STIMULATION ARRANGEMENTS, VENTILATION ARRANGEMENT, STIMULATION METHODS AND VENTILATION METHOD

Abstract

A stimulation arrangement comprising an induction device having a field generator configured to generate a spatial field, a sensor unit, and a control unit in communication with the induction device and the sensor unit. The field generator of the induction device is configured to be positioned at a human or animal patient such that an inspiration muscular structure of the patient is stimulatable by the spatial field, the sensor unit is configured to be positioned at the human or animal patient to sense a feedback of the respiratory system or the patient, and the control unit is configured to control the induction device to generate the spatial field and to receive a feedback signal from the sensor unit. The control unit is configured to evaluate the feedback signal received from the sensor unit, and to activate the field generator of the induction device when the feedback signal is indicative of an abnormality.

Claims

1-54. (canceled)

55. A stimulation arrangement comprising: an induction device having a field generator configured to generate a spatial field; a sensor unit; and a control unit in communication with the induction device and the sensor unit, wherein the field generator of the induction device is configured to be positioned at a human or animal patient such that an inspiration muscular structure of the patient is stimulable by the spatial field, the sensor unit is configured to be positioned at the patient to sense a feedback from the patient or from a respiratory system of the patient, the control unit is configured to control the induction device to generate the spatial field and to receive a feedback signal from the sensor unit, and the control unit is configured to evaluate the feedback signal received from the sensor unit, and to activate the field generator of the induction device when the feedback signal is indicative of an abnormality.

56. The stimulation arrangement of claim 55, wherein the sensor unit comprises: a pressure sensor unit to sense a pressure of a respiratory system of the patient, and wherein the abnormality is when a positive end-expiratory pressure, PEEP, is below a predefined pressure threshold, the pressure sensor unit including at least one of an airway pressure sensor, and the feedback signal is a pressure signal having an airway pressure component, and an esophageal pressure sensor and the pressure signal has an esophageal pressure component, wherein the control unit is configured to evaluate the pressure signal by calculating a transpulmonary pressure by subtracting the esophageal pressure component of the pressure signal from the airway pressure component of the pressure signal; and/or a sensor to sense an oxygen content of a gas supplied from the respiratory system to the patient, and wherein the abnormality is when the oxygen content is below a predefined oxygenation threshold.

57. The stimulation arrangement of claim 55, wherein the inspiration muscular structure comprises a diaphragm of the patient, an external intercostal muscle of the patient, an accessory muscle of inspiration of the patient, or a combination thereof.

58. The stimulation arrangement of claim 55, wherein the sensor unit comprises a hyperventilation sensor to sense a presence of hyperventilation of the patient, and the abnormality is when a presence of hyperventilation of the patient is identified, the hyperventilation sensor comprising at least one of an airflow sensor configured to be arranged at the patient to sense an air flow in the respiratory system of the patient, wherein the feedback signal is an airflow signal, and the control unit is configured such that the evaluated airflow signal represents hyperventilation when a breathing frequency determined from the airflow signal exceeds a threshold frequency of 15 per minute or more; and/or a carbon dioxide sensor configured to be arranged at the patient to sense carbon dioxide levels in the air or blood of the patient, wherein the feedback signal is a carbon dioxide signal, and the control unit is configured such that the evaluated carbon dioxide signal represents hyperventilation when a carbon dioxide level determined from the carbon dioxide signal is below a carbon dioxide threshold of 22 mmol/L or less.

59. The stimulation arrangement of claim 55, wherein the control unit is configured to activate the induction device such that the field generator generates pulses of the spatial field having a frequency of about 10 Hz to about 35 Hz.

60. The stimulation arrangement of claim 55, wherein the field generator of the induction device comprises an electrode and the spatial field generated by the field generator is an electric field, or a coil design and the spatial field generated by the field generator is an electro-magnetic field; and/or wherein the field generator of the induction device is configured to be positioned at the patient such that a Phrenic nerve is in the spatial field generated by the field generator when the induction device is activated.

