(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)

(19) World Intellectual Property

Organization
International Bureau
(10) International Publication Number
(43) International Publication Date
16 January 2014 (16.01.2014)
WO 2014/011159 Al
PO PCT

(51) International Patent Classification: (74) Agents: KUKKONEN, Carl, A., Ill et al; Mintz Levin
A61B 5/1455 (2006.01) A61B 5/0424 (2006.01) Cohn Ferris Glovsky and Popeo, P.C., One Financial Cen
ter, Boston, MA 021 11 (US).
(21) International Application Number:
PCT/US20 12/046094 (81) Designated States (unless otherwise indicated, for every
kind of national protection available): AE, AG, AL, AM,
(22) International Filing Date:
AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ,
10 July 2012 (10.07.2012)
CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO,
(25) Filing Language: English DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN,
HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR,
(26) Publication Language: English KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME,
(71) Applicant (for all designated States except US): DRAE- MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ,
GER MEDICAL SYSTEMS, INC. [US/US]; 6 Tech OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC, SD,
Drive, Andover, MA 01810 (US). SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR,
TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
(72) Inventor; and
(75) Inventor/Applicant (for US only): EL-GHOUCH, Moha¬ (84) Designated States (unless otherwise indicated, for every
mad, M. [US/US]; 3 Pine Grove Avenue, Nashua, NH kind of regional protection available): ARIPO (BW, GH,
(US). GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ,

[Continued on next page]

(54) Title: MEDICAL SENSORS WITH PLACEMENT SENSING TECHNOLOGY

(57) Abstract: A sensing system is described that can detect incorrect
placement, or placement disruption, of a medical or physiological
400 sensor relative to a patient, such as the patient's skin. In addition, the
sensing systems may include a control unit that can modify at least one
operational parameter upon detection of improper placement of one or
14 more medical or physiological sensors. Related systems, apparatus,
methods and articles are also described.

12 11

12
r
14

FIG. 7
 wo 2014/011159 Ai III III II II III III III II III II II II I I I III II I II
UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, Published:
TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK,
— with international search report (Art. 21(3))
EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU,
LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK,
SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ,
GW, ML, MR, NE, SN, TD, TG).
 MEDICAL SENSORS WITH PLACEMENT SENSING TECHNOLOGY

FIELD

[0001] The current subject matter is directed to medical sensors such as physiological

sensors that incorporate placement sensing technology to ensure that such sensors are

properly placed / adhered in relation to a patient.

BACKGROUND

[0002] Some medical sensors, or physiological sensors, can provide a number of benefits

to both patients and medical staff. Examples of medical sensors include electrocardiography

(ECG) electrode sensors and pulse oximeter sensors. One reason medical sensors can be

beneficial is due to their ability to provide continuous analysis and information of vital

physiological conditions, such as heart rate, hydration, etc. However, for some medical

sensors to be beneficial they must be correctly placed relative to the patient in order to work

properly. For instance, some medical sensors, such as ECG electrodes, must be in direct

contact with the patient's skin in order to attain accurate physiological readings.

[0003] Incorrect placement of some medical sensors may be unknown to either the

patient or medical staff due to the sensor continuing to provide sensed data as if it were

correctly placed, such as from sensing surrounding ambient light or noise. In this situation,

physiological issues may arise in the patient while the sensor continues to provide sensed

data that does not indicate any physiological issues with the patient. In another scenario, a
medical sensor may become incorrectly placed relative to a patient, such as due to movement

by the patient, which disrupts the attachment of one or more sensors resulting in sensed data

indicating the patient is experiencing physiological problems. In this situation, an alarm may

even be sounded and may cause medical staff to become unnecessarily alarmed about one or

more physiological problems associated with the incorrectly placed sensor readings. It is

also possible that medical staff may treat the patient, such as with medicaments, in response

to the incorrectly placed sensor. Under these circumstances, the patient may be placed at risk

due to unnecessary treatment and medical staff efforts may be unnecessarily wasted on false

sensor readings. Furthermore, issues resulting from incorrect placement of a sensor may

arise in many other sensor applications outside of medical devices. Therefore, there is a need

for sensors, such as medical sensors, to include one or more features which alert either the

patient or medical staff of incorrectly placed sensors.

