U.S. patent application number 16/572870 was filed with the patent office on 2020-05-07 for system and method for medical device identifier.
This patent application is currently assigned to RESMED INC.. The applicant listed for this patent is RESMED INC.. Invention is credited to Elliot Murray, Timothy SEMEN.
Application Number | 20200143915 16/572870 |
Document ID | / |
Family ID | 50434318 |
Filed Date | 2020-05-07 |
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United States Patent
Application |
20200143915 |
Kind Code |
A1 |
SEMEN; Timothy ; et
al. |
May 7, 2020 |
SYSTEM AND METHOD FOR MEDICAL DEVICE IDENTIFIER
Abstract
A method and system assists in management of data associated
with a home medical equipment (HME) device provided to a patient.
An HME identifier may be received by a physician terminal or an HME
provider terminal. In an example, an HME identifier may be stored,
encoded, engraved or otherwise applied to a component of an HME
device such as a removable storage medium (e.g., an SD card). A
records management system may then be searched for a patient record
associated with the HME device identifier based on retrieval of the
identifier from the component. If a patient record is found, the
identity of the patient may be verified. Optionally, if no such
patient record is found, then a new patient record associated with
the HME identifier may be created.
Inventors: |
SEMEN; Timothy;
(Wollstonecraft, AU) ; Murray; Elliot; (Surry
Hills, AU) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
RESMED INC. |
San Diego |
CA |
US |
|
|
Assignee: |
RESMED INC.
San Diego
CA
|
Family ID: |
50434318 |
Appl. No.: |
16/572870 |
Filed: |
September 17, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14432825 |
Apr 1, 2015 |
10460835 |
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PCT/AU2013/001124 |
Oct 1, 2013 |
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16572870 |
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61708437 |
Oct 1, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
G06F 16/245 20190101;
G06F 21/44 20130101; G06Q 50/24 20130101; G16H 10/60 20180101; G06F
21/6245 20130101; G06Q 10/087 20130101 |
International
Class: |
G16H 10/60 20060101
G16H010/60; G06F 16/245 20060101 G06F016/245; G06Q 10/08 20060101
G06Q010/08; G06F 21/62 20060101 G06F021/62; G06F 21/44 20060101
G06F021/44 |
Claims
1. A method for managing data associated with a home medical
equipment (HME) device provided to a patient, the method
comprising: receiving an HME device identifier associated with the
device; searching, by a processor, a records management system for
a patient record that is associated with the HME device identifier,
the search being performed by using a search key based on the HME
device identifier; if such a patient record is found, facilitating
a verification of identity of the patient; and granting a
permission to a user of the records management system to view or
modify the patient record, if the identity of the patient is
positively verified.
2. The method of claim 1, wherein the HME device identifier
associated with the HME device is received from a removable storage
medium.
3. The method of claim 2, wherein the HME device identifier is
engraved or encoded on an external surface of the removable storage
medium.
4. The method of claim 1, further including, before granting a
permission to the user to view or edit the patient record,
automatically associating the patient's record with an entity
providing the HME device identifier by receiving at least one of:
(i) a first item of information related to a physician associated
with the patient and (ii) a second item of information related to
an HME Provider associated with the patient.
5. The method of claim 4, wherein the first item of information
includes at least one of a physician identifier, a physician name,
a physician address, a physician organization name and a physician
organization address.
6. The method of claim 4, wherein the second item of information
includes at least one of an HME provider identifier, an HME
provider's name, and an HME provider organization address.
7. The method of claim 4, wherein the second item of information
includes an HME provider's inventory number for the HME device.
8. The method of claim 2, wherein the records management system is
accessed from a terminal associated with a physician or an HME
provider.
9. A method for managing data associated with a home medical
equipment (HME) device provided to a patient, the method
comprising: receiving, at a computer based record management
system, a request for a patient record associated with an HME
device identifier, the request being based on the HME device
identifier, the request being initiated by a user; identifying a
patient record associated with the HME device identifier;
receiving, at the record management system, a confirmation of
identity of the patient; and granting to the user at least one of a
permission to access the patient record and a permission to modify
the patient record, upon receiving a confirmation of the identity
of the user.
10. The method of claim 9, wherein the user is one of a physician
and HME provider.
11. The method of claim 9, further comprising storing an item of
information associated with the user into the patient record when
the user is granted permission to modify the patient record.
12. The method of claim 11, wherein the item of information
associated with the user is one of physician name, HME provider
name, physician address, HME provider address, physician's
organization name, physician's organization address, HME
organization's name and HME organization's address.
13. A system for managing data associated with a home medical
equipment (HME) device provided to a patient, the system
comprising: a memory; a reader device configured to accept a
removable storage medium including an HME device identifier, the
HME device identifier being a unique identifier to distinguish the
HME device provided to the patient from other HME devices
registered at a computer based records management system; and a
processor coupled to the memory and the reader device, the
processor being configured to: retrieve, using the reader device,
the HME device identifier that is stored on the removable storage
medium; search a records management system for a patient record
that is associated with the HME device identifier, the search being
performed by using a search key based on the HME device identifier;
facilitate a verification of an identity of the patient upon
locating a patient record that is associated with the HME device
identifier; and modify the patient record only when the identity of
the patient is positively verified.
14. The system of claim 13 wherein, the processor is further
configured to, before granting a permission to an entity providing
the HME device identifier to view and/or edit the patient record,
automatically associate the patient's record with the entity by
receiving at least one of: (i) a first item of information related
to a physician associated with the patient and (ii) a second item
of information related to an HME Provider associated with the
patient.
15. The system of claim 14, wherein the first item of information
includes at least one of a physician identifier, a physician name,
a physician address, a physician organization name, and a physician
organization address.
16. The system of claim 14, wherein the second item of information
includes at least one of an HME provider identifier, an HME
provider's name, an HME provider organization address, an HME
provider's name, and an HME provider organization address.
17. The system of claim 16, wherein the second item of information
includes an HME provider's inventory number for the HME device.
18. The system of claim 14, wherein the system is a terminal
associated with the entity.
19. The system of claim 18, wherein the entity is one of a
physician, medical organization, or HME provider.
20. A records management system for managing of data associated
with a home medical equipment (HME) device provided to a patient,
the records management system comprising: a memory; a reader device
configured to accept a removable storage medium including an HME
device identifier, the HME device identifier being a unique
identifier to distinguish the HME device provided to the patient
from other HME devices registered at a computer based records
management system; and a processor coupled to the memory and the
reader device, the processor being configured to: receive a request
for a record associated with an HME device identifier with a search
query, the search query being based on the HME device identifier,
the search query being initiated by a user; identify a patient
record associated with the HME device identifier; receive, at the
record management system, a confirmation of identity of the
patient; and grant to the user at least one of a permission to
access the patient record and a permission to modify the patient
record, upon receiving a confirmation of the identity of the
user.
21. The system of claim 20, wherein the processor is further
configured to store an item of information associated with the user
into the patient record when the user is granted permission to
modify the record.
22. The system of claim 21, wherein the item of information
associated with the user is one of physician name, HME provider
name, physician address, HME provider address, physician's
organization name, physician's organization address, HME
organization's name and HME organization's address.
23. A method for managing, by way of a computer based patient
records management system, data associated with a home medical
equipment (HME) device provided to a patient, the method
comprising: receiving, by way of a first processor, an HME device
identifier associated with the HME device from a removable storage
medium, the HME device identifier being a unique identifier to
distinguish the HME device provided to the patient from other HME
devices registered at a computer based records management system;
and verifying, by way of the first or a second processor, the
received HME device identifier; and providing access to a user to
the records management system, based on a positive verification of
the received HME device identifier.
24. The method of claim 23, further comprising the step of
searching, by a processor, the records management system for a
patient record that is associated with the HME device identifier,
the search being performed by using a search key based on the HME
device identifier.
Description
1 CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 14/432,825 filed on Apr. 1, 2015 which is a
national phase entry under 35 U.S.C. .sctn. 371 of International
Application No. PCT/AU2013/001124 filed Oct. 1, 2013, published in
English, which claims priority from U.S. Provisional Patent
Application No. 61/708,437 filed Oct. 1, 2012, all of which are
incorporated herein by reference.
2 BACKGROUND OF THE TECHNOLOGY
2.1 Field of the Technology
[0002] The present technology relates to device identifiers, such
as a serial number, of home medical equipment (HME) devices. The
technology may be implemented in conjunction with devices for the
diagnosis, treatment and/or amelioration of respiratory disorders,
and to procedures to prevent respiratory disorders. Thus, the
present technology may relate to medical devices, and their use for
treating respiratory disorders and for preventing respiratory
disorders.
2.2 Description of the Related Art
[0003] The respiratory system of the body facilitates gas exchange.
The nose and mouth form the entrance to the airways of a
patient.
[0004] The airways include a series of branching tubes, which
become narrower, shorter and more numerous as they penetrate deeper
into the lung. The prime function of the lung is gas exchange,
allowing oxygen to move from the air into the venous blood and
carbon dioxide to move out. The trachea divides into right and left
main bronchi, which further divide eventually into terminal
bronchioles. The bronchi make up the conducting airways, and do not
take part in gas exchange. Further divisions of the airways lead to
the respiratory bronchioles, and eventually to the alveoli. The
alveolated region of the lung is where the gas exchange takes
place, and is referred to as the respiratory zone. See West,
Respiratory Physiology--the essentials.
[0005] A range of respiratory disorders exist.
[0006] Obstructive Sleep Apnea (OSA), a form of Sleep Disordered
Breathing (SDB), is characterized by occlusion or obstruction of
the upper air passage during sleep. It results from a combination
of an abnormally small upper airway and the normal loss of muscle
tone in the region of the tongue, soft palate and posterior
oropharyngeal wall during sleep. The condition causes the affected
patient to stop breathing for periods typically of 30 to 120
seconds duration, sometimes 200 to 300 times per night. It often
causes excessive daytime somnolence, and it may cause
cardiovascular disease and brain damage. The syndrome is a common
disorder, particularly in middle aged overweight males, although a
person affected may have no awareness of the problem. See U.S. Pat.
No. 4,944,310 (Sullivan).
[0007] Cheyne-Stokes Respiration (CSR) is a disorder of a patient's
respiratory controller in which there are rhythmic alternating
periods of waxing and waning ventilation, causing repetitive
de-oxygenation and re-oxygenation of the arterial blood. It is
possible that CSR is harmful because of the repetitive hypoxia. In
some patients CSR is associated with repetitive arousal from sleep,
which causes severe sleep disruption, increased sympathetic
activity, and increased afterload. See U.S. Pat. No. 6,532,959
(Berthon-Jones).
[0008] Obesity Hyperventilation Syndrome (OHS) is defined as the
combination of severe obesity and awake chronic hypercapnia, in the
absence of other known causes for hypoventilation. Symptoms include
dyspnea, morning headache and excessive daytime sleepiness.
[0009] Chronic Obstructive Pulmonary Disease (COPD) encompasses any
of a group of lower airway diseases that have certain
characteristics in common. These include increased resistance to
air movement, extended expiratory phase of respiration, and loss of
the normal elasticity of the lung. Examples of COPD are emphysema
and chronic bronchitis. COPD is caused by chronic tobacco smoking
(primary risk factor), occupational exposures, air pollution and
genetic factors. Symptoms include: dyspnea on exertion, chronic
cough and sputum production.
[0010] Neuromuscular Disease (NMD) is a broad term that encompasses
many diseases and ailments that impair the functioning of the
muscles either directly via intrinsic muscle pathology, or
indirectly via nerve pathology. Some NMD patients are characterised
by progressive muscular impairment leading to loss of ambulation,
being wheelchair-bound, swallowing difficulties, respiratory muscle
weakness and, eventually, death from respiratory failure.
Neuromuscular disorders can be divided into rapidly progressive and
slowly progressive: (i) Rapidly progressive disorders:
Characterised by muscle impairment that worsens over months and
results in death within a few years (e.g. Amyotrophic lateral
sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in
teenagers); (ii) Variable or slowly progressive disorders:
Characterised by muscle impairment that worsens over years and only
mildly reduces life expectancy (e.g. Limb girdle,
Facioscapulohumeral and Myotonic muscular dystrophy). Symptoms of
respiratory failure in NMD include: increasing generalised
weakness, dysphagia, dyspnea on exertion and at rest, fatigue,
sleepiness, morning headache, and difficulties with concentration
and mood changes.
[0011] Chest wall disorders are a group of thoracic deformities
that result in inefficient coupling between the respiratory muscles
and the thoracic cage. The disorders are usually characterised by a
restrictive defect and share the potential of long term hypercapnic
respiratory failure. Scoliosis and/or kyphoscoliosis may cause
severe respiratory failure. Symptoms of respiratory failure
include: dyspnea on exertion, peripheral oedema, orthopnea,
repeated chest infections, morning headaches, fatigue, poor sleep
quality and loss of appetite.
[0012] Otherwise healthy individuals may take advantage of systems
and devices to prevent respiratory disorders from arising.
2.2.1 Systems
[0013] One known product used for treating sleep disordered
breathing is the S9 Sleep Therapy System, manufactured by
ResMed.
2.2.2 Therapy
[0014] Nasal Continuous Positive Airway Pressure (CPAP) therapy has
been used to treat Obstructive Sleep Apnea (OSA). The hypothesis is
that continuous positive airway pressure acts as a pneumatic splint
and may prevent upper airway occlusion by pushing the soft palate
and tongue forward and away from the posterior oropharyngeal
wall.
[0015] Non-invasive ventilation (NIV) has been used to treat OHS,
COPD, MD and Chest Wall disorders.
2.2.3 Patient Interface
[0016] The application of a supply of air at positive pressure to
the entrance of the airways of a patient is facilitated by the use
of a patient interface, such as a nasal mask, full-face mask or
nasal pillows. A range of patient interface devices are known,
however a number of them suffer from being one or more of
obtrusive, aesthetically undesirable, poorly fitting, difficult to
use and uncomfortable especially when worn for long periods of time
or when a patient is unfamiliar with a system. Masks designed
solely for aviators, as part of personal protection equipment or
for the administration of anaesthetics may be tolerable for their
original application, but nevertheless be undesirably uncomfortable
to be worn for extended periods, for example, while sleeping.
2.2.3.1 Seal-Forming Portion
[0017] Patient interfaces typically include a seal-forming
portion.
[0018] One type of seal-forming portion extends around the
periphery of the patient interface, and is intended to seal against
the user's face when force is applied to the patient interface with
the seal-forming portion in confronting engagement with the user's
face. The seal-forming portion may include an air or fluid filled
cushion, or a moulded or formed surface of a resilient seal element
made of an elastomer such as a rubber. With this type of
seal-forming portion, if the fit is not adequate, there will be
gaps between the seal-forming portion and the face, and additional
force will be required to force the patient interface against the
face in order to achieve a seal.
[0019] Another type of seal-forming portion incorporates a flap
seal of thin material so positioned about the periphery of the mask
so as to provide a self-sealing action against the face of the user
when positive pressure is applied within the mask. Like the
previous style of seal forming portion, if the match between the
face and the mask is not good, additional force may be required to
effect a seal, or the mask may leak. Furthermore, if the shape of
the seal-forming portion does not match that of the patient, it may
crease or buckle in use, giving rise to leaks.
[0020] Another form of seal-forming portion may use adhesive to
effect a seal. Some patients may find it inconvenient to constantly
apply and remove an adhesive to their face.
