# US 2018/0021577 A1 · Venous electrical stimulation apparatus and methods and uses thereof

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- Number: US 2018/0021577 A1
- Document ID: US20180021577A1
- Status: Published application
- Kind: A1
- Application number: 15/547,782
- Filed: 2016-01-27
- Published: 2018-01-25
- Earliest claimed: 2015-02-02
- Assignees: Novintum Medical Technology GmbH
- Applicants: Novintum Medical Technology GmbH
- Inventors: David Bruce PHILLIPS
- Web page: https://patentgrep.com/patent/US20180021577A1

## CPC

- A61N 1/36021: {for treatment of pain}
- A61B 5/150106: {Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced}
- A61M 5/422: {Desensitising skin}
- A61N 1/0456: {Specially adapted for transcutaneous electrical nerve stimulation [TENS]}
- A61N 1/0472: {Structure-related aspects}
- A61N 1/0492: {Patch electrodes (A61N1/0412, A61N1/0428 take precedence)}
- A61N 1/36031: {using physiological parameters for adjustment}
- A61N 1/36034: {specified by the stimulation parameters}
- A61N 1/445: {Hydro-electric baths}
- 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)
- 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)}

## Abstract

An electrical venous stimulation apparatus comprising a powered signal generator, the signal generator configured to generate a specified electrical output signal. The apparatus also includes a plurality of electrodes in electrical communication with the signal generator and configured, to be placed in electrical communication with a subject, The electrical output signal sent to the subject, includes an output voltage, electrical current, and waveform that changes with time in a preprogrammed repeating cycle. The output voltage, electrical current, and waveform are configured to elicit a physiological response that stimulates a plurality of peripheral nerves in the subject, activates a venous muscle pump mechanism in one or more limbs of the subject, and non-invasively alter the physiology of target vein(s), wherein the target vein(s) is caused to distend under the surface of the subject's skirt.

## Claims

### Claim 1

An electrical venous stimulation apparatus, for causing target veins in a subject to distend from under the surface of the subject's skin without the aid of compression, the apparatus comprising:
a power supply;
a signal generator powered by the power supply, the signal generator configured to generate a specified electrical output signal;
at least two electrodes in electrical communication with the signal generator and configured to be placed in electrical communication with the subject; and
at least two electrical leads configured to provide the electrical output signal generated by the signal generator to the at least two electrodes, each of the at least two electrical leads connecting a respective one of the at least two electrodes to the signal generator,
wherein the electrical output signal includes an output voltage, electrical current, and a waveform that changes with time in a preprogrammed repeating cycle, the output voltage, electrical current, and waveform being configured to elicit a physiological response that stimulates a plurality of peripheral nerves in the subject without the aid of compression, activates a venous muscle pump mechanism in one or more limbs of the subject without the aid of compression, and non-invasively alters the physiology of a target vein without the aid of compression, wherein the target vein is caused to distend under the surface of the subject's skin.

### Claim 2 (depends on 1)

The electrical venous stimulation apparatus of claim 1, further comprising at least two containers, wherein the first of the at least two electrodes is physically connected to a first of the at least two containers, and the second of the at least two electrodes is physically connected to a second of the at least two containers.

### Claim 3 (depends on 2)

The electrical venous stimulation apparatus of claim 2, wherein each of the at least two containers includes one or more recessed regions sized and arranged to receive fingers of the subject therein, and configured to hold a liquid electrolyte solution.

### Claim 4 (depends on 3)

The electrical venous stimulation apparatus of claim 3, wherein each of the at least two containers further comprises the liquid electrolyte solution electrically connected to a respective one of the at least two electrodes to deliver the electrical output signal to the subject through the liquid electrolyte solution.

### Claim 5 (depends on 1)

The electrical venous stimulation apparatus of claim 1, wherein the at least two electrodes comprises a pair of conductive electrode pads with an adhesive layer disposed on one side thereof.

### Claim 6 (depends on 5)

The electrical venous stimulation apparatus of claim 5, wherein one electrode pad of the pair of electrode pads is attached to a palmar surface of one hand of the subject, and the other electrode pad of the at least one pair of electrode pads is attached to an arm of the subject.

### Claim 7 (depends on 6)

The electrical venous stimulation apparatus of claim 6, wherein a positive output signal is supplied to the electrode pad attached to the palmar surface of the one hand of the subject, and a negative output signal is supplied to the electrode pad attached to the arm of the subject.

### Claim 8 (depends on 1)

The electrical venous stimulation apparatus of claim 1, further comprising a variable control configured to adjust a magnitude of the output voltage.

### Claim 9 (depends on 8)

The electrical venous stimulation apparatus of claim 8, wherein the magnitude of the output voltage is variable from about 0 to about 40 volts.

### Claim 10 (depends on 1)

The electrical venous stimulation apparatus of claim 1, wherein the subject is a human.

