Medical device for disinfecting the surface of the skin

Abstract

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

Description

[0001] Related Applications

[0002] This application is a continuation-in-part of U.S. Nonprovisional Application Serial No. 16 / 777,553, filed January 30, 2020, which claims the benefit of U.S. Provisional Patent Application Serial No. 62 / 804,415, filed February 12, 2019, the entire contents of both of which are incorporated herein by reference. TECHNICAL FIELD

[0003] The present invention relates to medical devices that disinfect the skin surface at the injection site prior to administration. BACKGROUND

[0004] Insulin and other injectable medications are commonly administered with medical devices such as drug delivery devices or drug delivery pens, with a disposable pen needle attached to facilitate access to the medication reservoir and allow fluid to flow from the reservoir through the needle and into the patient.

[0005] As technology and competition advance, driving the need for shorter, thinner, less painful, and more effective injections, the design of drug delivery devices such as pen needles and their components becomes increasingly important. The design needs to proactively address ergonomic improvements in injection technique, injection depth control and accuracy, safe use and transport for disposal, sterilization, disinfection, and misuse prevention, while maintaining the ability to be manufactured economically at large production scales.

[0006] Drug delivery devices, such as the exemplary drug delivery pen 10 shown in Figure 1 and Figure 2 may be designed for both subcutaneous and intradermal injections, and generally include a dose knob / button 22, an outer sleeve or housing 11, and a cap 50. The dose knob / button 22 allows a clinician or patient to set the dose of medication to be injected. The housing 11 is gripped by the user when injecting the medication. The user can 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 is also used to cover the septum 18 of the cartridge 16 in the drug delivery pen 10 before and after use. Otherwise, the septum 18 would be exposed.

[0007] Figure 2 is an exploded view of the drug delivery pen 10 of Figure 1 The dose knob / button 22 has a dual purpose and is used both to set the dose of medication to be injected and to inject the dose of medication through the cartridge 16 via the lead screw 12 and plunger / bung 14, which is attached to the drug delivery pen 10 through the body 20. In standard drug delivery pens, the dosing and delivery mechanisms are both located within the housing 11 and are not described in greater detail here, as they would be understood by one familiar with the art.

[0008] For operation, the drug delivery pen 10 is attached to a pen needle that includes a needle / cannula 30, a septum penetration cannula 32, and a hub 34. Specifically, distal movement of the plunger or stopper 14 within the cartridge 16 causes the drug to be forced into the needle 30 of the hub 34. The cartridge 16 is sealed by a septum 18 that is pierced by the septum penetration needle cannula 32 located within the hub 34. The hub 34 is preferably threadably attached to the main body 20, but other attachment means can be used.

[0009] To protect the user or anyone handling the pen needle from accidental needle sticks, an outer cover 38 attached to the hub 34 covers the hub 34. An inner shield 36 covers the patient needle 30 within the outer cover 38. The inner shield 36 can 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 the inner shield 36 are removed prior to use.

[0010] The cartridge 16 is typically a glass tube or vial that is sealed at one end with a septum 18 and at the other end with a stopper 14. The septum 18 can be pierced by the septum penetration sleeve 32 in the hub 34, but does not move relative to the cartridge 16. The stopper 14 can be displaced axially within the cartridge 16 while maintaining a fluid-tight seal.

[0011] Existing drug delivery pens are disclosed in U.S. Patent Application Publication No. 2006 / 0229562 to Marsh et al., published October 12, 2006, and No. 2007 / 0149924 to R. Marsh, published June 28, 2007, the entire contents of both of which are incorporated herein by reference for this purpose.

[0012] Medical devices such as the drug delivery pen 10 are typically prepared for use by disinfecting the septum 18 with an alcohol wipe prior to attaching a pen needle for drug delivery and disinfecting the skin surface at the injection site with a disinfecting wipe prior to administering the drug. However, there are challenges to consistently and accurately disinfecting the drug delivery pen 10 and the skin surface for safe patient care. Carrying an alcohol wipe and / or disinfecting wipe with the drug delivery pen 10 can be burdensome for the user. Further, the alcohol wipe and / or disinfecting wipe have a shelf life limitation and are typically only for single use. In some cases, the septum 18 can not be properly disinfected prior to use. It is not always feasible and difficult to ensure that best disinfection practices are followed at all times. Therefore, there is a need for improved disinfection devices and processes for use with medical devices such as the drug delivery pen 10. SUMMARY