[0021] A range of patient interface seal-forming portion
technologies are disclosed in the following patent applications,
assigned to ResMed Limited: WO 1998/004,310; WO 2006/074,513; WO
2010/135,785.
2.23.2 Positioning and Stabilising
[0022] A seal-forming portion of a patient interface used for
positive air pressure therapy is subject to the corresponding force
of the air pressure to disrupt a seal. Thus a variety of techniques
have been used to position the seal-forming portion, and to
maintain it in sealing relation with the appropriate portion of the
face.
[0023] One technique is the use of adhesives. See for example US
Patent publication US 2010/0000534.
[0024] Another technique is the use of one or more straps and
stabilising harnesses. Many such harnesses suffer from being one or
more of ill-fitting, bulky, uncomfortable and awkward to use.
2.2.3.3 Vent Technologies
[0025] Some forms of patient interface systems may include a vent
to allow the washout of exhaled carbon dioxide. Many such vents are
noisy. Others may block in use and provide insufficient washout.
Some vents may be disruptive of the sleep of a bed-partner 1100 of
the patient 1000, e.g. through noise or focussed airflow.
[0026] ResMed Limited has developed a number of improved mask vent
technologies. See WO 1998/034,665; WO 2000/078,381; U.S. Pat. No.
6,581,594; US Patent Application; US 2009/0050156; US Patent
Application 2009/0044808.
TABLE-US-00001 Table of noise of prior masks (ISO 17510-2: 2007, 10
cmH.sub.2O pressure at 1 m) A-weighted A-weighted sound power sound
level dbA pressure dbA Year Mask name Mask type (uncertainty)
(uncertainty) (approx.) Glue-on (*) nasal 50.9 42.9 1981 ResCare
nasal 31.5 23.5 1993 standard (*) ResMed nasal 29.5 21.5 1998
Mirage (*) ResMed nasal 36 (3) 28 (3) 2000 UltraMirage ResMed nasal
32 (3) 24 (3) 2002 Mirage Activa ResMed nasal 30 (3) 22 (3) 2008
Mirage Micro ResMed nasal 29 (3) 22 (3) 2008 Mirage SoftGel ResMed
nasal 26 (3) 18 (3) 2010 Mirage FX ResMed nasal pillows 37 29 2004
Mirage Swift (*) ResMed nasal pillows 28 (3) 20 (3) 2005 Mirage
Swift II ResMed nasal pillows 25 (3) 17 (3) 2008 Mirage Swift LT
((*) one specimen only, measured using test method specified in
ISO3744 in CPAP mode at 10 cmH.sub.2O)
[0027] Sound pressure values of a variety of objects are listed
below
TABLE-US-00002 A-weighted sound pressure dbA Object (uncertainty)
Notes Vacuum cleaner: Nilfisk 68 ISO3744 at 1 m Walter Broadly
Litter Hog: B+ distance Grade Conversational speech 60 1 m distance
Average home 50 Quiet library 40 Quiet bedroom at night 30
Background in TV studio 20
2.2.3.4 Nasal Pillow Technologies
[0028] One form of nasal pillow is found in the Adam Circuit
manufactured by Puritan Bennett. Another nasal pillow, or nasal
puff is the subject of U.S. Pat. No. 4,782,832 (Trimble et al.),
assigned to Puritan-Bennett Corporation.
[0029] ResMed Limited has manufactured the following products that
incorporate nasal pillows: SWIFT nasal pillows mask, SWIFT II nasal
pillows mask, SWIFT LT nasal pillows mask, SWIFT FX nasal pillows
mask and LIBERTY full-face mask. The following patent applications,
assigned to ResMed Limited, describe nasal pillows masks:
International Patent Application WO2004/073,778 (describing amongst
other things aspects of ResMed SWIFT nasal pillows), US Patent
Application 2009/0044808 (describing amongst other things aspects
of ResMed SWIFT LT nasal pillows); International Patent
Applications WO 2005/063,328 and WO 2006/130,903 (describing
amongst other things aspects of ResMed LIBERTY full-face mask);
International Patent Application WO 2009/052,560 (describing
amongst other things aspects of ResMed SWIFT FX nasal pillows).
2.2.4 PAP Device
[0030] The air at positive pressure is typically supplied to the
airway of a patient by a PAP device such as a motor-driven blower.
The outlet of the blower is connected via a flexible delivery
conduit to a patient interface as described above.
2.2.5 Sleep Detection
[0031] Sleep information may be useful for treating and/or
diagnosing respiratory issues or may simply be useful for
monitoring health.
2.2.6 Home Medical Equipment
[0032] Home medical equipment (HME) devices is a category of
medical devices used for the treatment of patients in their homes.
HME devices are usually prescribed by physicians and dispensed by
HME providers. Patient records regarding the use of HME devices may
be maintained in centralized medical databases, such as the
EASYCARE ONLINE.TM. database. Such centralized databases may give
access to patients' records to both physicians and HME
providers.
[0033] In order to manage a patient's treatment effectively, HME
providers and physicians need to work with the same set of patient
records. However, when a physician or HME provider is attempting to
access a patient record associated with an HME device for the first
time, he or she may create duplicate records. For example, the HME
provider or physician may mistype information used to search for
the records and as a result they may fail to find existing records
that are associated with the HME device. Without realizing that a
mistake has been made, the HME provider or physician may assume
that a record associated with the HME device has not been created
yet and, as a result, proceed to create a new patient record,
thereby causing duplicate records to exist.
[0034] Previous attempts to provide controlled access to patients'
records and prevent the creation of duplicates have been associated
with the introduction of systems of unique identifiers that had to
be manually recorded in the patient's file. Many such systems have
been found to be complex and unreliable. Accordingly, the need
still exists for a robust and reliable method for managing data
associated with a home medical equipment (HME) device provided to a
patient by providing a convenient, but at the same time well
controlled, access for creating and updating patients' records
stored in a centralized medical database.
BRIEF SUMMARY OF THE TECHNOLOGY
[0035] The present technology is directed towards providing health
or medical devices and may optionally be used with devices for the
diagnosis, amelioration, treatment, and/or prevention of
respiratory disorders having one or more of improved comfort, cost,
efficacy, ease of use and manufacturability.
[0036] For example, one aspect of the technology relates to a
frequent situation where a patient has already visited an HME
provider (also referred simply as an HME), however, when the
patient later visits a physician the HME still has not created a
patient record in a record management system or has created such a
record, but has not associated it with the corresponding physician.
According to this aspect, a method for managing data associated
with a home medical equipment (HME) device provided to a patient
may involve storing an HME device identifier on a removable storage
medium, such as an SD card or other type of memory device. When the
patient received the device from the HME, the device had already
included the removable storage medium having the unique identifier
stored on it. As in this case the HME had failed to create a
patient record, as this should be done by the physician. During the
patient's visit to the physician, the physician may receive the
storage medium from the patient and connect it to the web based
record management system. For that purpose, the physician will
first log on to the record management system. As described further
herein, various means, such as a Java.RTM. applet, may for example
be configured to facilitate the interaction between such a user and
the record management system. The physician log on may indicate to
the record management system the identity of the Physician
organization that accesses the system. The record management system
may receive the identification of the device and check if such an
identifier is already registered on the data management database.
When no such record has been previously created by the HME
provider, the physician has to create a new patient record in the
record management system. During the creation of the record, the
identity of the Physician organization and the HME identification
(e.g., number) of the device are automatically associated with the
patient record. Data of the particular physician from the
respective Physician organization, who has admitted the patient,
may also be received and stored on the system. As at least his
organization is automatically associated with the patient's record,
the physician then has full access to the record and can, for
example, upload any sleep data or other health data saved on the
memory device. The physician can then provide the removable storage
medium to the patient.
[0037] If the patient now takes the storage medium back to the HME
provider, the HME provider may use the HME device identifier stored
on the medium to locate the patient record created by the
physician. The HME provider is also asked to verify the identity of
the patient. For this purpose, the HME provider has to verify that
the patient's name and date of birth, as recorded in the record
management system, are identical to those of the patient who
provided the storage medium. Once the patient identity is verified,
the HME is also automatically associated with the patient's record,
by the details of the HME organization, location and, possibly, the
identity of the HME, being received by the system. Once associated
with the record, the HME provider can view and modify the record.
Afterwards, the HME provider may dispense the HME device back to
the patient.
[0038] In another aspect, a method is provided for use in
situations where a patient visits a physician after obtaining an
HME device from an HME provider. According to this aspect, when
dispensing the HME device, the HME provider may create a patient
record that associates the patient with an HME device identifier
stored on a removable storage medium. During the creation of the
record, the HME is automatically associated with the record, which
provides the HME with full access to the record. The HME provider
may then hand over the removable storage medium to the patient
along with the HME device. The patient may take the HME device to a
physician and provide the removable storage medium to the
physician. The physician may use the HME device identifier stored
on the medium to locate the patient record created by the HME
provider. Once the record is identified on the system, the
physician has to verify the identity of the patient, by comparing
patient's data (usually the client's name and date of birth)
displayed on the screen by the system, with information obtained
from the patient. Alternatively, the system may ask the physician
to type the patient's details, which are then compared with these
on the system. Once the identity of the patient has been positively
verified, the physician is automatically associated with the
system, by details of the physician's organization, organization
branch/location and, possibly, the identity of the HME, being
received by the system. Depending on predefined arrangements with
the Physician's organization, the physician can now either only
access, or access and modify the patient's data. For example, the
physician can upload new data from the memory device or may modify
the patient record to include information identifying the physician
as the one in charge of the patient's treatment with the HME
device.
[0039] In yet another aspect, when the patent record is initially
set up, the unique HME device identification number may be entered
either manually or be automatically extracted (e.g., by way of a
barcode scanner scanning the device identification number encoded
on the device, or by using wireless connectivity such as Bluetooth
to connect to the device which will have the number saved in its
internal memory). The HME device identifier is then transferred
from the internal memory onto the removable storage medium. From
this point on, either one of the physician and HME provider can
perform a records search and can access the patient record based on
reading the removable storage medium by using either a memory card
reader (or by using a barcode scanner, if the unique identification
number has been encoded on the outside of the storage medium). In
either case, the HME device identifier is loaded automatically and
submitted to the database that is searched. By removing the need to
enter the HME device identifier manually, typographical errors are
prevented from being introduced into the records search.
[0040] In yet another aspect, when either one of the physician and
HME provider is given a removable storage medium containing an HME
device identifier, and fails to find an existing patient record
associated with the identifier, they may create a new record and
associate the newly-created record with the HME device identifier.
Because the HME device identifier is copied automatically, either
from the removable storage medium or wirelessly, when records
searches are performed, the possibility of false negative searches
due to a mistyped HME device identifier is reduced. This in turn
increases the likelihood that a patient record associated with the
HME device identifier is going to be found if such exists, thereby
decreasing the likelihood of duplicate records being created.
[0041] Of course, portions of the aspects may form sub-aspects of
the present technology. Also, various ones of the sub-aspects
and/or aspects may be combined in various manners and also
constitute additional aspects or sub-aspects of the present
technology.
[0042] Other features of the technology will be apparent from
consideration of the information contained in the following
detailed description, abstract, drawings and claims.
3 BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0043] The present technology is illustrated by way of example, and
not by way of limitation, in the figures of the accompanying
drawings, in which like reference numerals refer to similar
elements including:
3.1 Treatment Systems
[0044] FIG. 1a shows a system in accordance with the present
technology. A patient 1000 wearing a patient interface 3000,
receives a supply of air at positive pressure from a PAP device
4000. Air from the PAP device is humidified in a humidifier 5000,
and passes along an air circuit 4170 to the patient 1000.
[0045] FIG. 1b shows a PAP device in use on a patient with a nasal
mask.
[0046] FIG. 1c shows a PAP device in use on a patient with a
full-face mask.
3.2 Therapy
3.2.1 Respiratory System
[0047] FIG. 2a shows an overview of a human respiratory system
including the nasal and oral cavities, the larynx, vocal folds,
oesophagus, trachea, bronchus, lung, alveolar sacs, heart and
diaphragm.
[0048] FIG. 2b shows a view of a human upper airway including the
nasal cavity, nasal bone, lateral nasal cartilage, greater alar
cartilage, nostril, lip superior, lip inferior, larynx, hard
palate, soft palate, oropharynx, tongue, epiglottis, vocal folds,
oesophagus and trachea.
3.3 Patient Interface
[0049] FIG. 3 shows a patient interface in accordance with one form
of the present technology.
3.4 Pap Device
[0050] FIG. 4a shows a PAP device in accordance with one form of
the present technology.
[0051] FIG. 4b shows a schematic diagram of the pneumatic circuit
of a PAP device in accordance with one form of the present
technology. The directions of upstream and downstream are
indicated.
[0052] FIG. 4c shows a schematic diagram of the electrical
components of a PAP device in accordance with one aspect of the
present technology.
[0053] FIG. 4d shows a schematic diagram of example processes or
algorithms implemented in a PAP device in accordance with an aspect
of the present technology. In this figure, arrows with solid lines
indicate an actual flow of information, for example via an
electronic signal.
3.5 Humidifier
[0054] FIG. 5 shows an example humidifier in accordance with one
aspect of the present technology.
3.6 Breathing Waveforms
[0055] FIG. 6a shows a model typical breath waveform of a person
while sleeping. The horizontal axis is time, and the vertical axis
is respiratory flow. While the parameter values may vary, a typical
breath may have the following approximate values: tidal volume, Vt,
0.5 L, inhalation time, Ti, 1.6 s, peak inspiratory flow, Qpeak,
0.4 Us, exhalation time, Te, 2.4 s, peak expiratory flow, Qpeak,
-0.5 Us. The total duration of the breath, Trot, is about 4 s. The
person typically breathes at a rate of about 15 breaths per minute
(BPM), with Ventilation, Vent, about 7.5 L/minute. A typical duty
cycle, the ratio of Ti to Trot is about 40%.
[0056] FIG. 6b shows a patient during Non-REM sleep breathing
normally over a period of about ninety seconds, with about 34
breaths, being treated with Automatic PAP, and the mask pressure
being about 11 cmH.sub.2O. The top channel shows oximetry (SpO2),
the scale has a range of saturation from 90 to 99% in the vertical
direction. The patient maintained a saturation of about 95%
throughout the period shown. The second channel shows quantitative
respiratory airflow, and the scale ranges from -1 to +1 LPS in a
vertical direction, and with inspiration positive. Thoracic and
abdominal movement are shown in the third and fourth channels.
[0057] FIG. 6c shows polysomnography of a patient before a
treatment. There are eleven signal channels from top to bottom with
a 6 minute horizontal span. The top two channels both are EEG
(electoencephalogram) from different scalp locations. Periodic
spikes in second represent cortical arousal and related activity.
The third channel down is submental EMG (electromyogram).
Increasing activity around time of arousals represent genioglossus
recruitment. The fourth & fifth channels are EOG
(electro-oculogram). The sixth channel is an electocardiogram. The
seventh channel shows pulse oximetry (SpO2) with repetitive
desaturations to below 70% from about 90%. The eighth channel is
respiratory airflow using nasal cannula connected to differential
pressure transducer. Repetitive apneas of 25 to 35 seconds
alternating with 10 to 15 second bursts of recovery breathing
coinciding with EEG arousal and increased EMG activity. The ninth
shows movement of chest and tenth shows movement of abdomen. The
abdomen shows a crescendo of movement over the length of the apnea
leading to the arousal. Both become untidy during the arousal due
to gross body movement during recovery hyperpnea. The apneas are
therefore obstructive, and the condition is severe. The lowest
channel is posture, and in this example it does not show
change.
