STERILE PROTECTIVE COVER COMPRISING A DEVICE FOR OPTHALMIC DELIVERY

• US 20180092770A1
• Filed: 10/04/2017
• Published: 04/05/2018
• Est. Priority Date: 03/14/2016
• Status: Abandoned Application

• Current Assignee: Virchow Biotech Inc., Virchow Biotech Pvt. Ltd. (Virchow Group)
• Original Assignee: Virchow Biotech Inc., Virchow Biotech Pvt. Ltd. (Virchow Group)
• Inventors: Nandigala, Hemanth, Tummuru, Murali Krishna Reddi, Vure, Prasad
• Application Number:
  US15/724,673
• Publication Number:
  US 20180092770A1
• Time in Patent Office: Days
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61M 2005/31588 electrically driven
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2422 using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
• CPC Class Codes: A61M 5/31546 Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
• CPC Class Codes: A61M 5/31576 Constructional features or modes of drive mechanisms for piston rods
• CPC Class Codes: A61M 5/31593 Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
• CPC Class Codes: A61M 5/3202 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 Class Codes: A61M 5/34 Constructions for connecting the needle , e.g. to syringe nozzle or needle hub connecting catheter tubes to hubs A61M25/0014

Abstract

Described herein is a sterile protective cover comprising an intracameral therapeutic agent delivery device in the form of a pen-injector comprising a cartridge container for dispensing multiple doses of a medicament, coupled to an actuation assembly within a housing. In some forms a needle assembly is coupled to the distal end of the cartridge container, provided with a removable cap received within the housing will be in optional pre-sterile or no-sterile condition. Use of such device for the prevention or treatment of ocular conditions or diseases is also disclosed. A sterile protective cover may be combined with an ophthalmic device, wherein the sterile protective cover is made of plastic, polythene, polyethylene, resin, rubber, polystyrene, polypropylene, polycarbonate, nylon, or combination thereof.

Claims

1. A cable-free, motor driven ophthalmic device in the form of a pen-injector, the device comprising:

(a) a cartridge assembly at the distal end of the device;

(b) an actuation assembly at the proximal end of the device covered with a housing comprising top and bottom housing covers;

(c) an over cap covering the cartridge assembly and locked with the housing of the actuation assembly; and

(d) a sterile protective cover.

2. A The device of claim 1, wherein the cartridge assembly comprises a cartridge holder with a pre-sterile multiple dose glass cartridge having an opening therein comprising the medicament, confined at the proximal end by a piston slidably received within the rearward opening of the cartridge.

3. The device of claim 2, wherein the cartridge assembly constitutes a separate isolated unit, and may be sterilized and readily fixed to the device during operation.

4. The device of claim 1, wherein the actuation assembly comprises a plunger rod, a motor, a printed circuit board (PCB) with dose setting buttons on it, and a rechargeable/replaceable battery mechanically and electronically supported by a PCB.

5. The device of claim 4, wherein the battery provides energy for driving the motor and thereby the piston within the cartridge for dispensing the medicament by means of the plunger rod extending from the motor towards the piston of the cartridge within the housing of the device.

6. The device of claim 1, wherein the over cap covers the cartridge assembly held in locked position with the actuation assembly.

7. The device of claim 1, wherein the over cap is replaced and a needle assembly is fixed to the opening of cartridge during administration.

8. An ophthalmic device disposed within a sterile protective cover, wherein the opthalmic device comprises a needle that is single or double pointed and mounted on a pen device coupled with a sterile cartridge chamber, the needle having a curved or flat edge.

9. A cable-free, motor driven ophthalmic device in the form of a pen-injector for precise and controlled delivery of pre-determined doses of medicament, the device comprising:

(a) a cartridge assembly;

(b) an actuation assembly comprising a plunger rod, a motor, a printed circuit board (PCB) with dose setting buttons on it, and a rechargeable/replaceable battery, the actuation assembly covered by a housing comprising top and bottom housing covers;

(c) an over cap covering the cartridge assembly and locked with the housing of the actuation assembly; and

(d) a sterile protective cover disposed over at least the housing.

10. A sterile protective cover for an ophthalmic device, wherein the sterile protective cover is made of plastic, polythene, polyethylene, resin, rubber, polystyrene, polypropylene, polycarbonate, nylon, or combination thereof.