Ambulatory respiratory assist device
11833096 · 2023-12-05
Assignee
Inventors
- Jacob Brenner (Princeton Junction, NJ, US)
- Christopher Polster (Portland, OR, US)
- Michael Sims (Mount Laurel, NJ, US)
Cpc classification
A61H2230/405
HUMAN NECESSITIES
A61H23/0245
HUMAN NECESSITIES
A61H2230/425
HUMAN NECESSITIES
International classification
A61H31/00
HUMAN NECESSITIES
Abstract
An ambulatory respiratory assist device utilizes a cuirass worn on the chest and/or abdomen and supported by a hip belt so that it does not place a load on the patient's shoulders. The belt also supports a ventilator that includes a pump and its power supply, valving, controls and auxiliary equipment. The device is optionally integrated with auxiliary features such as chest wall vibration, which can be achieved by utilizing cuirass pressure modulation, with shoulder or upper arm supports for simulating the “tripod position”, with positive pressure ventilation apparatus, or with patient monitoring. Shoulder or upper arm supports can extend directly from the belt to the shoulders or upper arms, utilized independently of the cuirass, and optionally integrated with one or more of the above-mentioned auxiliary features.
Claims
1. An ambulatory respiratory assist device comprising: a cuirass comprising a shell surrounded by a border shaped so that the entirety of said border is engageable with an anterior portion of at least one of a chest and an abdomen of a patient, said border having opposite, upwardly extending, side portions, said shell having a concave inner face shaped so that, when said border is in engagement with said anterior portion, an inflatable space is provided between said inner face of the shell and Said anterior portion within said border, whereby a compressive force can be exerted against said anterior portion when said space is inflated with air, and a pulling force can be exerted on the said anterior portion when air is evacuated from said space; means for maintaining said border of the cuirass in engagement with the said anterior portion and for supporting the weight of said cuirass when the patient is upright, said means including a weight-supporting belt attached to said shell, at least part of said weight-supporting belt being adapted to be secured around a region of the patient's trunk, said region being between the pelvic girdle and the inferior border of the patient's sternum, and to support substantially the entire weight of the cuirass when the patient is upright, said weight-supporting belt is secured around said region of the patient's trunk, and said border of the cuirass is in engagement with said anterior portion of at least one of the chest and abdomen of said patient; a pair of rigid underarm supporting elements integrated with the shell, each underarm-supporting element extending radially outward from one of the upwardly extending side portions of said border of said shell at a location such that it engages and supports an axilla of the patient when said border of the shell is in engagement with said anterior portion of at least one of the chest and abdomen of said patient, the underarm-supporting elements being sized and configured to provide sufficient underarm support to relieve auxiliary breathing muscles of the patient; an air pump connected through said shell for inflation of said inflatable space; and control means, comprising a sensor responsive to an effort by the patient to exhale, for causing said pump to deliver air to said inflatable space to assist the patient in exhaling; wherein said shell has sufficient rigidity to transmit the load of the upper torso of said patient to said region of the patient's trunk through said weight-supporting belt.
2. The ambulatory respiratory assist device according to claim 1, wherein said means for maintaining said border of the cuirass in engagement with said anterior portion and for supporting the weight of said cuirass includes a second belt connected to said cuirass at two locations remote from said weight supporting belt and adapted to extend around the patient's back from one of said locations to the other.
3. The ambulatory respiratory assist device according to claim 1, wherein said means for maintaining said border of the cuirass in engagement with said anterior portion and for supporting the weight of said cuirass includes a garment adapted to be worn by the patient, said cuirass being permanently attached to said garment.
4. The ambulatory respiratory assist device according to claim 1, wherein said means for maintaining said border of the cuirass in engagement with said anterior portion and for supporting the weight of said cuirass includes a vest adapted to be worn by the patient, said cuirass being permanently attached to said vest.
5. The ambulatory respiratory assist device according to claim 1, wherein said sensor of the control means is also responsive to an effort by the patient to inhale, and said control means is also for causing said pump to draw air from said inflatable space to assist the patient in inhaling.
6. The ambulatory respiratory assist device according to claim 1, including oscillating means for vibrating the patient's chest at a frequency of oscillation approximately equal to or exceeding 100 cycles per minute.
