# US 9,775,530 B2 · Foley catheter with ring electrodes

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- Number: US 9,775,530 B2
- Document ID: US9775530B2
- Status: Granted
- Kind: B2
- Application number: 14/531,578
- Filed: 2014-11-03
- Published: 2015-05-07
- Granted: 2017-10-03
- Earliest claimed: 2013-11-01
- Assignees: Medtronic Xomed, Inc.
- Applicants: Medtronic Xomed, Inc.
- Inventors: Wenjeng Li; Dwayne Yamasaki; Marc Zimmermann; Kevin Mauch
- Web page: https://patentgrep.com/patent/US9775530B2

## CPC

- A61B 5/6852: {Catheters}
- A61B 5/388: Nerve conduction study, e.g. detecting action potential of peripheral nerves
- A61B 5/4041: {Evaluating nerves condition}
- A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections}
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61N 1/0521: {Genital electrodes}
- A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control}
- A61B 2562/043: in a linear array
- A61M 2210/1089: Urethra
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- 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)

## Abstract

An apparatus for monitoring a nerve includes a Foley type catheter having an exterior surface, and first and second pairs of ring electrodes formed on the exterior surface of the Foley catheter. Each of the first and second pairs of ring electrodes is configured to perform at least one of stimulating the nerve and recording nerve activity.

## Claims

### Claim 1

An apparatus for monitoring a nerve, comprising:
a Foley type catheter having an exterior surface;
first and second pairs of ring electrodes formed on the exterior surface of the Foley catheter, wherein the second pair of ring electrodes delivers bipolar nerve stimulation, and the first pair of ring electrodes provides bipolar recording of nerve activity;
a processing apparatus to process the recorded nerve activity; and
a first conductor coupled to the processing apparatus and the first pair of ring electrodes to carry signals representing the recorded nerve activity to the processing apparatus.

### Claim 2 (depends on 1)

The apparatus of claim 1, and further comprising:
a second conductor coupled to the processing apparatus and the second pair of ring electrodes and configured to carry signals between the second pair of ring electrodes and the processing apparatus.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein the first and second pairs of ring electrodes each comprise an anode ring electrode and a cathode ring electrode.

### Claim 4 (depends on 1)

The apparatus of claim 1, and further comprising:
a third pair of ring electrodes formed on the exterior surface of the Foley catheter, wherein the third pair of ring electrodes is configured to perform at least one of stimulating the nerve and recording nerve activity.

### Claim 5 (depends on 4)

The apparatus of claim 4, wherein the first pair of ring electrodes includes first and second ring electrodes that are separated by a distance of about 5 mm to 10 mm, and wherein the second pair of ring electrodes includes third and fourth ring electrodes that are separated by a distance of about 5 mm to 10 mm, and wherein the third pair of ring electrodes includes fifth and sixth ring electrodes that are separated by a distance of about 5 mm to 10 mm.

### Claim 6 (depends on 5)

The apparatus of claim 5, wherein a center of the first pair of ring electrodes is separated from a center of the second pair of ring electrodes by a distance of about 18 mm to about 22 mm, and wherein a center of the second pair of ring electrodes is separated from a center of the third pair of ring electrodes by a distance of about 18 mm to about 22 mm.

### Claim 7 (depends on 6)

The apparatus of claim 6, wherein the third pair of ring electrodes is most distally positioned on the Foley catheter, and wherein the third pair of ring electrodes is positioned proximally from a proximal end of a balloon of the Foley catheter by a distance of about 35-40 mm.

### Claim 8 (depends on 1)

The apparatus of claim 1, wherein the first pair of ring electrodes includes first and second ring electrodes that are separated by a distance of about 5 mm to 10 mm, and wherein the second pair of ring electrodes includes third and fourth ring electrodes that are separated by a distance of about 5 mm to 10 mm.

### Claim 9 (depends on 8)

The apparatus of claim 8, wherein a center of the first pair of ring electrodes is separated from a center of the second pair of ring electrodes by a distance of about 8 mm to about 12 mm.

### Claim 10 (depends on 9)

The apparatus of claim 9, wherein the second pair of ring electrodes is most distally positioned on the Foley catheter, and wherein the second pair of ring electrodes is positioned proximally from a proximal end of a balloon of the Foley catheter by a distance of about 47-57 mm.

### Claim 11 (depends on 8)

The apparatus of claim 8, wherein a center of the first pair of ring electrodes is separated from a center of the second pair of ring electrodes by a distance of about 10.5 mm to about 14.5 mm.

### Claim 12 (depends on 11)

The apparatus of claim 11, wherein the second pair of ring electrodes is most distally positioned on the Foley catheter, and wherein the second pair of ring electrodes is positioned proximally from a proximal end of a balloon of the Foley catheter by a distance of about 68-78 mm.

### Claim 13 (depends on 1)

The apparatus of claim 1, and further comprising:
a third pair of ring electrodes formed on the exterior surface of the Foley catheter, wherein the third pair of ring electrodes is configured to perform at least one of stimulating the nerve and recording nerve activity, wherein the third pair of ring electrodes is most distally positioned on the Foley catheter, and wherein the third pair of ring electrodes is positioned proximally from a proximal end of a balloon of the Foley catheter by a distance of about 5-15 mm.

### Claim 14 (depends on 1)

The apparatus of claim 1, wherein at least one of the first and second pairs of ring electrodes is configured to be used for spontaneous recording during surgical dissection.

### Claim 15 (depends on 1)

The apparatus of claim 1, wherein at least one of the first and second pairs of ring electrodes is configured to provide therapeutic stimulation.

### Claim 16

A method of monitoring nerve activity, comprising:
deploying a Foley type catheter in a urethra of a human patient, wherein the Foley type catheter comprises a first pair of ring electrodes and a second pair of ring electrodes;
stimulating a nerve;
recording nerve activity resulting from the stimulation with at least one of the first and second pairs of ring electrodes; and
calculating a nerve conduction velocity based on the recorded nerve activity.

### Claim 17 (depends on 16)

The method of claim 16, and further comprising:
positioning the second pair of ring electrodes at a membranous urethra of the human patient for the stimulation.

### Claim 18 (depends on 16)

The method of claim 16, and further comprising:
identifying a nerve fiber type corresponding to the calculated nerve conduction velocity.

### Claim 19 (depends on 18)

The method of claim 18, and further comprising:
displaying the identified nerve fiber type on a monitor coupled to the Foley type catheter.

### Claim 20

A system for monitoring a nerve from a urethra of a patient, the system comprising:
a Foley type catheter configured to be deployed in the urethra and comprising a first pair of ring electrodes and a second pair of ring electrodes, wherein each of the first and second pairs of ring electrodes records nerve activity; and
a monitor apparatus in communication with the first and second pairs of ring electrodes to process the recorded nerve activity.

### Claim 21 (depends on 20)

The system of claim 20, wherein the Foley type catheter further comprises:
a third pair of ring electrodes configured to perform at least one of stimulating the nerve and recording nerve activity.
