Various exemplary embodiments of the invention relate to needle storage. use and disposal for medication delivery pens.
Medication delivery pens are typically used to inject medication into a patient. A person who must periodically self-inject doses of medication will typically carry a medication delivery pen, several single-use pen needles, and several cleaning swabs. A medication delivery pen is designed for safety and sterility. However, inefficiencies and inconveniences can arise.
It is an aspect of the present invention to provide a needle storage container that stores two or more needle magazines, each carrying a plurality of needles. Each of the plurality of needles is configured to engage a medication delivery pen for medication delivery. Specifically, the medication delivery pen engages one of the plurality of needles and provides medication delivery while the needle is in the needle magazine. The combination of the container and the magazine provides advantages in easy organization, accurate subcutaneous injection, allows for needle disposal after use and storage before use in the same magazine, and improves usage with an optimized workflow to reduce setup time and space. The bottom surface of the magazine provides a mounting surface for the needle to be inserted substantially perpendicular to a skin surface of a patient. The mounting surface reduces injection variability by providing a large flat contact surface around an insertion site of the skin of the patient, thereby improving injection comfort. In addition, since the needle is never removed from the magazine, the needle is barely seen and thus reduces needle phobia.
The needle magazine also reduces the likelihood of needle reuse in several ways. First, the needle magazine has a seal on a top surface that acts as a visual indicator to indicate to a user whether the needle is used or new. Second, when the needle is withdrawn after use, the needle is in a locked position preventing further movement and reuse. Finally. after the needle is locked, the needle is positioned deeper within a cavity of the magazine to provide the user a visual indication that the needle is used.
The foregoing and/or other aspects of the present invention can be achieved by providing a needle storage container comprising a first compartment including a needle magazine capable of carrying a plurality of unused and used needles. and an adapter configured to engage a medication delivery pen, and a second compartment configured to carry a cleaning agent, wherein the first compartment is sealed from the second compartment.
The foregoing and/or other aspects of the present invention can further be achieved by providing a needle magazine comprising a plurality of cavities each carrying a needle fixed to a needle post, a first seal disposed at a proximal end of each of the plurality of cavities, and a second seal disposed at a distal end of each of the plurality of cavities, wherein in a first position of the needle post, the needle is enclosed between the first and second seals and a distal end of the needle is disposed into the second seal, in a second position of the needle post, the first seal is pierced and the needle pierces the second seal for medication delivery, and in a third position of the needle post, the needle no longer pierces the second seal and is ready for disposal.
The foregoing and/or other aspects of the present invention can also be achieved by providing a pen assembly comprising a medication delivery pen, an adapter configured to be engaged to the medication delivery pen, and a needle magazine having a plurality of cavities that each carry a needle fixed to a needle post, wherein when the adapter is attached to the medication delivery pen and disposed into one of the plurality of cavities, fluid communication is established with the needle in the needle post and the medication delivery pen, and the needle post is moved from a first position to a second position in the cavity so that the needle extends beyond a bottom surface to provide medication delivery.
The foregoing and/or other aspects of the present invention can additionally be achieved by providing a method of using a plurality of needles stored in needle magazine, the method comprising connecting an adapter to a medication delivery pen, engaging the adapter to a needle post carrying the needle to establish fluid communication between the medication delivery pen and the needle, moving the needle post downward from a first position to a second position, administering medication via the needle, moving the needle post upward from the second position to a third position. and sending the needle magazine to a manufacturer or a waste management entity after use of all of the plurality of needles in the magazine.
Additional and/or other aspects and advantages of the present invention will be set forth in the description that follows, or will be apparent from the description, or may be learned by practice of the invention.
The above aspects and features of the present invention will be more apparent from the description for the exemplary embodiments of the present invention taken with reference to the accompanying drawings, in which:
The second compartment 16 is of a substantially rectangular shape and includes the cleaning agent 18 such as an alcohol swab, for example. Other cleaning agents 18 commonly known by those skilled in the art are contemplated herein. The cleaning agent 18 is used to sanitize an adapter septum 62 or a septum 6 of a medication delivery pen 2 prior to or after use.
