Abstract:
A medical treatment administration system for delivering a medical treatment to a patient. The system has a medical device, an electronic processor coupled to the medical device, and a sensor coupled to the processor. The sensor receives one or more signals which it transfers to the processor. The signals can be derived from the patient&#39;s physiological condition and/or the environment of the patient. The processor receives the signals and performs a calculation of the signal. Based on the result of the calculation, the processor regulates the distribution of medical treatment to the patient over a period of time.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of application Ser. No. 10/038,516 filed Jan. 3, 2002, now abandoned which is hereby incorporated by reference and upon which a claim of priority is based. 
    
    
     FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     None. 
     TECHNICAL FIELD 
     The present invention relates generally to a medical treatment apparatus for providing a medical treatment to a patient based on a calculated demand, and more specifically to a medical treatment administration system for delivering a medical treatment to a patient that is automatically triggered and controlled by a patient&#39;s physiological and/or environmental conditions. 
     BACKGROUND OF THE INVENTION 
     For many types of medical treatments, the impact and ultimate usefulness of the treatment depends on the patient&#39;s tolerability and sensitivity to the treatment. Such measures assist physicians in accurately and efficiently treating patients. To date, however, most medical treatments are provided to the patient based on objective measurements, rather than on actual measurements of the specific subject or environment of the subject. 
     For example, typical medical treatment parameters for many drug therapies are provided based on the generic circadian system. Under the circadian system it has been know in the medical industry that typical biological functions of plants and animals reoccur at approximately 24-hour intervals. In humans, the body&#39;s clock is located in the suprachiasmatic nucleus (SCN), a distinct group of cells found within the hypothalamus. The SCN controls or coordinates the circadian rhythm in the human body. Typically, a human&#39;s circadian rhythm is calibrated by the alternation of light through the eyes and darkness via melatonin secretion by the pineal gland. 
     Furthermore, the cellular metabolism and proliferation in normal human tissues display similar rhythms, and thus have predictable amplitudes and times of peak and trough. Such rhythms influence drug pharmacology, tolerability, and ultimate usefulness. For example, it has been thought that the circadian rhythm influences the uses and effects of anti-cancer medication, including tolerability and anti-tumor efficacy in cancer treatment. Therefore, in chronopharmacologic intervention, anti-cancer drugs are delivered according to a standard circadian rhythm, especially with chemotherapy. For example, Floxuridine delivery is typically given in four doses, each dose dependent on the time of the day:
         14% of dose between 9 am and 3 pm;   68% of dose between 3 pm and 9 pm;   14% of dose between 9 pm and 3 am; and,   4% of dose between 3 am and 9 am.       

     Generally, the time at which the medication is delivered is selected by the physician to objectively coincide, with changes in the patient&#39;s metabolism. However, the circadian rhythm is merely an estimate of the changes in the patient&#39;s metabolism, and is not based on the actual patient&#39;s metabolism. Thus, whether the medication delivery actually coincides with the patient&#39;s actual metabolism is neither evaluated nor determined. 
     Additionally, different medical treatments have different optimum dosing time-profiles. For example, different anti-tumor drugs are typically dosed at different times: Epirubicin and Daunorubicin are typically dosed at 2 hours after light onset; Cyclophasphamide is typically dosed at 12 hours after light onset; Cisplatin is typically dosed at 15 hours after light onset; and, Vinblastine is typically dosed at 18 hours after light onset. As can be seen, different drugs have different mechanisms of action. 
     Other factors, however, may also affect proper medical treatment. For example, the minimum sensitivity of normal tissue is thought to be related to the enzyme levels that affect drug metabolism (e.g., glutathione). An overall driver of these variables is thought to be the rest-activity cycle of the patient. Because of this effect, it is known that laboratory rat studies should be conducted with the animal subjected to a 12 hour light, and 12 hour dark cycle. 
     Nevertheless, it is known that different patients, and with regard to cancer treatment, even different tumors, are not all on the same circadian cycle. Thus, there are at least two aspects one needs to optimize during circadian therapy: (1) the peak sensitivity of the tumor(s); and, (2) the minimum sensitivity of the normal tissues. 
