Method and apparatus for location and temperature specific drug action such as thrombolysis

• US 6,245,095 B1
• Filed: 01/15/1999
• Issued: 06/12/2001
• Est. Priority Date: 03/24/1998
• Status: Expired due to Term

• Current Assignee: Zoll Circulation Incorporated (Asahi Kasei Corporation)
• Original Assignee: Innercool therapies Incorporated (Taxus Cardium Pharmaceuticals Group, Inc.)
• Inventors: Lasheras, Juan C., Dobak, John D. III
• Primary Examiner(s): Cohen, Lee
• Assistant Examiner(s): Kearney, R
• Application Number:
  US09/232,177
• Time in Patent Office: 879 Days
• Field of Search: 128/898, 607/96, 607/98, 607/99, 607/100, 607/101, 607/103, 607/104, 607/105, 607/106, 435/1.2, 604/28, 604/113, 604/114
• US Class Current: 607/105
• 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: A61B 2018/0281 using a tortuous path, e.g. formed by fins or ribs
• CPC Class Codes: A61F 2007/0056 for cooling
• CPC Class Codes: A61F 2007/126 for invasive application, e.g. for introducing into blood vessels
• CPC Class Codes: A61F 7/12 Devices for heating or cooling internal body cavities

Abstract

A method is provided of localizing a drug action where the drug is present throughout a vascular system. The localization occurs to within a volume of blood in a blood vessel, the vascular system having an initial temperature substantially within a first temperature range. A temperature-specific enzyme is delivered throughout a vascular system including a volume of blood in a blood vessel, the temperature-specific enzyme having a working temperature within a prespecified temperature range that does not substantially overlap the first temperature range. A heat transfer element is delivered to a blood vessel in fluid communication with the volume of blood. The temperature of the heat transfer element is adjusted such that the volume of blood in the blood vessel is heated or cooled to the prespecified temperature range. In this way, the action of the temperature-specific enzyme is substantially limited to the volume of blood heated or cooled. In an alternative embodiment, the temperature-specific enzyme is localized to the volume of blood in the blood vessel, and the heat transfer element is disposed in fluid communication with the volume of blood in the blood vessel. The enzyme localization may occur by way of direct injection or by way of injection through a lumen of a catheter. The injection lumen of the catheter may be disposed at least partially adjacent or in combination with the heat transfer element and its associated inlet and outlet lumens.

Claims

1. A method of localizing a drug action, the drug present throughout a vascular system, the localization occurring to within a volume of blood in a blood vessel, the vascular system having an initial temperature substantially within a first temperature range, comprising:

delivering a temperature-specific enzyme throughout a vascular system including a volume of blood in a blood vessel, the temperature-specific enzyme having a working temperature within a prespecified temperature range that does not substantially overlap the first temperature range;

delivering a heat transfer element to a blood vessel in fluid communication with the volume of blood; and

adjusting the temperature of the heat transfer element by passing a working fluid therethrough such that the volume of blood in the blood vessel is heated or cooled to the prespecified temperature range,

such that the action of the temperature-specific enzyme is substantially limited to the volume of blood heated or cooled.

2. The method of claim 1, wherein the adjusting includes inducing mixing in the blood to enhance a heat transfer rate.

3. The method of claim 2, wherein the adjusting further includes inducing mixing in the working fluid flowing through the heat transfer element.

4. A method of localizing a drug action to substantially within a volume of blood in a blood vessel, the vascular system having an initial temperature substantially within a first temperature range, comprising:

delivering a temperature-specific enzyme to a volume of blood in a blood vessel, the temperature-specific enzyme having a working temperature within a prespecified temperature range that does not substantially overlap the first temperature range;

delivering a heat transfer element to a blood vessel in fluid communication with the volume of blood; and

adjusting the temperature of the heat transfer element by passing a working fluid therethrough such that the volume of blood in the blood vessel is heated or cooled to the prespecified temperature range,

such that the action of the temperature-specific enzyme is substantially limited to the volume of blood heated or cooled.

5. The method of claim 4, wherein the delivering includes injecting the temperature-specific enzyme intravenously.

6. The method of claim 4, wherein the delivering includes injecting the temperature-specific enzyme through a lumen adjacent the heat transfer element.

7. The method of claim 4, wherein the delivering includes injecting the temperature-specific enzyme through a tip of the heat transfer element.