This invention relates to an apparatus or system for providing cardiac and/or pulmonary resuscitation and more particularly to such a system that is automated and capable of enhancing a patient's circulation and ventilation for an extended period.
State of the art methods and apparatus for providing external cardiac resuscitation are discussed to some extent in U.S. Pat. No. 5,806,512 (“'512 patent”). The '512 patent teaches the use of inflatable cuffs surrounding a patient's chest, abdomen and legs which are periodically inflated and deflated to force blood from the extremities to and through the heart with the chest and abdomen functioning in an out-of-phase relationship. Ventilation via a patient mask is also disclosed in the patent.
More recently a portable resuscitation/ventilation system using inflatable chest, abdominal and leg cuffs and a ventilator coupled to self-contained cylinders of compressed gas is described in international publication WO 2010/151278 A1 (“'278 pub.”) and disclosed on the web site AutoCPR.net. Solenoid operated valves, controlled by an electronic timer, connect the cuffs alternately to the compressed gas cylinders and to the ambient or atmosphere to inflate and deflate the cuffs in a timed sequence. For example, the chest and abdominal cuffs are operated in an out-of-phase sequence at a 30 cycles per minute rate, i.e., one second on (inflation) and one second off (deflation). The leg cuffs can be inflated and deflated at the same or a different rate. For example, the leg cuffs can be inflated continuously or inflated/deflated every fifth cycle of the chest cuff with the inflation period exceeding the deflation period. The portable gas supply is designed to provide adequate time to achieve the return of spontaneous circulation (ROSC) and patient transport to a hospital emergency department. A face mask and a tank of breathable gas provide ventilation for the patient. The resuscitator/ventilator of the '278 pub. is small enough to fit into a suitcase easily handled by a paramedic or other first responder. While it is believed to be cutting edge for its intended purpose, the use of compressed gas cylinders limits its operating time.
Recent clinical studies have demonstrated that the continued support of a patient's circulation (such as uninterrupted chest compression) after ROSC significantly improves the survival rate of patients after leaving the hospital. See, for example, the Journal of Emergency Medicine, 1008, Feb. 12, 2009 by M. Riscon, et al; the European Resuscitation Council Guideline for Resuscitation 2005 by A J Hadley, et al; Critical Care 2005, 9:287-290 by M H Weil and Shijie Sun; and Burst Stimulation Improves Hemodynamics during resuscitation etc. in Circulation: 2009, 2:57-62 by G. Walcott et al.
There is a need for a system/apparatus which will not only aid in achieving a patient's ROSC but in addition continue to support the patient's circulatory system over an adequate time period after ROSC to improve the out of hospital survival rates for patients suffering cardiac arrest or other serious heart problems.
A patient resuscitation system, in accordance with the present invention, includes a plurality of inflatable cuffs adapted to extend around separate portions of a patient's anatomy (e.g, chest, abdomen and legs) for increasing the patient's blood flow when periodically inflated/deflated (1) to achieve ROSC and subsequently (2) to continue the support of his/her circulatory system. A timer, such as the timer disclosed in the '278 pub., sets the inflation/deflation periods. Air for the inflation steps is provided by a primary low-pressure-high-volume-air-compressor connected to a volume chamber (i.e. to smooth out pressure fluctuations). A pneumatic circuit, including a pressurized gas source, such as a secondary compressor, provides a separate pneumatic control signal associated with each cuff bracketing each inflation period set by the timer. An air handler is individually connected between each cuff, the volume chamber and the atmosphere (or ambient) and responsive to the pneumatic control signals for inflating/deflating each cuff in accordance with the inflation/deflation periods set by the timer.
Each air handle preferably includes an inflation and a deflation diaphragm valve with the valves being located between the cuff, the volume chamber and the atmosphere, respectively. Preferably each diaphragm valve is normally open connecting the cuff to the volume chamber and to the atmosphere with each valve being arranged to close in response to the receipt of a control signal and open in the absence of a control signal. Accordingly, each cuff will be connected to the volume chamber for inflation purposes in the absence of a control signal being applied to the inflation diaphragm valve and in the presence of a control signal being applied to the deflation diaphragm valve closing off the cuff from the atmosphere and visa versa. Alternatively the diaphragm valves connecting the cuffs to the volume chamber can be closed independently of the operation of the timer.