     Standard chronopharmacologic intervention takes advantage of the circadian rhythm in drug tolerability by controlling the timing and dosing. Thus, it can reduce the effect of toxicity and improve the quality of life for the patient. Furthermore, with many drugs, including chemotherapy drugs, by administering a higher maximum tolerated dose at the least toxic circadian time, an improvement in survival may be derived. However, as explained above, there are numerous flaws with providing medical treatments following the standard circadian system. 
     Thus, a method and a means for subjectively determining, triggering and controlling the delivery of medical treatments for a specific patient is highly desirable. 
     SUMMARY OF THE INVENTION 
     The method and apparatus for providing medical treatment therapy of the present invention is based on actual data to calculate a strategic control. Generally, the system of the present invention comprises a medical device, a control algorithm coupled to the medical device, and a sensing device. 
     According to one aspect of the present invention, the sensing device automatically receives a signal and transfers the signal to the control algorithm. The control algorithm processes the signal received from the sensing device to determine whether the medical treatment should be delivered to the patient. Based on the result of the processed signal, the control algorithm develops a feedback control to control the delivery of the medical treatment to the patient. 
     According to another aspect of the present invention, a medical apparatus is provided for delivering a treatment to a patient. The medical apparatus comprises a medical device having a medical treatment, and a controller electrically connected to the medical device. The controller has a control algorithm stored therein that dynamically processes a signal received from a sensing device. The control algorithm develops a feedback control based on a result of processing the signal to determine whether medication should be delivered from the medical device to the patient and provides the feedback control to the medical device to control the delivery of the medical treatment to the patient. 
     According to another aspect of the present invention, the sensor is coupled to a patient to receive information from the patient concerning the physiological condition of the patient. The information received from the sensor is transferred to the control algorithm, where the control algorithm processes the information to control the delivery of the medication from the medical device to the patient based on the information that was processed. 
     According to another aspect of the present invention, the signal concerning the patient&#39;s physiological condition is selected from the group consisting of: the patient&#39;s heart rate, the patient&#39;s body temperature, the patient&#39;s activity, the patient&#39;s metabolic demand, the patient&#39;s cellular metabolism, and the patient&#39;s proliferation. 
     According to another aspect of the present invention, the sensor receives a signal from the patient&#39;s environment. The sensor transmits the signal to the processor, wherein the processor regulates the distribution of medical treatment from the medical device to the patient over a period of time based on a calculation of the signal. 
     According to another aspect of the present invention, the medical treatment administration system for delivering a medical treatment to a patient comprises a medical device and a first sensor. The medical device has a processor that regulates the distribution of medical treatment to the patient over a period of time based on a signal from the sensor. The first sensor, which is coupled to the processor, receives a signal from the patient concerning the patient&#39;s physiological condition and transmits the signal to the processor. The processor then processes the received signal to regulate the distribution of medical treatment from the medical device. 
     According to another aspect of the present invention, the medical treatment administration system further comprises a second sensor coupled to the processor. The second sensor obtains a signal based on a condition of the patient&#39;s environment and transmits the signal to the processor. Depending on the specific medical treatment to be administered to the patient, the processor requests the signal from one of the first sensor and second sensor. 
     According to another aspect of the present invention, the processor requests signals from both of the first sensor and second sensor, and the processor processes the signals and regulates the distribution of medical treatment from the medical device based on the cumulative result of the processed signals. 
     According to another aspect of the present invention, the sensor receives a plurality of signals from the patient concerning the patient&#39;s physiological condition and transmits the signals to the processor. The processor receives the signals, processes the signals and regulates the distribution of medical treatment from the medical device based on the cumulative result of the processed signals. 
     According to another aspect of the present invention, the medical treatment administration system further comprises a second medical device that delivers a medical treatment to the patient. The processor receives a signal from the second sensor, processes the second signal, and regulates the distribution of medical treatment from the second medical device to the patient. 
