# US 6,589,267 B1 · High efficiency external counterpulsation apparatus and method for controlling same

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- Number: US 6,589,267 B1
- Document ID: US6589267B1
- Status: Granted
- Kind: B1
- Application number: 09/710,692
- Filed: 2000-11-10
- Granted: 2003-07-08
- Earliest claimed: 2000-11-10
- Assignees: Vasomedical, Inc.
- Inventors: John C. K. Hui
- Web page: https://patentgrep.com/patent/US6589267B1

## CPC

- A61H 31/005: {with feedback for the user}
- A61G 7/05776: {with at least two groups of alternately inflated chambers}
- A61H 9/0078: {with intermittent or alternately inflated bladders or cuffs (mattresses for preventing bed-sores with alternated pressurized chambers A61G7/05776)}
- A61H 31/00: Artificial respiration by a force applied to the chest; Heart stimulation, e.g. heart massage (applying electric currents by contact electrodes for stimulation, e.g. heart pace-makers, A61N1/36 {; teaching or training models, demonstration models for medical purposes G09B23/288})
- A61H 31/006: {Power driven}
- A61H 31/008: {Supine patient supports or bases, e.g. improving air-way access to the lungs}
- A61G 13/06: raising or lowering of the whole table surface (A61G13/04 takes precedence)
- A61G 13/08: the table being divided into different adjustable sections
- A61G 2203/46: for temperature
- A61H 2031/025: {using the same pump for pressure and vacuum, not being driven at the respiratory rate, e.g. blowers}
- A61H 2201/0103: inflatable
- A61H 2201/1238: with hydraulic or pneumatic drive
- A61H 2201/165: Wearable interfaces
- A61H 2201/5007: computer controlled
- A61H 2201/501: connected to external computer devices or networks
- A61H 2205/10: Leg
- A61H 2230/04: Heartbeat characteristics, e.g. E.G.C., blood pressure modulation
- A61H: PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY (electrotherapy, magnetotherapy, radiation therapy or ultrasound therapy A61N)
- A61G: TRANSPORT, PERSONAL CONVEYANCES OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS (appliances for aiding patients or disabled persons to walk A61H3/00); OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES (embalming corpses A01N1/00)

## Abstract

The present invention provides a high efficiency external counterpulsation apparatus having accurate and reliable timing of inflation and deflation and reduced temperature of the pressurized gas, such that the gas flow temperature of the balloons is near to room temperature. The external counterpulsation apparatus also has a new gas distribution device and devices for monitoring the blood pressure and oxygen levels in the blood of a patient for improving safety. The present invention further provides a method for controlling the external counterpulsation apparatus.

## Claims

### Claim 1

An external counterpulsation apparatus for treating a patient, comprising:
a balloon assembly adapted to be received about the lower extremities of the patient, said balloon assembly including a plurality of inflatable devices;
a source of compressed fluid;
a fluid reservoir interconnected with said source of compressed fluid for inflating said inflatable devices; and
a fluid distribution assembly interconnected with said fluid reservoir for distributing compressed fluid from said source of compressed fluid to said inflatable devices;
said fluid distribution assembly including a selectively operable inflation/deflation valve interconnected between each of said inflatable devices and said fluid reservoir, each of said inflation/deflation valves having a pneumatically actuable power operator thereon and being interconnected with said balloon assembly and separately operable such that each of said inflatable devices is separately sequentially inflatable and deflatable, each of said inflation/deflation valves having an input interconnected with said fluid reservoir, an inflation/deflation port interconnected with one of said inflatable devices, and a deflation exhaust port in fluid communication with the atmosphere, said deflation exhaust port being normally open so as to default to said normally open condition upon loss of power to said power operator.

### Claim 2 (depends on 1)

An apparatus according to claim 1, further including a movable table upon which the patient is situated during treatment, said inflation/deflation valves being attached to said movable table for movement therewith.

### Claim 3 (depends on 2)

An apparatus according to claim 2, wherein said movable table is movable upon a plurality of wheels attached thereto.

