MXPA00001712A - Counterpulsation device using noncompressed air - Google Patents

Abstract

A counterpulsation device that operates without the use of compressed air or pressurized gas includes at least one inflatable cuff that is adapted to be placed about a selected portion of the patient's body. A conduit connects the inflatable cuff to an air transfer device so that noncompressed air can be transferred from the air transfer device to the cuff through the conduit to inflate the cuff. The conduit also connects the cuff to the air transfer device so that air can flow through the conduit to deflate the cuff. Another conduit is coupled to the first so that the air in the system can be selectively vented into the atmosphere. A series of valves are placed on the conduit to selectively control whether air is supplied to or withdrawn from the inflatable cuff. The air moving device preferably is a cylinder having a piston that moves through the cylinder to move the air from within the cylinder through the conduit and into or out of the cuff as desired. The piston moves through the cylinder through the use of a linear servo actuator that is controlled by an appropriately programmed electronic controller so that the inflation of the cuff is timed with portions of the patient's EKG signal and peripheral plethysmographic wave.

Description

CONTRAPULSATION DEVICE USING NON-COMPRESSED AIR BACKGROUND OF THE INVENTION This invention relates to a counterpulsation device and, more particularly, to a counterpulsation device that operates without the use of compressed air.

Various counterpulsation devices are known and used in the medical field. The counterpulsation devices typically include inflatable cuffs that are placed around the selected portions of a patient's body. Inflatable cuffs are typically placed around the calves, thighs and buttocks of a patient. The cuffs are inflated sequentially in a distant to close order during diastole. The inflating of the cuffs is synchronized to provide a second pressurized pulse of blood flow to all organs above the buttocks fist, when the heart is normally resting between beats. It has been shown that the extra impulse of blood flow relieves angina pectoris, increases cardiac output, thus improving the perfusion of the beds of organs, and improves renal, cardiac and cerebral circulation. In typical devices, a source of compressed air is used to inflate the cuffs and a vacuum pump is used to evacuate the cuffs when necessary. Currently available counterpulsation systems have several shortcomings and drawbacks, mainly because they require the use of compressed air. Compressed air is disadvantageous, since it must be handled carefully or it introduces potential problems. Systems that use compressed air can be too pressurized due to malfunction or blockage in the compressor or an associated accumulator. Too high pressure conditions should be minimized to avoid subjecting the patient to excessive pressure when inflating the cuffs. Under extreme conditions, the formation of excess pressure introduces the possibility that a portion of the system, such as a flexible tube or compressor housing, will break unexpectedly. Typical compressors also make conventional systems undesirably noisy, making them less ideal for hospitals or clinical facilities. Compressors and containers are also relatively large and complicated, which decreases their capacity so that they can be moved easily. Compressed air systems also require components such as vacuum pumps, which introduce additional cost, noise, complexity, and additional maintenance issues. Conventional systems require frequent maintenance because filters and other components must be replaced, especially in a counterpulsation application, where the entire machine can be used continuously for several hours. Additionally, the compressed air introduces the possibility of condensation formation within the system, which may interfere with the proper functioning of the valve, cuff and other component to further exacerbate maintenance issues. All the above drawbacks contribute to a major deficiency of conventional systems, namely that they are not portable and can not be used in different clinical facilities or hospitals. Another drawback associated with some of the available systems is that they are not versatile enough to provide counterpulsation therapy for a sufficiently wide variety of applications. There is a need for a counterpulsation device that provides the capabilities of the pressure operated systems that are currently available while having the advantage of not including the use of pressurized or compressed gas. This invention solves the deficiencies and drawbacks described above and provides a system that is versatile in the administration of counterpulsation therapy without the use of pressurized or compressed air.