In a preferred embodiment the inflation diaphragm valve, in the form of an air module, connects the associated cuff to the volume chamber when open and the deflation valve, in the form of an air relay, connects the associated cuff to the atmosphere when open.
Preferably there is a chest, abdominal, and two leg cuffs. The pneumatic circuit includes a control valve for each air handler. The control valves for the chest and abdominal cuffs have (1) an auto position (responsive to the timer) in which the control signals are directed to the inflation and deflation diaphragm valves alternately to inflate and deflate the chest and abdominal cuffs in an out-of-phase relationship and (2) an off position in which the pneumatic control signals are continuously (when present) applied to the inflation diaphragm valves to close the same. At the same time the deflation diaphragm valves are opened by the absence of the next control signal, resulting in a deflation mode for the cuffs in the off mode.
The control valve for the leg cuffs has an auto position in which the cuffs are alternately inflated and deflated in accordance with the dictates of the timer, an on position in which the cuffs are continuously inflated, and an off position in which the cuffs are continuously deflated.
Preferably the diaphragm valves are mounted in a common manifold block with the block providing fluid communication between each pair of (inflation and deflation) valves and the associated cuff.
A manually adjustable pressure/cycle rate valve may be coupled to the volume chamber and the timer for allowing the operator to select different cyclical rates (e.g. 30 or 20 cycles per minute) and different pressures (e.g. 150 or 100 mm Hg.) in the volume chamber. A ventilator, like the one disclosed in the '278 pub., may be included in the apparatus.
The face mask and cuffs may be disposable to comply with applicable health standards. The content of the '278 pub. (now U.S. Pat. No. 8,277,399) are incorporated in their entirety herein, by reference.
a and 5b are bottom and perspective views of the air module (inflation diaphragm valve), respectively.
a and 6b are front and perspective views of the air relay (deflation diaphragm valve), respectively.
a, 8b and 8c are cross sectional views of one of the ball valves of
a and 9b are a cross sectional and end view of an exhaust valve, respectively.
a and 10b are a cross sectional and end view of a back flow valve, respectively.
a, 11b and 11c are perspective, front and cross sectional views of the selector valve of
a and 12b are an end view and a cross sectional view, respectively, of the pressure compensated discharge valve which controls the pressure in the volume chamber.
a is a graph illustrating the control of gas pressure to the ventilator and cuffs in an exemplary mode.
Overview of the System Operating in an Exemplary Mode
Referring now to
In an automated exemplary mode, the chest and abdominal cuffs are continuously inflated and deflated in an out of phase relationship in one second intervals, that is, one second inflated and one seconded deflated, while the leg cuffs are inflated and deflated in 10 second and 2 second intervals, respectively. See
Discussion of the Air Handlers
All of the air handlers are identical with the chest cuff air handler 18 which is shown in a cross sectional view in
Referring again to
The air relay 34 (deflation diaphragm valve), mounted to the block 23 as shown, includes a tubular member 34a extending (at its distal or inlet end 34b) from a lateral bore 23b in the manifold block (which terminates at outlet 23c in the common longitudinal bore 23a) to a proximal end 34c. The proximal end is normally spaced a short distance from a flexible diaphragm 34d with an annular volume 34e, surrounding the tube 34a, which opens to the atmosphere or ambient via an outlet orifice 34f to exhaust the chest cuff when the diaphragm valve is open. A nipple 34g is arranged to conduct (pressurized) control signals to a chamber 34h which closes the deflation diaphragm valve.
The air handler 18 is shown in its normal state in
See
Discussion of the Pneumatic/Solenoid Circuitry and Accessory Components
Referring now to
The Pneutronics Division of Parker Hannifin Corporation offers such solenoids under the X-valve designation.
