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Medical device balloons with improved strength properties and processes for producing the same

a technology of strength properties and balloons, which is applied in the direction of electric/magnetic/electromagnetic heating, other domestic articles, and other directions to achieve the effect of improving balloon properties and high strength properties

Inactive Publication Date: 2006-07-13
BOSTON SCI SCIMED INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention is about methods for making balloons and their components, such as parisons. The invention is about controlling the way the material is extruded to create better balloons. By controlling the elongation of the material, the resulting balloons have improved properties. The invention also includes methods for making balloons with high strength, as well as medical devices and surgical procedures that use these balloons. The strength of the balloons can be measured in psi, and the invention provides several examples of balloons with strong walls.

Problems solved by technology

Conversely, polymer materials with relatively high tensile strengths and hardness tend to give balloons with low distension and high burst strengths, but at a sacrifice of susceptibility to pin holing, winging and / or loss of trackability.

Method used

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Examples

Experimental program
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examples

[0026] In the following examples the following abbreviations are used. [0027] Ex Example No. Alphabetic series are comparative, numeric series are invention examples. [0028] OD Outer diameter, as extruded. [0029] Die temp Extruder die zone temperature in degrees Fahrenheit. The extruder barrel was kept at 395° F. in these examples. [0030] Line speed Speed in feet / min of the puller. [0031] DDR Draw down ratio of the cross-sectional area from extrusion head opening to final tube dimensions. DDR=[(Die ID)2−(Tip OD)2] / [(Tubing OD)−(Tubing ID)2][0032] Elong@ break Given as percentage elongation determined on a 3″ long extruded tube which is stretched to break. [0033] Balloon 2x wall Thickness in inches of the balloon double wall as measured with a micrometer. [0034] Hoop Hoop ratio determined as balloon OD (mold diameter) / parison ID (as extruded). [0035] Distension The change in diameter as a % of start diameter for the stated ranges of 6:12 (6 atm to 12 atm) and 12:18 (12 atm to 18 atm)...

example 2

[0048] A freeze spray process was used to selectively reduce parison cone and waists as per Example 1 of U.S. Pat. No. 5,807,520.

example 3

[0049] Cones and waists were selectively reduced by a grinding and necking process which did not stretch the body-forming portion of the parison. Similar to Example 2, first paragraph of PCT / US01 / 26140, filed Aug. 22, 2001, attorney docket no S63.3-9928, corresponding to U.S. application Ser. No. 09 / 672330 filed Sep. 28, 2000.

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Abstract

A tubular parison for forming a medical device balloon. The parison is formed of a polymeric material, for instance a thermoplastic elastomer. The parison has an elongation at break which is not more than 80% of the elongation of the bulk polymeric material. The elongation of the parison is controlled by altering extrusion conditions. Balloons prepared from the parisons provide higher wall strength and / or higher inflation durability than balloons prepared from conventional parisons of the same material.

Description

BACKGROUND OF THE INVENTION [0001] Medical devices comprising catheter balloons are used in an increasingly widening variety of applications including vascular dilatation, stent delivery, drug delivery, delivery and operation of sensors and surgical devices such as blades, and the like. The desired physical property profile for the balloons used in these devices vary according to the specific application, but for many applications a high strength robust balloon is necessary and good softness and trackability properties are highly desirable. [0002] Commercial high strength balloons having wall strengths in excess of 20,000 psi, have been formed of a wide variety of polymeric materials, including PET, nylons, polyurethanes and various block copolymer thermoplastic elastomers. U.S. Pat. No. 4,490,421, Levy and U.S. Pat. No. 5,264,260, Saab describe PET balloons. U.S. Pat. No. 4,906,244, Pinchuk et al, and U.S. Pat. No. 5,328,468, Kaneko, describe polyamide balloons. U.S. Pat. No. 4,950...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): H05B6/00A61M25/00A61L31/00B29C48/09B29C48/86
CPCA61M25/1029B29C47/0004B29C47/0023Y10T428/1086B29L2031/7542A61L31/06A61L31/125B29C47/86B29C48/09B29C48/022B29C48/86B29C48/832B29C48/865B29C48/919C09K2323/06
Inventor WANG, LIXIAOCHEN, JOHN JIANHUALINDQUIST, JEFFREY S.LEE, NAO PAODEVENS, DOUGLAS A.
Owner BOSTON SCI SCIMED INC