commands the light emitting source 168 to cease emitting visible light 170.

The cap 50 also includes an indicator 66 that displays a number of conditions, such as when the electromagnetic radiation source 68 is activated or deactivated, when the light source 168 is activated or deactivated, when the disinfection/sterilization process of the medical device 10 or the skin surface 80 is completed, and the remaining life of the power source 60. The indicator 66 communicates with the microcontroller 62 to receive the status of one or more of these conditions prior to display. The indicator 66 displays these conditions through a number of media 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 membrane 18, or other surfaces or portions of the medical device such as the drug delivery pen 10 with an alcohol wipe or a sterile wipe. This is because the cover 50 alone may use electromagnetic radiation 70 and visible light 170 to disinfect 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 pack or sterile wipe with the drug delivery pen 10 and does not need to manage additional steps in sterilizing the skin surface 80, the membrane 18, or other surfaces or portions. In addition, the skin surface 80, the membrane 18, and other surfaces or portions are more reliably sterilized without user error such as ineffective sterilization or failure to sterilize.

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 accessory 40 as described above. Electromagnetic radiation source 68 and light emitting source 168 are then activated, either automatically or manually by a user. Electromagnetic radiation source 68 emits electromagnetic radiation 70 on exposed septum 18 of drug delivery pen 10 to disinfect septum 18. Other surfaces or portions of the drug delivery pen 10 are also sterilized. Prior to needle insertion, the light emitting source 168 emits visible light 170 toward the skin surface 80. After sterilization is complete, the cover 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 medication to the patient.

After drug delivery is completed, the pen needle will be removed from the cartridge 16 and discarded. The septum 18 of the drug 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 sterilized by the light source 168 in a similar manner as 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 the current limiting resistor 74 may control the power from the power supply 60 directly 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 operating, activating or pressing the length of time of the push button switch 72. That is, when switch 72 is operated or depressed, electromagnetic radiation source 68 and light emitting source 168 use power from power source 60 to illuminate electromagnetic radiation source 68 and light emitting source 168. When the switch 72 is not operating or is not depressed, the electromagnetic radiation source 68 and the light emitting source 168 do not use power from the power source 60. Thus, no sterilization is performed.

As described above, FIG. 7 shows an embodiment of the drug delivery pen 10 covered by a cover 50 comprising an electromagnetic radiation source 68 and a luminescent source 168 to sterilize the septum 18 and the skin surface 80 of the drug delivery pen 10, respectively. The features of the above-described embodiment may be equally applied to this embodiment as long as the operation of the features is not contradictory to the operation of this embodiment.

This embodiment advantageously allows for sterilization at a frequency allowed by the power supply. As discussed above with respect to feasibility studies, a basic button cell or similar small power source may operate the electromagnetic radiation source 68 and the light emitting source 168 to make multiple exposures over the life of the cell. 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 alcohol wipes or sterile wipes to sterilize the skin surface 80, the membrane 18, or other exposed surfaces or portions 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. Furthermore, the skin surface 80 is more conveniently sterilized simultaneously or alternately with respect to the sterilization of the septum 18 to improve workflow and optimize time. The 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 alcohol wipes and/or sterile wipes 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 in 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 a skin surface 80 at an injection site. The features of the above-described embodiment may be equally applied to this embodiment as long as the operation of these features is not contradictory to the operation of this embodiment. In particular, 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, the timer 264, the light source 268, and the switch 272 disclosed in this embodiment are identical or similar to the corresponding components in the above-described embodiments.

Instead of integrating the illumination source 268 into the drug delivery pen 10 as described in the embodiments above, this embodiment provides the illumination source 268 through an accessory 240 connected to the drug delivery pen 10. Accessory 240 may be attached to and detached 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, accessory 240 includes an optional container 250 that carries a light emitting source 268. The container 250 is a cylindrical cavity sized to store and retain the light-emitting source 268. For example, the light emitting source 268 is held in the container 250 by an adhesive, although other means of holding are also contemplated.

Accessory 240 also includes a mounting mechanism 252 that attaches the accessory to drug delivery pen 10. Fig. 8 shows the mounting mechanism 252 as including a mechanical clamp. However, other exemplary mounting mechanisms 252 may include, for example, universal covers, spring loaded locking mechanisms, press fit, adhesives, hook and loop fasteners (Velcro), threaded members, spring clips, and buttons 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 power source 60 through

electrical contacts

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

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

For use of medical products, the embodiment of the accessory 240 disclosed in fig. 8 advantageously provides visible light 270 to safely disinfect the skin application surface 80. Accessory 240 is advantageously adaptable to a variety of medical devices 10 and is configured to attach and detach for general and convenient use. For ease of use, accessory 240 may also be advantageously attached to and detached from 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 to illustrate the principles of the invention and its practical application to thereby enable others skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use contemplated. The description is not necessarily intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Any of the embodiments and/or elements disclosed herein may be combined with one another to form various additional embodiments not specifically disclosed, so long as they are not inconsistent with one another. Accordingly, additional embodiments are possible and are intended to be within the scope of the present specification and invention. The specification describes specific examples for achieving a more general goal that may be achieved in another manner.