7. The ambulatory respiratory assist device according to claim 1, including oscillating means for vibrating the patient's chest at a frequency of oscillation in the range from approximately 100 to 200 cycles per minute.
8. The ambulatory respiratory assist device according to claim 1, wherein said pump includes means for superimposing an oscillation on the pressure exerted by said pump on the interior of said inflatable space, said oscillation being at a frequency approximately equal to or exceeding 100 cycles per minute.
9. The ambulatory respiratory assist device according to claim 1, wherein said pump includes means for superimposing an oscillation on the pressure exerted by said pump on the interior of said inflatable space, said oscillation being at a frequency in the range from approximately 100 to 200 cycles per minute.
10. The ambulatory respiratory assist device according to claim 1, including a positive pressure ventilator the weight of which is supported by said weight-supporting belt and means, connected though a flexible tube to said positive pressure ventilator, for delivering air from said positive pressure ventilator to the patient's trachea.
11. The ambulatory respiratory assist device according to claim 1, including a positive pressure ventilator the weight of which is supported by said weight-supporting belt and a nasal cannula adapted to be brought into sealing relationship with the patient's nostrils and connected though a flexible tube to said positive pressure ventilator, for delivering air from said positive pressure ventilator to the patient's trachea through the nostrils.
12. The ambulatory respiratory assist device according to claim 1, including a nasal cannula and a sensor for monitoring at least one parameter of a set of parameters consisting of the amount of time the ambulatory respiratory assist device is worn by the patient, the amount of time the ambulatory respiratory assist device is used by the patient, the distance traveled by the patient in a predetermined interval; the patient's heart rate, the patient's pulse oximetry, and automated chest auscultation data of the chest, and means for reporting the sensed parameter.
13. The ambulatory respiratory assist device according to claim 1, including an oxygen supply container supported by said weight-supporting belt and a nasal cannula connected to said oxygen supply container for delivering oxygen from said container to the patient for breathing.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
(13) As shown in
(14) The shell has a flexible, compressible border 20 for engagement either directly, or through an article of clothing with an individual's chest and abdomen. The border 20 forms a seal between the shell and the patient's chest, allowing the air pressure or vacuum in the cuirass to exert a force on the patient's chest. A sealing border can formed of any of various materials. For example, the border can be composed of a resilient, compressible, foam, as in U.S. Pat. No. 5,573,498. The foam can be, for example, an open-cell polyurethane foam, or any other suitable resilient, compressible foam capable of forming a suitable seal. Alternatively, the border can be composed of a resilient pleated seal as in U.S. Pat. No. 6,345,618. In still another version of the cuirass, an inflatable bag can be incorporated into the shell, and in that case, a special sealing border becomes unnecessary.
(15) The belt 16 is configured to fit circumferentially around a region of the trunk of a patient 22, this region preferably being at least in part between the pelvic girdle and the inferior border of the patient's sternum. The belt is preferably a hip belt, i.e., a belt configured to fit around or slightly above the pelvic/sacral girdle and the gluteus maximi. However, it is possible to utilize a waist belt, i.e., one that fits above the iliac crest but below the inferior border of the sternum. When secured around a region that is at least in part between the pelvic girdle and the inferior border of the patient's sternum, the belt can provide support for the weight of the cuirass when the patient is upright. The belt also provides support for a portable ventilator unit 24, which may include a power supply in the form of an electric battery, and other equipment. The belt can also provide support for auxiliary equipment such as an oxygen tank. In addition, as described below, the belt may provide support for the patient's shoulders in order to aid the patient's accessory breathing muscles.
(16) In the embodiment shown in
(17) One end of an additional belt 36 is secured to one side of the cuirass shell 18 at an intermediate location 38 between the upper and lower ends of the shell, extends around the patient's back, and is similarly secured to an opposite side of the shell. Belt 26 maintains the cuirass border in sealing engagement with the patient's chest and abdomen. The border can be maintained in sealing engagement with the patient's chest and abdomen in other ways, for example by being located inside an outer garment such as a shirt, jacket, vest, jumpsuit or the like, which can be custom-fitted in order to ensure proper engagement of the border of the cuirass with the patient's chest and abdomen. Custom fitting can be carried out by using measurements of the patient's body taken manually or by means of an imaging apparatus used in conjunction with a computer program that generates the appropriate dimensions for the custom-fitted garment. The belt can have a fixed diameter if custom-fitted. However, alternatively it can be made adjustable, by incorporating an adjustable strap, preferably on one or both sides of the belt.