[0013] One aspect of the present disclosure provides a cap that can sanitize a skin surface at an injection site, either alone or in conjunction with sanitizing a medical device or a portion of a medical device, such as a septum surface. This configuration improves the workflow and convenience of users using various medical devices, such as medication delivery pens, syringes, patch pumps, safety pens, and insulin vials. Adverse injection practices are minimized as users are no longer reliant on sanitizing the skin surface, septum, or other exposed surface or portion of a medical device using alcohol wipes or sanitizing wipes. In fact, the cap can be configured to automatically sanitize the septum or other exposed surface or portion, thereby saving time. Moreover, sanitizing the skin surface concurrently or alternately with respect to sanitizing the septum is more convenient to improve workflow and optimize time. Sanitizing the medical device and skin surface using the cap is also more controllable or automated to meet high precision and performance requirements. Finally, users are no longer required to carry alcohol wipes and / or sanitizing wipes for the medical device and / or skin surface.

[0014] Another aspect of the present disclosure provides an accessory that can be attached to a device to sanitize a skin surface prior to an injection. This accessory provides visible light to safely sanitize the skin surface prior to a needle injection of the device. The accessory can also be adapted for use with various products including medical devices and configured to attach and detach for universal and convenient use.

[0015] The foregoing and / or other aspects of the present disclosure can be achieved by providing a medical device configured to sanitize a skin surface, the device comprising a power source to provide electrical power; a light source to sanitize the skin surface using electrical power received from the power source; and a switch configured to be operated by a user action, wherein upon activation of the switch, the electrical power from the power source is received by the light source to emit visible light and sanitize the skin surface.

[0016] The foregoing and / or other aspects of the present disclosure can also be achieved by providing a cap of a medical device configured to sanitize a skin surface, the cap comprising: a power source to power a microcontroller that senses and controls operation of the cap; a light source to emit visible light to sanitize the skin surface under control of the microcontroller; and a switch to cause the microcontroller to activate and deactivate the light source.

[0017] The foregoing and / or other aspects of the present application can also be achieved by providing a method of disinfecting a skin surface and injecting a medicament using a medical device, the method comprising disposing 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 medicament delivery; inserting a needle of the medical device into the skin surface; and injecting the medicament.

[0018] The foregoing and / or other aspects of the present application can additionally be achieved by providing an accessory configured to attach to a device to disinfect a skin surface, the accessory comprising a light emitting source to emit visible light to disinfect the skin surface; and a mounting mechanism configured to attach and detach the light emitting source and device.

[0019] The foregoing and / or other aspects of the present application can likewise be achieved by providing a method of disinfecting a skin surface and injecting a medicament 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 emitting source to emit 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 the medical device into the skin surface; and injecting a medicament.

[0020] Additional and / or other aspects and advantages of the present application will be set forth in part in the description that follows, and in part will be apparent from the description, or can be learned by practice of the present application. BRIEF DESCRIPTION OF DRAWINGS

[0021] The foregoing aspects and features of the present application will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that the drawings depict only typical embodiments of the application and are not therefore to be considered to be limiting of its scope, the application will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0022] Figure 1 is a perspective view of an assembled medicament delivery pen of the prior art;

[0023] Figure 2 is Figure 1 is an exploded perspective view of components of the medicament delivery pen and pen needle of

[0024] Figure 3 is a cross-sectional view of an exemplary embodiment of a cap of a medicament delivery pen;

[0025] Figure 4 is a schematic view of electrical components within the cap of Figure 3 without user input;

[0026] Figure 5 is a schematic view of electrical components within the cap of Figure 3a schematic diagram of electrical components within the cap of

[0027] Figure 6 a schematic diagram of the circuit of another exemplary embodiment of a cap;

[0028] Figure 7 is Figure 3 a cross-sectional view of an exemplary embodiment of a cap of a drug delivery pen of

[0029] Figure 8 is a cross-sectional view of an exemplary embodiment of an attachment to a drug delivery pen for disinfecting a skin surface. DETAILED DESCRIPTION

[0030] Figure 3 A cap 50 for a medical device, such as a drug delivery pen 10, is shown in accordance with an embodiment of the present application. The cap 50 includes a sidewall 52 and a top wall 54. The cap 50 is configured to enclose a distal portion of the drug delivery pen 10. In particular, 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. The sidewall 52 is connected to the top wall 54 and encircles the 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.

