RESPIRATION PROMOTING APPARATUS AND USE THEREOF

Abstract

A respiration promoting apparatus and a method for promoting respiration for coordinately stimulating a phrenic nerve of a patient for activating a diaphragm of the patient by a pulsating field that is produced by interference stimulation principles.

Claims

1.-40. (canceled)

41. A respiration promoting apparatus for co-ordinately stimulating a phrenic nerve of a human, comprising: a first field generator configured to generate a first spatial field having a first frequency and a first amplitude; a second field generator configured to generate a second spatial field having a second frequency and a second amplitude; and a control unit configured to control the first frequency and the second frequency so that the first spatial field and the second spatial field constructively and destructively interfere with each other, thereby forming a pulsating field for stimulating the phrenic nerve, wherein the control unit is further configured to adjust the pulsating field so that the phrenic nerve is positioned in the pulsating field.

42. The respiration promoting apparatus of claim 41, wherein the control unit is configured to adjust the first amplitude and/or the second amplitude of the first spatial field and the second spatial field such that the phrenic nerve is positioned within the pulsating field.

43. The respiration promoting apparatus of claim 41, wherein the control unit is configured to adjust the first frequency and/or the second frequency of the first spatial field and the second spatial field.

44. The respiration promoting apparatus of claim 41, wherein the first frequency and the second frequency are adjacent to each other in a frequency spectrum.

45. The respiration promoting apparatus of claim 41, wherein at least one of the first field generator and the second field generator is not in phase.

46. The respiration promoting apparatus of claim 41, wherein the pulsating field has a first amplitude-modulated waveform with an interference pattern, wherein the first spatial field and the second spatial field are superposed so that the interference pattern is a beat, and wherein an amplitude of the first amplitude-modulated waveform exceeds a predefined threshold.

47. The respiration promoting apparatus of claim 41, further comprising: a third field generator configured to generate a third spatial field; and a fourth field generator configured to generate a fourth spatial field, wherein the third spatial field and the fourth spatial field constructively and destructively interfere with each other to generate a further pulsating field so that a further phrenic nerve is positioned in the further pulsating field, and wherein the third spatial field and fourth spatial field constructively and destructively interfere with each other to generate a second amplitude-modulated waveform having a second interference pattern.

48. The respiration promoting apparatus of claim 47, wherein the third spatial field and fourth spatial field are superposed and wherein the second interference pattern is a beat, and/or wherein an amplitude of the second amplitude-modulated waveform exceeds a predefined threshold.

49. The respiration promoting apparatus of claim 41, wherein each of the first field generator and the second field generator comprises a pair of electrodes, each having two electrode patches, and wherein each of the electrode patches includes a body attachment structure and a multiplicity of electrodes that are mechanically attached to the body attachment structure.

50. The respiration promoting apparatus of claim 47, further comprising a biofeedback sensor configured to be positioned at the human such that it provides a feedback signal when a contraction of a diaphragm of the human occurs, wherein the control unit is operably coupled to the biofeedback sensor and configured to automatically adjust the pulsating field until the feedback signal is received.

51. The respiration promoting apparatus of claims 50, wherein the control unit is configured to automatically localize the phrenic nerve and/or the further phrenic nerve with respect to the field generators, and wherein the control unit is further configured and arranged so as to repetitively outputting stimulation signals by the field generators when such a determination is made by the control unit.

52. The respiration promoting apparatus of claim 51, wherein the time of stimulation of the phrenic nerve differs from a time of stimulation of the further phrenic nerve, wherein a distinct timely expectation window of the feedback signal of the biofeedback sensor as a response to the stimulation of the phrenic nerve supports spatial positioning of an amplitude of a first treatment envelope at the phrenic nerve, and wherein a distinct timely expectation window of the feedback signal of the biofeedback sensor as a response to the stimulation of the further phrenic nerve supports spatial positioning of an amplitude of a second treatment envelope at the further phrenic nerve.

53. The respiration promoting apparatus of claim 50, comprising a second biofeedback sensor coupled to the control unit, wherein the first biofeedback sensor is associated with the first spatial field and the second spatial field and the second biofeedback sensor is associated with the third spatial field and the fourth spatial field.