SUMMARY

[0004] In one aspect, a sensing system is disclosed that includes at least one or more

physiological sensors to sense one or more physiological attributes of the patient. In

addition, one or more placement sensors may be coupled to or adjacent to at least one

physiological sensor. The sensing system may further include a control unit coupled to one

or more physiological sensors and one or more placement sensors. The control unit may

cause at least one operational parameter of the sensing system to be modified when data

received by at least one placement sensor is outside a predetermined data range indicating

that at least one physiological sensor is at least partially incorrectly placed relative to the

patient.
[0005] Some methods for modifying one or more operational parameters of a sensing

system include receiving, by a control unit of the sensing system, data from either one or

more physiological sensors of the sensing system that are configured to be placed in relative

to a patient, such as in contact with the patient's skin, in order to sense one or more

physiological attributes of the patient. The method may further include receiving, by a

control unit, data from one or more placement sensors of the sensing system, coupled to or

adjacent to at least one physiological sensor. Furthermore, the method for modifying one or

more operational parameters of the sensing system may include modifying, by the control

unit, at least one operational parameter of the sensing system when data sent to the control

unit by at least one placement sensor is outside a predetermined data range that indicates that

the at least one placement sensor and coinciding physiological sensor, is incorrectly placed

relative to the skin.

[0006] Computer program products are described that comprise non-transitory machine-

readable media storing instructions, which when executed, cause one or more data processors

across one or more systems to perform the operations described herein. Similarly, computer

systems are also described that may include a processor and a memory coupled to the

processor. The memory may include one or more programs that cause the processor to

perform one or more of the operations described herein. Methods may be implemented by

one or more data processors across one or more computing systems.

[0007] Placement sensors (i.e., proximity, temperature, skin touch sensors) can detect of
at least one of when the physiological sensor is in proper placement and when the

physiological sensor is not correctly placed for proper functioning. By combining one or
more placement sensors with physiological sensors into a single sensing system the

placement sensors may provide useful information regarding whether the physiological

sensors are properly positioned in order to ensure accurate physiological data is being

gathered from the sensors. The ability of the sensing system to detect placement of one or

more physical sensors can improve patient care, as well as save cost and time by allowing a

user to more efficiently fix any problems associated with an incorrectly placed physiological

sensor.

[0008] The details of one or more sensing systems and methods are set forth in the

accompanying drawings and the description below. Other features and advantages will be

apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] These and other aspects will now be described in detail with reference to the

following drawings.

[0010] FIG. 1 illustrates a sensing system comprising a physiological sensor and at least

one placement sensor.

[0011] FIG. 2 shows a cross section view of the sensing system of FIG. 1 taken along

line 2-2 of FIG. 1.

[0012] FIG. 3 illustrates a sensing system including wireless communication.

[0013] FIG. 4 illustrates a sensing system including a physiological sensor having a

generally disc shape with more than one placement sensor functionally coupled to a

perimeter of the physiological sensor.

[0014] FIG. 5 illustrates a sensing system including a placement sensor generally

centrally located relative to a contact area of the physiological sensor.

[0015] FIG. 6 shows a cross section view of the sensing system of FIG. 5 taken along

line 6-6 of FIG. 5 .

[0016] FIG. 7 illustrates another sensing system comprising more than one placement

sensor functionally coupled to a physiological sensor where both sensors do not require

direct contact with a patient's skin.

[0017] Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

[0018] This document describes systems, methods, and articles that may improve patient

monitoring by integrating one or more skin touching or proximity technologies with one or

more medical sensor in order to prevent false readings from medical sensors, such as from

incorrect placement of medical sensors relative to a patient. Additionally, this document

describes systems, methods, and articles for modifying at least one operational parameter of

the system upon detection of incorrect placement, or placement disruption, of one or more

medical sensors, as will be described in greater detail below.

