Patent Application
20110306859
The present inventions relate to medical instrumentation systems. More particularly, they relate to multipurpose, modular platforms for mobile medical instrumentation.
There are four primary problems solved with this invention. The first is the issue of cost or price of medical equipment. Generally, medical equipment used in hospitals is expensive. One of the reasons for the excessive pricing is the complicated hardware and electronics. A common philosophy in design is to implement the microprocessing data processing units imbedded in the internal circuitry. This approach increases the research and development cycle, as the working load of the designing teams must accommodate the demand of the imbedded computer capabilities. This approach also increases substantially the cycles of modifications and improvements.
The second primary problem addressed is an issue of physical size. Medical equipment used in hospitals generally are large and voluminous. One of the reasons is the method used to process the data and the communication protocols. Another common philosophy in design is the direct connection to a personal computer to the medical device to perform the communication and computing duties. Although this solution partially remedies some of the costs in design, it adds volume and mass to the medical equipment.
The third issue addressed is one of flexibility of equipment and systems. Generally, medical equipment has a task-specific design. This narrow functionality has a direct impact on the total cost that an institution spends on medical equipment, as currently it is necessary to buy several pieces of expensive equipment to complete several medical tasks.
The fourth issue addressed is one of providing electrical connection between the equipment and the patient or user. Generally, medical equipment that captures biomedical signals (for example, electrocardiographs) connects the electrodes on the patient through a cumbersome system of wires. Additionally, the wires are affixed to the skin with glue. This feature limits the use of the system (for example, in pediatrics medicine and neonatal care, as peeling of the glued electrodes from the skin of the infant damages their delicate skin) or creates patient discomfort (for example, peeling of glued electrodes from hairy skins in adults).
Various systems have sought to address one or all of these issues. No optimal solution has yet been presented.
The Abbott i-STAT Point-of-Care system utilizes a flexible platform, based on disposable cartridges. This method allows the operator to perform different laboratory tests by simply selecting the proper cartridge for the test. In addition, the i-STAT is a handheld portable system. Thus, this system is a solution for large size in medical equipment. This system offers flexibility as it can be used to perform different biochemical tests with the same basic equipment by simply changing the cartridge.
The i-STAT system presents several problems. First, it performs only biochemical measurements. Thus, the system is not flexible enough to be adopted as a general platform for medical diagnosis. Second, the i-STAT system utilizes a proprietary computing and data processing platform, increasing the price and cost of development, as it is a purpose-specific solution. Third, the i-STAT system is not wireless and requires, either, manual data entry or connection to a computer via cable to access the data.
The Kiwok BodyKom system is an electrocardiograph system with a set of wires that connects the electrodes to a wireless unit connected to a cell phone via Bluetooth (http://www.kiwok.se/index.php). This system is a solution to large size and high price problems in medical equipment.
The deficiencies of the BodyKom system are as follows. First, it is exclusive for electrocardiography. Thus, the system is not flexible enough to be adopted as a general platform for medical diagnosis. Second, the BodyKom presents the problem of having wires for the connection of the electrodes, which limits the usability as the system is cumbersome. The presence of cables hinders the rapid readout of the electrocardiogram, presenting a critical problem in emergency situations. Third, the system presents the problem of utilizing glue to fix the electrodes to the skin. This feature limits the use of the system in pediatrics medicine and neonatal care.
The DRE system is a complete electrocardiogram. The system is small and portable, capable of connecting directly to a personal computer. The DRE system has wires to connect to the electrodes. This system is a solution to the problem of large size in medical equipment.
The DRE system presents several problems. First, the DRE is exclusive for electrocardiography. Thus, the system is not flexible enough to be adopted as a general platform for medical diagnosis. Second, the DRE system presents the problem of having wires for the connection of the electrodes, which limits the usability as the system is cumbersome. The presence of cables hinders the rapid readout of the electrocardiogram, presenting a critical problem in emergency situations. Third, the DRE system presents the problem of utilizing glue to fix the electrodes to the skin. This feature limits the use of the system in pediatrics medicine and neonatal care. Fourth, the DRE system utilizes a proprietary data display and processing platform, increasing the price and cost of development, as it is a purpose-specific solution.
