Controlled deployment balloon

• US 6,835,189 B2
• Filed: 10/15/2002
• Issued: 12/28/2004
• Est. Priority Date: 10/15/2002
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Musbach, Frank A., Horn, Daniel J.
• Primary Examiner(s): Thanh, LoAn H.
• Application Number:
  US10/271,830
• Publication Number:
  US 20040073165A1
• Time in Patent Office: 805 Days
• Field of Search: 604/96.01, 604/103.06, 604/103.07, 604/103-1-1, 604/916, 604/920, 606/192, 606/194, 623/1.1, 623/1.11
• US Class Current: 604/103.07
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril

Abstract

A dilatation balloon configured and formed to have a first inflation profile at a first pressure and a second inflation profile at a second higher pressure and methods of making and using the same.

Claims

1. A dilatation balloon having a body portion, cone portions and waist portions, said body portion further having a distal end, a proximal end, and a central region separating said distal end and said proximal end of said body portion of said ballon, said balloon configured and formed such that upon inflation to a first pressure said balloon exhibits a first inflation profile and upon inflation to a second pressure in excess of the first pressure said balloon exhibits a second inflation profile,

said central region of said body portion of said balloon in said first inflation profile having a diameter D₁ and a substantially cylindrical geometry and at least one of said proximal and distal ends of said body portion taken at a point between said central region and said cone portions exhibiting a diameter D₁″

less than D₁;

and said central region of said body portion of said balloon having a diameter D₁″

which is substantially equal to D₁ when the balloon is inflated to the second inflation profile, and wherein diameter D₁ remains substantially the same from the first inflation profile to the second inflation profile.

2. The dilatation balloon of claim 1 wherein said balloon exhibits its first inflation profile when subjected to pressures of about 2-4 atmospheres.

3. The dilatation balloon of claim 1 wherein said balloon exhibits its second inflation profile when subjected to pressures of about 5-12 atmospheres.

4. A catheter assembly comprising:

a) a catheter having a distal end;

b) an unexpanded inflatable balloon mounted on said catheter near the distal end of said catheter said inflatable balloon having a body portion with a central region, a distal end and a proximal end, and cone portions and waist portions and said balloon configured and formed to have a first inflation profile at a first pressure and upon inflation to a second pressure in excess of the first pressure said balloon exhibits a second inflation profile,

said central region of said body portion of said balloon in the first inflation profile having a diameter D₁ and a substantially cylindrical geometry and at least one of said proximal and distal ends of said body portion exhibiting a diameter D₁′

which is less than D₁ wherein D₁′

is taken at a point A between said central region of said body portion and said cone portions, D₁′

approaching D₁ as point A approaches said central region;

and said central region of said body portion of said balloon having a diameter D₁, and at least one of said proximal end and said distal end having a diameter D1″

which is substantially equal to D₁ when the balloon is inflated to the second inflation profile and wherein diameter D₁ remains substantially the same from the first inflation profile to the second inflation profile;

c) a stent mounted on said catheter over said balloon unexpanded balloon.

5. A method of implanting a tubular stent within a body lumen using a controlled deployment balloon the balloon having a body having a proximal end, distal end, and a central region separating said proximal end and said distal end of said body, and cone portions and waist portions, the method comprising the steps of:

providing an elongate tubular catheter assembly having an inflatable balloon mounted thereon, said balloon having a first inflation profile at a first inflation pressure and a second inflation profile at a second higher inflation pressure;

positioning an expandable tubular stent on the balloon;

positioning the balloon within a body lumen adjacent a treatment site;

inflating the balloon to the first inflation profile characterized in that the central region of said body portion has a diameter D₁ and a substantially cylindrical geometry, and at least one of said proximal and said distal end have a diameter D₁′

taken at a point A between said central region of said body and said cone portions which is less than D₁, D₁′

approaching D₁ as point A approaches said central region of said body portion;

increasing the inflation pressure to a second higher inflation pressure to further expand the stent such that said balloon inflates to the second inflation profile characterized in that the central portion of said body has a diameter D₁ and at least one of said proximal end and said distal end have a D₁″

taken at point A which is substantially equal to D₁ and wherein diameter D₁ remains substantially the same upon inflation from the first inflation profile to the second inflation profile.