Download Product catalogue - TNI medical AG

PRODUCT CATALOGUE
We like to support you
in doctor's practice
TNI medical AG
Hofmannstr. 8
97084 Würzburg
Germany
Phone +49 931 20 79 29-02 E-Mail: info@tni-medical.de
Fax +49 931 20 79 29-01 Web: www.tni-medical.com
at home
in clinic
PART NUMBER: 30200043 VERSION 1.1

Preface
2
Dear partners and customers,
Therapy
Diagnostics
the med-tech is part of the biggest growth markets worldwide. With cycles of innovation,
which are in average shorter than 5 years, the development of the med-tech
goes ahead in an even more rapid pace than the automobile industry.
Our industry is shaped by intensive exchange of medical research with technological
disciplines and the consequential development of appliances. The obtained insights
are implemented rapidly and precise into new products. TNI medical AG is
cutting-edge in the development of new technologies for respiratory support. We
are dedicated to maximize patient’s comfort with simultaneous maintenance of costefficiency.
Our new product TNI ® (therapy with nasal insufflations – application of
warm and humidified air respectively air/oxygen mixture with high flow rates into the
nose) starts with the most important point: the patient’s interface.
In exchange with physicians, patients and alliances it is our exercise to push and to
improve the development, the production and the comprehensive, reliable distribution
and service of diagnostic and respiratory devices constantly.
In this catalogue you will find our range of high-quality devices and accessories. Our
products aim to maximize patient’s comfort and the connected therapeutic success.
Aside our focus lays on intuitive handling, so that the products are cost-efficient and
safe to use in everyday-life of medical professionals and in patient’s home. We are
aware of our responsibility to the patients, the physicians and the clinical staff and
we maintain a complex, complete quality management system according to newest
requirements.
Newest insights of research in several centers in Europe and the USA flew immediately
in the development of this high-flow air- and oxygen-respiration and are recovered
on the TNI ® product family. The current results of clinical research as well as the
resulting possible application fields are also summarized for you in this catalogue.
A perfect supply of services and a distinguished after-sales-service are postulated by
us for a smooth cooperation between physicians, clinical staff, patients and supplier
of medical devices – for the well-being of the patients.
Ewald Anger
CEO TNI medical AG

Index
Therapy
Diagnostics
Product Overview ................................................................................................... 4
Device Overview ................................................................................................... 5
Part Numbers ....................................................................................... 5
Technical Specifications ................................................................ 6
Products ............................................................................................................... 7
TNI ® Products ................................................................................................... 7
TNI ® 20 ................................................................................................... 7
TNI ® 20s oxy (clinic) &
TNI ® 20 oxy (Home care) ................................................................ 8
Diagnostics ................................................................................................... 10
MS310 ....................................................................................... 10
TNI ® Effectiveness ................................................................................................... 12
Results from clinical tests and studies .................................................... 13
TNI ® Effectiveness on COPD .................................................... 16
TNI ® studies ............................................................................................................... 17
Case Reports ............................................................................................................... 52
Adults ............................................................................................................... 52
TNI ® 20 ................................................................................................... 52
TNI ® 20 oxy / TNI ® 20s oxy ................................................................ 53
Children ................................................................................................... 57
TNI ® 20 ................................................................................................... 57
Accessories ............................................................................................................... 58
PG system MS310 ....................................................................................... 58
TNI ® -therapy devices ....................................................................................... 62
NIC Nasal Insufflation Cannula .......................................................................... 67
About Us ............................................................................................................... 68
Contact Information ........................................................................................ 68
Contact Form ............................................................................................................... 69
3

Products
4
Therapy
O 2
Diagnostics
Therapy
Diagnostics
TNI ® 20 blows a stream of warm, humid room air at a rate
of about 20 liters per minute over a nasal applicator into the
patient’s nose.
TNI ® 20 oxy is a high-flow breathing therapy system
using an oxygen/air mixtures that combines the advantages
of a simple oxygen therapy with those of a breathing therapy
device for use at home.
TNI ® 20s oxy can be attached to the hospital infrastructure
by means of a standard pressure regulator and mixing
in oxygen.
Optional with mobile infusion stand including mounting
and basket for humidifier and connection unit.
MS310 Polygraph for mobile diagnose and therapy control
of sleep related breathing disorders, including an evaluation
software and connection to your systems via GDT
interface.

Products
Part Numbers
Part No. Device and Description
Therapy
405 00005 TNI ® 20 – High Flow Respiration by Therapy with Nasal Insufflation (TNI ® )
Diagnostics
The TNI ® 20 System provides a flow of warmed and moistened room air, administered
to the patient through a special low-noise and heated nasal applicator.
The system can deliver a total flow of up to 20 liters per minute, individually
adjustable according to prescription.
405 00006 TNI ® 20s oxy – High Flow Respiration by Therapy with Nasal Insufflation (TNI ® )
The TNI ® 20s oxy unit administers the patient a warm and moist air-oxygen
mixture of maximum 20 liters air per minute, administered to the patient
through a special low-noise and heated nasal applicator.
The air-oxygen mixture is delivered via hospital wall connections and is individually
adjustable according to prescription.
405 00007 TNI ® 20 oxy – High Flow Respiration by Therapy with Nasal Insufflation (TNI ® )
The TNI ® 20 oxy System provides a total flow of warmed and moistened room
air mixed with oxygen, administered to the patient through a special lownoise
and heated nasal applicator.
The generated air flow can be individually mixed with up to 8 liters of oxygen
per minute, from conventional sources such as an oxygen concentrator or
bottles of liquid oxygen.
The system can deliver a total flow of up to 20 liters per minute, individually
adjustable according to prescription.
30100020 Stand trolley "Fabio" TNI ® 20s oxy
Mobile infusion stand including mounting for humidifier and connection unit
and basket.
301 00018 TNI ® trolley "Fabio"
Mobile trolley including mounting for humidifier and connection unit and
basket.
DIAGNOSTICS
9A00002 MS310
Polygraph for mobile diagnose and therapy control of sleep related breathing
disorders, including an evaluation software and connection to your systems via
GDT interface.
THERAPY
5

Products
Technical Specifications
TNI ® THERAPY
6
Therapy
TNI Therapie Application TNI ® 20 TNI ® 20 oxy TNI ® 20s oxy
Adults:
OSA with (mild to moderate)
UARS
Overlap Syndrome
COPD Stage I
COPD Stage II
COPD Stage II and III with partial-insuffi ciency
COPD Stage III and IV with global-insuffi ciency
Fibrosis
After partial resection and lung transplantation
Children and young Poeple (very great effectiveness and therapy acceptability):
Flow Obstruction
OSA and OSA Symptoms
Facial deformity with spec. facial anatomie
Down-Syndrom
Infants and Pediatric:
Pulmonary dysplasia with oxygen demand
Chronic respiratory insuffi ciency
Alternative for non compliant CPAP-Users
Homecare application
TNI Therapie General
Settings:
Sum fl ow (L/min) 5 bis 20 5 bis 20 5 bis 25
O 2 (L/min) 0 bis 8 0 bis 16
Display actual-Flow
Technical Data:
Medical class (93/42/EWG)
Noise level < 32 dB (A) < 32 dB (A)
Main voltage 100-240 V AC 100-240 V AC 100-240 V AC
Frequency 50-60 Hz 50-60 Hz 50-60 Hz
Blower Unit:
Size L/B/H (cm) 25/21/23,5 26/21/23,5
Weight (kg) < 8,5 < 8,5
Humidifi er unit:
Size L/B/H (cm) 26/22/10 26/22/10 26/22/10
Weight (without Water) (kg) < 2,0 < 2,5 < 3,0
Applicator:
TNI Applicator for adults (standard)
TNI Applikator for adults (comfort)
TNI Pediatric Applicator
TNI Pediatric Adapter
TNI Paed Adapter (BC 2745, BC 2755)
Hose length (m) 1,8 1,8 1,8
Legend: yes restricte no
Diagnostics

Products
TNI ® products
TNI ® - Treatment with Nasal Insufflation
Method
Range of applications
With TNI ® , body position on stomach is
possible
ADVANTAGES:
•
•
•
•
•
•
•
•
•
•
Therapy
Diagnostics
TNI ® is a worlwide new method for breathing support. It doesn`t work with positive pressure respiration, it is
a high-flow breathing therapy. TNI ® conducts a warm, moistened flow of room air of maximum 20 liters per minute
to the patient over a special, particularly quiet applicator (nasal applicator) into the nose. Not covered by a
mask as with the CPAP therapy, the nose remains open. Simple exhaling is ensured. The open system without
mask or closed nasal prongs is thus an extremely comfortable alternative to CPAP and other methods for treating
sleep-related breathing disorders.
TNI ® 20
In home care the therapy device TNI ® 20 is used to treat sleep-related breathing disorders. At patients with a comparable
CPAP pressure up to 8 mBar the method shows a good effectiveness 1 . In addition, TNI ® has already been
used successfully as substitute therapy for patients with more severe symptom complexes who do not tolerate
CPAP.
standard package:
- 1 Blower unit
- 1 Humidifier unit
- 1 Applicator for adults
- 1 Connecting hose
- 1 Connecting cable
- 1 Mains power cable
- 1 Operating instructions
for the patient
- 1 Short Instructions
Humidifier unit
• placed at the bedside
• typically on the night table
High wearing comfort, easy to use
No side effects through a mask
Permanent communcation possible (displace of the mask is
not needed)
Relief of breathing effort
Nose and mouth do not dry out
Patient is constrained minimally in his mobility
No aspiration danger through vomiting
No break of the therapy at cough up of secretion
No setting of pressure or individual adaption
No known side effects.
→
→ →
Blower unit
• is placed at a distance from
the patient
• is placed on the floor
• at a radial distance of max.5
metres
Applicator
• is the patient interface
• looks like nasal prongs
• made of soft material which is comfortable to wear
1 Nilius G et al (2007): “Multicenterstudie zur Wirksamkeit der transnasalen Insufflation (TNI ® ) bei leichter bis mittelgradiger pharyngealer
Obstruktion und Schlafapnoe”, Somnologie 11, Supplement 1:26 [conference abstract]
7