Various groups have attempted solutions which include wireless EKG monitoring systems. A survey of various efforts may be found in the article “Development and Evaluation of a Bluetooth EKG Monitoring Sensor”, Proulx, J., Clifford, R., Sorensen, S., Dah-Jye, Lee, Archibald, J., Dept. of ECEn, Brigham Young Univ., Provo, Utah; (published in Computer-Based Medical Systems, 2006. CBMS 2006. 19th IEEE International Symposium on Computer-Based Medical Systems, page(s): 507-511, Salt Lake City, Utah, ISSN: 1063-7125, ISBN: 0-7695-2517-1, INSPEC Accession Number: 9187352, Digital Object Identifier: 10.1109/CBMS.2006.74, Current Version Published: 2006 Jul. 5). In the system developed and evaluated by the authors, a 3 lead wired system is connected to the patient in the classic Einthoven Triangle configuration, with the wires connected to an EKG sensor. An Analog-to-digital converter then passes the EKG signal to a serial-toBluetooth module. Bluetooth communication is than transmitted to a cellular phone, on which the EKG data is stored and/or displayed. Optionally, the data is then transmitted from the phone to a remote location, such as for analysis by medical professionals.
Despite the desirability for a solution maximizing the desirable advantages discussed herein, no solution has yet to be presented.
The invention is an adaptable multi-purpose medical instrumentation platform that uses the computing capabilities, communications, display capabilities, and other functions of a cellular telephone. The invention utilizes a series of cradles capable of housing the cellular telephone. The cradles preferably contain all the electronics, sensors, and additional hardware necessary to function. Each cradle has one or more specific application purposes. The user places the cell phone inside the cradle that confers the device the desired functionality. For its use, the user simply selects the cradle and places the cellular telephone inside the cradle. The cellular telephone has a series of preprogrammed software applications that complete the functionality of the invention. Preferably, there is a specific application software program for each specific cradle.
In one aspect of the invention, a system is provided for mobile medical instrumentation for use with a body. The system includes a primary wireless primary communication device. In one preferred embodiment, the wireless primary communication device is a cellular telephone. That device, in turn, preferably includes a housing, a display adjacent at least a portion of the housing, an internal processor, a wireless external communication circuit, a power source, and a communication input/output port adapted for communication with a cradle. The cradle, in turn, preferably includes an input sensor for receiving input from the body, the input sensor generating an output signal corresponding to the input, a processing circuit for receiving and processing the input sensor output signal, and a cradle input/output port adapted for communication with the wireless primary communication device and with the processing circuit.
In yet another aspect of the invention, the system provides for mobile medical instrumentation for use with a body. The system includes a primary wireless communication device, such as a cell phone or table computer, and one or more cradles. The cradles provides and interface to the body which provides for input of signals from the body, and optionally, therapeutic outputs to the body. Communication input/output ports provide for communication between the primary wireless communication device and the cradle. The cradle and the primary wireless communication device may be releasably joined together so as to form a unitary structure when contacting the body. Alternately, the cradle may interface with the body, and communicate wirelessly to the primary wireless communication device. A cradle adapted to provide for a portable electrocardiogram includes a plurality of electrodes adapted for contact or non-contact sensing of the body. In the preferred embodiment, three electrodes are arranged in a triangular arrangement, most preferably an Einthoven triangular arrangement, but with the distance between electrodes being 4 centimeters or less.
In yet another aspect, apparatus and methods include a cradle for a modular system for mobile medical instrumentation for use with a body, the cradle being adapted to interface with a wireless primary communication device. The cradle preferably includes an input sensor for receiving input from the body, the input sensor generating an output signal corresponding to the input, a processing circuit for receiving and processing the input sensor output signal, and a cradle input/output port adapted for communication with the wireless primary communication device and with the processing circuit.
In yet another aspect, the invention relates to a cradle for a modular system for mobile medical instrumentation for use with a body, adapted to measure the electrocardiogram of a patient, the cradle being adapted to interface with a wireless primary communication device, the wireless primary communications device having a face surface of length L and width W, an input sensor for receiving input from the body, the input sensor including multiple electrodes, the electrodes being located within the dimensions L and W, wherein L and W are sized to fit within the region of the size of the face surface, preferably where L and W are 4 centimeters or less, or 3 centimeters or less, or in from 1 to 2 centimeters. The system further preferably includes an input sensor generating an output signal corresponding to the input, a processing circuit for receiving and processing the input sensor output signal, and a cradle input/output port is adapted for communication with the wireless primary communication device and with the processing circuit.
In yet another aspect of the invention, a communications unit is provided for mobile medical communication for communications between two or more wireless units having incompatible wireless data communications formats. The communications unit provides for use with a first medical device adapted for use with a body and for wireless communication operating in a first wireless data format, and for use with a primary communication device, the primary communication device operating in a second wireless data format, the first wireless data format being incompatible with the second wireless data format. Preferably, the communications unit has a first receiver adapted to receive communications from the first medical device in a first wireless data format, a translator to convert a first wireless data format to a second wireless data format utilized by the wireless primary communication device, and a transmitter to send the converted second wireless data format to the primary communication device. Optionally, the primary communication device may operate with two or more wireless data formats, such as where the second wireless data format for communication with the communications unit is a local wireless data format, such as Bluetooth, and the other wireless data format is for cellular communications, such as GSM or CDMA.
