WO2008131294A1

WO2008131294A1 - Distributed interactive pain management systems and methods

Info

Publication number: WO2008131294A1
Application number: PCT/US2008/060920
Authority: WO
Inventors: Mark D. Wiederhold; Brenda Wiederhold
Original assignee: Wiederhold Mark D; Brenda Wiederhold
Priority date: 2007-04-20
Filing date: 2008-04-18
Publication date: 2008-10-30

Abstract

Pain management technology operable to provide interactive ameliorative stimulus to patients on demand and thereby reduce pain. The ameliorative stimulus is provided using virtual reality hardware and software, and distributed over cellular or other wired or wireless networks via mobile phones, PDAs, MP3 players, and other portable devices and associated peripherals.

Description

DISTRIBUTED INTERACTIVE PAIN MANAGEMENT SYSTEMS AND METHODS

Cross-Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application No.

60/913,217 filed April 20, 2007, the content of which is incorporated by reference herein in its entirety.

Field of the Invention

[0002] This invention relates to pain reduction therapies, and more particularly to pain reduction therapies implemented via software and distributed hardware devices.

Background of the Invention

[0003] Pain affects a large number of people throughout the world. According to one research organization, more than 75 million Americans live with "serious pain" and more than 100 million people in North America and Europe suffer from chronic pain. At least fifty million of these people are partially or totally disabled by pain.

[0004] Management of both short and long term pain is important, as is management of chronic pain. While short and long term pain conditions may be intermittent, the term "chronic pain" as used herein can mean that pain signals continually fire in the nervous system for weeks or even years. Common causes of chronic pain can include chronic illness, accidents, surgery, advanced cancer, lower back problems, arthritis, shingles, headaches, and fibromyalgia; however, chronic pain can also be the result of a wide variety of other causes. Additional forms of pain have been classified medically as procedural, acute, and rehabilitative; and patients suffering from these forms of pain may also benefit from pain reduction therapies.

[0005] Some pain can be treated with drugs, including a range of prescription pain medications. These drugs, however, can have a number of disadvantages, including cost, availability, cognitive or physical impairment, decreasing effectiveness, addictive qualities, abuse, and side effects ranging from mild to serious, and even death of the patient. Moreover, many prescription pain drugs do not provide acceptable pain relief for some patients. Many patients also have problems obtaining adequate medication to control their pain due to high costs or lack of access to the medication, for example. Nevertheless, pain drugs are widely administered today, being the third most prescribed prescription drug.

[0006] One method of helping pain sufferers that has gained recent attention is to provide mental distraction using virtual reality. Virtual reality (also denoted herein as VR) generally relates to simulation of real world or imaginary environments using computer systems and sensory stimulation devices, such as visual displays, audio, and tactile and motion devices. These systems can be used to combine two or three- dimensional images with dynamic audio stimuli to create a virtual reality into which the patient may become immersed. The patient may then focus on the virtual reality instead of the pain, meaning that less attention is available to process incoming pain signals, resulting in the potential for a drop in the amount of pain the patient feels.

[0007] Some virtual reality systems can provide 3D images, motion sensors, and a

180-degree field of view. However, most systems today are large, complex, and require headgear and/or other specialized hardware and software to create the virtual reality environment. As a consequence, these systems are many times only found in hospitals or specialized clinics. Unfortunately, pain does not normally decrease when the patient leaves a hospital or clinic, and patients generally cannot be under constant monitoring by medical care providers. Consequently, there is a need for systems and methods for more versatile, convenient, and compact pain management systems.

Summary of the Invention

[0008] Embodiments of the present invention are directed to pain management technology operable to provide ameliorative stimulus to patients to reduce pain at will. The ameliorative stimulus is provided interactively using virtual reality hardware and software, and distributed over cellular or other wired or wireless networks via mobile phones, PDAs, MP3 players, and other portable devices and associated peripherals. [0009] A first embodiment comprises a method for interactive pain management.

The method comprises presenting a multimedia ameliorative to a patient on a wireless device, obtaining a pain response measurement associated with the patient, and adjusting the multimedia ameliorative based on the pain response measurement. The method may also comprise obtaining a pain level indication from the patient, correlating the pain response measurement to the pain level indication for determining a correlated pain measurement, and adjusting the multimedia ameliorative based on the correlated pain measurement.

[0010] A second embodiment comprises a method for pain management. The method comprises distributing an interactive pain management application via a network to a portable device, and providing the interactive pain management application to the portable device on demand by a user. The method also comprises receiving measured physiological data from the portable device corresponding to pain felt by the user, receiving a pain level value from the portable device corresponding to an assessment of the pain level by the user, correlating the measured physiological signal to the pain level value to determine a pain measurement, and providing the interactive pain management application to the user based on the pain measurement.

[0011] A third embodiment comprises a portable device for interactive pain management. The portable device comprises logic for presenting the pain management application on a display of the portable device, receiving measured sensory stimulus data corresponding to a pain intensity of a patient, sending the measured sensory stimulus data to a remote server, and receiving an interactive pain management application based at least in part on the measured sensory stimulus data. The portable device further comprises logic for presenting a plurality of touch buttons on the display operable to allow the patient to select the pain level value, and receiving a pain level value corresponding to an assessment of the pain intensity by the patient.

[0012] A fourth embodiment comprises a multimedia ameliorative server comprising logic for receiving a measured sensory stimulus data from a portable device corresponding to a pain intensity of a user, and receiving a pain level value corresponding to an assessment of the pain intensity by the user. The multimedia ameliorative server further comprises logic for correlating the measured sensory stimulus data to the pain level value to determine a pain measurement, and providing an interactive multimedia ameliorative pain management application to the user responsive to the pain measurement.

