VENTILATION ARRANGEMENT AND TREATMENT METHOD

Abstract

A ventilation arrangement (1) comprises an induction device (2) and a control unit (3). The induction device (2) has an electro-magnetic field generator (21) with a coil design (211) configured to generate a spatial electro-magnetic field having a targeted shape. The control unit (3) is in communication with the induction device (2) and configured to control the induction device (2) to generate the electro-magnetic field. The electro-magnetic field generator (21) of the induction device (2) is configured to be positioned at a human or animal patient (5) such that, for activating a diaphragm of the patient (5), a Phrenic nerve of the patient (5) is stimulatable by the spatial electro-magnetic field generated by the coil design (211). The control unit (3) is connectable to a ventilation machine (6) to receive ventilation data about a ventilation of the patient (5). The control unit (3) is configured to evaluate the ventilation data and to operate the induction device (2) in accordance with the evaluated ventilation data.

Claims

1.-79. (canceled)

80. A ventilation arrangement comprising: an induction device configured to generate a spatial field having a targeted shape; and a control unit in communication with the induction device and configured to control the induction device to generate the spatial field, wherein the induction device is configured to be positioned at a human or animal patient such that, for activating a diaphragm of the patient, a Phrenic nerve of the patient is stimulable by the spatial field generated by the induction device, the control unit is configured to receive ventilation data about a ventilation of the patient, by being connectable to a ventilation machine to receive the ventilation data about the ventilation of the patient, and the control unit is configured to evaluate the ventilation data and to operate the induction device in accordance with the evaluated ventilation data.

81. The ventilation arrangement of claim 80, wherein the induction device has an electro-magnetic field generator with a coil design configured to generate a spatial electro-magnetic field being the spatial field having the targeted shape, and wherein the induction device is configured to be positioned at the human or animal patient by positioning the electro-magnetic field generator of the induction device at the human or animal patient such that the Phrenic nerve of the patient is stimulable by the spatial electro-magnetic field generated by the coil design.

82. The ventilation arrangement of claim 80, further comprising: a ventilation machine having a conduit interface configured to be connected to the respiratory system of the patient; an air flow generator configured to deliver air through the conduit interface into the respiratory system of the patient; and an interface unit configured to provide the ventilation data.

83. The ventilation arrangement of claim 80, wherein the control unit is configured to operate the induction device for a stimulation duration matched to a specific treatment of the patient, wherein the control unit is configured to define the stimulation duration.

84. The ventilation arrangement of claim 80, wherein the control unit is configured to operate the induction device at a repetition rate matched to a specific treatment of the patient, wherein the control unit is configured to define the repetition rate.

85. The ventilation arrangement of claim 84, wherein the specific treatment is: prevention of diaphragm muscle loss and/or reduction of risk of ventilator induced diaphragmatic dysfunction, wherein the repetition rate is in a range of about once per day to about 3 times per day, and wherein the stimulation duration is in a range of about 3 minutes to about 20 minutes; reduction of risk of developing an acute respiratory distress syndrome or ventilator associated pneumonia or ventilator-induced lung injury or atelectasis, wherein the repetition rate is in a range of about twice per hour to about every two hours, and wherein the stimulation duration is in a range of about 0.5 minutes to about 3 minutes; reduction of risk of developing an acute respiratory distress syndrome or ventilator associated pneumonia or ventilator-induced lung injury or atelectasis, and wherein the stimulation duration is in a range of about 1 breathing cycle to about 5 breathing cycles, wherein the repetition rate is in a range of about every minute to about every 30 minutes; prevention, delay or replacement of ventilation or reduction of high positive pressures during mechanical ventilation, and wherein the repetition rate is at every spontaneous breath of the patient, wherein the stimulation duration is continuously 24 hours a day; or prevention, delay or replacement of ventilation or reduction of high positive pressures during mechanical ventilation, and wherein repetition rate is, during night time, at every spontaneous breath of the patient, and, during day time, not operating the induction device.

86. The ventilation arrangement of claim 80, wherein the control unit is configured to operate the induction device to induce a breathing cycle in the patient or to induce a deep breath in the patient, wherein the ventilation arrangement comprises a sensor unit to sense an oxygen level in the blood of the patient or a carbon dioxide level in the blood of the patient, the control unit being in communication with the sensor unit, and the control unit being configured to operate the induction device when sensed oxygen level or the sensed carbon dioxide level bypasses a predefined threshold.