The systems, apparatus and methods of this invention have numerous advantages compared to prior designs. First, they provide a universal platform that minimizes the development cycle and production cost in biomedical equipment. This is a unique feature not found in other devices. Second, they are more economical to implement than other systems as the present invention may utilize the computing hardware already existing in a cellular telephone. Third, the device of the invention is more economical to implement than other systems as the present invention may take advantage of the display capabilities already existing in a communication device, e.g., cellular telephone. Fourth, the device of the invention is more flexible than other systems. This flexibility allows it to perform as a universal diagnostics platform, with applications in biochemistry, pathology, hematology, medical imaging, and bio-medical signals, or others known to those skilled in the art. Fifth, in electrocardiography, the device of the invention allows the direct application of the electrodes to the skin of the patient avoiding the use of electrodes glued to the skin of the patient. Alternately, a contact-less, e.g. capacitive system, may be used to obtain ECG signals through clothing. These features allow rapid readings in emergency situations, and avoids potential damage to the skin of the patient (as in newborns, premature babies, and burned patients). Sixth, the device of the invention can be used in both diagnostics and therapeutics. Examples of therapeutics include phototherapy and electrotherapy. This is a unique feature not found in other diagnostics devices.
The device of the invention uses the computer capabilities of a cellular telephone for different medical applications. The invention uses the display capabilities of a cellular telephone to communicate data to the user. The invention uses the transmission/receiver capabilities of a cellular telephone to send and receive biomedical information to other devices, including computers. The invention uses the input/output port of a cellular telephone to enter data, or biomedical signals, to the cellular telephone or other devices, including the hardware of the invention. The invention optionally uses the battery power of a cellular telephone to operate the hardware of the invention. The invention uses the transmitting/receiving capabilities of a cellular telephone to transmit/receive the biomedical data of the patient. The invention houses the electronic circuits and additional hardware in the body of a case that houses the cellular telephone.
The invention has a cellular telephone holder, referred to as the cradle 10. The device of the invention includes the necessary transducers 14, 22 and hardware encased in the cradle 10, for additional features which allows it to receive and transmit relevant biomedical signals. The input and output of the device of the invention can be used for diagnosis, treatment, patient identification, disease monitoring, patient evaluation, or any other activity related to medical clinical practice.
With particular reference to
The device of the invention has an electronic docking station that allows electronic communication between the electronics and hardware of the cradle 10 and the cellular telephone. This connector also provides the electric power to operate the electronics and other hardware in the cradle 10 by allowing access to the power of the battery 54 of the cellular telephone.
The device of the invention preferably has several cradles 10, each one for a different medical application. Each cradle 10 contains purpose-specific electronics and other hardware for proper performance. Each cradle 10 utilizes a specific software application that allows the communication with the hardware of the cradle 10, proper data acquisition and transmission of the biomedical data, and other functions as required. In an example, these software applications can be recognized by the telephone depending on the cradle 10 utilized, the telephone automatically starts the appropriate software application just by being connected to a specific cradle 10. Further, additional application software (apps) may be downloaded to the cradle 10 and/or the wireless primary communication device, e.g., cellular telephone, as desired.
With particular reference to
As to the cradle 10, it preferably includes an input sensor 14 for receiving input 12 from the body. The input sensor generates an output signal corresponding to the input. A processing circuit 38 receives and processes the input sensor output signal. Optionally, an amplifier 16 is adapted to receive an input from the sensor and the control system/processor 38. Preferably, the amplifier is a low noise amplifier. As to optional components, a digital to analog converter 16 may be disposed between the control system and the amplifier. Further, a digital signal processor may be disposed between the control system and the digital to analog converter. An analog to digital converter may be coupled to the amplifier. Finally, optionally, a digital signal processor may be coupled to the digital to analog converter.
A cradle 10 input/output port 18 is adapted for communication with the wireless primary communication device 40 and with the processing circuit 38. The I/O Port 18 optionally comprises a physical connection, or may comprise a wireless connection, or both.
