# US 2003/0171709 A1 · Proton generating catheters and methods for their use in enhancing fluid flow through a vascular site occupied by a calcified vascular occulation

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- Number: US 2003/0171709 A1
- Document ID: US20030171709A1
- Status: Published application
- Kind: A1
- Application number: 10/358,983
- Filed: 2003-02-04
- Published: 2003-09-11
- Earliest claimed: 2000-12-29
- Assignees: Corazon Technologies, Inc.
- Inventors: Brent R. Constantz; John Ross
- Web page: https://patentgrep.com/patent/US20030171709A1

## CPC

- A61N 1/306: {Arrangements where at least part of the apparatus is introduced into the body}
- A61B 17/22: Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- 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)
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61B 2017/22082: {after introduction of a substance}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## 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

### Claim 1

A catheter device comprising at its distal end:
a proton generating means; and
a vascular site flushing means.

### Claim 2 (depends on 1)

The catheter device according to claim 1, wherein said vascular site flushing means comprises:
a fluid introduction means; and
a fluid aspiration means.

### Claim 3 (depends on 1)

The catheter device according to claim 1, wherein said proton generating means is an electrode means.

### Claim 4 (depends on 3)

The catheter device according to claim 3, wherein said electrode means comprises:
an anode; and
a cathode.

### Claim 5 (depends on 1)

The catheter device according to claim 1, wherein said catheter device comprises at least two distinct elements which are movable relative to each other.

### Claim 6 (depends on 4)

The catheter device according to claim 4, wherein said catheter device further comprises a means for applying an electric potential between said cathode and said anode.

### Claim 7

A catheter device comprising at its distal end:
a proton generating means comprising an anode and a cathode;
a fluid introduction means; and
an aspiration means.

### Claim 8 (depends on 7)

The catheter device according to claim 7, wherein said catheter device comprises at least two distinct elements which are movable relative to each other.

### Claim 9 (depends on 7)

The catheter device according to claim 7, wherein said catheter device further comprises a means for applying an electric potential between said cathode and said anode.

### Claim 10 (depends on 7)

The catheter device according to claim 7, wherein said catheter device further comprises a vascular occlusion means.

### Claim 11

A method of enhancing fluid flow through a vascular site occupied by a vascular occlusion, said method comprising:
(a) generating protons from water in said vascular site in a manner sufficient to provide for a subphysiological pH in said vascular site; and
(b) maintaining said subphysiological pH in said vascular site for a period of time sufficient for fluid flow to be enhanced through said vascular site;
whereby fluid flow is enhanced through said vascular site.

### Claim 12 (depends on 11)

The method according to claim 11, wherein said method further comprises flushing said vascular site with an aqueous solution.

### Claim 13 (depends on 12)

The method according to claim 12, wherein said aqueous solution is an electrolyte solution.

### Claim 14 (depends on 12)

The method according to claim 12, wherein said protons are generated by electrolyzing water in said vascular site.

### Claim 15 (depends on 11)

The method according to claim 11, wherein said vascular occlusion comprises calcium.

### Claim 16 (depends on 11)

The method according to claim 11, wherein said occlusion is a total occlusion.

### Claim 17 (depends on 11)

The method according to claim 11, wherein said occlusion is a partial occlusion.

### Claim 18 (depends on 1, 11)

The method according to claim 11, wherein a catheter device according to claim 1 is used to generate protons in said vascular site.

### Claim 19 (depends on 1)

A system for enhancing fluid flow through a vascular site occupied by a vascular occlusion, said system comprising:
(a) a catheter device according to claim 1;
(b) a manifold;
(c) an aqueous fluid reservoir; and
(d) a source of negative pressure.

### Claim 20 (depends on 19)

The system according to claim 19, wherein said system further comprises a guidewire.

### Claim 21 (depends on 1)

A kit for use in enhancing fluid flow through a vascular site occupied by a vascular occlusion, said kit comprising:
a catheter device according to claim 1.

### Claim 22 (depends on 21)

The kit according to claim 21, wherein said kit further comprises a guidewire.
