Cap for injector pen

Abstract

A needle cap for an injector pen including a body having a closed end and an open end and a protrusion extending from the closed end for indicating that a needle will not pass through the closed end.

Description

CAP FOR INJECTOR PENRelated Applications

[0001] This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application Serial No. 63 / 601,991, filed on November 22, 2023, the entire disclosure of all of said prior applications being hereby incorporated herein by reference.Field of the Invention

[0002] The present invention relates to medical devices, and more particularly, to injector pens.Background of the Invention

[0003] Many patients require regular multiple doses of certain medications throughout the day. For example, diabetic patients may need multiple doses of insulin throughout the day. There are multiple delivery methods for insulin. Some diabetic patients may use insulin pumps, which are small computerized devices that deliver insulin throughout the day. Other patients may perform self-injection of insulin by using a syringe or an injector pen.

[0004] An injector pen is a device for injecting medicine repeatedly over a period of time. An injector pen may include a reservoir for containing medication, a pen needle, a dose selection dial, a plunger, and a plunger button. There are two types of pen needles primarily used: a standard pen needle and a safety pen needle. Standard pen needles include a removable outer cover, an inner cap that is removable, and a fixed needle. To use an injector pen with a standard pen needle, a patient must remove both the removable outer cover and the inner cap before performing an injection. Some safety pen needles include a removable outer cover, a fixed inner needle shield, and a mobile needle that extends beyond the fixed inner cover during use of the insulin pen, but is otherwise covered by the fixed inner needle shield. To use an injector pen with such a safety pen needle, a patient must remove the removable outer cover, but does not remove the fixed inner cover.

[0005] On September 27, 2018, the United States Food and Drug Administration released a safety communication indicating that patient confusion occurred where some patients weretrained using an injector pen with a safety pen needle but were later provided with an injector pen with a standard pen needle. Some patients subsequently developed high blood sugar (hyperglycemia) after failing to remove the inner cap prior to performing their injections, resulting in at least one death. Thus, there is a desire to provide a means of preventing patient confusion and improper use if patients are trained using an injector pen with a safety pen needle and are later provided with an injector pen with a standard pen needle.Summary of Embodiments of the Invention

[0006] Accordingly, it is an aspect of the present invention to provide a needle cap for an injector pen. The needle cap includes a body having a closed end and an open end and a protrusion extending from the closed end for indicating that a needle will not pass through the closed end.

[0007] Another aspect of the present invention is to provide a system for an injection pen needle. The system includes a needle assembly including a needle base and a needle fixed to and extending from the needle base. The system further includes an inner needle cap removably connected to the needle base for covering the needle. The inner needle cap includes a body having a closed end and an open end and a protrusion extending from the closed end for indicating that a needle will not pass through the closed end. The system further includes an outer needle cover for covering the inner needle cap and the needle assembly.

[0008] Yet another aspect of the present invention is to provide a system for an injection pen needle. The system includes a needle assembly including a needle base and a needle fixed to and extending from the needle base. The system further includes an inner needle cap removably connected to the needle base for covering the needle. The inner needle cap includes a body having a cylindrical shape and having a closed end having a circular shape and an open end anda protrusion extending from the closed end and over a geometric center of the closed end for indicating that a needle will not pass through the closed end. The system further includes an outer needle cover for covering the inner needle cap and the needle assembly.

[0009] 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.Brief Description of the Drawings

[0010] The above and / or other aspects and advantages of embodiments of the invention will be more readily appreciated from the following detailed description, taken in conjunction with the accompanying drawings, of which:FIG. 1 is an exploded side view of a related art pen needle and inner needle cap;FIG. 2 is a side view of a related art inner needle cap of FIG. 1 ;FIG. 3 is an exploded side view of a related art safety pen needle;FIGS. 4A-4D are perspective views of modified inner needle caps according to exemplary embodiments of the present invention; andFIGS. 5A-5D are perspective views of modified inner needle caps according to further exemplary embodiments of the present invention.Detailed Description

[0011] Reference will now be made in detail to embodiments of the present invention, which are illustrated in the accompanying drawings, wherein like reference numerals refer to like elements throughout. The embodiments described herein exemplify, but do not limit, the present invention by referring to the drawings.