54. A method for promoting respiration by stimulating a phrenic nerve of a human, wherein the method comprises steps of: generating by a first field generator a first spatial field having a first frequency and a first amplitude; generating by a second field generator a second spatial field having a second frequency and a second amplitude; controlling the first frequency and the second frequency so that the first spatial field and the second spatial field constructively and destructively interfere with each other, thereby forming a pulsating field for stimulating the phrenic nerve, and adjusting the pulsating field so that the phrenic nerve is positioned in the pulsating field.

55. The method of claim 54, wherein the pulsating field has a first amplitude-modulated waveform with an interference pattern and the method further comprising superposing the first spatial filed and the second spatial field so that the interference pattern is a beat.

56. The method of claim 54, further comprising generating a third spatial field by a third field generator and a fourth spatial field by a fourth field generator, so that the third spatial field and the fourth spatial field constructively and destructively interfere with each other to form a further pulsating field for stimulating a further phrenic nerve.

57. The method of claim 55, wherein an amplitude of the first amplitude-modulated waveform exceeds a predefined threshold in a region, and wherein the method further includes controlling size, shaping and positioning of the region by adjusting the amplitude and by adjusting placement of the first field generator and the second field generator.

58. The method of claim 54, wherein at least one of the first field generator and the second field generator is not in phase.

59. The method of claim 54, wherein the first spatial field and the second spatial field are generated by a first electrode pair and a second electrode pair, respectively, wherein each of the first electrode pair and the second electrode pair comprises two electrode patches, and wherein each of the electrode patches includes a body attachment structure and a multiplicity of electrodes that are mechanically attached to the body attachment structure as to be in a predetermined orientation.

60. The method of claim 54, further comprising: positioning a biofeedback sensor at the human, and providing a feedback signal using the biofeedback sensor when a contraction of a diaphragm of the human occurs; adjusting the pulsating field until the feedback signal is received; operably coupling a control unit to the biofeedback sensor, and automatically adjusting the pulsating field by the control unit until the feedback signal is received; and automatically localizing, by the control unit, the phrenic nerve with respect to a given set of electrodes, and repetitively outputting stimulation signals by the first field generator and the second field generator upon receiving the feedback signal.

61. The method of claim 56, wherein a time of stimulation of the phrenic nerve differs from a time of stimulation of the further phrenic nerve.

62. The method of claim 60, further comprising: supporting spatial positioning of the pulsating field at the phrenic nerve by a distinct timely expectation window of the feedback signal of the biofeedback sensor as a response to the stimulation of the phrenic nerve; and supporting spatial positioning of a further pulsating field at a further phrenic nerve by a distinct timely expectation window of the feedback signal of the biofeedback sensor as a response to the stimulation of the further phrenic nerve.

63. The method of claim 54, further comprising: positioning the first field generator on a neck of the human that is entirely on one side of a geometric plan; and positioning the second field generator on the neck of the human that is entirely on another side of the geometric plane, wherein the geometric plane intersects the neck of the human.

64. The method of claim 57, wherein controlling the size, shaping and positioning of the pulsating field is performed by adjusting relative amplitudes of the first spatial field and the second spatial field and by adjusting placement of the first field generator and the second field generator.

65. The method of claim 54, wherein an electric field is generated by an inductive source such as coil using time-varying magnetic fields.

66. The method of claim 54, wherein adjusting the pulsating field includes adjusting the first frequency and/or the second frequency to vary a frequency of the pulsating field.

67. The method of claim 54, wherein adjusting the pulsating field includes adjusting the first amplitude and/or the second amplitudes such that the phrenic nerve is positioned within the pulsating field.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0067] The respiration promoting apparatus and the method for promoting respiration of a patient according to the invention are described in more detail herein below by way of exemplary embodiments and with reference to the attached drawings, in which:

[0068] FIG. 1 shows a neck from the top view, and a conventional criss-cross configuration of two electrode pairs;

[0069] FIG. 2 shows a neck from the top vie, and a side-by-side configuration of electrode pairs comprising a total of four electrode pairs;

[0070] FIG. 3 shows a neck from the top view, and a conventional criss-cross configuration of four electrode pairs;

