# US 10,441,705 B2 · Medical wetness sensing devices and related systems and methods

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- Number: US 10,441,705 B2
- Document ID: US10441705B2
- Status: Granted
- Kind: B2
- Application number: 15/479,777
- Filed: 2017-04-05
- Published: 2018-10-11
- Granted: 2019-10-15
- Earliest claimed: 2017-04-05
- Assignees: Fresenius Medical Care Holdings, Inc.
- Applicants: Fresenius Medical Care Holdings, Inc.
- Inventors: Colin Weaver; Martin Joseph Crnkovich
- Web page: https://patentgrep.com/patent/US10441705B2

## CPC

- A61M 1/3656: {Monitoring patency or flow at connection sites; Detecting disconnections}
- A61F 13/01: Non-adhesive bandages or dressings
- A61M 1/14: Dialysis systems; Artificial kidneys; Blood oxygenators (semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00){; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis}
- A61M 1/3403: {Regulation parameters}
- A61M 5/16831: {Monitoring, detecting, signalling or eliminating infusion flow anomalies (low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066)}
- G01M 3/16: using electric detection means ({G01M3/045,} G01M3/06, G01M3/12, G01M3/20, G01M3/24, G01M3/26 take precedence)
- A61F 2013/00412: {for use with needles, tubes or catheters}
- A61M 2205/13: with means for the detection of operative contact with patient, e.g. lip sensor
- A61M 2205/15: Detection of leaks
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3561: local, e.g. within room or hospital
- A61M 2205/3592: using telemetric means, e.g. radio or optical transmission
- A61M 2205/50: with microprocessors or computers
- 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)}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- G01M: TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR

## Abstract

A medical wetness sensing device includes a base adapted to be disposed on a wearer of the medical wetness sensing device. The base includes a first electrical conductor and a second electrical conductor electrically insulated from the first electrical conductor. The first electrical conductor includes a hinge portion enabling a first portion of the first electrical conductor to deflect, at the hinge portion, relative to a second portion of the first electrical conductor. The medical wetness sensing device includes a controller electrically connected to the first electrical conductor and the second electrical conductor. The controller is configured to detect a presence or an absence of a medical fluid electrically connecting the first and second electrical conductors.

## Claims

### Claim 1

A medical wetness sensing device, comprising:
a base adapted to be disposed on a wearer of the medical wetness sensing device, wherein the base comprises
a first electrical conductor comprising a hinge portion enabling a first portion of the first electrical conductor to deflect, at the hinge portion, relative to a second portion of the first electrical conductor, and
a second electrical conductor electrically insulated from the first electrical conductor; and
a controller electrically connected to the first electrical conductor and the second electrical conductor, the controller configured to detect a presence or an absence of a medical fluid electrically connecting the first and second electrical conductors.

### Claim 2 (depends on 1)

The medical wetness sensing device of claim 1, wherein the first electrical conductor is interlocked with the second electrical conductor.

### Claim 3 (depends on 1)

The medical wetness sensing device of claim 1, wherein the first electrical conductor includes a plurality of longitudinal segments interconnected by a plurality of lateral segments.

### Claim 4 (depends on 1)

The medical wetness sensing device of claim 1, wherein:
the second electrical conductor comprises a hinge portion enabling a first portion of the second electrical conductor to deflect, at the hinge portion relative to a second portion of the second electrical conductor, and
the hinge portion of the first electrical conductor and the hinge portion of the second electrical conductor are collinear.

### Claim 5 (depends on 1)

The medical wetness sensing device of claim 1, wherein the first and second electrical conductors comprise a rigid polymeric material.

### Claim 6 (depends on 5)

The medical wetness sensing device of claim 5, wherein the rigid polymeric material has an elastic modulus between 0.1 and 5 GPa.

### Claim 7 (depends on 1)

The medical wetness sensing device of claim 1, wherein the hinge portion comprises a living hinge.

### Claim 8 (depends on 1)

The medical wetness sensing device of claim 1, wherein the hinge portion of the first electrical conductor has a thickness at most one-half of a maximum thickness of the first electrical conductor.

### Claim 9 (depends on 1)

The medical wetness sensing device of claim 1, wherein the first electrical conductor is formed from a polymer loaded with conductive materials.

### Claim 10 (depends on 1)

The medical wetness sensing device of claim 1, where the medical wetness sensing device comprises a first half and a second half, the first half and the second half being defined by a longitudinal axis of the medical wetness sensing device,
wherein the first portion of the first electrical conductor extends through the first half and the second half, and
wherein the second portion of the first electrical conductor extends through only the first half.

### Claim 11 (depends on 1)

The medical wetness sensing device of claim 1, wherein the hinge portion is a first hinge portion, and the first electrical conductor further comprises a second hinge portion enabling the second portion of the first electrical conductor to deflect, at the second hinge portion, relative to a third portion of the first electrical conductor.

### Claim 12 (depends on 1)

The medical wetness sensing device of claim 1, wherein:
the first electrical conductor comprises bosses,
the second electrical conductor comprises bosses, and
the medical wetness sensing device comprises a housing coupled to the bosses of the first electrical conductor and the second electrical conductor to separate the first electrical conductor from the second electrical conductor.

