Circumferential ablation device assembly and methods of use and manufacture providing an ablative circumferential band along an expandable member

• US 7,241,295 B2
• Filed: 05/10/2004
• Issued: 07/10/2007
• Est. Priority Date: 03/19/1999
• Status: Expired due to Term

• Current Assignee: Astrionix
• Original Assignee: Astrionix
• Inventors: Maguire, Mark A.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US10/842,093
• Publication Number:
  US 20040260277A1
• Time in Patent Office: 1,156 Days
• Field of Search: 606/41, 606/45, 606/49, 607/96, 607/98, 607/101, 607/102, 607/122
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00256 Creating an electrical block
• CPC Class Codes: A61B 2017/00318 Steering mechanisms
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00065 porous
• CPC Class Codes: A61B 2018/00136 with polymer
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00238 porous
• CPC Class Codes: A61B 2018/00369 Heart valves
• CPC Class Codes: A61B 2018/00815 measured by a thermistor
• CPC Class Codes: A61B 2018/00821 measured by a thermocouple
• CPC Class Codes: A61B 2018/044 the surgical action being effected by a circulating hot fluid
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00
• CPC Class Codes: Y10T 29/49169 Assembling electrical component directly to terminal or elongated conductor
• CPC Class Codes: Y10T 29/49888 Subsequently coating
• CPC Class Codes: Y10T 29/49982 Coating

Abstract

A medical balloon catheter assembly includes a balloon having a permeable region and a non-permeable region. The balloon is constructed at least in part from a fluid permeable tube such that the permeable region is formed from a porous material which allows a volume of pressurized fluid to pass from within a chamber formed by the balloon and into the permeable region sufficiently such that the fluid may be ablatively coupled to tissue engaged by the permeable region. The non-permeable region is adapted to substantially block the pressurized fluid from passing from within the chamber and outwardly from the balloon. The porous material may be a porous fluoropolymer, such as porous polytetrafluoroethylene, and the pores may be created by voids that are inherently formed between an interlocking node-fibril network that makes up the fluoropolymer. Such voids may be created according to one mode by expanding the fluoropolymer. The balloon may be formed such that the porous material extends along both the permeable and non-permeable regions. In one mode of this construction, the porous material is porous along the permeable region but is non-porous along the non-permeable region, such as for example by expanding only the permeable region in order to render sufficient voids in the node-fibril network to provide permeable pores in that section. The voids or pores in the porous material may also be provided along both permeable and non-permeable sections but are substantially blocked with an insulator material along the non-permeable section in order to prevent fluid from passing through. The insulator material may be dip coated, deposited, or extruded with the porous material in order to fill the voids. The insulator material may in one mode be provided along the entire working length of the balloon and then selectively removed along the permeable section, or may be selectively exposed to only the non-permeable sections in order to fill the voids or pores there.

Claims

1. A tissue ablation device assembly, comprising:

an elongate catheter body with a proximal end portion and a distal end portion, the proximal and distal end portions defining a longitudinal axis there between;

an expandable member mounted along said distal end portion of said elongate catheter body and defining an interior chamber, said expandable member having an exterior surface adapted for engagement with a region of tissue when in an expanded condition;

first and second longitudinally spaced expansion elements mounted along the distal end portion of the elongate catheter, the first and second expansion elements coupled to said expandable member for expanding said expandable member; and

an ablation element supported from the elongate catheter body within said interior chamber, said ablation element being shaped for emitting ablative energy through said expandable member for ablating at least a portion of the region of tissue.

2. The tissue ablation device assembly of claim 1, wherein said first and second expansion elements are capable of providing said expandable member with a tapered shape.

3. The tissue ablation device assembly of claim 2, wherein said expandable member has a reducing diameter in the distal direction when in said expanded condition.

4. The tissue ablation device assembly of claim 1, wherein said first and second expansion elements are fluidly coupled to a fluid source.

5. The tissue ablation device assembly of claim 1, wherein said ablation element is an ultrasound transducer.

6. The tissue ablation device assembly of claim 1, further comprising a fluid passageway extending through said elongate catheter body and communicating with said interior chamber, said fluid passageway being adapted to be fluidly coupled to a fluid source for delivering a volume of fluid from said fluid source to said interior chamber.

7. The tissue ablation device assembly of claim 6, wherein said fluid passageway is capable of delivering an ablative medium into said interior chamber.

8. The tissue ablation device assembly of claim 7, wherein said ablative medium fills a central region of said interior chamber between said first and second expansion elements.

9. The tissue ablation device assembly of claim 7, wherein said expandable member is formed at least in part with a porous membrane for allowing said ablative medium to pass through said porous membrane for ablatively coupling said ablation element to the region of tissue.

10. The tissue ablation device assembly of claim 9, wherein said porous membrane forms a permeable band along said expandable member.

11. The tissue ablation device assembly of claim 1, wherein said expandable member is adapted for engagement with a circumferential region of tissue when in said expanded condition.

12. The tissue ablation device assembly of claim 1, wherein said first and second expansion elements are located within said interior chamber of said expandable member.

13. The tissue ablation device assembly of claim 12, wherein said first and second expansion elements are inflatable elements provided at proximal and distal ends of said interior chamber.

14. The tissue ablation device assembly of claim 13, wherein said interior chamber of said expandable member is configured to be filled with an ablative medium in a region between said first and second inflatable elements.

15. A tissue ablation device assembly, comprising:

an elongate catheter body with a proximal end portion and a distal end portion, the proximal and distal end portions defining a longitudinal axis there between;

an expandable member mounted along said distal end portion of said elongate catheter body, said expandable member having an interior surface and an extenor surface, wherein the exterior surface is adapted for engagement with a region of tissue when in an expanded condition;

first and second longitudinally spaced expansion elements mounted along said distal end portion of said elongate catheter body and surrounded by said expandable member, wherein an interior chamber is enclosed by the interior surface of said expandable member extending between said first and the second expansion elements; and

an ablation element supported from the elongate catheter body within said interior chamber, said ablation element being shaped for emitting ablative energy through said expandable member for ablating at least a portion of the region of tissue.

16. A tissue ablation device assembly, comprising:

an elongate catheter body with a proximal end portion and a distal end portion, the proximal and distal end portions defining a longitudinal axis there between;

an expandable member mounted along said distal end portion of said elongate catheter body and defining an interior chamber, said expandable member having an exterior surface adapted for engagement with a region of tissue when in an expanded condition, wherein said expandable member is formed at least in part with a porous membrane forming a permeable band along said expandable member for allowing said ablative medium to pass through said porous membrane for ablatively coupling said ablation element to the region of tissue;

a fluid passageway extending through said elongate catheter body and communicating with said interior chamber, said fluid passageway being adapted to be fluidly coupled to a fluid source for delivering a volume of fluid from said fluid source to said interior chamber, wherein said fluid passageway is capable of delivering an ablative medium into said interior chamber;

first and second longitudinally spaced expansion elements mounted along the distal end portion of the elongate catheter, the first and second expansion elements coupled to said expandable member for expanding said expandable member; and

an ablation element supported from the elongate catheter body within said interior chamber, said ablation element being shaped for emitting ablative energy through said expandable member for ablating at least a portion of the region of tissue.