87. The ventilation arrangement of claim 80, wherein the ventilation data comprises a tidal breath of the patient, wherein the ventilation arrangement comprises a tidal breath sensor to sense the tidal breath of the patient, the control unit being in communication with the tidal breath sensor.

88. The ventilation arrangement of claim 87, wherein the control unit is configured to: adjust a field intensity and a train duration of the induction device such that the tidal breath is in a range of about 3 ml per kg body weight to about 6 ml per kg body weight, adjust a field intensity and a train duration of the induction device such that the patient produces a tidal breath in a range of about 6 ml per kg body weight to about 8 ml per kg body weight, adjust a field intensity and a train duration of the induction device such that the patient produces a tidal breath in a range of about 0 ml per kg body weight to about 3 ml per kg body weight, or adjust a field intensity of the induction device such that the patient produces deep and strong breaths in a range of about 9 ml per kg body weight to about 15 ml per kg body weight.

89. The ventilation arrangement of claim 87, wherein the control unit is configured to re-adjust operation of the induction device in accordance with tidal breath of the patient.

90. The ventilation arrangement of claim 80, wherein the ventilation data comprises a diaphragm contraction of the patient, wherein the ventilation arrangement comprises a diaphragm contraction sensor to sense the diaphragm contraction of the patient, the control unit being in communication with the diaphragm contraction sensor, and wherein the control unit is configured to re-adjust operation of the induction device in accordance with diaphragm contraction of the patient.

91. The ventilation arrangement of claim 80, wherein the control unit is configured to operate the induction device such that trains of the generated spatial field are provided, and wherein each train comprises an increase of an intensity of the spatial field ending at a target intensity of the spatial field.

92. A method of providing a specific treatment to a human or animal patient, comprising: obtaining an induction device configured to generate a spatial field having a targeted shape; positioning the induction device at a human or animal patient; and operating the induction device to stimulate a Phrenic nerve of the patient by the spatial field such that a diaphragm of the patient is activated.

93. The method of claim 92, wherein the patient is ventilated.

94. The method of claim 92, wherein the induction device has an electro-magnetic field generator with a coil design to generate a spatial electro-magnetic field as the spatial field having the targeted shape, wherein the electro-magnetic field generator of the induction device is positioned at a human or animal patient, and wherein the induction device is operated to stimulate the Phrenic nerve of the patient by the spatial electro-magnetic field generated by the coil design.

95. The method of claim 92, wherein operating the induction device to stimulate the Phrenic nerve of the patient comprises operating the induction device for a stimulation duration matched to the specific treatment, comprising a step of defining the stimulation duration in accordance with the specific treatment.

96. The method of claim 92, wherein operating the induction device to stimulate the Phrenic nerve of the patient comprises repeatedly operating the induction device at a repetition rate matched to the specific treatment, comprising a step of defining the repetition rate in accordance with the specific treatment.

97. The method of claim 96, wherein the specific treatment is prevention of diaphragm muscle loss and/or reduction of risk of ventilator induced diaphragmatic dysfunction, wherein the repetition rate is in a range of about once per day to about 3 times per day, and wherein the stimulation duration is in a range of about 3 minutes to about 20 minutes.

98. The method of claims 92, wherein the specific treatment is reduction of risk of developing an acute respiratory distress syndrome or ventilator associated pneumonia or ventilator-induced lung injury, and the induction device is repeatedly operated in regular intervals throughout the day.

99. The method of claim 96, wherein the specific treatment is reduction of risk of developing an acute respiratory distress syndrome or ventilator associated pneumonia or ventilator-induced lung injury or atelectasis, wherein the repetition rate is in a range of about twice per hour to about every two hours, and wherein the stimulation duration is in a range of about 0.5 minutes to about 3 minutes.

100. The method of claim 96, wherein the specific treatment is reduction of risk of developing an acute respiratory distress syndrome or ventilator associated pneumonia or ventilator-induced lung injury or atelectasis, wherein the stimulation duration is in a range of about 1 breathing cycle to about 5 breathing cycles, and wherein the repetition rate is in a range of about every minute to about every 30 minutes.

101. The method of claim 92, wherein the specific treatment is keeping or rebuilding function of the respiratory center which is connected to the phrenic nerve.

102. The method of claim 92, wherein the specific treatment is induction of breathing cycles or stimulation of deep breathing, comprising measuring an oxygen level or a carbon dioxide level in the blood of the patient, and operating the induction device when the measured oxygen level or carbon dioxide level bypasses a predefined threshold.

