Pulmonary vein isolation balloon catheter

Patent metadata

Field	Value
Publication number	US-2021177505-A1
Application number	US-201816758799-A
Country	US
Kind code	A1
Filing date	Oct 26, 2018
Priority date	Oct 27, 2017
Publication date	Jun 17, 2021
Grant date	—

Abstract

An elongate medical device having a device longitudinal axis and a device distal region, the medical device comprising a balloon at the device distal region and having a balloon longitudinal axis, the balloon comprising a balloon inflatable portion with a first length configured to transition from a deflated state to an inflated state and includes a portion of the balloon proximal portion and a portion of the balloon distal portion, a balloon proximal portion with a second length, a balloon distal portion with a third length, wherein, in the inflated state, the balloon is symmetrical about the balloon longitudinal axis and the balloon comprises a first profile shape with a second length and a second profile shape with a third length, and wherein the balloon distal portion comprising the second profile shape comprises a tissue contacting surface where a substantial portion of the tissue contacting surface is concave.

First claim

What is claimed is:

1 . An elongate medical device having a device longitudinal axis and a device distal region, the medical device comprising:
a balloon at the device distal region and having a balloon longitudinal axis, the balloon comprising
a balloon inflatable portion with a first length that is configured to transition from a deflated state to an inflated state and includes a portion of the balloon proximal portion and a portion of the balloon distal portion;
a balloon proximal portion with a second length, and
a balloon distal portion with a third length,

wherein, in the inflated state, the balloon is symmetrical about the balloon longitudinal axis and a plan view of the balloon comprises a first profile shape with a second length and a second profile shape with a third length, and
wherein the balloon distal portion comprising the second profile shape comprises a tissue contacting surface where a substantial portion of the tissue contacting surface is concave.

2 . The medical device of claim 1 , wherein the first profile shape and the second profile shape are each defined by a polynomial expression, wherein the polynomial expression is at least a second degree polynomial.

3 . The medical device of claim 1 , wherein second profile shape is defined by one or more curves.

4 . The medical device of claim 3 , wherein the first profile shape is defined by one or more curves.

5 . The medical device of claim 1 , wherein the second profile shape is defined by a linear portion inbetween two curved portions.

6 . The medical device of claim 5 , wherein the first profile shape is defined by a linear portion inbetween two curved portions.

7 . The medical device of claim 1 , wherein the second profile shape is defined by one or more radii.

8 . The medical device of claim 7 , wherein the first profile shape is defined by one or more radii.

9 . The medical device of claim 7 , wherein the second profile shape is further defined by a first angle.

10 . The medical device of claim 8 , wherein the first profile shape is further defined by a second angle.

11 . The medical device of claim 1 , wherein the first profile shape comprises a concave shape.

12 . The medical device of claim 1 , wherein the first profile shape and the second profile shape comprise equal concave shapes.

13 . The medical device of claim 1 , wherein the first profile shape and the second profile shape comprise unequal concave shapes.

14 . The medical device of claim 1 , wherein the proximal portion comprises a plurality of profile shapes.

15 . The medical device of claim 1 , wherein the second length and the third length are equal.

16 . The medical device of claim 1 , wherein the second length is less than the third length.

17 . The medical device of claim 1 , wherein the first length is between 10 and 60 mm.

18 . The medical device of claim 7 , wherein the one or more radii are each between 1 and 5 mm

19 . A system for treating atrial fibrillation, the system comprising:
a balloon delivery catheter including proximal and distal ends; and an ablation balloon comprising a first section, a second section, a third section, and an inflatable section that comprises the second section and a portion of the first section and a portion of the third section, where the ablation balloon is coupled to the distal end of the balloon delivery catheter, wherein the first section has a first profile shape, the third section with a second profile shape is a portion of the third section is configured to engage with an ostium of a pulmonary vein for aligning a longitudinal axis of the ablation balloon with a longitudinal axis of the pulmonary vein, and
the second section couples the first and third sections of the ablation balloon, with a varying circumference; and
wherein at least a portion of one of the second section and third section of the ablation balloon is configured, when the inflatable section is inflated, to engage with an antrum of the pulmonary vein along an uninterrupted length and circumference, and deliver a uniform ablation therapy to the pulmonary vein antrum.

20 . The system of claim 19 , wherein the ablation balloon is configured to deliver a consistent ablation therapy delivery along the uninterrupted length and circumference of the pulmonary vein antrum.

21 . The system of claim 20 , wherein the first profile shape and the second profile shape comprise equal concave shapes.

22 . The system of claim 20 , wherein the first profile shape and the second profile shape comprise unequal concave shapes.

23 . The system of claim 20 , wherein the ablation balloon has a longitudinal length between 10 and 60 mm

24 . The system of claim 20 , wherein the ablation balloon ablates tissue using one or more of cryogenic fluid ablation, laser energy, radiofrequency energy, microwave energy, irreversible electroporation, chemical reaction, and high-intensity focused ultrasound.

25 . A balloon catheter for pulmonary vein isolation comprising:
a catheter shaft configured to deploy an ablation balloon into a pulmonary vein; the ablation balloon coupled to a distal end of the catheter shaft, and configured to
deploy from an undeployed configuration to a deployed configuration having a concave tissue contacting surface,
engage, by a portion the concave tissue contacting surface, a tissue wall of the pulmonary vein along an uninterrupted length and circumference of an antrum and ostia of the pulmonary vein; and
wherein the ablation balloon is configured to deliver a uniform ablation therapy to the antrum of the pulmonary vein engaged by the portion of the concave tissue contacting surface of the ablation balloon.

26 . The balloon catheter of claim 25 , wherein the uniform ablation therapy comprises one or more of the following: cryoablation, laser energy, radiofrequency energy, microwave energy, irreversible electroporation, chemical reaction, and high-intensity focused ultrasound.

27 . The balloon catheter of claim 25 , wherein the ablation balloon includes a first portion with a first profile radius, a third portion with a second profile radius which is greater than the first profile radius, and a second portion coupled between the first and third portions of the ablation balloon, with a varying circumference; and
the third portion is configured to engage with an ostia of a pulmonary vein, and at least one of the second and the third portions configured to engage with an uninterrupted length and circumference of an antrum of the pulmonary vein and deliver a tissue ablation therapy to the antrum.

28 . The balloon catheter of claim 27 , wherein the first profile radius and the second profile radius comprise equal concave shapes.

29 . The balloon catheter of claim 27 , wherein the first profile shape and the second profile shape comprise unequal concave shapes.

30 . The balloon catheter of claim 27 , wherein the ablation balloon has a longitudinal length between 10 and 60 mm

31 . An expandable medical device comprising:
a balloon that is configured to transition from a deflated state to an inflated state, wherein when the balloon is in the inflated state, the balloon comprises a first profile shape on a proximal portion and a second profile shape on a distal portion, where t

Assignees

• St Jude Medical Cardiology Div Inc

Inventors

• Tegg Troy T
• Gonzalez Salome A
• Sutermeister Derek C

Classifications

• A61B2018/0262

  using a circulating cryogenic fluid · CPC title

• A61B2018/00375

  Ostium, e.g. ostium of pulmonary vein or artery · CPC title

• A61B18/24

  with a catheter (A61B18/26, A61B18/28 take precedence) · CPC title

• A61M25/1002

  characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence) · CPC title

• A61B2018/0022

  Balloons · CPC title