Cryogenically enhanced intravascular interventions

• US 6,468,297 B1
• Filed: 02/23/2000
• Issued: 10/22/2002
• Est. Priority Date: 02/24/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: CryoVascular Systems, Inc. (Boston Scientific Corporation)
• Inventors: Tatsutani, Kristine, Williams, Ronald, Joye, James, Williams, Richard S.
• Primary Examiner(s): Peffley, Michael
• Assistant Examiner(s): Vrettakos, Peter J
• Application Number:
  US09/511,191
• Time in Patent Office: 972 Days
• Field of Search: 607/113, 607/106, 62/501, 62/512, 128/898, 604/521
• US Class Current: 607/113
• 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 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61B 2017/22062 to be filled with liquid
• 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

Abstract

Techniques and devices for treating atherosclerotic disease use controlled cryogenic cooling, often in combination with angioplasty and/or stenting. A combination cryogenic/angioplasty catheter may cool the diseased blood vessel before, during, and/or after dilation. Controlled cooling of the vessel wall reduces actual/observed hyperplasia as compared to conventional uncooled angioplasty. Similar reductions in restenosis may be provided for other primary treatments of the blood vessel, including directional arthrectomy, rotational arthrectomy, laser angioplasty, stenting, and the like. Cooling of vessel wall tissues will often be performed through plaque, and the cooling process will preferably take the thermodynamic effects of the plaque into account.

Claims

1. A method for inhibiting restenosis of a blood vessel region, the blood vessel region subjected to a primary treatment effecting an initial reduction in stenosis and inducing the restenosis, the method comprising:

cooling an inner surface of the blood vessel region;

reducing cooling so that the inner surface of the blood vessel warms;

re-cooling the warmed inner surface so as to define at least one cooling/warming/cooling cycle, the at least one cycle having cooling temperatures and times sufficient to remodel the blood vessel region such that the restenosis of the blood vessel is measurably inhibited.

2. The method of claim 1, the blood vessel having plaque disposed between a lumen and a vessel wall tissue, wherein the cooling step comprises cooling the vessel wall tissue, and wherein the cooling step is performed by:

engaging a surface of the plaque with a cooling surface; and

cooling the plaque with the cooling surface according to at least one of a cooling surface temperature and a cooling surface cooling time based at least in part on a thickness of the plaque so that the plaque cools the vessel wall tissue.

3. The method of claim 2, wherein the vessel wall tissue is cooled to a target temperature in a range from about −

5°

C. to about −

15°

C.

4. The method of claim 3, wherein the cooling surface cools the plaque to a temperature significantly below the target temperature.

5. The method of claim 4, wherein the cooling surface cools the plaque to a temperature below the range.

6. The method of claim 3, wherein the vessel wall tissue is cooled to the target temperature for less than about 60 seconds.

7. The method of claim 6, wherein the vessel wall tissue is cooled to the target temperature for a time of at least about 10 seconds.

8. The method of claim 7, wherein a rate of change of the temperature of the vessel wall tissue is significantly less than a rate of change of a plaque surface temperature.