COMPENDIUM OF THE INVENTION In general terms, this invention is a counterpulsation device that operates without the use of compressed air or pressurized gas to create compression in the tissue. The invention includes several basic parts. At least one inflatable cuff is provided which is adapted to be placed around a selected portion of the patient's body. A conduit connects the inflatable cuff to an air movement device, so that uncompressed air can be transferred from the air movement device to the cuff through the inflating duct. This conduit also performs a second function of allowing the air to leave the fist, which deflates the fist. A series of valves are associated with the conduit to selectively control whether the air is supplied to or removed from the inflatable cuff. The air moving device is preferably a cylinder having a piston that moves through the cylinder to move air from within the cylinder through the conduit and into or out of the fist, as desired. The piston moves preferably through the cylinder by the use of a linear servo actuator that is controlled by a properly programmed electronic controller, so that the inflating of the cuff is synchronized with portions of the patient's EKG signal and the plethysmographic wave peripheral. In the preferred embodiment, there are two cuffs that are placed around the lower portion or calves of the patient's legs. There are also preferably two cuffs that should be placed around the patient's thighs and a fist that is placed around the patient's buttocks. In an alternative application, the cylinder sucks from a specific gas or liquid container with special characteristics that allow more complete and rapid volume / pressure changes inside the cuffs. Still in another form of realization, a multi-wave unit, non-distensible, encompasses the entire lower hemi-body. In this example, the unit is segmented into a section of ankle, calf, thigh, and buttocks. Tissue compression is applied to each component sequentially without direct material interaction with the tissue and, therefore, avoids cutaneous irritation that may otherwise occur with continuous inflating and deflating of the cuff. In an alternative embodiment, the apparatus that produces tissue compression to provide augmentation can be applied only on every two heart beats, every second heartbeat, or every third heartbeat, depending on which sequence produces the best magnification. The various features and advantages of this invention will be apparent to those skilled in the art from the following description of the currently preferred embodiment. The drawings that accompany the detailed description can be briefly described as follows.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic illustration of a counterpulsation system according to the invention. Figure 2 is a more detailed schematic illustration of selected portions of a system designed in accordance with this invention. Figures 3A and 3B constitute a flow chart summarizing the method of operation of a system designed in accordance with this invention. Figure 4 is a flow chart illustrating a portion of the procedures associated with the use of this invention. Figure 5 is another flow chart illustrating another portion of the method of this invention. Figure 6 illustrates an example of a computer screen designed in accordance with this invention. Figure 7 illustrates schematically a computer software device designed in accordance with this invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Figure 1 illustrates schematically, in simplified form, a system counterpulsation including a computer terminal 10 that allows a physician or other healthcare professional to operate the counterpulsation system to deliver a desired therapy regimen to a patient 11. The computer 10 communicates with a controller 20 communicating with a second controller 12 which controls the operation of an air movement device 14. A series of conduits 16 and valves 18 are controlled by the controller 20. A plurality of inflatable cuffs 22, 24, 26 are inflated and deflated as the air movement device moves air through the conduits 16 and valves 18 to the cuffs For simplicity, only one conduit 16 is shown in Figure 1. Figure 2 schematically illustrates, in greater detail, the selected portions of the counterpulsation system.The plurality of inflatable cuffs 22, 24 and 26 are adapted to be placed around the calves, thighs and buttocks of a patient, respectively. they are inflated in a sequence to improve blood flow in a generally distant to near direction.The synchronization of the inflating of the cuffs is synchronized with portions of the patient's EKG signal and the plethysmographic wave to achieve the desired therapeutic effect, which can be varied depending of the needs in each particular situation The preferred embodiment includes two cuffs 22A and 22B for the calves of the the patient, two fists 24A and 24B for the thighs and an individual fist 26 which is fitted around the buttocks. As the cuffs are inflated, the pressure against the body causes the impulse of additional blood flow desired. For simplicity, this specification refers to a "fist", but it should be understood that a pair of fists are included. The preferred embodiment includes cuffs having a relatively rigid exterior with an internal inflatable portion directed towards the skin of the patient. The air movement device 14 is illustrated as an air transfer device 28 which preferably includes a cylinder 20 and a piston 32. A robotic linear actuator 33 moves the piston 32 within the cylinder 30, as indicated by the electronic controller 12, which communicates with the contractor 20 which is programmed to achieve a desired counterpulsation therapy regimen. The air transfer device 28 more preferably uses uncompressed air, which is a significant deviation from the previous counterpulsation systems. Other non-compressed fluids may also be used depending on the criteria for a specific situation. Air is typically preferred because of its easy availability and the ability to discharge to the atmosphere. A first conduit 29 and a second conduit 31 connect the inflatable cuffs to the air transfer device 28 through a transient pressure suppressor 55, directional control valves 64A or 64B so that uncompressed air can be transferred through of the third conduit 34 in a first direction to inflate the cuffs. The use of the control valve 64A or 64B depends on the direction of displacement of the piston 32 within the cylinder 30, as will be more apparent from this description. A fourth conduit 36 couples the cuffs to the air transfer device 28 through a transient vacuum suppressor 56 and directional control valves 66A or 66B, so that the air can flow in a second direction, caused by the movement of the piston. 32 inside the cylinder 30, to deflate the cuffs. Again, the control valve to be operated depends on the direction in which the piston is moving 32. A fifth conduit 38 and a sixth conduit 39 connect the first conduit 29 and the second conduit 31, respectively, to the surrounding atmosphere through a noise filter 40A, so that the air transfer device 28 can be vented to the atmosphere, by recharging the cylinder 30 with air for the subsequent stroke of the piston 32, or by releasing the excess air, if necessary. In the preferred embodiment, the cylinder 30 includes two holes 42 and 44. The solenoid valves 58 and 60 are positioned within the path between the conduits 29 and 31 and the two conduits 38 and 39, respectively. The fifth conduit 38 and the sixth conduit 39 are directly coupled with the holes 42 and 44 through solenoid valves 58 and 60. To control the amount of uncompressed air transferred to the cuffs, a pressure transmitter 48 is included to determine the amount of air pressure through the third conduit 34. The pressure gauges 54A, 54C are also used to visually quantify instantaneous pressure and inflation characteristics of the calf, thigh and buttock cuffs , respectively. When the pressure transmitter 48 indicates a pressure build-up in the cuffs, one of the solenoid valves 58 and 60 is activated, depending on the direction of travel of the piston 32. The solenoid valves 58 and 60 are connected to the transmitter pressure 48, so that valves 58 and 60 can be selectively opened to vent air through conduits 38 and 39 and noise filter 40A. In this way, the air in the third conduit 34 never exceeds the preselected level. An additional safety measure includes the addition of pressure relief valves 53A, 53B and 53C that mechanically prevent pressure build-up beyond the therapeutic set point in the calf, thigh and buttock cuffs, respectively. Similarly, the solenoid valves 58 and 60 are joined with a pressure transmitter 50. When it is desirable to vent a vacuum within the first and second conduits 29 and 31 through the noise filter 40A, the transmitter 50 activates the solenoid 58 and 60, depending on the direction of displacement of the piston 32. The solenoid valves 58 and 60 are connected to the pressure transmitter 