[0019] Some medical sensors, such as pulse oximeters or electrocardiography (ECG)

electrodes use sensing technology to detect various physiological conditions of a patient. For

example, ECG electrodes may use sensing technology to detect the electrical activity of a

patient's heart over a period of time by detecting and amplifying electrical charges on the

patient's skin resulting from a beating heart. This may be accomplished by attaching at least

one ECG sensor to the outer skin of the patient. Also, pulse oximeters may monitor the

oxygenation of a patient's hemoglobin by placing a sensor on or near the patient's skin in

order to pass light with varying wavelengths through the patient to a photodetector. The

change in absorbance of light through the patient may enable the pulse oximeters to monitor

the oxygenation of blood in the patient.

[0020] Positioning of both the ECG electrodes and pulse oximeters relative to the patient
is important for proper functioning and gathering of accurate physiological readings. For

instance, in order for the ECG electrodes to work properly and obtain accurate physiological

data the ECG electrodes must be in contact with a patient's skin. In the event one or more

ECG electrodes were disrupted, such as no longer in contact with the patient's skin, accurate

heart activity readings would no longer be attainable by the ECG electrodes. Similarly,

contact with a patient's skin is necessary for some pulse oximeters to obtain accurate

physiological readings from a patient. Some pulse oximeters may function properly without

direct skin contact but may require positioning within a generally defined proximity relative

to the patient. Therefore, both proximity and skin touch sensors may be functionally

integrated with one or more physiological sensors, such as pulse oximeters and ECG sensors,

for assisting in determining the placement of the physiological sensors. Proximity and skin
touch sensors may detect at least one of when the physiological sensor is in proper placement

and when the physiological sensor is not correctly placed for proper functioning. By

combining either proximity or skin touch sensors with physiological sensors into a single

sensing system the proximity or touch sensors may provide useful information regarding

whether the physiological sensors are properly positioned in order to ensure accurate

physiological data is being gathered from the sensors.

[0021] Skin touch and proximity sensing technologies may be found in various devices

and applications. For instance, skin touch sensing technologies may be found in touch

screen cell phones for activating and interacting with the cell phone. Some skin touch

technologies include capacitive sensors which may work by detecting anything that is

conductive or has a dielectric different than air. Proximity sensing technologies may be

found in, for example, some car bumpers which may be used to detect the proximity of

adjacent cars and objects. In general, a proximity sensor may be able to detect the presence

of one or more target objects within a generally predefined distance range without any

physical contact. Some proximity sensors may emit an electromagnetic field,

electromagnetic beam, or electromagnetic radiation in a general direction of the target object

in order to detect changes in a return signal. Furthermore, proximity sensors may differ

depending on the target object. For instance, a capacitive sensor may be more suitable when

the target object is comprised of at least part of a human body. By way of further example,

an inductive proximity sensor may be more suitable when the target object is comprised of

metal. However, any variety of skin touch and proximity sensing technologies may be used

in any of the sensing systems disclosed herein without departing from the scope of this
disclosure. For instance, another example of proximity and skin touch sensing technologies

can include temperature sensing technology that can detect one or more surface or

surrounding temperatures.

[0022] FIGS. 1 and 2 illustrate a sensing system 10 which includes at least one placement

sensor 12 functionally coupled or adjacent to a physiological sensor 14. The sensing system

10 may also include a control unit 16. The control unit 16 may include software and

hardware, such as a processor 18, which may collect and analyze data provided by one or

more placement sensors 12 and physiological sensors 14. In addition, the control unit 16

may function to monitor data received by at least one of the placement sensors 12 and change

at least one operational parameter of the sensing system 10 when data being received by a

placement sensor 12 is outside of a predetermined data range. Data received by a placement

sensor 12 may include values or signals upon which the control unit 16 may analyze against a

predetermined data range, such as a value range or signal range. In addition, the control unit

16 may include an alarm 20 which may be activated by the control unit 16 upon receiving

data outside of a predetermined data range by one or more placement sensors 12.