[0058] FIG. 6d shows patient flow data where the patient is
experiencing a series of total obstructive apneas. The duration of
the recording is approximately 160 seconds. Flow ranges from about
+1 Us to about -1.5 L/s. Each apnea lasts approximately 10-15
s.
[0059] FIG. 6e shows a scaled inspiratory portion of a breath where
the patient is experiencing low frequency inspiratory snore.
[0060] FIG. 6f shows a scaled inspiratory portion of a breath where
the patient is experiencing an example of flattened inspiratory
flow limitation.
[0061] FIG. 6g shows a scaled inspiratory portion of a breath where
the patient is experiencing an example of"mesa" flattened
inspiratory flow limitation.
[0062] FIG. 6h shows a scaled inspiratory portion of a breath where
the patient is experiencing an example of"panda ears" inspiratory
flow limitation.
[0063] FIG. 6i shows a scaled inspiratory portion of a breath where
the patient is experiencing an example of "chair" inspiratory flow
limitation.
[0064] FIG. 6j shows a scaled inspiratory portion of a breath where
the patient is experiencing an example of"reverse chair"
inspiratory flow limitation.
[0065] FIG. 6k shows a scaled inspiratory portion of a breath where
the patient is experiencing an example of "M-shaped" inspiratory
flow limitation.
[0066] FIG. 6l shows a scaled inspiratory portion of a breath where
the patient is experiencing an example of severely "M-shaped"
inspiratory flow limitation.
[0067] FIG. 6m shows data for a patient with Cheyne-Stokes
respiration. There are three channels--oxygen saturation (SpO2), a
signal indicative of flow and the third, movement. The data span
six minutes. The signal representative of flow was measured using a
pressure sensor connected to nasal cannulae. The patient exhibits
apneas of about 22 seconds and hyperpneas of about 38 seconds.
Higher frequency low amplitude oscillation during apnea is
cardiogenic.
[0068] FIG. 6n shows data for a patient with another example of
Cheyne-Stokes respiration, using the same three channels as in FIG.
6m. The data span ten minutes. Generally, in the flow data signal
of FIG. 6n the patient is experiencing hypopneas in place of the
apneas illustrated in FIG. 6m.
3.7 Serial Number Identification
[0069] FIG. 7 depicts a schematic diagram of a patient record
management system in accordance with one aspect of the
disclosure.
[0070] FIG. 8 depicts a schematic diagram of hardware devices used
in the patient record management system of FIG. 1 in accordance
with another aspect of the disclosure.
[0071] FIG. 9 depicts a schematic diagram of an electronic patient
record in accordance with aspects of the disclosure.
[0072] FIG. 10 depicts a schematic diagram of a sample patient
compliance report in accordance with aspects of the disclosure.
[0073] FIG. 11 depicts a schematic diagram of a user interface for
modifying patient records, i.e. by adding therapy data to the
patient record.
[0074] FIG. 12 depicts a flowchart of a process in accordance with
aspects of the disclosure.
[0075] FIG. 13 depicts a flowchart of a process associated with the
process of FIG. 12.
[0076] FIG. 14 depicts a flowchart of another process associated
with the process of FIG. 12.
[0077] FIG. 15 depicts a flowchart of a process in accordance with
aspects of the disclosure.
[0078] FIG. 16 depicts a flowchart of a process associated with the
process of FIG. 15.
[0079] FIG. 17 depicts a flowchart of another process associated
with the process of FIG. 15.
[0080] FIG. 18A depicts a flowchart of process associated with
FIGS. 14 and 17.
[0081] FIG. 18B depicts a flowchart of another process associated
with FIGS. 14 and 17.
4 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY
[0082] Before the present technology is described in further
detail, it is to be understood that the technology is not limited
to the particular examples described herein, which may vary. It is
also to be understood that the terminology used in this disclosure
is for the purpose of describing only the particular examples
discussed herein, and is not intended to be limiting.
4.1 Treatment Systems
[0083] In one form, the present technology may be incorporated
within or in communication (wired or wireless) with apparatus for
treating a respiratory disorder. The apparatus may comprise a flow
generator or blower for supplying pressurised respiratory gas, such
as air, to the patient 1000 via an air delivery tube leading to a
patient interface 3000.
4.2 Therapy
[0084] In one form, the present technology comprises a method for
treating a respiratory disorder comprising the step of applying or
adjusting positive pressure to the entrance of the airways of a
patient 1000. The treatment (e.g. positive pressure) may be any
type such as a CPAP treatment, automatic titrating pressure (APAP),
bi-level PAP or other suitable respiratory treatment.
4.2.1 Nasal CPAP for OSA
[0085] For example, in one form, the present technology comprises a
method of treating Obstructive Sleep Apnea in a patient by applying
nasal continuous positive airway pressure to the patient.
[0086] In certain embodiments of the present technology, a supply
of air at positive pressure is provided to the nasal passages of
the patient via one or both nares.
[0087] In certain embodiments of the present technology, mouth
breathing is limited, restricted or prevented.
4.3 Patient Interface 3000
[0088] A non-invasive patient interface 3000 in accordance with one
aspect of the present technology may optionally include any one or
more of the following functional aspects: a seal-forming structure
3100, a plenum chamber 3200, a positioning and stabilising
structure 3300 and a connection port 3600 for connection to air
circuit 4170. In some forms a functional aspect may be provided by
one or more physical components. In some forms, one physical
component may provide one or more functional aspects. In use the
seal-forming structure 3100 is arranged to surround an entrance to
the airways of the patient so as to facilitate the supply of air at
positive pressure to the airways.
4.3.1 Seal-Forming Structure 3100
[0089] In one form of the present technology, a seal-forming
structure 3100 provides a sealing-forming surface, and may
additionally provide a cushioning function.
[0090] A seal-forming structure 3100 in accordance with the present
technology may be constructed from a soft, flexible, resilient
material such as silicone.
[0091] In one form, the seal-forming structure 3100 comprises a
sealing flange 3110 and a support flange 3120. Preferably the
sealing flange 3110 comprises a relatively thin member with a
thickness of less than about 1 mm, for example about 0.25 mm to
about 0.45 mm, that extends around the perimeter 3210 of the plenum
chamber 3200. Support flange 3120 may be relatively thicker than
the sealing flange 3110. The support flange 3120 is disposed
between the sealing flange 3110 and the marginal edge 3220 of the
plenum chamber 3200, and extends at least part of the way around
the perimeter 3210. The support flange 3120 is or includes a
spring-like element and functions to support the sealing flange
3110 from buckling in use. In use the sealing flange 3110 can
readily respond to system pressure in the plenum chamber 3200
acting on its underside to urge it into tight sealing engagement
with the face.
[0092] In one form the seal-forming portion of the non-invasive
patient interface 3000 comprises a pair of nasal puffs, or nasal
pillows, each nasal puff or nasal pillow being constructed and
arranged to form a seal with a respective naris of the nose of a
patient.
[0093] Nasal pillows in accordance with an aspect of the present
technology include: a frusto-cone, at least a portion of which
forms a seal on an underside of the patient's nose; a stalk, a
flexible region on the underside of the cone and connecting the
cone to the stalk. In addition, the structure to which the nasal
pillow of the present technology is connected includes a flexible
region adjacent the base of the stalk. The flexible regions can act
in concert to facilitate a universal joint structure that is
accommodating of relative movement--both displacement and
angular--of the frusto-cone and the structure to which the nasal
pillow is connected. For example, the frusto-cone may be axially
displaced towards the structure to which the stalk is
connected.
[0094] In one form the non-invasive patient interface 3000
comprises a seal-forming portion that forms a seal in use on an
upper lip region (that is, the lip superior) of the patient's
face.
[0095] In one form the non-invasive patient interface 3000
comprises a seal-forming portion that forms a seal in use on a
chin-region of the patient's face.
4.3.2 Plenum Chamber 3200
[0096] Preferably the plenum chamber 3200 has a perimeter 3210 that
is shaped to be complementary to the surface contour of the face of
an average person in the region where a seal will form in use. In
use, a marginal edge 3220 of the plenum chamber 3200 is positioned
in close proximity to an adjacent surface of the face. Actual
contact with the face is provided by the seal-forming structure
3100. Preferably the seal-forming structure 3100 extends in use
about the entire perimeter 3210 of the plenum chamber 3200.
4.3.3 Positioning and Stabilising Structure 3300
[0097] Preferably the seal-forming structure 3100 of the patient
interface 3000 of the present technology is held in sealing
position in use by the positioning and stabilising structure
3300.
4.3.4 Vent 3400
[0098] In one form, the patient interface 3000 includes a vent 3400
constructed and arranged to allow for the washout of exhaled carbon
dioxide.
[0099] One form of vent 3400 in accordance with the present
technology comprises a plurality of holes, for example, about 20 to
about 80 holes, or about 40 to about 60 holes, or about 45 to about
55 holes.
[0100] Preferably the vent 3400 is located in the plenum chamber
3200. Alternatively, the vent 3400 is located in a decoupling
structure 3500, e.g. a swivel 3510.
4.3.5 Decoupling Structure(s) 3500
[0101] In one form the patient interface 3000 includes at least one
decoupling structure 3500, for example a swivel 3510 or a ball and
socket 3520.
4.3.6 Connection Port 3600
[0102] Connection port 3600 allows for connection to the air
circuit 4170.
4.3.7 Forehead Support 3700
[0103] In one form, the patient interface 3000 includes a forehead
support 3700.
4.3.8 Anti-Asphyxia 3800
[0104] In one form, the patient interface 3000 includes an
anti-asphyxia valve 3800.
4.3.9 Ports 3900
[0105] In one form of the present technology, a patient interface
3000 includes one or more ports, that allow access to the volume
within the plenum chamber 3200. In one form this allows a clinician
to supply supplemental oxygen. In one form this allows for the
direct measurement of a property of gases within the plenum chamber
3200, such as the pressure.
4.4 Pap Device 4000
[0106] An example PAP device 4000 in accordance with one aspect of
the present technology may be formed with mechanical and pneumatic
components 4100, electrical components 4200 and may be programmed
to execute one or more algorithms 4300. The PAP device preferably
has an external housing 4010, preferably formed in two parts, an
upper portion 4012 of the external housing 4010, and a lower
portion 4014 of the external housing 4010. In alternative forms,
the external housing 4010 may include one or more panel(s) 4015.
Preferably the PAP device 4000 comprises a chassis 4016 that
supports one or more internal components of the PAP device 4000. In
one form a pneumatic block 4020 is supported by, or formed as part
of the chassis 4016. The PAP device 4000 may include a handle
4018.
[0107] The pneumatic path of the PAP device 4000 preferably
comprises an inlet air filter 4112, an inlet muffler 4122, a
controllable pressure device 4140 capable of supplying air at
positive pressure (preferably a blower 4142), and an outlet muffler
4124. One or more pressure sensors and flow sensors are included in
the pneumatic path.
[0108] The preferred pneumatic block 4020 comprises a portion of
the pneumatic path that is located within the external housing
4010.
[0109] The PAP device 4000 preferably has an electrical power
supply 4210, one or more input devices 4220, a central controller
4230, a therapy device controller 4240, a therapy device 4245, one
or more protection circuits 4250, memory 4260, transducers 4270,
data communication interface 4280 and one or more output devices
4290. Electrical components 4200 may be mounted on a single Printed
Circuit Board Assembly (PCBA) 4202. In an alternative form, the PAP
device 4000 may include more than one PCBA 4202.
[0110] The central controller 4230 of the PAP device 4000 is
programmed to execute one or more algorithm 4300 modules,
preferably including a pre-processing module 4310, a therapy engine
module 4320, a pressure control module 4330, and further preferably
a fault condition module 4340.
4.4.1 PAP Device Mechanical & Pneumatic Components 4100
4.4.1.1 Air Filter(s) 4110
[0111] A PAP device in accordance with one form of the present
technology may include an air filter 4110, or a plurality of air
filters 4110.
[0112] In one form, an inlet air filter 4112 is located at the
beginning of the pneumatic path upstream of a blower 4142. See FIG.
4b.
[0113] In one form, an outlet air filter 4114, for example an
antibacterial filter, is located between an outlet of the pneumatic
block 4020 and a patient interface 3000. See FIG. 4b.
[0114] Muffler(s) 4120
[0115] In one form of the present technology, an inlet muffler 4122
is located in the pneumatic path upstream of a blower 4142. See
FIG. 4b.
[0116] In one form of the present technology, an outlet muffler
4124 is located in the pneumatic path between the blower 4142 and a
patient interface 3000. See FIG. 4b.
4.4.1.2 Pressure Device 4140
[0117] In an example form of the present technology, a pressure
device 4140 for producing a flow of air at positive pressure is a
controllable blower 4142. For example the blower may include a
brushless DC motor 4144 with one or more impellers housed in a
volute. The blower may be preferably capable of delivering a supply
of air, for example about 120 litres/minute, at a positive pressure
in a range from about 4 cmH.sub.2O to about 20 cmH.sub.2O, or in
other forms up to about 30 cmH.sub.2O.
[0118] The pressure device 4140 may be under the control of the
therapy device controller 4240.
4.4.1.3 Transducer(s) 4270
[0119] In one form of the present technology, one or more
transducers 4270 are located upstream of the pressure device 4140.
The one or more transducers 4270 are constructed and arranged to
measure properties of the air at that point in the pneumatic
path.
[0120] In one form of the present technology, one or more
transducers 4270 are located downstream of the pressure device
4140, and upstream of the air circuit 4170. The one or more
transducers 4270 are constructed and arranged to measure properties
of the air at that point in the pneumatic path.
[0121] In one form of the present technology, one or more
transducers 4270 are located proximate to the patient interface
3000.
4.4.1.4 Anti-Spill Back Valve 4160
[0122] In one form of the present technology, an anti-spill back
valve is located between the humidifier 5000 and the pneumatic
block 4020. The anti-spill back valve is constructed and arranged
to reduce the risk that water will flow upstream from the
humidifier 5000, for example to the motor 4144.
4.4.1.5 Air Circuit 4170
[0123] An air circuit 4170 in accordance with an aspect of the
present technology is constructed and arranged to allow a flow of
air or breathable gasses between the pneumatic block 4020 and the
patient interface 3000.
4.4.1.6 Oxygen Delivery
[0124] In one form of the present technology, supplemental oxygen
4180 is delivered to a point in the pneumatic path.
[0125] In one form of the present technology, supplemental oxygen
4180 is delivered upstream of the pneumatic block 4020.
[0126] In one form of the present technology, supplemental oxygen
4180 is delivered to the air circuit 4170.
[0127] In one form of the present technology, supplemental oxygen
4180 is delivered to the patient interface 3000.
4.4.2 PAP Device Electrical Components 4200
4.4.2.1 Basic PAP Device
[0128] Some basic PAP devices, such as PAP device 4000, are
essentially electromechanical devices that do not include
processing capabilities.
4.4.2.1.1 Power Supply 4210
[0129] Power supply 4210 supplies power to the other components of
the basic PAP device 4000: the input device 4220, the central
controller 4230, the therapy device 4245, and the output device
4290.
