Device for facilitating needle injections

Abstract

To provide a device to aid in pen needle injection.SOLUTION: A system is provided, including: a safety pen; and a device configured to aid in needle insertion of the safety pen. The device comprises a housing including: a mounting surface configured to contact a skin surface; and a hole configured to receive the safety pen, wherein the hole is configured to allow the safety pen to bottom out in the hole to position the safety pen for the needle insertion. The safety pen comprises a safety mechanism cooperating with a safety pen needle that includes a main body, a boss, and a hub having the needle fixed to the boss. The safety mechanism shields and locks the needle after the needle is used to prevent the needle from being used again.SELECTED DRAWING: Figure 5

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. Section 119(e) of U.S. Provisional Application No. 62 / 608,981, filed December 21, 2017, which is incorporated by reference in its entirety.

[0002] FIELD OF THEINVENTION FIELD OF THEINVENTION This invention relates generally to needle injections, and in particular to needle injections performed with a safety pen needle. [Background technology]

[0003] 2. Background of the Invention Safety pen needles are well known in the art for use with medical and other injectors, particularly medication delivery pen injectors. Shielding of the used needle before and after injection is provided by such devices. However, due to the presence of the shield, it may be difficult for a medical professional to identify the exposed needle or needle injection and provide for safe activation.

[0004] Subcutaneous injection can be difficult to confirm when using safety pen needles in patients with a high body mass index (BMI) or tender skin, as shown in Figures 1 and 2. For example, indentation of the skin during injection can lead to problems such as variations in injection force, bruising due to excessive pressure, premature activation of the safety mechanism, and angled needle insertion.

[0005] Traditional pen needles can also cause problems when the skin is indented during injection. These problems include varying injection forces, bruising from excessive pressure, and causing angled needle insertion. Summary of the Invention

[0006] One aspect of the present invention is to provide a device that assists in pen needle injections. Such a device automatically flattens a patient's skin, particularly skin with a high BMI or soft skin. The device essentially self-centers the pen needle, reducing excess force and minimizing the chance of premature actuation, providing a more reliable and accurate subcutaneous needle insertion process.

[0007] The above and / or other aspects of the present invention may be accomplished by providing a device configured to aid needle insertion with a syringe, the device including a housing having a mounting surface configured to contact a skin surface, a bore configured to engage with a syringe, and a taper substantially concentric with the bore to improve engagement with the syringe.

[0008] Additional and / or other aspects and advantages of the invention will be set forth in or will be obvious from the detailed description that follows, or may be learned by practice of the invention. [Brief description of the drawings]

[0009] The above aspects and features of the present invention will become more apparent from the following detailed description of exemplary embodiments of the present invention, taken in conjunction with the accompanying drawings.

[0010] [Figure 1] FIG. 1 is a side perspective view of a prior art safety pen needle and a patient's skin. [Diagram 2] FIG. 2 is a side perspective view of the needle of a prior art safety pen needle being inserted into a patient's skin. [Diagram 3] FIG. 3 is a front perspective view of a first exemplary embodiment of a device for facilitating pen needle injections. [Figure 4] FIG. 4 is a cross-sectional view of the device of FIG. 3 configured to engage a safety pen needle and placed on a skin surface. [Diagram 5] FIG. 5 is a cross-sectional view of the device of FIG. 3 engaged with a safety pen needle, the pen needle penetrating the patient's skin. [Figure 6]FIG. 6 is a front perspective view of a second exemplary embodiment of the device of FIG. 2 including an LED. [Figure 7] FIG. 7 is a cross-sectional view of the device of FIG. [Figure 8] FIG. 8 is a schematic diagram of the electrical circuitry of the device of FIG. [Figure 9] 9 is a cross-sectional view of a third exemplary embodiment of a medication delivery pen having a pen needle configured to engage a device; and [Figure 10] FIG. 10 is a cross-sectional view of the device of FIG. 9 engaging a pen needle and piercing a patient's skin. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS As noted above, Figure 1 illustrates a medication delivery pen 8 attached to a prior art disposable safety pen needle 10, which includes a housing 12, a movable needle shield 14 that forms part of the safety mechanism, and a needle cannula 16. The safety pen needle 10 is injected into a patient's skin surface 78. Problems may arise when using the safety pen needle 10. As shown in Figure 2, pressure applied to the safety pen needle 10 on a patient with soft skin or a high body mass index (BMI) may cause indentation 77 in the skin surface 78. This indentation 77 may create uncontrolled and variable injection forces.