[0023] Placement sensors 12 may function to provide data to the control unit 16 relating

to the positioning of one or more physiological sensors 14 relative to the patient, such as the

patient's skin 11. Any one placement sensor 12 may include a skin touch sensor for sensing

contact between a physiological sensor 14 and the patient's skin 11. Alternatively or in

combination, any one placement sensor 12 may include a proximity sensor for sensing the

placement of the physiological sensor 14 relative to the patient, such as the patient's skin 11.

Furthermore, one or more temperature sensors may be used in addition to or in place of one
or more placement sensors 12 of the sensing system 10. For example, a temperature sensor

may detect one or more of a surface, e.g., the patient's skin, or surrounding temperature. In

addition, the control unit 16 can receive the temperature readings from the temperature

sensors for processing and analysis. By way of further example, the control unit 16 can be

programmed to have a predetermined temperature range of at or near body temperature

which may generally define a temperature range indicating that one or more physiological

sensors 16 are correctly placed relative to the patient. A predetermined temperature range,

such as at or near body temperature, can be programmed in the sensing system 10 such that

when the control unit 16 receives a temperature reading outside of the predetermined

temperature range, the control unit can modify at least one operational parameter of the

sensing system 10.

[0024] A number of factors may be considered when determining the appropriate number
of placement sensors 12 (i.e., inductive proximity sensors, capacitive proximity sensors, skin

touch sensors, temperature sensors, etc.) to have functionally coupled or adjacent to a

physiological sensor 14 including the type of physiological sensor 14, the size and shape of

the physiological sensor 14, the material comprising the physiological sensor 14, and the

sensitivity of the physiological sensor 14. Therefore, any number of placement sensors 12

may be functionally coupled or adjacent to one or more physiological sensors 14 without

departing from the scope of this disclosure.

[0025] FIG. 2 shows more than one placement sensor 12 functionally coupled to a

physiological sensor 14 and in contact with the skin 11 of a patient. As shown in this

configuration, the placement sensors 12 allow a contact area 22 of the physiological sensor
14 to contact the skin 11 of the patient. For example, in the event the contact area 22 of the

physiological sensor 14 were to lose contact with the skin 11 of the patient, at least one of the

placement sensors 12 may sense the loss in contact. The control unit 16 may then be able to

detect a change in data readings by one or more placement sensors 12 detecting a loss in

contact between the contact area 22 and skin 11. Once the control unit 16 detects a change in

data readings indicating a loss in contact, the control unit 16 may modify at least one

operational parameter of the sensing system 10, such as activating the alarm 20. For

example, the alarm 20 may alert the patient and medical staff and allow at least the medical

staff to attend to the patient in order to ensure the physiological sensors 14 are properly

placed. This may ensure that accurate data is being received by the physiological sensors 14

which may allow improved patient monitoring and treatment of one or more physiological

attributes of a patient.

[0026] In addition or alternatively, some operational parameters that may be modified by

the sensing system 10 upon detection of an improperly placed physiological sensor 14

include one or more visual cues, such as one or more lights, which may change in either

brightness or color. The ability of the sensing system 10 to either audibly alert or visually cue

medical staff relating to the placement of one or more physiological sensors 14 saves time

and money by reducing wasted time treating a patient, or not treating a patient, based on

incorrect data being received by improperly placed physiological sensors 14. Furthermore,

the sensing system 10 may include one or more monitors 30 for displaying, for example, one

more data or representations relating to one or more physiological attributes or placement

conditions of one or more placement sensors 12 or physiological sensors 14.

[0027] In addition, any one of the placement sensors 1 may be either in direct or

wireless communication with the control unit 16. For example, FIG. 3 illustrates a sensing

system 100 including wireless communication between the placement sensors 12 and control

unit 16. The sensing system 100 may further include a wireless transmitter 28 for

transmitting wireless data characterizing the sensed physiological attributes to a remote data

collection system 26. Furthermore, the wireless transmission may be deactivated when the at

least one operational parameter of the sensing system is modified. FIG. 1 illustrates an

example of direct communication between the placement sensors 12, physiological sensor 14

and the control unit 16. Any one of the physiological sensors 14 or placement sensors 12

may be in direct or indirect communication with the control unit 16.