(18) The cuirass can also be integrated with the garment, i.e., built into the garment so that the belt 26, or a similar temporary support to hold the cuirass in position, becomes unnecessary. In the example shown in
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(20) In the embodiment of the invention shown in
(21) The microcontroller 66 also operates a solenoid valve driver 72, which controls the opening and closing of the valves in a set of four solenoid valves 74, 76, 78, and 80.
(22) The sensor board, microcontroller, motor driver, pump and solenoid valve driver are powered from a power supply 81, preferably a battery of electrochemical cells, through connections indicated by letters a-e.
(23) Solenoid valves 76 and 78 are connected respectively from the inlet and outlet ports of the pump 70 to a common flexible conduit 82 which leads to the interior space in the cuirass 14. Solenoid valves 74 and 80 are connected respectively from the inlet and outlet ports of the pump 70 to atmospheric intake and outlet ports 84 and 86.
(24) In the operation of the ventilator, when the sensor board 62 detects inhalation, it causes the solenoid valve driver to close valves 74 and 78 and to open valves 76 and 80, thereby causing the pump 70 to draw a vacuum on interior of the cuirass through valve 76 and to exhaust the withdrawn air to the atmosphere through valve 80 and port 86. When the sensor board 62 detects exhalation, it causes the solenoid valve driver to close valves 76 and 80 and to open valves 74 and 78, thereby causing the pump 70 to draw air from the atmosphere through port 84 and valve 74 and to inflate the cuirass though valve 78 and conduit 82.
(25) The microcontroller controls the timing of the valves to accommodate the patient's breathing pattern in order to avoid ventilator dyssynchrony, a problem common with ventilators and other respiratory assisting devices. The microcontroller can also control the motor driver in order to regulate the speed of operation of the pump and thereby regulate the pressures within the shell of the cuirass.
(26) The ventilator system in
(27) The ventilator can also be controlled by a sensor (not shown) responsive to pressure in the cuirass shell, or by various combinations of two or more sensors including a nasal cannula sensor, a chest strap sensor, and a cuirass pressure sensor.
(28) The cuirass/ventilator apparatus can also be utilized concurrently with a positive pressure ventilator (PPV). A PPV creates a positive pressure at the patient's mouth, nose, and/or trachoestomy, pushing air into those orifices. The combination of the cuirass/ventilator apparatus with the positive pressure ventilator is synergistic in that it can prevent dynamic airway collapse (DAC), which can be caused not only by increased expiratory effort by the patient but also by the cuirass-ventilator. In DAC, external pressure on the small airways causes those airways to collapse. Further increase in intrathoracic pressure cannot increase air flow rate because of “choke points” in small airways. By combining PPV with cuirass ventilation-based compression of the thorax, the airways are stented open by the PPV and therefore not collapsed by the pressure exerted on the thorax by the cuirass/ventilator. Therefore, air can flow more rapidly out of the patient's airways than in the case of a cuirass/ventilator apparatus used by itself.
(29) In the embodiment illustrated in
(30) The positive pressure ventilator 90 in this embodiment is responsive to signals pressure sensor board is responsive to signals from a chest strap sensor 96, similar to the chest strap sensor 88 in
(31) The PPV can have a variety of different pressure vs. time functions, such as CPAP (continuous positive pressure ventilation) or BiPAP (alternating between higher and lower pressure levels), or more complex functions of pressure vs. time. The cuirass-ventilator combination and the PPV can be synchronized, with time delays in some cases, and share sensor information with each other. A variety of interfaces between the PPV and patient can be used. These interfaces include, but are not limited to: a nasal cannula (which can be generic or custom-fit, or concealed with eyeglasses for aesthetics), the nasal pillow cannula, a high-flow nasal cannula, a full or partial face mask, and tracheostomy variants. In the case of a tracheostomy, a very small tracheostomy can be utilized, since, in the case of a combination of the cuirass/ventilator apparatus and PPV, the cuirass/ventilator combination does not need to provide full ventilatory support, and is assisted by, and provides assistance to, the positive pressure ventilator.