[0013] A fifth embodiment comprises a method for account management for a remote interactive pain management application. The method comprises receiving a request from a wireless device to provide the remote interactive pain management service to a user, requesting payment authorization from the user, and receiving the payment authorization from the user. The method further comprises providing the interactive pain management application operative to engage a plurality of levels of brain distraction, wherein said brain distraction is designed to reduce a user's perception of pain.

[0014] A sixth embodiment comprises a method for remote interactive pain management. The method comprises obtaining pain measurement data, sending the pain measurement data to a remote server, and receiving an interactive pain management application based on the pain measurement data.

[0015] A seventh embodiment comprises a computer-readable medium including program code for interactive pain management. The program code presents a multimedia ameliorative to a patient on a wireless device, obtains a pain response measurement for the patient, and adjusts the multimedia ameliorative based on the pain response measurement. The computer-readable medium may also comprise program code for obtaining a pain level value from the patient, correlating the pain response measurement to the pain level value to determine a correlated pain measurement, and adjusting the multimedia ameliorative based on the correlated pain measurement.

Brief Description of the Drawings

[0016] The following figures are provided for purposes of illustration only and merely depict exemplary embodiments of the invention. These drawings are provided to facilitate the reader's understanding of the disclosure and should not be considered limiting of the breadth, scope, or applicability of the disclosure. It should further be noted that these drawings are not necessarily drawn to scale.

[0017] Figure 1 is an illustration of a distributed interactive pain management system according to an embodiment of the invention. [0018] Figure 2 is an illustration of a distributed interactive pain management server according to an embodiment of the invention.

[0019] Figure 3A is an illustration of a distributed interactive pain management operating environment according to an embodiment of the invention.

[0020] Figure 3B is an illustration of a distributed interactive pain management operating environment according to an embodiment of the invention.

[0021] Figure 4 shows an exemplary flow diagram illustrating a distributed interactive pain management process in accordance with an embodiment of the invention.

[0022] Figure 5 shows an exemplary flow diagram illustrating a server side distributed interactive pain management process in accordance with an embodiment of the invention.

[0023] Figure 6 shows an exemplary flow diagram illustrating a client side distributed interactive pain management process in accordance with an embodiment of the invention.

[0024] Figure 7 is an illustration of a multimedia ameliorative application entitled

Shell Island Application according to an embodiment of the invention.

[0025] Figure 8 is an illustration of a multimedia ameliorative application entitled

Windy City Application according to an embodiment of the invention.

[0026] Figures 9-11 illustrate exemplary data showing subjective pain ratings with and without a mobile phone virtual reality treatment according to one or more embodiments of the invention.

Detailed Description of the Preferred Embodiment

[0027] In the following description of preferred embodiments, reference is made to the accompanying drawings which form a part hereof, and in which it is shown by way of illustration specific embodiments in which the invention may be practiced. It is to be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the preferred embodiments of the present invention. [0028] Furthermore, although embodiments of the invention are described herein in terms of systems and methods for interactive pain management via a mobile phone, the invention is not necessarily limited to such mobile phone applications, and other types of devices having similar characteristics (e.g., PDAs, MP3 players) may be utilized in accordance with the present invention. As would be apparent to one of ordinary skill in the art after reading this description, these are merely examples and the embodiments of the invention are not limited to operating in accordance with these examples.

[0029] The present invention relates generally to pain management, and particularly to pain management using virtual reality systems. As mentioned above, many typical contemporary virtual reality systems require large and complex headgear to generate the virtual reality environment and are therefore typically found only in hospitals or clinics. In order to provide pain management therapy and treatment outside of a hospital or clinical environment, various embodiments of the present invention have been designed, developed, and tested to provide more and/or varying interactive pain reducing virtual reality environments to a patient on demand over a distributed system using mobile devices.

[0030] Figure 1 is an illustration of a distributed interactive pain management system 100 according to an embodiment of the invention. Distributed interactive pain management system 100 comprises a wireless display device 104, a sensor device 106, and a pain management server 118.

[0031] The wireless display device 104 comprises a multimedia display 112, a plurality of pain intensity buttons (which can function as a pain scale) 110, and a request pain management button 108. The wireless display device 104 may communicate with the pain management server 118 and the sensor device 106 via communication links 116 and 114 respectively. Wireless display device 104 is configured and operative to execute one or more VR application programs on demand such as those described in further detail below.

[0032] In order to support VR functionality, wireless display device 104 may include one or more computer processors, memory, display devices, audible output devices such as speakers, buzzers and the like, as well as one or more interfaces for connection of peripheral devices. Wireless display device 104 may also include one or more wireless components to enable wireless capabilities such as are used in cellular telephony and/or as used in wireless local area networks such as IEEE 802.11 (Wi-Fi) networks or other local or wide area networks. Wireless display device 104 typically includes memory such as RAM, ROM, flash memory, or other memory technologies for storing one or more software modules that may contain operating systems, device and interface controls, application programs or other related functionality. Embodiments of software modules according to aspects of the present invention are further described below with respect to several exemplary VR application programs. Wireless display device 104 may include one or more interfaces for connection to one or more peripheral devices. Peripheral devices are optional, however, when used they may include sensory output devices such as headphones, visual displays such as two dimension or three dimensional displays, tactile devices, motion devices, and other output devices. Peripheral devices may also include input devices such as sensors, microphones, pushbuttons, switches, joysticks, or other sensory input devices. In some embodiments peripheral devices may be used to provide virtual reality outputs to user 102 such as visual and/or audible virtual reality outputs as well as inputs such as feedback sensors related to a user's response to pain management virtual reality outputs.