[0028] The control unit 16 may be programmed such that when any one of the placement
sensors 12 reads data outside of a predetermined data range, at least one of the operational

parameters of the sensing system 10 is modified. For example, the control unit 16 may

activate an alarm 20 when data acquired by at least one of the placement sensors 12 is

outside of a predetermined data range. Additionally, the control unit 16 may be able to

indicate to a user which placement sensor 12 is reading data outside of a predetermined

range. This may be particularly beneficial when the sensing system includes more than one

placement sensor 12. The ability of the control unit 16 to indicate which placement sensor

12 is reading data outside of a predetermined data range may save cost and time by allowing

a user to more efficiently fix any problems associated with an incorrectly placed

physiological sensor 14.

[0029] In addition, the control unit 16 may be programmed to disrupt the power source to

any power consuming source in the sensing system 10 anytime after the control unit 16

receives placement sensor 1 data which is outside of a predetermined data range. This may

benefit the sensing system 10 by saving power, such as battery power, that would otherwise

be wasted on sensing of incorrect data. Any number of sensing system 10 operational

parameters may be modified in response to the control unit 16 receiving placement sensor 12

data outside of a predetermined data range without departing from the scope of this

disclosure. As shown by way of example in FIG. 3, a self contained power source 24 may be

in direct communication with either the placement sensor 12 or physiological sensor 14. The

power source 24 may form a compact unit with the placement sensor 12 and physiological

sensor 14, as shown in FIG. 3 .

[ 0030 ] The placement and coupling of one or more placement sensors 12 relative to any

one of the physiological sensors 14 may vary and may depend on, for example, allowing at

least one of the physiological sensors 14 or placement sensors 12 to work most effectively.

For instance, some physiological sensors 14 may include a contact area 22 which is

configured to contact the skin 11 of a patient and allow the physiological sensor 14 to gather

physiological data. However, the contact area 22 may be comprised of a material which may

impede the ability of the placement sensor 12 to effectively sense physiological sensor 14

positioning relative to the patient's skin 11. In this instance, it may be beneficial to ensure

placement of the placement sensor 12 is not in direct contact with the contact area 22 of the

physiological sensor 14. However, any number of configurations between one or more
placement sensors 1 and physiological sensors 14 may be constructed without departing

from the scope of this disclosure.

[0031] FIGS. 1-6 illustrate example sensing systems having various placement sensor 12

configurations. In particular, FIG. 1 shows a physiological sensor 14 functionally coupled to

two placement sensors 12, with a placement sensor 12 positioned on opposite sides of the

physiological sensor 14. By way of further example, FIG. 3 shows a physiological sensor 14

functionally coupled to four placement sensors 12, with a placement sensor 12 positioned on

each side of the physiological sensor 14. These configurations may be beneficial, for

example, if the physiological sensor 14 is flexible such that it may peel away from the skin

11 along one or more sides. In the configurations shown in FIGS. 1 and 3, at least one

placement sensor 12 may be able to detect partial detachment, such as due to peeling, of the

physiological sensor 14 from the skin 11 of the patient. In addition, and particularly if one of

the placement sensors 12 is a proximity sensor, the sensor system 10 may detect at least

partial misalignment or positioning outside of a predetermined distance range of the

physiological sensor 14 relative to the target object. A target object can, for example, be at

least one of a plastic object, a metal object, or at least part of a patient's skin 11. However,

any target object may be comprised of any number of materials without departing from the

scope of this disclosure.

[ 0032 ] FIG. 4 illustrates another sensing system 200 comprising a physiological sensor
14 having a generally disc shape with more than one placement sensor 12 coupled to the

perimeter of the physiological sensor 14. Similar to the sensing systems 10 and 100

discussed in FIGS. 1 and 3, the placement of the placement sensors 12 relative to the
physiological sensor 14 may allow the control unit 16 to detect partial detachment or partial

incorrect placement of the physiological sensor 14. Any number of placement sensors 12

may be functionally coupled in any number of configurations to a physiological sensor 14

without departing from the scope of this disclosure.

