Medical delivery devices having low lubricant syringe barrels
The present disclosure relates to medical delivery devices that include a barrel having an inner surface, and in at least one embodiment, the inner surface is hydrophilic. The medical delivery device may further include a stopper may having an elastomeric body, one or more fluoropolymer layers, and two or more ribs laminated to the one or more fluoropolymer layers. In some embodiments, the contact angle of the inner surface of the barrel is less than about 58°. Additionally, the stopper includes a sliding surface that is less than about 2.0 mm. The barrel provides inner surface that in combination with the fluoropolymer laminate or fluoropolymer film achieve high levels of air and liquid impermeability while also maintaining an acceptably low break loose force, low average glide force, and low glide force variation. In some embodiments, the compressibility stopper against the barrel is greater than about 7.9%.
1. A medical delivery device comprising:
a barrel having an inner surface;
a stopper positioned within the barrel, the stopper contacting at least a portion of the inner surface of the barrel; the stopper having a compressibility of greater than 7.9% measured against the barrel, the stopper comprising two or more ribs where each rib having a compressibility of greater than 7.9% provides a contact width (w) with the inner surface of the barrel in a compressed state, the contact width (w) of at least one of said ribs is less than 1.0 mm and the sum of the contact widths of said ribs is less than 2.0 mm; and
a plunger rod or actuation mechanism to displace the stopper;
wherein the inner surface of the barrel has a water contact angle between 1° and 58°,
wherein the stopper comprises an elastomeric body and the stopper is at least partially covered with one or more fluoropolymer layers, and
wherein the compressibility (C) is defined by the following formula:
C %=(( v - y )/ v )×100
where
v is the maximum outer diameter of the rib(s) in a non-compressed state, and
y is the inner diameter of the inner surface of the barrel.
2. The medical delivery device of claim 1 , wherein the stopper has an average glide force less than 4 N.
3. The medical delivery device of claim 1 , wherein the inner surface of the barrel has a water contact angle between 10° and 35°.
4. The medical delivery device of claim 1 , wherein the inner surface is free or substantially free of lubricants.
5. The medical delivery device of claim 1 , wherein the one or more fluoropolymer layers comprise a composite material having a barrier layer and a porous layer, the barrier layer comprising at least one member selected from densified expanded polytetrafluoroethylene, polytetrafluoroethylene, fluorinated ethylene propylene, polyvinylidene fluoride, polyvinylfluoride, perfluoropropylvinylether, Parylene AF-4, Parylene VT-4, a perfluoroalkoxy polymer, and copolymers and combinations thereof.
6. The medical delivery device of claim 1 , wherein the one or more fluoropolymer layers comprises expanded polytetrafluoroethylene.
7. The medical delivery device of claim 1 , wherein the medical delivery device is an auto-injector.
8. The medical delivery device of claim 1 , wherein the medical delivery device is a syringe.
9. The medical delivery device of claim 1 , wherein the stopper has a glide force variation less than 1.3 N when calculated according to the Glide Force Variation test method, the glide force variation being defined by the following formula:
Glide Force Variation=√{square root over (Σ i=1 n ( x i −AGF) 2 /n )}
x i =force measurement of a data point between 10 and 28 mm for a 1 ml long syringe,
AGF =average glide force is the average slide force recorded between 10 and 28 mm for a 1 ml long syringe,
n=the number of data points between 10 and 28 mm for a 1 ml long syringe.
10. The medical delivery device of claim 1 , wherein the barrel is formed of a glass material (e.g. borosilicate glass), a ceramic material, one or more polymeric materials (e.g. polypropylene, polyethylene, and copolymers thereof), a metallic material, a plastic material (e.g. cyclic olefin polymers (COC) and cyclic olefin copolymers (COP)), or combinations thereof.
11. The medical delivery device of claim 1 , wherein the barrel is a glass barrel.
12. The medical delivery device of claim 1 , wherein at least one of the two or more ribs is covered with one or more fluoropolymer layers.