IP Library Granted Patent US 12,478,282
Granted Patent B2
US 12,478,282 · App. 15/468,613 · Granted Nov 25, 2025

Methods and systems for collecting spirometry data

Inventors: Achim Schuelke (Winterhausen, DE); Stefan Schindelmann (Leinach, DE); Michael Worth (Wuerzburg, DE); Bernd Mark (Seinsheim, DE)
Assignee: eResearchTechnology, Inc.
A61B5/087A61B5/002A61B5/0022A61B5/097A61B5/1172A61B5/1495A61B5/7405A61B5/7445G06F21/32G16H40/67H02J7/0044H02J50/10H02J50/80A61B5/1176A61B5/7415A61B5/743A61B2560/0214A61B2560/0431A61B2560/0456A61B2562/0219A61B2562/029H01M10/4257H04W4/80
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Quick Facts
Patent No.
US 12,478,282
App. No.
15/468,613
Granted
Nov 25, 2025
Kind
B2
Abstract

Disclosed herein are spirometers that can be used for assessment of pulmonary lung function. The disclosed systems, computer readable mediums and methods can be directed towards use in a variety of settings by health care professionals, clinical trial specialists, and individual users.

Claims (136)

1 . A system for assessing pulmonary function comprising:

(a) a mouthpiece having a cylindrical body and plural flow sensors, each flow sensor being disposed at a different location along a flow path of the cylindrical body, the cylindrical body having a first end and a second end, wherein the first end is opposite from the second end and at least the first end is configured to interact with a human mouth, wherein each flow sensor can generate pulmonary function data from a breath sample provided by a subject;

(b) a wireless detection unit having an interface for receiving at least the second end of the mouthpiece, wherein the mouthpiece is removable from the wireless detection unit;

(c) a base station configured to communicate with the wireless detection unit;

(d) a first biometric sensor on the base station configured to collect biometric data of the user and a second biometric sensor on the wireless detection unit configured to collect biometric data of the subject, wherein the user and the subject are not a same individual; and

(e) a non-transitory computer readable medium including instructions,

wherein the mouthpiece in combination with the plural flow sensors form a pneumotach tube,

wherein the instructions, when executed by the system, i) cause the base station to receive the pulmonary function data, ii) cause the system to authenticate the user based on the biometric data of the user, iii) cause the system to allow different defined rights to different users authenticated using the biometric data of the user, iv) cause the biometric data of the user collected by the first biometric sensor to control access to an application, wherein the application provides access to operate the wireless detection unit, and (v) cause the system to authenticate the subject based on the biometric data of the subject,

wherein the wireless detection unit or the base station includes one or more indicator elements to direct the subject through a sequence for providing the breath sample,

wherein the system is configured to determine a validity of the pulmonary function data based on the sequence for providing the breath sample,

wherein the system is configured to perform a cross-correlation analysis that cross-correlates the pulmonary function data generated by the subject with stored pulmonary function data,

wherein the system is configured to select the stored pulmonary function data based on identifying information of one or more subjects or select the stored pulmonary function data based on plural variables, the plural variables including the identifying information of one or more subjects and at least one of: an identity of the authenticated user, one or more ambient conditions measured when the breath sample is provided, and the determined validity of the pulmonary function data, and

wherein the system is configured to standardize the pulmonary function data of the subject based on the cross-correlation analysis, the standardized pulmonary function data being used to assess pulmonary function of the subject.

2 . The system of claim 1 , wherein the wireless detection unit further comprises a power source.

3 . The system of claim 2 , wherein the power source is a battery.

4 . The system of claim 3 , wherein the battery is a lithium ion battery pack.

5 . The system of claim 4 , wherein the wireless detection unit further comprises a charging receiver coil.

6 . The system of claim 5 , wherein the charging receiver coil is a wireless charging receiver coil.

7 . The system of claim 1 , wherein the wireless detection unit further comprises a gyroscope or an accelerometer.

8 . The system of claim 7 , wherein the gyroscope or accelerometer detects axial changes including orientation, rotation, and vibration.

9 . The system of claim 1 , wherein the one or more indicator elements comprises one or more audible source.

10 . The system of claim 1 , wherein the one or more indicator elements comprises one or more light emitting diodes.

11 . The system of claim 10 , wherein the one or more light emitting diodes direct the subject or the user.

12 . The system of claim 11 , wherein the one or more light emitting diodes direct the subject to inhale, hold air in lungs, or exhale.

13 . The system of claim 12 , wherein the one or more light emitting diodes direct the subject to inhale, hold air in lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds.

