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

• US 6,500,174 B1
• Filed: 11/05/1999
• Issued: 12/31/2002
• Est. Priority Date: 07/08/1997
• Status: Expired due to Term

• Current Assignee: Atrionix, Inc. (Johnson & Johnson)
• Original Assignee: Atrionix, Inc. (Johnson & Johnson)
• Inventors: Peacock, James C. III, Maguire, Mark A.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/435,283
• Time in Patent Office: 1,152 Days
• Field of Search: 604/93, 604/100, 604/95, 604/97, 606/41, 606/45, 606/49, 607/96, 607/98, 607/101, 607/102, 607/116, 607/119, 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 which are inherently formed between an interlocking node-fibril network which 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 therethrough. 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 method for treating a region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

expanding a balloon from a radially collapsed condition to a radially expanded condition with a volume of pressurized fluid within a chamber defined at least in part by the balloon such that a permeable section along an intermediate region of a working length of the balloon engages the region of tissue;

ablatively coupling the pressurized fluid with the region of tissue across the permeable section of the balloon; and

substantially blocking the pressurized fluid from ablatively coupling externally of the balloon along a non-permeable section of the working length.

2. The method of claim 1, further comprising:

allowing the fluid to weep across the permeable section and into the region of tissue without forming pressurized jets of fluid across the permeable section.

3. The method of claim 1, further comprising:

in the radially expanded condition, engaging the permeable section with a circumferential region of tissue along the location; and

while the permeable section is engaged with the circumferential region of tissue, forcing the pressurized fluid outwardly from the permeable section in a circumferential pattern into the circumferential region of tissue.

4. The method of claim 3, further comprising:

in the radially expanded condition, engaging the permeable section with a circumferential region of tissue along a pulmonary vein.

5. The method of claim 3, further comprising:

in the radially expanded condition, engaging the permeable section with a circumferential region of tissue which surrounds a pulmonary vein ostium along a posterior left atrial wall.

6. The method of claim 3, wherein the pressurized fluid is an electrically conductive fluid, and further comprising:

electrically coupling an ablation electrode to the pressurized fluid; and

ablating the region of tissue with the pressurized fluid as it passes outwardly form the balloon through the permeable section and into the region of tissue.

7. The method of claim 6, further comprising:

substantially shielding adjacent regions of tissue adjacent to the circumferential region of tissue and engaged with the working length from electrically coupling to the ablation electrode while the ablation electrode is electrically coupled to the circumferential region of tissue via the pressurized fluid along the permeable section.

8. The method of claim 7, further comprising in the radially expanded condition, radially engaging the non-permeable section with an adjacent region of tissue adjacent to the circumferential region of tissue engaged with the permeable section.

9. The method of claim 8, wherein the non-permeable section is a first non-permeable section, and the adjacent region of tissue is a first adjacent region of tissue, and further comprising:

in the radially expanded condition, radially engaging a second non-permeable section with a second adjacent region of tissue which is adjacent to the circumferential region of tissue opposite the first adjacent region of tissue.

10. A tissue ablation device assembly for ablating a circumferential region of tissue at a location where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion and a distal end portion;

a circumferential ablation member with an expandable member having first and second end portions with first and second expandable elements, respectively, and also an intermediate region between the first and second end portions with an outer skin extending between the first and second expandable elements such that a fluid chamber is formed at least in part by the first and second expandable elements and the outer skin, wherein the fluid chamber is adapted to be fluidly coupled to a pressurizeable source of fluid, and the outer skin has a permeable section that is substantially permeable to a volume of fluid within the chamber.

11. A medical catheter assembly, comprising:

an elongate body having a proximal end portion and a distal end portion;

a balloon coupled to the distal end portion and having first and second end portions and an intermediate region therebetween, wherein the first and second end portions comprise a substantially elastomeric material, and the intermediate region comprises a substantially non-elastomeric material.