As used in this application, the terms "front," "rear," "upper," "lower," "upward," "downward," and other orientation descriptors are intended to facilitate description of exemplary embodiments of the present invention and are not intended to limit the structure of exemplary embodiments of the present invention to any particular position or orientation. Terms of degree, such as "substantially" or "about" are understood by one of ordinary skill to refer to a reasonable range outside of a given value, such as the general tolerances associated with the manufacture, 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 supply that supplies power;

a light emitting source for disinfecting the skin surface using power received from the power source; and

a switch configured to be operated by a user action; wherein the method comprises the steps of

When the switch is activated, power from the power source is received by the light source to emit visible light and disinfect the skin surface.

2. The cap of claim 1, the power source comprising a battery.

3. The cap of claim 1, further comprising an electromagnetic radiation source that emits UV light using power received from a power source to disinfect a medical device or a portion of a medical device.

4. A cap according to claim 3, wherein the electromagnetic radiation source radiates electromagnetic radiation to disinfect the medical device or a portion of the medical device.

5. A cover according to claim 3, wherein the electromagnetic radiation source is disposed inside the cover.

6. A cap according to claim 3, wherein

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

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

7. A medication pen needle assembly, the medication pen needle assembly comprising:

a cap according to claim 3;

a medical device comprising a drug delivery pen; and

pen needle attached to a 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.

8. A medication pen needle assembly, the medication pen needle assembly comprising:

the cap of claim 1;

a 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.

9. The cap of claim 1, wherein

The medical device comprises a medicine bottle; and is also provided with

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

10. The cap of claim 1, the light source being disposed on an outer surface of the cap.

11. The cap of claim 1, the light emitting source emitting visible light in a wavelength range between 400nm and 410 nm.

12. A cover according to claim 3, the light emitting source operating simultaneously with the electromagnetic radiation source.

13. A cap according to claim 3, the light emitting sources being alternately operated with respect to the electromagnetic radiation source.

14. The cover of claim 4, the emission from the source of electromagnetic radiation having a wavelength different from the wavelength of the radiation from the source of electromagnetic radiation.

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

a power supply for powering the microcontroller, said microcontroller sensing and controlling operation of the cover;

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

a switch causes the microcontroller to activate and deactivate the light emitting source.

16. The cover of claim 15, further comprising:

an electromagnetic radiation source that radiates electromagnetic radiation under control of the microcontroller to disinfect the medical device or a portion of the medical device; wherein the method comprises the steps of

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

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

18. The cap of claim 16, further comprising an indicator indicating at least one of whether the electromagnetic radiation source is activated, whether the light source is activated, whether any sterilization process is complete, and the remaining life of the power source.

19. The cover 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. A method of disinfecting and injecting a drug to a skin surface using a medical device, the method comprising:

providing a light emitting source on an outer surface of a cover 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 visible light from a light emitting source;

removing the cap of the medical device to initiate drug delivery;

inserting a needle of a medical device into a skin surface; and

the drug is injected.

21. The method of claim 20, further comprising:

disposing an electromagnetic radiation source on an inner surface of the cover;

activating the electromagnetic radiation source to radiate electromagnetic radiation to disinfect the medical device or a portion of the medical device; and

the medical device or a portion of the medical device is exposed to electromagnetic radiation from an electromagnetic radiation source.

22. The method of claim 21, further comprising:

securing the cap to a medical device comprising a drug delivery pen; wherein the method comprises the steps of

The electromagnetic radiation source is automatically activated.

23. The method of claim 22, further comprising removing the pen needle from the medical device to expose a septum of the medical device prior to securing the cap.

24. The method of claim 21, wherein the electromagnetic radiation source emits ultraviolet light having a bandwidth between 250nm and 280nm to disinfect the medical device or a portion of the medical device.

25. An accessory configured to be attached to a device to disinfect 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.

26. The accessory of claim 25, wherein the device comprises one of a drug delivery pen, a syringe, a patch pump, and a safety pen.

27. The accessory of claim 25, wherein

The device includes one of a drug delivery pen having a pen cap and an injector having an injector shield; and is also provided with

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

28. The accessory of claim 25, wherein the mounting mechanism comprises one of a universal cover, a spring loaded member, a press fit, an adhesive, threads, and a button.

29. The accessory of claim 25, further comprising:

a power supply that supplies power to the light-emitting source; and

a switch for activating and deactivating the light emitting source.

30. The accessory of claim 25, further comprising a container for carrying the light emitting source.

31. 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 a medical device, the cover comprising:

a power source for providing electric power,

an electromagnetic radiation source for emitting electromagnetic radiation for sterilization using power received from a power source, an

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

the accessory of claim 25, wherein,

the mounting mechanism is attached to the outer surface of the cover, and

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

32. The assembly of claim 31, wherein

The mounting mechanism includes an electrical contact;

the cover of the medical device includes an electrical contact; and is also provided with

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

33. A method of disinfecting and injecting a drug to a skin surface using a medical device, the method comprising:

mounting an accessory to an outer surface of a cap of a medical device, the accessory comprising a light source that emits visible light to disinfect the skin surface;

activating the light emitting source to disinfect the skin surface;

removing the cap of the medical device;

inserting a needle of a medical device into a skin surface; and

the drug is injected.

34. The method of claim 33, further comprising:

disposing an electromagnetic radiation source on an inner surface of a cap of a medical device;

securing the cap to the medical device; and

electrical communication is established between the cover and the accessory.