     According to another aspect of the present invention, the medical apparatus, comprises a programmable medical device for administering a medical treatment to a patient, and a controller. The programmable medical device has a first input device for entering control commands for the programmable medical device, and the controller has a second input device for entering control commands for the controller. The input devices may be located in the same location, or one or more input devices may be located at a remote location, which may or may not be the same remote location. 
     According to another aspect of the present invention, the sensing device of the present invention comprises a vital signs monitor coupled to the patient. The vital signs monitor obtains a first signal from the patient and transfers a second signal to the controller. 
     According to another aspect of the present invention, the sensing device comprises an activity sensor coupled to the patient. The activity sensor obtains a first signal from the patient and transfers a second signal to the controller. 
     According to another aspect of the present invention, the sensing device obtains a signal based on the cellular metabolism of the patient. 
     According to another aspect of the present invention, the sensing device obtains a signal based on the cellular proliferation in the patient. 
     According to another aspect of the present invention, the sensing device comprises a light sensor coupled to the controller, the light sensor obtaining a first signal based on the ambient light and sending a second signal to the controller. 
     According to another aspect of the present invention, the sensing device and the controller having the control algorithm are an integral component. 
     According to yet another aspect of the present invention, a method to provide medical treatment for a patient is provided. The delivery of the medical treatment may be triggered by one or more physiological or environmental conditions of the patient. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       To understand the present invention, it will now be described by way of example, with reference to the accompanying drawings in which: 
         FIG. 1  is a block diagram of a medical treatment administration system of the present invention; 
         FIG. 2  is a block diagram of a variation of the medical treatment administration system of  FIG. 1 , including remote controlling; 
         FIG. 3  is a block diagram of another variation of the medical treatment administration system of  FIG. 1 , including where the controller is a component of the medical device; 
         FIG. 4  is a block diagram of another variation of the medical treatment administration system of  FIG. 1 , including a variety of sensing devices; 
         FIG. 5  is a block diagram of another variation of the medical treatment administration system of  FIG. 1 , including a variety of sensing devices; 
         FIG. 6  is a block diagram of another variation of the medical treatment administration system of  FIG. 1 , including where the controller and the sensing device are an integral component; 
         FIG. 7  is a block diagram of another variation of the medical treatment administration system of  FIG. 1 , including a plurality of medical treatment devices; 
         FIG. 8  is a block diagram of another variation of the medical treatment administration system of  FIG. 7 , including a processor for a plurality of medical treatment devices; 
         FIG. 9  is a front elevation view of one embodiment of an infusion pump utilized with the present invention; 
         FIG. 10  is a block diagram of one type of a control algorithm of the present invention; 
     
    
    
     DETAILED DESCRIPTION 
     While this invention is susceptible of embodiments in many different forms, there is shown in the drawings and will herein be described in detail a preferred embodiment of the invention with the understanding that the present disclosure is to be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspect of the invention to the embodiment illustrated. 
     Referring now in detail to the Figures, there is shown a medical treatment administration system  10  utilizing a medical treatment delivery control to distribute the medical treatment based on the condition of the specific patient and/or a change in the environment of the specific patient. As shown in  FIG. 1 , one embodiment of the medical treatment administration system  10  includes a medical device  12 , a control algorithm  26  coupled to the medical device  12 , and a sensor  16  coupled to the patient  18 . The medical device  12  may be one of a variety of devices, including, but not limited to infusion pumps, ventilators, insulin delivery devices, and anesthesia delivery devices, however, one of ordinary skill in the art would understand that other medical devices could be utilized without departing from the scope of the invention. Additionally, the medical device  12  may be a programmable medical device. 