### Claim 11 (depends on 1)

The electrical venous stimulation apparatus of claim 1, wherein the signal generator further comprises:
power switch;
an oscillator including an integrated circuit;
a variable control configured to adjust a magnitude of the output voltage in response to an input; and
output circuitry comprising:
a first stage including at least two operational amplifiers and a capacitor; and
a second stage including a center tap transformer.

### Claim 12

A method of stimulating peripheral target veins in a subject, without the aid of compression, to cause the veins to distend from under a surface of the subject's skin to facilitate venipuncture, the method comprising:
generating an adjustable electrical output signal with an electrical venous stimulation apparatus, the signal including an adjustable output voltage, an adjustable current, and an adjustable output voltage waveform configured to elicit a physiological venous response in the subject that causes the target vein in the subject to distend from under the surface of the subject's skin without the aid of compression, the electrical stimulation apparatus comprising:
(i) a powered signal generator configured to generate the adjustable electrical output signal, and
(ii) at least two electrodes in electrical communication with the signal generator and configured to be placed in electrical communication with the subject;
electrically connecting the at least two electrodes to the subject; and
transmitting the output signal to the subject via the at least two electrodes to elicit the physiological venous response in the subject that causes the target vein in the subject to distend from under the surface of the subject's skin without the aid of compression.

### Claim 13 (depends on 12)

The method of claim 12, further comprising:
monitoring, by an electrical feedback system in the signal generator, the biological electrical feedback from the subject in the form of the subject's biological electrical resistance and capacitance;
comparing, using a microprocessor integrated in the signal generator, the electrical feedback from the subject with the transmitted output signal; and
automatically adjusting subsequent output signals to be sent to the subject based on the comparison between the transmitted output signal and the electrical feedback.

### Claim 14 (depends on 12)

The method of claim 12, wherein the subject is a human.

### Claim 15

A method of suppressing pain signals at a venous needle stick site of a subject, the method comprising:
generating an adjustable electrical output signal with an electrical venous stimulation apparatus, the signal including an adjustable output voltage, an adjustable current, and an adjustable output voltage waveform configured to elicit a physiological venous response in the subject that causes a target vein in the subject to distend from under a surface of the subject's skin without the aid of compression, the electrical stimulation apparatus comprising:
(i) a powered signal generator configured to generate the adjustable electrical output signal, and
(ii) at least two electrodes in electrical communication with the signal generator and configured to be placed in electrical communication with the subject;
electrically connecting the at least two electrodes to the subject; and
transmitting the output signal to the subject via the at least two electrodes to stimulate peripheral nerves of the subject and activate a venous pump mechanism in at least one limb of the subject to thereby suppress pain signals at the venous needle stick site of the patient.

### Claim 16 (depends on 15)

The method of claim 15, wherein the subject is a human.

### Claim 17

A method of accessing a vein of a person, the method comprising:
receiving a portion of a first limb of the person into a first container that is physically connected to a first electrode;
receiving a portion of a second limb of the person into a second container that is physically connected to a second electrode;
supplying a liquid electrolytic solution into the first and second containers, wherein (i) the liquid electrolytic solution of the first container is in contact with the portion of the first limb and is electrically connected to the first electrode, and (ii) the liquid electrolytic solution of the second container is in contact with the portion of the second limb and is electrically connected to the second electrode;
electrically stimulating the portions of the first and second limbs with at least one electrical signal generated by an electrical signal generator, the electrical signal provided to the liquid electrolytic solution of each of the first and second containers by the respective electrodes in contact with the liquid electrolytic solution;
causing at least one vein in at least one limb of the person to distend in response to the electrical stimulation; and
inserting a tip of a needle into the vein while the vein is distended to access the vein.

### Claim 18 (depends on 17)

The method of claim 17, wherein the visibility of the vein is greater after the electrical stimulation than before the electrical stimulation.

### Claim 19 (depends on 18)

The method of claim 18, wherein a height of a skin surface adjacent to the vein is greater after the electrical stimulation than before the electrical stimulation due to the distension of the vein

### Claim 20

A method of accessing a vein of a person, the method comprising:
attaching a first electrode to a hand of the person;
attaching a second electrode to an arm of the person;
electrically stimulating a portion of a limb of the person with at least one signal generated by an electrical signal generator, the electrical signal provided to both the first electrode and the second electrode;
causing at least one vein in the limb of the person to distend in response to the electrical stimulation; and
inserting a tip of a needle into the vein while it is distended to access the vein.

### Claim 21

A kit for OK with a signal generator, the kit comprising:
at least two containers for holding an electrolytic solution;
a pre-filled bottle of Epsom salt;
a bottle of deonized water;
at least two electrodes; and
at least two electrical leads for connecting the electrodes to a signal generator.
