Tip Cap and an Injection Device Having a Distal Tip Sealed by a Tip Cap

Patent metadata

Field	Value
Publication number	US-2016151584-A1
Application number	US-201414905104-A
Country	US
Kind code	A1
Filing date	Jul 18, 2014
Priority date	Jul 18, 2013
Publication date	Jun 2, 2016
Grant date	—

Abstract

A tip cap includes a closed distal end portion having a transverse proximal surface, a peripheral skirt extending in the proximal direction from said proximal surface and having an inner surface designed to cooperate with the outer surface of the injection device tip, a nipple protruding from said proximal surface and designed to engage the injection device tip. The inner cavity of the tip cap is such that the outer fillet has a radius of curvature ranging from 0.4 to 0.6 mm, the inner fillet has a radius of curvature ranging from 0.25 to 0.35 mm, the nipple base width ranges from 1.4 to 1.6 mm, and the dome-shaped proximal portion of the nipple has a radius of curvature ranging from 0.55 to 0.70 mm.

First claim

1 . A tip cap configured to be sealingly mounted on a distally projecting tip of an injection device having a passageway extending therethrough, the tip cap having an axis and comprising:
a closed distal end portion having a substantially transverse proximal surface; a substantially cylindrical peripheral skirt extending in the proximal direction from the proximal surface of the distal end portion, said peripheral skirt having an inner surface configured to cooperate with an outer surface of the projecting tip of the injection device; a nipple protruding from the proximal surface of the distal end portion in the proximal direction, said nipple having a dome-shaped proximal portion and being designed to engage the projecting tip of the injection device tip; an inner cavity thus being formed in the tip cap, the bottom of said cavity being a part of the proximal surface of the distal end portion and having a substantially annular shape which is connected to the peripheral skirt inner surface by an outer fillet and to the nipple by an inner fillet; wherein: the outer fillet has a radius of curvature ranging from 0.4 to 0.6 mm; the inner fillet has a radius of curvature ranging from 0.25 to 0.35 mm; the nipple base width, substantially in the plane of the proximal surface of the distal end portion, ranges from 1.4 to 1.6 mm; and the dome-shaped proximal portion of the nipple has a radius of curvature ranging from 0.55 to 0.70 mm.

2 . The tip cap according to claim 1 , wherein the outer fillet has a radius of curvature ranging from 0.45 to 0.55 mm.

3 . The tip cap according to claim 1 , wherein the inner fillet has a radius of curvature ranging from 0.27 to 0.33 mm, for example around 0.3 mm.

4 . The tip cap according to claim 1 , wherein the nipple base width, substantially in the plane of the proximal surface of the distal end portion, ranges from 1.45 to 1.55 mm.

5 . The tip cap according to claim 1 , wherein the dome-shaped proximal portion of the nipple has a radius of curvature ranging from 0.6 to 0.70 mm.

6 . The tip cap according to claim 1 , wherein the nipple axial length ranges from 1.2 to 1.4 mm.

7 . The tip cap according to claim 1 , wherein the tip cap is made of an elastomeric material.

8 . The tip cap according to claim 1 , wherein the tip cap is made of a material chosen among: natural rubber, acrylate-butadiene rubber, cis-polybutadiene, chloro or bromobutyl rubber, chlorinated polyethylene elastomers, polyalkylene oxide polymers, ethylene vinyl acetate, fluorosilicone rubbers, hexafluoropropylene-vinylidene fluoride-tetrafluoroethyleneterpolymers, butyl rubbers, polyisobutene, synthetic polyisoprene rubber, silicone rubbers, styrene-butadiene rubbers, tetrafluoroethylene propylene copolymers, thermoplastic-copolyesters, thermo-plastic elastomers, or the like or a combination thereof.

9 . A tip cap assembly for use with an injection device having a passageway extending therethrough and having a distally projecting tip, the tip cap assembly comprising:
a collar securely engageable around the injection device tip; a tip cap according to claim 1 , sealingly engageable with the injection device tip; a rigid outer cap securely disposed around the tip cap, and having a proximal portion engageable with the collar, said rigid outer cap comprising a tamper indicator arrangement for indicating a separation of the rigid outer cap and the collar.

10 . An injection device comprising:
a barrel having a passageway extending therethrough and having a distally projecting tip; a tip cap according to claim 1 , the tip cap being sealingly mounted on the injection device tip.

11 . An injection device comprising:
a barrel having a passageway extending therethrough and having a distally projecting tip; a tip cap assembly according to claim 9 , the tip cap assembly being mounted on the injection device tip so that the tip cap sealingly engages the injection device tip.

Assignees

• Becton Dickinson France

Inventors

• Deleuil Nicolas
• Bensallah Moussa

Classifications

• A61M2005/312

  comprising sealing means, e.g. severable caps, to be removed prior to injection by, e.g. tearing or twisting · CPC title

• A61M5/347

  rotatable, e.g. bayonet or screw (A61M5/344 takes precedence) · CPC title

• A61M5/3202 Primary

  Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001) · CPC title

• A61M5/31

  Details · CPC title

• A61M5/344 Primary

  using additional parts, e.g. clamping rings or collets · CPC title