The pneumatic circuit includes manually adjustable ball valves 52, 54 and 56 with solenoid receptive ports S for accommodating automatic operation of the system in cooperation with air module interrelated ports A. Closure ports C provide closure of the air modules in cooperation with the control signal ports A, as will be explained. Ball valve 56 includes an additional function of allowing the continuous inflation of the leg cuffs by preventing control signals from reaching the air module 40. An exhaust diaphragm valve 43, when closed due to the absence of a control signal applied to nipple 43g, allows the control signal passing through the restrictor 26j to close the air relay 42 allowing the cuffs to inflate. Air bleed orifice 41a also plays a part in controlling the operation of exhaust valve 43 by exhausting the pressure present at nipple 43g when the associated control signal is absent.
As discussed above, in an exemplary mode, the chest and abdomen cuffs are inflated and deflated alternately. As a result, when the chest cuff solenoid 46 is actuated to connect the pneumatic line 26b to the pressurized line 26a, the abdomen solenoid 48 is inactivated disconnecting the line 26c from the control signal source, i.e. line 26a. The control signal applied to nipple 38g of air relay 38 closes off the abdomen cuff from the atmosphere while the abdomen cuff is connected to the volume chamber 16a as a result of the absence of a control signal being applied to the nipple 36h of the abdomen air module 36, thereby allowing the abdomen cuff to inflate. At the same time the control signal on line 26b is routed through ports S and A of the three-way valve 52 to the nipple 32h of the chest air module via line 26e. The presence of the control signal closes off the chest cuff from the volume chamber, while the air relay 34 is open due to the absence of a control being applied to nipple 34g, connecting the chest cuff to the atmosphere.
When the abdomen solenoid is activated the control signal is applied to the chest air relay 34 (via nipple 34g) and to abdomen air module 36 (via line 26f and nipple 36h) disconnecting the abdomen cuff from the volume chamber and the chest cuff from the atmosphere. The absence of a control signal being applied to the air relay 38 and the air module 32 results in inflating the chest cuff and deflating the abdomen cuff.
The ball valves 52 and 54 can be rotated to connect the A ports to the C ports for closing the chest and abdominal air modules by connecting line 26a to the nipples 32h and 36h, thereby overriding the operation of the respective solenoid valves. In response to the absence of the next control signal the air relays 34 and 38 will open to connect the associated cuffs to the atmosphere resulting in the deflation of the cuffs.
Since the leg cuff(s)' air handler operates independently, several accessories, namely exhaust valve 43, bleed orifice 41a and flow restrictor 26j are needed for its control. The exhaust valve 43 has its input nipple 43g connected in parallel with the input nipple to the leg cuff(s)' air module as shown. As a result when solenoid 50 is activated (as shown) a control signal is applied to the input nipples 40h and 43g of the air module 40 and exhaust valve 43, respectively, via ports S and A in the ball valve 56 to close the air module and open the exhaust valve. At the same time the control signal pressure at the input nipple 42g of air relay 42 is exhausted to the atmosphere through exhaust valve 43 allowing this relay to open. Restrictor 26i serves the function of allowing the exhaust valve, when open, to drop the pressure at the nipple 42g thereby removing the control signal to that relay and allowing it to open, deflating the cuffs The restrictor 26i aids in the accomplishment of this function by restricting the flow through line 26a.
When the solenoid 50 is inactivated (or open) the control signal disappears from the air module 40 and the exhaust valve 43. This action connects the air module to the volume chamber, closes the exhaust valve 43 and applies the control signal (say 15 psi), via restrictor 26j, to the air relay 42. This control signal closes the air relay 42 and disconnects the leg cuff(s) from the atmosphere, allowing the cuff(s) to inflate.