Optionally, the cradle 10 includes a processor 38. The processor may be used alone or in combination with other processors, such as the internal processor of the wireless primary communications device 48. The form of processor may be of any type consistent with the inventions herein. The cradle 10 further includes memory 26, 28, 34. The memory serves to optionally store data indicative of the identification 26 of the cradle 10 application. Further, the memory may store data indicative of cradle identification information 28. The cradle 10 optionally includes a power source 32, such as a battery, or may utilize another power source, such as the power source 54 of the wireless primary communications device.
The cradle 10 additionally optionally includes an output 22 for interfacing with the body. One such output may provide radiation 24 to the body. Phototherapy may be provided to the body via the radiation. In another application, the output 22 device may transmit to the body information to control an implant within the body, such as a pacemaker or implanted pump. Optionally. a digital to analog (D/A) converter 20 is coupled to output 24.
The cradle 10 may additionally optionally include auxiliary sensors 30. One such sensor may be a temperature sensor. Optionally, an auxiliary external communication circuit 22 may be provided with the cradle 10.
As to the wireless primary communication device 40, it includes an internal processor 48. The form of processor may be of any type consistent with the inventions herein. The wireless primary communications device further includes memory 56. The memory serves to optionally store data indicative of the identification of cradle 10 application. Further, the memory may store data indicative of cradle 10 identification information. The wireless primary communications device preferably includes it's own power source 54, most commonly being a battery.
The wireless primary communications device preferably includes a housing 44 and a display 42 adjacent at least a portion of the housing 44. The display of the primary wireless communication devices is preferably flat. Optionally it may comprise a touch screen, such as an LCD touch screen. The display also may be a flexible display. 3-dimensional displays may also be utilized. A wireless external communication circuit 50 is included. It further includes a communication input/output port 46 adapted for communication with the cradle 10. The I/O Port optionally comprises a physical connection, or may comprise a wireless connection, or both.
Preferably, an attachment mechanism is provided to couple the wireless primary communications device and the cradle 10. The attachment mechanism may be a latch, such as a mechanical latch. Preferably, the attachment mechanism is releasable.
In yet another aspect, apparatus and methods include a cradle 10 for a modular system for mobile medical instrumentation for use with a body, the cradle 10 being adapted to interface with a wireless primary communication device. The cradle 10 preferably includes an input sensor 14 for receiving input from the body, the input sensor generating an output signal corresponding to the input, a processing circuit for receiving and processing the input sensor output signal, and a cradle 10 input/output port adapted for communication with the wireless primary communication device and with the processing circuit.
A first embodiment and example of the invention is the implementation of a portable electrocardiograph. This application allows the health care provider to measure directly the electrocardiogram by placing the electrodes directly on the skin of the patient, avoiding the use of skin adhesives that have the potential to damage the skin; this feature is particularly crucial in premature and newborn babies, as the peeling of the electrodes damages the delicate skin of the infant. Furthermore, in addition to being inexpensive and portable, this embodiment of the invention is completely wireless, making it a one-piece handheld device without cables or added pieces. This feature is crucial in emergency situations, where rapid measurements are critical.
The electrode distribution is understood with particular reference to
In classic, prior art, bipolar electrocardiogram recording, leads I, II, and III define a triangle known as Einthoven's triangle (shown in
A crucial component in the development of the device of the invention in this example is the fact that the Einthoven's triangle can be collapsed to a minimum of 3-4 cm side triangle (Human++: From technology to emerging health monitoring concepts. Penders, J. et al. 5th International Summer School Symposium on Medical Devices and Biosensors, 2008. pp 94-98 ISBN: 978-1-4244-2252-4). EKG signals have successfully been measured where the distance between electrodes has been on the order of 1 cm, and again on the order of 2 cm.
The present embodiment of the invention has three electrodes fixed on the back of the cradle 10 housing the cellular telephone. These electrodes are positioned in a way that they form a triangle with smaller dimensions than the previously described Einthoven's triangle (shown in
Configuration of the cradle 10, location of the electrodes and usage:
Amplifier circuit and lead selection.
Cell Phone Connectivity. This embodiment allows the user to send the electrocardiogram and the patient information either to a central computer system, for storage and future analysis, and/or to another cellular telephone.
In a second embodiment, the device of the invention is used to collect, store, display, relay, and transmit biomedical signals. This application allows the implementation of low-power, short range transmissions carrying the information of a biomedical signal to a cellular telephone.
In this embodiment, the cradle 10, described in detail in embodiment 1, houses a low power transmitter/receptor. One of the advantages of this embodiment is the reduction in the power of the radio signals applied to the patient.
The first example of this embodiment is presented in
A second example of this embodiment is presented in
As shown in
In a third embodiment, the device of the invention is used to measure clinical laboratory variables by housing the necessary hardware in the cradle 10 and utilizing a removable cartridge where the biological sample is placed.