Products
TNI ® 20s oxy (Clinic) &
TNI ® 20 oxy (Home care)
Range of applications
8
Therapy
Diagnostics
With the TNI ® 20s oxy and TNI ® 20 oxy exist a new, extremely easily applicable therapy option for treating respiratory
insufficiency, which fills the gap between simple oxygen therapy with low flows and noninvasive respiration.
The therapy is very easy to apply and much more comfortable for the patient as comparable therapy forms due
to the moistening and the warming of the air/oxygen flow and the low impact on the patient's spontaneous
breathing.
Clinical Range of applications:
• COPD
• Respiratory insufficiency
• Post-operative ventilatory support
• Prophylactic therapy after cardiac surgery
• Ventilatory support after extubation
• Ventilatory support after a stroke
• Ventilatory support after anesthesia
• Diseases with severe chronic hypoxemia
(e.g.pulmonary hypertension)
• Rehabilitation after lung diseases
• Weaning from ventilation
Ventilatory support at home with TNI ® 20 oxy
The TNI ® 20s oxy is also available in a competitive version for home care. It uses a very quiet and reliable air source,
which was originally developed for therapy in the field of sleep medicine. This also allows nightly use without
difficulty. The TNI ® 20 oxy allows combining the air of the mobile air source with oxygen from standard medical
oxygen sources, for example an oxygen concentrator or bottles with liquid oxygen.
Possible applications at home:
• Ventilatory support by respiratory Insufficiency
• Overlap syndrome
• Pulmonary fibrosis
• Cystic fibrosis
• Asthma
• Rhinitis or Sinusitis
• Cardiac insufficiency
• Neuromuscular and thoracic diseases such as
post-tuberculosis syndrome and post-polio
syndrome
CLINIC
→
Humidifier unit
→
O 2
→
Oxygen source
Connection unit
Humidifier unit
→
→
Applicator
→
→
Blower unit
Applicator
HOME CARE

Products
ADVANTAGES:
Therapy
Diagnostics
TNI ® 20 oxy as competitive version for home care makes a re-integration in familiar surroundings at
home possible earlier and with less difficulty.
There is no longer a choice between losing ventilatory support and arranging for expensive and complicated
care.
•
•
•
•
•
•
•
Relief of breathing effort
No aspiration danger though vomiting
Warms and moistens the added oxygen, hence no dry out of mouth and nose
Enhances the cough up through warm and moist air
No break of the respiratory support at cough up of secretion
No setting of the pressure or individual adaption needed
Swirls the air/oxygen mixture in the dead air volume
Increases thereby ventilation and provides a CO wash out
Improves respiratory efficiency: (VD/VT) and so the air ventilation of the lung (VA)
Enriches the VD with "usable" air/oxygen mixture
Reduces the arterial CO content by improving the VA. (Not achievable by administering only pure
oxygen)
• 2
•
•
• 2
standard package of TNI ® 20 oxy:
- 1 Blower unit with the valve for oxygen
admixture (techn. reflux reduction valve)
- 1 Humidifier unit
- 1 Applicator for adults
- 1 Connecting hose
- 1 Connecting cable
- 1 Mains power cable
- 1 Oxygen and safety tube
- 1 Operating instructions
- 1 mix table air/oxygen
available accessory
TNI ® trolley "Fabio"
→
→
→
Mobile TNI ® trolley including mounting for
blower and connection unit and basket.
Mounting for
connection unit
Mounting for
humidifier unit
Basket
Mounting for
blower unit
→
→
→
standard package of TNI ® 20s oxy:
- 1 Blower unit
- 1 Connection unit
- 1 Applicator for adults
- 1 Connecting hose
- 1 Mains power cable
- 1 Operating instructions
- 1 Short Instructions with mix table air/oxygen
- 1 Sensor cable
available accessory
Stand trolley "Fabio" TNI ® 20s oxy
Mobile infusion stand including mounting for
humidifier and connection unit and basket.
9

Products
Diagnostic products
MS310 - mobile screening for sleep related disorders
10
Therapy
Diagnostics
MS310 is a medical device to recording and diagnosting of sleep related disorders in familiar surroundings of the
patient, particularly for the detection and the analysis of apnoes and hypopnoes, desaturation, snoring noises,
respiratory frequency, snoring frequency and pulse frequency variations. Additionally the MS310 can be used to
control CPAP therapies.
.
Recording possibilities:
• Respiration with a thermistor (nasal/oral) or a nasal cannula (pressure signal)
• Respiratory motions (thorax and abdomen) with piezoelectrical strech sensors
(2 piezosensors per sensor for excellent signal quality)
• Oxygen stauration (SpO 2 ) and pulse frequency (incl. pulse wave curve) with a
fingerclip (integrated pulse oximeter)
• Body position (back, abdominal, left, right, standing) with the integrated
position sensor
• Snoring sounds, measured via the integrated microphone
• Snoring frequency, snoring level, measured via the integrated microphone
• nCPAP/BiLevel pressure
• CPAP/BiLevel- respiration
The sensors were especially designed for ambulant application
and is characterized by easy handling. The design
of the MS310 polygraph is compact and user-friendly.
The software of the MS300 lets you create individual reports.
Results of any analysis can be arranged as coloured
graphics, tables and free textfields and printed for the patient
in easiest manner. Through the GDT interface test results
can be transferred to the practice software. Starting
from the practice software, any patient can be chosen in
the MS300 software and results can be displayed graphically.
• Expansion port (Extension-Bus, AUX) is ready for further sensors

Products
Large options
� PLM option
GDT interface (standard 2.1)
standard package:
� ECG option
� insurance card reader
� softfingerclip
-1 MS310 recorder
-1 oxygen saturation sensor
-1 nasal sensor (Thermistor nasal/oral)
-1 thorax sensor and snoring microphone
-1 Abdomen sensor
-2 carrying ledge 1,50m (coloured at the inside)
-2 carrying ledge 1,10m
-1 neck belt
-2 wristbands
-1 CPAP pressure sensor, complete
-1 T-connection mit connection tube CPAP
-1 USB cable
-2 batteries, 1,5 V Mignon
-1 disinfectant
-1 plaster
-1 CD MS300 Windows Software
-1 instruction manual
-1 quick reference for the patient
-1 suitcase
ADVANTAGES:
•
•
•
•
•
•
•
•
Therapy
Diagnostics
Robust and easy to apply sensors
Highly comfortable wearing (integrated sensors)
Fast and save diagnostic
Automated and manual analysis
Easy handling
Low operating costs
Connection to the practice's software via
GDT interface
ECG- / PLM option
1 st command: Request a new examination over the practice-DP to the MS310 software
(record type 6302)
2 nd command: Transmission of the most important examination results (index) to the practice-DP
(record type 6310)
3 rd command: Request measuring data (raw data) over the practice-DP and display examination results
(record type 6311)
incl. patient bag and
battery charger
11

TNI ® Effectiveness
Mechanisms of ventilatory support measurements taken
at the Johns Hopkins Hospital in Baltimore 1 (USA)
and further clinical studies 2 have shown that breathing
is effectively supported by high-flow ventilation, for
example with TNI ® .
A positive end-expiratory pressure (PEEP) is built, which leads
to an increase of the maximal inspiratory flow and to an increase
of the tidal volume. This supportive effect increases
ventilation and lowers the work of breathing.
As a result, a reduction of respiratory frequency is also observed.
This comparatively comfortable method of ventilatory
support has great potential in clinical therapy in addition
to its application in sleep medicine.
Effectiveness 1: Increase of the outside pressure
12
Flow
(ml/s)
P 0
SG
(cmH 2 O)
-15
Microphone
Inspiration
100
SaO 2
(%)
90
Expiration
30s
Therapy
Hypopnea Hypopnea
97
93
Figure 2: Effect on Sleep Disordered Breathing
Turbulence and increased “outside”
resistance increase the pressure
Diagnostics
TNI Off TNI 20L/min
High flow decreases the pressure
also in an open system
The TNI ® therapy decreases the pressure difference generated by the effort between the thorax and upper airways. With
20l/min the decrease in the pressure difference is approx. 2 – 4 mbar.
Effectiveness 2: Increase of the „PEEP“
1. Increase PEEP
↓
2. Improve inspiration
↓
3. Increase of tidal volume
↓
4. Decrease in the work of breathing
↓
5. Shift of the Pcrit
•
•
•
® The TNI Therapy
creates a PEEP of
2 – 4 mbar
Replacement of the
„Purse one`s lips“
used for active expiration
during the day
respiratory muscles
relief
1 McGinley BM et al (2007), “A nasal cannula can be used to treat obstructive sleep apnea.” Am. J. Respir. Crit. Care Med. 176(2):194-200
2 Ciccolella DE et al (2001), “Administration of high-flow, vapour-phased, humidified nasal cannula air (HF_HNC) decreases work of breathing
(WOB) in healthy subjects during exercise”, Am. J. Respir. Crit. Care Med. 163(5) Part 2: A622
Flow
95
PEEP: “Positive End Expiratory Pressure”
Esophagus pressure
PEEP w/o TNI
PEEP with TNI
compare Schneider and Schwartz, APSS 2005

TNI ® Effectiveness
Possible Effectiveness 3: „Tension“ of the upper airway?
1. Increase PEEP
2. Decrease the pressure fluctuations during the respiration
Therapy
3. Anatomical „stretch“of the upper respiratory system decrease the collapsibility
Possible Effectiveness 4: Control mechanism?
Activation of a control mechanism in the nose or in
the upper airways
Consideration: The effect is seen after some breaths
have been drawn.
Results from clinical tests and studies
RDI
50
40
30
20
10
0
1 2
Pre - Post treatment
adults OSA
Events/hr Events/hr Events/hr Events/hr
60
50
40
30
20
10
0
60
50
40
30
20
10
0
60
50
40
30
20
10
0
Figure 3: Sleep Disordered Breathing Indices On and Off TNI
60
50
40
30
20
10
0
Diagnostics
This is examined in scientific studies
Flow
Esophagus pressure
AHI AHI (Events/hr) (Events/hr)
60
50
40
30
20
10
0
TNI ON Effect after 6 – 7 breaths
children OSA
Total 60 NREM 60 REM
50
p

TNI ® Effectiveness
Mannino et al. (2007), Global burden of COPD: risk factors, prevalence, and future
trends. The Lancet 370:765-773.
14
Therapy
General information about COPD and respiratory insufficiency
Diagnostics
COPD is a disorder of hitherto massively underestimated importance. According to a study published in the
prominent medical professional journal The Lancet, today 10.1% of the entire world population suffers from
this disorder 1 . According to expert estimations, the annual total cost of pulmonary diseases amounts to about a
hundred billion euros alone in Europe. Approximately half of this sum is caused by cases of COPD. In Germany,
the annual costs of COPD is estimated to be
between 5.5 and 8.5 billion euros 2 , and according
to the AOK local health care fund, COPDrelated
disorders already account for 25 million
work disability days a year in Germany 3 . By the
year 2020, COPD is expected to become the
third most frequent cause of death worldwide;
in 2000, 2.7 million people died due to consequences
of the disease 4 .
COPD cannot be cured. Therefore the longterm
breathing therapy used at home in the
course of the disease plays a major role. Apart
from the conventional support with oxygen and
mask respiration, TNI is now introducing a high-
flow breathing therapy with oxygen-air mixture.
This method unites the advantages of an
oxygen therapy with that of oxygen support via mask. The patient is treated in his or her own familiar domestic
environment. With the easily used TNI ® applicator, similar to the nasal applicator, the patient is considerably
more comfortable than when using a comparably effective breathing therapy with mask. In addition, there is a
cost advantage for the health insurance funds.
TNI ® Effectiveness
Current results show that TNI ® 20 oxy significantly improves
blood gas values, and in contrast to simple
oxygen therapy, at low flow rates, and effects not only a rise in
the oxygen saturation, but also a decrease of the CO 2 partial
pressure. This demonstrably supports respiration and reduces the
work of breathing so that the patient perceptibly recovers.
1 Buist AS et al (2007), “International variation in the prevalence of COPD (The BOLD Study): a population-based prevalence study” The Lancet
370(9589):741-750
2 Vogelmeier, C et al (2007), “Leitlinie der Deutschen Atemwegsliga und der Deutschen Gesellschaft für Pneumologie und Beatmungsmedizin zur
Diagnostik und Therapie von Patienten mit chronisch obstruktiver Bronchitis und Lungenemphysem (COPD)“ Pneumologie 61: e1-e40
3 Konietzko, N, Fabel H (2000), „Weißbuch Lunge 2000“. Thieme Verlag
4 Maio, S et al (2006), “The global burden of chronic respiratory diseases“ Breathe 3(1): 21-29