[0012] Specifically, the medical practitioner may not be able to accurately and consistently determine the amount or strength of force that the safety pen needle 10 must apply to the skin surface 78. As a result, the safety mechanism of the safety pen needle 10 may be prematurely activated by excessive injection force. As will be further explained below, once the safety mechanism is activated and subsequently locked, the safety pen needle 10 is no longer operable. Alternatively, the recess 77 may make it difficult for the safety shield 14 to fully retract and activate the safety mechanism. In this case, the safety pen needle 10 may potentially be reused if the safety mechanism is not activated, which is undesirable. Finally, excessive injection force and applied pressure from the medical practitioner may also create bruising on the patient's skin surface 78.

[0013] The depressions 77 in the skin surface 78 may also create an angled insertion of the needle 16 of the safety pen needle 10. Because flat placement on the skin surface 78 is difficult to achieve, the needle 16 of the safety pen needle 10 is often not inserted in a substantially perpendicular orientation to the skin surface 78. Thus, the medical practitioner is uncertain whether the safety pen needle 10 is inserted into the desired subcutaneous region of the skin. If the safety pen needle 10 is inserted beyond the subcutaneous region of the skin, unwanted access to the patient's muscles may be obtained. If the safety pen needle 10 is inserted and positioned in the dermal or epidermal region of the skin rather than the subcutaneous region, the patient may not experience the proper medication effect.

[0014] The pitting 77 in the skin surface 78 can make it difficult to achieve consistent depth of drug deposition into the subcutaneous region of the skin. In other words, injection reproducibility and reduced injection variability are difficult to achieve when pitting 77 in the skin surface 78 occurs during needle injection.

[0015] Angled insertion of needle 16 into safety pen needle 10 can cause premature activation of the safety mechanism. Additionally, if safety pen needle 10 does not engage skin surface 78 in a substantially perpendicular orientation, accidental needlestick injury to healthcare personnel can occur.

[0016] Similar problems can occur with traditional pen needles when the skin is indented during injection. These problems include variability in injection force, variability in drug deposition depth, bruising from excessive pressure, and angled needle insertion.

[0017] To avoid problems associated with indentations 77 in the skin surface 78, medical practitioners typically stretch the skin surface 78 to create a flat surface. Alternatively, medical practitioners pinch the patient's skin surface 78 to access the subcutaneous layer of the skin. However, these methods are unreliable and inconsistent ways to achieve proper needle depth and separate the subcutaneous layer. Also, handling the skin surface 78 can result in bruising.

[0018] In view of the problems in the prior art as discussed above, a device 25, as shown in Figure 3, is provided to aid in needle insertion with an injector, such as a safety pen needle 10. While the particular device 25 shown is intended for use with a safety pen needle 10 having a retractable shield 14, embodiments of device 25 may be used with commonly available safety pen needles (Figures 3-8) and conventional pen needles (Figures 9 and 10), as well as injectors other than pen needles, such as syringes.

[0019] As shown in Figures 3-5, the device 25 includes a housing 30. Preferably, the housing 30 is made of a transparent or translucent white or light colored polymer to allow for illumination as further described below. The housing 30 is preferably rectangular in shape and similar in size to a credit card. Preferably, the housing 30 is shaped substantially like a flat credit card. However, other shapes and sizes are contemplated to improve ergonomics. For example, the housing 30 can include finger grips to provide easier handling and be contoured in an appropriate shape. The shape and size of the housing 30 can be varied so long as an adequate surface area is provided to engage the skin surface 78 and achieve the benefits described herein.

[0020] The housing 30 includes a top surface 34 and a bottom surface 38. Preferably, both the top and bottom surfaces 34, 38 are substantially flat and smooth. Alternatively, the top and / or bottom surfaces 34, 38 can be designed to include different contours, such as a smooth convex surface or a smooth concave surface. Such contours can provide a better user experience, such as, for example, tactile feedback identifying proper or improved skin contact.

