Balloon design to enhance cooling uniformity

• US 9,861,423 B2
• Filed: 11/23/2015
• Issued: 01/09/2018
• Est. Priority Date: 01/27/2012
• Status: Active Grant

• Current Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Original Assignee: Medtronic CryoCath LP (Medtronic Plc)
• Inventors: Lalonde, Jean-Pierre, Davie, Scott W., Wittenberger, Dan
• Primary Examiner(s): Carey, Michael
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US14/948,906
• Publication Number:
  US 20160074090A1
• Time in Patent Office: 778 Days
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• 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 2018/0022 Balloons
• CPC Class Codes: A61B 2018/00255 arranged one inside another
• CPC Class Codes: A61B 2018/00375 Ostium, e.g. ostium of pulmonary vein or artery
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00648 using more than one sensed parameter
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/00994 combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0268 with restriction of flow
• CPC Class Codes: A61B 2018/0275 using porous elements
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension

Abstract

A device, system, and method for enhancing cooling uniformity and efficiency of cryogenic fluids and providing a treatment element the shape of which can be adjusted for multiple purposes. The device may include a balloon catheter and fluid dispersion element, the fluid dispersion element directing the flow of coolant from a fluid injection element the interior wall of the balloon. The method of changing the shape of the treatment element may include retracting and extending a shaft to which the distal neck of a balloon is coupled, so that the balloon goes from a first shape to a second shape.

Claims

1. A medical device comprising:

an expandable element including an interior wall, an exterior wall, an adjustable distal neck, and a fixed proximal neck;

a disk-shaped fluid distribution membrane disposed within the expandable element so as to divide the expandable element into a first portion that is distal to the fluid distribution membrane and a second portion that is proximal to the fluid distribution membrane, the fluid distribution membrane including a plurality of apertures proximate at least a portion of the interior wall that allow the transit of fluid from the first portion to the second portion; and

a fluid injection element within the first portion,

the expandable element having a first shape when the distal neck is oriented outward and away from the expandable element, and a second shape when the distal neck is oriented inward and within the expandable element.

2. The device of claim 1, wherein the expandable element is a balloon.

3. The device of claim 1, wherein the fluid distribution membrane is a deformable membrane.

4. The device of claim 3, wherein the deformable membrane meters transit of coolant from the first portion to the second portion.

5. The device of claim 1, wherein the fluid distribution membrane is at least one of gas permeable, liquid permeable, and a combination of gas permeable and liquid permeable.

6. The device of claim 1, wherein the fluid distribution membrane includes an outer edge and an inner edge, the outer edge being in contact with a portion of the interior wall of the expandable element and the inner edge defining a central aperture.

7. The device of claim 6, wherein the outer edge is affixed to the interior wall of the expandable element.

8. The device of claim 6, further comprising:

a first shaft having a proximal end, a distal end, and a lumen extending therebetween, the proximal neck of the expandable element being coupled to the distal end of the first shaft; and

a second shaft having a distal end and a proximal end and being slidably disposed within the lumen of the first shaft, the distal neck of the expandable element being coupled to the distal end of the second shaft.

9. The device of claim 8, wherein the inner edge is in contact with the second shaft, the second shaft being slidably disposed through the central aperture.

10. The device of claim 8, wherein the second shaft includes the fluid injection element.

11. The device of claim 8, wherein the second shaft is slidably movable with respect to the coolant delivery element.

12. The device of claim 1, wherein the expandable element includes one or more sensors, the one or more sensors including at least one of temperature sensors and pressure sensors.

13. A method for enhancing the efficiency of a medical device for cooling tissue, the method comprising:

providing an expandable element having a longitudinal axis, an interior wall, an exterior wall, a fixed proximal neck, an adjustable distal neck, and a fluid distribution element disposed within the expandable element so as to divide the expandable element into a first portion and a second portion, the fluid distribution element lying in a plane that is at least substantially orthogonal to the longitudinal axis of the expandable element, the fluid distribution element having an outer edge that is in contact with the interior wall of the expandable element, the adjustable distal neck being coupled to a slidably movable sheath, the expandable element having a first shape when the sheath is in an extended position and having a second shape when the sheath is in a retracted position;

injecting coolant through a fluid injection element within the first portion, the fluid distribution element guiding coolant toward the interior wall of the first portion, through the fluid distribution element, and into the second portion.

14. The method of claim 13, wherein the fluid distribution element includes a plurality of apertures proximate the inner wall of the expandable element, the apertures allowing for the metered transit of the fluid from the first portion to the second portion.

15. The method of claim 14, wherein the expandable element defines a longitudinal axis, the plurality of apertures of the fluid distribution element being radially arranged about the longitudinal axis.

16. The method of claim 13, wherein the fluid distribution element is a deformable membrane.

17. The method of claim 16, wherein the fluid distribution element meters transit of coolant from the first portion to the second portion.

18. The method of claim 13, wherein the expandable element includes one or more sensors, the one or more sensors including at least one of temperature sensors and pressure sensors.