[0130] In one form of the present technology, power supply 4210 is
internal of the external housing 4010 of the PAP device 4000. In
another form of the present technology, power supply 4210 is
external of the external housing 4010 of the PAP device 4000.
4.4.2.1.2 Input Device(s) 4220
[0131] Input devices 4220 comprises buttons, switches or dials to
allow a person to interact with the PAP device 4000. The buttons,
switches or dials may be physical devices, or software devices
accessible via a touch screen. The buttons, switches or dials may,
in one form, be physically connected to the external housing 4010,
or may, in another form, be in wireless communication with a
receiver that is in electrical connection to the central controller
4230.
[0132] In one form the input device 4220 may be constructed and
arranged to allow a person to select a value and/or a menu
option.
4.4.2.1.3 Central Controller 4230
[0133] In one form of the present technology, the central
controller 4230 is a dedicated electronic circuit configured to
receive input signal(s) from the input device 4220, and to provide
output signal(s) to the output device 4290 and/or the therapy
device 4245 controller.
[0134] In one form, the central controller 4230 is an
application-specific integrated circuit. In another form, the
central controller 4230 comprises discrete electronic
components.
4.4.2.1.4 Therapy Device 4245
[0135] In one form of the present technology, the therapy device
4245 is configured to deliver therapy to a patient 1000 under the
control of the central controller 4230. Preferably the therapy
device 4245 is a positive air pressure device 4140.
4.4.2.1.5 Output Device 4290
[0136] An output device 4290 in accordance with the present
technology may take the form of one or more of a visual, audio, and
haptic output. A visual output may be a Liquid Crystal Display
(LCD) or Light Emitting Diode (LED) display. An audio output may be
a speaker or audio tone emitter.
4.4.2.2 Microprocessor-Controlled PAP Device
4.4.2.2.1 Power Supply 4210
[0137] In one form of the present technology power supply 4210 is
internal of the external housing 4010 of the PAP device 4000. In
another form of the present technology, power supply 4210 is
external of them.
[0138] In one form of the present technology power supply 4210
provides electrical power to the PAP device 4000 only. In another
form of the present technology, power supply 4210 provides
electrical power to both PAP device 4000 and humidifier 5000.
4.4.2.2.2 Input Devices 4220
[0139] In one form of the present technology, a PAP device 4000
includes one or more input devices 4220 in the form of buttons,
switches or dials to allow a person to interact with the device.
The buttons, switches or dials may be physical devices, or software
devices accessible via a touch screen. The buttons, switches or
dials may, in one form, be physically connected to the external
housing 4010, or may, in another form, be in wireless communication
with a receiver that is in electrical connection to the central
controller 4230.
[0140] In one form the input device 4220 may be constructed and
arranged to allow a person to select a value and/or a menu
option.
4.4.2.2.3 Central Controller 4230
[0141] In one form of the present technology, the central
controller 4230 is a processor suitable to control a PAP device
4000 such as an x86 INTEL processor.
[0142] A processor suitable to control a PAP device 4000 in
accordance with another form of the present technology includes a
processor based on ARM Cortex-M processor from ARM Holdings. For
example, an STM32 series microcontroller from ST MICROELECTRONICS
may be used.
[0143] Another processor suitable to control a PAP device 4000 in
accordance with a further alternative form of the present
technology includes a member selected from the family ARM9-based
32-bit RISC CPUs. For example, an STR9 series microcontroller from
ST MICROELECTRONICS may be used.
[0144] In certain alternative forms of the present technology, a
16-bit RISC CPU may be used as the processor for the PAP device
4000. For example a processor from the MSP430 family of
microcontrollers, manufactured by TEXAS INSTRUMENTS, may be
used.
[0145] The processor is configured to receive input signal(s) from
one or more transducers 4270, and one or more input devices
4220.
[0146] The processor is configured to provide output signal(s) to
one or more of an output device 4290, a therapy device controller
4240, a data communication interface 4280 and humidifier controller
5250.
[0147] The processor, or multiple such processors, is configured to
implement the one or more methodologies described herein such as
the one or more algorithms 4300 expressed as computer programs
stored in a computer readable storage medium, such as memory 4260.
In some cases, as previously discussed, such processor(s) may be
integrated with a PAP device 4000. However, in some devices the
processor(s) may be implemented discretely from the flow generation
components of the PAP device, such as for purpose of performing any
of the methodologies described herein without directly controlling
delivery of a respiratory treatment. For example, such a processor
may perform any of the methodologies described herein for purposes
of determining control settings for a ventilator or other
respiratory related events by analysis of stored data such as from
any of the sensors described herein.
4.4.2.2.4 Clock 4232
[0148] Preferably PAP device 4000 includes a clock 4232 that is
connected to processor.
4.4.2.2.5 Therapy Device Controller 4240
[0149] In one form of the present technology, therapy device
controller 4240 is a pressure control module 4330 that forms part
of the algorithms 4300 executed by the processor.
[0150] In one form of the present technology, therapy device
controller 4240 is a dedicated motor control integrated circuit.
For example, in one form a MC33035 brushless DC motor controller,
manufactured by ONSEMI is used.
4.4.2.2.6 Protection Circuits 4250
[0151] Preferably a PAP device 4000 in accordance with the present
technology comprises one or more protection circuits 4250.
[0152] One form of protection circuit 4250 in accordance with the
present technology is an electrical protection circuit.
[0153] One form of protection circuit 4250 in accordance with the
present technology is a temperature or pressure safety circuit.
4.4.2.2.7 Memory 4260
[0154] In accordance with one form of the present technology the
PAP device 4000 includes memory 4260, preferably non-volatile
memory. In some forms, memory 4260 may include battery powered
static RAM. In some forms, memory 4260 may include volatile
RAM.
[0155] Preferably memory 4260 is located on PCBA 4202. Memory 4260
may be in the form of EEPROM, or NAND flash.
[0156] Additionally or alternatively, PAP device 4000 includes
removable form of memory 4260, for example a memory card made in
accordance with the Secure Digital (SD) standard.
[0157] In one form of the present technology, the memory 4260 acts
as a computer readable storage medium on which is stored computer
program instructions expressing the one or more methodologies
described herein, such as the one or more algorithms 4300.
4.4.2.2.8 Transducers 4270
[0158] Transducers may be internal of the device, or external of
the PAP device. External transducers may be located for example on
or form part of the air delivery circuit, e.g. the patient
interface. External transducers may be in the form of non-contact
sensors such as a Doppler radar movement sensor that transmit or
transfer data to the PAP device.
4.4.2.2.8.1 Flow
[0159] A flow transducer 4274 in accordance with the present
technology may be based on a differential pressure transducer, for
example, an SDP600 Series differential pressure transducer from
SENSIRION. The differential pressure transducer is in fluid
communication with the pneumatic circuit, with one of each of the
pressure transducers connected to respective first and second
points in a flow restricting element. Other flow sensors may be
implemented such as a hot wire mass airflow sensor.
[0160] In use, a signal representing total flow Qt from the flow
transducer 4274 is received by the processor.
4.4.2.2.8.2 Pressure
[0161] A pressure transducer 4272 in accordance with the present
technology is located in fluid communication with the pneumatic
circuit. An example of a suitable pressure transducer is a sensor
from the HONEYWELL ASDX series. An alternative suitable pressure
transducer is a sensor from the NPA Series from GENERAL
ELECTRIC.
[0162] In use, a signal from the pressure transducer 4272, is
received by the processor. In one form, the signal from the
pressure transducer 4272 is filtered prior to being received by the
processor.
4.4.2.2.8.3 Motor Speed
[0163] In one form of the present technology a motor speed signal
4276 is generated. A motor speed signal 4276 is preferably provided
by therapy device controller 4240. Motor speed may, for example, be
generated by a speed sensor, such as a Hall effect sensor.
4.4.2.2.9 Data Communication Systems 4280
[0164] In one preferred form of the present technology, a data
communication interface 4280 is provided, and is connected to the
processor. Data communication interface 4280 is preferably
connectable to remote external communication network 4282. Data
communication interface 4280 is preferably connectable to local
external communication network 4284. Preferably remote external
communication network 4282 is connectable to remote external device
4286. Preferably local external communication network 4284 is
connectable to local external device 4288.
[0165] In one form, data communication interface 4280 is part of
the processor. In another form, data communication interface 4280
is an integrated circuit that is separate from the processor.
[0166] In one form, remote external communication network 4282 is
the Internet. The data communication interface 4280 may use wired
communication (e.g. via Ethernet, or optical fibre) or a wireless
protocol to connect to the Internet.
[0167] In one form, local external communication network 4284
utilises one or more communication standards, such as Bluetooth, or
a consumer infrared protocol.
[0168] In one form, remote external device 4286 is one or more
computers, for example a cluster of networked computers. In one
form, remote external device 4286 may be virtual computers, rather
than physical computers. In either case, such remote external
device 4286 may be accessible to an appropriately authorised person
such as a clinician.
[0169] Preferably local external device 4288 is a personal
computer, mobile phone, tablet or remote control.
4.4.2.2.10 Output Devices Including Optional Display, Alarms
[0170] An output device 4290 in accordance with the present
technology may take the form of one or more of a visual, audio and
haptic unit. A visual display may be a Liquid Crystal Display (LCD)
or Light Emitting Diode (LED) display.
4.4.2.2.10.1 Display driver 4292
[0171] A display driver 4292 receives as an input the characters,
symbols, or images intended for display on the display 4294, and
converts them to commands that cause the display 4294 to display
those characters, symbols, or images.
4.4.2.2.10.2 Display 4294
[0172] A display 4294 is configured to visually display characters,
symbols, or images in response to commands received from the
display driver 4292. For example, the display 4294 may be an
eight-segment display, in which case the display driver 4292
converts each character or symbol, such as the figure "0", to eight
logical signals indicating whether the eight respective segments
are to be activated to display a particular character or
symbol.
4.4.3 PAP Device Algorithms 4300
4.4.3.1 Pre-Processing Module 4310
[0173] An pre-processing module 4310 in accordance with the present
technology receives as an input, raw data from a transducer, for
example a flow or pressure transducer, and preferably performs one
or more process steps to calculate one or more output values that
will be used as an input to another module, for example a therapy
engine module 4320.
[0174] In one form of the present technology, the output values
include the interface or mask pressure Pm, the respiratory flow Qr,
and the leak flow Ql.
[0175] In various forms of the present technology, the
pre-processing module 4310 comprises one or more of the following
algorithms: pressure compensation algorithm 4312, vent flow
algorithm 4314, leak flow algorithm 4316, respiratory flow
algorithm 4318, and jamming detection algorithm 4319.
4.4.3.1.1 Pressure Compensation
[0176] In one form of the present technology, a pressure
compensation algorithm 4312 receives as an input a signal
indicative of the pressure in the pneumatic path proximal to an
outlet of the pneumatic block. The pressure compensation algorithm
4312 estimates the pressure drop in the air circuit 4170 and
provides as an output an estimated pressure, Pm, in the patient
interface 3000.
4.4.3.1.2 Vent Flow
[0177] In one form of the present technology, a vent flow algorithm
4314 receives as an input an estimated pressure, Pm, in the patient
interface 3000 and estimates a vent flow of air, Qv, from a vent
3400 in a patient interface 3000.
4.4.3.1.3 Leak Flow
[0178] In one form of the present technology, a leak flow algorithm
4316 receives as an input a total flow, Qt, and a vent flow Qv, and
provides as an output a leak flow Ql by calculating an average of
Qt-Qv over a period sufficiently long to include several breathing
cycles, e.g. about 10 seconds.
[0179] In one form, the leak flow algorithm 4316 receives as an
input a total flow, Qt, a vent flow Qv, and an estimated pressure,
Pm, in the patient interface 3000, and provides as an output a leak
flow Ql by calculating a leak conductance, and determining a leak
flow Ql to be a function of leak conductance and pressure, Pm.
Preferably leak conductance is calculated as the quotient of low
pass filtered non-vent flow Qt-Qv, and low pass filtered square
root of pressure Pm, where the low pass filter time constant has a
value sufficiently long to include several breathing cycles, e.g.
about 10 seconds.
4.4.3.1.4 Respiratory Flow 4318
[0180] In one form of the present technology, a respiratory flow
algorithm 4318 receives as an input a total flow, Qt, a vent flow,
Qv, and a leak flow, Ql, and estimates a respiratory flow of air,
Qr, to the patient, by subtracting the vent flow Qv and the leak
flow Ql from the total flow Qt.
4.4.3.2 Therapy Engine Module 4320
[0181] In one form of the present technology, a therapy engine
module 4320 receives as inputs one or more of a pressure, Pm, in a
patient interface 3000, and a respiratory flow of air to a patient,
Qr, and provides as an output, one or more therapy parameters in a
therapy parameter determination process 4329.
[0182] In one form of the present technology, a therapy parameter
is a CPAP treatment pressure Pt.
[0183] In one form of the present technology, a therapy parameter
is one or more of a level of pressure support, and a target
ventilation.
4.4.3.2.1 Phase Determination
[0184] In one form of the present technology, the PAP device 4000
does not determine phase.
[0185] In one form of the present technology, a phase determination
algorithm 4321 receives as an input a signal indicative of
respiratory flow, Qr, and provides as an output a phase of a
breathing cycle of a patient 1000.
[0186] In one form, the phase output is a discrete variable with
values of either inhalation or exhalation.
[0187] In one form, the phase output is a discrete variable with
values of one of inhalation, mid-inspiratory pause, and
exhalation.
[0188] In one form, the phase output is a continuous variable, for
example varying from 0 to 1, or 0 to 2Pi.
[0189] In one form, the phase output is determined to have a
discrete value of inhalation when a respiratory flow Qr has a
positive value that exceeds a positive threshold. In one form, a
phase is determined to have a discrete value of exhalation when a
respiratory flow Qr has a negative value that is more negative than
a negative threshold.
4.4.3.2.2 Waveform Determination
[0190] In one form of the present technology, a control module 4330
controls a therapy device 4245 to provide an approximately constant
positive airway pressure throughout a respiratory cycle of a
patient.
[0191] In one form of the present technology, a control module 4330
controls a therapy device 4245 to provide positive airway pressure
according to a predetermined waveform of pressure vs phase. In one
form, the waveform is maintained at an approximately constant level
for all values of phase. In one form, the waveform is a square
wave, having a higher value for some values of phase, and a lower
level for other values of phase.
[0192] In one form of the present technology a waveform
determination algorithm 4322 receives as an input a value
indicative of current patient ventilation, Vent, and provides as an
output a waveform of pressure vs. phase.
4.4.3.2.3 Ventilation Determination 4323
[0193] In one form of the present technology, a ventilation
determination algorithm 4323 receives an input a respiratory flow
Qr, and determines a measure indicative of patient ventilation,
Vent.
[0194] In one form ventilation determination algorithm 4323
determines a current value of patient ventilation, Vent, as the
half the low-pass filtered absolute value of respiratory flow,
Qr.
4.4.3.2.4 Determination of Inspiratory Flow Limitation
[0195] In one form of the present technology, a processor executes
one or more algorithms for the detection of inspiratory flow
limitation.
[0196] In one form the flow limitation algorithm 4324 receives as
an input a respiratory flow signal Qr and provides as an output a
metric of the extent to which the inspiratory portion of the breath
exhibits inspiratory flow limitation.