50, so that the valves 58 and 60 can be selectively opened to reduce the vacuum level in the conduits 29 or 31, through the noise filter 40A. In this way, the vacuum in the fourth conduit 36 never exceeds a preselected level. A series of solenoid valves 70, 72 and 74 are positioned along the third conduit 34 to selectively supply air to the cuffs 22, 24 and 26, respectively. A series of solenoid valves 76, 82 and 84 are positioned along the fourth conduit 36 to selectively supply vacuum to the cuffs 22, 24 and 26, respectively. The phrase "supply vacuum" is synonymous with "venting" the fists. A series of solenoid valves 86, 88 and 90 are positioned along the calf, thigh and buttock supply conduits, which are derived from conduit 34, to selectively vent the cuffs to the atmosphere, if desired. These valves are normally preferably closed valves. In the case of a loss of power in the system, or if an electrical or electro-mechanical failure is detected by the controller 20, these valves are opened, ventilating the cuffs to the atmosphere and eliminating all the pressure applied from the patient. The orientation of the various valves illustrated in Figure 2 is suitable for inflating the cuff 22 causing air to be transferred through the third conduit 34 after the movement of the piston 32. In the preferred embodiment, the robotic linear actuator 33 is moves in response to a command presented by the controller 20. The controller 20 communicates with the computer 10, which is linked with devices such as an electrocardiogram 100 (shown schematically in Figure 1), and a plethysmograph 102. The moment preferred to move the linear actuator 33 is arranged based on a portion of the electrocardiogram signal and the peripheral plethysmographic wave. In particular, the linear actuator 33 moves the piston 32 half stroke each time the cuffs must be inflated, or in the case of an increased demand for air volume, the semi-strokes are repeated. When the computer 10 properly programmed and the controller 12 determine that it is time to inflate the cuffs, several stages are performed. The first stage consists of evacuating the fists of the existing air. Secondly, the linear actuator 33 moves the piston 32 through the half stroke cylinder 20. Half stroke (according to the drawing) includes that the piston 32 moves from a position indicated in B and upwards (according to the drawing) to the position indicated in A. In other words, Figure 2 illustrates the piston 32 that has moved half a stroke from the position indicated in B to the illustrated position, which corresponds to the complete distance between the two extreme positions furthest from the displacement of the piston 32. When the linear actuator 33 moves. the piston 32 half stroke, the movement of air within the cylinder 30 is transferred through the third conduit 34 directly to the inflatable cuffs. Since the cuffs are inflated most preferably in a distant, close sequence, first the cuff 22 is inflated, followed by the cuff 24 and then followed by the cuff 26. Accordingly, the controller 20 sequentially opens the valves 70. , 72 and 74 in a synchronized pattern, which corresponds to a desired therapeutic regimen. Since the cuffs are inflated during diastole, the pressure of the cuffs acts on the patient's body, and the circulatory system, so that a second impulse of blood flow is provided to the parts of the body that are above the cuff. the buttocks 26. The cuffs remain inflated for a preselected time, which corresponds to the counterpulsation system that is in a support pattern. The next pulse of the patient's heart, and more specifically, in the next appropriate portion of the EKG signal, repeats the evacuation pattern of the cuffs and the subsequent inflation of the same. The cuffs are evacuated by opening the valves 76, 82 and 84, so that the air from inside the cuffs is transferred through the fourth passage 36 inside the cylinder 30. Each half stroke of the piston 32 preferably results in the cuffs being inflated As the piston 32 moves from an initial position indicated in B, through half stroke, to the position indicated in A, the air is transferred through the orifice 42, the control valve 64A and the third conduit 3.4. This stroke also creates a vacuum behind the piston 32, as it moves through the cylinder 30, which must be transferred through the orifice 44 and the control valve 66B, when moving from the position indicated in A, through a half-stroke, return to the position indicated in B, air being transferred through the orifice 44, the control valve 64B and the third conduit 34. This stroke also creates a vacuum behind the piston 32, as it moves through the cylinder 30, which must be transferred through the orifice 42, the control valve 66 and the fourth conduit 36. It is important to indicate that the system does not use pressurized or compressed air during inflation or deflation of the cuffs. This represents a significant advantage over the previous counterpulsation systems, because the compressed air requires a source or pump of compressed air, at least one container and a vacuum pump, which can introduce the problems and difficulties described above. Another significant advantage of this invention is that it provides a portable system that is versatile for various applications in different installations. For example, therapy administered with a system designed in accordance with this invention improves cardiac output and improves conditions characterized by deficient perfusion of organs, such as acute and chronic myocardial ischemia, acute or chronic renal failure, acute and chronic cerebrovascular insufficiency. and peripheral vascular disease. By making small changes in the operating parameters, the illustrated embodiment can be adapted to assist haemostasis after invasive procedures and for the treatment of lymphedema. The system of this invention provides an external, non-invasive, non-toxic and atraumatic technique. The air or other non-pressurized or non-pressurized fluid is, therefore, easily usable to achieve a desired counterpulsation therapy regimen. The system of the invention includes a valve arrangement, as illustrated in Figure 2, to control the direction and amount of air flow through the system. The control of the positions or activation of each of the valves as described above is achieved by programming the computer 10 and the controller 20. Once given this description, those skilled in the art will be able to select the electronic components and software. suitable to achieve the operation described above and to meet the needs of a particular therapy regimen. The particular time and sequence of inflating and deflating the cuffs will vary according to the particular therapeutic needs of a particular situation. Figures 3A and 3B include a flow chart summarizing the general operating procedure of a counterpulsation system designed in accordance with this invention. The preferred operating sequence will be described in more detail below. The preferred embodiment includes a program module within the computer 10 that guides the physician or healthcare professional through a series of steps or procedures to initiate the counterpulsation system. The computer preferably includes a display screen to represent a series of messages and images that lead the technician through the initiation process. The display screen is more preferably a contact screen that allows interaction with the computer by contacting the specific portions of the screen, as the orientations may indicate. The initialization of the counterpulsation system preferably includes, but is not necessarily limited to the following steps. The operator of the counterpulsation therapy system preferably starts the session by connecting the computer 10 at 110 in FIG. 3A. At this point, the program module within the computer 10 begins by orienting the operator through the series of procedures he needs to complete to initialize the system. As shown in Figure 3A, the computer 10 will not begin the therapy session until the preconditions have been satisfied at 112. With reference to Figure 4, the first part of the preconditions or procedures that need to be performed is illustrated in 114 in the form of a flow chart. Initially at 116, the operator enters a password to allow access to the system. The computer 10 is preferably programmed to recognize the selected passwords to control the number of individuals who are allowed to operate the system. After the password has been verified, then the operator installs the system at 118. The system preferably includes a carriage, as illustrated in FIG. 1, which facilitates easy movement of the therapy system between patient rooms. or other places. A typical scenario would include moving the carriage to a suitable position, connecting treatment cuffs 22, 24 and 26 to the appropriate parts of the machine, and installing some peripheral devices, such as a computer printer to provide a paper copy printout. of information about the therapy session, as desired.