TNI ® Effectiveness
Resp. Insuffizienz
Progression of
respiratory insufficiency
Nightly Hypoventilation
Precursor to Pursed
Lip Breathing
Nearly not noticable
LTOT
TNI ® +O2
NIV
TNI ® instead of NIV
time
Case reports respiratory insufficiency
Therapy
Diagnostics
BGA groups under conventional therapy
Group 1: paO 2 ↑ and paCO 2 ↓ ► desirable
Group 2: paO 2 ↑ and paCO 2 = ► acceptable
Group 3: paO 2 ↑ and paCO 2 ↑ ► problem
Group 4: paO 2 = and paCO 2 =↑ ► big problem
CO 2 - wash out with TNI ®
Applicator
air-/oxygen mixture
CO 2
15

TNI ® Effectiveness
TNI ® Effectiveness on COPD
•
16
swirls the air-oxygen mixture in the dead air volume.
Therapy
• increases thereby ventilation and provides a CO wash out.
2
•
•
Diagnostics
improves respiratory efficiency: (VD/VT) and so the air ventilation of the
lung (VA).
enriches the VD with „usable“ air-oxygen mixture.
• reduces the arterial CO content by improving the VA. (Not achievable
2
by only administering pure oxygen)
•
•
•
•
Normal condition
mucuous
normal mucuous
TNI ® ...
muscle layer
Pathological restriction
warms and moistens the added oxygen.
enhances the cough up through warm/moist air.
has no side effects.
mucuous membrane
swelling
increased mucuous
positive results demonstratable by BGA.
... A NEW THERAPY

TNI ® Studies
O2 (l)
9
8
7
6
5
4
3
2
1
Therapy
STIT-1: Evaluation of safety and efficacy
of shorttime TNI ® treatment
in patients with COPD
– First interim analysis
Background
COPD is projected to be the third leading cause of death
worldwide by 2020. Long-term oxygen therapy (LTOT) is one of
the established treatment strategies in the GOLD algorithm.
Nasal insufflation of warm, humidified air at a high flow rate
(TNI ® ) is a new and simplified method in non-invasive
ventilation.
Until now, this method (TNI ® ) was successfully evaluated in the
treatment of OSA patients (1). However, no data on safety and
efficacy of TNI ® in COPD patients are currently available.
Aim
Our multicenter (Pic. 1), controlled study was designed to
examine the safety of trans-nasal high flow oxygen insufflation
by TNI ® in patients with COPD (GOLD °III/IV).
The study was further conducted to assess a possible reduction
of necessary oxygen delivery in LTOT patients and its effect on
hyperinflation.
58%
STIT-1 Study Centres
Innsbruck Bern Dresden
Oxygen Delivery
0
0,00
1 2
Pic. 4 without TNI with TNI
Pic. 5
21%
21%
Results
Concerning safety TNI ® delivery was well tolerated in all
patients and no significant differences were found for several
spirometric parameters tested (RV, TLC, VC, IC, ERV, Raw,
FEV1, DLCO) (Pic. 2, 3, 6, 7).
Furthermore, the necessary oxygen delivery to reach a
sufficient paO2 in COPD patients was significantly lower by
using the TNI ® system (- 0.92 ± 0.84 L/min, p = 0.003*)
compared to conventional oxygen administration (Pic. 4, 5)
Statistics were performed with SPSS using Wilcoxon analysis.
H. Vogelsinger 1 , M. Halank 2 , S. Braun 2 , S. Ott 3 , S. Desole 1 , T.Geiser 3 , C.M. Kaehler 1
1 Pneumology Service, Department of General Internal Medicine, Medical University of Innsbruck
2 Pneumologie, Medizinische Klinik und Poliklinik I, University Hospital Carl Gustav Carus Dresden
3 Klinik und Poliklinik für Pneumologie, Universitätsspital Bern, Inselspital
Pic. 1 Tab. 1 Pic. 2
O2 (l)
3,50
3,00
2,50
2,00
1,50
1,00
0,50
3,04
Oxygen Delivery
__________
*
2,12
1 2
without TNI with TNI
Methods
Diagnostics
The trial has been approved by the national ethic committees.
Stable patients with COPD °III/IV with indication for LTOT
(ATS/ERS criteria) are enrolled. The following inclusion criteria
have to be met: age 30-80, stable disease without exacerbation
for at least 14 days prior inclusion, Hb > 100 g/l, a normal
paCO2, RV/TLC < 0,65 and no current participation in another
study.
So far 14 subjects were recruited (Tab. 1): 14 males, age 68.8 ±
5.2 yr, FEV1 ranged from 23 to 49 % predicted. All patients were
explored for standard LTOT treatment and for the new TNI ®
method. Oxygen supplementation was performed in 10 min
intervals each with an augmentation of 0.5 - 1 L/min until a pO2
� 60mmHg was achieved.
Using the high flow strategy of TNI ® , oxygen was mixed with
warm and humidified air and a constant flow rate of 15 L/min
which was administered through an open nasal cannula.
Blood gas analysis and lung function tests were performed
according to the protocol.
Conclusion
0,527 0,526
In conclusion, we can postulate that treatment with TNI ® seems
to be safe in patients with COPD °III/IV and that the necessary
oxygen delivery in LTOT patients can be reduced significantly.
Acknowledgment: The authors thank TNI ® medical for contributions to this study
including technical support.
References: (1) McGinley B et al (2007): “A Nasal Cannula Can Be Used to Treat Obstructive Sleep Apnea, Am. J. Respir. Crit. Care Med. 176(2):194-200.
Correspondence: Prof. Dr. Christian M. Kähler - Medical University of Innsbruck - Anichstrasse 35; A-6020 Innsbruck - e-mail: c.m.kaehler@i-med.ac.at
160
150
140
%
130
120
110
100
56
54
52
50
%
48
46
44
42
160,26 159,33
57
RV (% predicted)
1 2
prior TNI after TNI
RV/TLC (%)
40
0,0
1 2
Pic. 6
prior TNI after TNI
Pic. 7
56
Pic. 3
kPa/ltr/s
0,6
0,5
0,4
0,3
0,2
0,1
%
250
200
150
100
50
0
158
prior TNI
RV Improvement
229
230
116
after TNI
Raw (kPa/ltr/s)
221
210
P 002
P 013
1 2
prior TNI after TNI
P 010
17

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18
Effect of an Open Nasal Cannula System (TNI) in
hypercapnic respiratory failure in COPD patients
G. Nilius¹, U. Domanski¹, K.J. Franke¹, K.H. Ruhle¹, H. Schneider²
¹ HELIOS Klinik Hagen-Ambrock
² John-Hopkins-University, Baltimore
HELIOS Klinik Hagen
Ambrock
Klinik für Pneumologie
breathing frequency
without TNI with TNI
30,00
25,00
20,00
15,00
10,00
5,00
breathing frequency
0,00
1 2 3 4 5 6 7
Patient No
Methods:
6 COPD patients and 1 patient with
kyphoscoliosis (mean age 69.4 ± 15.5
years, BMI 25.4 ± 10.3 kg/m²) with a
hypercapnic respiratory failure without
acidosis were treated with 2l/min oxygen
insufflation for 1 hour and the TNI system
for another 1 hour on a general
pulmonary ward. The respiratory rate was
constantly monitored and capillary blood
gas analysis was performed at the
beginning and the end of each phase.
capillary blood gas analysis
PCO2 without TNI PCO2 with TNI
Therapy
Results:
TNI reduced the breathing frequency from
20.0 ± 4.3 (oxygen) to 18.1± 4.1 (TNI) per
minute (p

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Influence of the transnasal insufflation (TNI) on respiratory pressure amplitude
and respiratory middle pressure in comparison to spontaneous respiration and
CPAP in people with healthy lungs
Bräunlich, J.; Beyer, D.; Hammerschmidt, S.; Seyfarth, H.-J.; Wirtz, H.
University Leipzig, Department of Pneumology, Department internal medicine , Neurology and Dermatology
Introduction: The already in neonatology established transnasal insufflation implies application of a heated,
humidified and continuous airflow between 16 and 24 l/min.
The clinical application shows significant decline of pC02.
The therapeutic mechanisms and efficiency of this method are however indistinct in adults. First examinations
showed increased respiratory pressure, decline of dyspnea, decrease of respiratory frequency and enhanced
oxygenation.
Method: By means of a thin water-filled tube system the measured
pressures in nose and tounge area were transferred via amplifier to
a recorder. The experiments were executed nasal and orally, while
sitting, lying and under spontaneous respiration, TNI and CPAP.
Pressure gradients between in- and exspiration as well as variation
of respiratory middle pressures were detected while using the
corresponding methods.
As test persons people with healthy lungs were adducted.
Pressure in mbar
�������������������������������������������
Spontaneous
breathing
Pressure in mbar
��������������������������������������
Spontaneous
breathing
TNI
���������
������
Medium-pressure breathing, sitting nose n=16
Results: All combinations showed
significant increase of respiratory
pressure amplitude under TNI in
comparison to spontaneous
respiration. Application of a CPAP
with low pressure (4 mbar) did not
show significant modifications. All
experiments showed significantly
increased respiratory middle
pressure by transnasal insufflation
in comparison to spontaneous
respiration. Application of CPAP
resulted in reaffirmed increase of
respiratory middle pressure.
1 McGinley et al. (2007): A nasal cannula can be
used to treat obstructive sleep apnoe. 2 Chatila et
al. (2004): The effects of High-flow vs. Low-Flow
oxygen in exercise in advanced obstructive airway
disease.
Discussion: At continuous compliance the transnasal insufflation increases the ventilation by accentuation of the
respiratory pressure amplitude and increase of respiratory middle pressure. The middle respiratory pressure will
hereby only be increased slightly, thus an alveolar recruitment not being in the foreground. Ventilation work seems
to be minimized by overcoming the statical and dynamical resistances. As how far the respiratory muscle pump
will be released is not yet defined. Using TNI leads to a shifting on the pressure-volume-curve. Whether or not an
additional elution effect supports CO2-decrease , i.e. which patients profit from this breathing support, has to be
subject to further investigations.