[0012] The embodiments are not intended to be mutually exclusive so that the features of one embodiment can be combined with other embodiments as long as they do not contradict each other.

[0013] It will be understood by one skilled in the art that this disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The embodiments herein are capable of other embodiments, and capable of being practiced or earned out in vanous ways. Phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting.The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0014] Unless limited otherwise, the terms “connected,” “coupled,” and “mounted,” and variations thereof herein are used broadly and encompass direct and indirect connections, couplings, and mountings. In addition, the terms “connected” and “coupled”" and variations thereof are not restricted to physical or mechanical connections or couplings. Further, terms such as “up,” “down,” “bottom,” “top,” “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 skilled in the art to refer to reasonable ranges around and including the given value and ranges outside the given value, for example, general tolerances associated with manufacturing, assembly, and use of the embodiments. The term “substantially” when referring to a structure or characteristic includes the characteristic that is mostly or entirely.

[0015] FIG. 1 illustrates an injector pen having a standard pen needle 22. The injector pen includes, for example, a body, which may be plastic, such as polycarbonate, polypropylene, or polyethylene. A front part, which may be metal, such as stainless steel extends from the plastic body, and the standard pen needle extends from the front part. A cartridge containing a medication may be placed at least partially within the plastic body. The front part may include a clear cartridge window and an indicator scale for allowing a patient to view the cartridge and determine an amount of medication remaining in the cartridge. The plastic body further includes a body window for allowing the patient to view the cartridge, a clip-on panel, a dose display indicating a dose value (i.e., a quantity of medication to be injected), an injection button for initiating injection of the medication, and a cartridge release button for releasing the cartridge for replacement. A needle guard and front cap are both removably connected to the body for covering the standard pen needle 22.

[0016] FIG. 1 further illustrates the standard pen needle 22. The standard pen needle 22 includes a needle assembly 48 connected to the front part of the injector pen. The needleassembly includes a needle base 50 and a hollow needle 52 fixed to and extending from the needle base 50. A removable inner needle cap 54 is removably connected to the needle base 50 and covers the hollow needle 52 when attached. The inner needle cap 54 is generally shaped as a cylinder with one end covered and the other end opened. An outer needle cover 56 is removably connected to the front part of the injector pen or the needle base 50 for covering the inner needle cap 54 and the needle assembly 48. During use of the injector pen having the standard pen needle 22, both the outer needle cover 56 and the inner needle cap 54 must be removed to allow for injection of the medication in the cartridge. The hollow needle 52 of the injector pen is then inserted into a patient’s body.

[0017] FIG. 2 shows a side view of the inner needle cap 54. The inner needle cap 54 includes a cylindrical body 58, a circular closed end 60, and a circular open end 62 that may include a rim 64.

[0018] FIG. 3 shows a safety pen needle 70. The safety pen needle 70 includes a needle assembly 72 including a needle base 74, a fixed inner needle shield 76, and needle 78 movable relative to the fixed inner needle shield 76. The fixed inner needle shield 76 is generally shaped as an open cylinder. An outer needle cover 80 is removably connected to the needle base 74 or another feature of an injector pen for covering the needle assembly 72. During use of an injector pen having the safety pen needle 70, the outer needle cover 80 must be removed, but the fixed inner needle shield 76 is not removed. The injector pen is placed into contact with human skin and the needle 78 is actuated to extend beyond the fixed inner needle shield 76 and into a patient’s body.