[0031] Embodiments of the cap 50 disclosed herein are most commonly configured to be mounted to a drug delivery pen 10 with the pen needle absent. However, through appropriate modification, other types of medical devices requiring disinfection, 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) can incorporate the cap 50 for disinfection purposes. Any surface or portion of the medical device contained within the cap 50 and exposed to the electromagnetic radiation source 68 can be disinfected.

[0032] With respect to the drug delivery pen 10, operation of the cap 50 can still occur even if the pen needle is attached to the drug delivery pen 10 and covered by the cap 50. In this case, the pen needle can be disinfected instead of the septum 18. However, this scenario is generally not preferred as it is not recommended to reuse pen needles.

[0033] The cap 50 is configured to be indirectly connected to the drug delivery pen 10 via the universal fitting 40 Figures 3-5or directly to a drug delivery pen (not shown) without a universal fitting 40. An exemplary embodiment of a 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 upon rotation 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. Further, using ribs, pleats, or scallops provides an expandable, contractible, and / or frictional surface at the interface between the distal end of the cap 50 and the body 20 using a universal fitting 40. The universal fitting 40 can have a pointed tip to provide a mechanical engagement between the cap 50 and the body 20. Finally, another embodiment of a 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.

[0034] The use state of the universal fitting 40 is provided as feedback to the microcontroller 62, as further described below and as shown in Figure 4 and Figure 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, for example, an uncapped position when one or both of these connections is disengaged. Alternatively, the universal fitting 40 can be used without the cooperation of the microcontroller 62, as further described in Figure 6

[0035] The universal fitting 40 can also cooperate with the microcontroller 62 to issue a command for emitting electromagnetic radiation 70 and / or visible light 170 based on the state change. For example, when the universal fitting 40 and the cap 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 is disengaged, the microcontroller 62 does not issue a command for emitting electromagnetic radiation 70 and / or visible light 170.

[0036] The cap 50 includes a power source 60 that provides power to the cap 50. The power source 60 is preferably a flexible battery that is wrapped along the inner surface of the sidewall 52. The power source 60 can also be a lithium battery. Finally, the power source 60 can be a wired circuit that provides power (AC / DC current) to the cap 50.

[0037] If the power source 60 is a battery, the battery 60 can be rechargeable via solar, motion, or electricity (wired or wireless). Alternatively or additionally, the battery 60 can be discarded and replaced. Further, the cap 50 can be replaced when the battery 60 is depleted. The power source 60 can be disposed on the inner or outer surface of the sidewall 52 or the top wall 54.

[0038] As shown in Figures 3-5 ​As shown, power supply 60 is configured to specifically supply power to the microcontroller 62 of cover 50 or directly to the electromagnetic radiation source 68 (see Figure 1). Figure 6 It provides power. The electromagnetic radiation source 68 (internal light source) can emit electromagnetic radiation in a selected wavelength range, including ultraviolet (UV) light 70.

[0039] In another embodiment, as described below, the light 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, Figure 7 The illustrated embodiment may include both an electromagnetic radiation source 68 and a light source 168, while another embodiment may include only the light source 168. The electromagnetic radiation source 68 can be configured and applied in the same way as the other features of the drug delivery pen 10 disclosed herein.

[0040] As is 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 general accessory 40 (as described above), the timer 64, the indicator 66, the electromagnetic radiation source 68, the light source 168, and the switch 72.

[0041] Electromagnetic radiation source 68 advantageously emits electromagnetic radiation 70 to sterilize the diaphragm 18 of the drug delivery pen 10. Electromagnetic radiation 70 is also emitted onto other surfaces or portions of the drug delivery pen 10 surrounded by the cap 50. Electromagnetic radiation source 68 is disposed on the inner surface of the top wall 54 of the cap 50.