TNI ® Studies
Correct Citation for publication:
Therapy
Diagnostics
Treatment of Sleep-Disordered Breathing in Chronic Obstructive Pulmonary Disease with Nocturnal
Nasal Insufflation. C.D. Brown, M.D., L.B. Herpel, M.D., K.L. Goring, M.D., P.L. Smith, M.D., R.A. Wise,
M.D., H. Schneider, M.D., Ph, A.R. Schwartz. Proc Am Thor Soc 2007,, A709
Poster Board #F64] Treatment of Sleep-Disordered Breathing in Chronic Obstructive Pulmonary
Disease with Nocturnal Nasal Insufflation, [Publication Page: A709]
C.D. Brown, M.D., L.B. Herpel, M.D., K.L. Goring, M.D., P.L. Smith, M.D., R.A. Wise, M.D., H. Schneider,
M.D., Ph, A.R. Schwartz, M.D., Baltimore, MD
Introduction: Sleep-disordered breathing (SDB) with inspiratory flow limitation (IFL) is common in patients
with COPD, even without frank apneas or hypopneas. Nocturnal nasal insufflation (NNI) may relieve IFL and
upper airway obstruction during sleep to improve gas exchange and sleep quality in COPD.
Methods: Non-hypoxemic individuals with a wide range of COPD severity underwent baseline
polysomnography to determine the severity of sleep-disordered breathing. On a separate night, subjects
were exposed to alternating trials of NNI (20 L/min), oxygen (2 L/min), and room air during NREM sleep.
SDB indices including arousal-terminated IFL event rates, the apnea-hypopnea index (AHI) and
transcutaneous carbon dioxide (TcCO2) were compared among conditions.
Results: NNI decreased the arousal frequency, AHI, and TcCO2 from the room air and oxygen conditions.
NNI resulted in a 50% reduction in IFL events compared to room air (p=0.04) whereas oxygen was
associated with a 120% increase in IFL events. TcCO2 increased during oxygen treatment and fell during
NNI compared to the room air condition (Figure 1, p=0.001 for NNI vs. room air).
Conclusion: NNI decreased SDB and improved nocturnal ventilation in patients with COPD. The CO2
response to NNI suggests that IFL contributes to the development of nocturnal hypoventilation in COPD and
that NNI may constitute a novel treatment for SDB in COPD.
21

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Therapy
A Nasal Cannula Can Be Used to Treat Obstructive
Sleep Apnea
Brian M. McGinley 1 , Susheel P. Patil 1 , Jason P. Kirkness 1 , Philip L. Smith 1 , Alan R. Schwartz 1 , and
Hartmut Schneider 1
Diagnostics
1 JohnsHopkinsSleepDisordersCenter,DivisionofPulmonaryandCriticalCareMedicine,JohnsHopkinsUniversity,Baltimore,Maryland
Rationale: Obstructive sleep apnea syndrome is due to upper airway
obstruction and is associated with increased morbidity. Although
continuous positive airway pressure efficaciously treats obstructive
apneas and hypopneas, treatment is impeded by low adherence
rates.
Objectives: To assess the efficacy on obstructive sleep apnea of a
minimally intrusive method for delivering warm and humidified air
through an open nasal cannula.
Methods: Eleven subjects (age, 49.7 � 5.0 yr; body mass index, 30.5 �
4.3 kg/m 2 ), with obstructive apnea–hypopnea syndrome ranging
from mild to severe (5 to 60 events/h), were administered warm
and humidified air at 20 L/minute through an open nasal cannula.
MeasurementsandMainResults: Measurements were based on standard
sleep-disordered breathing and arousal indices. In a subset
of patients pharyngeal pressure and ventilation were assessed to
determine the mechanism of action of treatment with nasal insufflation.
Treatment with nasal insufflation reduced the mean apnea–
hypopnea index from 28 � 5 to 10 � 3 events per hour (p � 0.01),
and reduced the respiratory arousal index from 18 � 2 to 8 � 2
events per hour (p � 0.01). Treatment with nasal insufflation reduced
the apnea–hypopnea index to fewer than 10 events per hour
in 8 of 11 subjects, and to fewer than 5 events per hour in 4 subjects.
The mechanism of action appears to be through an increase in
end-expiratory pharyngeal pressure, which alleviated upper airway
obstruction and improved ventilation.
Conclusions: Our findings demonstrate clinical proof of concept that
a nasal cannula for insufflating high airflows can be used to treat
a diverse group of patients with obstructive sleep apnea.
Keywords:treatmentwithnasalinsufflation,TNI;pharyngealpressure
Obstructive sleep apneasyndrome is duetoupper airwayobstruction
leading to intermittent hypoxemia, sleep fragmentation,metabolicdysfunction(1,2),andincreasedcardiovascular
morbidity and mortality (3, 4). Current treatment options, includingcontinuouspositiveairwaypressure(5),oralappliances
(6),andsurgicalprocedures(7),areoftenintrusiveorinvasive,
and not well tolerated, leaving a vast number of subjects untreated
(8, 9). Therefore, improved therapeutic strategies are
requiredtotreatsleepapneasandhypopneasandtheirassociatedmorbidityandmortality.Upperairwayobstructionisduetoincreasedpharyngealcollapsibility(10–12),whichdecreasesinspiratoryairflowasmanifested
by snoring andobstructive hypopneasand apneas (13).
This defect in upper airway collapsibility can be overcomeby
elevatingnasalpressure.Infact,somewhatgreaterlevelsofnasal
(ReceivedinoriginalformSeptember18,2006;acceptedinfinalformMarch14,2007)
SupportedbyHL-72126,HL-50381,HL-37379,HL-077137,NHMRC-353705,
andSeleonGmbH,Germany.
Correspondence and requests for reprints should be addressed to Hartmut
Schneider,M.D.,Ph.D.,JohnsHopkinsAsthmaandAllergyCenter,5501Hopkins
BayviewCircle,Room4B47,Baltimore,MD21224.E-mail:hschneid@jhmi.edu
Am J Respir Crit Care Med Vol 176. pp 194–200, 2007
Originally Published in Press as DOI: 10.1164/rccm.200609-1336OC on March 15, 2007
Internet address: www.atsjournals.org
AT A GLANCE COMMENTARY
Scientific Knowledge on the Subject
Highlevelsofcontinuouspositiveairwaypressure(CPAP)
areneededtoalleviateobstructiveapneas;lowcompliance
withCPAPimpedesitstherapeuticeffectiveness;and,becausehypopneascanbetreatedwithlowlevelsofCPAP,nasalinsufflationofairmighteffectivelytreatmildobstructivesleepapnea.
What This Study Adds to the Field
Nasalinsufflation canprovide distinctclinicaladvantages
overCPAPforasubstantialproportionofthepatientpopulationwithsleepapnea.
pressure are required to abolish apneas than hypopneas, and
to restore normal levels of inspiratory airflow (12, 14). Thus,
minimallyintrusivemethodsfordeliveringlowlevelsofairway
pressuremayberemarkablyeffectiveintreatinghypopneas.
At present, continuous positive airway pressure (CPAP) is
most effective in eliminating apneas and hypopneas, although
long-termeffectivenessiscompromisedbylowadherencethat
is estimated at only 50 to 60% (15, 16). Poor adherence has
beenattributedtothesideeffectsassociatedwithnasalCPAP,
includingdifficultytoleratingpressureandthenasalmaskinterface,nasal
irritation, claustrophobia, andskin breakdown (17,
18).Toaddresstheseissues,wedevelopedasimplifiedmethod
forincreasingpharyngealpressurebydeliveringwarmandhumidifiedairatacontinuoushighflowratethroughanopennasal
cannula.Thepresentstudywasdesignedtodeterminewhether
treatment with nasal insufflation (TNI) alleviates obstructive
sleepapneaandhypopneaacrossaspectrumofdiseaseseverity.
Some of the results of these studies have been previously reportedintheformofabstracts(19,20).
METHODS
Participants
SubjectswererecruitedfromtheJohnsHopkinsSleepDisordersCenter
(Johns Hopkins University, Baltimore, MD) if they had more than
fiveobstructivedisorderedbreathingepisodesperhourofsleepona
standardovernightpolysomnogram.Patientswereselectedtoprovide
abalancedrangeofdiseaseseverityencompassingaspectrumofmild
(apnea–hypopnea index [AHI] � 5–15 events/h, n � 3), moderate
(AHI,15–30events/h,n�5),andsevere(AHI �30events/h,n�3)
sleep apnea (Table 1), withacomparable mixof sex and body mass
index.SevenpatientswerereceivingCPAP,fourofwhom(subjects3,
6, 9, and 10) participated in the study because they had difficulties
toleratingCPAP,withcompliancedefinedasCPAPusefor4hoursor