[0033] Multimedia display 112 provides an interactive virtual reality software application for mobile and portable platforms designed to target specific areas or functions of the user's brain in order to alter brain response to pain stimuli. Research and testing has shown that the efficacy of virtual reality brain distraction can be related to the extent of the user's immersion in the virtual reality environment, as well as the type of interaction required by the user. For example, it has been shown that while passive activity may provide some benefit, such as might occur when a user merely observes an audiovisual program (e.g., a television program or movie), the deeper concentration required for virtual reality interaction provides greater engagement of areas of the brain capable of reducing the amount of pain a patient may otherwise be experiencing.

[0034] As will be illustrated in examples below, multimedia for multimedia display 112 may provide visual or audible output, as well as other sensory outputs such as tactile, thermal, or other types of output. In some embodiments the virtual reality environment may be implemented directly on the portable or mobile device using speakers, buzzers, display screens such as LCD displays and the like, whereas in other embodiments some or all of the virtual reality functionality may be implemented on other peripheral devices such as detachable speakers, external visual displays, virtual reality headgear including two or three dimensional visual displays, or other sensory output peripherals known in the art.

[0035] Some applications can provide a higher level of brain engagement, such as interactive computer video games. Video games, however, are typically based on a predefined or scripted outcome that in time tends to result in a user learning to respond to a particular situation and, consequently, decreased pain reduction within the brain. As a result, approaches based on standard video games may provide some degree of pain relief initially, but the efficacy may eventually decrease as the underlying "scripting" or preset program paths are repeated and learned.

[0036] In order to provide a higher degree of sustained pain relief, an alternate approach to virtual reality embodiments can also be used in accordance with various embodiments. In these embodiments, the virtual reality application can create an environment that continuously stimulates a user's creativity. Some exemplary embodiments of this approach are further described below with respect to specific applications that have been implemented and tested.

[0037] With further reference to FIG. 1, the physiological sensor device 106 monitors the pain response of the patient 102. In order to optimize the ameliorative nature of the virtual reality presentation, the level of pain in the patient is monitored, and the virtual reality presentation is customized to reduce the pain response of the patient receiving the presentation. Examples of physiological sensors that can be most practical in terms of ease of use, accuracy, simplicity, and low cost comprise skin conductance, skin temperature and heart rate variability (HRV) (i.e., mathematical calculation based upon the interbeat interval (IBI)). HRV may be measured using the physiological sensor device 106 that measures the heart rate. A more simplistic approach could be to use the simple heart rate.

[0038] Although, in this example, the physiological sensor device 106 is a clip on finger device used to measure the HRV, the level of pain in the patient may be measured by various means. For example, the physiological sensor device may measure of the movement activity, oculometrics, biological/physiological responses, and voice stress of the patient. The movement activity of the patient may indicate restlessness caused by discomfort such as a fight or flight reaction, and may be measured by, for example, wrist- mounted actigraphy. Oculometrics are measurements of eye movement, and motion of the eye may indicate a desire to escape pain. Examples of oculometrics are blinking, saccadic eye movement, pupillary movements, and pupil light reflex. Biological and physiological responses measure pain in a manner similar to the way a lie detector measures evasion. Examples of biological and physiological responses that may be used for pain detection are skin conductance, electroencephalograms (EEG), and heart rate. Voice stress can indicate patient stress or discomfort, and can be measured by measuring signal properties of the voice audio. In some embodiments the wireless display device 104 may include integrated sensors, such as biomedical sensors to measure patient pain metrics such as pulse rate or temperature, for example.

[0039] The pain management server 118 can comprise a pain management application (e.g., virtual reality images) database 120, a sensor data and pain scale database 126, and a user profile database 128. The pain management server 118 correlates the sensor data and pain intensity and determines a virtual reality image (VR application) from the pain management applications database 120 to be sent to the wireless display device 104.

[0040] The user profile database 128 may be used for an account management system for remote interactive pain management. The account management system can receive a request from a wireless device to provide the remote interactive pain management service to a user, request payment authorization from the user, and receive the payment authorization from the user. The account management system can then provide an interactive pain management service as discussed herein. Data pertaining to usage of the interactive pain management application and a user profile are stored in a user profile data base 128. The user profile database 128 may also be used for processing the data to produce accounting data based on the user' s profile, and requesting payment for the usage of the pain management application. The user profile may be an existing user profile, or a new user profile may be created. The user profile may include, without limitation, user identification, user base line pain measures data, payment history, and a type of the interactive pain management application used.

[0041] Generally, the wireless display device 104 (or a plurality of clients) may access the pain management server 118 via a network 116. The pain management server 118 and the wireless display device 104, according to one or more embodiments of the invention, may include any one of various types of computer devices, having, for example, a processing unit, a memory (including a storage device), and a communication interface, as well as other conventional computer components (e.g., an input device, such as a keyboard and mouse, or an output device, such as a display). For example, the wireless display device 104 may comprise user devices such as a desktop computer, laptop computer, mobile device such as a mobile phone and web-enabled phone, smart phone, and the like.

[0042] The wireless display device 104 may communicate with the pain management server 118 using suitable communication interfaces via the network 106, such as the Internet. The wireless display device 104 and the pain management server 118 may communicate, in part or in whole, via wireless or hardwired communications, such as an Ethernet, IEEE 802.11b wireless, or the like. Additionally, communication between the wireless display device 104 and the pain management server 118 may include various servers such as a mail server, mobile server, image server, and the like.

