Patent Description:
This invention relates to safety pen needle assemblies.

Safety pen needle assemblies are well known in the art for use with medical injectors, particularly medication delivery pen injectors. Shielding of a used needle before and after injection is provided by such devices. However, it can be difficult for a health care professional to confirm needle exposure or needle injection as well as provide safety activation. As such, a user may inadvertently inject prematurely or experience a false injection.

Transmission of biological material or disease is not a concern with the needle being in a clean state; however, a safety activation mechanism can prevent the health care professional or a patient from suffering an incidental needle stick. The safety pen needle must be properly disposed of since the needle cannot be used subsequently on a patient.

In <CIT> a disposable double pointed injection needle has a needle hub to which a thin needle cannula is permanently fastened and which needle hub can be mounted on to a syringe comprising a dose setting and injection mechanism and a cartridge containing a liquid medicine to be injected subcutaneously into a human body. The needle hub of <CIT> is provided with a safety shield guided on the outside surface of the needle hub. In <CIT>, the safety shield is urged in a direction away from the needle hub by a spring located between the needle hub and the safety shield. The safety shield of <CIT> has a number of protrusions guided in guiding tracks on the outside surface of the needle hub. The guiding tracks in <CIT> are designed such that the safety shield during injection is moved towards the needle hub, and after injection is moved away from the needle hub by the spring and locked in an irreversible position where the safety shield covers the needle cannula and prevents accidental needle stick injuries.

<CIT>, <CIT>, <CIT>, <CIT>, and <CIT> show further state of the art relevant for the present disclosure.

It is an aspect of the present invention to provide a variable indicator on a safety pen needle to indicate needle cannula exposure and safety activation. Such a safety pen needle provides advantages in informing the health care professional that the needle cannula is extended and injected into a skin of the patient. Also, the safety pen needle provides a safety activation lock to prevent the needle cannula from further exposure or contamination after use.

The foregoing and/or other aspects of the present invention can be achieved by providing a safety pen needle assembly comprising a hub, a needle cannula engaged to the hub, the needle cannula having a distal end for insertion into a patient, and a proximal end extending into the hub, a sleeve surrounding the hub and needle cannula, a shield including a window, the shield surrounding the sleeve and movable relative to the sleeve from a first position, to a second position and to a third position to expose and cover the distal end of the needle cannula, and a spring urging the shield to move relative to the sleeve from the second position to the third position, wherein the window indicates when the needle cannula is extended in the second position.

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:.

<FIG> illustrates a typical medication delivery pen <NUM> connected to a first embodiment of a safety pen needle <NUM>. The safety pen needle <NUM> includes a hollow needle cannula <NUM> engaged to a hub <NUM>. The needle cannula <NUM> includes a sharpened distal end that injects and dispenses medicament to a patient and a proximal end that is in fluid communication with a vial, cartridge or reservoir within the medication delivery pen <NUM>.

The needle cannula <NUM> is engaged to the hub <NUM> and extends beyond a proximal end of the hub <NUM> at all stages of operation. In one embodiment, the hub <NUM> includes indicia such as colors, numbers, patterns (such as stripes or spots), textures and/or symbols to indicate needle cannula exposure. Further explanation of the indication of needle cannula exposure is described below.

The hub <NUM> is surrounded by a movable sleeve <NUM>. A distal end of the sleeve <NUM> provides a stopping surface when the needle cannula <NUM> contacts a skin of a patient. From the distal end of the sleeve <NUM>, the needle cannula <NUM> is extended and injected into a patient.

In a first position, as illustrated in <FIG>, when the safety pen needle <NUM> is ready for operation, the sleeve <NUM> encloses and surrounds the needle cannula <NUM> and hub <NUM>. The hub <NUM> partially encloses the needle cannula <NUM> in this first position. In a third position, as illustrated in <FIG>, when the safety pen needle <NUM> is in a safe mode after use, the sleeve <NUM> partially encloses and surrounds the needle cannula <NUM> and hub <NUM>. The hub <NUM> fully encloses the needle cannula <NUM> in this third position. However, in a second position, as illustrated in <FIG>, when the safety pen needle <NUM> is deployed for medication delivery, the needle cannula <NUM> extends beyond the hub <NUM> and the sleeve <NUM>.

In view of the above, the safety pen needle <NUM> is a single needle cannula <NUM> device that advantageously hides the needle cannula <NUM> when not in use (the first and third positions). In other words, the needle cannula <NUM> is only exposed in the second position during medication delivery. The safety pen needle <NUM> having the single needle cannula <NUM> is also different from a typical pen needle magazine where a plurality of pen needles is provided for use by the medication delivery pen <NUM>.