TNI ® Studies
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McGinley,Patil,Kirkness,etal.:ObstructiveSleepApneaTreatment 195
TABLE 1. ANTHROPOMETRICS AND SLEEP-DISORDERED BREATHING INDICES
DiseaseSeverity
Mild Moderate Severe
Subject1 Subject2 Subject3 Subject4 Subject5 Subject6 Subject7 Subject8 Subject9 Subject10 Subject11 Mean SEM
Anthropometricdata
Sex M M M F F M F M F M F
Age,yr 33 24 49 39 31 56 42 53 70 77 56 49.7 5.0
Height,cm 168 190.5 180.0 152.4 160 182.9 154.9 172.7 157.5 182.9 172.7 170.7 4.1
Weight,kg 70.9 120.9 74 63.9 70.9 91.7 169.1 72.0 60.0 86.8 66.67 81.9 12.7
BMI,kg/m 2 25.2 33.2 22.6 27.4 27.6 27.4 70.3 24 24.1 25.9 22.35 30.5 4.3
Sleep-disorderedbreathing
AHI,events/h 5 8 13 19 20 21 22 30 39 46 58 27.7 4.7
HI,events/h 4 7 12 19 20 20 19 26 4 29 23 17.9 2.4
AI,events/h 1 1 1 0 0 1 3 4 35 17 35 9.8 4.3
AveragebaseSa O2 ,% 96.7 95.2 94.2 97.5 96.5 96 97.3 94.7 97.2 93.8 95.4 95.8 0.4
AveragelowSa O2 ,% 94.5 93.4 92.3 93.3 92.4 91.3 91.9 90.9 87.1 87.3 90.4 91.0 0.7
Definitionofabbreviations:AHI �apnea–hypopneaindex;AI �apneaindex;BMI �bodymassindex;HI �hypopneaindex;Sa O2 �oxygensaturation.
morepernight,for70%ormoreofnights.Patientswereexcludedif
theyhadcentralsleepapneaorseriousmedicalconditions.Informed
consentwasobtainedfromallsubjects,andtheJohnsHopkinsUniversityInstitutionalReviewBoardapprovedtheprotocol.
Study Procedures
Polysomnography.PolysomnographywasperformedwithSomnologica
biosignal recording and analysis software (Embla, Broomfield, CO).
Signalsincludedelectroencephalograms(C3-A2,A2-O1),leftandright
electrooculograms,submentalelectromyogram,tibialelectromyogram,
electrocardiogram,oxyhemoglobinsaturation,bodypositionviainfraredvideo
camera,nasal cannula formeasuring airflow (Nights 2and
3),andthoracicandabdominalbeltsformeasuringrespiratoryeffort.
OnNight1,apneumotachometer(21)attachedtoanasalCPAPmask
(Respironics,Murraysville,PA)andafluid-filledcatheter(CooperSurgical,Trumbull,CT)wereusedtomeasureventilationandsupraglottic
pressureonandoffTNI.
Nasalinsufflation. Anaircompressor(Seleon,Freiburg,Germany)
deliveredatthenoseaconstantflowrateofupto20L/minute,which
wastheupperlimitofthecurrenttechnology,giventhedimensionsof
the cannula. A heater and humidifier regulated the temperatureand
humidity.Aheatedwirewasincorporatedintothelumenofthenasal
cannula tubing to achieve a temperature of 30 to 33�C and relative
humidity of approximately 80% at the nasal outlet (Figure 1). (For
nasalcannuladimensions,seethecaptiontoFigure1).
Study Protocols
OnNight1(titrationnight),subjectsinitiatedsleepon5L/minuteon
TNI for reasons of comfort. When subjects had established a stable
period (� 10 min) of non–rapid eye movement (NREM) sleep, TNI
wasappliedat0,10,or20L/minutefor5-minuteintervalsinrandom
order. These trials were repeated a minimum of three times at each
TNIlevelinthesupinepositionduringNREMsleep.
SubjectswerethenrandomizedtoseparatenightsonandoffTNI
at20L/minute.Standardpolysomnographicrecordingtechniqueswere
employedtocharacterizesleepandbreathingpatternsonthesenights.
OnthebasisofthefindingsintheTNItitrationstudy,weanticipated
that patients who had predominantly hypopneas would experience a
greatereffectthanthosewhoalsohadobstructiveapneas.
Analysis
Polysomnography.Standardpolysomnographicscoringtechniqueswere
used to stage sleep (22), arousals(23), and respiratoryevents, which
werescoredaccordingtothe“Chicagocriteria”(24).
Respiratoryindices. Inbrief,anapneawasdefinedascompletecessationofairflowformorethan10seconds.Hypopneawasdefinedas
a greater than 30% reduction of airflow. Flow-limited events were
scored ashypopneas ifairflow was reducedless than30% compared
withadjacentbreathsandwasassociatedwitheitheranarousalfrom
sleeporoxyhemoglobindesaturationequaltoorgreaterthan3%.Each
respiratory event (apnea and hypopnea) was subclassified as either
centralorobstructiveonthebasisofassessmentoftherespiratoryflow
and effort signals (supraglottic pressure catheter or abdominal and
thoracicplethysmography)(24).Bodypositionwascarefullymonitored
during both the baseline and treatmentnights, and anAHI for each
individualwascalculatedforthesupineandsidepositionsseparately.
AnoverallAHIwasthenproducedbyweightingthetimespentineach
body position on the first night. On the second night, we applied a
positionalweightingfactorfromthefirstnighttocalculateanoverall
AHI.
Arousal analysis. Arousals were scored as an abrupt shift in frequencythatincluded
�, �,and �frequenciesgreaterthanorexceeding
16Hz,butnotspindlesafteraminimumof10consecutivesecondsof
stablesleep,andarousalsinREMwerescoredonlyifaccompaniedby
anincreaseinsubmentalelectromyogramamplitude(23).Assessment
Figure1. Nasalcannulafordeliveryofwarmhumidifiedairtoapatient
(treatmentwithnasalinsufflation).Ascanbeseen,thecannulaisdesignedtoleavethenoseopen,andthusapatientcanexpirefreely
throughthenose.Dimensionsofthecannulaareasfollows:length,
1,800mm;outerdiameter,5mm.DimensionsofthetubeaftertheY
piece:length,440mmeach;innerdiameter,3.4mm;dimensionof
theprongs,5mm(outerdiameter,eachnostril).Thecannulahasbeen
designedtodecreaseanypotentialnoisecausedbythehighflowof
air,minimizingnoise-inducedsleepdisruption.
45

TNI ® Studies
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196 AMERICANJOURNALOFRESPIRATORYANDCRITICALCAREMEDICINE VOL 176 2007
of interrater variability was performed by two board-certified sleep
physiciansinasubsetofsubjects(n �9).
Breathingdynamics. End-expiratorypharyngealpressure,peakinspiratoryairflow,andrespiratoryeffortweremeasuredonthebasisof
the10breathsimmediatelyprecedingandthelast10breathsofeach
TNItrial.
Statistical Analysis
Dataarereportedasmeans �SEM.Asignranktestwasperformed
(Stata 8;StataCorp,CollegeStation,TX) tocompare (1)differences
inpolysomnographic indices betweenbaselinediagnostic andclinical
treatmentnightand(2)differencesinbreathingdynamicsonandoff
TNI.pValueslessthan0.05wereconsideredsignificant.
RESULTS
Subject Demographics
Elevensubjects(6menand5women;age,49.7 �5.0yr;body
massindex,30.5 �4.3kg/m 2 )completedthestudy.Bydesign,
ourstudypopulationencompassedawidespectrumfrommildto
severediseaseseverity(Table1).Ingeneral,patientswithmilder
diseaseseverityhadpredominantlyobstructivehypopneas(AHI,
5–15events/h),whereasthosewithmoreseveresleepapnea(AHI,
�30events/h)hadmanymoreobstructiveapneas.
TNI Titration at 10 versus 20 L/Minute: Night 1
Figure2illustratestheeffectofTNIat10and20L/minuteon
airflowdynamicsandsupraglotticpressureinonesubjectwith
predominantly obstructive hypopnea (subject 1, indicated by
opencirclesinFigure4).BreathsoffTNI(Figure2,left)during
a hypopnea were characterized by a plateauing of inspiratory
flowassupraglotticpressurecontinuedtofall,andsnoring(microphone
signal). A TNI flow rate of 10 L/minute (Figure 2,
middle) slightly increasedend-expiratory supraglottic pressure
and decreased inspiratory effort swings. Nevertheless, inspiratoryflow
limitationandsnoringpersisted.Incontrast,breaths
on TNI at 20 L/minute (Figure 2, right) were no longer flow
limitedasindicatedbyaroundedinspiratoryflowcontour,an
increaseinpeakinspiratoryairflow,amarkeddeclineinsupraglotticpressureswings,andtheabsenceofsnoring.Similarresultswerefoundinallourstudyparticipants.
Effect on Sleep-disordered Breathing Indices
In Figure 3, the effect of TNI at 20 L/minute on the sleepdisorderedbreathingpatternisillustratedforonesubjectwith
obstructive hypopneas. Figure 3 (left) depicts two obstructive
hypopneas(seehorizontalbars)asindicatedbydecreasedinspiratoryairflow,progressivelyincreasingrespiratoryeffort(Psg),
snoring(seemicrophonetrace),andoxygendesaturations.When
TNI was administered (Figure 3, right), sleep and breathing
patternsstabilized,asreflectedbythereductioninsupraglottic
pressure swings, and resolution of inspiratory flow limitation,
snoring,andoxyhemoglobindesaturation.
InFigure4,thesleep-disorderedbreathingresponsesofsubjectstoTNI(20L/min)arepresentedfortheclinicaltreatment
night(TNIon)andthebaselinediagnosticnight(TNIoff).Two
maineffectscanbediscerned.First,TNIledtoareductionin
theoverall AHI(28 �5to10 �3events/h,p�0.01;Figure
4,left)andsomeimprovementoftheAHIwasobservedineach
subject(Figure4,left).Ineightofthesesubjects,theAHIfell
below10events/hour.Ofthethreeremainingsubjects,thenasal
cannula dislodged for 2.5 hours in one subject (Figure 4, left,
soliddiamonds), and hence the AHI fellonly minimallyfrom
19to17,whereasmoremarkedreductionsintheAHI,from46
to27andfrom39to23events/hour,wereobservedfortheother
two(Figure4,left,barsandplussymbols).
Second,TNIresponsesinhypopneasandapneasareshown
separately (Figure 4, middle and right, respectively). TNI decreasedthehypopneaindex(Figure4,middle)from18
�2to
8 �2events/hour(p �0.01),andalsoreducedthenumberof
obstructiveapneasinthethreesubjectswhohadanapneaindex
greaterthan10events/hourduringsleep(subjects9,10,and11in
Table1,andrepresentedbyplus,bar,andsolidtrianglesymbols,
respectively,inFigure4,right).Ascanbeseen,apneicsubjects
9,10,and11hadareductioninapneaindexfrom36to17,from
17to11,andfrom35to6eventsperhourofsleep,respectively,
suggestingthatTNIcandecreaseapneasaswellashypopneas.
Assessmentofinterratervariabilitywasperformedwithanintraclasscorrelationcoefficient(ICC)forobstructiverespiratoryevents(ICC,1.0),respiratoryarousals(ICC,0.98),andspontaneousarousals(ICC,0.8),indicatinggoodagreementbetweenreviewersinallcategories;disagreementsbetweenreviewerswere
minor(Table2).
Figure2. Airflow and
supraglottic pressure
(Psg)responsetotreatmentwithnasalinsufflation
(TNI) in one subject(subject1).During
baseline, with TNI off
(left),largeswingsinsupraglotticpressureand
flattening of the inspiratory
airflow contour
occurredassupraglottic
pressure continued to
fall,indicatingupperairway
obstruction (left).
Whereas TNI at 10 L/
minute had no significant
effect on airflow
andsupraglotticpressure
swings(middle),TNIat20L/minuteincreasedend-expiratoryPsgfrom0to2.2cmH 2O,whichwasassociatedwithanincreaseinpeakinspiratory
airflowfrom290to360ml/second,andrespiratoryeffortmarkedlydeclinedasindicatedbyreductionsofthesupraglotticpressureswingsfrom
–15to–3cmH 2O.