[0197] In one form of the present technology, the inspiratory
portion of each breath is identified by a zero-crossing detector. A
number of evenly spaced points (for example, sixty-five),
representing points in time, are interpolated by an interpolator
along the inspiratory flow-time curve for each breath. The curve
described by the points is then scaled by a scaler to have unity
length (duration/period) and unity area to remove the effects of
changing respiratory rate and depth. The scaled breaths are then
compared in a comparator with a pre-stored template representing a
normal unobstructed breath, similar to the inspiratory portion of
the breath shown in FIG. 6a. Breaths deviating by more than a
specified threshold (typically 1 scaled unit) at any time during
the inspiration from this template, such as those due to coughs,
sighs, swallows and hiccups, as determined by a test element, are
rejected. For non-rejected data, a moving average of the first such
scaled point is calculated by processor for the preceding several
inspiratory events. This is repeated over the same inspiratory
events for the second such point, and so on. Thus, for example,
sixty five scaled data points are generated by processor, and
represent a moving average of the preceding several inspiratory
events, e.g. three events. The moving average of continuously
updated values of the (e.g. sixty five) points are hereinafter
called the "scaled flow", designated as Qs(t). Alternatively, a
single inspiratory event can be utilised rather than a moving
average.
[0198] From the scaled flow, two shape factors relating to the
determination of partial obstruction may be calculated.
[0199] Shape factor 1 is the ratio of the mean of the middle (e.g.
thirty-two) scaled flow points to the mean overall (e.g.
sixty-five) scaled flow points. Where this ratio is in excess of
unity, the breath will be taken to be normal. Where the ratio is
unity or less, the breath will be taken to be obstructed. A ratio
of about 1.17 is taken as a threshold between partially obstructed
and unobstructed breathing, and equates to a degree of obstruction
that would permit maintenance of adequate oxygenation in a typical
user.
[0200] Shape factor 2 is calculated as the RMS deviation from unit
scaled flow, taken over the middle (e.g. thirty two) points. An RMS
deviation of about 0.2 units is taken to be normal. An RMS
deviation of zero is taken to be a totally flow-limited breath. The
closer the RMS deviation to zero, the breath will be taken to be
more flow limited.
[0201] Shape factors 1 and 2 may be used as alternatives, or in
combination. In other forms of the present technology, the number
of sampled points, breaths and middle points may differ from those
described above. Furthermore, the threshold values can other than
those described.
4.4.3.2.5 Determination of Apneas and Hypopneas 4325
[0202] In one form of the present technology, a processor executes
one or more algorithms for the determination of the presence of
apneas and/or hypopneas.
[0203] Preferably the one or more algorithms receive as an input a
respiratory flow signal Qr and provide as an output a flag that
indicates that an apnea or respectively an hypopnea has been
detected.
[0204] In one form, an apnea will be said to have been detected
when a function of respiratory flow Qr falls below a flow threshold
for a predetermined period of time. The function may determine a
peak flow, a relatively short-term mean flow, or a flow
intermediate of relatively short-term mean and peak flow, for
example an RMS flow. The flow threshold may be a relatively
long-term measure of flow.
[0205] In one form, a hypopnea will be said to have been detected
when a function of respiratory flow Qr falls below a second flow
threshold for a predetermined period of time. The function may
determine a peak flow, a relatively short-term mean flow, or a flow
intermediate of relatively short-term mean and peak flow, for
example an RMS flow. The second flow threshold may be a relatively
long-term measure of flow. The second flow threshold is greater
than the flow threshold used to detect apneas.
4.4.3.2.6 Determination of Snore
[0206] In one form of the present technology, a processor executes
one or more snore algorithms for the detection of snore.
[0207] In one form the snore algorithm 4326 receives as an input a
respiratory flow signal Qr and provides as an output a metric of
the extent to which snoring is present.
[0208] Preferably the algorithm 4326 comprises the step of
determining the intensity of the flow signal in the range of 30-300
Hz. Further preferably, algorithm 4326 comprises a step of
filtering the respiratory flow signal Qr to reduce background
noise, e.g. the sound of airflow in the system from the blower.
4.4.3.2.7 Determination of Airway Patency
[0209] In one form of the present technology, a processor executes
one or more algorithms for the determination of airway patency.
[0210] In one form, airway patency algorithm 4327 receives as an
input a respiratory flow signal Qr, and determines the power of the
signal in the frequency range of about 0.75 Hz and about 3 Hz. The
presence of a peak in this frequency range is taken to indicate an
open airway. The absence of a peak is taken to be an indication of
a closed airway.
[0211] In one form, the frequency range within which the peak is
sought is the frequency of a small forced oscillation in the
treatment pressure Pt. In one implementation, the forced
oscillation is of frequency 2 Hz with amplitude about 1
cmH.sub.20.
[0212] In one form, airway patency algorithm 4327 receives as an
input a respiratory flow signal Qr, and determines the presence or
absence of a cardiogenic signal. The absence of a cardiogenic
signal is taken to be an indication of a closed airway.
4.4.3.2.8 Determination of Treatment Pressure
[0213] In one form of the present technology, a processor executes
one or more algorithms for the determination of a target treatment
pressure Pt.
[0214] For example, the therapy parameter determination process
4329 receives input such as one of more of the following:
[0215] i. A measure of respiratory phase;
[0216] ii. A waveform;
[0217] iii. A measure of ventilation;
[0218] iv. A measure of inspiratory flow limitation;
[0219] v. A measure of the presence of apnea and/or hypopnea;
[0220] vi. A measure of the presence of snore;
[0221] vii. a sleep stage indication; and
[0222] viii. A measure of the patency of the airway.
[0223] This processing may determine the treatment pressure Pt as a
function of indices or measures of one or more of flow limitation,
apnea, hypopnea, patency, sleep stage and snore and also may
optionally rely on a target ventilation from a target ventilation
determination process 4328. In one implementation, these measures
are determined on a single breath basis, rather than on an
aggregation of several previous breaths.
4.4.3.3 Control Module 4330
[0224] A control module 4330 in accordance with one aspect of the
present technology receives as an input a target treatment pressure
Pt, and controls a therapy device 4245 to deliver that
pressure.
[0225] A control module 4330 in accordance with one aspect of the
present technology receives as an input an EPAP pressure and an
IPAP pressure, and controls a therapy device 4245 to deliver those
respective pressures.
4.4.3.4 Detection of Fault Conditions 4340
[0226] In one form of the present technology, a processor executes
one or more methods for the detection of fault conditions.
Preferably the fault conditions detected by the one or more methods
includes at least one of the following: [0227] Power failure (no
power, or insufficient power) [0228] Transducer fault detection
[0229] Failure to detect the presence of a component [0230]
Operating parameters outside recommended ranges (e.g. pressure,
flow, temperature, PaO.sub.2) [0231] Failure of a test alarm to
generate a detectable alarm signal.
[0232] Upon detection of the fault condition, the corresponding
algorithm signals the presence of the fault by one or more of the
following: [0233] Initiation of an audible, visual &/or kinetic
(e.g. vibrating) alarm [0234] Sending a message to an external
device [0235] Logging of the incident
4.4.3.5 Therapy Device 4245
[0236] In a preferred form of the present technology, the therapy
device 4245 is under the control of the control module 4330 to
deliver therapy to a patient 1000.
[0237] Preferably the therapy device 4245 is a positive air
pressure device 4140.
4.5 Humidifier 5000
4.5.1 Humidifier
[0238] In one form of the present technology there is provided a
humidifier 5000 which may typically include a water reservoir and a
heating plate.
4.6 Serial Number Identification
[0239] FIG. 7 depicts a schematic diagram of a patient records
management system 100. As illustrated, the patient records
management system 100 includes a records management system 110 for
storing one or more records relating to the use of an HME device
130 by a patient 120. The records management system 110 may provide
a centralized database that enables the accessing of the patient's
(120) records over a communication network 160. The records
management system 110 may further be configured to process the
patient's records and generate at-a-glance compliance reports for
the patient. The records management system 110, in one example may
be ResMed's EASYCARE ONLINE.TM. system, but it may also be any type
of patient record management system. The records management system
110 may include one or more database servers, as well as any other
equipment that is commonly found in record management systems
(e.g., NAS drives, UPS devices, network switches, or gateways).
[0240] HME device 130 may be a respiratory treatment device, such
as a continuous positive air pressure (CPAP) device. The HME device
130 may include a processor and a removable medium drive (or port)
for accepting a removable storage medium 170. The removable storage
medium 170 may be an SD card, but in other examples it may be a USB
drive, mini-CD, DVD, or any other type of removable storage medium.
In yet other examples, the removable storage medium may be an RFID
card, a Bluetooth enabled token, or any other token having
short-range wireless capabilities.
[0241] Physician terminal 140 may be a processor-based device
located at various physician premises, such as a hospital, clinic,
or office. The physician terminal may be a computer, smart phone, a
tablet, or another processor based device. The physician terminal
140 may be associated with a physician that is in charge of the
treatment of the patient 120 with the HME device 130.
Alternatively, the terminal 140 may belong to a physician, whose
office the patient incidentally visits, e.g., on the way to
work.
[0242] HME provider terminal 150 may be a device located at the
premises of an HME provider. The HME provider terminal may be a
processor-based device, such as a computer, smart phone, a tablet,
or another processor based device. The HME provider terminal 150
may be associated with an HME provider in charge of dispensing the
HME device 130 to the patient 120. Both the physician terminal 140
and the HME provider terminal 150 may be connected to the records
management system 110 via a communications network 160. In this
example, the network 160 is the Internet, but in other examples the
network 160 may be another type of switched or non-switched network
(e.g. ATM, TCP/IP etc.)
[0243] The removable storage medium 170 may store an identifier for
the HME device, compliance data, and prescription data. Data stored
on the removable storage medium 170 may be uploaded to the records
management system 110 and stored into one or more electronic
records associated with the patient 120. The data may be uploaded
by either one of the physician terminal 140 and the HME provider
terminal 150. More particularly, either one of the terminals 140
and 150 may retrieve data from the removable storage medium 170 and
transmit the retrieved data, over the network, 160, to records
management system 110 for storage in a record associated with the
patient 120.
[0244] Although in this example a removable storage medium is used
to store the identifier for the HME device 130, as well as other
data, in other examples non-removable memory may be used to store
this information, such as RAM or an SSD drive that is part of the
HME device. Furthermore, although in this example data stored in
the HME device 130 is communicated to the terminals 140 and 150 by
physically placing the storage medium 170 into a reader device (or
port) on the terminals, in other examples the data, including the
device identification number, may be communicated via a wireless
connection, such as Bluetooth, Wireless USB, WiFi, GSM or GPRS.
[0245] FIG. 8 depicts a schematic diagram of hardware devices of
the patient records management system 100 in accordance with
another aspect of the disclosure. According to this example, the
records management system 110 may include at least a server 200.
The server 200 may include a processor 210 and memory 220. Memory
220 may store information accessible by processor 210, including
executable code 240 that may be executed by the processor 210. The
memory also includes data 230 that may be retrieved, manipulated or
stored by the processor. The memory may be of any type of
non-transitory tangible media capable of storing information
accessible by the processor, such as a hard-drive, memory card,
ROM, RAM, DVD, CD-ROM, write-capable, and read-only memories. The
processor 210 may be any well-known processor, such as commercially
available processors or any of the processing circuits described in
more detail throughout this specification. Alternatively, the
processor may be a dedicated controller such as an ASIC.
[0246] Data 230 may be retrieved, stored or modified by processor
210 in accordance with the executable code 240. For instance,
although the system and method are not limited by any particular
data structure, the data may be stored in computer registers, in a
relational database as a table having a plurality of different
fields and records, or XML documents. The data may also be
formatted in any computer-readable format such as, but not limited
to, binary values, ASCII or Unicode. Moreover, the data may
comprise any information sufficient to identify the relevant
information, such as numbers, descriptive text, proprietary codes,
pointers, references to data stored in other memories (including
other network locations) or information that is used by a function
to calculate the relevant data.
[0247] The data 230 may include compliance data record 232 and
patient record 234. The compliance data record 232 may include
information related to the usage of the HME device 130 by the
patient 120, such as information identifying time periods during
which the HME device 130 is used; detected respiratory events;
sensor data obtained by the HME device 130, which can include leak
events, minute ventilation, tidal volume and respiratory rate; as
well as information relating to various settings of the HME
device.
[0248] The patient record 234 may include one or more data records
configured to store any type of information related to the
treatment of the patient 120 with the HME device 130. Each data
record may be a file, a database data structure, or any other type
of data structure. As illustrated in FIG. 9, the patient record 234
may include one or more of a "patient information" portion 310, a
"physician information" portion 320, an "HME device information"
portion 330, an "HME provider information" portion 340, and a
permissions structure 350.
[0249] The "patient information" portion 310 may include
information relating to the patient 120, such as a name, address,
age, gender, weight, height, diagnosis, prescription, or any other
information that is commonly found in medical records. The
"physician information" portion 320 may include information
relating to one or more physicians that are associated with the
patient 120. For each physician, the portion 320 may include a
name, address, license number, or any other type of physician
information that is commonly kept in medical records.
[0250] The "HME device information" portion 330 may include
information relating to an HME device that has been assigned to the
patient 120. In this example, the portion 320 may include an
identifier for the HME device 130 (e.g., HME device identifier),
model number, make, firmware version, software version or any other
similar information. Notably, the identifier stored in the portion
330 may be a copy of the identifier 174 that is stored on the
removable storage medium 170. The "HME provider information"
portion 340 may include information to an HME provider that has
dispensed the HME device 130. The information may include an
identifier for the HME Provider (e.g., company name), address,
inventory number for the HME device 130, details of the specific
HME that works with the patient, or any other similar information.
The permission structure 350 may identify one or more users (e.g.,
physicians, HME providers, payers, etc.) that are permitted to
access, modify, and/or share the patient record 234. The permission
structure 350 may be an alphanumerical string, bit string, a text
file, a list or another data structure. Depending on predetermined
arrangements, some of the users may have a limited access to the
patient's data, including only the ability to view the data or to
only to upload new data. Other users may be given full access to
the patient's data, including editing the data. In this example,
the permission structure 350 may associate user log-in names with
specific permission sets. In instances, where the user log-in names
are entity-wide (e.g., one user name for a whole hospital, clinic,
or HME provider) the same permission sets may be granted to all
users who log using the same credential.
[0251] Returning to FIG. 8, in one aspect, the executable code 240
may include an online portal 242 for accessing the records
management system 110. The online portal 242 may interact with the
physician terminal 140 or HME provider terminal 150 to provide
access to patient records that are stored in the records management
system 110. More specifically, the online portal may include
software (e.g., web-services software) for receiving and executing
requests that are transmitted by the terminals 140 and 150 over the
network 160. Such requests may be search requests or requests to
create, access, modify, or share patient records.
[0252] In another aspect, the executable code 240 may include
database server software, such as an SQL server, that is configured
to receive instructions, over the network 160, to retrieve or store
data into the patient record 234. The instructions may be
transmitted by the physician terminal 140 and/or the HME provider
terminal 150. To that end, the compliance data record 232 and
patient record 234 may be implemented as database data structures,
such as tables, records, columns, rows.