[0043] The pain management server 118 may be programmed to format data, accessed from local or remote databases or other sources of data, for presentation to patient 102 of the wireless display device 104, for example, in the formats discussed in detail below. The pain management server 118 may utilize various web data interface techniques such as the Common Gateway Interface (CGI) protocol and associated applications (or "scripts"), Java™ "servlets", e.g., Java™ applications running on the pain management server 118, or the like to present information and receive input from the wireless display device 104. The pain management server 118 may be implemented as, for example, a computer program, and may include a web server module, e.g., Apache™ or the like. The pain management server 118 , although described herein in the singular, may actually comprise plural computers, programs, devices, backends, and the like, communicating (wired or wireless) and cooperating to perform the functions described herein.

[0044] The pain management server 118 can be a centralized facility, or any or all of its various functions can be distributed across a plurality of facilities or locations in a geographically diverse manner. Further, the various functions described herein as attributable to the pain management communication can be distributed to and among the various facilities the pain management server 118 services. Various elements of the pain management server 118 may communicate in part or in whole via wireless or hardwired communications links, such as an Ethernet, IEEE 802.11b wireless, or the like.

[0045] Figure 2 is an illustration of distributed interactive pain management server 200 according to an embodiment of the invention. Figure 2 illustrates a typical computing system 200 that may be employed to implement processing functionality in embodiments of the invention. For example, computing systems of this type may be used in clients and servers. Those skilled in the relevant art will also recognize how to implement the invention using other computer systems or architectures. Distributed interactive pain management server 200 can include one or more processors, such as a processor 202, a main memory module 210, information storage system 220, and a communications interface 224.

[0046] Processor 202 can be implemented using a general or special purpose processing engine such as, for example, a microprocessor, microcontroller or other control logic. In this example, processor 202 is connected to a bus 208 or other communication medium.

[0047] The main memory module 210 can be coupled to bus 208 and configured to store, executable instructions, algorithms, calculation variables, constants, parameters, and the like for storing information and instructions. For example, the memory module 210 may be operable to store data sensory pain measurements data, pain intensity level values, user profile data, and equations for calculating pain management feedback parameters. Memory module 210 also includes non- volatile memory for storing instructions to be executed by processes 202. In a further embodiment, the memory module 210 may include a cache memory for storing temporary variables or other intermediate information during execution of instructions to be executed by processor 202. The memory 210 may include a device control/operating system 212. The memory 210 may include one of more virtual reality program modules 214/216.

[0048] The information storage system 220 may include, for example, a media drive and a removable storage interface. The media drive may include a drive or other mechanism to support fixed or removable storage media, such as a hard disk drive, a floppy disk drive, a magnetic tape drive, an optical disk drive, a CD or DVD drive (R or RW), or other removable or fixed media drive. Storage media may include, for example, a hard disk, floppy disk, magnetic tape, optical disk, CD or DVD, or other fixed or removable medium that is read by and written to by media drive. As these examples illustrate, the storage media may include a computer-readable storage medium having stored therein particular computer software or data.

[0049] In alternative embodiments, information storage devices 220 may include other similar components for allowing computer programs or other instructions or data to be loaded into distributed interactive pain management server 200. Such components may include, for example, a removable storage unit and a storage unit interface, such as a program cartridge and cartridge interface, a removable memory (for example, a flash memory or other removable memory module) and memory slot, and other removable storage units and interfaces that allow software and data to be transferred from the removable storage unit to distributed interactive pain management server 200.

[0050] The communications interface 224 can be used to allow software and data to be transferred between computing system 200 and external devices. Examples of communications interface 224 can include a modem, a network interface (such as an Ethernet or other NIC card), a communications port (such as for example, a USB port), a PCMCIA slot and card, etc. Software and data transferred via communications interface 224 are in the form of signals which can be electronic, electromagnetic, optical, or other signals capable of being received by communications interface 224. These signals are provided to communications interface 224 via a communication channel 228. This communication channel 228 may carry signals and may be implemented using a wireless medium, wire or cable, fiber optics, or other communications medium. Some examples of a channel include a phone line, a cellular phone link, an RF link, a network interface, a local or wide area network, and other communications channels 228 to perform features or functions of embodiments of the invention. The processor may perform the specified operations, be compiled to do so, and/or be combined with other software, hardware, and/or firmware elements (e.g., libraries for performing standard functions) to do so.

[0051] Figures 3A-3B are illustrations of two distributed interactive pain management operating environments according to two embodiments of the invention. In these embodiments as described below, the present invention relates to distributed pain management using a wired or wireless network and portable or mobile devices configured to implement such a VR environment through one or more software applications or modules. Figure 3A illustrates a distributed pain management system 300 according to one embodiment of the present invention. As shown in Figure 3A, distributed pain management system 300 may comprise a cellular network 330 with one or more mobile phones or other portable devices 310. In another embodiment as shown in Figure 3B the distributed pain management system 300 may comprise a different wired or wireless network such as one based on the IEEE 802.11 WLAN standard (Wi-Fi) or other network standards. In an exemplary embodiment a portable device 310 may be a mobile phone. Alternately, a portable device may be a personal digital assistant (PDA) such as a Blackberry device, Palm Treo, MP3 player, or other similar portable device. In some embodiments a portable device 310 may be a personal computer such as a notebook computer, palmtop computer, or other mobile computer device.

[0052] The system 300 as shown in Figure 3A can include one or more cellular towers 306 (only one is shown in Figure 3A) or other cellular network devices, and as shown in Figure 3B can include one or more wireless network devices such as wireless access point 305 (only one is shown in Figure 3B). In either configuration, the mobile phone or other portable device may be connected to one or more servers such as server 301 as shown in Figure 3A, or server 312 as shown in Figure 3B. These servers 301/312 may be used to provide applications, controls, feedback signals, data storage, or other functions related to distribution, control, and monitoring of pain management systems and may also store information related to particular users (e.g., user profile) of the pain management system as explained above.