The divider wall 20 separates the first compartment 14 from the second compartment 16. The divider wall 20 is unitary to the main housing 12 to provide an interface that separates the two compartments 14, 16 and acts as a hermetic, liquid or airtight seal. Alternately, the divider wall 20 can be a feature inserted into the main housing 12 and integrated with seals to provide similar sealing benefits described above.
Finally, each of the compartments 14, 16 includes a compartment cover 22. The compartment covers 22 are each disposed on top surface of one of the compartments 14, 16. The compartment covers 22 are hinged above the divider wall 20 such that the compartment covers 22 open and close in opposing directions. Accordingly, the compartments covers 22 open and close to provide access and restrict access to the contents in each of the compartments 14, 16.
The adapter septum 62 is disposed at a distal end and on an internal surface of the hollow adapter 60 to selectively allow or restrict fluid flow. The adapter septum 62 is configured to engage one of the plurality of needles 74 in the needle magazine 30. Specifically, the proximal end of one of the needles 74 is configured to pierce the adapter 62 to establish fluid communication.
The snap ring member 64 is a circumferential protrusion disposed on an external surface of the adapter 60. The snap ring member 64 is also disposed near the distal end of the adapter 60. The plurality of needles 74 is each fixed to a needle post 70 and the needle post 70 is configured to engage the snap ring member 64 when one of the needles 74 pierces the adapter septum 62. This engagement is described below in more detail.
As illustrated in
Specifically. the medication delivery pen 2 includes an external thread 4 and the septum 6 as commonly understood by one skilled in the art. The external thread 4 is configured to thread into and engage the inner thread 66 of the adapter 60. The septum 6 is a seal that selectively holds medicament inside a cartridge of the medication delivery pen 2. Fluid communication is established between the medication delivery pen 2 and the adapter 60 when the hollow protruding portion 68 surrounded by the inner thread 66 of the adapter 60 pierces the septum 6 and the inner thread 66 fully engages the external thread 4.
The retainer plate 32 is a thick, circular sheet disposed on a top surface 34 as illustrated in
Each of the plurality of cavities 38 is tapered so that a diameter of one of the cavities 38 at a proximal end 42 is greater than a diameter of the cavity 38 at a distal end 44. The plurality of cavities 38 being tapered advantageously provides increased friction and engagement between the needle post 70 and the adapter 60 when the needle post 70 travels from a first position, to a second position and to a third position. Further description of these positions is set forth below.
The plurality of cavities 38 includes a protrusion 40, as best illustrated in
The needle magazine 30 also includes the plurality of first seals 46 disposed near a proximal end of the cavities 38 and on the top surface 34 aligned with each of the cavities 38. The plurality of first seals 46 is sandwiched between the retainer plate 32 and the top surface 34 and is adhered to the top surface 34. Preferably. the first seals 46 individual enclose each of the plurality of cavities 38. Once one of the first seals 46 is pierced, the first seal 46 is not reusable.
The first seals 46 are composed of any combination of a plastic, polymer, foil or metallic material. The material of the first seals 46 provides a hermetic, liquid or airtight seal for each of the cavities 38 in the magazine 30. Preferably, the first seals 46 are colored in green, orange or any other visibly contrasting color, for example. The colored first seals 46 advantageously provide a visually distinct appearance that the respective cavity 38 has not been accessed.
Alternately, the needle magazine 30 includes a first seal 46 comprising a single sheet that spans the top surface 34 and sandwiched between the top surface 34 and the retainer plate 32. In this configuration, different portions of the first seal 46 corresponding to and aligned with each of the plurality of cavities 38 are pierced when the cavity 38 is accessed and used.
The second seal 48 is disposed in each of the cavities 38 near a distal end and adjacent to the bottom surface 36. The second seal 48 more closely functions as a reusable septum or valve. The use of the seals 46, 48 during the operation of the needle magazine 30 is described below.
Prior to use of the needle magazine 30, each needle 74 and the needle post 70 is in the first position between the first and second seals 46, 48. The distal end of the needle 74 is preferably disposed above the second seal 48 or alternately disposed in the second seal 48. In either case, the distal end of the needle 74 does not extend through the second seal 48 in this position. The presence and color of the first seals 46 advantageously indicate that the respective cavity 38 has not been previously accessed. Subsequently, the user moves the adapter 60 attached to the medication delivery pen 2 to pierce the one of the first seals 46 in one of the cavities 38 and access the needle 74 and needle post 70.