12. An ablation device assembly for ablating a circumferential region of tissue at a location within a body space where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion, a distal end portion, and a longitudinal axis; and

a balloon located along the distal end portion and having a balloon skin that forms a chamber and also a working length and which is inflatable with an ablation medium in order to expand from a radially collapsed condition to a radially expanded condition,

wherein the working length comprises first and second end portions and an intermediate region extending between the first and second end portions relative to the longitudinal axis, the working length enclosing at least in-part the chamber which is adapted to couple to a source of the ablation media, the intermediate region having an expanded outer diameter when in the radially expanded condition that is adapted to engage a substantial portion of the circumferential region of tissue, the balloon skin along the intermediate region comprising a porous fluoropolymer which is sufficiently permeable to allow a volume of the ablation medium within the chamber to be ablatively coupled to the substantial portion of the circumferential region of tissue, and the balloon skin along the first and second end portions comprises an elastomer which is substantially non-permeable for substantially preventing the volume of the ablation medium within the chamber from ablatively coupling to tissue directly across the first and second end portions.

13. The assembly of claim 12, wherein the elastomer is selected from the group of materials consisting of polyurethane, silicone, mylar, latex, and combinations and blends thereof.

14. The assembly of claim 12, wherein the elastomer exhibits at least about a 400% elastic expansion before yield.

19. The assembly of claim 12, wherein the pores along the non-permeable section are substantially blocked with an insulator material.

20. The assembly of claim 19, wherein the insulator material comprises a polymer.

21. The assembly of claim 20, wherein the polymer comprises an elastomer.

22. The assembly of claim 19, wherein the insulator material comprises a deposited material along the non-permeable section.

23. The assembly of claim 22, wherein the deposited material is chosen from the group consisting of plasma deposited materials, vapor deposited materials, ion beam deposited materials, sputter coated materials, and combinations thereof.

24. The assembly of claim 19, wherein the insulator material comprises a thermoplastic material which is melted to the porous polytetrafluoroethylene material along the non-permeable section.

25. The assembly of claim 19, wherein the porous polytetrafluoroethylene material further comprises an outer surface, and the insulator material further comprises a coating over the outer surface.

26. The assembly of claim 25, wherein the insulator material comprises a dip-coated material.

27. The assembly of claim 19, wherein the insulator material substantially fills the pores along the non-permeable section.

28. The assembly of claim 19, wherein the insulator material substantially covers the pores along the non-permeable section.

29. The assembly of claim 28, wherein the insulator material comprises a tubular material which is positioned in a coaxial relationship relative to the porous polytetrafluoroethylene material along the non-permeable section.

30. The assembly of claim 29, wherein the porous polytetrafluoroethylene material further comprises an outer surface, and the tubular material is coaxially positioned over the outer surface.

31. The assembly of claim 29, wherein the tubular material comprises an elastomer.

32. The assembly of claim 29, wherein the tubular material is adhered to the porous polytetrafluoroethylene material.

33. The assembly of claim 29, wherein the tubular material is un-adhered to the porous polytetrafluoroethylene material.

34. The assembly of claim 33, wherein

the porous polytetrafluoroethylene material further comprises a porous tube which is relatively non-compliant; and

the tubular material further comprises an elastomer which is relatively compliant;

such that the balloon in the radially collapsed condition is characterized by the porous polytetrafluoroethylene material in a folded condition and also by the tubular material in a relatively non-stretched condition, and the balloon in the radially expanded condition is characterized by the porous polytetrafluoroethylene material in an unfolded condition and also by the tubular material in a radially stretched condition.

15. An ablation device assembly for ablating a circumferential region of tissue at a location within a body space where a pulmonary vein extends from an atrium, comprising:

an elongate body with a proximal end portion, a distal end potion, and a longitudinal axis; and

an expandable member located along the distal end portion and having a working length that is expandable from a radially collapsed condition to a radially expanded condition;

wherein in the radially expanded condition, the working length has a proximal end and a distal end and also has a tapered shape with a distally reducing outer diameter from the proximal end to the distal end, the working length enclosing at least in-part a chamber which is adapted to couple to a source of an ablation medium and having first and second end portions and an intermediate region extending between the first and second end portions relative to the longitudinal axis, the intermediate region having an expanded outer diameter adapted to engage a substantial portion of the circumferential region of tissue, the intermediate region being sufficiently permeable to allow a volume of the ablation medium within the chamber to be ablatively coupled to the substantial portion of the circumferential region of tissue, and the first and second end portions being substantially non-permeable to substantially prevent the volume of the ablation medium within the chamber from ablatively coupling to tissue direly across the first and second end portions.

