The invention is directed to a disposable pen needle for use with a drug delivery device, such as a medication pen, and an interface for removably joining the pen needle and the drug delivery device.
Pen needles are widely used in medication delivery systems for self-administered injectable drugs. Commonly used pen needles have a single stainless steel cannula (hollow needle) extending through a needle-bearing hub. The non-patient (non-injection) end of the needle pierces the septum of the drug storage compartment of the medication pen, while the patient (injection) end of the needle is adapted for insertion into the patient's tissue.
Such pen needles typically have a uniform gauge, so both ends of the cannula have the same inner and outer diameters. Thinner needles (generally greater than 28 gauge) may be preferred for patient comfort, but if these are of uniform gauge they may not reliably pierce the conventionally thick septum of the drug storage compartment, e.g., due to needle buckling, and/or may unduly restrict flow. Solutions to these problems have included needles with a thicker non-injection end; however, such dual-gauge needles tend to be difficult and costly to manufacture.
Standard pen needles, if mishandled, can also present a risk of needle stick injury at the non-patient end during assembly with and removal from the medication pen, and during used pen needle disposal. Protective solutions typically have entailed the use of rather elaborate shielding arrangements for the non-patient end. See, for example, U.S. Pat. Nos. 7,314,464, 7,384,414 and 7,462,168, all of which are assigned to the assignee of the present application, and the disclosures of which are fully incorporated herein by reference.
The invention affords simple and effective solutions to the above-noted problems by providing several types of disposable (i.e., single-use) pen needles, each having an abbreviated non-injection (non-patient) end, i.e., one that is not intended to pierce the septum of the drug storage compartment of a medication pen. Several types of interfaces are provided to serve as intermediaries between these pen needles and a medication pen. The interfaces are equipped to pierce the septum of the pen's drug storage compartment and thereby enable drug flow to a mounted pen needle.
In one aspect, the invention concerns a disposable pen needle that includes a hub having a distal hub portion, a proximal hub portion adapted for attachment to a medicament delivery device, and a hub bore extending through the hub from the distal hub portion to the proximal hub portion. A needle (cannula) is mounted to the hub, the needle having a distal injection end and a proximal needle portion terminating in a non-injection end. At least part of the proximal needle portion resides in the hub bore, and the non-injection end of the needle, if exposed outside the hub bore, is spaced from the hub no more than about one-half the length of the hub bore. Thus, in some embodiments the non-injection end of the needle is not exposed outside the hub bore and need not be beveled or sharpened, while in other embodiments the non-injection end is exposed outside the hub bore
In embodiments according to this aspect of the invention, the proximal hub portion includes internal threads adapted to mount the pen needle. In other embodiments, the proximal hub portion includes external threads adapted to mount the pen needle. In still other embodiments, the proximal hub portion includes a mounting boss through which the hub bore extends. In certain embodiments, the distal hub portion and the proximal hub portion are separately formed parts, each having a respective hub bore segment, and the hub portions are joined together with their hub bore segments aligned after the needle is mounted in the hub bore segment of the distal hub portion.
In another aspect, the invention concerns a reusable interface adapted for use between a medicament delivery device and a disposable pen needle. The interface includes a body having a spike adapted to pierce a seal (septum) of a medicament container housed in the device, and a recess axially aligned with the spike and adapted to mate with a disposable pen needle. The spike has an axial bore that extends through the spike and communicates with the recess. “Reusable” in the context of the invention means an interface that can be left installed on a medicament delivery device and used with a succession of disposable pen needles.
In embodiments according to this aspect of the invention, the body has a collar that surrounds the spike and is adapted to mate with a portion of the device. In these and other embodiments, the collar may be internally threaded and/or the recess may be internally threaded or smooth. In other embodiments, there is a bore-sealing, puncturable septum in the recess. In any of these embodiments, the spike may be tapered and may have at least one transverse external rib. Any of these embodiments may include a cap adapted to cover the recess when the interface is not mated with a pen needle; and the cap may be tethered to the body or separate from it.
Yet another aspect of the invention concerns a medicament delivery system that includes any of the disposable pen needle embodiments disclosed herein combined with any of the reusable interfaces disclosed herein.
Embodiments of the disclosed invention are described in detail below only by way of example, with reference to the accompanying drawings, in which:
The figures are generally schematic and not necessarily to scale.
