METHOD OF MAKING AN IMPROVED BALLOON CUFF TRACHEOSTOMY TUBE

• US 20090091066A1
• Filed: 09/08/2008
• Published: 04/09/2009
• 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: Kenowski, Mike A., Teixeira, Scott M., Sleva, Michael, Schumacher, James F.
• Granted Patent: US 8,313,687 B2
• Time in Patent Office: Days
• US Class Current: 264/521
• 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:

providing a raw tube composed of a thermoplastic polymer,

preheating the raw tube in an asymmetric mold to a temperature sufficient to soften the material of the tube,

stretching the tube,

inflating the tube with compressed gas to stretch the material of the tube to contact the heated wall of the mold while allowing the tube to retract;

cooling the completed balloon; and

removing the completed balloon from the mold.

2. The method according to claim 1 in which the completed balloon has differential wall thickness, with an upper region having a thickness of from about 15 to about 30 micrometers and a lower region having a thickness of from about 5 to about 15 micrometers.

3. The method of claim 1 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.

4. The method of claim 1 further comprising the step, after inflating the tube, of heat setting the balloon by heating it to a temperature and for a time sufficient to orient the amorphous polymer portions.

5. The method of claim 1 further comprising the step, after cooling the tube, of evacuating the tube in order to collapse the balloon.

6. 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.

7. The method of claim 6 further comprising the steps of:

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.;

removing said balloon from said mold.

8. The method of claim 7 further comprising the step, prior to removing said balloon from said mold, of:

collapsing said balloon so that it may be withdrawn without damage.

9. The method of claim 6 wherein said raw tube comprises a thermoplastic polymer, said tube having an asymmetric wall thickness.

10. The method of claim 9 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.