14 . The system of claim 1 , wherein the wireless detection unit transmits the data collected using the pneumotach tube to the base station over a network.

15 . The system of claim 14 , wherein the wireless detection unit transmits the data collected using the pneumotach tube to the base station via short-range wireless communications.

16 . The system of claim 14 , wherein the network is a wireless network.

17 . The system of claim 16 , wherein the base station communicates with the wireless detection unit using a personal area network, Infrared Transmission, short-range wireless communications, or any combination thereof.

18 . The system of claim 16 , wherein the base station communicates with two or more wireless detection units.

19 . The system of claim 16 , wherein the wireless detection unit and the base station are separated by a distance.

20 . The system of claim 1 , wherein the base station further comprises a visual display.

21 . The system of claim 20 , wherein the visual display displays the pulmonary function data in real-time.

22 . The system of claim 21 , wherein the system is configured to determine a validity of the pulmonary function data, and wherein the visual display comprises an animated icon indicating the validity of the pulmonary function data in real-time.

23 . The system of claim 20 , wherein the system is configured to determine a success or failure to transmit the data collected using the pneumotach tube from the wireless detection unit, and wherein the visual display displays a user icon or a subject icon that provides feedback regarding the success or failure to transmit the data collected using the pneumotach tube from the wireless detection unit.

24 . The system of claim 1 , wherein the base station further comprises a power source.

25 . The system of claim 24 , wherein the power source is a battery.

26 . The system of claim 25 , wherein the battery is a lithium ion battery pack.

27 . The system of claim 6 , wherein the base station further comprises a charging transmitter coil.

28 . The system of claim 27 , wherein the charging transmitter coil is a wireless charging transmitter coil.

29 . The system of claim 1 , wherein the system further comprises a humidity sensor.

30 . A system for assessing pulmonary function comprising:

(a) a mouthpiece having a cylindrical body and plural flow sensors, each flow sensor being disposed at a different location along a flow path of the cylindrical body, the cylindrical body having a first end and a second end, wherein the first end is opposite from the second end and at least the first end is configured to interact with a human mouth, wherein each flow sensor can generate pulmonary function data from a breath sample provided by a subject;

(b) a wireless detection unit having an interface for receiving at least the second end of the mouthpiece, wherein the mouthpiece is removable from the wireless detection unit, wherein the wireless detection unit further comprises a charging receiver coil;

(c) a base station configured to communicate with the wireless detection unit, wherein the base station comprises a touch visual display and a docking cradle, wherein the docking cradle comprises a charging transmitter coil and is sized and adapted to store the wireless detection unit and to wirelessly charge the wireless detection unit;

(d) a first biometric sensor on the base station configured to collect biometric data of the user and a second biometric sensor on the wireless detection unit configured to collect biometric data of the subject, wherein the user and the subject are not a same individual; and

(e) a non-transitory computer readable medium including instructions,

wherein the mouthpiece in combination with the plural flow sensors form a pneumotach tube,

wherein the instructions, when executed by the system, i) cause the base station to receive the pulmonary function data, ii) cause the system to authenticate the user based on the biometric data of the user, and iii) cause the system to allow different defined rights to different users authenticated using the biometric data of the user, iv) cause the biometric data of the user collected by the first biometric sensor to control access to an application, wherein the application provides access to operate the wireless detection unit, and (v) cause the system to authenticate the subject based on the biometric data of the subject,

wherein the wireless detection unit or the base station includes one or more indicator elements to direct the subject through a sequence for providing the breath sample,

wherein the system is configured to determine a validity of the pulmonary function data based on the sequence for providing the breath sample,

wherein the system is configured to perform a cross-correlation analysis that cross-correlates the pulmonary function data generated by the subject with stored pulmonary function data,

wherein the system is configured to select the stored pulmonary function data based on identifying information of one or more subjects or select the stored pulmonary function data based on plural variables, the plural variables including the identifying information of one or more subjects and at least one of: an identity of the authenticated user, one or more ambient conditions measured when the breath sample is provided, and the determined validity of the pulmonary function data, and

wherein the system is configured to standardize the pulmonary function data of the subject based on the cross-correlation analysis, the standardized pulmonary function data being used to assess pulmonary function of the subject.

31 . The system of claim 30 , wherein the wireless detection unit further comprises a power source.

32 . The system of claim 30 , wherein the charging receiver coil is a wireless charging receiver coil.

33 . The system of claim 30 , wherein the wireless detection unit further comprises a gyroscope or an accelerometer.

34 . The system of claim 33 , wherein the gyroscope or accelerometer detects axial changes including orientation, rotation, and vibration.