[0042] In another embodiment, the light source 168 advantageously emits visible light 170 for disinfecting the skin surface 80 at the injection site prior to needle insertion. Visible light 170 can also be applied to other medical devices and surfaces. However, this application is less effective for disinfection than ultraviolet light emitted by the electromagnetic radiation source 68.

[0043] like Figure 7 As shown, the light 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 source 168 may also be disposed on the outer surface of the side wall 52 of the cover 50, on the 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.

[0044] In yet another embodiment, the power source 60 and the electromagnetic radiation source 68 are both stacked on the inner surface of the top wall 54 of the cover 50. Thus, the electromagnetic radiation source 68 is positioned far from the power source 60, allowing electromagnetic radiation 70 to be emitted directly onto the diaphragm 18 of the drug delivery pen 10 and other surfaces or portions of the drug delivery pen 10.

[0045] In another embodiment, the electromagnetic radiation source 68 is positioned such that the electromagnetic radiation 70 is not directly emitted onto the septum 18. Although it is more effective to radiate the electromagnetic radiation 70 directly on the septum 18, this configuration is not critical for effective operation and disinfection.

[0046] The 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 Figure 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 small footprints, and consume much less energy due to their instant on / off capability. However, any energy source that disinfects can be used.

[0047] A variety of wavelength ranges from the electromagnetic spectrum can be used for disinfection. For example, the relative effectiveness of UV light wavelengths for this process is known as the germicidal action spectrum, which peaks at a maximum wavelength of 265 nm (UV-C). Thus, the preferred wavelength range for the UV light 70 is between 250 nm and 280 nm. The exposure range required for many applications is between 10 mJ / cm 2 and 100 mJ / cm 2 .

[0048] In view of the foregoing, alternative wavelengths can be used. All ultraviolet light wavelengths shorter than 300 nm are effective for disinfection and killing microorganisms. The primary principle of operation is based on ultraviolet germicidal irradiation (UVGI). This method of disinfection uses shortwave ultraviolet light to kill or inactivate microorganisms by damaging their nucleic acids and disrupting their DNA or causing photodegradation of their DNA. Thus, this method of disinfection can be harmful to humans and inorganic materials, such that, for example, exposure to these wavelengths can severely damage the skin and eyes.

[0049] UVGI is commonly used to disinfect instruments such as safety glasses, instruments, pipettes, and other equipment. Laboratory personnel also disinfect glassware and plasticware in this manner. Microbiology laboratories use UVGI to disinfect surfaces within a biological safety cabinet (“hood”) between uses (see the following link, incorporated herein by reference for this purpose: https: / / www.medicaldesignandoutsourcing.com / uvc-leds-energizing-new-generation portable-healthcare-disinfection-devices / ). Thus, it is best to conduct ultraviolet disinfection in the absence of humans and inorganic materials. However, the limitations of ultraviolet disinfection reduce its usefulness in certain situations.

[0050] Given enough energy and time, longer wavelengths can be equally effective. However, disinfection at each location should be managed separately 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 of 400-700 nm. Light in the wavelength range of 400-410 nm, also known as violet light, specifically has disinfecting power on bacterial cells, but ultraviolet light does not have all the same effects on mammalian cells. This visible light application can preferably be a mixed wavelength application, although monochromatic light is also possible. Human cells can be exposed to visible light without causing harm to the human cells and without loss of cell viability. For example, it has been shown in the literature that visible light kills 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 sophisticated method of coping with oxidative damage than bacterial cells, making bacterial cells more primitive and less resistant to visible light.

[0051] The destruction of microorganisms by ultraviolet light 70 is an exponential process. The higher the exposure given, the higher the proportion of microorganisms destroyed. Thus, the exposure required to destroy 99% is twice the value to destroy 90%. Thus, the exposure required to kill 99.9% is three times the value to destroy 90%, and the exposure required to kill 99.99% is four times the value to destroy 90%.