[0033] FIGS. 5 and 6 illustrate another sensing system 300 comprising a placement

sensor 12 generally centrally located relative to the contact area 22 of the physiological

sensor 14. This configuration may allow a single placement sensor 12 to ensure at least

partial contact between the contact area 22 of a physiological sensor 14 and the patient, such

as the skin 11. Additionally, this configuration may allow the placement sensor 12 and

physiological sensor 14 to form a more compact unit. Alternatively or in addition, this

configuration may allow a single placement sensor 12, such as a proximity sensor, to detect

at least partial misalignment or positioning outside of a predetermined distance range of the

physiological sensor 14 relative to the patient.

[ 003 ] FIG. 7 illustrates another sensing system 400 comprising more than one
placement sensor 12 functionally coupled to a physiological sensor 14. For example, the

physiological sensor 14 shown in FIG. 7 can include a physiological sensor that does not

require direct contact with a patient's skin, such as a pulse oximeter. Therefore, the more

than one placement sensors 12 shown in FIG. 7 can be proximity sensors that can sense the

placement of the physiological sensor 14 relative to a target object, such as a patient's skin

11. For example, a proximity sensor can detect the presence of one or more target objects

within a generally predefined distance range without any physical contact. Therefore, if the

presence of one or more target objects, such as the patient's skin 11, is not detected within a
predefined distance range relative to the physiological sensor 14 at least one of the placement

sensors 12 can sense improper placement of the target object. The control unit 16 may then

be able to detect data readings by one or more placement sensors 12 detecting the improperly

placed target object relative to the physiological sensor 14. Once the control unit 16 detects

data readings indicating the target object placed outside of a predetermined distance range

relative to the physiological sensor 14, the control unit 16 may modify at least one

operational parameter of the sensing system 10, such as activating the alarm 20. For

example, the alarm 20 may alert the patient and medical staff and allow at least the medical

staff to attend to the patient in order to ensure the target object is properly placed relative to

the physiological sensor 14.

[0035] The number and placement of the placement sensors 12 relative to the

physiological sensors 14 are not limited to the example sensing systems 10, 100, 200, 300

and 400 disclosed herein. Any number of configurations may be formed between one or

more placement sensors 12 with one or more physiological sensors 14, including having the

placement sensor 12 functionally coupled or adjacent to a top side of the physiological sensor

14, without departing from the scope of the provided disclosure.

[0036] Aspects of the subject matter described herein may be embodied in systems,
apparatus, methods, and/or articles depending on the desired configuration. In particular,

aspects of the subject matter described herein may be realized in digital electronic circuitry,

integrated circuitry, specially designed ASICs (application specific integrated circuits),

computer hardware, firmware, software, and/or combinations thereof. These various

implementations may include implementation in one or more computer programs that are
executable and/or interpretable on a programmable system including at least one

programmable processor, which may be special or general purpose, coupled to receive data

and instructions from, and to transmit data and instructions to, a storage system, at least one

input device, and at least one output device.

[ 0037 ] These computer programs (also known as programs, software, software

applications, applications, components, or code) include machine instructions for a

programmable processor, and may be implemented in a high-level procedural and/or object-

oriented programming language, and/or in assembly/machine language. As used herein, the

term "machine-readable medium" refers to any computer program product, apparatus and/or

device (e.g., magnetic discs, optical disks, memory, Programmable Logic Devices (PLDs))

used to provide machine instructions and/or data to a programmable processor, including a

machine-readable medium that receives machine instructions as a machine-readable signal.

The term "machine-readable signal" refers to any signal used to provide machine instructions

and/or data to a programmable processor.

