Cryoplasty apparatus and method

• US 6,875,209 B2
• Filed: 09/27/2002
• Issued: 04/05/2005
• Est. Priority Date: 09/27/2001
• Status: Expired due to Fees

• Current Assignee: Galil Medical Ltd. (Boston Scientific Corporation)
• Original Assignee: Galil Medical Ltd. (Boston Scientific Corporation)
• Inventors: Schechter, Doris, Zvuloni, Roni, Amir, Uri, Bliweis, Mordechai, McGlone, James
• Primary Examiner(s): Peffley, Michael
• Application Number:
  US10/255,834
• Publication Number:
  US 20030060762A1
• Time in Patent Office: 921 Days
• Field of Search: 606 20- 26
• US Class Current: 606/21
• 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 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00101 using an array of thermosensors
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/00041 Heating, e.g. defrosting
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: F25B 9/02 using Joule-Thompson effect; using vortex effect

Abstract

The present invention relates to apparatus, systems, and methods utilizing cryogenic cooling in an angioplasty balloon catheter for treatment of arterial stenosis and prevention of restenosis. More particularly, the present invention relates to an angioplasty balloon catheter utilizing expansion of compressed gas to effect Joule-Thomson cooling of an angioplasty balloon, and optionally further incorporating external temperature sensors utilizable to identify a locus for treatment of arterial stenosis. The present invention further relates to angioplasty treatment systems incorporating such a catheter, and to cryogenic angioplasty methods for treating arterial stenosis and discouraging restenosis.

Claims

1. An angioplasty balloon catheter useable to treat arterial stenosis, comprising:

a) a gas input lumen for supplying a pressurized gas;

b) a first inflatable balloon containing a first variable volume;

c) a Joule-Thomson orifice for passing said pressurized gas from said gas input lumen into said first variable volume so as to cool and inflate said first inflatable balloon; and

d) a plurality of thermal sensors operable to report external temperatures along a selected length of said catheter, thereby enabling said catheter to report a temperature gradient alone a selected segment of a body conduit when said catheter is inserted into said body conduit, said plurality of thermal sensors being distributed along an expandable spiral sensing loop having a distal end anchored to a distal portion of said catheter, said sensing loop being spirally wound around a section of shaft of said catheter and being operable to expand away from said shaft, thereby enhancing thermal communication between said sensors distributed along said sensing loop and body tissues adjacent to said catheter.

2. The catheter of claim 1, wherein said spiral sensing loop is designed and constructed to expand away from said shaft of said catheter when a proximal end of said sensing loop is pushed toward said anchored distal end of said sensing loop.

3. The catheter of claim 1, wherein said spiral sensing loop is designed and constructed to contract toward said shaft of said catheter when a proximal end of said sensing loop is pulled away from said anchored distal end of said sensing loop.

4. A system for angioplastic treatment of arterial stenosis and for reducing restenosis, comprising:

a) An angioplasty balloon catheter useable to treat arterial stenosis, having a gas input lumen for supplying a preasurized gas, a first inflatable balloon containing a first variable volume, and a Joule-Thomson orifice for passing said pressurized gas from said gas input lumen into said first variable volume of said first inflatable balloon so as to cool and inflate said first inflatable balloon;

b) a supply of compressed cooling gas operable to supply cooling gas to said gas input lumen;

c) a cooling gas input valve controlling delivery of compressed cooling gas from said supply of compressed cooling gas to said gas input lumen; and

d) a plurality of thermal sensors operable to report external temperatures along a selected length of said catheter, thereby enabling said catheter to report a temperature gradient along a selected segment of a body conduit when said catheter is inserted into said body conduit, said plurality of thermal sensors being distributed along an expandable spiral sensing loop having a distal end anchored to a distal portion of said catheter, said sensing loop being spirally wound around a section of shaft of said catheter and being operable to expand away from said shaft, thereby enhancing thermal communication between said sensors distributed along said sensing loop and body tissues adjacent to said catheter.

5. The system of claim 4, wherein said spiral sensing loop is designed and constructed to expand away from said shaft of said catheter when a proximal end of said sensing loop is pushed toward said anchored distal end of said sensing loop.

6. The system of claim 4, wherein said spiral sensing loop is designed and constructed to contact toward said shaft of said catheter when a proximal end of said sensing loop is pulled away from said anchored distal end of said sensing loop.