### Claim 4 (depends on 2)

An apparatus according to claim 2, wherein said inflation/deflation valves are mounted on an underside of said table, and the patient being situatable upon an upper side of said table.

### Claim 5 (depends on 2)

An apparatus according to claim 2, wherein said table further includes an articulatable portion thereof and a main portion thereof allowing selective angulation of said articulatable portion with respect to said main portion.

### Claim 6 (depends on 5)

An apparatus according to claim 5, wherein said table includes a power-operable elevation assembly selectively operable to adjust the height thereof.

### Claim 7 (depends on 1)

An apparatus according to claim 1, further including a computer-implemented system for recording patient information for the patient receiving the treatment, said computer-implemented system including:
a patient data structure for storing demographic information for one or more patients receiving treatment;
a patient treatment data structure for storing treatment information for one or more patients receiving treatment; and
a computing device connected to the apparatus for controlling operation of the apparatus, said computing device further operative to receive at least one of demographic information and treatment information and to store the information in the corresponding patient data structure or patient treatment data structure.

### Claim 8 (depends on 7)

An apparatus according to claim 7, wherein said computing device is receptive of patient demographic information and operable to store the patient demographic information into the patient data structure.

### Claim 9 (depends on 8)

An apparatus according to claim 8, wherein the patient demographic information includes a patient identifier, a patient name, and at least some patient medical data.

### Claim 10 (depends on 7)

An apparatus according to claim 7, wherein the computing device is receptive of patient treatment information and operable to store the patient treatment information into the patient treatment data structure.

### Claim 11 (depends on 10)

An apparatus according to claim 10, wherein the patient treatment information includes at least one of ECG data from the patient, blood pressure data from the patient, heart rate data from the patient and inflation/deflation cycle data associated with the external counterpulsation device.

### Claim 12 (depends on 7)

An apparatus according to claim 7, wherein the computing device is adapted to communicate at least one of the patient demographic information and the patient treatment information over a communication link to a second computing device.

### Claim 13 (depends on 7)

An apparatus according to claim 7, wherein said computing device controls the distribution of the compressed fluid to the balloon assembly, thereby inflating and deflating the inflatable devices.

### Claim 14

An external counterpulsation apparatus for treating a patient, comprising:
a balloon assembly adapted to be received about the lower extremities of the patient, said balloon assembly including a plurality of inflatable devices;
a source of compressed fluid;
a fluid reservoir interconnected with said source of compressed fluid for inflating said inflatable devices; and
a fluid distribution assembly interconnected with said fluid reservoir for distributing compressed fluid from said source of compressed fluid to said inflatable devices;
said fluid distribution assembly including a selectively operable inflation/deflation valve interconnected between each of said inflatable devices and said fluid reservoir, each of said inflation/deflation valves having a power operator thereon and being interconnected with said balloon assembly and separately operable such that each of said inflatable devices is separately sequentially inflatable and deflatable, each of said inflation/deflation valves having an input interconnected with said fluid reservoir, an inflation/deflation port interconnected with one of said inflatable devices, and a deflation exhaust port in fluid communication with the atmosphere, said deflation exhaust port being normally open so as to default to said normally open condition upon loss of power to said power operator, wherein each of said inflation/deflation valves is a rotary actuable valve.

### Claim 15

An external counterpulsation apparatus for treating a patient, comprising:
a balloon assembly adapted to be received about the lower extremities of the patient, said balloon assembly including a plurality of inflatable devices;
a source of compressed fluid;
a fluid reservoir interconnected with said source of compressed fluid for inflating said inflatable devices; and
a fluid distribution assembly interconnected with said fluid reservoir for distributing compressed fluid from said source of compressed fluid to said inflatable devices;
said fluid distribution assembly including a selectively operable inflation/deflation valve interconnected between each of said inflatable devices and said fluid reservoir, each of said inflation/deflation valves having a power operator thereon and being interconnected with said balloon assembly and separately operable such that each of said inflatable devices is separately sequentially inflatable and deflatable, each of said inflation/deflation valves having an input interconnected with said fluid reservoir, an inflation/deflation port interconnected with one of said inflatable devices, and a deflation exhaust port in fluid communication with the atmosphere, said deflation exhaust port being normally open so as to default to said normally open condition upon loss of power to said power operator, wherein each of said inflation/deflation valves is a rotary actuable butterfly valve.