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McGinley,Patil,Kirkness,etal.:ObstructiveSleepApneaTreatment 197
Figure3. Effectoftreatmentwithnasalinsufflation(TNI)onobstructivehypopneasinonesubjectduringnon–rapideyemovement(NREM)sleep.
Left:TNIoff.Right:TNI20L/minute.Horizontallinesbelowtheflowsignaldemarcateindividualhypopneaeventswithoxyhemoglobindesaturations
of4and3%,respectively.NotethemarkeddeclineinthesnoringsignalonTNIcomparedwithTNIoff.Microphone �digitallydisplayedsnoring
auditorysignal;Psg �supraglotticcatheterpressure(cmH 2O);Sa O2 �oxygensaturation.
Mechanism of Action
Toexploretheunderlyingmechanismsresponsiblefortheeffect
of TNI on sleep-disordered breathing we assessed inspiratory
airflow,end-expiratorysupraglotticpressure,andrespiratoryeffortinasubgroupofsubjects(n
�7).InFigure5,theimmediate
respiratory responsesto TNIatarateof20 L/minuteforone
subject with obstructive hypopneas are demonstrated. As can
be seen in Figure 5, breaths off TNI were characterized by
inspiratoryflowlimitationindicatedbyaplateauingofinspiratoryflowassupraglotticpressurecontinuedtofall(seeinspiratory
flow limitation threshold marked by the horizontal dashed
line).AfterTNIwasinitiated,therewasaninstantaneousincrease
Figure4.Sleep-disordered
breathingindices.Shown
are apnea and hypopneaindicesduringthe
baseline(Bsl)diagnostic
night and the clinical
treatmentnightforindividual
subjects. Individual
subject symbols
areconsistentbetween
panels.TNI �treatment
withnasalinsufflation.
47

TNI ® Studies
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198 AMERICANJOURNALOFRESPIRATORYANDCRITICALCAREMEDICINE VOL 176 2007
TABLE 2. INTERRATER RELIABILITY
Respiratory Spontaneous
AHI ArousalIndices ArousalIndices
Subject Scorer1 Scorer2 Scorer1 Scorer2 Scorer1 Scorer2
C 20 21 21 23 7 5
D 16 15 16 15 7 5
E 7 6 9 7 4 3
F 7 7 3 3 0 0
G 24 25 20 24 8 4
H 8 8 8 8 2 1
I 10 10 5 15 1 0
J 5 5 5 5 6 3
K 86 86 64 64 0 0
Mean 20 20 17 18 4 2
SE 26 26 19 19 3 2
ICC 1.00 0.98 0.80
Definition ofabbreviations:AHI �apnea–hypopnea index; ICC � intraclass
correlationcoefficient.
Individualdataarepresentedforasubsetofpatients(n �9),scoredbytwo
experienced board-certified sleep medicine physicians, for the analysis of interscoreragreementfortheapnea–hypopneaindices,respiratoryandspontaneousarousalindices.
inend-expiratorysupraglotticpressure(Figure5,circled1)and
meaninspiratoryairflow(Figure5,circled2).Nevertheless,inspiratory
flow limitation was still present over a short period of
breathsinwhichsupraglotticpressureswingsdeclinedgradually
onabreath-by-breathbasis(Figure5,circled3),indicatingthat
improvementsinairflowwereassociatedwithprogressivereductionsinrespiratorydrive.Oncethesupraglotticpressureswings
no longer fell below the threshold for flow limitation (Figure
5, circled4), theinspiratory airflowcontour assumed around,
non–flow-limitedpattern(Figure5,circled5).
Pooled data for a subset of subjects (n � 7) demonstrate
that TNI increased end-expiratory pharyngeal pressure from
atmosphericto1.8 �0.1cmH 2O(p �0.04),increasedinspiratory
airflowfrom255.1 �54.2to363.5 �26.7ml/second(p �0.04),
anddecreasedsupraglotticpressureswingsfrom11.3 �0.5to
4.4 �0.6cmH 2O(p �0.04).Thus,TNIalleviatesupperairway
obstructionthroughanimmediateincreaseinpharyngealpressureincombinationwithgradualreflexivereductionsinventilatorydrive.
Sleep Characteristics and Arousal Indices
AsshowninTable3,TNIreducedtherespiratory-relatedarousal
frequency(18 �4to8�2events/h,p �0.01),withoutachange
inthespontaneousarousalfrequency(3 �1to3�1,p�0.65).
Therewasnooverallchangeintotalsleeptime,sleepefficiency,
orsleepstagedistribution,perhapsasaresultofourrelatively
smallsamplesize.However,eachpatientexhibitedanimprovementinsleepstagedistribution,witheitheragreaterpercentage
oftimeindeeperstagesofNREMsleep(subjects3,4,5,6,8,
and11)oragreaterpercentageoftotalsleeptimespentinREM
sleep(subjects1,2,7,9,and10),suggestingthatTNIimproved
sleepquality.
DISCUSSION
Ourstudywasdesignedtoexaminetheeffectoftreatmentwith
nasalinsufflation(TNI)onobstructivesleepapnea.Inabroad
spectrumofpatients,wefoundasignificantreductionininspiratoryflowlimitationseverityonTNIat20versus10L/minute,and
improvementinsleepapneaseverityasreflectedbyamarkedfall
inboththeapnea–hypopneaandarousalindicesonTNIat20
L/minute.Thereliefofupperairwayobstructionwasmostlikely
duetosmallbutconsistentincreasesinpharyngealpressureon
TNI,whichdecreasedtheseverityofinspiratoryflowlimitation.
Mechanism of Action of TNI
To determine the mechanism of action of TNI, we assessed
airflowdynamicsandsupraglotticpressureresponsestoTNIat
alowrate(10L/min)andahighrate(20L/min)duringperiods
ofhypopneasduringNREMsleep.WhereasTNIat10L/minute
hadnoeffectonairflowdynamics,TNIat20L/minuteincreased
peak inspiratory airflow and reduced supraglottic pressure
swings. Although these changes were relatively modest, sleep
andbreathingpatternsimprovedmarkedlyinallsubjectsreceivingTNI.Theseimprovementscanbeattributedprimarilytothe
increaseinpharyngealpressurewhilereceivingTNI.Inspiratory
airflow increases approximately 50 ml/second per cm H 2O of
Figure5. Mechanism of action.Airflowandsupraglottic
pressureareshownduringthe
transition from flow-limited
breathingwithTNIoff,tonon–
flow-limited breathing with
TNI at 20 L/minute. Psg �
supraglotticcatheterpressure
(cmH 2O).Numbersincircles:
1,increaseinend-expiratory
Psg;2,increaseinmeaninspiratoryairflow;3,decreasein
supraglottic pressure swings
onabreath-by-breathbasis;4,
Psg threshold for inspiratory
flow limitation; and 5, a
round, non–flow-limited inspiratorypattern.

TNI ® Studies
Therapy
Diagnostics
McGinley,Patil,Kirkness,etal.:ObstructiveSleepApneaTreatment 199
TABLE 3. SLEEP CHARACTERISTICS AND AROUSAL INDICES
Baseline TNI,20L/min
Mean SEM Mean SEM pValue
TST,min 317.9 26.0 326.7 12.3 0.64
Sleepefficiency,% 79.5 5.2 85.5 3.3 0.24
NREM,%TST 84.2 1.9 87.2 2.6 0.43
Stage1,% 12.7 3.1 13.2 4.0 0.56
Stage2,% 65.2 4.0 68.2 4.2 0.56
Stage1,% 6.3 1.8 6.3 1.8 0.84
REM,%TST 14.1 2.2 12.8 2.6 0.87
Arousalindices
Respiratory 18.3 3.7 8.3 1.5 0.005
Spontaneous 3.4 2.2 3.1 0.4 0.65
Total 21.6 3.6 11.4 1.5 0.007
Definitionofabbreviation:NREM �non–rapideyemovement;TST �totalsleep
time.
Groupdataarepresentedforboththebaselineandclinicaltreatmentnight
withTNIat20L/minute.
CPAPpressureapplied(25).TNIatarateof20L/minuteled
toasimilarincreaseininspiratoryairflow(45ml/spercmH2O).
Thepeakinspiratoryairflowsofourpatientsduringhypopneas
wereonlymildlyreducedtoapproximately230ml/second,and
rosetoapproximately300ml/second,alevelpreviouslyassociatedwiththeeliminationofinspiratoryflowlimitationandstabilizationofbreathingpatterns(25).Thus,improvementsinpeak
inspiratory airflow were likely due to increases in pharyngeal
pressure,whichwereofsufficientmagnitudetotreathypopneas
wheninspiratoryairflowlevelsareonlymildlyreduced.
Effect of TNI on Sleep-disordered Breathing
Althoughweexpectedmarked improvementsintheAHI primarilyinpatientswithhypopneasratherthanobstructiveapneas,
TNIloweredtheAHIinallsubjects,regardlessoftheapnea–
hypopneadistribution.Althoughtheprimarymechanismofactionappearstoberelatedtoincreasesinend-expiratorypharyngeal
pressure, other factors may have further improved
ventilationinadditiontoalleviatingupperairwayobstruction.
First, even small increases in pharyngeal pressure may have
increasedlungvolume.Increasesinlungvolumeleadtoimprovementsinbothoxygenstoresandupperairwaypatency(26–30),
both of which may further stabilize breathing patterns during
sleep.Asventilationimprovedinourpatientsduringsleep,enhancedsleepcontinuity(decreasedarousalfrequency)mayhave
also contributed to further reductions in the apnea–hypopnea
indices(31,32).Indeed,wefoundatrendtowardimprovement
in sleep stage distribution in all subjects, with a reduction in
respiratory arousals, and no change in spontaneous arousals.
Additional benefitsmay have accruedfrom insufflatingairdirectlyintothenose,whichmayproduceconcomitantreductions
indead spaceventilation. Therefore,improvements inoxygen
stores, ventilation, and sleep continuity, along with enhanced
upper airway patency,are likely responsibleforthe beneficial
responsestoTNI.Weacknowledgethatobstructivesleepapnea
was not completely eliminated in all of our patients, and that
nasalCPAPmightstillbemoreefficaciousinreducingtheAHI
duringtreatmentnights.Nevertheless,reducedcompliancewith
CPAPcansignificantlycompromiselong-termtherapeuticeffectiveness,leavingasignificantportionofpatientsuntreatedovertime(33).PoorCPAPcompliancehasbeenattributedtocumbersome
masks, and to difficulties in exhaling against a high
backpressure (17). In contrast, TNI offers a simplified nasal
interfacefordeliveringrelativelylowlevelsofpharyngealpressure,
which may enhance long-term compliance, and overall
therapeuticeffectiveness,andthusmightreducelong-termcardiovascular
and metabolic complications of obstructive sleep
apnea.
Limitations
Thereareseverallimitationsinthecurrentstudy.First,weused
onlyflowratesof10and20L/minuteinourstudy.Itispossible
thathigherflowrateswouldhavebeenevenmoreeffectivein
eliminatingallrespiratoryevents.However,weusedrelatively
lowflowratestobalancethecomfortofnasalinsufflationwith
efficacy.Indeed,therewerenoreportsofsignificantdiscomfort
orsideeffectsafterafullnightoftreatmentwithTNIat20L/
minute,withtheexceptionofreportsthatairtemperatureswere
either too warm (n � 2) or cold (n � 1) for initiating sleep.
Nevertheless, the majority of subjects did not have difficulty
initiatingormaintainingsleepascomparedwithbaseline.None
ofthepatientscomplainedaboutnoiserelatedtotheuseofTNI,
whichweacknowledgemightresultfrompatientmotivation,or
perception relative to their previous experience with CPAP.
Moreover,assessmentofsleep architecturebetweennightson
and off TNI indicates a trend toward improvement, without
changeinspontaneousarousalindices.Second,itispossiblethat
the cannula may have dislodged during the night, accounting
forthetreatmentfailureinatleastonepatient.Althoughitis
not yet clear how a minor dislodgement of the cannula can
affectefficacy,thefactthatthemajorityofourpatientshada
substantialreductioninsleep-disorderedbreathingindicessuggeststhattheexactpositionofthenasalcannulaisnotcritical.
Third, the occurrence ofapneas might be dependenton body
position. We accounted for body position between the two
nights, thus eliminating the impact of achange in position on
thetreatmenteffect.Fourth,TNIwasusedforonlyonenight.
Althoughpatientsdidnotreportanydiscomfortwhenusingit
foronenight,theresponsemightbedifferentwhenusingTNI
repeatedlyoverseveralnights.FurtherstudiesofTNIadministeredoverseveralnightswouldberequiredtoexamineitseffect
relative to CPAP. Fifth, assessment of both spontaneous and
respiratory arousals is potentially associated with poor agreementbetweenscorers.Alldatainthisstudywerereviewedby
twoexperiencedboard-certifiedsleepphysicians(H.S.andS.P.).
Toassessqualityassuranceofourscoring,theinterraterreliabilitywasanalyzedforasubsetofpatients(n�9),andwascomparabletopreviousassessmentsofinterraterreliabilityofbothspontaneousandrespiratoryarousalindices(ICC,0.72;95%confidence
interval:0.44,0.88)withexperiencedfull-timescorers(34).
Implications
Thereareseveralclinicalimplicationsofourfindings.First,our
findingsprovideevidencethatTNImayofferaviabletreatment
alternativetopatientswithobstructivehypopneasandapneas.
ThefindingthatTNIalleviatedobstructivehypopneasinallbut
onepatientpredictsahighlikelihoodoftreatmentsuccessina
similarpatientpopulation.Aretrospectiveanalysisofourpatient
database with 4,746 patients with obstructive sleep apnea–
hypopneasyndromestudiedbetween1981and2000,whoseAHI
was greaterthan10, showedthat28.4% ofthese patients had
predominantly obstructive hypopneas (more than 90% of all
events) and would meet the polysomnographic and anthropometriccharacteristicsofourstudypopulation.Second,ourfindings
that TNI also had an effect on obstructive apnea in our
patientswithanapneaindexofgreaterthan15impliesthatTNI
may be beneficial in some patientswith obstructive apneas as
well.Furtherstudiesarerequiredtoelucidatethepolysomnographicand/orclinicalpredictorsofaTNIresponse.Third,we
usedafixedflowrateandcannulasize,whichmayobviatethe
needfortitrationstudies.Indeed,itmaybepossibletoofferan
49