[0052] While the preferred wavelength ranges of ultraviolet light 70 and visible light 170 are required, the duration of the emission of ultraviolet light 70 and visible light 170 required for disinfection is a function of distance, power, time, and wavelength. The exposure required (i.e., UV dose, visible light dose, or energy) can be calculated using the following formula:

[0053] Light dose (J / m2) = Irradiance (W / m2) x Exposure time (seconds)

[0054] The necessary wavelength and exposure time can be calculated based on the required dose of UV light 70, as set forth in the following table:

[0055] Bacteria - Ultraviolet light dose correlation table:

[0056]

[0057]

[0058]

[0059] Alternatively, the energy consumption can be calculated using the target wavelength by the following formula:

[0060] E = hc / λ Joules

[0061] in:

[0062] h = Planck's constant (6.626 x 10⁻⁶) -34 Js)

[0063] c = speed of light (2.998 × 10⁻⁶) 8 ms -1 )

[0064] λ = wavelength in meters

[0065] Once the target energy is determined, energy consumption (i.e. power) can be calculated using the following equation:

[0066]

[0067] When calculating power P (in watts), a suitable power source 60 can be selected to provide the required energy for the desired duration. For example, assuming a pen cap size (approximately 3.14 cm) 2 Within the range of 100 mJ / cm 2 A 10-second exposure (based on patient comfort) under UV disinfection requires approximately 0.0314 watts of energy. Assuming visible (violet) light has a longer wavelength, it will consume more energy under the same conditions. This analysis suggests that a basic button cell or similar small power source is suitable for operating multiple exposures to both UV and visible light over the battery's lifespan. The amount of time required for disinfection is related to the distance from the light source, the light dose, the wavelength, and the microorganisms.

[0068] Cover 50 also includes a switch 72, which causes microcontroller 62 to generate commands to activate and deactivate electromagnetic radiation source 68 and light source 168. Alternatively, as Figure 6 As shown, switch 72 itself connects and disconnects power supply 60 from electromagnetic radiation source 68 and light source 168 to control the irradiation of electromagnetic radiation source 68. For example... Figure 3 As shown, switch 72 is disposed on the inner surface of sidewall 52 of cover 50. However, switch 72 may be disposed on any inner or outer surface of cover 50. Switch 72 may be an actuated switch, such as a micro switch, spring-loaded switch, or push-button switch. In another embodiment, switch 72 includes a first switch and a second switch to individually activate and deactivate electromagnetic radiation source 68 and light source 168, respectively.

[0069] Specifically, the microswitch and / or spring-loaded switch can be activated based on pressure from the user before injection (manual) or force applied between the cap 50 and the drug delivery pen 10 during assembly (automatic). Figure 4As shown, when increased pressure is sensed, microswitch 72 sends a signal to microcontroller 62 to activate electromagnetic radiation source 68 and light source 168 (capped, pressed position). When the user releases pressure or when cap 50 and drug delivery pen 10 are removed, the pressure decreases and microswitch 72 sends a signal to microcontroller 62 to deactivate electromagnetic radiation source 68 and light source 168 (capped, relaxed position).

[0070] Therefore, the spring force provides one activation of the electromagnetic radiation source 68 and the light source 168. After a predetermined period of time, the electromagnetic radiation source 68 and the light source 168 are deactivated. Alternatively, a manual switch can be implemented to trigger the activation of the electromagnetic radiation source 68 and the light source 168 for the desired duration before each use. In this respect, the activation and deactivation of the electromagnetic radiation source 68 and the light source 168 can be automatic, instantaneous, simultaneous, or alternating, based on programming signals from the microcontroller 62 or the engagement and disengagement of the microswitch 72.

[0071] If provided as a spring-loaded switch, switch 72 can release the spring force when it receives increased pressure during assembly of cap 50 to drug delivery pen 10. The spring force provides initial activation of electromagnetic radiation source 68 and light source 168. After a predetermined period of time, electromagnetic radiation source 68 and light source 168 are deactivated.

[0072] Timer 64 can be incorporated into spring-loaded switch 72, for example, to provide a predetermined time period for electromagnetic radiation emission and visible light emission, or a time delay before the start of electromagnetic radiation emission and visible light emission. Timer 64 can be activated when switch 72 is engaged. For example, when the distance between electromagnetic radiation source 68 and the diaphragm 18 of drug delivery pen 10 is two inches, timer 64 can cause electromagnetic radiation source 68 to emit electromagnetic radiation 70 at a wavelength of 265 nm for up to 120 seconds. Similarly, timer 64 can cause light source 168 to emit visible light 170 at a wavelength of 405 nm for a specific amount of time at a specific distance between light source 168 and skin surface 80. Timer 64 can also cooperate with microcontroller 62 to modify the commands used to activate and deactivate electromagnetic radiation source 68 and light source 168.