35 . The system of claim 30 , wherein the one or more indicator elements comprises one or more audible source.

36 . The system of claim 30 , wherein the one or more indicator elements comprises one or more light emitting diodes.

37 . The system of claim 36 , wherein the one or more light emitting diodes direct the subject or the user.

38 . The system of claim 37 , wherein the one or more light emitting diodes direct the subject to inhale, hold air in lungs, or exhale.

39 . The system of claim 38 , wherein the one or more light emitting diodes direct the subject to inhale, hold air in lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds.

40 . The system of claim 30 , wherein the wireless detection unit transmits the data collected using the pneumotach tube to the base station over a network.

41 . The system of claim 40 , wherein the wireless detection unit transmits the data collected using the pneumotach tube to the base station via short-range wireless communications.

42 . The system of claim 40 , wherein the network is a wireless network.

43 . The system of claim 42 , wherein the base station communicates with the wireless detection unit using a personal area network, Infrared Transmission, short-range wireless communications, or any combination thereof.

44 . The system of claim 42 , wherein the base station communicates with two or more wireless detection units.

45 . The system of claim 42 , wherein the wireless detection unit and the base station are separated by a distance.

46 . The system of claim 30 , wherein the touch visual display displays the pulmonary function data in real-time.

47 . The system of claim 46 , wherein the system is configured to determine a validity of the pulmonary function data, and wherein the touch visual display comprises an animated icon indicating the validity of the pulmonary function data in real-time.

48 . The system of claim 46 , wherein the system is configured to determine a success or failure to transmit the data collected using the pneumotach tube from the wireless detection unit, and wherein the touch visual display displays a user icon or a subject icon that provides feedback regarding the success or failure to transmit the data collected using the pneumotach tube from the wireless detection unit.

49 . The system of claim 30 , wherein the base station further comprises a power source.

50 . The system of claim 49 , wherein the power source is a battery.

51 . The system of claim 50 , wherein the battery is a lithium ion battery pack.

52 . The system of claim 32 , wherein the charging transmitter coil is a wireless charging transmitter coil.

53 . A system for assessing pulmonary function comprising:

(a) a mouthpiece having a cylindrical body and plural flow sensors, each flow sensor being disposed at a different location along a flow path of the cylindrical body, the cylindrical body having a first end and a second end, wherein the first end is opposite from the second end and at least the first end is configured to interact with a human mouth, wherein each flow sensor can generate pulmonary function data from a breath sample provided by a subject;

(b) a wireless detection unit having an interface for receiving at least the second end of the mouthpiece, wherein the mouthpiece is removable from the wireless detection unit, wherein the wireless detection unit further comprises a power source and a charging receiver coil;

(c) a base station configured to communicate with the wireless detection unit over short-range wireless communications, wherein the base station comprises a docking cradle and a touch visual display, wherein the docking cradle comprises a charging transmitter coil and is sized and adapted to store the wireless detection unit and to wirelessly charge the wireless detection unit;

(d) a first biometric sensor on the base station configured to collect biometric data of the user and a second biometric sensor on the wireless detection unit configured to collect biometric data of the subject, wherein the user and the subject are not a same individual; and

(e) a non-transitory computer readable medium including instructions,

wherein the mouthpiece in combination with the plural flow sensors form a pneumotach tube,

wherein the instructions, when executed by the system, i) cause the base station to receive the pulmonary function data, ii) cause the system to authenticate the user based on the biometric data of the user, and iii) cause the system to allow different defined rights to different users authenticated using the biometric data of the user, iv) cause the biometric data of the user collected by the biometric sensor to control access to an application, wherein the application provides access to operate the wireless detection unit, and (v) cause the system to authenticate the subject based on the biometric data of the subject,

wherein the wireless detection unit or the base station includes one or more indicator elements to direct the subject through a sequence for providing the breath sample,

wherein the system is configured to determine a validity of the pulmonary function data based on the sequence for providing the breath sample,

wherein the system is configured to perform a cross-correlation analysis that cross-correlates the pulmonary function data generated by the subject with stored pulmonary function data,

wherein the system is configured to select the stored pulmonary function data based on identifying information of one or more subjects or select the stored pulmonary function data based on plural variables, the plural variables including the identifying information of one or more subjects and at least one of: an identity of the authenticated user, one or more ambient conditions measured when the breath sample is provided, and the determined validity of the pulmonary function data, and

wherein the system is configured to standardize the pulmonary function data of the subject based on the cross-correlation analysis, the standardized pulmonary function data being used to assess pulmonary function of the subject.

54 . The system of claim 53 , wherein the charging receiver coil is a wireless charging receiver coil.