Once the machine has been properly installed, the operator is then oriented by the computer 10 to proceed with the preparation of the patient for therapy at 120. As shown in the flow diagram of Figure 5, the operator is preferably guided through a series of steps by the computer 10. As indicated in 122, the operator needs to observe the patient and obtain certain information, such as the current blood pressure and the current heart rate. Then, at 124, the operator uses the computer 10 to access the database of the patient profile indicated at 126. Once the database has been accessed, the operator then uses the computer 10 to update the database of the patient. data to incorporate the information of the operator's current observations with respect to the patient. Figure 6 shows an example of a computer display screen indicating the preferred parts of the patient database 126 that should be completed before starting a counterpulsation therapy session. The patient profile database designed in accordance with this invention preferably includes record information, such as date 128 and time 130, in which each session has been administered. The patient identification information, such as a patient ID, the first surname 132A, the second surname 132B and the name 132C, allows the database to follow the history records for each patient. Operator identification appears at 134. Observations regarding the patient's physical condition are entered into 136 including factors such as weight, blood pressure and heart rate of the patient. In addition, the condition of the patient's body parts on which the treatment cuffs will be placed (ie, the patient's legs) should also be entered into the database. Once all the necessary information has been entered, the operator can then proceed to the next step by saving the new data in the database 126 at 138. As illustrated in Figure 6, a contact screen system is useful and provides an efficient way to guide an operator through the initial procedures required before starting a counterpulsation therapy session. In the most preferred embodiment, the program module within the computer 10 requires that an operator follow a specific sequence of steps (such as verifying that the equipment has been installed, followed by the introduction of all the necessary information in the database). patient profile data), before the computer 10 allows the therapy system to be used. In the most preferred embodiment, the system operator is not allowed to continue to a next stage or procedure until the current stage or procedure has been completed and until the termination has been verified by computer 10. Returning to Figure 5, the next step is preferably to place the patient in a suitable position and place the treatment cuffs 22, 24 and 26 on the selected body parts of the patient at 140. Once the treatment cuffs have been properly placed on the patient and this information is entered into the computer 10, the operator is then oriented ~ to install some external devices that are necessary to complete the treatment. In the preferred embodiment, the counterpulsation therapy is carried out by synchronizing the inflation and deflation of the treatment cuffs with certain characteristics of the EKG signal and the patient's plethysmographic blood pressure wave. Therefore, a conventional EKG 100 and a conventional pulse oximetry measurement system 102 must be properly installed so that the necessary signals can be obtained and communicated to the computer 10. The program module within the computer 10 preferably recognizes when a signal is provided. valid EKG signal and plethysmography, which validates that external devices are properly in position and operational. At the time when the preconditions are satisfied and the operator has authorized the treatment, the computer 10 will proceed with the administration of the counterpulsation therapy. Returning to FIGS. 3A and 3B, a series of operative steps are schematically illustrated. Once the computer 10 begins the treatment cycle, the first stage 150 is preferably to establish baseline conditions, such that the valves 70, 72, 74, 76, 82, 84, 58 and 60 are closed, and they cause the system to be paused for a preselected time period that is preferably less than 100 milliseconds. If stage one is completed successfully, then stage two is performed.