[0073] like Figure 5 As shown, when provided as a push-button switch, switch 72 can be deflected, released, and / or make electrical contact with microcontroller 62 based on, for example, an operation (such as pressing) by a user such as a clinician or patient. In this way, the user can control the activation and deactivation of electromagnetic radiation source 68 and light source 168.

[0074] The switch 72 can also be a proximity sensor, a Hall effect sensor, a photoelectric sensor, an optical sensor, and a force sensor. Those skilled in the art generally understand the operation of these sensors. The proximity sensor can sense that the cover 50 is disposed on the medication delivery pen 10 and indicate this to the microcontroller 62. Subsequently, the microcontroller 62 can command the electromagnetic radiation source 68 to emit the electromagnetic radiation 70 and command the light source 168 to emit the visible light 170. When the cover 50 is removed from the medication delivery pen 10, the proximity sensor notifies the microcontroller 62 of this and the microcontroller commands the electromagnetic radiation source 68 to stop emitting the electromagnetic radiation 70 and the light source 168 to stop emitting the visible light 170.

[0075] The cover 50 also includes an indicator 66 that displays a plurality of conditions such as indicating 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 complete, and the remaining life of the power source 60. The indicator 66 is in communication 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 plurality of media known to those skilled in the art such as, for example, color, symbol, and text.

[0076] The cover 50 described above provides advantages not realized in the prior art. The cover 50 improves the workflow and convenience of a user, such as a clinician or patient, using the medication delivery pen 10. Specifically, 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 medication delivery pen 10 with an alcohol wipe or a disinfectant wipe. This is because the cover 50 can individually disinfect the skin surface 80, the septum 18, and other surfaces or portions of the medication delivery pen 10 using the electromagnetic radiation 70 and the visible light 170. Therefore, the user does not need to carry a separate alcohol wipe or disinfectant wipe with the medication delivery pen 10 and does not need to manage an additional step in the process of disinfecting the skin surface 80, the septum 18, or other surfaces or portions. Furthermore, the skin surface 80, the septum 18, and other surfaces or portions are more reliably disinfected without user errors such as ineffective disinfection or failure to disinfect.

[0077] 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 use of the universal fitting 40 as described above. The electromagnetic radiation source 68 and the light emitting source 168 are then activated automatically or manually by the user. The electromagnetic radiation source 68 emits electromagnetic radiation 70 on the exposed septum 18 of the drug delivery pen 10 to sterilize the septum 18. Other surfaces or portions of the drug delivery pen 10 are also sterilized. The light emitting source 168 emits visible light 170 to the skin surface 80 prior to needle insertion. 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.

[0078] After drug delivery is complete, the pen needle is 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 restarted similarly as described above. If another dose of medication is to be dispensed, another skin surface 80 can also be sterilized by the light emitting source 168 in a similar manner as described above. This sterilization process can be repeated between multiple injections of the drug delivery pen 10.

[0079] In a simpler embodiment as described above and Figure 6 shown, the push button switch 72 and the current limiting resistor 74 can control the power from the power source 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 the length of time 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 operated or 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.

[0080] As described above, Figure 7 An embodiment of the drug delivery pen 10 is shown covered by the 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 of the drug delivery pen 10, respectively. The features of the above-described embodiments can be equally applied to this embodiment, as long as the operation of the features is not contradictory to the operation of this embodiment.

[0081] This embodiment advantageously allows for disinfection at the frequency permitted by the power source. As described above with respect to the feasibility study, a basic button cell or similar small power source can operate the electromagnetic radiation source 68 and the light source 168 for multiple exposures over the life of the battery. Due to its long-term use, this configuration has minimal limitations on shelf life and efficacy.

[0082] Additionally, the dual disinfection technology disclosed in this 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 disinfectant wipes to disinfect the skin surface 80, the septum 18, or other exposed surfaces or portions of the drug delivery pen 10. In fact, the cap 50 can be configured to automatically disinfect the septum 18 or other exposed surfaces or portions of the drug delivery pen 10, thereby saving time. Moreover, disinfecting the skin surface 80 concurrently or alternately with respect to the disinfection of the septum 18 more conveniently disinfects to improve the workflow and optimize time. Disinfecting 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 disinfectant wipes for the medical device and / or the skin surface 80. Accordingly, the disclosed embodiments provide such solutions for the drug delivery pen 10 for safe skin disinfection using light within the visible spectrum.