55 . The system of claim 53 , wherein the wireless detection unit further comprises a gyroscope or an accelerometer.

56 . The system of claim 55 , wherein the gyroscope or accelerometer detects axial changes including orientation, rotation, and vibration.

57 . The system of claim 53 , wherein the one or more indicator elements comprises one or more audible source.

58 . The system of claim 53 , wherein the one or more indicator elements comprises one or more light emitting diodes.

59 . The system of claim 58 , wherein the one or more light emitting diodes direct the subject or the user.

60 . The system of claim 59 , wherein the one or more light emitting diodes direct the subject to inhale, hold air in lungs, or exhale.

61 . The system of claim 60 , wherein the one or more light emitting diodes direct the subject to inhale, hold air in lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds.

62 . The system of claim 53 , wherein the wireless detection unit transmits the data collected using the pneumotach tube to the base station over a network.

63 . The system of claim 62 , wherein the network is a wireless network.

64 . The system of claim 63 , wherein the base station communicates with the wireless detection unit using a personal area network, Infrared Transmission, or short-range wireless communications.

65 . The system of claim 63 , wherein the base station communicates with two or more wireless detection units.

66 . The system of claim 63 , wherein the wireless detection unit and the base station are separated by a distance.

67 . The system of claim 53 , wherein the touch visual display displays the pulmonary function data in real-time.

68 . The system of claim 67 , wherein the system is configured to determine a validity of the pulmonary function data, and wherein the touch visual display comprises an animated icon indicating the validity of the pulmonary function data in real-time.

69 . The system of claim 67 , wherein the system is configured to determine a success or failure to transmit the data collected using the pneumotach tube from the wireless detection unit, and wherein the touch visual display displays a user icon or a subject icon that provides feedback regarding the success or failure to transmit the data collected using the pneumotach tube from the wireless detection unit.

70 . The system of claim 53 , wherein the base station further comprises a power source.

71 . The system of claim 70 , wherein the power source is a battery.

72 . The system of claim 71 , wherein the battery is a lithium ion battery pack.

73 . The system of claim 54 , wherein the charging transmitter coil is a wireless charging transmitter coil.

74 . The system of claim 53 , wherein the system further comprises a humidity sensor.

75 . The system of claim 1 , wherein the pneumotach tube is a lilly type pneumotach tube.

76 . The system of claim 30 , wherein the pneumotach tube is a lilly type pneumotach tube.

77 . The system of claim 53 , wherein the pneumotach tube is a lilly type pneumotach tube.

78 . The system of claim 1 , wherein the system further comprises a temperature sensor and a humidity sensor for measuring ambient conditions of the one or more ambient conditions.

79 . The system of claim 78 , wherein the temperature sensor and the humidity sensor are connected to the system by short-range wireless communications.

80 . The system of claim 78 , wherein the system is configured to compensate or adjust the pulmonary function data collected using the pneumotach tube based on an ambient condition measurement made by the temperature sensor and an ambient condition measurement made by the humidity sensor.

81 . The system of claim 30 , wherein the system further comprises a temperature sensor and a humidity sensor for measuring ambient conditions of the one or more ambient conditions.

82 . The system of claim 81 , wherein the temperature sensor and the humidity sensor are connected to the system by short-range wireless communications.

83 . The system of claim 81 , wherein the system is configured to compensate or adjust the pulmonary function data collected using the pneumotach tube based on an ambient condition measurement made by the temperature sensor and an ambient condition measurement made by the humidity sensor.

84 . The system of claim 53 , wherein the system further comprises a temperature sensor and a humidity sensor for measuring ambient conditions of the one or more ambient conditions.

85 . The system of claim 84 , wherein the temperature sensor and the humidity sensor are connected to the system by short-range wireless communications.

86 . The system of claim 84 , wherein the system is configured to compensate or adjust the pulmonary function data collected using the pneumotach tube based on an ambient condition measurement made by the temperature sensor and an ambient condition measurement made by the humidity sensor.

87 . The system of claim 1 , wherein the user is a healthcare provider and the subject is a patient.

88 . The system of claim 30 , wherein the user is a healthcare provider and the subject is a patient.

89 . The system of claim 53 , wherein the user is a healthcare provider and the subject is a patient.

90 . The system of claim 1 , wherein the defined rights comprise an ability to amend the subject's demographics on the system.

91 . The system of claim 30 , wherein the defined rights comprise an ability to amend the subject's demographics on the system.

92 . The system of claim 53 , wherein the defined rights comprise an ability to amend the subject's demographics on the system.