[0253] According to another aspect, the executable code 240 may
include software for processing the compliance data record 232 and
generating reports based on the record. The generated reports may
be compliance reports, such as the report 410 that is depicted in
FIG. 10. As illustrated, the reports may identify times at which
the patient was using the HME device 130, the manner in which the
HME device 130 is used, or any other type of information related to
the usage of the HME device 130.
[0254] According to yet another aspect, the executable code 240 may
include an HTTP server for providing users with a webpage for
accessing and interacting with the records management system 110.
In instances where the application 250 is implemented as a
Java.RTM. applet, the web server may transmit (e.g., serve) the
applet to the terminals 140 and 150 when a user of the terminals
has logged in. Once it is started and running on one of the
physician terminal 140 and HME provider terminal 150, the Java.RTM.
applet may start interacting with the online portal 242 to create,
access, modify, or share patient records that are stored by the
records management system 110.
[0255] The removable storage medium 170 may store device
information 172 and compliance data 176. The device information 172
may include a model number for the HME device 130, make of the HME
device 130, firmware version, or any other similar information
related to the HME device. In some instances, the device
information 172 may include an HME device identifier 174. The HME
device identifier 174 may be number, string, alphanumerical string,
or another object that is capable of distinguishing the HME device
from one or more other HME devices. In one aspect, the HME device
identifier 174 may be unique for the records management system 110,
such as an identifier that can be entered only once into the
records management system 110 and be associated with only one HME
device. In another aspect, the HME device identifier 174 may be the
HME device's manufacturer's serial number, the removable storage
medium's 170 manufacturer's serial number, or any other type of
information.
[0256] In one aspect, the HME device identifier 174 may be recorded
on the removable storage medium 170 by the HME device 130 (e.g., by
using a reader/writer that is built into the HME device 130).
Alternatively, the HME device identifier 174 may be recorded onto
the removable storage medium 170 by a physician, HME provider, or
the manufacturer of the HME device 130. In yet another example, the
HME device identifier 174 may be engraved or encoded on an external
surface of a component of the HME device, such as the removable
storage medium 170 such that it may be read by a scanning device
(such as reader device 143, reader device 153, or any other
scanning device). In this way, the HME device identifier 174 may be
encoded or engraved as a bar code, such as a two-dimensional,
three-dimensional, QR code, or any other machine readable code. In
still another example, the HME device identifier may not be stored
on a removable storage medium, but may be encoded or engraved on a
tag that may be attached to the HME device or the patient, such
that the tag may be read by the scanning device. In still other
aspects, the tag may be an RFID enabled ID tag that may be stored
on the patient's person, such as in a wallet or a pocket. In this
way, the patient need not be required to remove the RFID tag from
their wallet or pocket in order to transmit the HME identifier, but
need only be within RFID communication distance. In instances where
the HME device identifier 174 is a manufacturer's serial number for
the HME device 130, the HME device identifier 174 may be generated
in the manner manufacturer serial numbers are normally generated.
In other instances, however, where the HME device identifier 174 is
not a manufacturer's serial number, the HME device identifier 174
may be generated by the records management system 110 and provided
to the HME device, the HME device's 130 manufacturer, a physician,
or an HME provider for recording onto the removable storage medium
170. In such instances, the HME device identifier 174 may be any
type of string, number, or object that is capable of distinguishing
the HME device 130 from the HME device identifiers for other HME
devices that are associated with records stored in the records
management system 110. The HME device identifier 174 may be
distributed by the records management system 110 over the network
160. Although in this example the records management system 110
acts as the issuing authority for the HME device identifier 174, in
other examples the issuing authority may be separate from the
records management system 110.
[0257] The physician terminal 140 may include a memory 141, a
reader device 143, and a processor 144. The memory 141 may include
at least one of volatile memory (e.g., RAM) and non-volatile memory
(e.g., SSD, flash, hard drive. The reader device 143 may be an SD
card reader, CD-ROM reader, RFID receiver, Bluetooth receiver, a
short range wireless receiver, a USB port, a Serial Port, an SATA
port, or any another device that may be used to read information
from the removable storage medium. The processor 144 may be any
type of special-purpose or general-purpose processor, such as FPGA,
x86, or MIPS. The processor 144 may be coupled to both the memory
141 and the reader device 143.
[0258] As illustrated, the physician terminal 140 may store in the
memory 141 a physician information record 142. The physician
information record 142 may be a file, database data structure, or
any other type of data structure that stores information about the
physician associated with the physician terminal 140. As discussed
above with respect to the "physician information" portion 320, the
information stored in the physician information record 142 may
include a name, address, license number, or any other type of
physician information that is commonly kept in medical records.
[0259] The HME provider terminal 150 may include a memory 151, a
reader device 153, and a processor 154. The memory 151 may include
at least one of volatile memory (e.g., RAM) and non-volatile memory
(e.g., SSD, flash, hard drive. The reader device 153 may be an SD
card reader, CD-ROM reader, RFID receiver, Bluetooth receiver, a
short range wireless receiver, a USB port, a Serial Port, an SATA
port, or any another device that may be used to read information
from the removable storage medium. The processor 154 may be any
type of special-purpose or general-purpose processor, such as FPGA,
x86, or MIPS. The processor 154 may be coupled to both the memory
151 and the reader device 153.
[0260] The HME provider terminal 150 may store in the memory 151,
an HME identification record 152. The HME provider identification
record 152 may be a file, database data structure, or any other
type of data structure that stores information about the HME
provider associated with the HME provider terminal 150. As
discussed above with respect to the "HME provider information"
portion 340, the information stored in the record 152 may include
an identifier for the HME Provider (e.g., company name), address,
or any other similar information.
[0261] Both the physician terminal 140 and the HME provider
terminal 150 may execute instances of a record management
application 250. The record management application may include
software for storing and retrieving information from the patient
record 234. For example, the record management application 250 may
be browser-based (e.g., a Java.RTM. applet), standalone, or any
other type of application. When executed on the physician terminal
140, the application 250 may be configured to perform, at least in
part, the process 600 discussed with respect to FIG. 6. When
executed on the HME provider terminal 150, the application 250 may
be configured to perform, at least in part, the process 900
discussed with respect to FIG. 9. Although the terminals 140 and
150 execute different instances of the same software, in other
examples the terminals 140 and 150 may execute different software
applications.
[0262] The record management application 250 may provide users with
an interface 500 for associating the HME device 130 with the
patient record 234. As illustrated in FIG. 11, the interface 500
may include interface components 510-540 and a button 550. Each one
of the interface components 510-540 may be a text input field, a
text output field, or any other type of user interface component
for inputting and/or outputting information (e.g., text or bitmap
data). The interface component 510 may display information that has
been retrieved from the portable removable storage medium 170 by
the terminal executing the application 250 (e.g. physician terminal
140 or HME provider terminal 150). More particularly, the interface
component 510 may display at least some of the device information
172 (data), including, but not limited to, the identifier 174.
[0263] The interface component 520 may be an input field for
entering patient information. Alternatively, the interface
component 520 may be an output field for displaying patient
information that has been retrieved from the patient record 234.
The interface component 530 may be an input field for entering
physician information. Alternatively, the interface component 530
may be an output field for displaying patient information that has
been retrieved from the "physician information" portion 320 of the
patient record 234. As yet another alternative, the component 530
may be an output field for displaying information that is stored in
the physician information record 142.
[0264] The interface component 540 may be an input field for
entering HME provider information. Alternatively, the interface
component 540 may be an output field for displaying HME information
that has been retrieved from the "HME provider record" of patient
record 234. As yet another alternative, the interface component 540
may be an output field for displaying information that is stored in
the HME provider information record 152. The upload button 550 may
be a button that triggers the upload and storage into the patient
record 234 of at least some of the information displayed by any one
of the interface components 510-540. For example, pressing the
button 550 may result in uploading and storing of the identifier
174 that has been copied from the removable storage medium 170.
[0265] FIG. 12 depicts a flowchart of a process 600 related to the
association of the HME device 130 with a patient record. The
process of association is essentially the same, regardless of
whether it is performed at the physician terminal 140 or an HME
provider terminal 150. (FIG. 15 depicts an analogous process
performed at an HME provider terminal 150.) At task 610, a user
logs on to the records management system 110 by using the physician
terminal 140. The user may be an agent of an entity, such as a
hospital, clinic, hospital chain, HME provider organization, or a
physician organization. In this example, the user is a physician.
In one aspect, when logging in, the user may be authenticated using
a credential, such as a log-in name, password and/or a security
certificate. The credential may belong to an entity that the user
is an agent of (e.g., the physician's own practice, clinic or
hospital). Alternatively, the credential may be personal to the
user. After the log in is completed, a user session is initiated at
the records management system 110 for the user.
[0266] At task 620, the HME device identifier 174 is received by
the physician terminal 140. The identifier may be provided to the
system by inserting the removable storage medium 170 into a reader
(or port) on the physician terminal 140 or an HME provider terminal
150. Alternatively, the identifier may be entered manually or even
transmitted by the HME device by using a wireless or wired
connection (e.g., Bluetooth or USB, GSM, GPRS, RFID, NFC, Bluetooth
low energy (BLE), WIFI, etc.), or may be received from a scanning
device. In either instance, the physician terminal 140 (or the HME
provider terminal 150) may retrieve the HME device identifier
without requiring the user to type it.
[0267] In other examples, a scanner, such as a barcode scanner, may
scan a surface (e.g., external) of a component of the HME device
such as the removable storage medium 170, to ascertain the HME
device identifier 174, which may be engraved or encoded on a
surface of the removable storage medium. In yet another example,
the HME device identifier 174 may be retrieved by scanning a tag
with the HME device identifier 174 encoded or engraved thereon, or
the HME identifier may be transmitted from an RFID tag that may be
stored on the patient's person or with the HME device.
[0268] At task 630, an authentication may be performed that
utilizes the removable storage medium 170 (and/or more particularly
the HME device identifier stored on the removable storage medium
170) as a security token or a password for accessing or modifying
at least one of the records stored on the records management system
110. In some instances, the patient records management system 100
may permit the physician terminal 140 to perform the tasks 640-660
(discussed below) only if the physician terminal 140 and the
removable storage medium 170 are collocated. A collocation may be
considered to exist when the removable storage medium 170 is
inserted into, or is otherwise reachable (e.g., via a short-range
wireless connection, such as Bluetooth or RFID) by reader device
143 of the physician terminal 140).
[0269] Put differently, in some instances, the user may be required
to be in physical possession of the removable storage medium 170
before one or more of the tasks 640-660 are executed. This feature
may be useful in situations where a credential of a large
organization (e.g., hospital or hospital chain) is used to log-in
at task 610 and accesses to records associated with a given HME
device is wanted to be restricted only to select few of the
organization's employees (or agents). Notably, according to this
example, the same removable storage medium that is used by the HME
device 130 to collect compliance data may also be used as a
hardware security token by (healthcare) entities, such as
hospitals, physician practices, or HME providers. Thus, the
entities may use the removable storage medium 170 to gain
authorization to create, access, modify, or share records in the
records management system 110 that are associated with the HME
device 130.
[0270] In other instances, however, collocation between the
removable storage medium 170 and the physician terminal 140 may not
be required for the execution of the process 600 to proceed. In
such instances, the HME device identifier obtained at task 620 may
be used as a software token without the physical location of the
removable storage medium 170 being accorded any significance. In
either instance, however, at task 630, the HME device identifier
received at task 620 may be validated and only upon a positive
validation may the execution of at least one of tasks 640-660 be
permitted to proceed.
[0271] In one aspect, the validation may include transmitting the
identifier to a remote server (e.g., server 200) and receiving a
response from the remote server that includes information about an
HME device that is associated with the identifier. For example, the
response may include information indicating the make, model number,
and/or serial number of the associated HME device. The information
from the response may be compared to information stored on the
removable storage medium 170 and if there is a match, the serial
number may be considered valid. In another aspect, the validation
may include computing a hash code of the identifier, or using
another similar approach, to ensure that the identifier retrieved
from the removable storage medium 170 has not been corrupted. In
yet another aspect, the validation may include ascertaining that
the HME device identifier possesses a property that is known (or
required) to be possessed by all valid HME device identifiers. In
some instances, the execution of the process 600 may proceed to
task 630 only if the identifier provided at task 610 is
successfully validated.
[0272] At task 640, the physician terminal 140 searches the records
management system 110 for a patient record associated with the HME
device identifier 174. The search may involve submitting a search
query to the server 200 with the search key being at least
partially based on the HME device identifier 174 (e.g., the
identifier 174 being used as a search key). In some instances, the
search query may be generated automatically by the physician
terminal 140, without the terminal's user having to manually type
the HME device identifier 174 or the query itself. In some
instances, the terminal 140 may transmit the search query only if
the terminal 140 is collocated with the removable storage
medium.
[0273] If the search fails to return a patient record associated
with the HME device identifier, task 650 is executed and a new
record is created and associated with the HME device 130.
Alternatively, a search may be performed based on the patient's
name and manually assign a device to the respective patient record.
Otherwise, if the search returns a patient record, at task 660, the
returned record is modified to identify, depending on the entity
providing the memory device and the identification number, either
the physician associated with the physician terminal 140 or the HME
associated with the respective HME provider terminal 150. This
identification is also referred to as an association. Whilst such
as automatic association of the patient's record with the entity
providing the HME device identifier can be effected during or after
providing access or editing rights to the entity, it is best if it
is effected before the provision of such an access. After a
physician or an HME is associated with the patient record, they
have access to it and can view and/or edit the record.
[0274] FIG. 13 depicts a flowchart of a process 700 associated with
the creation of a new record for the patient 120 and associating
that record with: (1) an HME device and (2) a physician (or another
entity) in charge of a patient's treatment with the HME device. The
process 700 may be executed, e.g. at step 650 of the process 600,
in situations where a patient has already visited an HME, however
no patient record has been created on the record management system
at the time when later the patient visits the physician's office.
As discussed above, the physician may first log onto the record
management system, and perform a search based on the HME device
identifier that is stored on the removable storage device. The
records management system may receive the identification number of
the HME device and check if the number is already registered to one
of the patient records that are stored in the records management
system 110. As in this example no such a record has been previously
created by the HME provider, the physician has to create a new
patient record in the record management system. Process 700
provides the details of the process of creating such a new
record.
[0275] At task 710, a new record is allocated under the patient's
name. In one aspect, the allocation may include the physician
terminal 140 transmitting, over the network 160, a query (e.g., a
database query or another type of query) to the server 200
instructing it to create a new patient record under the name of the
patient 120. The query may include the patient's name or any other
type of patient information as a parameter.
[0276] At task 720, the HME device identifier 174 is copied
automatically from the removable storage medium 170 to the
newly-created patient record. The automatic copying of the HME
device identifier 174 removes the need for an operator to manually
type the device identifier, and thus eliminates the possibility of
a typographical error being introduced when the HME device
identifier 174 is copied. The copying may include the physician
terminal 140 transmitting, over the network 160, a query to the
server 200 instructing it to store the HME device identifier into
the newly-created patient record. The HME device identifier 174 may
be transmitted as part of the query.
[0277] At task 730, the physician terminal 140 receives a user
input identifying a preferred physician location and stores an
indication of the preferred location into the patient record. The
indication may be stored by transmitting a query, over the network
160, from the physician terminal 140 to the server 200. Task 730
may be executed only when there are multiple physician locations
identified in the physician information record 142 that is stored
on the physician terminal 140. Alternatively, instead of receiving
a manually entered user input, the system may be arranged to
automatically detect and record the location choice, based on
information associated with a location of the physician terminal
140 or a server associated with the physician terminal 140.