[0083] Figure 8 Another embodiment is shown providing an accessory 240 configured to mount to a drug delivery pen 10 to disinfect a skin surface 80 at an injection site. The features of the above embodiments can equally apply to this embodiment, so long as the operation of those features is not contradicted by the operation of this embodiment. In particular, the accessory 240 can be used with any device, including any of the above medical devices 10, as well as syringes with or without a syringe shield and drug delivery pens with or without a cap. At least the power source 260, the timer 264, the light source 268, and the switch 272 disclosed in this embodiment are the same as or similar to the corresponding components in the above embodiments.

[0084] Instead of integrating the light source 268 into the drug delivery pen 10 as described in the above embodiments, this embodiment provides the light source 268 through an accessory 240 that connects to the drug delivery pen 10. The accessory 240 is attachable to and detachable from the drug delivery pen 10, such as the drug delivery pen 10 shown. Figure 8 In particular, the cap 50 of the drug delivery pen 10 is configured to engage the accessory 240.

[0085] In one embodiment, the accessory 240 includes an optional container 250 that carries the light source 268. The container 250 is a cylindrical cavity sized to store and hold the light source 268. For example, the light source 268 is held in the container 250 by an adhesive, although other holding means are also contemplated.

[0086] The accessory 240 also includes a mounting mechanism 252 that attaches the accessory to the drug delivery pen 10. Figure 8 The mounting mechanism 252 is shown as including a mechanical clip. However, other exemplary mounting mechanisms 252 can include, for example, a universal cap similar to the universal fitting described above, a spring-loaded locking mechanism, a pressure fit, an adhesive, a hook-and-loop fastener (Velcro), a threaded member, a spring clip, and a button. The mounting mechanism 252 is advantageously selected based on the particular device 10 being used.

[0087] The mechanical clip 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 clip 252 includes electrical contacts 254 that engage electrical contacts 256 of the drug delivery pen 10 at the compressed portion. In this manner, electrical power is transmitted from the power source 60 through the electrical contacts 254, 256 and through an electrical wire disposed in the hollow mechanical clip 252 to electrically connect to and provide energy to the power source 260.

[0088] In another embodiment, the power source 260 is a separate, independent battery, such as a battery or rechargeable battery commonly used in watches. Thus, the power source 260 provides electrical energy to the timer 264, the light source 268, and the switch 272. In another embodiment, the accessory 240 is configured to attach to the drug delivery pen 10 including the cap 50 having the electromagnetic radiation source 68, as similarly described in the previous embodiment.

[0089] For use of the medical product, in Figure 8 The embodiment of the accessory 240 disclosed in the Summary provides visible light 270 to safely disinfect the skin application surface 80 for use of the medical product. The accessory 240 is advantageously adaptable to a variety of medical devices 10 and configured to attach and detach for universal and convenient use. For convenient use, the accessory 240 can also advantageously attach to and detach from non-medical devices 10, such as an accessory for a phone or a wallet. Finally, the accessory 240 also provides similar advantages as described above.

[0090] Having provided the foregoing detailed description of certain exemplary embodiments, the principles of the application and its practical application are thus made clear to others skilled in the art, enabling others to understand various embodiments and to make and use the application in its numerous forms, as appropriate for the particular use to which it is to be applied. The description is not intended to be exhaustive or to limit the application to the precise embodiments disclosed. Any

[0091] As used in this application, the terms "front," "back," "up," "down," "upwardly," "downwardly," and other orientation descriptors are intended to facilitate the description of the exemplary embodiments of the application and are not intended to limit the structure of the exemplary embodiments of the application to any particular location or orientation. The terms of degree such as "substantially" or "approximately" are understood by those of ordinary skill to refer to reasonable ranges around a given value, e.g., general tolerances associated with manufacture, assembly, and use of the recited embodiments.

