Blinding cap for rigid needle shield and related syringe assembly
Inventors
Locati, Patrick • HUNKELER, Guido • Duerr, Alain
Assignees
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Publication Number
US-11077242-B2
Publication Date
2021-08-03
Expiration Date
Abstract
A blinding cap for covering a rigid needle shield that is covering a needle of a syringe includes an elongated body extending between a proximal end and an opposing distal end, the body at least partially bounding a chamber. An annular sleeve projects from the proximal end of the body and at least partially bounds a channel. A first flange radially inwardly projects from the body into the chamber, the first flange at least partially bounding an opening that provides communication between the chamber and the channel.
Core Innovation
The invention provides a blinding cap for covering a rigid needle shield that covers a needle of a syringe. The blinding cap includes an elongated body extending between a proximal end and an opposing distal end, where the body at least partially bounds a chamber, and an annular sleeve projecting from the proximal end of the body and at least partially bounding a channel. A first flange comprising a continuous annular ring radially inwardly projects from the body into the chamber, and the first flange encircles an opening that provides communication between the chamber and the channel.
In a syringe assembly, a rigid needle shield having a proximal end with a proximal end face is removably coupled to the distal end of a syringe barrel so that the needle is received within a cavity of the rigid needle shield. The blinding cap is disposed over at least a portion of the rigid needle shield, with a portion of the blinding cap disposed proximally behind the proximal end face, and as the blinding cap is moved distally relative to the syringe barrel, the portion of the blinding cap engages against the proximal end face of the rigid needle shield.
The invention also uses an annular seal secured to and encircling a portion of the blinding cap and a portion of the syringe barrel, where the seal has perforations formed thereon. A method is provided in which the blinding cap is rotated relative to the syringe barrel to break the seal, followed by pulling the blinding cap distally so the portion of the blinding cap engages against the proximal end face and separates the rigid needle shield from the syringe barrel.
The described cap and interface structure facilitate blinded clinical trial use by preventing visual detection of differences in rigid needle shields during a blinded study.
Claims Coverage
The independent claims cover 4 related inventive features directed to a blinding cap, syringe assemblies, and a method of use.
Blinding cap with chamber, channel, and radially inward flange
A blinding cap including an elongated body bounding a chamber, an annular sleeve projecting from a proximal end bounding a channel, and a first flange comprising a continuous annular ring radially inwardly projecting into the chamber to encircle an opening that provides communication between the chamber and the channel.
Syringe assembly with removably coupled rigid needle shield, proximal engagement, and perforated annular seal
A syringe assembly comprising a syringe barrel with a needle, a rigid needle shield removably coupled to the distal end of the syringe barrel to receive the needle within a recessed cavity, a blinding cap disposed over at least a portion of the rigid needle shield with a portion proximally behind the proximal end face such that distal movement engages the proximal end face, and an annular seal secured to and encircling a portion of the blinding cap and a portion of the syringe barrel, the seal having perforations formed thereon.
Method using blinding cap to break seal and separate rigid needle shield
A method for using a syringe assembly comprising rotating a blinding cap of the syringe assembly relative to the syringe barrel to break an annular seal, and then pulling the blinding cap distally relative to the syringe barrel so that a portion of the blinding cap engages against the proximal end face of the rigid needle shield and separates the rigid needle shield from the syringe barrel.
Syringe assembly with slot, elongated chamber, sleeve channel, and flange into the slot
A syringe assembly comprising a rigid needle shield removably coupled to a syringe barrel to receive a needle within a recessed cavity, a slot formed between the rigid needle shield and the distal end of the syringe barrel, and a blinding cap covering the rigid needle shield including an elongated body bounding a chamber with the rigid needle shield disposed within the chamber, an annular sleeve projecting from the proximal end bounding a channel with a portion of the syringe barrel disposed within the channel, and a first flange comprising a continuous annular ring radially inwardly projecting into the slot and encircling an opening providing communication between the chamber and the channel.
Across the independent claims, the primary inventive coverage centers on the structural relationship between an elongated body chamber, a proximal annular sleeve channel, and a continuous annular flange that encircles an opening and engages or is received at a rigid needle shield interface. The claims further associate this blinding cap structure with a syringe assembly including a removably coupled rigid needle shield and, in certain embodiments, an annular seal with perforations, and a method that breaks the seal and separates the rigid needle shield via distal movement of the blinding cap.
Stated Advantages
Prevent visual detection of differences in rigid needle shields during a blinded study.
Documented Applications
Blinded clinical trials using a syringe assembly with a blinding cap to cover a rigid needle shield.
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