[0053] Figures 4-6 show exemplary flow diagrams illustrating distributed interactive pain management processes 400-600 according to embodiments of the invention. The various tasks performed in connection with these processes may be performed by software, hardware, firmware, a computer-readable medium having computer executable instructions for performing the process method, or any combination thereof. It should be appreciated that processes 400-600 may include any number of additional or alternative tasks. The tasks shown in Figures 4-6 need not be performed in the illustrated order, and these processes may be incorporated into a more comprehensive procedure or process having additional functionality not described in detail herein. For illustrative purposes, the following description of processes 400-600 may refer to elements mentioned above in connection with Figures 1-3. In various embodiments, portions of processes 400-600 may be performed by different elements of systems 100- 300, e.g., multimedia display, pain intensity buttons, request pain management button, pain management server, and sensor device.

[0054] Figure 4 shows an exemplary flow diagram illustrating a distributed interactive remote pain management process 400 in accordance with an embodiment of the invention. The distributed interactive remote pain management process 400 may be operated via software and distributed hardware devices including wired and wireless telephones, personal digital assistants (PDAs), or other devices such as wireless devices connected to networks such as 802.11 (Wi-Fi) networks. The distributed interactive pain management process 400 may begin by a request for interactive pain management being sent from a wireless device (task 402) to a remote server.

[0055] The distributed interactive pain management process 400 may then continue with the request for interactive pain management being received by an interactive pain management server (task 404). The interactive pain management server may comprise one or more software modules implemented as standalone or distributed software applications. In some embodiments the software may be stored and executed directly on the portable device, whereas in other embodiments the software may be distributed to the device, in whole or part, from a remote location such as a server via unidirectional or bidirectional transmission links. Embodiments of software modules may comprise one or more modules stored in RAM, ROM, firmware, or other software storage means known in the art, wherein the software may be executed on a microprocessor or microcontroller. In some embodiments virtual reality software may be configured and operative independent of a particular language, thereby providing advantages such as ease of use to pain sufferers, independent of the languages they know or their culture.

[0056] The distributed interactive remote pain management process 400 may then continue with the wireless device sending physiological sensor data and pain intensity level values (i.e., user's pain measurement data) to the interactive pain management remote server (task 406). In one or embodiments additional hardware and/or software may be provided to sense user metrics and provide feedback to the system to provide monitoring of user response and/or closed loop feedback to the virtual reality system to improve pain reduction. For example, user physiological sensory input measurements may include metrics such as pulse rate, blood pressure, skin or other body temperatures, or other physical parameters. The user can also select a subjective pain intensity level using numeric pain intensity scales 1-M (where M is the highest pain intensity (level) via pain intensity buttons 110. Similarly, pain level (intensity) can be rated subjectively using other means such as colors, sounds, or simple descriptive pain intensity scale.

[0057] The distributed interactive pain management process 400 may then correlate the physiological sensor data with the pain intensity values (task 408) to select a multimedia ameliorative corresponding to the user pain measurement data.

[0058] The distributed interactive pain management process 400 may then continue with the interactive pain management server sending a multimedia ameliorative to the wireless device (task 410). The multimedia ameliorative may be a virtual reality image from a virtual reality application. In various embodiments, the virtual reality application comprises software operative to provide pain reduction by engaging particular areas of the brain in tasks designed to reduce the sensation of pain. The virtual reality application can also comprise a combination of hardware and software for presenting images, video, text, graphics, audio, tactile, or other sensory stimuli to a user on demand. Research has demonstrated that pain may be managed by brain distraction. Brain imaging shows that being distracted can have a real, measurable effect in decreasing the intensity of pain signals in the brain. Virtual reality (VR) environments can provide a more immersive experience than other forms of distraction, and research indicates that VR can actually change the way the brain physically registers pain, not just a person's perception of the incoming pain signals. There is also evidence that the residual effect of VR for pain distraction is a "rewiring" of the brain, which may result in decreased pain as well as decreased depression and increased physical activity.

[0059] Figure 5 shows an exemplary flow diagram illustrating a server side distributed interactive pain management process 400 in accordance with an embodiment of the invention. In one embodiment, the invention relates to a distributed virtual reality system comprising hardware and software for distributing virtual reality applications via wired or wireless networks to portable or mobile devices such as mobile phones, personal digital assistants (PDAs), portable computers, or other similar wired or wireless devices. Such wireless applications may be provided or distributed in conjunction with a cellular carrier or other wireless provider, standalone internet based services, cellular application providers, dedicated high end medical device distribution methods, outsourced patient management services, or by other means of wired or wireless distribution know in the art. Wireless functionality may provide for distribution of one or more VR applications to a user, as well as transmission of user information to medical providers and/or remote medical data storage devices or facilities such as medical data storage facilities at hospitals, clinics, and the like.

[0060] The distributed interactive pain management process 500 may begin by accepting a request for an interactive wireless pain management server 118 to be sent to a wireless device (task 502). The distributed interactive pain management process 500 may then continue by the pain management server 118 receiving physiological sensor data from the wireless device (task 504). The distributed interactive pain management process 500 may then continue with the pain management server 118 receiving a user's pain level (intensity) selection from the wireless device (task 506).

[0061] The distributed interactive pain management process 500 may then correlate data from the physiological sensors with data associated with the user's pain level selection (task 508). The distributed interactive pain management process 500 may then continue with the interactive pain management server sending a multimedia ameliorative, such as a virtual reality image corresponding to the correlated data, to the wireless device (client) (task 510).