The sleeve <NUM> is multicolored and cooperates with a shield <NUM> to visually indicate the status of the safety pen needle <NUM> in the first, second and third positions. In another embodiment, the hub <NUM> and shield <NUM> can also cooperate together to display the status of the safety pen needle <NUM> in a similar manner. The sleeve <NUM> cooperates with a window <NUM> in the shield <NUM> as described below to depict the status of the safety pen needle <NUM>. The window <NUM> may comprise an opening (cut-out) in the shield <NUM> with or without a transparent cover.

The sleeve <NUM> is partially surrounded by the shield <NUM> in the first and third positions. The shield <NUM> is movably connected to the hub <NUM>, the needle cannula <NUM> and the sleeve <NUM>. The shield <NUM> is also pressurized by a spring (see <FIG>) to urge the movement of the shield <NUM>.

Specifically, in the first position as illustrated in <FIG>, the shield <NUM> is in a ready or retracted position and the spring urges the shield <NUM> toward the retracted position. However, the shield <NUM> is in an unlocked state and is free to move. The spring does not prevent the shield <NUM> from moving. Rather, the health care professional can overcome the spring force to move the shield <NUM>. The shield <NUM> also partially surrounds the sleeve <NUM>.

In the second position as illustrated in <FIG>, the health care professional operates the device by pushing down on the medication delivery pen <NUM> which is connected to the safety pen needle <NUM>. This pressure causes the needle cannula <NUM> to deploy into the skin of the patient for medication delivery. In this position, the shield <NUM> is extended and moves to a second position to overcome the pressurized force by the compressed spring. The movement of the shield <NUM> causes the hub <NUM> and the needle cannula <NUM> to move from a retracted position (first position) to an extended position (second position). The shield <NUM> fully surrounds the sleeve <NUM>, and the needle cannula <NUM> extends beyond the shield <NUM> and sleeve <NUM> in the second position.

In the third position as illustrated in <FIG>, the health care professional removes the medication delivery pen <NUM> that is connected to the safety pen needle <NUM> from the patient. Upon removal, the spring urges the shield <NUM> to move back to the third position. The sleeve <NUM> also moves back to expose the hub <NUM> and the needle cannula <NUM>. However, the needle cannula <NUM> is fully enclosed in the hub <NUM> in the third position. Thus, the spring advantageously provides automatic retraction of the shield <NUM> and the needle cannula <NUM> after use in the second position as the safety pen needle <NUM> moves to the third position. Similar to the first position, the shield <NUM> partially surrounds the sleeve <NUM>.

In the third position, a locking mechanism (see <FIG>) of the safety pen needle <NUM> locks the shield <NUM> and prevents the safety pen needle <NUM> from further use. Specifically, the needle cannula <NUM> is fully enclosed by the hub <NUM> and is unable to be exposed in the second position or return for use in the first position. The locking mechanism may include, for example, a tab on an inner surface of the shield <NUM> and a slot on an outer surface of the hub <NUM>, although various other configurations are contemplated herein.

According to the first embodiment, the first position and the third position, as illustrated in <FIG> and <FIG>, are different from each other. Specifically, in the third position, the shield <NUM> and sleeve <NUM> are in a further retracted position when compared to the first position. According to another embodiment, the first position and the third position are the same position. In this alternate embodiment, the locking mechanism is configured to be used in the third position but not the first position. In another embodiment, the sleeve <NUM> is rotated to angularly displace the third position from the first and second position.

The shield <NUM> includes the window <NUM> which visibly indicates needle cannula exposure and safety activation. Specifically, as illustrated in <FIG>, the window <NUM> visually exposes a white portion <NUM> of the sleeve <NUM> to represent the ready position. In this first position, the safety pen needle <NUM> is ready for operation and is in an unlocked state to allow various components to move.

As illustrated in <FIG>, the window <NUM> visually exposes a green portion <NUM> of the sleeve <NUM> to represent the fully deployed position. In this second position, the needle cannula <NUM> of the safety pen needle <NUM> is exposed, inserted into the patient and is dispensing medication. This visual indication advantageously provides the health care professional confirmation that the needle cannula is in the skin of the patient. This visual indication is a significant improvement over a mere tactile notification or needle cannula sensation that the health care professional may previously have relied upon to confirm needle cannula insertion. Another advantage this visual indication provides is less training for health care professionals and reduced risk of injection errors.

