By a News Reporter-Staff News Editor at Pharma Business Week A patent by the inventors Dasbach, Uwe (Frankfurt am Main, DE); Dette, Christoph (Frankfurt am Main, DE); Nober, Peter (Rommersheim, DE); Sonntag, Fiete (Ahaus, DE); Eisengarthen, Christoph (Ginsheim, DE), filed on November 23, 2012, was published online on July 4, 2017, according to news reporting originating from Alexandria, Virginia, by NewsRx correspondents (see also Pharmaceutical Companies).
Patent number 9694143 is assigned to Sanofi-Aventis Deutschland GMBH (Frankfurt am Main, DE).
The following quote was obtained by the news editors from the background information supplied by the inventors: "Administering a medicament by injection is a process which presents a number of risks and challenges for patients and healthcare professionals, both mental and physical. Improper handling of medicament delivery devices may result in needle stick injuries. In any situation in which a patient or healthcare professional is required to manually attach/remove the needle assembly, there is a risk of needle stick injury.
"In addition, manually attaching the needle assembly to the medicament delivery device can lead to over-tightening, which can result in injury when removing the needle assembly and/or structural damage to the medicament delivery device. Attempts to remove an over-tightened needle assembly can adversely affect other components of the medicament delivery device (e.g., in a reusable device, a cartridge holder may be loosened).
"Further, manually attaching the needle assembly may lead to mismatch of screw threads, resulting in an obliquely-oriented needle. This may lead to a defective septum or to an inaccurate injection.
"Thus, there is a need for a device for safely attaching and removing a needle assembly to/from a medicament delivery device."
In addition to the background information obtained for this patent, NewsRx journalists also obtained the inventors' summary information for this patent: "It is an object of the present invention to provide a needle assembly attachment and removal device for attaching a needle assembly to and removing the needle assembly from a medicament delivery device.
"In an exemplary embodiment, a needle assembly attachment and removal device according to the present invention comprises a case having a base and a longitudinal axis, a carriage axially movable with the case from a first position to a second position, a carrier rotatably coupled to the carriage and adapted to hold a needle assembly, and a gearing arrangement rotatably coupled to the carriage and adapted to rotate the carrier in a first rotational direction as the carriage moves from the first position to the second position and in a second rotational direction as the carriage moves from the second position to the first position.
"In an exemplary embodiment, the needle assembly attachment and removal device further comprises a retainer coupled to the case or the carriage or the carrier and adapted to align a medicament delivery device with the needle assembly.
"In an exemplary embodiment, the base has a larger cross-section than the case.
"In an exemplary embodiment, the needle assembly attachment and removal device further comprises a cap clamp coupled to the carrier and adapted to engage an outer cap of the needle assembly. The cap clamp includes resilient clamp arms adapted to engage a portion of the outer cap. The needle assembly attachment and removal device further comprises a push rod slidably coupled to the carriage, and a clamp ring coupled to the push rod and adapted to apply a compressive force on the clamp arms to maintain engagement with the portion of the outer cap. The push rod urges the clamp ring against the clamp arms when the push rod engages the base.
"In an exemplary embodiment, the gearing arrangement includes a rack disposed in the case, and a pinion having a first gear face adapted to engage a gear wheel coupled to the carrier and a second gear face adapted to engage the rack. The rack is disposed at an angle relative to the longitudinal axis of the case, and the second gear face has a variable diameter. The gearing arrangement further includes a torsion spring applying a rotational biasing force to the pinion, and movement of the carriage from the first position to the second position causes the pinion to rotate and energize the torsion spring. The carriage rotates about the longitudinal axis and a rotational axis of the pinion is orthogonal to the longitudinal axis.
"In an exemplary embodiment, the needle assembly attachment and removal device further comprises a compression spring adapted to engage a spring stop formed on the base. The compression spring is energized when the carriage is in the second position.
"In an exemplary embodiment, the carriage includes a resilient pin adapted to engage a retaining groove in the case. As the carriage moves from the first position to the second position, the pin enters a first portion of the retaining groove and deflects toward a longitudinal axis of the case. When the pin engages a second portion of the retaining groove, the carriage is locked in the second position. When the pin is engaged in the second portion of the retaining groove, an axial force on the carriage directed toward the base causes the pin to disengage the second portion and enter a third portion of the retaining groove which allows the carriage to return to the first position. A force in the compression spring propels the carriage toward the first position when the pin enters the third portion of the retaining groove.
"In an exemplary embodiment, the needle assembly attachment and removal device further comprises a clutch disposed between the cap clamp and the carrier. The clutch prevents rotation of the cap clamp relative to the carrier in the first rotational direction until a predetermined torque is applied on the outer cap. The clutch prevents rotation of the cap clamp relative to the carrier in the second rotational direction.
"In an exemplary embodiment, the carriage includes guide wheels adapted to engage channels formed in the base.
"In an exemplary embodiment the needle assembly attachment and removal device may be used with delivery devices such as injection pens (e.g. for re-usable or disposable Insulin or Heparin pens) and with all kinds of needle assemblies, such as pen needles.
"The needle assembly attachment and removal device allows for an easy and safe mounting and demounting of needle assemblies onto a delivery device while preventing a user from needle stick injuries.
"The needle assembly attachment and removal device allows the application of the proper torque to engage the needle assembly and the delivery device. This may avoid an unwanted disassembling of a cartridge holder from a body of the delivery device which may occur, if the torque for releasing the needle assembly is greater than the release torque of the cartridge holder.
"The risk of human error when mounting the needle assembly is minimized. This results in a reduced risk for loose needles, destroyed threads caused by excessive torque or crossed threads. The risk of an obliquely-oriented needle is also eliminated.
"The needle assembly attachment and removal device allow for single handed operation.
"The needle assembly attachment and removal device may be adapted for screw-type mounting and demounting accessories in different applications which require frequent attachment and removal.
"In an exemplary embodiment, the needle assembly attachment and removal device according to present invention further comprises a needle assembly engagement mechanism disposed on the retainer. The needle assembly engagement mechanism is adapted to selectively engage an outer cap of the needle assembly. The needle assembly engagement mechanism comprises a clip adapted to slide transversely relative to the retainer between an engagement position for engaging the outer cover and a disengagement position for disengaging the outer cover, a lever adapted to move the clip between the engagement position and the disengagement position, and a spring applying a biasing force on the lever to maintain the clip in the engagement position. The clip includes a partially circular rim that is adapted to engage the outer cover of the needle assembly in the engagement position. The lever is operably coupled to a button that is adapted to actuate the lever.
"Further scope of applicability of the present invention will become apparent from the detailed description given hereinafter. However, it should be understood that the detailed description and specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description."
URL and more information on this patent, see: Dasbach, Uwe; Dette, Christoph; Nober, Peter; Sonntag, Fiete; Eisengarthen, Christoph. Needle Assembly Attachment and Removal Device. U.S. Patent Number 9694143, filed November 23, 2012, and published online on July 4, 2017. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9694143.PN.&OS=PN/9694143RS=PN/9694143
Keywords for this news article include: Pharmaceutical Companies, Sanofi-Aventis Deutschland GMBH.
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