[0062] Figure 6 shows an exemplary flow diagram illustrating a client side distributed interactive pain management process 600 in accordance with an embodiment of the invention. In some embodiments, the present invention may be used to supplement therapies such as hypnosis, biofeedback, chronic pain management with oral or injected medication, surgical intervention for intractable pain, and certain forms of physical therapy and rehabilitation. Embodiments of the present invention may be incorporated in existing treatment protocols as an additional modality during regularly scheduled sessions with the patient, or used in standalone sessions with the clinic patient. Pain management systems may be included in a package for the patient to take home after surgery.

[0063] The distributed interactive pain management process 600 may begin by a request for interactive pain management being sent from a wireless device (task 602). The distributed interactive pain management process 600 may then continue with the wireless device measuring physiological data with a sensor (task 604). The distributed interactive pain management process 600 may then receive pain level (intensity) data from the patient (task 606).

[0064] In some embodiments the wireless device may include hardware and software to present a virtual reality environment to the wireless device and may also include integrated sensors, such as biomedical sensors, that can measure patient pain metrics such as pulse rate or temperature, such as skin temperature, and may store such information, use such information for closed loop feedback control, and may also provide such information to a medical care provider such as a medical doctor, nurse, or other medical care provider.

[0065] The distributed interactive pain management process 600 may then send the physiological and the pain level data to the pain management server 118 (task 608). The distributed interactive pain management process 600 may then continue with the wireless device receiving a multimedia ameliorative such as a virtual reality image corresponding to the correlated data from the interactive pain management server 118 (task 610).

[0066] Figure 7 is an illustration of a multimedia ameliorative application entitled

Shell Island Application according to an embodiment of the invention. In one embodiment of the present invention a virtual reality application entitled Shell Island has been developed. Shell Island includes four levels of brain engagement. The first level of engagement is exploration, done by allowing a user to explore the island. Various huts, avatars, and objects are placed throughout the island to keep the user's eyes occupied while exploring.

[0067] Eventually the user will encounter a second level of engagement, which is designed to target brain engagement related to searching. The user can look for certain characters that provide the user with information on types of activities available. Magical shells are scattered along a shoreline for the user to seek. Once the user finds a shell, he or she is drawn into the third level of engagement, which targets mental engagement related to decision-making. The user must decide whether or not he or she wants to keep the shell. Additional decision making engagement is provided by allowing the user to select a color to paint the shells and the placement of the shells on a hut. The fourth level of user engagement is targeted towards experiencing the user's final composition. In the case of the Shell Island, the final composition provides both visual and auditory stimulation.

[0068] Figure 8 is an illustration of a multimedia ameliorative application entitled

Wind City Application according to an embodiment of the invention. In one embodiment of the present invention, an application entitled Wind City has been designed and developed to provide multiple levels of brain stimulation and distraction to decrease pain. The VR environment of wind city can be summarized in three words - Advanced, Romantic, and Sanctified. It is advanced in a clean and elegant way. The entire city is powered solely by wind; it is unlike anything else that you would expect to see from a metropolitan concrete jungle. A waterfall comes mysteriously down from above. It is also the main water source for the residents. Engineers have perfectly designed and implemented a water canal system to run water across the city. The system is incredibly intriguing so that it seems like it defies the law of physics. Outsiders would say that the technology of Windy City inhabitants is almost magical. The locals would tell you that they are just blessed by God. Ancient Greek mythology style buildings and architecture can be found throughout the land. Sacred temples placed high above the mountain are off limit to most but a selected few. The main attraction though is the Main Temple that is situated just below the mountain. The lucky ones who are invited to the Main Temple will have the opportunity to witness its god-like technology.

[0069] Windy City allows a user to experience up to four different levels of brain engagement, similar to those described above with respect to Shell Island. The first level of engagement occurs when the user walks around in Wind City enjoying the scenery and interacting with the residents. The user can go to almost anywhere in the city without restriction, for instance, they can choose to look at the waterfall for as long as they desire. The second level of engagement occurs when the user looks for the Main Temple. The searching process involves talking to the locals for hints and locating landmarks or specific signs that lead one to the Main Temple. When the user finally gets into the Temple he or she can create a unique creature based on construction with DNA building blocks, engaging the third level of brain distraction. The degree of user immersion need not merely be a function of the particular hardware, but rather can also be controlled by the application and associated VR environment. For example, in Windy City the creative process involved in building the DNA helps capture the attention of the player and thus enhances the user immersion in the VR world. Finally, a forth level of engagement occurs when the user watches the creature that he/she has just created come to life in the VR environment and move about in front of the user's own eyes.

[0070] Benefits of the present invention may include, but are not limited to, rapid pain relief, pain reduction benefits that may last for long periods of time after treatment, up to several hours in some cases. When used frequently, both the quality and duration of pain relief may be improved. Usage may be done on demand by the patient, and not limited or constrained by availability or authorization by a medical care provider. Users can manage pain with systems according to the present invention multiple times during the day to provide ongoing pain reduction benefits. Because of the level of device integration and the distributed nature of some applications, users may be required to follow an initial training regime; however, such training may be minimal. Pain reduction may be achieved for a variety of types of pain including acute pain, chronic pain, procedural pain, rehabilitative pain, and other forms of pain. Such pain may be caused by accidents or other injuries, headaches, back problems, muscle tension, work related tension, abdominal pain, or myriad other causes.