(32) As mentioned above, it has been observed that COPD patients breathe more comfortably when in a position known as the “tripod position.” In the tripod position, the arms are supported on the knees or on some fixed object in front of the patient. It is for this reason that COPD patients often utilize front-wheel walkers, rollators, etc.
(33) The cuirass-ventilator apparatus of the invention can be adapted to achieve an effect similar to that of the “tripod position,” by including elements that support the shoulders and chest from the belt surrounding the region of the patient's trunk between the pelvic girdle and the inferior border of the sternum.
(34) In an embodiment shown in
(35) The load imposed by the patient's shoulders on these two shoulder supports is transmitted through the cuirass to the cuirass supporting belt 104. Thus, in this embodiment, the cuirass serves two purposes: its inflation and deflation by the ventilator aids in respiration by alternately lifting and compressing chest, and its shell provides a simple mounting for the shoulder supports, which also aid respiration, complementing the effect of inflation and deflation of the cuirass by relieving the auxiliary breathing muscles.
(36) In an alternative embodiment depicted in
(37) In another embodiment, the cuirass-ventilator apparatus or a device designed to support a patient's shoulders from the hips, is combined with an apparatus that effects chest wall vibration. Chest wall vibration has been shown to decrease dyspnea on exertion (DOE). The vibration is believed to confuse the sensors in the chest wall, lungs, and diaphragm that detect stretch and create the sensation of shortness of breath. The cuirass, which is already on the chest, can serve as a platform for chest wall vibration.
(38) The effect of chest wall vibration (CWV) on dyspnea is relatively small, and consequently, it has not come into widespread use. Because of the relatively small effect of chest wall vibration, physicians have not enthusiastically prescribed CWV devices. Moreover, patients have been unwilling to undergo the inconvenience of wearing a device that only had a small benefit. However, when incorporated into a cuirass/ventilator combination, or into an apparatus that aids in breathing while providing for patient mobility by supporting the patient's shoulders or upper arms from the hips, a chest wall vibration apparatus can provide additional benefits that are desirable both to the physician and to the patient.
(39) Chest wall vibration can be achieved in any of various ways, such as by the use of piezoelectric vibrating strips or bars fitted between the patient's ribs. However, in the case of the cuirass/ventilator apparatus described above, the vibration can be effected by superimposing on the pressure variation cycle at the breathing rate in the cuirass, typically an inhalation/exhalation cycle at a rate in range from approximately 6 to 60 cycles per minute, a higher frequency pressure oscillation preferably at a frequency of at least approximately 100 cycles per minute, and preferably in the range from approximately 100 to 200 cycles per minute. The superimposed pressure oscillation can be achieved by utilizing a piston pump and solenoid valves as in the embodiments in
(40) As shown in
(41) When chest wall vibration is achieved by varying the air pressure in the cuirass, a typical pressure variation over the breathing cycle is as shown in
(42) The magnitude of the superimposed pressure variations can also be controlled by the use of a pressure accumulator, and, when chest wall vibration is not desired, the accumulator can be utilized to eliminate the pressure variations substantially completely, in order to achieve a pressure variation cycle similar to that depicted in
(43) The ambulatory respiratory assist device can also include a sensor for monitoring at least one parameter of a set of parameters consisting of the amount of time the ambulatory respiratory assist device is worn by the patient, the amount of time the ambulatory respiratory assist device is used by the patient, the distance traveled by the patient in a predetermined interval, the patient's heart rate, the patient's pulse oximetry, and automated chest auscultation data of the chest. In this case, means are provided for reporting the sensed parameter either to the patient, or to another individual, e.g., a family member or the patient's physician. Reports of sensed variables can be used to aid in the prediction of acute exacerbations. For example if the patient's activity, such as the amount of walking, decreases for a few days in a row, this may predict an acute exacerbation, and the care providers and patients can be alerted via text message, telephone, or by other suitable means.
(44) The cuirass-ventilator apparatus of the invention can also be utilized with chest wall strapping (CWS), i.e., the placement of constrictive bands around the chest to decrease chest wall and/or chest compliance. CWS has been shown to improve DOE in COPD patients. The chest wall strapping can be independent of the cuirass, or can utilize straps that secure the cuirass to the patient's chest. In the latter case, tension around the chest is increased by increasing the pressure between the cuirass shell and the patient's body.