[0071] FIG. 4 shows a conceptual diagram that illustrates envelope amplitude with two current channels producing two original waveforms;

[0072] FIG. 5 shows an exemplary embodiment of an interference of the first and second spatial field in frequency domain, where the first spatial field has a first frequency f.sub.1 and the spatial field has a second frequency f.sub.2;

[0073] FIG. 6 shows a configuration with four electrode pairs of which each electrode position is selected from a multitude of electrodes;

[0074] FIG. 7 shows a configuration with 2 electrode pairs of which each electrode position is selected from a multitude of electrodes comprised in an electrode array attached to an electrode patch (20), each of these connected to a controller, which is also connected to a biofeedback sensor (19);

[0075] FIG. 8 shows a neck from the top view, and four electro-magnetic coils placed around the neck.

DESCRIPTION OF EMBODIMENTS

[0076] In the following description certain terms are used for reasons of convenience and are not intended to limit the invention. The terms “right”, “left”, “up”, “down”, “under” and “above” refer to directions in the figures. The terminology comprises the explicitly mentioned terms as well as their derivations and terms with a similar meaning. Also, spatially relative terms, such as “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like, may be used to describe one element's or feature's relationship to another element or feature as illustrated in the figures. These spatially relative terms are intended to encompass different positions and orientations of the devices in use or operation in addition to the position and orientation shown in the figures. For example, if a device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be “above” or “over” the other elements or features. Thus, the exemplary term “below” can encompass both positions and orientations of above and below. The devices may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein interpreted accordingly. Likewise, descriptions of movement along and around various axes include various special device positions and orientations.

[0077] To avoid repetition in the figures and the descriptions of the various aspects and illustrative embodiments, it should be understood that many features are common to many aspects and embodiments. Omission of an aspect from a description or figure does not imply that the aspect is missing from embodiments that incorporate that aspect. Instead, the aspect may have been omitted for clarity and to avoid prolix description. In this context, the following applies to the rest of this description: If, in order to clarify the drawings, a figure contains reference signs which are not explained in the directly associated part of the description, then it is referred to previous or following description sections. Further, for reason of lucidity, if in a drawing not all features of a part are provided with reference signs it is referred to other drawings showing the same part. Like numbers in two or more figures represent the same or similar elements.

[0078] FIG. 1 shows a neck from the top view as indicated by reference sign 11, and a conventional criss-cross configuration of two electrode pairs 12, 13 that produce two pulsating fields 16, 17 respectively two treatment envelopes 16, 17. Thereby, the first respectively left phrenic nerve 9 lies in the first target area/treatment envelope 16 (first area of maximum amplitude) and the second respectively right phrenic nerve 10 lies in the second target area/treatment envelope 17 (second area of maximum amplitude).

[0079] FIG. 2 shows a neck from the top view as indicated by reference sign 11, and a side-by-side configuration of electrode pairs comprising a total of four electrode pairs 12, 13, 14, 15, producing two pulsating fields with two treatment envelopes 16, 17. While this solution requires more electrode pairs, the location of the first pulsating fields with the treatment envelope 16 (left phrenic nerve 9) can be individually adjusted by replacing the relating two electrode pairs 12, 13 and the second pulsating fields with the second treatment envelope 17 (right phrenic nerve 10) can be individually adjusted by replacing the relating two electrode pairs 14, 15.

[0080] FIG. 3 shows a neck from the top view as indicated by reference sign 11, and a conventional criss-cross configuration of four electrode pairs 12, 13, 14, 15 that produce four treatment envelopes, wherein the left phrenic nerve 9 lies a first pulsating fields with the treatment envelope 16 and the right phrenic nerve 10 lies a second pulsating fields with the treatment envelope 17. The other two treatment envelopes 16′, 17′ remain unused in this case since none of the phrenic nerve is positioned therein.

[0081] FIG. 4 is a conceptual diagram that illustrates envelope amplitude. Thereby, two current channels produce two original waveforms, wherein channel one produces original waveform 1 and channel two produces original waveform 2. The amplitude of original waveform 1 is E1 (3) and the amplitude of original waveform 2 is E2 (4). Interference of the two original waveforms 1, 2 produces an amplitude-modulated (AM) waveform 6. The top of the envelope is a signal 5. The peak amplitude of that signal is the envelope amplitude EN (7). Targeting is based on controlling the spatial position of a region where the envelope amplitude is above a threshold 8 (e.g. of the phrenic nerve) or is at a maximum, and this area is called treatment envelope.