Claims

1. A cap for a medical device, the cap configured to disinfect a skin surface, the cap comprising: a power source to provide electrical power; a light source to disinfect the skin surface using electrical power received from the power source, the light source disposed on an outer surface of the cap; a switch configured to be operated by a user action and to cause a microcontroller to activate and deactivate the light source and an electromagnetic radiation source, the microcontroller to sense and control operation of the cap; and an electromagnetic radiation source disposed inside the cap to emit UV light, wherein when activated, electrical power from the power source is received by the light source to emit visible light and disinfect the skin surface, and electrical power from the power source is received by the electromagnetic radiation source to emit UV light to disinfect the medical device or a portion of the medical device, and the medical device comprises one of a medication delivery pen and a syringe.

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

3. The cap of claim 1, wherein the electromagnetic radiation source emits light at a bandwidth to disinfect the portion of the medical device; the light source emits light at a different bandwidth than light emitted from the electromagnetic radiation source; and the portion of the medical device is a surface of the medical device.

4. The cap of claim 1, wherein the light source emits visible light at a wavelength range between 400 nm and 410 nm.

5. The cap of claim 1, wherein the light source operates concurrently with the electromagnetic radiation source.

6. The cap of claim 1, the light source operates alternately with respect to the electromagnetic radiation source.

7. The cap of claim 1, a wavelength of emission from the light source is different than a wavelength of radiation from the electromagnetic radiation source.

8. A medication pen needle assembly, the medication pen needle assembly comprising: the cap of claim 1; wherein electrical power from the power source is applied to the electromagnetic radiation source to radiate electromagnetic radiation on a needle of the pen needle.

9. A medication pen needle assembly, the medication pen needle assembly comprising: the cap of claim 1; and a universal fitting disposed between the cap and a medication delivery pen to secure the cap to the medication delivery pen.

10. A cap for a medical device, the cap configured to disinfect a skin surface, the cap comprising: a power source to power a microcontroller to sense and control operation of the cap; a light source to emit visible light to disinfect the skin surface under control of the microcontroller, the light source disposed on an outer surface of the cap; an electromagnetic radiation source disposed inside the cap to emit UV light to disinfect the medical device or a portion of the medical device under control of the microcontroller; and a switch to cause the microcontroller to activate and deactivate the light source and the electromagnetic radiation source; wherein the medical device comprises one of a medication delivery pen and a syringe.

11. The cap of claim 10, wherein the switch comprises a microswitch, a proximity sensor, a hall effect sensor, a photoelectric sensor, or a force sensor.

12. The cap of claim 10, wherein the switch comprises an optical sensor. ​ ​ 13. The cap of claim 10, 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 either disinfection process is complete, and a remaining life of the power source.

14. The cap of claim 10, further comprising a timer that controls at least one of a time delay, a duration of the radiation, and a duration of the emitted visible light.

15. An accessory for a medical device, the accessory configured to attach to a medical 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 the medical device; wherein the medical device comprises one of a drug delivery pen having a pen cap and a syringe having a syringe shield; the pen cap or the syringe shield of the medical device comprises an electromagnetic radiation source that emits UV light to disinfect the device or a portion of the device; and the mounting mechanism attaches to one of the pen cap and the syringe shield, the medical device further comprises: a power source that provides power to the light emitting source; and a switch configured to cause a microcontroller to activate and deactivate the light emitting source and the electromagnetic radiation source, the microcontroller sensing and controlling operation of the pen cap or the syringe shield.

16. The accessory of claim 15, wherein the mounting mechanism comprises one of a universal cap, a spring loaded member, a pressure fit, an adhesive, a screw thread, and a button.

17. The accessory of claim 15, further comprising a container for carrying the light emitting source.

18. A medical assembly, the assembly configured to disinfect a skin surface and a medical device or a portion of a medical device, the assembly comprising: a cap of the medical device, the cap comprising: a power source that provides power, an electromagnetic radiation source that emits electromagnetic radiation for disinfection using power received from the power source, and a switch configured to be operated by a user action; and the accessory of claim 15, wherein the mounting mechanism attaches to an outer surface of the cap, 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 for disinfection.

19. The assembly of claim 18, wherein the mounting mechanism and the cap of the medical device each comprise an electrical contact; and the electrical contact of the mounting mechanism engages the electrical contact of the cap of the medical device to power the light emitting source from the power source. ​ ​ ​

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