### Claim 13 (depends on 1)

The medical wetness sensing device of claim 1, wherein
the first electrical conductor comprises bosses having end portions,
the second electrical conductor comprises bosses having end portions, and
the end portions of the bosses of the first electrical conductor and the end portions of the bosses of the second electrical conductor define a surface of the base to be disposed on the wearer.

### Claim 14 (depends on 1)

The medical wetness sensing device of claim 1, wherein the base comprises a cover covering at least a portion of the first electrical conductor and at least a portion of the second electrical conductor.

### Claim 15 (depends on 14)

The medical wetness sensing device of claim 14, further comprising a housing within which the controller is contained, the housing engaging the cover to form a fluid tight seal that inhibits entry of fluid into an interior of the housing.

### Claim 16 (depends on 14)

The medical wetness sensing device of claim 14, wherein:
the cover defines multiple portions of the first electrical conductor that are exposed on a surface of the base to be disposed on the wearer and multiple portions of the second electrical conductor that are exposed on the surface, and
the controller is configured to detect the presence of the medical fluid when at least one of the multiple portions of the first electrical conductor and at least one of the multiple portions are electrically connected by the medical fluid.

### Claim 17 (depends on 14)

The medical wetness sensing device of claim 14, wherein the cover comprises an elastomeric material.

### Claim 18 (depends on 1)

The medical wetness sensing device of claim 1, further comprising a wireless transmitter.

### Claim 19 (depends on 1)

The medical wetness sensing device of claim 1, wherein the first portion of the first electrical conductor is positioned at a central portion of the medical wetness sensing device, and the second portion of the first electrical conductor extends radially outward from the central portion.

### Claim 20 (depends on 19)

The medical wetness sensing device of claim 19, wherein:
the second electrical conductor comprises a portion overlying the first portion of the first electrical conductor and positioned at the central portion of the medical wetness sensing device, and
the medical wetness sensing device comprises an insulator positioned between the first portion of the first electrical conductor and the portion of the second electrical conductor to electrically insulate the first electrical conductor from the second electrical conductor.

### Claim 21 (depends on 19)

The medical wetness sensing device of claim 19, wherein the first electrical conductor comprises at least three portions extending radially outward from the central portion.

### Claim 22 (depends on 19)

The medical wetness sensing device of claim 19, wherein the first electrical conductor comprises at least four portions extending radially outward from the central portion.

### Claim 23 (depends on 22)

The medical wetness sensing device of claim 22, wherein the second electrical conductor comprises at least four portions extending radially outward from the central portion.

### Claim 24 (depends on 19)

The medical wetness sensing device of claim 19, wherein the central portion contains the controller.

### Claim 25 (depends on 19)

The medical wetness sensing device of claim 19, wherein:
the second electrical conductor comprises a hinge portion enabling a first portion of the second electrical conductor to deflect, at the hinge portion, relative to a second portion of the second electrical conductor, and
the hinge portion of the first electrical conductor is positioned along a first arc of a circle encompassing the central portion, and the hinge portion of the second electrical conductor is positioned along a second arc of the circle.

### Claim 26

A dialysis system, comprising:
a dialysis machine comprising a wireless receiver;
a medical wetness sensing device comprising
a base comprising first and second electrical conductors configured to be electrically connected to one another when a medical fluid is present on a surface of the base to be disposed on a wearer of the medical wetness sensing device, the first electrical conductor comprising a hinge portion to enable a first portion of the first electrical conductor to deflect, at the hinge portion, relative to a second portion of the first electrical conductor, and
a controller to generate a signal indicating a presence or an absence of the medical fluid on the surface; and
a wireless transmitter configured to transmit the signal to the wireless receiver.

### Claim 27 (depends on 26)

The dialysis system of claim 26, wherein the dialysis machine is a hemodialysis machine.

### Claim 28

A method, comprising:
puncturing, using a needle, an access site on skin of a patient to access a corporeal blood circuit of the patient; and
deforming a medical wetness sensing device at a hinge portion of the medical wetness sensing device to place the medical wetness sensing device on a region of the patient surrounding the access site.

### Claim 29 (depends on 28)

The method of claim 28, wherein the hinge portion includes a living hinge.

### Claim 30 (depends on 28)

The method of claim 28, wherein the medical wetness sensing device comprises:
a base adapted to be worn on skin of a wearer of the medical wetness sensing device and adapted to contact medical fluid external to the medical wetness sensing device, wherein the base comprising
a first electrical conductor comprising a hinge portion, the hinge portion enabling a first portion of the first electrical conductor to deflect, at the hinge portion, relative to a second portion of the first electrical conductor;
a second electrical conductor electrically insulated from the first electrical conductor; and
a controller electrically connected to the first electrical conductor and the second electrical conductor, the controller configured to detect a presence or an absence of the medical fluid electrically connecting the first and second electrical conductors.

### Claim 31 (depends on 28)

The method of claim 28, further comprising securing the medical wetness sensing device to the skin with cloth wrapped around an arm of the patient.

### Claim 32 (depends on 28)

The method of claim 28, further comprising initiating a hemodialysis treatment using a dialysis machine configured to receive a signal from the medical wetness sensing device, the signal indicating an absence or presence of a medical fluid on an inner surface of the medical wetness sensing device.