As illustrated in <FIG>, the window <NUM> visually exposes a red portion <NUM> of the sleeve <NUM> to represent the safe mode in the third position. In this third position, the needle cannula <NUM> is retracted into the hub <NUM> and is locked from further exposure and use. This visual indication advantageously provides the health care professional notice that the safety pen needle <NUM> is in safe activation mode. Such an indication protects patients and health care professionals from being contaminated by used needle cannulas.

In other embodiments, alternative types of indicia such as numbers, patterns (such as stripes or spots), textures and/or symbols can replace or supplement the green, red or white portions <NUM>, <NUM>, <NUM> of the sleeve <NUM> as described above. Different patterns or textures can advantageously aid those who are blind, color blind or in cases where red/green colors, for example, are perceived differently in other countries. Additionally, in one embodiment, the window <NUM> can be tinted to adjust what is visually displayed.

<FIG> illustrates a second embodiment of the safety pen needle <NUM> described above having a smart ring <NUM> but without a window. The smart ring <NUM> is a circular ring disposed at a proximal end of the safety pen needle <NUM>. When the safety pen needle <NUM> is engaged to the medication delivery pen <NUM>, the smart ring <NUM> is disposed between the safety pen needle <NUM> and the medication delivery pen <NUM>.

The smart ring <NUM> includes electronics such as electrical contacts or sensors <NUM> that cooperate with the remaining components of the safety pen needle <NUM> to sense positional and/or spatial arrangements to determine a position of the shield <NUM> and dose data. For example, the smart ring <NUM> is able to determine needle insertion and needle exposure time, needle insertion rate and needle exposure rate, the number of injections performed, time intervals between injections and the number of needles used or available for injection.

The smart ring <NUM> also determines the position of the shield <NUM> to identify which of the three positions the safety pen needle <NUM> is operating in as described above. The smart ring <NUM> communicates positional data or dose data to an external smart device for monitoring and status notification such as if the safety pen needle <NUM> is in the first, second or third positions. The external smart device can be, for example, a mobile phone, laptop, iPad, a smart medication delivery pen or other processing device.

The smart ring <NUM> communicates data wirelessly or via a wireline connection to the external smart device. Different wireless connectivity methods can be used (e.g., Bluetooth™ or Wi-Fi or near field communication (NFC) technology) which can, in turn, impact device pairing if needed and the need for proximity of the external smart device. For example, Bluetooth™ employs a particular device pairing process. The proximity of the two communicating platforms relative to each other depends on the connectivity method used.

<FIG> illustrates a third embodiment of the safety pen needle <NUM> described above having a smart ring <NUM> and the window <NUM>. This embodiment incorporates the smart ring <NUM> technology described in the second embodiment, as well as the visual indication feature of the window <NUM> described in the first embodiment. This configuration advantageously provides data communication and status indication through the window <NUM> at the same time.

In this embodiment, the sleeve <NUM> is rotated during operation to angularly displace the second position from the first and third position. Accordingly, the sleeve <NUM> rotates and axially moves from the first position (white portion <NUM>) to the second position (green portion <NUM>) and displays the status through the window <NUM>. After use, the sleeve <NUM> rotates and axially moves from the second position (green portion <NUM>) to the third position (red portion <NUM>).

In addition to the advantages described above in the first embodiment, the use of the smart ring <NUM> in the safety pen needle <NUM> of the second and third embodiments can prohibit injection until the needle cannula has been fully exposed or fully extended. Such a feature can further mitigate the risk of a failed injection.

<FIG> illustrates a fourth embodiment of the safety pen needle <NUM> that functions in a similar manner as the embodiments described above. Specifically, the safety pen needle <NUM> includes an outer shield <NUM> with three colored dots <NUM>, <NUM>, <NUM> that cooperate with a sleeve <NUM> having a window <NUM>. The safety pen needle <NUM> further includes an inner shield <NUM> and a needle <NUM> fixed to a needle hub <NUM> that cooperates with a spring <NUM> to allow for needle <NUM> movement between an extended and a retracted position.

The outer shield <NUM> slides in and out and rotates, depending on the state of the safety pen needle <NUM>. Three dots, white <NUM>, red <NUM>, and green <NUM> are located on the outer shield <NUM> such that one of the three dots <NUM>, <NUM>, <NUM> aligns with the window <NUM> in the sleeve <NUM>, depending on the state of the safety pen needle <NUM>.

In the ready position (as delivered), the white dot <NUM> is visible in the window <NUM>. During injection, the outer shield <NUM> will retract into the sleeve <NUM> and rotate, bringing the green dot <NUM> into view in the window <NUM>. In the locked state, the shield <NUM> will move forward, bringing the red dot <NUM> into view through the window <NUM>. The spring <NUM> provides a spring force to return the outer shield <NUM> of the safety pen needle <NUM> into the retracted position.