[0019] In circumstances where a patient is trained using an injector pen with a safety pen needle 70 and are later provided with an injector pen with a standard pen needle 22, the patient may be confused between the fixed inner needle shield 76 of the safety pen needle 70 and the inner needle cap 54 of the standard pen needle 22. This confusion may result in the patient failing to remove the inner needle cap 54, resulting in the hollow needle 52, and thus medication, not entering the patient’s body. This may be because the patient does not get a close enough look at the fixed inner needle shield 76 of the safety pen needle 70 and the inner needle cap 54 to note the presence of the circular closed end 60 on the standard pen needle 22 and lack of the circularclosed end 60 on the fixed inner needle shield 76, or because the patient, upon seeing the circular closed end 60 on the standard pen needle 22, assumes that the hollow needle 52 will pass through the circular closed end 60 or that there is a small, difficult to see hole in the circular closed end 60 through which the hollow needle 52 will pass.

[0020] FIGS. 4A-4D show various exemplary of inner needle caps 154 in accordance with embodiments of the present invention. According to the illustrated embodiments, the inner needle caps 154 each include a cylindrical body 58, a circular closed end 60, and a circular open end 62. But one skilled in the art will appreciate that embodiments of the preset invention can have other shapes without departing from the present invention’s scope. The circular open end 62 may include a rim. Further, each of the modified inner needle caps 154 include an indicator protrusion 166 extending from the circular closed end 60 such that the protrusion extends over the geometric center of the circular closed end. In the embodiment of FIG. 4A, the indicator protrusion 166 has a semi-circular arc shape 190. In the embodiment of FIG. 4B, the indicator protrusion 166 has a torus shape 192. In the embodiment of FIG. 4C, the indicator protrusion 166 has a pillar 194 supporting an oval toroid shape 196. In the embodiment of FIG. 4D, the indicator protrusion 166 has a T-shape formed from a pillar 198 supporting a cylinder 200 perpendicular to the pillar 198.

[0021] The indicator protrusions 166 extending from the circular closed ends 60 provide an indication to a patient that the hollow needle 52 of the standard pen needle 22 will not pass through the circular closed end 60 of the modified inner needle caps 154, as there is clearly more solid, physical structure through which the hollow needle 52 would have to pass to perform the injection. These indicator protrusions 166 thus prevent confusion in patients and prevent patients from assuming the hollow needle 52 is entering their body while the modified inner needle cap 154 is in place. As such, the patients will be more likely to receive the medication as expected, even if the patients are trained using an injector pen with a safety pen needle 70 and are later provided with an injector pen with a standard pen needle 22 with which the patients are not trained.

[0022] FIGS. 5A-5D show various exemplary of inner needle caps 154 in accordance with further embodiments of the present invention. Similar to the embodiments described above withrespect to FIGS. 4A-4D, in the illustrated embodiments of FIGS. 5A-5D, the inner needle caps 154 each include a cylindrical body 58, a circular closed end 60, and a circular open end 62. But one skilled in the art will appreciate that embodiments of the preset invention can have other shapes without departing from the present invention’s scope. The circular open end 62 includes a rim 64. Further, each of the modified inner needle caps 154 include an indicator protrusion 166 extending from the circular closed end 60 such that the protrusion extends over the geometric center of the circular closed end. Furthermore, each of the modified inner caps 154 includes a concave cavity 65 disposed on the circular closed end 60. The concave cavity 65 advantageously provides a space for a linger of the patient to rest while more effectively holding the indicator protrusion 166.

[0023] In the embodiment of FIG. 5 A, the indicator protrusion 166 has a semi-circular arc shape 190. In the embodiment of FIG. 5B, the indicator protrusion 166 has a torus shape 192. In both FIGS. 5 A and 5B, at a central portion of the concave cavity 65 includes a central protrusion 61. The central protrusion 61 advantageously provides a tactile surface that acts as a friction surface for the finger of the patient to engage. Also, the central protrusion 61 cooperates with the indicator protrusion 166 to advantageously indicate to the patient that the hollow needle 52 of the standard pen needle 22 will not extend through the circular closed end 60. In the embodiment of FIG. 5C, the indicator protrusion 166 has a pillar 194 supporting an oval toroid shape 196. In the embodiment of FIG. 5D, the indicator protrusion 166 has a T-shape formed from a pillar 198 supporting a cylinder 200 perpendicular to the pillar 198. The pillars 196, 198 in FIGS. 5C and 5D also advantageously indicate to the patient that the needle will not extend through the circular closed end 60.