[0071] In some embodiments, systems and methods according to the present invention may be provided in a more efficient way independent of regulatory agency requirements such as those imposed by the food and drug administration (FDA) or other medical device or medical care regulatory agencies. For example, some embodiments may be provided such that they are do not require FDA 510(k) medical device clearance. Alternately, reduced regulatory approval may be used, such as, for example, providing embodiments that may be covered by FDA 510(k) medical device clearance rather than investigational device exemption (IDE) or premarket approval (PMA).

[0072] Clinical testing of prototype embodiments of VR pain reduction hardware and software according to aspects of the present invention have been done in San Diego, California. In one series of tests, six clinic patients, ranging in age from 22 to 68, tested the VR environment with a head-mounted display (HMD) and wearing noninvasive physiological sensors. All six participants reported a drop in pain while in the VR environment, and the magnitude of pain reduction from the VR compared to the pain focus condition was large (75.8%) and significant. A nonparametric Wilcoxon signed rank test indicated that the mean pain rating during the VR condition was significantly lower than the session with no distraction (p = 0.028), where "p" stand for significance. Each of the six participants exhibited higher mean skin temperature when engaged in the VR environment than when in the pain focus condition. A paired t-test also indicated that the overall mean temperature was significantly higher when participants were using VR (df = 5; p = 0.004), where "df ' refers to degree of freedom. A higher average temperature in VR suggests a reduced level of discomfort and anxiety, substantiates the self-reported pain ratings, and suggests that VR is an effective method of reducing pain and psychological distress.

[0073] In testing an embodiment using a mobile phone and wireless cellular network, significant efficacy was found in a study of five participants with chronic low back pain. This is remarkable given the small screen of the mobile phone and the absence of sophisticated immersion equipment such as an HMD. As in the study above, a pain focus condition was compared to a virtual environment focus condition. Data on heart rate and skin temperature were collected, as well as pain intensity ratings obtained from self-report questionnaires. The results from this testing as shown in Figures 9-11 for both subjective and objective form.

[0074] Figure 9 is a box plot 900 (mean plus minus 2 standard errors of mean) illustrating the difference (p < 0.05) in subjective pain rating using a visual analog scale between the control condition (without VR treatment) and the mobile phone virtual reality condition (with VR treatment) in participants with chronic pain.

[0075] Figure 10 is a box plot 1000 (mean plus minus 2 standard errors of mean) illustrating the difference (p < 0.012) in subjective pain rating using a numeric pain intensity scale between the control condition (without VR treatment) and the mobile phone virtual reality condition (with VR treatment) in participants with chronic pain.

[0076] Figure 11 is a box plot 1100 (mean plus minus 2 standard errors of mean) illustrating the difference (P < 0.001) in subjective pain rating using a simple descriptive pain intensity scale between the control condition (without VR treatment) and the mobile phone virtual reality condition (with VR treatment) in participants with chronic pain.

[0077] Similar to the hospital system described above, all participants reported a drop in pain while in the mobile phone virtual environment, as shown in Figures 9-11, with significance ranging from p < 0.05 to p < 0.001, depending upon which of the three pain rating scales is used. In addition, objective data demonstrated by the significant decrease in heart rate (p < 0.05) and the significant increase in skin temperature (p = 0.007) while the participant was in the virtual environment substantiates the three self- reported subjective pain ratings, indicating a reduced level of pain and anxiety. This demonstrates that VR can be an effective method of reducing distress associated with pain, even with a small display such as is provided by a cellular phone.

[0078] Terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term "including" should be read as mean "including, without limitation" or the like; the term "example" is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; and adjectives such as "conventional," "traditional," "normal," "standard," "known" and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Likewise, a group of items linked with the conjunction "and" should not be read as requiring that each and every one of those items be present in the grouping, but rather should be read as "and/or" unless expressly stated otherwise. Similarly, a , of items linked with the conjunction "or" should not be read as requiring mutual exclusivity among that group, but rather should also be read as "and/or" unless expressly stated otherwise. Furthermore, although items, elements or components of the disclosure may be described or claimed in the singular, the plural is contemplated to be within the scope thereof unless limitation to the singular is explicitly stated. The presence of broadening words and phrases such as "one or more," "at least," "but not limited to" or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent.

[0079] Although the present invention has been fully described in connection with embodiments thereof with reference to the accompanying drawings, it is to be noted that various changes and modifications will become apparent to those skilled in the art. Such changes and modifications are to be understood as being included within the scope of the present invention as defined by the appended claims.

Claims

WHAT IS CLAIMED IS:

1. A method for remote interactive pain management, the method comprising: presenting a multimedia ameliorative to a patient on a wireless device; obtaining a pain response measurement for the patient; and adjusting the multimedia ameliorative based on the pain response measurement.

2. The method of claim 1, further comprising: obtaining a pain level value from the patient; correlating the pain response measurement to the pain level value to determine a correlated pain measurement; and adjusting the multimedia ameliorative based on the correlated pain measurement.

3. The method of claim 2, wherein obtaining the pain level value comprises receiving the pain level value from the wireless device, wherein the pain level value corresponds to a subjective assessment of a pain intensity from the patient.

4. The method of claim 1, wherein obtaining the pain response measurement comprises receiving measured physiological data from the wireless device corresponding to pain felt by the patient.

5. The method of claim 1, wherein the wireless device comprises a mobile phone.

6. The method of claim 1, wherein the multimedia ameliorative engages a plurality of levels of brain distraction, wherein the brain distraction is designed to reduce perception of pain of the patient.

7. The method of claim 1, wherein the multimedia ameliorative is presented via a network.

8. The method of claim 1, wherein the pain response measurement comprises at least one of the group of movement activity, oculometrics, biological and/or physiological responses, and voice stress.