[ 0038 ] The implementations set forth in the foregoing description do not represent all

implementations consistent with the subject matter described herein. Instead, they are merely

some examples consistent with aspects related to the described subject matter. Wherever

possible, the same reference numbers will be used throughout the drawings to refer to the

same or like parts. Although a few variations have been described in detail above, other

modifications or additions are possible. In particular, further features and/or variations may

be provided in addition to those set forth herein. For example, the implementations described

above may be directed to various combinations and subcombinations of the disclosed

features and/or combinations and subcombinations of several further features disclosed

above. In addition, the logic flows described herein do not require the particular order

shown, or sequential order, to achieve desirable results. Other embodiments may be within

the scope of one or more claims.

[0039] Although a few sensing systems have been described in detail above, other
modifications are possible. Other sensing systems may be within the scope of the following

claims.
 CLAIMS

What is claimed is:

1. A sensing system comprising:

one or more physiological sensors to sense one or more physiological

attributes of a patient;

one or more placement sensors coupled to or adjacent to at least one

physiological sensor; and

a control unit coupled to the one or more physiological sensors and the

one or more placement sensors that causes at least one operational parameter of the sensing

system to be modified when data received by at least one placement sensor is outside a

predetermined data range that indicates the at least one physiological sensor is at least

partially incorrectly placed relative to the patient.

2. The sensing system of claim 1, wherein the at least one placement

sensor includes one or more of a temperature sensor, a skin touch sensor configured to be

placed in contact with skin of the patient, or a proximity sensor configured to be placed

within a predetermined distance range relative to a target object.

3. The sensing system of claim 2, wherein the skin touch sensor

comprises a capacitive sensor measuring capacitance.

4. The sensing system of claim 2, wherein the proximity sensor includes

one of an inductive proximity sensor or a capacitive proximity sensor.

5. The sensing system of claim 2, wherein the target object includes at

least one of a plastic, metal, or at least part of a human body.

 6. The sensing system of any of the preceding claims, wherein modifying

at least one operational parameter comprises: turning off one or more power sources in the

sensing system.

7. The sensing system of any of the preceding claims, further comprising

a self-contained power source.

8. The sensing system of any of the preceding claims, further comprising

a wireless transmitter for transmitting wireless data characterizing the sensed physiological

attributes to a remote data collection system, and wherein wireless transmission is

deactivated when the at least one operational parameter is modified.

9. The sensing system of any of the preceding claims, wherein at least

one physiological sensor is a pulse oximeter sensor.

10. The sensing system of any of the preceding claims, wherein at least

one physiological sensor is an ECG electrode sensor.

11. The sensing system of any of the preceding claims, further comprising

a notification element that provides a visual cue indicating whether data sent to the control

unit by one or more placement sensors indicates that the placement sensors are correctly

placed relative to the patient.

12. The sensing system of any of the preceding claims, further comprising

a monitor for displaying one or more data or representations relating to data sent to the

control unit.

13. The sensing system of any of the preceding claims, further comprising

a notification element that provides an audible alarm indicating whether data sent to the
control unit by one or more placement sensors is outside a predetermined data range that

indicates that the placement sensors are incorrectly placed relative to the patient.

14. A method for modifying one or more operational parameters of a

sensing system comprising:

receiving, by a control unit of the sensing system, data from one or more

physiological sensors of the sensing system that are configured to be placed in contact with

skin of a patient to sense one or more physiological attributes of the patient;

receiving, by a control unit, data from one or more placement sensors of the

sensing system, coupled to or adjacent to at least one physiological sensor; and

modifying, by the control unit, at least one operational parameter of the

sensing system when data sent to the control unit by at least one placement sensors is outside

a predetermined data range that indicates that the at least one placement sensor is incorrectly

placed relative to the skin.

15. The method of claim 14, further comprising at least one placement

sensor comprising one or more of a temperature sensor, a skin touch sensor configured to be

placed in contact with skin of the patient, or a proximity sensor configured to be placed

within a predetermined distance range relative to a target object.

16. The method of claims 14 or 15, further comprising a sensing system

wherein the skin touch sensor comprises a capacitive sensor measuring capacitance.

17. The method of any of claims 14 through 16, further comprising a

sensing system wherein the proximity sensor includes one of an inductive proximity sensor

or a capacitive proximity sensor.