103. The method of claim 96, wherein the specific treatment is prevention, delay or replacement of ventilation or reduction of high positive pressures during mechanical ventilation, wherein the repetition rate is at every spontaneous breath of the patient, wherein the stimulation duration is continuously 24 hours a day, and wherein the induction device is operated to stimulate the Phrenic nerve of the patient superimposed in a target rhythm not being synchronous with spontaneous breath of the patient.

104. The method of claim 96, wherein the specific treatment is prevention, delay or replacement of ventilation or reduction of high positive pressures during mechanical ventilation, wherein the repetition rate is, during night time, at every spontaneous breath of the patient, and, during day time, not operating the induction device, and wherein the induction device is operated to stimulate the Phrenic nerve of the patient superimposed in a target rhythm not being synchronous with spontaneous breath of the patient.

105. The method of claim 92, wherein a field intensity and a train duration of the induction device are adjusted such that: the patient produces a tidal breath in a range of about 3 ml per kg body weight to about 6 ml per kg body weight, the patient produces a tidal breath in a range of about 6 ml per kg body weight to about 8 ml per kg body weight, the patient produces a tidal breath in a range of about 0 ml per kg body weight to about 3 ml per kg body weight, or the patient produces deep and strong breaths in a range of about 9 ml per kg body weight to about 15 ml per kg body weight.

106. The method of claim 92, wherein operating the induction device comprises providing trains of the generated spatial field, wherein each train comprises an increase of an intensity of the spatial field ending at a target intensity of the spatial field.

107. A ventilation arrangement comprising; an induction device configured to generate a spatial field having a targeted shape; and a control unit in communication with the induction device and configured to control the induction device to generate the spatial field, wherein the induction device is configured to be positioned at a human or animal patient such that, for activating a diaphragm of the patient, a Phrenic nerve of the patient is stimulable by the spatial field generated by the induction device, and the control unit is configured to operate the induction device to induce a breathing cycle in the patient or to induce a deep breath in the patient.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0109] The ventilation arrangement and the method according to the invention are described in more detail herein below by way of exemplary embodiments and with reference to the attached drawing, in which.

[0110] FIG. 1 shows a schematic view of an embodiment of a ventilation arrangement according to the invention implementing an embodiment of a method according to the invention;

[0111] FIG. 2 shows a graph of a spatial field over time generated by an embodiment of a ventilation arrangement according to the invention in accordance with an embodiment of a method according to the invention; and

[0112] FIG. 3 shows a graph of the spatial field generation of FIG. 2 in a wider time frame.

DESCRIPTION OF EMBODIMENTS

[0113] FIG. 1 shows an embodiment of a ventilation arrangement 1 according to the invention, i.e. according to the first and third aspects of the invention. The ventilation arrangement 1 includes a ventilation machine 6, an electro-magnetic induction device 2 (in the following also referred to as EMI device), a processing unit 3 and a sensor unit 4 having an oxygen or carbon dioxide sensor. The EMI device 2 comprises 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 towards a neck 52 of a patient 5. The electro-magnetic field has a central targeted shape with a focality area at which the electro-magnetic field maximally extends into the neck 52. Further, the EMI 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 EMI device 2. The joint 222 holds the coils 211 at the neck 52 of the patient 5.

[0114] The ventilation machine 6 comprises a ventilator 61 as air flow generator from which ventilation tubes 63 extend, and a mouthpiece 62 as conduit interface. The mouthpiece 62 is a tube provided through a mouth of the patient into the respiratory system of the patient 5.

[0115] The control unit 3 has a user interface 31 for exchanging information with a practitioner supervising or setting up ventilation of the patient 5. For example, the user interface 31 can be embodied as touch screen allowing to in- and output information. Further, the control unit 3 is equipped with a device interface 32 arranged to be coupled to an interface unit of the ventilation machine 6, the EMI device 2 and the sensor unit 4 by wires 33. Like this, the control unit 3 is in communication with the ventilation machine 6, the EMI device 2 and the sensor unit 4.

[0116] More specifically, the control unit is configured to receive ventilation data about the ventilation of the patient 5 from the ventilation machine 6 and to control the EMI device 2 to generate the electro-magnetic field in accordance with the evaluated ventilation data as described in more detail below. Furthermore, the control unit is configured to manipulate the joint 222 to automatically vary the position of the focality area 213 of the electro-magnetic field 212 generated by the coils 211 and 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 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.