The first example of this embodiment corresponds to electrochemical methods, such as amperometric measurements using substrate specific enzyme-linked reactions, or voltmetric measurements. This example is presented in
The second example of this embodiment corresponds to optical methods to measure the concentration of the substance in the biological sample. For translucent samples the concentration can be measured using the well-known Beer-Lambert's law, in which the optical absorbance of the sample is a function of the concentration and the length of the path of the light beam. In this case, the length of the path corresponds to the thickness of the sample, i.e. the thickness of the cartridge, which is constant; thus, the differences in absorbance are due only to differences in concentration in two given samples. This example for this embodiment, utilizes a light source within the cradle 10 (for example, a light emitting diode) and a light intensity sensor (for example, a photoresistor).
In a fourth embodiment, the device of the invention is used to measure the concentration of cells in a blood sample, using the Coulter's principle. In this embodiment a cartridge is used to handle a saline-diluted sample of blood. The impedance change across a narrow channel is measured while the blood sample is forced through. In an example of this embodiment, a microfluidics chip is used to handle the blood sample, house the channels, and provide the electric connectors to measure the impedance. This method allows measurement of the size and concentration of blood cells.
In another embodiment, the device of the invention measures the absorbance of red and infrared wavelengths, necessary to evaluate the oxygenation level. In a first example of this embodiment the cradle 10 houses the electronics with the light emitter and detector. The cradle 10 has a void space where the finger or the earlobe is inserted for the measurement. In a second example of this embodiment, the light source and light sensor are placed on either a ring or a clip that can be placed on a finger or the earlobe of the patient. These devices can be connected to the cradle 10 of the device of the invention either with a wire or a wireless transmitter. In a third example of this embodiment, the light source and the light sensor are fixed on the surface, parallel to each other, and use the principle of reflective pulse oximetry (Independent Component Analysis Applied to Pulse Oximetry in the Estimation of the Arterial Oxygen Saturation (SpO2)—a Comparative Study. Jensen, T. et al., 31st Annual International Conference of the IEEE EMBS Minneapolis, Minn., USA, Sep. 2-6, 2009, pp 4039-4044).
In another embodiment, the device of the invention performs spirometry measurements. The cradle 10 houses an air flow meter that connects to a mouth piece. The results of the flow measurements are plotted with respect to time to display volume-time curves and flow-volume loops. The device of the invention is capable of measuring physiologically relevant parameters such as: forced vital capacity, tidal volume, and total lung capacity.
In another embodiment, the cradle 10 of the device of the invention houses an infrared light source and an infrared detector to measure expired carbon dioxide concentration. The cradle 10 houses also a oxygen sensor probe. The device of the invention calculates the metabolic rate by measuring the total volume of the gas and the content of oxygen and carbon dioxide. This principle has been used by others to calculate the metabolic rate (U.S. Pat. No. 5,363,857 and U.S. Pat. No. 6,955,650). Nitric oxide may be measured via a nitric oxide sensor within a cradle 10, preferably via a nitric oxide electrode based gas sensor.
In another embodiment, the cradle 10 of the device of the invention houses an infrared thermography camera, connected to the video input of the cellular telephone. The practitioner uses this device to visualize find temperature differences on the body of the patient. This technology is valuable in finding breast cancer (infrared mammography), skin and sinus infections, and to detect areas of poor circulation in diabetes and other conditions.
In another embodiment, the cradle 10 of the device of the invention houses a plurality of Light Emitting Diodes (LEDs), or other source of light, used to provide phototherapy to the patient. These LEDs can be placed on the front surface, or the back of the cradle 10. These LEDs can provide phototherapy for the user, when using other capabilities of the cellular telephone. The cellular telephone has the capability to precisely quantify the dose of the phototherapy administered and report it to the practitioner.
All publications and patents cited in this specification are herein incorporated by reference as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Although the foregoing invention has been described in some detail by way of illustration and example for purposes of clarity and understanding, it may be readily apparent to those of ordinary skill in the art in light of the teachings of this invention that certain changes and modifications may be made thereto without departing from the spirit or scope of the following claims.
This application claims priority to and benefit of U.S. Provisional Application Ser. No. 61/332,024, filed May 6, 2010, entitled “Multipurpose, Modular Platform for Mobile Medical Instrumentation”, the content of which is hereby incorporated by reference in its entirety as if fully set forth herein.
| Number | Date | Country | |
|---|---|---|---|
| 61332024 | May 2010 | US |
