Proton generating catheters and methods for their use in enhancing fluid flow through a vascular site occupied by a calcified vascular occlusion

• US 7,778,701 B2
• Filed: 11/17/2005
• Issued: 08/17/2010
• Est. Priority Date: 12/29/2000
• Status: Expired due to Fees

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordia Corporation (CITIC Corp. Ltd.)
• Inventors: Ross, John, Constantz, Brent R.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): BERDICHEVSKY, AARTI
• Application Number:
  US11/283,052
• Publication Number:
  US 20060155241A1
• Time in Patent Office: 1,734 Days
• Field of Search: 604/20, 604/21, 604/22, 604/191, 604/192, 604/194, 604/507, 606/48, 606/159
• US Class Current: 604/20
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• 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 2017/22082 after introduction of a substance
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body

Abstract

Catheter devices and methods are provided for enhancing fluid flow through a vascular site occupied by a calcified lesion. The catheter devices of the subject invention at least include, at their distal end, a proton generating means, and in many embodiments also include a flushing means. In using the subject devices, the distal end of the catheter is placed proximal to the vascular occlusion and protons are generated, e.g., via proton generation from water, in a manner sufficient to reduce the pH of the vascular site in the region proximal to the occlusion. The subphysiologic pH is maintained for a period of time sufficient for fluid flow through the vascular site to be enhanced. Also provided are kits comprising the subject catheter devices for use in the subject methods.

Claims

1. A catheter device comprising at its distal end:

a proton generating means comprising an anode and a cathode spaced apart from each other a distance of about 0.5 mm to about 2 mm;

a fluid introduction means;

an aspiration means that is separate from the fluid introduction means, the fluid introduction means and the aspiration means being configured to flush a target site with an aqueous fluid comprising water plus one or more solutes;

a vascular occlusion means for maintaining the aqueous fluid at a target site for a predetermined time, the proton generating means being configured to lower the pH of the aqueous fluid at the target site to a subphysiologic level; and

a means for applying a low voltage potential between the cathode and the anode for creating protons.