Next, the adapter 60 attached to the medication delivery pen 2 engages the needle post 70 and moves the needle post 70 downward from the first position to the second position. In the second position, the distal end of the needle 74 pierces the second seal 48, extends through the second seal 48 and beyond the bottom surface 36 of the magazine 30. The needle 74 is now ready for medication delivery.
After medication delivery, the adapter 60 attached to the medication delivery pen 2 moves the needle post 70 upward from the second position to the third position. In this position, the distal end of the needle 74 is disposed in the second seal 48 (see
The bottom surface 36 advantageously provides an increased mounting surface to reduce localized pressure at the insertion site by spreading the pressure or injection force evenly across the surface area of the mounting surface. The mounting surface also advantageously improves accurate and consistent needle depth into the skin surface by automatically stretching and flattening the skin prior to injection of the needle 74. Specifically, if the needle 74 is inserted beyond a subcutaneous region of the skin, a muscle of the patient may be undesirably accessed. If the needle 74 is inserted and placed in a dermis or epidermis region of the skin instead of the subcutaneous region, the patient may not experience proper medication effectiveness. Finally, the mounting surface advantageously provides a flat surface so that the needle 74 can be inserted accurately at substantially a 90° angle with respect to the surface of the skin. Such a mounting surfaces improves injection repeatability and reduces injection variability.
Each of the plurality of cavities 38 includes the needle post 70 fixed to the respective needle 74. Each needle post 70 includes a snap ring groove 72 and a locking member 76. The snap ring groove 72 is configured to engage the snap ring member 64 of the adapter 60. Specifically, when the adapter 60 is connected to the medication delivery pen 2 and enters into one of the plurality of cavities 38, the snap ring groove 72 of the needle post 70 mates with the snap ring member 64 of the adapter 60. This engagement allows the adapter 60 connected to the medication delivery pen 2 to move the needle post 70 from the first position, to the second position and to the third position.
The locking member 76 of the needle post 70 is a plurality of linear slots circumferentially disposed on an exterior surface of the needle post 70. One of the plurality of linear slots of the locking member 76 is configured to engage the protrusion 40 in each of the cavities 38. Alternately, the protrusion 40 can engage a top surface of the needle post 70 to lock the needle post 70 in the cavity 38. The needle post 70 moves between three positions while interacting with the protrusion 40. These positions are briefly described below.
In the first position, the needle post 70 is disposed between the first and second seals 46, 48, the distal end of the needle 74 is preferably disposed in the second seal 48, and the needle 74 is ready for use. In this position, an outer surface of the needle post 70 compresses the protrusion 40.
In the second position, the needle post 70 is moved downward from the first position by the adapter 60 connected to the medication delivery pen 2. In this position, the needle 74 pierces and extends through the second seal 48 and is ready for medication delivery. In addition, the needle post 70 is moved past the protrusion 40 of the cavity 38 where the protrusion 40 is disposed above the needle post 70.
After the needle 74 is used, the needle post 70 is moved to the third position. In the third position, the needle post 70 moves upward from the second position and the locking member 76 engages the protrusion 40 of the cavity 38. In this position, the needle post 70 is locked in the cavity 38 and unable to move to the first or second positions, and also cannot be removed from the cavity 38. In addition, the distal end of the needle 74 is disposed in the second seal 48 and no longer extends through the second seal 48. Finally, the third position of the needle post 70 is between the first position and the second position. Accordingly, the needle post 70 is disposed in a position recessed from the top surface 34 compared to the first position to advantageously indicate to the user that the needle 74 is used.
The detailed operation of the pen assembly 1 is described as follows.
The adapter 60 is also attached to the medication delivery pen 2. Specifically, the inner threads 66 of the adapter 60 engage the external thread 4 of the medication delivery pen 2. When the inner thread 66 and the external thread 4 are fully engaged, the hollow protruding portion 68 of the adapter 60 pierces the septum 6 of the medication delivery pen 2 to establish fluid communication. Subsequently, the user aligns the medication delivery pen 2 to one of the plurality of cavities 38 in the needle magazine 30. The presence and color of the first seals 46 advantageously indicate that the respective cavity 38 has not been previously accessed. The pen assembly 1 is now ready for operation.