[0024] As similarly described above, the indicator protrusions 166 of FIGS. 5A-5D extending from the circular closed ends 60 provide an indication to a patient that the hollow needle 52 of the standard pen needle 22 will not pass through the circular closed end 60 of the modified inner needle caps 154, as there is clearly more solid, physical structure through which the hollow needle 52 would have to pass to perform the injection. These indicator protrusions 166 thus prevent confusion in patients and prevent patients from assuming the hollow needle 52 is entering their body while the modified inner needle cap 154 is in place. As such, the patientswill be more likely to receive the medication as expected, even if the patients are trained using an injector pen with a safety pen needle 70 and are later provided with an injector pen with a standard pen needle 22 with which the patients are not trained.

[0025] Although only a few embodiments of the present invention have been shown and described, the present invention is not limited to the described embodiments. For example, different shapes and forms of the indicator protrusion 166 may be used. Further, the body of the modified inner needle cap 154 may be a shape other than cylindrical (e.g., a triangular prism, a rectangular prism, etc.). It will be appreciated by those skilled in the art that other changes may also be made to the disclosed embodiments without departing from the scope of the invention. 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. All such changes and combinations are considered to be within the scope of the invention as defined by the appended claims and their equivalents. Unless the phrase “means for” is used in the claims, no language in the specification or the claims is intended to invoke 35 U.S.C. 112(f).

Claims

What is claimed is:

1. A needle cap for an injection pen, comprising: a body having a closed end and an open end; and a protrusion extending from the closed end for indicating that a needle will not pass through the closed end.

2. The needle cap of claim 1, wherein the body has a cylindrical shape.

3. The needle cap of claim 1, wherein the closed end has a circular shape.

4. The needle cap of claim 1, wherein the protrusion has a semi-circular arc shape.

5. The needle cap of claim 1, wherein the protrusion has a torus shape.

6. The needle cap of claim 1 , wherein the protrusion includes a pillar supporting an oval toroid shape.

7. The needle cap of claim 1, wherein the protrusion has a T-shape.

8. The needle cap of claim 1, wherein the protrusion extends over a geometric center of the closed end.

9. A system for an injection pen needle, comprising: a needle assembly including a needle base and a needle fixed to and extending from the needle base; an inner needle cap removably connected to the needle base for covering the needle, the inner needle cap comprising: a body having a closed end and an open end; and a protrusion extending from the closed end for indicating that a needle will not pass through the closed end; and an outer needle cover for covering the inner needle cap and the needle assembly.

10. The system of claim 9, wherein the body has a cylindrical shape.

11. The system of claim 9, wherein the closed end has a circular shape.

12. The system of claim 9, wherein the protrusion has a semi-circular arc shape.

13. The system of claim 9, wherein the protrusion has a torus shape.

14. The system of claim 9, wherein the protrusion includes a pillar supporting an oval toroid shape.

15. The system of claim 9, wherein the protrusion has a T-shape.

16. The system of claim 9, wherein the protrusion extends over a geometric center of the closed end.

17. A system for an injection pen needle, comprising: a needle assembly including a needle base and a needle fixed to and extending from the needle base; an inner needle cap removably connected to the needle base for covering the needle, the inner needle cap comprising: a body having a cylindrical shape and having a closed end having a circular shape and an open end; and a protrusion extending from the closed end and over a geometric center of the closed end for indicating that a needle will not pass through the closed end; and an outer needle cover for covering the inner needle cap and the needle assembly.

18. The system of claim 17, wherein the protrusion has a semi-circular arc shape.

19. The system of claim 17, wherein the protrusion has a torus shape.

20. The system of claim 17, wherein the protrusion includes a pillar supporting an oval toroid shape.

21. The system of claim 17, wherein the protrusion has a T-shape.

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