93 . The system of claim 1 , wherein the first biometric sensor is a fingerprint sensor, wherein the biometric data of the user includes a fingerprint of the user, wherein the fingerprint sensor is configured to selectively permit access to a feature of the system based on the fingerprint of the user.

94 . The system of claim 1 , wherein the base station further comprises an ambient sensor for measuring an ambient condition of the one or more ambient conditions and a docking cradle sized and adapted to store the wireless detection unit, wherein the ambient sensor is configured to measure barometric pressure.

95 . The system of claim 1 , wherein the pneumotach tube is disposable and pre-calibrated.

96 . The system of claim 94 , wherein the system is configured to assess the pulmonary function based on the pulmonary function data and a barometric pressure measurement made by the ambient sensor.

97 . The system of claim 1 , wherein the pulmonary function data collected using the pneumotach tube is transmitted from the wireless detection unit.

98 . The system of claim 93 , wherein the feature of the system comprises pulmonary function data stored on the system.

99 . The system of claim 93 , wherein the feature of the system comprises operation of the wireless detection unit.

100 . The system of claim 93 , wherein the feature of the system comprises pulmonary function data stored on the system for a plurality of subjects.

Assignments (11)
RELEASE OF SECURITY INTEREST IN INTELLECTUAL PROPERTY RECORDED AT REEL 069939 AND FRAME 0472 Recorded Mar 24, 2026
From: ALTER DOMUS (US) LLC
To: ERESEARCHTECHNOLOGY, INC.; BIOCLINICA, INC.
Reel/Frame 075224/0052 →
RELEASE OF SECURITY INTEREST AT REEL/FRAME 051832/0777 Recorded Jan 17, 2025
From: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
To: ERESEARCHTECHNOLOGY, INC.; BIOMEDICAL SYSTEMS LLC (F/K/A BIOMEDICAL SYSTEMS CORPORATION)
Reel/Frame 069939/0212 →
SECURITY AGREEMENT Recorded Jan 17, 2025
From: BIOCLINICA, INC.; ERESEARCHTECHNOLOGY, INC.
To: ALTER DOMUS (US) LLC, AS COLLATERAL AGENT
Reel/Frame 069939/0472 →
RELEASE OF SECURITY INTEREST AT REEL/FRAME 051837/0001 Recorded Jan 17, 2025
From: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
To: ERESEARCHTECHNOLOGY, INC.; BIOMEDICAL SYSTEMS LLC (F/K/A BIOMEDICAL SYSTEMS CORPORATION)
Reel/Frame 069939/0303 →
RELEASE OF SECURITY INTEREST Recorded Feb 7, 2020
From: NEWSTAR FINANCIAL, INC.
To: ERESEARCHTECHNOLOGY, INC.; ICARDIAC TECHNOLOGIES, INC.
Reel/Frame 051754/0867 →
SECOND LIEN SECURITY AGREEMENT Recorded Feb 6, 2020
From: BIOMEDICAL SYSTEMS LLC; ICARDIAC TECHNOLOGIES LLC; ERESEARCHTECHNOLOGY, INC.
To: GOLDMAN SACHS BANK USA
Reel/Frame 051837/0001 →
FIRST LIEN SECURITY AGREEMENT Recorded Feb 5, 2020
From: BIOMEDICAL SYSTEMS LLC; ICARDIAC TECHNOLOGIES LLC; ERESEARCHTECHNOLOGY, INC.
To: GOLDMAN SACHS BANK USA
Reel/Frame 051832/0777 →
RELEASE OF SECURITY INTEREST Recorded Feb 4, 2020
From: GOLDMAN SACHS BANK USA
To: ERESEARCH TECHNOLOGY, INC.; BIOMEDICAL SYSTEMS CORPORATION; ICARDIAC TECHNOLOGIES, INC.
Reel/Frame 051717/0031 →
SECURITY AGREEMENT Recorded Nov 27, 2017
From: ICARDIAC TECHNOLOGIES, INC.; ERESEARCHTECHNOLOGY, INC.
To: GOLDMAN SACHS BANK USA, AS COLLATERAL AGENT
Reel/Frame 044511/0305 →
SECURITY INTEREST Recorded Nov 27, 2017
From: ICARDIAC TECHNOLOGIES, INC.; ERESEARCHTECHNOLOGY, INC.
To: NEWSTAR FINANCIAL, INC., AS COLLATERAL AGENT
Reel/Frame 044224/0125 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 9, 2017
From: SCHUELKE, ACHIM; SCHINDELMANN, STEFAN; WORTH, MICHAEL; MARK, BERND
To: ERESEARCHTECHNOLOGY, INC.
Reel/Frame 042658/0483 →