Method of making an improved balloon cuff tracheostomy tube

• US 8,313,687 B2
• Filed: 09/08/2008
• Issued: 11/20/2012
• Est. Priority Date: 09/20/2007
• Status: Active Grant

• Current Assignee: SunMed Group Holdings LLC
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Sleva, Michael, Schumacher, James F., Teixeira, Scott M., Kenowski, Michael A.
• Primary Examiner(s): Crispino, Richard
• Assistant Examiner(s): Royston, Elizabeth
• Application Number:
  US12/206,583
• Publication Number:
  US 20090091066A1
• Time in Patent Office: 1,534 Days
• Field of Search: 264/535, 128/207.15, 604/103.06, 604/103.07
• US Class Current: 264/535
• CPC Class Codes: A61M 16/0434 Cuffs
• CPC Class Codes: A61M 16/0445 Special cuff forms, e.g. undulated
• CPC Class Codes: A61M 16/0465 Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
• CPC Class Codes: A61M 16/0488 Mouthpieces; Means for guiding, securing or introducing the tubes guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02
• CPC Class Codes: B29C 2049/4605 containing an inert gas, e.g. helium
• CPC Class Codes: B29C 2049/4608 Nitrogen
• CPC Class Codes: B29C 2049/7831 characterised by pressure values or ranges
• CPC Class Codes: B29C 2049/7832 Blowing with two or more pressure levels
• CPC Class Codes: B29C 2049/7862 characterised by temperature values or ranges
• CPC Class Codes: B29C 2049/78645 characterised by temperature values or ranges
• CPC Class Codes: B29C 2949/0715 the preform having one end closed
• CPC Class Codes: B29C 2949/072 having variable wall thickness
• CPC Class Codes: B29C 2949/0721 Tangentially varying thickness
• CPC Class Codes: B29C 2949/08 Preforms made of several individual parts, e.g. by welding or gluing parts together
• CPC Class Codes: B29C 49/06 Injection blow-moulding
• CPC Class Codes: B29C 49/10 using mechanical means for prestretching
• CPC Class Codes: B29C 49/64 Heating or cooling preforms, parisons or blown articles
• CPC Class Codes: B29C 49/6605 Heating the article, e.g. for hot fill
• CPC Class Codes: B29C 49/783 blowing pressure
• CPC Class Codes: B29K 2105/258 Tubular
• CPC Class Codes: B29L 2022/022 : Balloons
• CPC Class Codes: B29L 2031/753 : Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008

Abstract

There is provided a method of making a balloon having a differential thickness. The method uses a raw tube composed of a thermoplastic polymer which is placed in an asymmetrical mold. The tube is preheated in the mold to a temperature sufficient to soften the material of the tube and inflated with a gas to generally uniformly stretch the material of the tube while allowing the tube to retract lengthwise, thus forming a balloon. The resulting completed balloon has a differential wall thickness wherein the upper region has a thickness of from about 15 to about 30 micrometers and the lower region has a thickness of from about 5 to about 15 micrometers.

Claims

1. A method for making a balloon having differential wall thickness comprising the steps of:

placing a raw tube having a lumen in an asymmetrical mold, said mold having an opening on each end through which the tube protrudes;

holding said tube tightly on each end of said mold;

preheating said mold and tube to a temperature between 50 and 120 °

C.;

stretching said tube about 50 to 200 percent over a time period of between 5 and 60 seconds with pressure applied internally with air, nitrogen or another inert gas at about 0.5 bar, while the temperature is maintained;

pressurizing said tube with pressure applied internally with air, nitrogen or another inert gas at a pressure between about 0.5 and 2 bar while allowing said tube to retract lengthwise by 10 to 50 percent over a time period of between 5 and 15 seconds, to form a balloon;

heating the tube while still in the mold with its ends held tightly, to a temperature of 130-165 °

C. for a time of about 30-90 seconds and at a pressure to keep the balloon inflated;

cooling said balloon at about 20-50 °

C.;

collapsing said balloon so that it may be withdrawn without damage;

removing said balloon from said mold;

wherein the completed balloon has differential wall thicknesses, consisting of a continuous upper region having a thickness of from 15 to about 30 micrometers and consisting of a continuous lower region having a thickness of from about 5 to 15 micrometers.

2. The method of claim 1 wherein said raw tube comprises a thermoplastic polymer, said tube having an asymmetric wall thickness.

3. The method of claim 2 wherein said thermoplastic polymer is selected from the group consisting of thermoplastic polyurethane polymers, thermoplastic polyolefin elastomers, thermoplastic polyolefin block copolymers, SBS di-block elastomers, SEBS tri-block elastomers, polyvinyl chloride, low density polyethylene, polyethylene terephthalate and blends and mixtures thereof.