61. The stimulation arrangement of claim 55, wherein the induction device comprises a second field generator configured to generate a second spatial field, the second field generator of the induction device is configured to be positioned at the patient such that an expiration muscular structure of the patient is stimulable by the second spatial field, the control unit is configured to operate the induction device such that the field generator and the second field generator generate coordinated pulses of the spatial field and the second spatial field to coordinately stimulate the inspiration muscular structure of the patient and the expiration muscular structure of the patient one after the other, the second field generator of the induction device comprises either a second electrode and the second spatial field generated by the second field generator is a second electric field, or a second coil design and the second spatial field generated by the second field generator is a second electro-magnetic field, and the control unit is configured to de-activate the second field generator of the induction device such that the second spatial field is not generated when the feedback signal received from the sensor unit is indicative of the abnormality.

62. The stimulation arrangement of claim 56, comprising an input structure configured to set the predefined pressure threshold and/or the predefined oxygenation threshold, wherein the input structure comprises a user interface.

63. The stimulation arrangement of claim 55, further comprising: a constraining device configured to provide an airflow resistance in the respiratory system of the patient; and an activator configured to manually activate the field generator of the induction device such that the spatial field is generated, wherein the activator comprises a button accessible by the patient.

64. A stimulation method of stimulating a human or animal patient to ventilate the patient or to assist breathing of the patient, comprising: positioning a field generator of an induction device at the patient, the field generator being configured to generate a spatial field, such that an inspiration muscular structure of the patient is stimulable by the spatial field; positioning a sensor unit at the patient to sense a feedback from the patient or from a respiratory system of the patient; evaluating a feedback signal provided by the sensor unit; and activating the field generator of the induction device such that the spatial field is generated when the feedback signal is indicative of an abnormality.

65. The stimulation method of claim 64, wherein the inspiration muscular structure comprises a diaphragm of the patient, an external intercostal muscle of the patient, an accessory muscle of inspiration of the patient, or a combination thereof.

66. The stimulation method of claim 64, wherein the sensor unit comprises: a pressure sensor unit to sense a pressure of the respiratory system of the patient, and wherein the abnormality is when a positive end-expiratory pressure, PEEP, is below a predefined pressure threshold, the pressure sensor unit including an airway pressure sensor and the feedback signal is a pressure signal with an airway pressure component, and an esophageal pressure sensor and the pressure signal has an esophageal pressure component, and wherein evaluating the feedback signal includes evaluating the pressure signal provided by the pressure sensor unit and comprises calculating a transpulmonary pressure by subtracting the esophageal pressure component of the pressure signal from the airway pressure component of the pressure signal.

67. The stimulation method of claim 64, wherein the sensor unit comprises a hyperventilation sensor to sense a presence of hyperventilation of the patient, and wherein the abnormality is when a presence of hyperventilation of the patient is identified, the hyperventilation sensor unit.

68. The stimulation method of claim 67, wherein the hyperventilation sensor comprises at least one of: an airflow sensor configured to be arranged at the patient to sense an air flow in the respiratory system of the patient, wherein the feedback signal is an airflow signal, and the evaluated airflow signal represents hyperventilation when a breathing frequency determined from the airflow signal exceeds a threshold frequency of 15 per minute or more; and/or a carbon dioxide sensor configured to be arranged at the patient to sense carbon dioxide levels in the air or blood of the patient, wherein the feedback signal is a carbon dioxide signal, and the evaluated carbon dioxide signal represents hyperventilation when a carbon dioxide level determined from the carbon dioxide signal is below a carbon dioxide threshold of 22 mmol/L or less.

69. The stimulation method of claim 64, wherein the sensor unit comprises a sensor to sense an oxygen content of a gas supplied from the respiratory system to the patient, and wherein the abnormality is when the oxygen content is below a predefined oxygenation threshold.

70. The stimulation method of claim 64, wherein activating the field generator of the induction device comprises generating pulses of the spatial field, wherein the pulses of the spatial field have a frequency of about 10 Hz to about 35 Hz.