[0117] The ventilation machine 6 is configured to mechanically ventilate the patient 5 by advancing air through the mouthpiece 62 into the respiratory system of the patient 5. More specifically, the ventilator 61 is configured to deliver the air through the mouthpiece 62. The control unit 3 is configured to control the ventilator 61 to deliver the air according to a breathing scheme defined in the control unit 3. Moreover, the control unit 3 regulates the activation of the diaphragm in coordination with the breathing scheme such that activation of the diaphragm via the Phrenic nerve 53 is coordinated with the ventilation of the patient 5.

[0118] For being able to provide various treatments during ventilation, the control unit 3 is configured to define combinations of a stimulation duration and a repetition rate, and to operate the EMI device 2 in accordance with the defined stimulation duration and the determined repetition rate. Thereby, the control unit 3 provides a selection of treatments to the practitioner via the user interface 31. The practitioner selects an appropriate treatment and sets parameters involved.

[0119] For allowing prevention of diaphragm muscle loss and/or reduction of risk of VIDD, a first operation mode is set in the control unit 3 by defining the stimulation duration to be in a range of about 3 minutes to about 20 minutes and the repetition rate to be in a range of about once per day to about 3 times per day.

[0120] For allowing reduction of a risk of developing an ARDS, a second operation mode is set in the control unit 3 by defining the repetition rate to be in a range of about twice per hour to about every two hours and the stimulation duration to be in a range of about 0.5 minutes to about 3 minutes.

[0121] For alternatively allowing reduction of the risk of developing ARDS, a third operation mode is set in the control unit 3 by defining the stimulation duration to be in a range of about 1 breathing cycle to about 5 breathing cycles and the repetition rate to be in a range of about every minute to about every 30 minutes.

[0122] For inducing breathing cycles or stimulating deep breathing, a fourth operation mode is set in the control unit 3. In this fourth operation mode, the control unit 3 evaluates an oxygen level or a carbon dioxide level in the blood of the patient 5 measured by the oxygen or carbon dioxide sensor of the sensor unit 4 and compares it to a predefined threshold. The control unit 3 then operates the EMI device 2 when the measured oxygen level or carbon dioxide level bypasses the predefined threshold. In particular, it operates the EMI device 2 when the measured oxygen level is below the threshold or when the measured carbon dioxide level is above the threshold.

[0123] The sensor unit 4, further comprises a tidal breath sensor and a diaphragm contraction sensor. The control unit is configured to evaluate signals provided by the tidal breath sensor and the diaphragm sensor as needed in a specific therapy.

[0124] In FIG. 2 generation of a spatial field by operating an induction device of an embodiment of the ventilation arrangement according to the invention or by applying an embodiment of the method according to the invention is illustrated. In particular, the generated spatial field is intended to advantageously stimulating the Phrenic nerves of a patient for activating the diaphragm of the patient.

[0125] In the graph of FIG. 2, the abscissa represents time t and the ordinate represents intensity I of the spatial field generated by the induction device. As can be seen, the spatial field is provided by plural consecutive trains T of plural pulses P. Each pulse is characterized by a varying electro-magnetic field such as a sine pulse of 200 μs pulse duration.

[0126] The intensity I of the plurality of pulses P of one single train T increases from a low initial intensity I.sub.0 to a target intensity I.sub.t. Once the target intensity is reached, no further increase occurs. Like this, each train is provided with a ramp R of intensity I of the spatial field. Further, each train T of the plurality of trains has an identical train duration d.sub.T. Between each two following trains T an inter-train break B.sub.it is provided, in which no spatial field is generated. During a stimulation duration ds, the trains T are regularly provided one after the other intermitted the inter-train breaks B.sub.it.

[0127] FIG. 3 shows the generation of the spatial field of FIG. 2 on a wider scale. Thereby, it can be seen that plural consecutive stimulations as depicted in FIG. 2 are provided. In particular, each stimulation provided for the stimulation duration ds is followed by an inter-stimulation break b.sub.is such that each two following stimulations are intermitted by one inter-stimulation break b.sub.is. Each one stimulation over the stimulation duration d.sub.S and its following inter-stimulation break b.sub.is together form a repetition rate r, which is, e.g., 15 Hz.

[0128] The stimulation protocol shown in FIG. 2 and FIG. 3 allows for inducing contraction of the diaphragm of the patient during each train T such that inhalation by the patient results. During the inter-train beaks Bit the diaphragm is relaxed such that exhalation by the patient results. The train duration d.sub.T is about 0.5 s to 2 s and is synchronized with the breathing of the patient and/or a ventilation machine. The duration of the inter-train breaks B.sub.it is, e.g., in the range of 1 s to 12 s.

[0129] 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.

[0130] 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.

[0131] 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.