[0021] Top surface 34 has a pattern 42 of information including at least one of a brand or trademark, a company name and logo, patient information, educational instructions, identification information, an image, a bar code, and a scannable QR code (shown). In one embodiment, a patient or medical professional can use the camera of a smart phone or mobile device to scan a QR code that is linked to a website that provides information regarding the proper operation of safety pen needle 10 and device 25.

[0022] The bottom surface 38 provides a resting surface and is configured to contact a patient's skin surface 78. Figure 4 shows the device 25 resting on a patient's skin surface 78 prior to needle insertion. Figure 5 shows the device 25 resting on a patient's skin surface 78 once the needle 16 of the safety pen needle 10 has been inserted. As noted above, the bottom surface 38 is substantially flat and smooth to advantageously create a flat skin surface 78 for needle insertion of the safety pen needle 10.

[0023] 3-5 also show the housing 30 having a taper 50 and a hole 46 configured to engage the safety pen needle 10. The taper 50 is substantially concentric with the hole 46. The taper 50 and the hole 46 have a different color than the rest of the housing 30. Preferably, the housing 30 is uncolored or a lighter color and can be transparent, translucent or opaque, while the taper 50 and the hole 46 are a darker color. The selected color advantageously allows the taper 50 and the hole 46 to be more noticeable on the housing 30.

[0024] The taper 50 includes a first diameter 54 and a second diameter 58. The first diameter 54 of the taper 50 is located at the bottom surface 38 of the housing 30. The second diameter 58 of the taper 50 is located at the top surface 34 of the housing 30. The second diameter is larger than the first diameter.

[0025] The second diameter 58 of the taper 50 is preferably sized slightly larger than the outer diameter of the housing 12 of the safety pen needle 10. The first diameter 54 of the taper 50 is preferably sized slightly smaller than the outer diameter of the housing 12 of the safety pen needle 10. In other words, the taper 50 is configured to substantially correspond to the tapered outer surface of the safety pen needle 10, but allow for ease of insertion. In this manner, the depth of insertion of the safety pen needle 10 is advantageously controlled.

[0026] Specifically, when the safety pen needle 10 is inserted into the taper 50, the distal end of the housing 12 of the safety pen needle 10 initially enters via a loose fit. The distal end of the housing 12 of the safety pen needle 10 then bottoms out, e.g., with a loose or tight or snug fit, and in the latter case is secured to the first diameter 54 of the device 25. As a result, the distal end of the housing 12 of the safety pen needle 10 is flush with the mounting surface 38 of the device 25. Thus, during use, the bottom surface 38 of the device 25 provides a greater and more evenly distributed surface pressure against the skin surface 78 for improved needle insertion.

[0027] In another embodiment, the taper 50 includes a first diameter 54, a second diameter 58, and a third diameter (not shown). The second diameter 58 is the same as in the embodiment above. The first diameter 54 is smaller than the outer diameter of the housing 12 of the safety pen needle 10, but large enough for the safety shield 14 to enter. The third diameter creates a stepped surface below the taper 50 and between the first diameter 54 and the second diameter 58. The third diameter is sized slightly larger than the outer diameter of the housing 12 of the safety pen needle 10. In operation, the safety pen needle 10 is inserted into the second diameter 58 of the taper 50 and bottoms out on the stepped surface at the third diameter. Although the housing 12 of the safety pen needle 10 is not flush with the mounting surface 38, the thickness of the stepped surface is known, and therefore the depth of insertion can also be controlled in this manner.

[0028] 3-5, when engaged, bore 46 and taper 50 substantially self-center safety pen needle 10 within device 25. Bore 46 also advantageously provides a substantially perpendicular needle entry of safety pen needle 10 upon engagement with a patient's skin surface 78.

[0029] The device 25 is intended to be easily cleaned using common cleaning methods and materials, such as isopropyl alcohol, bleach, and other cleaning agents. To provide this advantage, the device 25 is designed, for example, to have no shallow crevices or areas into which dirt can accumulate.

[0030] Figures 4 and 5 illustrate the operation of the safety pen needle 10 and device 25. In Figure 4, the safety pen needle 10 has not yet been used; therefore, the safety mechanism is not locked. The device 25 is placed on a patient's skin surface 78. Specifically, the resting surface 38 contacts the skin surface 78 via a compressive force applied by the patient or a medical professional.