71. The stimulation method of claim 64, wherein the field generator of the induction device comprises: an electrode and the spatial field generated by the field generator is an electric field; or a coil design and the spatial field generated by the field generator is an electro-magnetic field.

72. The stimulation method of claim 64, wherein the induction device comprises a second field generator configured to generate a second spatial field, the second field generator of the induction device is configured to be positioned at the human or animal patient such that an expiration muscular structure of the patient is stimulable by the second spatial field, the induction device is operated such that the field generator and the second field generator generate coordinated pulses of the spatial field and the second spatial field to coordinately stimulate the inspiration muscular structure of the patient and the expiration muscular structure of the patient one after the other, and the second field generator of the induction device comprises a second electrode and the second spatial field generated by the field generator is a second electric field, or the second field generator of the induction device comprises a second coil design and the second spatial field generated by the second field generator is a second electro-magnetic field.

73. The stimulation method of claim 72, comprising de-activating the second field generator of the induction device such that the second spatial field is not generated when the feedback signal is indicative of the abnormality.

74. The stimulation method of claim 69, comprising setting the predefined pressure threshold and/or the predefined oxygenation threshold, wherein a user interface is provided for setting the predefined pressure threshold and/or the predefined oxygenation threshold.

75. The stimulation method of claim 64, comprising providing an airflow resistance in the respiratory system of the patient.

76. The stimulation method of claim 64, comprising manually activating the field generator of the induction device such that the spatial field is generated, wherein the field generator of the induction device is activated by the patient pushing a button.

77. The stimulation method of claim 64, wherein the field generator of the induction device is configured to be positioned at the patient such that a Phrenic nerve is in the spatial field generated by the field generator when the induction device is activated.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0142] The various aspects of the invention are described in more detail herein below by way of exemplary embodiments and with reference to the attached drawing.

[0143] FIG. 1 shows a schematic view of an embodiment of a stimulation and ventilation arrangement according to the invention implementing embodiments of methods according to the invention.

[0144] FIG. 1 shows exemplary stimulation arrangement 1 according to the invention. The ventilation machine 1 has a first implementation an electro-magnetic induction device 2 comprising an electro-magnetic field generator 21 with two coils 211 as coil design. The coils 211 are located in one common plane and configured to generate a spatial electro-magnetic field 212. When operated, the two coils 211 generate the electro-magnetic field 212 towards a neck 52 of a patient 5. The electro-magnetic field 212 has a central targeted shape with a target area 213 at which the electro-magnetic field 212 maximally extends into the neck 52. Alternatively, the induction device can comprise one or two electrodes for generate electrical fields for stimulate the nerve of the patient.

[0145] The induction device 2 has a mounting arrangement 22 with a neck arc 221 arranged at the neck 52 of the patient 5 and fixed to a bed 51 the patient 5 lies on. The neck arc 221 is equipped with a joint 222 as repositioning structure of an electro-magnetic field adjustment mechanism of the induction device 2. The joint 222 holds the coils 211 at the neck 52 of the patient 5.

[0146] The stimulation arrangement 1 further comprises a ventilator 11 as air flow generator from which ventilation tubes 13 extend. The ventilation machine 1 has a mouthpiece 12 as conduit interface of the ventilation machine 1 or as adapter of the EMI device. The mouthpiece 12 is applied to a mouth as entry point into the respiratory system of the patient 5. The ventilation tubes 13 are coupled to a flow sensor 41 of a sensor unit 4 or the induction device 2.

[0147] The stimulation arrangement 1 further has a controller 3 as a processing unit with a calibration unit 31 and a field adjustment unit 32 of the electro-magnetic field adjustment mechanism. The controller 3 is in communication with the flow sensor 41, the ventilator 11 and the joint 222 via respective wires 33.

[0148] The calibration unit 31 is configured to manipulate the joint 222 to automatically vary the position of the target area 213 of the electro-magnetic field 212 generated by the coils 211 and the controller 3 to vary the field strength of the electro-magnetic field 212. The aim of varying field strength and position of the electro-magnetic field 212 is to adjust the electro-magnetic field 212 such that it specifically stimulates a Phrenic nerve 53 of the patient 5. Upon stimulation of the Phrenic nerve 53, a diaphragm of the patient 5 is activated. Thereby, an airflow or breathing is induced which is sensed by the flow sensor 41.