Step two 152 preferably includes evacuating fists 22, 24 and 26 under vacuum, which includes opening valves 76, 82 and 84. Valves 70, 72 and 74 remain closed and valves 58 and 60 are also closed. Once stage 2 is completed successfully, the cuffs are then vented to the atmosphere as a third stage 154. In this stage, valves 86, 88 and 90 are opened so that the air or vacuum remaining within the cuffs 22, 24 and 26 are ventilated to the atmosphere through the noise filter 40B. The next fourth stage 156 preferably provides a delay between the ventilation of the cuffs to the atmosphere and the start of the sequential inflating of the cuffs. During this stage, the valves 86, 88 and 90 are closed and the other valves remain in the condition that they are in stage 3. Once stage four is completed successfully, the fifth stage 158 is preferably to inflate the first fist of treatment 22. The valve 76 is closed to maintain air within the cuff 122. The valve 70 is opened to allow air from the third conduit 34 to be transferred into the cuff 22. A servo motor is activated in the linear actuator 33 for moving the piston 32 through the housing 30 to move the uncompressed air through the hole 42 in the housing 30 and into the third conduit 34. During this procedure, the valves 58 and 60 remain closed unless a pressure is detected undesirable high inside the third conduit 34. If undesirable high pressure is achieved, the valve 58 or 60 is selectively opened (selection determined by the direction of movement of the piston 32) p To regulate the pressure within the third conduit 34. Once the inflating of the first fist 22 has been successfully completed, the next step 160 is to inflate the fist 24. As indicated previously, the fist 24 is preferably positioned around the thighs of the patient's legs. During this step, the valve 72 opens to allow the uncompressed air from the third conduit 34 to flow in and inflate the cuff 24. The valves 76 and 82 are kept closed so that the cuffs 22 and 24 remain inflated. As in the inflating of the cuff 22, the pressure transmitter 48 monitors the pressure within the third conduit 34 and, if necessary, the valve 58 or 60 selectively vent part of the uncompressed air to the atmosphere. Once the cuff 24 is successfully inflated, the cuff 26 is then inflated. During this step 162, the valve 74 is opened, while the rest of the valves are closed so that the air flows in and inflates the cuff 26. When all cuffs are inflated successfully, the system preferably maintains the inflated condition for a preselected amount of time. During this maintenance cycle 164, valves 58 and 60 are opened, while the rest of the valves are closed to maintain the desired inflation of the cuffs. During this time, air is allowed to pass from the filter 40A through the conduits 38 and 39, through the valves 58 and 60 and through the conduits 29 and 31 into the cylinder that recharges and equalizes the cylinder pressures in the cylinder. preparation for the next sequence of races. As indicated in Figures 3A and 3B, each of the steps must be completed successfully before the system continues automatically until the next stage. In the event that the system is unable to verify that the stage was completed successfully, a fault condition 166 is indicated and all valves, except valves, are automatically deactivated. At the same time, the linear actuator 33 preferably returns to a rest position (i.e., the piston 32 in the position B), so that the piston 32 is ready to begin a stroke through the housing 30. After the cuffs have been inflated sequentially and successfully, then the system deflates automatically and cyclically and ventilates the cuffs and repeats the inflation procedure according to the synchronization requirements of a particular counterpulsation therapy regimen. Once given this description, technicians in medical therapy will be able to determine the time of inflating and deflating the cuffs and coordinating this with the natural blood flow of the patient to provide the desired therapy effect. In the preferred embodiment, the patient database 126 is automatically updated to include information regarding the length of a particular therapy session, and to record variable data, including readings of the heart rate, oximetry of impulses, etc. The total duration of a therapy session may vary as a result of interruptions in the treatment procedure. For example, a patient can activate a stop switch 100A, to interrupt the treatment at any time and for any reason. For example, a patient may feel that the cuffs are inflated too much causing discomfort. Therefore, it is useful to allow the patient to activate a switch 110A to interrupt the therapy session so that an adjustment of the amount of inflation can be made to provide more comfort to the patient. More preferably, the computer 10 communicates with the controller 20 so that the counterpulsation system can not be operated unless and until the physician or other healthcare professional operating the system has completed the various stages of the initialization process. In other words, the initialization process is part of a program module within the computer 10 that acts as an activation device for operating the counterpulsation system. This is a significant feature of this invention since it ensures the proper functioning of the system, which gives rise to the desired therapy effect. Once this description is given, the technicians in the field will be able to develop the necessary software to achieve the desired results. Once the system starts to operate, a closed-loop control is achieved due to the intercommunication between the computer 10 and the electronic controller 20. Although a separate computer and electronic controllers have been illustrated and described in this specification, the technicians in The subject will appreciate that a single module or unit or a different number of microprocessors or controllers could be used, depending on the needs of the particular situation. An example of an embodiment is illustrated schematically in Figure 7. The computer 10 includes a program having three modules or components. A main control module 200 includes the code necessary to operate the system. The main control module 200 includes, for example, the software necessary to recognize the EKG and the plethysmographic wave signals and to detect the failure conditions or the interruptions requested by the patient. A second portion or module 210 of the program within the host 10 is preferably responsible for the interface portions of the system operator. This module 210 is responsible for guiding the user through the contact screen on the computer to enter the desired information necessary to indicate that each of the initialization procedures has been completed successfully. This module 210 communicates with the module 200 so that the system controller can properly verify that all necessary procedures have been completed before the start of the therapy session. A third module 220 is preferably provided, which is responsible for the database 126 of the patient profile. The module 220 includes all the history data and the software necessary to maintain the data for each of the patients in a format that can be used. Although the three modules are illustrated, those skilled in the art will recognize that a variety of configurations and combinations can achieve the results provided by the three exemplary modules.