9. The method of claim 8, wherein the movement activity comprises wrist- mounted actigraphy.

10. The method of claim 8, wherein the oculometrics comprise at least one of the group of blinking, saccadic eye movement, pupillary movements, and pupil light reflex.

11. The method of claim 8, wherein the biological and/or physiological responses comprise at least one of the group of skin conductance, electroencephalogram (EEG), and heart rate.

12. A method for pain management, the method comprising: receiving a demand from a portable device; and distributing an interactive pain management application via a network to the portable device in response to the demand.

13. The method of claim 12, further comprising: receiving measured physiological data from the portable device corresponding to pain felt by a user; receiving a pain level value from the portable device corresponding to an assessment of the pain felt by the user; correlating the measured physiological data to the pain level value to determine a pain measurement; and providing the interactive pain management application to the user based on the pain measurement.

14. A portable device for interactive pain management, the portable device comprising logic for: presenting a pain management application on a display of the portable device; receiving measured sensory stimulus data corresponding to a pain intensity of a patient; sending the measured sensory stimulus data to a remote server; and receiving an interactive pain management application based in part on the measured sensory stimulus data.

15. The method of claim 14, further comprising logic for: presenting a plurality of touch buttons on the display operable to allow the patient to select the pain level value; and receiving the pain level value corresponding to an assessment of the pain intensity by the patient.

16. A multimedia ameliorative server comprising logic for: receiving measured sensory stimulus data from a portable device corresponding to a pain level of a user; receiving a pain level value corresponding to an assessment of the pain level by the user; correlating the measured sensory stimulus data to the pain level value to determine a pain measurement; and providing an interactive multimedia ameliorative pain management application to the user responsive to the pain measurement.

17. The multimedia ameliorative server of claim 16, further comprising a database operable to store data pertaining to the pain measurement.

18. The multimedia ameliorative server of claim 16, further comprising a multimedia ameliorative database operable to store plurality of multimedia ameliorative pain management applications.

19. The multimedia ameliorative server of claim 16, further comprising a user profile database operable to store data pertaining to usage of the multimedia ameliorative pain management applications, and user profile data.

20. The multimedia ameliorative server of claim 19, further comprising logic for: generating accounting data based on the user profile data; and requesting payment for the usage of the pain management application.

21. The multimedia ameliorative server of claim 16, wherein the measured sensory stimulus data comprise at least one of the group of movement activity, oculometrics, biological and/or physiological responses, and voice stress.

22. A method for account management for a remote interactive pain management system, the method comprising: receiving a request from a wireless device to provide the remote interactive pain management service to a user; requesting payment authorization from the user; receiving the payment authorization from the user; and providing the interactive pain management application operative to engage a plurality of levels of brain distraction, wherein said brain distraction is designed to reduce a user' s perception of pain.

23. The method of claim 22, further compromising: storing data pertaining to a usage of the interactive pain management application and a user profile in a user profile data base; processing the data to produce accounting data based on the user profile; and requesting payment for the usage of the interactive pain management application.

24. The method of claim 23, further comprising using an existing user profile.

25. The method of claim 23, further comprising creating a new user profile.

26. The method of claim 23, wherein the user profile comprises at least one of the group of user's identification, user's base line pain measures data, payment history, and a type of the interactive pain management application used.

27. A method for remote interactive pain management, the method comprising: obtaining pain measurement data; sending the pain measurement data to a remote server; and receiving an interactive pain management application responsive to the pain measurement data.

28. The method of claim 27, wherein the obtaining step further comprises: receiving a plurality of physiological signals each corresponding to a pain level of a patient; and receiving a pain level value from the patient corresponding to the patient's assessment of the pain level.

29. The method of claim 28, wherein the physiological signals comprise at least one of the group of movement activity, oculometrics, biological and/or physiological responses, and voice stress.

30. The method of claim 29, wherein the biological and/or physiological responses comprise at least one of the group of skin conductance, electroencephalogram (EEG), and heart rate.

31. A computer-readable medium for interactive pain management, comprising program code for: presenting a multimedia ameliorative to a patient on a wireless device; obtaining a pain response measurement for the patient; and adjusting the multimedia ameliorative based on the pain response measurement.

32. The computer-readable medium of claim 31 , further comprising program code for: obtaining a pain level value from the patient; correlating the pain response measurement to the pain level value to determine a correlated pain measurement; and adjusting the multimedia ameliorative based on the correlated pain measurement.

33. The computer-readable medium of claim 32, wherein the pain level value corresponds to a patient's assessment of a patient's pain intensity.

34. The computer-readable medium of claim 33, wherein the pain response measurement comprises measured physiological data from the wireless device corresponding to the patient' s pain intensity.

35. The computer-readable medium of claim 31, wherein the wireless device comprises a mobile phone.

36. The computer-readable medium of claim 31, wherein the multimedia ameliorative engages a plurality of levels of brain distraction, wherein said brain distraction is designed to reduce a patient's perception of pain.

37. The computer-readable medium of claim 31, wherein the multimedia ameliorative is presented via a network.

38. The computer-readable medium of claim 31, wherein the pain response measurement comprises at least one of the group of movement activity, oculometrics, biological and/or physiological responses, and voice stress.

39. The computer-readable medium of claim 38, wherein the oculometrics comprise at least one of the group of blinking, saccadic eye movement, pupillary movements, and pupil light reflex.

40. The computer-readable medium of claim 38, wherein the biological and/or physiological responses comprise at least one of the group of skin conductance, electroencephalogram (EEG), and heart rate.

41. The computer-readable medium of claim 38, wherein the movement activity comprises wrist-mounted actigraphy.