     In one embodiment, an infusion pump  20 , illustrated in  FIG. 9 , is utilized as the medical device  12  for administering a liquid medicant to the patient  18 . Typically, the medical device  12  has a supply of medication (not shown) and a means for delivering the medication (not shown) to the patient  18 . With the infusion pump  20 , the supply of medication is typically a liquid medicant retained in a syringe or IV-type bag. Additionally, with an infusion pump  20  the means for delivering the medication includes a liquid injection device, often a hollow needle or catheter, adapted to be connected to the patient, a conduit or tubing connected to the liquid injection device, a pumping mechanism for pumping the liquid medicant through the conduit and into the patient via the liquid injection device, and a controller for controlling the pumping mechanism. However, when other types of medical devices are utilized, the medical treatment and the means for delivering the treatment will likely vary to be in accord with the specific medical device. For example, a ventilator provides oxygen to the patient, an insulin delivery mechanism delivers insulin to the patient, and an anesthesia device provides anesthesia gas or anesthesia medication to the patient. 
     In the embodiment illustrated in  FIG. 1 , the sensor  16  is coupled to the patient  18  and receives information from the patient  18  concerning the physiological condition of the patient  18 . As is understood by one of ordinary skill in the art, such physiological conditions may include, but are not limited to, the patient&#39;s heart rate, the patient&#39;s body temperature, the patient&#39;s blood pressure, the patient&#39;s activity level, the patient&#39;s cellular metabolism, the patient&#39;s cellular proliferation, the patient&#39;s metabolic demand, the patient&#39;s SpO 2  level, etc. Such factors, as well as other factors known by one of ordinary skill in the art, are understood to be triggering events for the distribution of medical treatment, and especially drug therapy, to individuals in the treatment of medical conditions. Additionally, the sensing device may comprise an input device for receiving a manual input. The manual input may be provided by a health care provider or the patient. One example of the patient providing input for the sensing device is where the medical device  12  is a insulin delivery mechanism. As such, the patient may provide input to the sensor indicating the type of food consumed by the patient. 
     In one embodiment, multiple sensors  16  are comprised in a portable multiparametric physiological monitor for continuous monitoring of certain physical parameters of the patient. The monitor has sensors  16  including: EKG electrodes, a chest expansion sensor, an accelerometer, a chest microphone, a barometric pressure sensor, a body temperature sensor and an ambient temperature sensor. Each of the sensors provides an output signal to an analog-to-digital converter (ADC). 
     In such an embodiment, the sensors  16  may be provided in a body strap (not shown) which, could comprise a chest strap upon which are distributed the various sensors and supporting electronics. (It will be recognized by those skilled in the art that a multiparametric monitoring device may also be mounted by a strap about a part of the body other than the chest). The chest strap is adapted to fit around the torso of the patient  18 . 
     The variety of parametric sensors  16  are located on the strap as most appropriate for the parameter (or parameters) which it detects. Each of the sensors  16  provides an electrical input to analog circuitry which filters and amplifies the sensor signals, as known in the art of signal processing, and outputs them to an analog-to-digital converter, which may be part of controller hardware. The sensors in the strap may be as follows: a pectoralis temperature sensor which senses the temperature of the surface of the patient&#39;s chest; barometric pressure sensor which senses the ambient barometric pressure of the patient&#39;s environment; chest expansion (ventilation) sensor which detects the tension on the chest strap as an indication of the expansion and contraction of the patient&#39;s chest; accelerometer which detects movement and inclination of the patient&#39;s body; ambient temperature sensor which senses the ambient temperature of the patient&#39;s environment; microphone which detects sounds from within the patient&#39;s torso; underarm temperature sensor which senses the temperature of the side of the patient&#39;s torso underneath the arm; and, EKG electrodes which detect electrical signals caused by action of the heart muscle. The EKG electrodes are used in combination with ground, or reference, electrodes, and are placed in contact with the skin of the patient&#39;s chest to detect electrical signals generated by the pumping action of the patient&#39;s heart muscle. The EKG (electrocardiogram) is an indication of the patient&#39;s heart activity, as is well known in the a field of medicine. 
     Also as shown in  FIG. 1 , sensor  17  may be provided in addition to, or in substitution of, sensor  16 . Sensor  17  obtains information concerning the environment of the patient  18 . Typically, the sensors  16 , 17  automatically obtain the signal concerning the physiological condition of the patient and/or the condition of the environment, respectively, without intervention from the patient  18 . Depending on the information required by the control algorithm  26 , multiple sensors  16 , 17  may be utilized in series or in parallel ( FIGS. 1 ,  4 ,  7  and  8 ). 