As schematically illustrated also in Figure 7, the controller 12 is programmed with a program module 230. This program module 230 interacts with the program module 200, so that the linear robot driver 33 is activated to move the controller. the piston 32 according to the needs of the desired therapy regimen. This module 230 preferably includes commercially available instructions for moving the linear actuator 33. The controller 20 is programmed with a program module 240, which is responsible for operating several valves in the system, so that the cuffs are inflated and deflated to achieve desired therapeutic effect. The closed circuit communication and automatic operation of the program modules 200 to 240 provides a significant advantage for the actuation of a counterpulsation therapy system designed in accordance with this invention. Closed loop control not only ensures proper and safe operation of the system but also automatically provides and updates a database of a patient's profile that could be used to determine the effectiveness of a counterpulsation therapy regimen for an individual patient or groups of selected studios. The above description is exemplary in nature rather than limiting. Variations and modifications to the described embodiment may be apparent to those skilled in the art, without necessarily departing from the scope and spirit of this invention. The scope of the legal protection given to this invention can be determined only by studying the following claims.

Claims (37)

Claims

1. A set for administering external counterpulsation therapy to a patient, comprising: a flammable cuff that is adapted to be placed around a selected part of the patient's body; a fluid movement device that moves uncompressed fluid; an inflation conduit interconnecting said cuff and said fluid movement device, which allows the uncompressed fluid to move through said inflatable conduit towards said cuff in a first direction to selectively inflate said cuff; a deflation conduit interconnecting said cuff and said fluid movement device, which allows the uncompressed air to move through said deflation conduit in a second direction to selectively deflate said cuff; and a valve that selectively couples said fist to said ducts to selectively inflate and deflate said fist in this manner.