[0082] FIG. 5 shows an exemplary embodiment of an interference of the first and second spatial field in frequency domain, where the first spatial field has a first frequency f.sub.1 and the spatial field has a second frequency f.sub.2.

[0083] The two frequencies f.sub.1 and f.sub.2 are associated either to two pairs of electrodes and two electric fields respectively, or by two coils and two magnetic fields. The fields have similar but not identical frequency. For example, the first frequency is 4995 Hz while the second frequency is 5005 Hz. These two fields are preferably arranged so that they overlap or superpose with each other. The relevant point is between the two sources, assuming the fields have the same amplitude. The effect is the biggest in the middle between the two field sources, i.e., the fields from a point source decrease with a radius. The interference pattern of the two fields yields a beat with 10 Hz, i.e., f.sub.1-f.sub.2 and a carrier frequency of 5000 Hz which is

[00001]$\frac{\left(f_1-f_2\right)}{2}.$

[0084] Thus, the beat is located in the middle between the two field sources, the amplitude varies with 10 Hz, and the fundamental frequency of 5000 Hz is the active frequency. Considering the threshold, only a few wave crests can activate the nerves. There may be an activation pattern corresponding to the state of the art. The effective wave crests repeat at a frequency of 20 Hz, i.e., both maxima and minima of the 10 Hz envelope can lead to activation.

[0085] If the field generator is configured to coordinatedly emit both frequencies, it can be achieved, for example, that one frequency is fixed, e.g., 5005 Hz as described above, and the other can be adjusted, either by the user or by an intelligent algorithm that maximizes the feedback. If the second output is set to 4995 Hz, the interference pattern described above can obtained. By varying the second frequency slightly, the location of the maximum interference can be shifted back and forth between the two field generators, thereby control the point of maximum effect, where the basic frequency remains about 5000 Hz.

[0086] FIG. 6 shows a schematic connectivity or arrangement of four electrode pairs, where each electrode position is selected from a multitude of electrodes comprised in an electrode array attached to an electrode patch 20. Each of these electrode patches 20 is connected to a control unit 18. In another embodiment of the present invention, the four electrode pairs can be replaced with four coils.

[0087] FIG. 7 shows a schematic connectivity or arrangement of two electrode pairs, wherein each electrode position is selected from a multitude of electrodes comprised in an electrode array attached to an electrode patch 20. Each of these electrode patches 20 is connected to a controller 18; which is also connected to a biofeedback sensor 19 (e.g. pressure, flow, EMG or ultrasound etc.). Similar as above, in another embodiment of the present invention, the two electrode pairs can be replaced with two coils.

[0088] FIG. 8 shows a neck from the top view as indicated by reference sign 11. In this embodiment, four electro-magnetic coils 21 are placed around the neck. The electro-magnetic coils 21 may or may not comprise a ferrite core, i.e. a magnetic core producing electro-magnetic fields with interference.

[0089] 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.

[0090] 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.

[0091] 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.

LIST OF REFERENCE SIGNS

[0092] 1 first waveform

[0093] 2 second waveform

[0094] 3 amplitude of first waveform

[0095] 4 amplitude of second waveform

[0096] 5 envelope of amplitude modulated waveform (=signal)

[0097] 6 amplitude-modulated waveform

[0098] 7 envelope amplitude (E.sub.N)

[0099] 8 threshold of (phrenic) nerve

[0100] 9 left (first) phrenic nerve

[0101] 10 right (second) phrenic nerve

[0102] 11 top view neck

[0103] 12 first electrode pair

[0104] 13 second electrode pair

[0105] 14 third electrode pair

[0106] 15 fourth electrode pair

[0107] 16 first target region=first treatment envelope

[0108] 17 second target region=second area of maximum envelope amplitude=second treatment envelope

[0109] 18 control unit

[0110] 19 biofeedback sensor

[0111] 20 electrode patch comprising electrode array

[0112] 21 electro-magnetic coil with or without ferrite core