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200 AMERICANJOURNALOFRESPIRATORYANDCRITICALCAREMEDICINE VOL 176 2007
empiric,streamlinedtherapeuticapproachwithTNIforalarge
proportionofpatientswithsleepapnea.
Insummary,ourstudyprovidesclinicalproofofconceptfor
employingTNIasanoveltreatmentforpatientswithobstructive
sleep apnea–hypopnea syndrome. Because one flow rate and
cannulasizewassufficienttostabilizebreathingpatternsinthe
majority of our subjects, titration may be obviated, thereby
streamliningtheinitiationoftreatment.Moreover,theminimally
intrusivenasalinterfaceofTNImayimprovepatientadherence,
andmayultimatelyprovemoreeffectiveinmanagingthelongterm
morbidity and mortality of sleep apnea. Further studies
willberequiredtoextendthesefindingsandtodeterminethe
ultimateroleofTNIinmanagingobstructivesleepapnea.
ConflictofInterestStatement: B.M.M.doesnothaveafinancialrelationshipwith
acommercialentitythathasaninterestinthesubjectofthismanuscript.S.P.P.
doesnothaveafinancialrelationshipwithacommercialentitythathasaninterest
inthesubjectofthismanuscript.J.P.K.doesnothaveafinancialrelationshipwith
acommercialentitythathasaninterestinthesubjectofthismanuscript.P.L.S.
doesnothaveafinancialrelationshipwithacommercialentitythathasaninterest
inthesubjectofthismanuscript.A.R.S.received$18,000in2006,underaprivate
licensingagreementbetweenDr.SchwartzandSeleonGmbH.Thetermsofthis
arrangementarebeingmanagedbyJohnsHopkinsUniversityinaccordancewith
itsconflictofinterestpolicies.H.S.received$78,000from2003to2006.Under
a private licensing agreement between Dr. Schneider and Seleon GmbH,
Dr.Schneiderreceivesconsultingfees(U.S.$18,000in2006)andisentitledto
royaltypaymentsonthefuturesalesofproductsdescribedinthisarticle.Under
aseparatelicensingagreementbetweenDr.SchneiderandSeleonGmbHand
JohnsHopkinsUniversity,Dr.Schneiderisentitledtoashareofroyaltyreceived
bytheuniversityonsalesofproductsdescribedinthisarticle.Thetermsofthis
arrangementarebeingmanagedbyJohnsHopkinsUniversityinaccordancewith
itsconflictofinterestpolicies.Fundingforthestudydescribedinthisarticlewas
partiallyprovidedbySeleonGmbH.
Acknowledgment : The authors thank Mr. Peter DeRosa and Mr. Christopher
Smithforcontributionstothisstudy,whichincludedtechnicalsupport,data
collection,andhelpinthepreparationoftablesandfigures.
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51

Case Reports
Adults
TNI ® 20
52
Therapy
Diagnostics
Sex: male Age: 67 years weight/height: 110 kg, 189 cm
Diagnosis: COPD IV with acute exacerbation (BODE 4), severe respiratory global insufficiency,
chron. cor pulmonale, moderate centrilobular lung emphysema
Previous therapy form/values: Oxygen therapy: 2l/min O 2 in domestic surroundings
pCO 2 : 64.6 mmHg
pO 2 : 39.9 mmHg
sO 2 : 75.1%
TNI ® 20 therapy/values: 20l/min only room air (without oxygen addition) Values after 12 days
pCO 2 : 43.0 mmHg
pO 2 : 55.2 mmHg
sO 2 : 88.7%
Evaluation of the patient: Feeling of well-being connected with good sleep, desires to continue therapy
Sex: male Age: 73 years weight/height: 88 kg, 173 cm
Diagnosis: Severe OSA
Previous therapy form/values: CPAP
sO 2 : at least 79 %
RDI dead: 46.6
RDI–REM: 33.8
TNI ® 20 therapy/values: 20l/min room air
sO 2 :at least 83 %
RDI dead: 4
RDI–REM: 11.7
Evaluation of the patient: good sleep
Sex: male Age: 78 years
Diagnosis: COPD stage 4 with respiratory global insufficiency
Previous therapy form/values: Oxygen therapy: 1l/min O 2 ,
pCO 2 : 60 mmHg
pO 2 : 46 mmHg
sO 2 : 79%
TNI ® 20 therapy/values: 20l/min room air Values after: 30 min:
pCO 2 : 55mmHg
pO 2 : 56 mmHg
sO 2 : 88%

Case Reports
TNI ® 20 oxy / TNI ® 20s oxy
Therapy
Diagnostics
Sex: male Age: 50 years weight/height: 145 kg, 170 cm
Diagnosis: Obesitas hypoventilation syndrome with respiratory global insufficiency
Previous therapy form/values: Oxygen 3-4 l/min
Under TNI ® 20s oxy: Improved values:
pCO 2 situation improved as trend
Oxygen situation negligibly improved
No oxygen addition
Night personnel terminated therapy, not instructed
Sex: male Age: 78 years
Diagnosis: COPD stage 4, hypercapnia, chronic cor pulmonale with respiratory global
insufficiency, wants to die according to his own assertion, rejects mask
Initial values: pCO 2 : ca 70 mmHg
sO 2 : below 45%
Previous therapy form/values: Oxygen therapy: 2l/min O 2
pCO 2 : 75 mmHg
sO 2 : 92%
TNI ® 20s oxy therapy/values: 2l/min O 2 and 12l/min room air Values according to 24 h duration of therapy
pCO 2 : 50 mmHg
sO 2 : 92%
Evaluation of the patient: declining dyspnea already after 2 h
Sex: male Age: 72 years
Diagnosis: Obesitas hypoventilation syndrome
Previous therapy form/values: Oxygen therapy: 2l/min O 2
sO 2 : 74%
TNI ® 20s oxy therapy/values: 18l/min room air Values after: 1h:
no improvement in trend discernible
sO 2 : 74%
Oxygen therapy: 2l/min O 2 and 18l/min room air
Values after: 15 min: night of sleep:
pCO 2 : unchanged sO 2 : 74%
sO 2 : 92%
Evaluation of the patient: sleeps better than in a long time
53

Case Reports
TNI ® 20 oxy / TNI ® 20s oxy
54
Sex: female Age: 80 years
Therapy
Diagnostics
Diagnosis: Deterioration of general condition with increasing rest dyspnea, increased central bronchial
pattern and significant central and peripheral congestion as well as a pneumonic infiltrate
with free discharge in the right lower flaps
Therapy Date/time pCO 2 pO 2 sO 2
Initial situation
without 11.07.07 / 12.32 h 29 mmHg 47 mmHg 87%
oxygen therapy
3l/min O 2 11.07.07 / 13.00 h 31 mmHg 54 mmHg 90%
TNI ® -therapy
TNI ® 16+5 O 2 11.07.07 / 14.55 h 30 mmHg 62 mmHg 94%
TNI ® 16+5 O 2 11.07.07 / 16.11 h 33 mmHg 65 mmHg 95%
TNI ® 16+5 O 2 12.07.07 / 8.03 33 mmHg 62 mmHg 93%
Counter check
without 13.07.07 / 8.41 h 32 mmHg 43 mmHg 83%
4l/min O 2 14.07.07 / 10.12 h 35 mmHg 62 mmHg 93%
Comment: the blood gases could not be maintained with only O 2 , which was not the case with TNI ® .
With TNI ® therapy: good oxygenation, lower CO 2 values, therefore the better alternative to
pure O2 supply.
Sex: male Age: 75 years
Diagnosis: COPD stage 4 with respiratory global insufficiency, pneumonic bilateral, increasing
decompensation after acetabulum fracture, rest dyspnea, somnolent
Previous therapy form/values: NIV respiration (BiPAP, p=18/10 mbar, AF: 15/min),
patient has not tolerated a mask
TNI ® 20s oxy therapy/values: 8l/min O2 and 14l/min room air
pCO 2 : 39 mmHg
pO 2 : 78 mmHg
sO 2 : 95,9%
Comment: Stabilization of the blood values without NIV, discharge to a normal ward