[0031] 5, the safety pen needle 10 is then inserted into the hole 46 of the device 25. The safety shield 14 is retracted inside the housing 12 of the safety pen needle 10, activating the safety mechanism. At the same time, the needle 16 of the safety pen needle 10 is inserted into the patient's skin surface 78 and the medication is delivered.

[0032] After medication delivery is complete, the safety pen needle 10 is removed from the device 25. Once the safety pen needle 10 is removed, the safety mechanism extends from the housing 12 to cover the needle 16. The safety mechanism locks to permanently shield the needle 16 and prevent the safety pen needle 10 from being used again.

[0033] In addition to providing a substantially self-centering safety pen needle 10 and a substantially normal penetration of the skin as described above, device 25 provides additional benefits not realized in the prior art. The flat resting surface 38 of device 25 provides automatic flattening of skin surface 78 at the target site, which is particularly useful for patients with a high BMI or soft skin. A healthcare professional can apply pressure directly and / or via safety pen needle 10 to device 25 to flatten it against skin surface 78.

[0034] Planarizing the skin surface 78 advantageously allows for deposition of the agent at a consistent depth into the subcutaneous region of the skin, thus making injections more reproducible and reducing injection variability.

[0035] Due to the relatively large surface area of ​​device 25, a range of forces can be advantageously applied by the medical practitioner to ensure that needle 16 of safety pen needle 10 enters the subcutaneous layer of the patient's skin. As a result, use of device 25 to assist needle insertion of safety pen needle 10 provides superior performance over manually stretching and flattening the skin or pinching the skin.

[0036] When the needle 16 of the safety pen needle 10 is inserted substantially perpendicularly into the patient's skin, it is much less likely that the safety mechanism will be inadvertently or prematurely activated. Thus, it is less likely that the safety mechanism will unintentionally lock the safety pen needle 10 prior to use. In view of the above, when the device 25 is used to assist, patients and medical personnel will have more confidence in the use of the safety pen needle 10 and results will be more reliable.

[0037] 6-8 show a second exemplary embodiment of device 25. This embodiment is similar to the embodiment above, but further includes a light emitting diode (LED) 70 that illuminates transparent or translucent housing 30. LED 70 is disposed within housing 30 adjacent hole 46. As shown in the electrical schematic of FIG. 8, LED 70 is connected to battery 72 via switch 74 and resistor 76 for selective activation and deactivation. Switch 74 can be provided as a button or membrane switch on top surface 34 of housing 30, or on a side of housing 30 adjacent where device 25 is gripped during use, so that the switch can be easily operated by a user.

[0038] The LED 70 advantageously illuminates the housing 30 to better visualize the taper 50 and the bore 46 of the device 25. As discussed above, the distinct color of the housing 30 relative to the taper 50 and the bore 46, in combination with the LED 70, advantageously allows the taper 50 and the bore 46 to be even more prominent on the housing 30. Thus, medical personnel and patients can better view the self-centering mechanism of the device 25 in order to most effectively use the safety pen needle 10.

[0039] The LED 70 also advantageously aids medical personnel and patients in using the device 25 and safety pen needle 10 in dark locations. These low lighting conditions are typical in hospitals and outpatient care facilities.

[0040] 9 and 10 illustrate a third embodiment of an apparatus 125 for use with a conventional pen needle 110 attached to a medication delivery pen 8. The pen needle 110 includes a hub 112 having a body at a proximal end of the hub 112, a boss disposed at a distal end of the hub 112, and a needle cannula 116. The needle cannula 116 is secured to the boss at the distal end of the hub 112.

[0041] The device 125 is similar to the embodiments described above, but is configured for use with a conventional pen needle 110. The device 125 includes a housing 130 having a top surface 134 and a bottom surface 138, as described above. The device 125 includes a bore 146 having a first diameter 154 and a second diameter 158. The first and second diameters 154, 158 are substantially concentric. The first diameter 154 is sized to be larger than the outer diameter of the needle 116, larger than the outer diameter of the boss of the hub 112, and smaller than the outer diameter of the body of the hub 112. The first diameter 154 opens into a stepped surface 150. The stepped surface 150 is recessed from the top surface 134 at a second diameter 158. The second diameter 158 is sized to be slightly larger than the outer diameter of the body of the hub 112 to guide the pen needle 110 into the bore 146. In another embodiment (not shown), the second diameter 158 is tapered, similar to the first embodiment, to facilitate insertion of the pen needle 110 into the device 125 .

