Lubricant system for hypodermic needles and method for its application

• US 5,911,711 A
• Filed: 06/29/1998
• Issued: 06/15/1999
• Est. Priority Date: 06/29/1998
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Pelkey, Brian J.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Finkel, Sharon
• Application Number:
  US09/106,669
• Time in Patent Office: 351 Days
• Field of Search: 604/265, 604/264, 604/266, 604/272, 524/862, 524/730, 524/731, 524/588, 524/858, 524/86, 528/15, 528/31, 528/32, 427/2.12, 427/452, 427/387, 427/388, 427/2, 427/409, 427/435
• US Class Current: 604/265
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 5/32 Needles; Details of needles pertaining to their connection with syringe or hub infusion needles A61M5/158; Accessories for bringing the needle into, or holding the needle on, the body A61M5/42, A61M5/46 take precedence; guide needles for catheters A61M25/065; Devices for protection of needles apparatus specially adapted for cleaning or sterilising needles A61M5/001
• CPC Class Codes: A61M 5/3286 Needle tip design, e.g. for improved penetration
• CPC Class Codes: A61M 5/329 characterised by features of the needle shaft
• CPC Class Codes: B05D 5/08 to obtain an anti-friction or anti-adhesive surface rendering particulate materials free-flowing in general, e.g. making them hydrophobic B01J2/30
• CPC Class Codes: B05D 7/546 each layer being cured, at least partially, separately
• CPC Class Codes: C08L 83/04 Polysiloxanes
• CPC Class Codes: C09D 183/04 Polysiloxanes

Abstract

A lubricated hypodermic needle of the invention includes an elongate tube with an outside surface, a proximal end, a distal end and an open bore therethrough. The needle has a hub attached to the proximal end of the needle that is used to attach the needle to a fluid handling device. The invention includes a lubricious coating applied to and adherent to the outside surface of the tube. The lubricious coating has a first layer formed from an at least partially cured organosiloxane copolymer and polydimethylsiloxane that has a viscosity greater than about 1000 centistokes. The lubricious coating has a second layer, applied as a secondary operation onto the first layer, that includes a polydimethylsiloxane having a viscosity between about 50 centistokes and about 350 centistokes.

Claims

1. A lubricated hypodermic elongate tube needle comprising:

an elongate tube having an outside surface, a proximal end, a distal end and an open bore therethrough;

a hub attached to said proximal end of said elongate tube for attaching said elongatic tube to a fluid handling device;

a lubricious coating applied to and adherent to said outside surface of said elongate tube comprising a first layer formed from an at least partially cured organosiloxane copolymer and polydimethylsiloxane having a viscosity greater than about 1000 centistokes and a second layer, applied as a secondary operation onto said at least partially cured first layer, including a polydimethylsiloxane having a viscosity between about 50 centistokes and about 350 centistokes.

2. The hypodermic needle of claim 1 wherein said partially cured organosiloxane copolymer of said first layer further comprises about fifty percent (w/w) dimethyl cyclosiloxane and dimethoxysilyldimethylaminoethylaminopropyl silcone polymer.

3. The hypodermic needle of claim 1 wherein said first layer of said lubricious coating further comprises a ratio of said at least partially cured organosiloxane copolymer to said polydimethylsiloxane of about two parts (w/w) of said at least partially cured organosiloxane copolymer to about one part (w/w) of polydimethylsiloxane having a viscosity about 12,500 centistokes.

4. A method for lubricating hypodermic needles comprising:

applying a coating of a first material comprising an organosilane copolymer including a polydimethylsiloxane having a viscosity greater than about 1000 centistokes to an outside surface of a hypodermic needle;

allowing said first material to at least partially cure; and

applying, as a secondary operation, a coating of a second material comprising a polydimethylsiloxane having a viscosity between about 50 centistokes and about 350 centistokes onto said at least partially cured first layer.

5. The method of claim 4 wherein said first applying step further comprises applying said polydimethyl siloxane of said first layer coating material having a viscosity of about 12,500 centistokes.

6. The method of claim 4 wherein each of said applying steps for said first material and said second material further each comprises dipping said needles in a solution of each of said materials comprising a fugitive solvent.

7. The method of claim 6 wherein said dipping of said needles in each said solutions of each of said materials comprising a fugitive solvent further comprises selecting HCFC-141b as said fugitive solvent and and preparing said solutions by mixing said first material at a concentration of about six parts of said first material in about ninety-four parts HCFC-141b and mixing said second material at a concentration of about three parts of said second material to about ninety seven parts HCFC-141b.

8. The method claim 7 wherein each of said dipping steps includes an allowing step wherein said needle is allowed a residence time in each of said solutions of said materials sufficient time sufficient for acquiring each of said coatings of said materials.