2. The assembly according to claim 1, further comprising a plurality of said cuffs and wherein a first pair of said cuffs are adapted to be received around the calves of the patient, a second pair is adapted to be received around the thighs of the patient. Patient and a third cuff is adapted to be received around the patient's buttocks and where said cuffs are inflated in sequence from said first pair to said third cuff.

3. The assembly according to claim 1, wherein said fluid comprises air and said movement device comprises a cylinder and a movement member that reciprocates within said cylinder to move the uncompressed air in a first and second direction, respectively.

4. The assembly according to claim 3, further comprising an electronic controller, and a linear actuator that moves said movement member within said responsive cylinder to said electronic controller.

5. The assembly according to claim 4, further comprising a valve device connecting said conduits and said air moving device so that the uncompressed air moves in the first direction through said inflation conduit and is created a vacuum in said deflation conduit regardless of the direction of movement of said movement member within said cylinder.

6. The assembly according to claim 5, further comprising a delivery conduit and a valve device selectively connecting said inflation conduit to the atmosphere, so that uncompressed air in said inflation conduit can be moved through said inflation conduit. release conduit to the atmosphere.

7. The assembly according to claim 5, further comprising a delivery conduit in a valve device selectively connecting said deflation conduit to the atmosphere, so that uncompressed air in said deflation conduit can be selectively vented to the atmosphere .

8. The assembly according to claim 1, further comprising an exhaust valve coupled with said conduits to selectively allow air to be vented to the atmosphere from said conduits.

9. The assembly according to claim 1, further comprising an electronic controller that controls said fluid movement device and a computer that communicates with a plethysmograph and with said electronic controller, said computer being programmable to achieve a counterpulsation therapy regimen. desired and being programmed to allow said movement device to operate only after an operator of said assembly completes a series of predetermined steps to initiate the desired counterpulsation therapy regimen.

10. A set of counterpulsation therapy, comprising: an inflatable cuff that is adapted to be placed around a selected part of a patient's body; a conduit in communication with said fist; a fluid movement device including a housing having a first hole and a second hole and a movement member moving within said housing in a first direction to move uncompressed fluid out of said housing through said first hole and moves inside said housing in a second direction to move uncompressed fluid out of said housing through said second hole; and a valve that selectively couples said conduit to said first orifice when said moving member moves in said first direction and selectively couples said conduit to said second orifice when said moving member moves in said second direction, so that the fluid does not flow. The tablet exiting from the housing moves inwardly and at least partially through said conduit whenever said movement member moves within said housing.

11. The assembly according to claim 10, further comprising a plurality of valves, including a first valve that selectively connects said fist to said duct, which allows the uncompressed fluid to move in said fist, a second valve that selectively connects said conduit to the atmosphere, which allows said fist to be vented to the atmosphere through a portion of said conduit.

12. The assembly according to claim 10, wherein there are a plurality of said cuffs and where a first pair of said cuffs are adapted to be received around the calves of the patient, a second pair is adapted to be received around the patient's thighs and a third cuff is adapted to be received around the patient's buttocks, and wherein said cuffs are inflated in sequence from a further portion of said first pair to a closer portion of said third cuff.

13. The assembly according to claim 10, further comprising an electronic controller and a linear actuator that cyclically moves said movement member in the first and second directions responsive to said controller.

14. The assembly of claim 10, wherein said movement member causes the uncompressed air to enter said casing through said second orifice when said movement member moves in said first direction and through said first orifice when said movement member it moves in said second direction, and wherein said valve includes a first and a second check valve that selectively couples said duct to said second hole when said movement member moves in said first direction and said first hole when said movement member is moved. moves in said second direction, respectively.

15. The assembly of claim 10, wherein said conduit comprises an inflation conduit and further comprising a second valve and a deflation conduit that is in communication with said cuff, said fluid movement device and said second valve, and wherein said second The valve selectively couples said deflation conduit to said second orifice of said movement device when said movement member moves in said first direction and selectively couples said deflation conduit to said second orifice. said movement device when said movement member moves in said first direction, so that the uncompressed fluid within said deflation conduit moves inside said casing whenever said movement member moves inside said casing.

16. The assembly of claim 15, further comprising a plurality of cuffs and a plurality of bypass conduits coupled with said cuffs, respectively, and wherein a valve device selectively couples each of said bypass conduits to said conduit or said lumen conduit. deflated, respectively.

17. The assembly of claim 16, comprising a first valve that selectively couples said bypass conduits to said conduit, a second valve that selectively couples said bypass conduits to said deflation conduit and a third valve that selectively couples said bypass conduit to the atmosphere.

18. A method for controlling a counterpulsation therapy system, including a computer controlling the operation of the system, comprising the steps of: (A) defining a plurality of procedures to be performed by a system operator; (B) guiding the operator, who uses the computer, to perform the plurality of procedures from step (A); (C) verify that each procedure is complete, using the computer; and (D) operating the counterpulsation therapy system only when the verification of step (C) has been completed.