[0278] At task 740, at least a part of the physician information
record 142 is automatically copied into the patient record. The
copied information may include physician name, address, license
number, telephone number, or any other type of physician
information that is normally kept in medical records. The
information may be stored into the patient record by transmitting a
query, over the network 160, from the physician terminal 140 to the
server 200. The automatic copying of physician information removes
the need for an operator to enter physician's information manually
every time a patient is associated with an HME device.
[0279] At task 750, permissions structure 350 is modified to permit
the physician associated with the physician's terminal 140 to
access, modify, or share the newly-created patient's file. Thus,
the physician is automatically associated with the patient's record
and obtains certain rights to access and/or edit data in the
record.
[0280] FIG. 14 depicts a flowchart of a process 800 associated with
the updating of a record associated with the HME device 130 to
include information about the physician in charge of the patient's
120 treatment. The process 800 may be executed, e.g. at step 660 of
the process 600, in situations where a patient visits the
physician's office after an HME provider has created a patient
record in a database of the records management system 110 and
associated that record with the HME device identifier 174.
Generally, access is granted to a medical entity (a physician or an
HME) who is in possession of the SD card and, therefore, in
possession of the device identification number. In this sense the
identification number on the SD card is the key for accessing the
patient record.
[0281] At task 810, a database record is retrieved responsive to
the search performed at task 630. In this example, the physician
terminal 140 receives a handle (or identifier) for a patient record
in the records management system 110 that is associated with the
provided HME device identifier 174. In other examples, however, the
physician terminal 140 may receive a copy of the identified
record.
[0282] At task 820, a determination is made whether the user that
is logged on (e.g., the physician associated with the physician
terminal 140) is permitted to modify the retrieved record. If the
physician is already associated with the patient record by the HME
or another entity, the physician is permitted to modify the
retrieved record. The determination may be made, for example, based
on (i) a permissions structure, such as the structure 350 and (ii)
a log-in name (or another credential) used by the physician to
log-in at task 610. If the physician is pre-authorized to modify
the retrieved patient file, task 840 may be executed. Otherwise the
execution of the process 800 proceeds to task 830, where the
physician verifies the patient's identity to ensure that the
retrieved record is for the same patient that is being treated by
the physician.
[0283] At task 830, it is determined whether the retrieved record
belongs to the patient 120 (e.g., the patient that provided the
removable storage medium 170 to a physician or a HME provider).
Upon finding a match, the server 200 modifies the permissions
structure associated with the retrieved patient record to permit
the user associated with the physician terminal 140 to access,
share, and/or modify the retrieved data object. If a match is not
found, the user is refused permission to modify the retrieved
patient record and the process 800 terminates.
[0284] At task 840, at least a part of the physician information
record 142 is automatically copied into the patient record. The
copied information may include physician name, address, license
number, telephone number, or any other type of physician
information that is normally kept in medical records. The
information may be stored into the patient record by transmitting a
query, over the network 160, from the physician terminal 140 to the
server 200. Task 840 may be executed only if the physician
associated with the physician terminal 140 is permitted to modify
the retrieved data structure.
[0285] FIG. 15, depicts a flowchart of a process 900 related the
association of the HME device 130 with a patient record. As
mentioned in relation to FIG. 12, the process of association is the
essentially the same, regardless of whether it is performed at the
physician terminal 140 or an HME provider terminal 150.
[0286] At task 910 a representative of an HME provider (e.g., HME
provider employee) logs onto the records management system 110. At
task 920, the HME device identifier 174 is received by the HME
provider terminal 150. The identifier may be provided by physically
removing the removable storage medium 170 from the HME device 130
and inserting it into a reader (or port) on the HME provider
terminal 150. Alternatively, the identifier may be transmitted by
the HME device to the HME provider terminal by using a wireless or
wired connection (e.g., Bluetooth or USB).
[0287] At task 930, an authentication is performed that utilizes
the removable storage medium 170 (and/or the HME device identifier
174 stored on the removable storage medium 170) as a security token
for accessing the records management system 110. Task 930 is
identical to task 630. At task 940, the HME provider terminal 150
searches the records management system 110 for a patient record
associated with the HME device identifier 174. The search may
involve submitting a search query to the server 200 with the search
key being at least partially based on the HME device identifier
174. In some instances, the search query may be generated
automatically by the HME provider terminal 150 without the
terminal's user having to manually type the HME device identifier
174 or the search query. If the search fails to return a patient
record associated with the HME device identifier, task 950 is
executed and a new record is created for the patient 120.
Otherwise, if the search returns a patient record, at task 960, the
returned record is modified to identify, depending on the entity
providing the memory device and the identification number, either
the physician associated with the physician terminal 140 or the HME
associated with the respective HME provider terminal 150. This
identification is also referred to as an association. After a
physician or an HME is associated with the patient record, they
have access to it and can view and/or edit the record.
[0288] FIG. 16 depicts a flowchart of a process 10-1000 associated
with the creation of a new record for the patient 120 and
associating that record with: (1) the HME device 130 and (2) an HME
provider dispensing the HME device 130. The process 10-1000 may be
executed, e.g. at step 950 of the process 900, in situations where
a patient visits HME provider prior to visiting a physician's
office to obtain guidance on how to use the device.
[0289] At task 10-1010, a new record is allocated under the
patient's name. In one aspect, the allocation may include the HME
provider terminal 150 transmitting, over the network 160, a query
to the server 200 instructing it to create a new patient record
under the name of the patient 120. The query may include the
patient's name or any other type of patient information.
[0290] At task 10-1020, the HME device identifier 174 is
automatically copied from the removable storage medium 170 to the
patient record. The automatic copying dispenses with the need to
manually type the device identifier into the HME provider terminal
150, and thus eliminates the possibility of a typographical error
being introduced.
[0291] At task 10-1030, the HME provider terminal 150 receives a
user input identifying a preferred HME provider location and stores
an indication of the preferred location into the newly-created
patient record. The indication may be stored by transmitting a
query, over the network 160, from the HME provider terminal 150 to
the server 200 instructing the server 200 to store the preferred
location into the patient record. Task 10-1030 may be executed only
when HME provider locations are identified in the HME provider
information record 152. Alternatively, instead of receiving a
manually entered user input, the system may be arranged to
automatically detect and record the location choice, based on
information associated with a location of the HME provider terminal
150 or a server associated with the HME provider terminal 150.
[0292] At task 10-1040, at least a part of the HME provider
information record 152 is automatically copied into the patient
record. The copied information may include an identifier for the
HME Provider (e.g., company name), address, or any other similar
information. The information may be stored into the patient record
by transmitting a query, over the network 160, from the HME
provider terminal to the server 200. The automatic copying of
physician information dispenses with the need for an operator to
enter the HME provider's information manually every time a patient
is associated with an HME device.
[0293] At task 10-1050, permissions structure 350 is modified to
permit the HME provider associated with the HME provider terminal
150 to access, modify, or share the newly-created patient's file.
Thus, the HME provider is automatically associated with the
patient's record and obtains certain rights to access and/or edit
data in the record.
[0294] FIG. 17 depicts a flowchart of a process 10-1100 associated
with the updating of a record associated with the HME device 130 to
include information about the HME provider dispensing the device.
The process 10-1100 may be executed, e.g. at step 960 of the
process 900, in situations where a patient visits the HME
provider's office after a physician has created a patient record in
the records management system 110 and associated that record with
the HME device.
[0295] At task 10-1110, a database record is retrieved responsive
to the search performed at task 930. In this example, the HME
provider terminal 150 receives a handle (or identifier) for a
patient record in the records management system 110 that is
associated with the HME device identifier 174. In other examples,
however, the HME provider terminal may receive a copy of the
identified record.
[0296] At task 10-1120, a determination is made whether the user
that is logged on (e.g., the HME provider) is permitted to modify
the retrieved record. If the HME provider is already associated
with the patient record by the physician or another entity, the HME
provider is permitted to modify the retrieved record. The
determination may be made, for example, based on (i) a permissions
structure, such as the structure 350 and (ii) a log-in name (or
another credential) used by the HME provider to log-in at task 910.
If the HME provider is pre-authorized to modify the retrieved
patient file, task 10-1140 may be executed. Otherwise the execution
of the process 800 proceeds to task 10-1130, where the HME provider
verifies the patient's identity to ensure that the retrieved record
is for the same patient that is being treated by the physician.
[0297] At task 10-1130, it is determined whether the retrieved
record belongs to the patient 120 (e.g., the patient that provided
the removable storage medium 170 to a physician or a HME
provider.). Upon finding a match, modifying, by the server 200, the
permissions structure associated with the retrieved patient record
to permit the user associated with the HME provider terminal 150 to
access, share, and/or modify the retrieved data object. If a match
is not found, the user is refused permission to modify the
retrieved patient record, and the process 10-1100 terminates.
[0298] At task 10-1140, at least a part of the HME provider
information record 152 may be automatically copied into the patient
record. The copied information may include HME provider name,
organization address, telephone number, or any other type of
physician information that is normally kept in medical records. The
information may be stored into the patient record by transmitting a
query, over the network 160, from the HME provider terminal 150 to
the server 200. Task 10-1140 may be executed only if the HME
provider associated with the HME provider terminal 150 is permitted
to modify the retrieved data structure.
[0299] FIG. 18A depicts a flowchart of a process 10-1200A
associated with the verification of a patient's identity by a user,
in accordance with one example of task 830 or 10-1130. The user may
be a physician using the physician terminal 140 (step 830) or an
HME provider using the HME provider terminal 150 (step 10-1130).
The process 10-1200A may be performed to ensure that the record
retrieved by the search performed at task 640 or 940 belongs to the
user associated with the HME device 130 (e.g., the user or patient
120). Executing the process 10-1200A may prevent physicians or HME
providers from modifying the wrong patient record in the records
management system 110.
[0300] At task 10-1210A, one or more items of information are
retrieved from the record retrieved at task 640 (or 940) and
presented to the user. The items of information may include patient
name, patient address, age, date of birth, social security number,
or other similar information. At task 10-1220A, user input is
received indicating whether the presented information belongs to
the patient 120. For example, the information may be displayed on a
display screen of a terminal together with a "Yes" and "No" buttons
and the user may be permitted to click on one of those buttons to
indicate whether the displayed information matches that of the
patient 120. If the indication is positive, at task 10-1230A the
user is granted permission to modify, access, or share the record
retrieved at task 640 (or 940). In instances where the user has
logged in using an entity-wide credential, permission may be
granted to the whole entity. Otherwise, if the user input indicates
that the presented information does not belong to the patient 120,
permission is denied at task 10-1240A.
[0301] FIG. 18B depicts a flowchart of a process 10-1200B
associated with the verification of a patient's identity by a user,
in accordance with another example of tasks 830 and 10-1130. In
this example, the user is required to use an item of information
about the patient 120 as a password. Furthermore, in this example,
the user may be denied permission to view or otherwise access the
record retrieved at task 640 (or 940) until the process 10-1200B is
completed successfully. The process 10-1200B may be executed by one
of the terminals 140 and 150, by the server 200, or by both the
server 200 and one of the terminals 140-150.
[0302] At task 10-1210B, the user is required to provide a first
item of information about the patient 120 (e.g., name, age,
address, etc.) At task 10-1220B, an indication of the first item of
information is received as user input. At task 10-1230B, a second
item of information is obtained from the record obtained at task
640 (or 940). The second item of information may be of the same
type as the first item. That is, if the first item is a patient
name, then the second item may also be a patient name or if the
first item is patient social security number, then the second item
may also be a social security number. At task 10-1240B, a
determination is made whether the first item matches the second
item of information. The two items of information are identical or
otherwise satisfy a predetermined condition that specifies what it
means for two information items to match. If the two items of
information match, task 10-1250B is executed and the user is
granted permission to modify, access, or share the record retrieved
at task 640 (or 940). As discussed above, in instances where the
user has logged in using an entity-wide credential, permission may
be granted to the whole entity. Otherwise, if the two items do not
match, permission is denied at task 10-1260B.
[0303] FIGS. 12-18B are provided as an example. At least some of
the tasks associated with FIGS. 12-18B may be performed in a
different order than represented, performed concurrently or
altogether omitted. Furthermore, some or all of the tasks discussed
with respect to processes 600 to 10-1100 may be combined together
into a single embodiment. For instance, although in the above
example three layers of authentication are used, namely at tasks
610/910, 630/930, and 830/10-1130, in other examples none or fewer
of those authentication layers may be employed. For example, as
indicated by the dashed lines of their respective blocks, the
execution of tasks 630/930 may be optional. That is, in some
instances, the process 600/900 may be executed without the
removable storage medium 170 (or the HME device identifier 174
stored on the removable storage medium 170) being used for
authentication purposes. In another example, the removable storage
medium 170 or the HME device identifier stored on the removable
storage medium 170 may be only informally used as an authentication
mechanism. In such situations, the authentication discussed with
respect to task 610/910 may have to be performed successfully in
order for the user to be permitted to execute one or more of the
remaining tasks or subtasks in the process 600/900. In yet another
example, the authentication mechanism discussed with respect to
tasks 830/10-1130 may be the only authentication mechanism
used.
[0304] In some instances, the determination whether a user should
be permitted to execute one or more of the tasks associated with
process 600/900, in accordance with any one of the authentication
mechanisms discussed with respect to tasks 610/910, 630/930, and
830/10-1130, may be made by the records management system 110, in
other instances the determination may be made on the
client-device-end (e.g., by the terminal 140 or the terminal 150).
It should be understood that, in some instances, at least some of
the tasks or subtasks associated with the processes 600 and 900 may
be executed using one of the processors 144 and 154. Moreover, in
some instances, at least some of the tasks or subtasks associated
with the processes 600 and 900 may be executed by the records
management application 250.
[0305] Although in the above examples, tasks 710-750 are executed
by making remote calls to the records management system 110 to
include and modify the patient record 234, in other examples tasks
710-750, 810, 840, 10-1010-1050, 10-1110, and 10-1140 may executed
by creating a record (e.g., a text file, database table, or another
data structure) in local memory, modifying the record while it is
still in local memory, and then uploading the record to the server
200. In that regard, the patient record 234 is not limited to being
a database record, and rather it can be any other file or data
structure capable of storing the information discussed above. The
disclosure is not limited to any particular type of data record or
method for modifying data records.
[0306] Although the portions 310-360 of the patient record 234 are
depicted in FIG. 9 as integrated together in the same data
structure, in other examples they may be independent data
structures. Furthermore, in other examples, the patient record 234
may be a text file, or another type of file, that is not part of a
relational database. In such instances, the executable code 240 may
include any software for accessing or modifying that file. The
disclosure is not limited to any particular implementation of the
records storage aspects of the record management system.
[0307] Although in this example the server 200 is described as
performing a plurality of functions by itself, in other examples
the functions of the server 200 may be distributed among multiple
servers that are part of the records management system 110. For
example, the HTTP server discussed above may be executed on a
different device (and not on the server 200). As another example,
the database (or another similar system) that is used to store the
patient records may also be implemented on a different device (and
not on the server 200). To that end, although in the above examples
the records management system 110 is depicted as including a single
server, in other examples the records management system 110 may
include multiple servers (dedicated to performing different
functions), load balancers, network switches, or any other similar
equipment that is normally associated with record management
systems.