In other embodiments, alternative types of indicia such as numbers, patterns (such as stripes or spots), textures and/or symbols can replace or supplement the green, red or white colored dots <NUM>, <NUM>, <NUM> of the outer shield <NUM> as described above. Different patterns or textures can advantageously aid those who are blind, color blind or in cases where red/green colors, for example, are perceived differently in other countries.

<FIG> illustrate a fifth embodiment of the safety pen needle having a locking mechanism comprising locking rails <NUM> and slots <NUM> as described below. <FIG> illustrates a needle hub <NUM> having the locking rails <NUM>. The locking rails <NUM> are an extruded rectangular member along a longitudinal surface of the needle hub <NUM>. The locking rails <NUM> are disposed on an outer surface of the needle hub <NUM> in a substantially central axial position. Two locking rails <NUM> are disclosed to be equidistant along the outer surface of the needle hub <NUM>, although more or fewer locking rails are contemplated.

<FIG> illustrates an inner shield <NUM> having the slots <NUM>. The slots <NUM> are internal rectangular cavities disposed at a proximal end surface of the inner shield <NUM>. As the slots <NUM> extend beyond the proximal end surface at the proximal end of the inner shield <NUM>, the slots <NUM> are open and exposed along a length of the inner shield <NUM>. The slots <NUM> are sized to engage the locking rails <NUM> of the needle hub <NUM>. More or fewer slots <NUM> are contemplated based on the number of corresponding locking rails <NUM> in the needle hub <NUM>.

<FIG> illustrates the slots <NUM> of the inner shield <NUM> being aligned to the locking rails <NUM> of the needle hub <NUM> prior to assembly. Subsequently, as illustrated in <FIG>, the inner shield <NUM> slides over the needle hub <NUM> to engage the locking rails <NUM> in the slots <NUM>. In this position, the locking rails <NUM> are aligned to openings of the slots <NUM>. Thus, the safety pen needle is in a retracted, unlocked position. The locking rails <NUM> are exposed because the slots <NUM> do not enclose the locking rails <NUM> along a majority of the length of the slot <NUM>.

<FIG> illustrates an extended position of the safety pen needle. Specifically, the inner shield <NUM> moves forward via a spring force from a spring (not illustrated). The spring is preferably a torsion spring, although other springs are contemplated. <FIG> illustrates the slots <NUM> of the inner shield <NUM> disengaged from the rails <NUM> of the needle hub <NUM>.

At this point, as illustrated in <FIG>, torsion from the spring causes the inner shield <NUM> to rotate relative to the needle hub <NUM>. Thus, the rails <NUM> are misaligned to the slots <NUM> and the inner shield <NUM> can no longer slide back over the needle hub <NUM>. That is, the inner shield <NUM> is not able to return to the retracted, unlocked position. In this manner, the safety pen needle is in an extended, locked position preventing engagement of the inner shield <NUM> and the needle hub <NUM>.

The foregoing detailed description of the certain exemplary embodiments has been provided for the purpose of 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. Any of the embodiments and/or elements disclosed herein may be combined with one another to form various additional embodiments not specifically disclosed, as long as they 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.

Claim 1:
A safety pen needle assembly (<NUM>, <NUM>) comprising:
a hub (<NUM>, <NUM>);
a needle cannula (<NUM>, <NUM>) cooperating with the hub, the needle cannula having a distal end for insertion into a patient, and a proximal end extending into the hub;
a sleeve (<NUM>, <NUM>) surrounding the hub and needle cannula;
a shield (<NUM>) including a window (<NUM>, <NUM>), the shield surrounding the sleeve and movable relative to the sleeve from a first position where the sleeve encloses the needle cannula and hub, to a second position where the needle cannula extends beyond the hub and the sleeve;
a locking mechanism (<NUM>) that engages the shield to the hub to prevent further use of the needle cannula; and
a spring (<NUM>) urging the shield;
characterized in that the safety pen needle assembly (<NUM>, <NUM>) further comprises:
the shield (<NUM>) being-movable relative to the sleeve to a third position where the distal end of the needle cannula is partially surrounded by the sleeve and the hub encloses the needle cannula;
the spring (<NUM>) urging the shield to move relative to the sleeve from the second position where the spring is compressed to the third position; and
a smart ring (<NUM>) having electrical contacts or sensors that determine two or more of a position of the shield, needle insertion and needle exposure time, needle insertion rate and needle exposure rate, the number of injections performed, time intervals between injections or the number of needles used or available for injection; wherein
the window indicates needle cannula exposure via an indicia on the hub and safety activation via the locking mechanism.