19. The method of claim 18, wherein step (A) includes assigning a preselected order in which the plurality of procedures must be performed.

20. The method of claim 19, wherein the step (C) includes verifying that the procedures were completed in the preselected order.

21. The method of claim 18, wherein step (B) includes providing a computer screen representation that visually indicates the procedures to be performed.

22. The method of claim 21, wherein step (B) includes providing a different computer screen representation for each plurality of procedures and wherein said representation includes visible instructions that guide the operator through the procedure.

23. The method of claim 18, wherein step (C) includes requiring the operator to provide a predefined entry to the computer indicating that the procedures have been completed.

24. The method of claim 23, wherein step (C) includes requiring the operator to provide a separate predefined entry to the computer that each indicates that one of the respective procedures has been completed.

25. The method of claim 24, wherein the step (A) includes assigning a preselected order in which a plurality of procedures must be performed and where steps (B) and (C) are performed in sequence for each of the procedures and where the method includes not allowing an operator to continue from a current procedure to a subsequent procedure until the operator provides an indication that the current procedure has been successfully completed.

26. The method of claim 18, wherein at least one of the methods of step (A) includes arranging and initiating an external device for monitoring a patient condition, and wherein step (C) includes providing the computer with a signal from the device external that verifies that the external device has been disposed of properly and is operational.

27. The method of claim 18, wherein the methods of step (A) include entering a patient identifier; enter the current state of the patient that includes one or more of the group consisting of current blood pressure, current heart rate, current body temperature, current weight, current condition of the skin in the part of the body around which the fist is placed; arranging an electrocardiogram device so that the device provides an indication of the patient's heart rate to the computer; and arranging a plethysmograph device so that the device provides an indication of the patient's blood pressure to the computer.

28. The method of claim 27, wherein step (C) includes verifying that the procedures of step (A) are performed sequentially in the order listed in claim 10.

29. A counterpulsation therapy system, comprising: at least one inflatable cuff that is adapted to be positioned around a selected portion of a patient's body; an air movement device; a conduit that couples said fist to said air movement device; a valve coupled to said duct and selectively controllable to selectively control the inflation and deflation of said fist, allowing the movement of selected air through said duct; and an electronic controller controlling said air movement device and said valve, said controller also including a program module that orients a system operator through a plurality of initiation procedures and verifies that each of said procedures is completed. before said controller drives said air movement device and said valve.

30. The system of claim 29, wherein said controller orients the operator through a preselected series of said procedures in a preselected order and wherein said controller requires verification that each of said procedures has been completed before allowing an operator to perform a subsequent procedure, and wherein said controller will not allow said air movement device and said valve to be operative until each of said procedures has been completed in said preselected order.

31. The system of claim 29, further comprising a computer representation screen and wherein said controller orients the operator through said procedures by controlling the images visible on the rendering screen, which are indicative of the required procedures.

32. The system of claim 29, further comprising a plurality of cuffs, a plurality of conduits and a plurality of valves and wherein said controller controls each of said valves to selectively inflate and deflate said cuffs in a preselected order.

33. The system of claim 32, further comprising an electrocardiogram that provides a first signal indicative of the patient's heart rate and a plethysmograph that provides a second signal indicative of the peripheral blood pressure wave of the patient and where said controller communicates with said patient. electrocardiogram and said plethysmograph, so that said controller synchronizes the inflation and deflation of said sensitive cuffs to at least one of said first and second signals.

34. The system of claim 29, wherein said controller further comprises a memory portion, which includes a patient's historical database, which includes a plurality of patient records each having a unique patient identifier and session data. of therapy, including each patient record an indicator of each therapy session and recorded data that are indicative of the effects of the therapy sessions.

35. A computer readable medium encoded with a data structure, comprising: an operations program module that controls the operation of a counterpulsation therapy system, including at least one inflatable cuff, an air movement device, a conduit which couples the cuff to the air movement device and at least one valve that selectively allows the flow of air through the conduit, said operation program module controlling the operation of the air movement device and the valve to control this way the inflating and deflating of the fist; and a patient profile data module that includes a plurality of patient records that each include a patient identifier; indicators of the patient's condition associated with each therapy session, identifiers of the therapy sessions, and data recorded during each therapy session; and wherein said operations program module automatically updates said patient profile data module during a therapy session.

36. The computer-readable medium of claim 35, wherein said indicators of the patient's condition include heart rate and blood pressure readings taken before initiating a therapy session and a descriptor indicative of an observable condition of the body parts. of the patient around which the inflatable cuff is placed.

37. The computer readable medium of claim 35, wherein said data recorded during each therapy session includes an electrocardiogram signal profile indicative of the patient's heart rate and heart function and a plethysmographic waveform profile indicative of the blood pressure of the patient.