 18. The method of any of claims 14 through 17, further comprising

activating an audible alarm indicating whether data sent to the control unit by one or more

placement sensors is outside a predetermined data range indicating that the placement sensors

are incorrectly placed relative to the patient.

19. The method of any of claims 14 through 18, further comprising

modifying the at least one operational parameter of the sensing system including providing a

visual cue indicating whether data sent to the control unit by one or more placement sensors

indicates that the placement sensors are correctly placed relative to the patient.

20. The method of any of claims 14 through 19, further comprising

modifying the at least one operational parameter of the sensing system including displaying

one more data or representations relating to data sent to the control unit on a monitor.

2 1. The method of any of claims 14 through 20 further comprising

modifying the at least one operational parameter of the sensing system including turning off

one or more power sources in the sensing system.

22. The method of any of claims 14 through 2 1, further comprising a self-

contained power source.

23. The method of any of claims 14 through 22, further comprising at least

one physiological sensor including a pulse oximeter sensor.

24. The method of any of claims 14 through 23, further comprising at least

one physiological sensor including an ECG electrode sensor.

 25. The method of any of claims 14 through 24, further comprising

modifying the at least one operational parameter of the sensing system including deactivating

wireless transmission of wireless data characterizing sensed physiological attributes from a

wireless transmitter to a remote data collection system.

A . CLASSIFICATION OF SUBJECT MATTER
INV. A61B5/1455 A61B5/0424
ADD.

According to International Patent Classification (IPC) or to both national classification and IPC

B. FIELDS SEARCHED
Minimum documentation searched (classification system followed by classification symbols)
A61B

Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched

Electronic data base consulted during the international search (name of data base and, where practicable, search terms used)

EPO-Internal , WPI Data

C. DOCUMENTS CONSIDERED TO BE RELEVANT

Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No.

US 2009/163787 A l (MANNHEIMER PAUL D [US] 1-25

ET AL) 25 June 2009 (2009-06-25)
paragraphs [0012] - [0071]; figures 2a-2c,
3a-3c, 4,7a,7b,8,9a-9b,10,ll

US 2010/076282 A l (SANDM0RE DONALD [US]) I -9 ,

25 March 2010 (2010-03-25) II- 25
paragraphs [0027] - [0045]; figures
6a, 6b, 7 ,8 ,3 ,4

D E 20 2008 014621 U l (PAPASTEFAN0U 1,2,5,

GE0RGI0S [DE]) 19 March 2009 (2009-03-19) 10,14,24
paragraph [0001] - paragraph [0004] ;
figure 1

□ Further documents are listed in the continuation of Box C. See patent family annex.

* Special categories of cited documents :

"A" document defining the general state of the art which is not considered
to be of particular relevance
"E" earlier application or patent but published on or after the international
filing date
"L" documentwhich may throw doubts on priority claim(s) orwhich is
cited to establish the publication date of another citation or other
special reason (as specified)
"O" document referring to an oral disclosure, use, exhibition or other
means
"P" document published prior to the international filing date but later than
the priority date claimed
"T" later document published after the international filing date or priority
date and not in conflict with the application but cited to understand
the principle or theory underlying the invention
"X" document of particular relevance; the claimed invention cannot be
considered novel or cannot be considered to involve an inventive
step when the document is taken alone
"Y" document of particular relevance; the claimed invention cannot be
considered to involve an inventive step when the document is
combined with one or more other such documents, such combination
being obvious to a person skilled in the art
"&" document member of the same patent family

Date of the actual completion of the international search Date of mailing of the international search report

14 December 2012 21/12/2012

Name and mailing address of the ISA/ Authorized officer

European Patent Office, P.B. 5818 Patentlaan 2
NL - 2280 HV Rijswijk
Tel. (+31-70) 340-2040,
Fax: (+31-70) 340-3016 De la Hera, German
 Patent document Publication Patent family Publication
cited in search report date member(s) date

US 2009163787 Al 25-06-2009 NONE

US 2010076282 Al 25-03-2010 NONE

D E 202008014621 U l 19-03-2009 NONE