Cross-sectional views of the ball valves 52, 54 and 56 are shown in
Referring now to
The backflow or check valve 64, illustrated in
Discussion of the Selector Switch for Setting the Cyclical Rate and Volume Chamber Pressure
Referring now to
Referring again to
Discussion of the Modification of the '278 Pub. Timer
A modification of the timer disclosed in FIG. 4B of the '278 pub., necessary to respond to the digital signal from the rate selector 60 (
Discussion of the Ventilator Components
Referring again to
There has been disclosed a simple and versatile system or apparatus for not only aiding a patient undergoing cardiac arrest to achieve the return of spontaneous circulation but to continue supporting the patient's circulation to improve his/her chances of long term survival after ROSC has been achieved. The diaphragm valves and air compressors are highly reliable and efficient, requiring little maintenance. It is to be noted that the various air pressures discussed above are by way of example only. Obviously the volume chamber pressure has to be adequate to properly inflate the cuffs; by the same token the control signal pressure must be sufficiently greater than the volume chamber pressure to insure closure of the diaphragm valves in the configuration as shown. While the apparatus is illustrated as operating in an automated mode with a higher cuff pressure and cyclical rate to achieve ROSC and with a lower pressure and cyclical rate subsequently, the invention is not so limited.
It is also to be noted that while the air modules and air relays are shown as being normally open and closed in response to the application of a control signal, one or both may be configured to be normally closed and opened in response to the control signal. As an example, the air relays may have a configuration similar to the exhaust valve 43 so that in the absence of a control signal the cuffs will be inflated and in response to a control signal the cuffs will be deflated. The system may be mounted on a wheeled cart for portability in a hospital or used in a paramedic's truck with compressors operating off of the truck's electrical system. While those skilled in the art may discover modifications or even improvements to the disclosed apparatus it is believed that such modifications will not involve a departure from the scope and spirit of our invention as defined in the appended claims.
Number | Name | Date | Kind |
---|---|---|---|
3461858 | Michaelson | Aug 1969 | A |
3880149 | Kawaguchi | Apr 1975 | A |
3885554 | Rockwell, Jr. | May 1975 | A |
3889668 | Ochs et al. | Jun 1975 | A |
3896794 | McGrath | Jul 1975 | A |
3942518 | Tenteris et al. | Mar 1976 | A |
4297999 | Kitrell | Nov 1981 | A |
4349015 | Alferness | Sep 1982 | A |
4397306 | Weisfeldt et al. | Aug 1983 | A |
4407588 | Arichi et al. | Oct 1983 | A |
4424806 | Newman et al. | Jan 1984 | A |
4575651 | Hoelzer | Mar 1986 | A |
4638837 | Buike et al. | Jan 1987 | A |
4753226 | Zheng et al. | Jun 1988 | A |
4770165 | Hayek | Sep 1988 | A |
4775801 | Baum | Oct 1988 | A |
4930498 | Hayek | Jun 1990 | A |
5036841 | Hamilton | Aug 1991 | A |
5310111 | Linck | May 1994 | A |
5327887 | Nowakowski | Jul 1994 | A |
5370603 | Newman | Dec 1994 | A |
5490820 | Schock et al. | Feb 1996 | A |
5514079 | Dillon | May 1996 | A |
5725485 | Ribando et al. | Mar 1998 | A |
5806512 | Abramov et al. | Sep 1998 | A |
6030353 | Van Brunt | Feb 2000 | A |
6095139 | Psaros | Aug 2000 | A |
6589267 | Hui | Jul 2003 | B1 |
6591835 | Blanch | Jul 2003 | B1 |
6676614 | Hansen et al. | Jan 2004 | B1 |
7074177 | Pickett et al. | Jul 2006 | B2 |
7258676 | Calderon et al. | Aug 2007 | B2 |
20030233061 | Hui | Dec 2003 | A1 |
20050011518 | Biondo et al. | Jan 2005 | A1 |
20050126578 | Garrison et al. | Jun 2005 | A1 |
20100326442 | Hamilton et al. | Dec 2010 | A1 |
Number | Date | Country |
---|---|---|
WO 2010151278 | Dec 2010 | WO |