### Claim 16 (depends on 15)

An apparatus according to claim 15, wherein each of said rotary actuable butterfly valves includes a rotatable rotor and a butterfly valve element rotatably attached to said rotor for rotation therewith, said rotor being rotatable through a maximum rotation angle of approximately 60 degrees between open and closed positions of said butterfly valve element.

### Claim 17 (depends on 16)

An apparatus according to claim 16, wherein each of said rotary actuable butterfly valves includes a pair of said butterfly valve elements attached to said rotor for rotation therewith, a first of said butterfly valve elements being in fluid communication between said input and said inflation/deflation port and being normally closed, and a second of said butterfly valve elements being in fluid communication between said deflation exhaust port and said inflation/deflation port and being normally open.

### Claim 18 (depends on 17)

An apparatus according to claim 17, wherein an inflation passageway through each of said butterfly valves between said input port and said inflation/deflation port is more restricted than a deflation passageway between said inflation/deflation port and said deflation exhaust port.

### Claim 19

An external counterpulsation apparatus for treating a patient, comprising:
a balloon assembly adapted to be received about the lower extremities of the patient, said balloon assembly including a plurality of inflatable devices;
a source of compressed fluid;
a fluid reservoir interconnected with said source of compressed fluid for inflating said inflatable devices; and
a fluid distribution assembly interconnected with said fluid reservoir for distributing compressed fluid from said source of compressed fluid to said inflatable devices;
said fluid distribution assembly including a selectively operable inflation/deflation valve interconnected between each of said inflatable devices and said fluid reservoir, each of said inflation/deflation valves having a power operator thereon and being interconnected with said balloon assembly and separately operable such that each of said inflatable devices is separately sequentially inflatable and deflatable, each of said inflation/deflation valves having an input interconnected with said fluid reservoir, an inflation/deflation port interconnected with one of said inflatable devices, and a deflation exhaust port in fluid communication with the atmosphere, said deflation exhaust power being normally open so as to default to said normally open condition upon loss of power to said power operator;
said source of compressed fluid including a compressor, said apparatus further including a power ramp-up device that upon startup of said apparatus converts electrical power to said compressor from 110/120 VAC 50/60 hz to three-phase 220 VAC at a variable frequency and increases the electrical power to a preselected full power level over a period of approximately three to approximately five seconds.

### Claim 20

A method for monitoring the treatment of a patient who is receiving treatment from an external counterpulsation system, comprising the steps of:
displaying an electrocardiogram (ECG) signal taken from the patient;
displaying a plethysmograph waveform signal taken from the patient; and
displaying a timing signal that is indicative of an inflation/deflation cycle of the external counterpulsation system.

### Claim 21

A method for monitoring the treatment of a patient who is receiving treatment from an external counterpulsation system, comprising the steps of:
displaying an electrocardiogram (ECG) signal taken from the patient;
displaying a pressure signal indicative of the blood pressure of the patient; and
displaying a timing signal that is indicative of an inflation/deflation cycle of the external counterpulsation system, said timing signal displaying a timing bar for each inflation/deflation cycle, wherein a leading edge of the timing bar corresponds to the initiation of inflation and a trailing edge of the timing bar corresponds to the initiation of deflation.

### Claim 22 (depends on 21)

The method of claim 21, further comprising the step of adjusting the timing of the inflation/deflation cycle of the external counterpulsation system.

### Claim 23 (depends on 21)

The method of claim 21, wherein the external counterpulsation device further comprises:
at least one adaptable balloon device adapted to be received about a lower extremity of the patient;
a fluid distribution device connected to the balloon device for distributing a compressed fluid thereto; and
a computing device connected to the fluid distribution device for controlling the distribution of the compressed fluid to the balloon device, thereby inflating and deflating the balloon device.