16. The assembly of claim 15, wherein the tapered shape is “

pear”

-shaped and has a contoured surface between the proximal end and the distal end, the intermediate region being positioned along the contoured surface adjacent the proximal end.

17. A medical catheter assembly, comprising:

an elongate body with a proximal end portion and a distal end portion and a longitudinal axis; and

a balloon positioned along the distal end portion and which defines a chamber that is adapted to fluidly couple to a pressurizable fluid source, the balloon having a working length relative to the longitudinal axis which is expandable with a volume of pressurized fluid from the pressurizable fluid source from a radially collapsed condition having a radially collapsed profile to a radially expanded condition having a radially expanded profile which is larger than the radially collapsed profile;

wherein the working length has a non-permeable section which is constructed to substantially prevent the pressurized fluid from passing from within the chamber and outwardly through and from the balloon when in the radially expanded condition, and a permeable section which is constructed at least in part of a porous polytetrafluoroethylene material having a plurality of nodes which are interconnected by a plurality of fibrils, the porous polytetrafluoroethylene material including a plurality of pores formed by voids located between the nodes and fibrils, the plurality of pores comprising an inherent void volume adapted to substantially allow the pressurized fluid to pass from within the enclosed chamber and outwardly trough and from the balloon when in the radially expanded condition.

18. A medical catheter assembly, comprising:

an elongate body with a proximal end portion and a distal end portion and a longitudinal axis; and

a balloon positioned along the distal end portion and which defines a chamber that is adapted to fluidly couple to a pressurizable fluid source, the balloon having a working length relative to the longitudinal axis which is expandable with a volume of pressurized fluid from the pressurizable fluid source from a radially collapsed condition having a radially collapsed profile to radially expanded condition having a radially expanded profile which is larger than the radially collapsed profile;

wherein the working length has a non-permeable section which is constructed to substantially prevent the pressurized fluid from passing from within the chamber and outwardly through and from the balloon when in the radially expanded condition, and a permeable section which is constructed at least in part of a porous polytetrafluoroethylene material having a plurality of pores comprising an inherent void volume adapted to substantially allow the pressurized fluid to pass from within the enclosed chamber and outwardly through and from the balloon when in the radially expanded condition, the porous polytetrafluoroethylene material extending along both the non-permeable and permeable sections and having a length with the plurality of pores located along the length, and wherein the pores along the non-permeable section are substantially blocked and non-permeable to the pressurized fluid within the chamber and the pores along the permeable section are substantially open and permeable to pressurized fluid within the chamber.

35. A medical catheter assembly, comprising:

an elongate body with a proximal end portion and a distal end portion and a longitudinal axis; and

a balloon positioned along the distal end portion and which defines a chamber that is adapted to fluidly couple to a pressurizable fluid source, the balloon having a working length relative to the longitudinal axis which is expandable with a volume of pressurized fluid from the pressurizable fluid source from a radially collapsed condition having a radially collapsed profile to a radially expanded condition having a radially expanded profile which is larger than the radially collapsed profile,

wherein the working length has a non-permeable section which is constructed to substantially prevent the pressurized fluid from passing from within the chamber and outwardly through and from the balloon when in the radially expanded condition, and a permeable section which is constructed at least in part of a porous polytetrafluoroethylene material including a plurality of pores comprising an inherent void volume and adapted to substantially allow the pressurized fluid to pass from within the enclosed chamber and outwardly through and from the balloon when in the radially expanded condition, the porous polytetrafluoroethylene material formed from a tape which is oriented with adjacent windings which are secured to each other to form a continuous porous tube that defines at least in part the chamber.