     The sensors  16 , 17  may be any device that is capable of receiving a signal (i.e., information), whether from an individual  16 , such as a signal concerning the individuals heart rate, body temperature, blood pressure, activity level, cellular metabolism, cellular proliferation, metabolic demand, SpO 2  level, etc., or based on an environmental condition  17 , such as the ambient temperature, ambient light condition, etc. As shown in  FIGS. 4 and 5 , such sensors  16 , 17  may include, but are not limited to, vital signs monitors, blood pressure monitors, light sensors, environmental sensors and activity sensors. Additionally, as shown in  FIG. 6 , rather than being a separate component, the sensors  16 , 17  may be integral with the controller  28 . 
     The signal received from the sensor  16 , 17  is electrically transferred  24  to a control algorithm  26 . As shown in  FIGS. 2 ,  3  and  6 , the control algorithm  26  may be a part of the controller  28  (also referred to as a processor). Additionally, as shown in  FIG. 3 , the controller  28  may be a component of the medical device  12 . Depending on the specific medical treatment to be administered to the patient  18 , the control algorithm  26  may request signals from one or more sensors  16 , 17 . While it is understood that the rest-activity or metabolism cycle of a patient can be determined invasively by measuring various elements including blood cell counts, plasma or serum concentration of cortisol, liver enzymes, and creatine, other methods may also be available. For example, the rest-activity or metabolism cycle of a patient can also be measured non-invasively by the vital sign or activity of the patient. Additionally, it has been found that the body temperature of a patient drops during the night, and that a patient&#39;s heart rate drops when the patient is at rest. Accordingly, such signals are obtained by the sensors  16 , 17 , and such information is transferred  24  to the control algorithm  26  for processing. 
     It is understood that the control algorithm  26  will likely be different for each different medical treatment, and further it is also understood that the control algorithm  26  may be different for different patients, even for the same medical treatment. One example of a control algorithm  26  is shown in  FIG. 10 . As shown in  FIG. 10 , the control algorithm  26  is utilized to control the delivery of medication to a patient as a function of the patient&#39;s  18  heart rate. In this embodiment the control algorithm  26  receives a signal of the patient&#39;s heart rate from one of the sensors  16 . The control algorithm  26  continually processes the signal  30  by comparing the signal with the maximum heart rate. If the heart rate signal is less than the maximum heart rate signal the control algorithm develops a feed back control  32  to reduce the rate of infusion of the infusion pump  12  by 2%. If the heart rate signal is not less than the maximum heart rate signal the control algorithm further determines if the infusion therapy has been completed. If the infusion therapy has not been completed, feedback control  32  is provided to continue infusion. Additional processing  30  of the heart rate signal is subsequently continued. If the infusion therapy has been completed, feedback control  32  is provided to stop the infusion pump  12 . 
     After the control algorithm  26  receives the transferred signal  24  it processes  30  the signal through the control algorithm  26  and a resultant feedback control  32  is developed. If multiple signals are requested and received from a plurality of sensors  16 , 17 , and are required in order to determine if the medical treatment is to be delivered to the patient  18 , each required signal is processes  30  through the control algorithm  26  as programmed, and a resultant feedback control  32  is developed. The feedback control  32  operates as a control signal for the medical device  12  to control or regulate delivery of the medical treatment to the patient  18 . 
     This is accomplished by transferring  34  the feedback control  32  that was developed by the control algorithm  26  to the medical device  12 . The feedback control  32  provides the commands for operation of the medical device  12 . As shown in  FIG. 1 , the feedback control  32  typically provides one of two signals or commands to the medical device  12 : deliver  36  medical treatment to the patient  18  or do not deliver  38  medical treatment to the patient. If the feedback control  32  provides a signal to deliver  36  the medical treatment it may also provide a signal to the medical device  12  indicating the amount and rate of treatment to provide to the patient  18 . 