[0042] In operation, the medication delivery pen 8 is held such that the pen needle 110 is inserted into the bore 146 of the device 125. The distal end of the body of the hub 112 bottoms out in contact with the stepped surface 150 of the device 125. At the same time, the needle cannula 116 is inserted into the patient's skin. Force applied by the user is transferred through the medication delivery pen 8 to the distal end of the body of the hub 112. The stepped surface 150 receives the applied force and distributes the force across the bottom surface 138 of the device 125. Thus, the device 125 provides many of the advantages discussed above, primarily to prevent indentation of the skin surface, provide a substantially smooth surface for the needle cannula 116 to be inserted in a substantially vertical direction, reduce variability in injection force, and reduce variability in injection deposition depth.

[0043] The foregoing detailed description of certain exemplary embodiments is provided for the purpose of illustrating the principles of the invention and its practical application, so that those skilled in the art can understand the invention in its various embodiments and make various modifications suitable for the particular use envisaged. 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 each other, unless mutually inconsistent, to form various additional embodiments not specifically disclosed. Thus, additional embodiments are possible and are intended to be included within the scope of the specification and the invention. This specification describes specific examples for achieving more general goals that may be achieved in other ways.

[0044] The terms "front", "back", "top", "bottom", "upward", "downward", and other directional descriptors used in this application are intended to facilitate the description of exemplary embodiments of the invention, and are not intended to limit the structures of exemplary embodiments of the invention to any particular position or orientation. Terms of degree, such as "substantially" or "approximately", will be understood by those skilled in the art to refer to reasonable ranges outside of the given values, e.g., typical tolerances associated with the manufacture, assembly, and use of the described embodiments.

Claims

1. 1. A system including a safety pen and a device configured to facilitate needle insertion of said safety pen, said device comprising: A housing, a resting surface configured to contact a skin surface; a bore configured to receive the safety pen, a hole configured to allow the safety pen to bottom out within the hole to position the safety pen for needle insertion; Equipped with the safety pen includes a safety mechanism cooperating with a safety pen needle including a hub having a body, a boss, and a needle secured to the boss, the safety mechanism shielding and locking the needle after use to prevent reuse; The system comprises a safety pen housing, the housing of the device being configured such that when the safety pen bottoms out within the hole, a bottom end surface of the safety pen housing is flush with the mounting surface of the housing of the device.

2. The system of claim 1 , wherein the housing has a uniform thickness.

3. The system of claim 1 , wherein the housing is transparent or translucent.

4. The system of claim 1 , wherein the housing comprises a substantially rectangular shape.

5. The system of claim 1 , wherein the mounting surface is substantially flat.

6. 10. The system of claim 1, wherein the housing bears patterned information including at least one of a brand or trademark, a company name and logo, patient information, educational instructions, identification information, images, bar codes, and scannable QR codes.

7. The system of claim 6 , wherein the pattern of information is disposed on a surface of the housing opposite the mounting surface of the housing.

8. The system of claim 1 , wherein a surface of the housing opposite the mounting surface of the housing is substantially flat.

9. The system of claim 1 , wherein the hole is tapered to improve reception of the safety pen.

10. a first diameter of the taper positioned at the mounting surface of the housing; a second diameter of the taper is located on a surface of the housing opposite the mounting surface of the housing; The system of claim 9 , wherein the second diameter is greater than the first diameter.

11. 10. The system of claim 9, wherein the tapered bore substantially corresponds to a tapered exterior surface of the safety pen.

12. The system of claim 1 , wherein the housing includes an LED that illuminates the housing.

13. The system of claim 12 , wherein the LED is adjacent the hole in the housing.

14. The system of claim 1 , wherein the mounting surface comprises a flat, smooth and continuous surface.

15. The system of claim 1 , wherein the mounting surfaces are evenly distributed around the hole.

16. The system of claim 1 , wherein premature activation of the safety mechanism is prevented.

17. The system of claim 1 , wherein the safety mechanism is activated to shield and lock the needle after use.

18. 10. The system of claim 1, wherein the safety mechanism, when activated, locks to permanently shield the needle from reuse.

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