The cavity 38 is narrower as the needle post 70 moves from the first position to the second position. The tapered cavity 38 advantageously strengthens the engagement between the snap ring member 64 of the adapter 60 and the snap ring groove 72 of the needle post 70. This strengthened engagement reduces the likelihood of inadvertent disengagement of the adapter 60 to the needle post 70 when the needle post 70 is moving.
In addition, the bottom surface 36 of the needle magazine 30 contacts the skin of the patient during needle insertion and medication delivery. The bottom surface 36 of the magazine advantageously provides an increased and flat mounting surface for the needle 74 to be inserted substantially perpendicular to the skin surface of the patient. The mounting surface further reduces localized pressure at the insertion site and injection pain by providing a large flat contact surface around the insertion site of the skin of the patient that spreads the pressure or injection force evenly across the mounting surface. The mounting surface also advantageously improves accurate and consistent needle depth into the skin surface by automatically stretching and flattening the skin prior to injection of the needle 74.
After medication delivery,
The third position also illustrates that the needle 74 is retracted into the cavity 38 and the distal end of the needle 74 is disposed in the second seal 48. The distal end of the needle 74 does not extend through the second seal 48 in this position. The third position of the needle post 70 is between the first position and the second position. Accordingly, the needle post 70 in the third position is advantageously recessed from the top surface 34 so that the user can visually see that the needle 74 has been used.
After all the needles 74 have been used and placed in the third position in the cavity 38 of the needle magazine 30, the user can advantageously send the needle magazine 30, via mail, for example, to a manufacturer or a waste management entity for safe and sterile disposal. Optionally. the manufacturer can advantageously recycle and reuse various components of the needle magazine 30.
For example, the manufacturer can sterilize and reuse some or all of the cavities 38 in the needle magazine 30. Specifically, the manufacturer can replace the used needle 74 with the unused needle 74 in one or more cavities 38 and seal the respective cavity 38 with seals 46, 48. The needle magazine 30 can then be shipped and ultimately sold for reuse.
In another example, the needle storage container 10 can be sent back to the manufacturer. The manufacturer can replace the cleaning agent 18 in the second compartment 16. In addition, all the needles 74 in the magazines 30 and the adapter 60 can be replaced. The needle storage container 10 can then be shipped and ultimately sold for reuse.
The storage and use of the needles 74, as well as the disposal of the needles 74 in the same needle magazine 30 provides many advantages and benefits. There is no need for separate packages for storage and disposal of needles 74. This is because the needle magazine 30 advantageously synchronizes needle 74 use and disposal. This versatile arrangement provides better usage, optimizes workflow, minimizes setup time and optimizes space.
The foregoing detailed description of the certain exemplary embodiments has been provided for explaining the principles of the invention and its practical application, thereby enabling others skilled in the art to understand the invention for various embodiments and with various modifications as are suited to the particular use contemplated. This description is not necessarily intended to be exhaustive or to limit the invention to the precise embodiments disclosed. In addition, any of the embodiments, features and/or elements disclosed herein may be combined with one another to form various additional combinations not specifically disclosed, as long as the embodiments, features and/or elements being combined do not contradict each other. Accordingly, additional embodiments are possible and are intended to be encompassed within this specification and the scope of the invention. The specification describes specific examples to accomplish a more general goal that may be accomplished in another way.
As used in this application, the terms “front,” “rear,” “upper,” “lower,” “upwardly,” “downwardly,” and other orientational descriptors are intended to facilitate the description of the exemplary embodiments of the present invention, and are not intended to limit the structure of the exemplary embodiments of the present invention to any particular position or orientation. Terms of degree, such as “substantially” or “approximately” are understood by those of ordinary skill to refer to reasonable ranges around and including the given value, for example, general tolerances associated with manufacturing, assembly, and use of the described embodiments.
Filing Document | Filing Date | Country | Kind |
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PCT/US19/29329 | 4/26/2019 | WO |