     As shown in  FIG. 7 , multiple medical devices  12   a ,  12   b  may be utilized to deliver  36  medical treatments to the patient  18 . The specific medical treatments may be the same, and may merely be dosed differently, or each medical device  12   a , 12   b  may deliver  36  a different medical treatment to the patient  18 . Further, as also shown in  FIG. 7 , separate control algorithms  26   a , 26   b  may be utilized for each medical device  12   a , 12   b , respectively. The embodiment of  FIG. 7 , utilizes two distinct control algorithms  26   a , 26   b , and numerous sensors  16   a ,  16   b  and  17 . Sensors  16   a ,  17  transfer  24  signals to control algorithm  26   a , which, depending on the treatment to be delivered  36  to the patient  18 , may process  30  the signals from one or both of the sensors  16   a , 17  to develop a resultant feedback control  32   a . Sensor  16   b  transfers  24  a signal to control algorithm  26   b  which likewise processes  30  the signal and develops a resultant feedback control  32   b . Feedback control  32   a  is sent to the first medical device  12   a  to control the delivery  36   a  of medical treatment to the patient  18 , while feedback control  32   b  is sent to the second medical device  12   b  to control the delivery  36   b  of medical treatment to the same patient  18 . 
     Conversely, as shown in  FIG. 8 , one control algorithm  26  may control multiple medical devices  12   a , 12   b . In this embodiment, one control algorithm  26  is utilized with a plurality of sensors  16   a ,  16   b  and  17 . Sensors  16   a ,  16   b  and  17  transfer  24  signals to the control algorithm  26 , which, depending on the treatment to be delivered  36  to the patient  18 , may process  30  the signals from one or more of the sensors  16   a ,  16   b  and  17  to develop one or more resultant feedback controls  32   a , 32   b . Feedback control  32   a  is sent to the first medical device  12   a  to control the delivery  36   a  of medical treatment to the patient  18 , while feedback control  32   b  is sent to the second medical device  12   b  to control the delivery  36   b  of medical treatment to the same patient  18 . Accordingly, in this embodiment the control algorithm  26  for the first medical device  12   a  is the same control algorithm  26  as for the second medical device  12   b.    
     Because the medical treatment apparatus  10  may be utilized with different treatment therapies, the control algorithm  26  is generally modified or changed for each different treatment therapy. Thus, as shown in  FIGS. 1 and 2 , an input device  42  is generally provided to adjust and set the control parameters  44  of the control algorithm  26 . The input device  42  may be coupled to the controller  28  or directly to the control algorithm  26 . While the control algorithm  26  may be manually input, it may also be dynamically downloaded as from a database or network. 
     Further, as shown in  FIG. 1 , the medical device  12  may also have an input device  48  therefor. The input device  48  for the medical device  12  allows a user, typically an authorized clinician to enter control commands  50  to adjust or set control parameters for the medical device  12 . In an alternate embodiment, the input device for the medical device  12  is the same as the input device for the controller/control algorithm. 
     As shown in  FIG. 2 , a remote controller  46  (i.e., a remote input device) may be provided for remotely adjusting or setting the control parameters of the control algorithm  26  and/or controller  28 . The remote controller  46  is disposed at a room location (i.e. a second location) remote from the room location at which the medical device  12  is located (i.e., a first location). The remote controller  46  could be disposed in a different room of the same building in which the medical device  12  is disposed, or in a different building than the one in which the medical device  12  is disposed. The remote controller  46  is connected to a conventional voice/data modem  52  via a data link  54 , and the modem  52  is also connected to a telephone  56  via a voice link  58 . The medical device  12  is connected to a conventional voice/data modem  60  via a data link  62 , and the modem  60  is connected to a telephone  64  via a voice link  66 . The two modems  52 ,  60  are interconnected to bidirectional voice and data communication via a communication link  68 , which could be a telephone line, for example. Additionally, the remote controller  46  may communicate with the control algorithm  26  via an internet, an intranet and a wireless network. Furthermore, the remote controller  26  may be a server. 
     While the specific embodiments have been illustrated and described, numerous modifications come to mind without significantly departing from the spirit of the invention, and the scope of protection is only limited by the scope of the accompanying Claims.