[0149] The controller is configured to evaluate the feedback signal sent by the flow sensor 41, where the feedback signal includes the measurement airflow indicative of occurrence of hyperventilation, towards during the respiratory cycle, including the end of expiration. For instance, if the breathing frequency determined from the airflow exceeds a certain value, it indicates that the patient is under hyperventilation. In order to solve this abnormality, the stimulation can be activated, by generating the electro-magnetic field using the induction device 2.

[0150] Alternatively or additionally, the sensor unit 4 can includes a pressure sensor for measure the positive end-expiratory pressure, PEEP. If that is below a predefined value, it indicates that the breathing of the patient is abnormal. Hence, the the stimulation can be activated, by generating the electro-magnetic field using the induction device 2.

[0151] In other words, the field generator can receive an activation signal from the flow sensor 41 upon detection of detection of an abnormality. Further, it is configured to stop variation of the position of the target area 213 of the electro-magnetic field 212 and the controller 3 to stop variation of the field strength of the electro-magnetic field 212 when the activation feedback is received.

[0152] The ventilator 11 is configured to deliver air through the mouthpiece 12 into the respiratory system of the patient 5. Thereby, the controller 3 is configured to control the ventilator 11 to deliver air into the respiratory system according to a breathing scheme defined in the controller 3. In particular, the controller 3 regulates the activation of the diaphragm such that activation of the diaphragm via the Phrenic nerve 53 is coordinated with the ventilation of the patient 5.

[0153] As discussed above the sensor unit 4 can comprises a plurality of sensors, each being capable for detecting or measuring certain parameters related to the breathing and stimulation. For instance, the sensor unit 4 can comprise a flow sensor and a pressure sensor. In this case, the controller 3 can evaluate both the PEEP and the hyperventilation signals, and activate the stimulation or adjust the stimulation strength upon one of them or both of them being indicative of an abnormality.

[0154] In view of the above the present invention describes several conditions for starting and adjusting the stimulation. Each of the conditions indicate to an abnormality of the breathing. Upon detection of the abnormality, the stimulation can be controlled, e.g. starting the stimulation, or increase/decrease the intensity of the stimulation.

[0155] This description and the accompanying drawings that illustrate aspects and embodiments of the present invention should not be taken as limiting-the claims defining the protected invention. In other words, while the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive. Various mechanical, compositional, structural, electrical, and operational changes may be made without departing from the spirit and scope of this description and the claims. In some instances, well-known circuits, structures and techniques have not been shown in detail in order not to obscure the invention. Thus, it will be understood that changes and modifications may be made by those of ordinary skill within the scope and spirit of the following claims. In particular, the present invention covers further embodiments with any combination of features from different embodiments described above and below.

[0156] The disclosure also covers all further features shown in the Figs. individually although they may not have been described in the afore or following description. Also, single alternatives of the embodiments described in the figures and the description and single alternatives of features thereof can be disclaimed from the subject matter of the invention or from disclosed subject matter. The disclosure comprises subject matter consisting of the features defined in the claims or the exemplary embodiments as well as subject matter comprising said features.

[0157] Furthermore, in the claims the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. A single unit or step may fulfil the functions of several features recited in the claims. The mere fact that certain measures are recited in mutually different dependent claims does not indicate that a combination of these measures cannot be used to advantage. The terms “essentially”, “about”, “approximately” and the like in connection with an attribute or a value particularly also define exactly the attribute or exactly the value, respectively. The term “about” in the context of a given numerate value or range refers to a value or range that is, e.g., within 20%, within 10%, within 5%, or within 2% of the given value or range. Components described as coupled or connected may be electrically or mechanically directly coupled, or they may be indirectly coupled via one or more intermediate components. Any reference signs in the claims should not be construed as limiting the scope.