Case Reports
TNI ® 20 oxy / TNI ® 20s oxy
Sex: female
Diagnosis: COPD with acute exacerbation
Patient admission
Ward 1 due to clin. CO 2
narcosis
Ward 1
Ward 2 placement
Begin high-flow
Ward 2
10 min prior to transport
to D1 due to sepsis
Ward 1 Transport without
high-flow
Therapy
Therapy pO 2 (mmHg) pCO 2 (mmHg)
2 lpm O 2 with nasal
applicator
4 lpm O 2 with nasal
applicator
2 lpm O 2 with nasal
applicator
20 lpm high-flow
(4 lpm O 2 /16 lpm air)
20 lpm high-flow
(4 lpm O 2 /16 lpm air)
20 lpm high-flow
(4 lpm O 2 /16 lpm air)
71 54
217 135
67 105
42 88
50 80
54 48
CPAP with 6 lpm O 2 44 77
Ward 1 Castor Helm 7 lpm O 2 66 91
Diagnostics
Comment: The exhaustion of the breathing musculature resulting in shallow breathing with reduced
ventilation to the lungs due to insufficient strength and producing insufficient O2 intake
can be compensated by the breathing support. The built up PEEP reduces the danger of
expiratory collapse of the respiratory tract at COPD and achieves sufficient CO2 respiration.
The patient has accepted the high flow very well.
Case report
Flow / O 2 Without CO 2 / O 2 30 min 1,5 h 2,5 h 4 h 6 h 7 h 9 h
16/2 8,4/6,8 8,2/6,7 8,1/6,5 7,9/6,8
18/2 8,5/5,3 8,1/7,2 8,2/6,9 8,1/6,3 7,9/7,1 7,6/6,9 7,5/7,6 7,8/6,5
20/2 8,3/6,8 7,8/6,8 7,3/6,9 7,2/7,0 7,6/6,6 7,7/6,9 7,6/6,7
55

Case Reports
TNI ® 20 oxy / TNI ® 20s oxy
56
Sex: male Age: 72 years
Therapy
Diagnosis: 1. Bronchial – CA re OL, T2 N2 Mx, inoperative due to
2. severe COPD with respiratory global insufficiency
Problem: severe, especially night-time dyspnea, frequent nocturnal
alarm of the medical emergency service.
Rest – BGA: O 2 : 52 mm Hg
CO 2 : 48 mm Hg
Furthermore phase night-time desaturation to
minimum 65 %
Diagnostics
Rest – BGA below 2,5l O 2 : O 2 : 59 mm Hg
CO 2 : 56 mm Hg, thus due to CO 2 retention O 2 – supply
not possible via nasal applicator.
Previous therapy form/values: BIPAP therapy with O 2 supply for subjective intolerance and
significantly overinflated lungs failed (FEV1: o,7 l; ITGV 180 %
plan, TLC 160 % plan)
TNI ® 20 oxy therapy/values: 2l/min O 2 and 16l/min room air:
rest – BGA: O 2 : 65 mm Hg
CO 2 : 43 mm Hg
Comment: Subjectively free of complaints, nocturnal continued sleep possible, night-time
minimum saturation: 85 % (versus 65 % before therapy)
Sex: male Age: 72 years
Diagnosis: 1. Central sleep-related respiratory disorders ( AHI 40 per hour ) for
2. Morbus parkinson
3. condition after apoplectic insult
Previous therapy form/values: CPAP / BIPAP: therapy not possible due to mask intolerance,
O 2 : Insufflation per nasal applicator (2l and 4l) without effect on AHI
TNI ® 20 oxy therapy/values: 2l/min O 2 and 18l/min room air:
AHI 11 per hour and significant improvement of the diurnal symptoms.

Case Reports
Children
TNI ® 20
Case report 1-year child:
Successful breathing support of a previously early birth with nasal insufflation
Therapy
Diagnostics
Summary of the case example: The patient was a one year old boy, born prematurely in the 27th week,
with multiple disorders: acute respiratory insufficiency, epilepsy, infantile cerebral paresis, tetra spastic,
retinopathy, BDP, supply of a gastrostroma and bronchopneumonia. He was admitted as an inpatient to
the ward with a feverish pulmonary infection with a significantly obstructive component. With copious tracheobronchial
secretions, he exhibited an acute respiratory insufficiency with hypoxemia and hypercapnia.
An increasing deterioration of the pulmonary situation with an oxygen desaturation between 9% and 25%
(determined by a monitor) could not be prevented despite intensive suctioning off of secretion and supply
of oxygen. Thereafter the nasal insufflation was applied with sedation with an initial flow of 10-12 l/min
of medical air and additionally 3-4 l/min of oxygen over 24 hours. After completed stabilization, the flow
could be reduced to 8 l/min air and 1-2 l/min oxygen. The therapy was applied for several days until significant
improvement of the pulmonary situation.
Case report preemie (female): from the 38th week of pregnancy
Diagnosis: Eutropic newborn from the 38th pregnancy week
CHARGE syndrome, central sleep apnea syndrome, recurrent apnea attacks,
condition after aspiration pneumonia
Previous therapy form/values: NIV respiration, mask was not tolerated
TNI ® 20 therapy: is well accepted, average sO 2 waste products
Case report 3-year-old (male)
Diagnosis: Massive obstructive sleep apnea syndrome
M. Crouzon with multiple seam synostosis, emphasized in the area of the coronary and
sagittal seams, condition after choanal stenosis, operative expansion on both sides 06/2006,
deployment of intranasal placeholders
Previous therapy form/values: NIV respiration, has not tolerated a mask
TNI ® 20 therapy: is well accepted
Case report 3-year-old (male)
Diagnosis: Massive obstructive sleep apnea syndrome
Free trisomy 21 with typical dysmorphic stigmata, extreme psychomotoric development
disruption, condition after atrioventricular septum defect, AV flaps insufficiency, secondary
pulmonary hypertension.
Previous therapy form/values: NIV respiration, has not tolerated a mask, autistic sleeping
ritual, therefore mask adjustment not possible
TNI ® 20 therapy: is well accepted, subjective and objective OSAS significantly better
57

Accessories Catalogue
PG system MS310
58
part number labeling
9B00001 thermistor for MS310
9B00002 oxygen saturation sensor for
MS310
9B00013 Softtip Sensor SpO2
for MS310
9B00014 EKG - Sensor for MS310
9B00015 PLM - Sensor for MS 310
9B00003 carrying disk with thorax sensor
and snoring microphone for
MS310
Therapy
Diagnostics

PG system MS310
part number labeling
9B00004 abdomen sensor for MS310
9B00005 CPAP pressure sensor for MS310
9B00008 carrying ledge for thorax and
abdomen 110 cm for MS310
9B00009 carrying ledge for thorax and
abdomen 150 cm for MS310
40400083 Nasal cannula diagnosis with
Luer Lock connection for
Adults
40400081 Nasal cannula 21inch/53cm
Therapy
Diagnostics
59

Accessory
PG system MS310
60
part number labeling
40400044 battery NiMH 2850 mAh
9B00010 neck belt for MS310
40400016 T-connection for MS310
40400017 connection tube CPAP for MS310
9B00016 instruction manual MS310
40400045 patient case for PG,
B35 x H28 x T9
Therapy
Diagnostics

Accessory
PG system MS310
part number labeling
40400043 battery charger incl. 4 batteries
with min. 2850 mA
40400042 chipcard reader SCM SCR3311
für MS310 USB incl. SW
9B00017 suitcase for MS 310
Therapy
Diagnostics
61

Accessory
TNI ® -therapy devices
62
part number labeling
8C11003 TNI ® applicator for adults
(standard)
8C11004 TNI ® applicator for adults
(comfort)
8C11005 TNI ® applicator for children
(standard)
Therapy
Diagnostics
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
40100006 TNI ® applicator for new born � TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
40100007 TNI ® applicator for Infant � TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
40100005 TNI ® pediatric adapter � TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy

Accessory
TNI ® -therapy devices
part number labeling
40300103 TNI ® Paed adapter BC 2745
for new born
40300102 TNI ® Paed adapter BC 2755
for baby
40300105 TNI ® Paed Adapter BC 3780
for Infant
7A05157 TNI ® Adapter with Temperature
sensor
7A04067 TNI ® connection cable
180 cm
Therapy
Diagnostics
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
4F57002 TNI ® filter of the blower unit � TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
63

Accessory
TNI ® -therapy devices
64
part number labeling
8Z06047 TNI ® hose set 5,40 m -
elongation
Therapy
Diagnostics
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
7A06079 TNI ® housing lid � TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
4K06032 TNI ® O-Ring � TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
4F81047 TNI ® humidifier cover � TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
4F81046 TNI ® seperator panels humidifier
unit
4F81042 TNI ® pritective cover of operating
elements
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy

Accessory
TNI ® -therapy devices
part number labeling
40200010
30100012
30100013
30100014
30100015
TNI ® power cable GER
TNI ® power cable UK
TNI ® power cable IT
TNI ® power cable USA, CA
TNI ® power cable Z.A.
8Z03001 TNI ® connecting hose blower/
humidifier unit
30100019 TNI ® water reservoir humidifier
unit
30200007 additional information for healthcare
professionals
30200029 operating instruction
TNI ® 20s oxy
30200027 operating instructionTNI ® 20 oxy
for patients
Therapy
Diagnostics
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
65

Accessory
TNI ® -therapy devices
66
part number labeling
8Z01004 operating instructions TNI ® 20
for patients
Therapy
Diagnostics
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
30100018 Trolley „Fabio“ � TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy
30100020 Trolley „Fabio“ with
pillar 131 cm
� TNI ® 20
� TNI ® 20 oxy
� TNI ® 20s oxy

Accessory
Nasal Insufflation Cannula (NIC)
part number labeling
40100001 Nasal Insufflation Cannula
- complete silicone -
for NIC-Therapie
40100004 Nasal Insufflation Cannula
- part silicone -
for NIC-Therapie
Therapy
Diagnostics
�
67

About us
68
Therapy
Diagnostics
TNI medical AG develops, produces, and sells diagnostic and therapeutic devices for
breathing therapy. Our products are primarily used for home treatments, especially
during sleep. With its newly introduced TNI ® breathing therapy, TNI medical AG focuses
on maximizing patient comfort with simultaneous simplification of the application. This
leads to greater cost efficiency.
The company with its headquarters in Freiburg and further subsidiaries in Dessau and
Würzburg was founded in August 2007 as spin-off of seleon gmbh, an internationally
top-ranking technological firm for mechanical breathing therapies. The syndromes sleep
apnea and chronic obstructive pulmonary disease (COPD) primarily treated with our applications
currently show the highest incidence growth rates worldwide.
Contact
TNI medical AG
Hofmannstr. 8
97084 Würzburg
Germany
Phone: +49 931 20 79 29-02 E-Mail: info@tni-medical.de
Fax: +49 931 20 79 29-01 Web: www.tni-medical.com
Service Hotline: +49 931 2079 29-02

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Therapy
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TNI ® 20
TNI ® 20 oxy
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69

TNI medical AG
Hofmannstr. 8
97084 Würzburg
Germany
Phone +49 931 20 79 29-00 E-Mail: info@tni-medical.de
Fax +49 931 20 79 29-01 Web: www.tni-medical.com