As used herein, the “distal” direction is the direction toward the injection site, i.e., toward the patient (injection) end of the needle (cannula), and the “proximal” direction is the opposite direction, i.e., toward the non-patient (non-injection) end of the needle. The “axial” direction is along, or parallel to, the longitudinal axis of the needle, which is generally arranged axially on a medication pen.
A conventional medication pen 2 shown in many of the drawing figures has an externally threaded end 4 for mounting a pen needle and houses a medicament container 6 having a pierceable septum 8 at its dispensing end.
Referring to
Importantly, in this embodiment the non-injection end 28 of the needle is not beveled or sharpened, and is not exposed outside hub bore 22, so it cannot pierce septum 8 of container 6. Septum piercing is accomplished instead by interface member 30, which has a disk-like collar 32 from which a tapered spike 34 extends. Referring to
Referring to
In this embodiment, too, the non-injection end 78 of the needle is not beveled or sharpened, and is not exposed outside of hub bore 72, so it cannot pierce the septum 8 of container 6. Septum piercing is accomplished instead by interface member 80, which has a proximally extending smooth spike 82 with an axial bore 84 open at both ends. Spike 82 is part of a molded body that includes an internally threaded collar 86 adapted to mate with the externally threaded end 4 of a medication pen 2. The body also includes a distally facing threaded recess 88 adapted to mate with the threaded proximal hub portion 68 of hub 64. The spike's axial bore 84 opens into recess 88. Thus, when interface member 80 is screwed onto medication pen 2, its spike 82 pierces septum 8 of container 6 and remains in place by virtue the threaded connection (see
Capping of recess 88 prevents the escape of medicament from container 6 when no pen needle is installed.
Referring to
Referring to
The rear mating (inner) face of distal hub portion 112 has at least two grooves 126 that radiate from the central hub bore. Grooves 126 accommodate respective split ends 128 of the stainless steel cannula 122, which are formed by a laser or other suitable means. Distal hub portion 112 also has two recesses or windows 132 configured to receive and preferably tightly mate with two distally facing lugs 130 on proximal hub portion 114. After the cannula 122 is mounted in the hub bore segment of distal hub portion 112 with its split ends in grooves 126, the two hub portions 112, 114 are pressed together with their hub bore segments aligned. The two hub portions are held together by frictional and/or tight mechanical locking engagement of lugs 130 in recesses 132, which eliminates the need for applying adhesive or undergoing a curing process. Thus, in this embodiment too, the non-injection end 128 of the needle 122 is not beveled, sharpened or exposed outside of the hub bore.
The embodiment shown in
Referring to
In each of the above-described embodiments, the flow of medicament to the stainless steel needle is enhanced due to the larger lumen of the plastic interface that directly feeds medicament to the needle. This allows the use of even smaller gauge needles for improved patient comfort. The abbreviated (concealed or very short) non-patient end of the needle also minimizes the risk of needle stick injuries.
The above description of preferred embodiments is not to be deemed limiting of the invention, which is defined by the following claims and their equivalents.
This application is the U.S. national stage of International Application No. PCT/US16/35104, filed on May 31, 2016, which claims priority to U.S. Provisional Application No. 62/169,408, filed on Jun. 1, 2015.
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/US2016/035104 | 5/31/2016 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2016/196518 | 12/8/2016 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
1746009 | Mulford | Feb 1930 | A |
3092108 | Friedman | Jun 1963 | A |
20040254543 | Griffiths | Dec 2004 | A1 |
20090018503 | Walton et al. | Jan 2009 | A1 |
20090247958 | Carlyon | Oct 2009 | A1 |
20100286610 | Chang | Nov 2010 | A1 |
20100292656 | Groskopf | Nov 2010 | A1 |
20110152822 | Drunk | Jun 2011 | A1 |
20110230827 | Mori | Sep 2011 | A1 |
20120150128 | Zhao | Jun 2012 | A1 |
20150126925 | Fuke et al. | May 2015 | A1 |
20150328412 | Bates et al. | Nov 2015 | A1 |
Number | Date | Country |
---|---|---|
102008025002 | Dec 2009 | DE |
2703028 | Mar 2014 | EP |
2014528783 | Oct 2014 | JP |
200948408 | Dec 2009 | TW |
WO-2012043161 | Apr 2012 | WO |
WO-2014105667 | Jul 2014 | WO |
WO-2017189169 | Nov 2017 | WO |
WO-2017189171 | Nov 2017 | WO |
Number | Date | Country | |
---|---|---|---|
20180169350 A1 | Jun 2018 | US |
Number | Date | Country | |
---|---|---|---|
62169408 | Jun 2015 | US |