[0308] As these and other variations and combinations of the
features discussed above can be utilized without departing from the
subject matter as defined by the claims, the foregoing description
of exemplary aspects should be taken by way of illustration rather
than by way of limitation of the subject matter as defined by the
claims. It will also be understood that the provision of the
examples described herein (as well as clauses phrased as "such as,"
"e.g.", "including" and the like) should not be interpreted as
limiting the claimed subject matter to the specific examples;
rather, the examples are intended to illustrate only some of many
possible aspects.
4.7 Glossary
[0309] For the purposes of the present technology disclosure, in
certain forms of the present technology, one or more of the
following definitions may apply. In other forms of the present
technology, alternative definitions may apply.
4.7.1 General
[0310] Air: In certain forms of the present technology, air
supplied to a patient may be atmospheric air, and in other forms of
the present technology atmospheric air may be supplemented with
oxygen.
[0311] Continuous Positive Airway Pressure (CPAP): CPAP treatment
will be taken to mean the application of a supply of air or
breathable gas to the entrance to the airways at a pressure that is
continuously positive with respect to atmosphere, and preferably
approximately constant through a respiratory cycle of a patient. In
some forms, the pressure at the entrance to the airways will vary
by a few centimeters of water within a single respiratory cycle,
for example being higher during inhalation and lower during
exhalation. In some forms, the pressure at the entrance to the
airways will be slightly higher during exhalation, and slightly
lower during inhalation. In some forms, the pressure will vary
between different respiratory cycles of the patient, for example
being increased in response to detection of indications of partial
upper airway obstruction, and decreased in the absence of
indications of partial upper airway obstruction.
4.7.2 Aspects of PAP Devices
[0312] Air circuit: A conduit or tube constructed and arranged in
use to deliver a supply of air or breathable gas between a PAP
device and a patient interface. In particular, the air circuit may
be in fluid connection with the outlet of the pneumatic block and
the patient interface. The air circuit may be referred to as air
delivery tube. In some cases there may be separate limbs of the
circuit for inhalation and exhalation. In other cases a single limb
is used.
[0313] APAP: Automatic Positive Airway Pressure. Positive airway
pressure that is continually adjustable between minimum and maximum
limits, depending on the presence or absence of indications of SDB
events.
[0314] Blower or flow generator: A device that delivers a flow of
air at a pressure above ambient pressure.
[0315] Controller: A device, or portion of a device that adjusts an
output based on an input. For example one form of controller has a
variable that is under control--the control variable--that
constitutes the input to the device. The output of the device is a
function of the current value of the control variable, and a set
point for the variable. A servo-ventilator may include a controller
that has ventilation as an input, a target ventilation as the set
point, and level of pressure support as an output. Other forms of
input may be one or more of oxygen saturation (SaO.sub.2), partial
pressure of carbon dioxide (PCO.sub.2), movement, a signal from a
photoplethysmogram, and peak flow. The set point of the controller
may be one or more of fixed, variable or learned. For example, the
set point in a ventilator may be a long term average of the
measured ventilation of a patient. Another ventilator may have a
ventilation set point that changes with time. A pressure controller
may be configured to control a blower or pump to deliver air at a
particular pressure.
[0316] Therapy: Therapy in the present context may be one or more
of positive pressure therapy, oxygen therapy, carbon dioxide
therapy, control of dead space, and the administration of a
drug.
[0317] Motor: A device for converting electrical energy into rotary
movement of a member. In the present context the rotating member is
an impeller, which rotates in place around a fixed axis so as to
impart a pressure increase to air moving along the axis of
rotation.
[0318] Positive Airway Pressure (PAP) device: A device for
providing a supply of air at positive pressure to the airways.
[0319] Transducers: A device for converting one form of energy or
signal into another. A transducer may be a sensor or detector for
converting mechanical energy (such as movement) into an electrical
signal. Examples of transducers include pressure sensors, flow
sensors, carbon dioxide (CO.sub.2) sensors, oxygen (O.sub.2)
sensors, effort sensors, movement sensors, noise sensors, a
plethysmograph, and cameras.
[0320] Volute: The casing of the centrifugal pump that receives the
air being pumped by the impeller, slowing down the flow rate of air
and increasing the pressure. The cross-section of the volute
increases in area towards the discharge port.
4.7.3 Aspects of the Respiratory Cycle
[0321] Apnea: Preferably, apnea will be said to have occurred when
flow falls below a predetermined threshold for a duration, e.g. 10
seconds. An obstructive apnea will be said to have occurred when,
despite patient effort, some obstruction of the airway does not
allow air to flow. A central apnea will be said to have occurred
when an apnea is detected that is due to a reduction in breathing
effort, or the absence of breathing effort.
[0322] Breathing rate: The rate of spontaneous respiration of a
patient, usually measured in breaths per minute.
[0323] Duty cycle: The ratio of inhalation time, Ti to total breath
time, Ttot.
[0324] Effort (breathing): Preferably breathing effort will be said
to be the work done by a spontaneously breathing person attempting
to breathe.
[0325] Expiratory portion of a breathing cycle: The period from the
start of expiratory flow to the start of inspiratory flow.
[0326] Flow limitation: Preferably, flow limitation will be taken
to be the state of affairs in a patient's respiration where an
increase in effort by the patient does not give rise to a
corresponding increase in flow. Where flow limitation occurs during
an inspiratory portion of the breathing cycle it may be described
as inspiratory flow limitation. Where flow limitation occurs during
an expiratory portion of the breathing cycle it may be described as
expiratory flow limitation.
[0327] Types of flow limited inspiratory waveforms:
[0328] (i) Flattened: Having a rise followed by a relatively flat
portion, followed by a fall.
[0329] (ii) M-shaped: Having two local peaks, one at the leading
edge, and one at the trailing edge, and a relatively flat portion
between the two peaks.
[0330] (iii) Chair-shaped: Having a single local peak, the peak
being at the leading edge, followed by a relatively flat
portion.
[0331] (iv) Reverse-chair shaped: Having a relatively flat portion
followed by single local peak, the peak being at the trailing
edge.
[0332] Hypopnea: Preferably, a hypopnea will be taken to be a
reduction in flow, but not a cessation of flow. In one form, a
hypopnea may be said to have occurred when there is a reduction in
flow below a threshold for a duration. In one form in adults, the
following either of the following may be regarded as being
hypopneas:
(i) a 30% reduction in patient breathing for at least 10 seconds
plus an associated 4% desaturation; or (ii) a reduction in patient
breathing (but less than 50%) for at least 10 seconds, with an
associated desaturation of at least 3% or an arousal.
[0333] Hyperpnea: An increase in flow to a level higher than normal
flow.
[0334] Inspiratory portion of a breathing cycle: Preferably the
period from the start of inspiratory flow to the start of
expiratory flow will be taken to be the inspiratory portion of a
breathing cycle.
[0335] Patency (airway): The degree of the airway being open, or
the extent to which the airway is open. A patent airway is open.
Airway patency may be quantified, for example with a value of one
(1) being patent, and a value of zero (0), being closed.
[0336] Positive End-Expiratory Pressure (PEEP): The pressure above
atmosphere in the lungs that exists at the end of expiration.
[0337] Peak flow (Qpeak): The maximum value of flow during the
inspiratory portion of the respiratory flow waveform.
[0338] Respiratory flow, airflow, patient airflow, respiratory
airflow (Qr): These synonymous terms may be understood to refer to
the PAP device's estimate of respiratory airflow, as opposed to
"true respiratory flow" or "true respiratory airflow", which is the
actual respiratory flow experienced by the patient, usually
expressed in litres per minute.
[0339] Tidal volume (Vt): The volume of air inhaled or exhaled
during normal breathing, when extra effort is not applied.
[0340] (inhalation) Time (Ti): The duration of the inspiratory
portion of the respiratory flow waveform.
[0341] (exhalation) Time (Te): The duration of the expiratory
portion of the respiratory flow waveform.
[0342] (total) Time (Ttot): The total duration between the start of
the inspiratory portion of one respiratory flow waveform and the
start of the inspiratory portion of the following respiratory flow
waveform.
[0343] Typical recent ventilation: The value of ventilation around
which recent values over some predetermined timescale tend to
cluster, that is, a measure of the central tendency of the recent
values of ventilation.
[0344] Upper airway obstruction (UAO): includes both partial and
total upper airway obstruction. This may be associated with a state
of flow limitation, in which the level of flow increases only
slightly or may even decrease as the pressure difference across the
upper airway increases (Starling resistor behaviour).
[0345] Ventilation (Vent): A measure of the total amount of gas
being exchanged by the patient's respiratory system, including both
inspiratory and expiratory flow, per unit time. When expressed as a
volume per minute, this quantity is often referred to as "minute
ventilation". Minute ventilation is sometimes given simply as a
volume, understood to be the volume per minute.
4.7.4 PAP Device Parameters
[0346] Flow rate: The instantaneous volume (or mass) of air
delivered per unit time. While flow rate and ventilation have the
same dimensions of volume or mass per unit time, flow rate is
measured over a much shorter period of time. Flow may be nominally
positive for the inspiratory portion of a breathing cycle of a
patient, and hence negative for the expiratory portion of the
breathing cycle of a patient. In some cases, a reference to flow
rate will be a reference to a scalar quantity, namely a quantity
having magnitude only. In other cases, a reference to flow rate
will be a reference to a vector quantity, namely a quantity having
both magnitude and direction. Flow will be given the symbol Q.
Total flow, Qt, is the flow of air leaving the PAP device. Vent
flow, Qv, is the flow of air leaving a vent to allow washout of
exhaled gases. Leak flow, Ql, is the flow rate of unintentional
leak from a patient interface system. Respiratory flow, Qr, is the
flow of air that is received into the patient's respiratory
system.
[0347] Leak: Preferably, the word leak will be taken to be a flow
of air to the ambient. Leak may be intentional, for example to
allow for the washout of exhaled CO.sub.2. Leak may be
unintentional, for example, as the result of an incomplete seal
between a mask and a patient's face.
[0348] Noise, conducted: (how measured, typical values)
[0349] Noise, transmitted: (how measured, typical values)
[0350] Pressure: Force per unit area. Pressure may be measured in a
range of units, including cmH.sub.2O, g-f/cm.sup.2, hectopascal.
1cmH.sub.2O is equal to 1 g-f/cm.sup.2 and is approximately 0.98
hectopascal. In this specification, unless otherwise stated,
pressure is given in units of cmH.sub.2O. For nasal CPAP treatment
of OSA, a reference to treatment pressure is a reference to a
pressure in the range of about 4-20 cmH.sub.2O, or about 4-30
cmH.sub.2O. The pressure in the patient interface is given the
symbol Pm.
[0351] Sound Power: The energy per unit time carried by a sound
wave. The sound power is proportional to the square of sound
pressure multiplied by the area of the wavefront. Sound power is
usually given in decibels SWL, that is, decibels relative to a
reference power, normally taken as 10.sup.-12 watt.
[0352] Sound Pressure: The local deviation from ambient pressure at
a given time instant as a result of a sound wave travelling through
a medium. Sound power is usually given in decibels SPL, that is,
decibels relative to a reference power, normally taken as
20.times.10.sup.-6 pascal (Pa), considered the threshold of human
hearing.
4.7.5 Terms for Ventilators
[0353] Adaptive Servo-Ventilator: A ventilator that has a
changeable, rather than fixed target ventilation. The changeable
target ventilation may be learned from some characteristic of the
patient, for example, a respiratory characteristic of the
patient.
[0354] Backup rate: A parameter of a ventilator that establishes
the minimum respiration rate (typically in number of breaths per
minute) that the ventilator will deliver to the patient, if not
otherwise triggered.
[0355] Cycled: The termination of a ventilator's inspiratory phase.
When a ventilator delivers a breath to a spontaneously breathing
patient, at the end of the inspiratory portion of the breathing
cycle, the ventilator is said to be cycled to stop delivering the
breath.
[0356] EPAP (or EEP): a base pressure, to which a pressure varying
within the breath is added to produce the desired mask pressure
which the ventilator will attempt to achieve at a given time.
[0357] IPAP: desired mask pressure which the ventilator will
attempt to achieve during the inspiratory portion of the
breath.
[0358] Pressure support: A number that is indicative of the
increase in pressure during ventilator inspiration over that during
ventilator expiration, and generally means the difference in
pressure between the maximum value during inspiration and the
minimum value during expiration (e.g., PS=IPAP-EPAP). In some
contexts pressure support means the difference which the ventilator
aims to achieve, rather than what it actually achieves.
[0359] Servo-ventilator: A ventilator that measures patient
ventilation has a target ventilation, and which adjusts the level
of pressure support to bring the patient ventilation towards the
target ventilation.
[0360] Spontaneous/Timed (S/T)--A mode of a ventilator or other
device that attempts to detect the initiation of a breath of a
spontaneously breathing patient. If however, the device is unable
to detect a breath within a predetermined period of time, the
device will automatically initiate delivery of the breath.
[0361] Swing: Equivalent term to pressure support.
[0362] Triggered: When a ventilator delivers a breath of air to a
spontaneously breathing patient, it is said to be triggered to do
so at the initiation of the respiratory portion of the breathing
cycle by the patient's efforts.
[0363] Ventilator: A mechanical device that provides pressure
support to a patient to perform some or all of the work of
breathing.
4.7.6 Anatomy of the Respiratory System
[0364] Diaphragm: A sheet of muscle that extends across the bottom
of the rib cage. The diaphragm separates the thoracic cavity,
containing the heart, lungs and ribs, from the abdominal cavity. As
the diaphragm contracts the volume of the thoracic cavity increases
and air is drawn into the lungs.
[0365] Larynx: The larynx, or voice box houses the vocal folds and
connects the inferior part of the pharynx (hypopharynx) with the
trachea.
[0366] Lungs: The organs of respiration in humans. The conducting
zone of the lungs contains the trachea, the bronchi, the
bronchioles, and the terminal bronchioles. The respiratory zone
contains the respiratory bronchioles, the alveolar ducts, and the
alveoli.
[0367] Nasal cavity: The nasal cavity (or nasal fossa) is a large
air filled space above and behind the nose in the middle of the
face. The nasal cavity is divided in two by a vertical fin called
the nasal septum. On the sides of the nasal cavity are three
horizontal outgrowths called nasal conchae (singular "concha") or
turbinates. To the front of the nasal cavity is the nose, while the
back blends, via the choanae, into the nasopharynx.
[0368] Pharynx: The part of the throat situated immediately
inferior to (below) the nasal cavity, and superior to the
oesophagus and larynx. The pharynx is conventionally divided into
three sections: the nasopharynx (epipharynx) (the nasal part of the
pharynx), the oropharynx (mesopharynx) (the oral part of the
pharynx), and the laryngopharynx (hypopharynx).
4.8 Other Remarks
[0369] A portion of the disclosure of this patent document contains
material which is subject to copyright protection. The copyright
owner has no objection to the facsimile reproduction by anyone of
the patent document or the patent disclosure, as it appears in the
Patent and Trademark Office patent file or records, but otherwise
reserves all copyright rights whatsoever.
[0370] Unless the context clearly dictates otherwise and where a
range of values is provided, it is understood that each intervening
value, to the tenth of the unit of the lower limit, between the
upper and lower limit of that range, and any other stated or
intervening value in that stated rang