36. A medical catheter assembly, comprising:

an elongate body with a proximal end portion and a distal end portion and a longitudinal axis; and

a balloon positioned along the distal end portion and which defines a chamber that is adapted to fluidly couple to a pressurizable fluid source, the balloon having a working length relative to the longitudinal axis which is expandable with a volume of pressurized fluid from the pressurizable fluid source from a radially collapsed condition having a radially collapsed profile to a radially expanded condition having a radially expanded profile which is larger than the radially collapsed profile;

wherein the working length comprises a non-permeable section which is constructed to substantially prevent the pressurized fluid from passing from within the chamber and outwardly through and from the balloon when in the radially expanded condition, and a permeable section having a plurality of pores adapted to substantially allow the pressurized fluid to pass from within the enclosed chamber and outwardly through and from the balloon when in the radially expanded condition, the working length comprising a polytetrafluoroethylene material having a length which extends along both the non-permeable and permeable sections, the polytetrafluoroethylene material being substantially non-porous along the non-permeable section and porous along the permeable section.

37. The assembly of claim 36, wherein the polytetrafluoroethylene material along the non-permeable section further comprises a plurality of non-permeable pores which are sufficiently small to prevent passage of the pressurized fluid from within the chamber and outwardly from the balloon through the non-permeable section.

38. The assembly of claim 37, wherein the polytetrafluoroethylene material further comprises a plurality of nodes which are interconnected by a plurality of fibrils such that the plurality of pores are formed by voids between the nodes and the fibrils;

and

the polytetrafluoroethylene material along the non-permeable section further comprises a second plurality of nodes which are interconnected by a second plurality of fibrils such that the non-permeable pores are formed from a plurality of non-permeable voids between the second plurality of nodes and the second plurality of fibrils.

39. The assembly of claim 36, wherein the polytetrafluoroethylene material is expanded along the permeable section and is relatively un-expanded along the non-permeable section.

40. A medical catheter assembly, comprising:

an elongate body with a proximal end portion and a distal end portion and a longitudinal axis; and

a balloon positioned along the distal end portion and which defines a chamber that is adapted to fluidly couple to a pressurizable fluid source, the balloon having a working length relative to the longitudinal axis which is expandable with a volume of pressurized fluid from the pressurizable fluid source from a radially collapsed condition having a radially collapsed profile to a radially expanded condition having a radially expanded profile which is larger than the radially collapsed profile;

wherein the working length has a non-permeable section which is constructed to substantially prevent the pressurized fluid from passing from within the chamber and outwardly through and from the balloon when in the radially expanded condition, and a permeable section which is constructed at least in part of a porous fluoropolymer material including a plurality of pores adapted to substantially allow the pressurized fluid to pass from within the enclosed chamber and outwardly through and from the balloon when in the radially expanded condition, the permeable and non-permeable sections being located longitudinally adjacent each other along the working length relative to the longitudinal axis, the working length having a proximal section and a distal section and a tapered region with a distally reducing outer diameter from the proximal section to the distal section, and the permeable section is located along the tapered region.

41. A medical catheter assembly, comprising:

an elongate body with a proximal end portion and a distal end portion and a longitudinal axis; and

a balloon positioned along the distal end portion and which defines a chamber that is adapted to fluidly couple to a pressurizable fluid source, the balloon having a working length relative to the longitudinal axis which is expandable with a volume of pressurized fluid from the pressurizable fluid source from a radially collapsed condition having a radially collapsed profile to a radially expanded condition having a radially expanded profile which is larger than the radially collapsed profile;

wherein the working length has a non-permeable section which is constructed to substantially prevent the pressurized fluid from passing from within the chamber and outwardly through and from the balloon when in the radially expanded condition, and a permeable section which is constructed at least in part of a porous fluoropolymer material including a plurality of pores adapted to substantially allow the pressurized fluid to pass from within the enclosed chamber and outwardly through and from the balloon when in the radially expanded condition, the working length having a proximal section and a distal section and a tapered region with a distally reducing outer diameter from the proximal section to the distal section, and the permeable section is located along the tapered region.

42. The assembly of claim 41, wherein the permeable section comprises a circumferential band which circumscribes the working length.