US20090281464A1 - Medical treatment system including an ancillary medical treatment apparatus with an associated data storage medium - Google Patents

Abstract

A medical treatment system includes an electronic controller with a medical treatment apparatus, a data reader, an ancillary treatment apparatus used with the electronic medical treatment apparatus and a data storage medium associated with the ancillary treatment apparatus. The controller is configured to receive information from the data storage medium, and to control the medical treatment apparatus with medical treatment parameters compatible with the desired medical treatment and the ancillary treatment apparatus.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• The present application claims the benefit of priority of U.S. Provisional Application No. 61/051,289 filed May 7, 2008, which is incorporated herein by reference.
FIELD OF THE INVENTION
• Embodiments of the invention relate to medical treatment, and to systems, kits, methods and computer program products for medical treatment and fee provisioning for the same.
BACKGROUND INFORMATION
• Medical systems using medical treatment kits, ancillary apparatuses and treatment articles with medical treatment devices are subject to operation and billing errors of the medical personnel administering the treatment with such components. As a result, medical procedure charges may be incorrect, cross-contamination between patients using the same apparatus may occur, the wrong components may be used together or the wrong medical treatment parameters may be applied.
• Accordingly, it is desirable to have a medical system and treatment methods that avoid such problems.
SUMMARY OF THE INVENTION
• Systems, kits, methods and computer program products for medical treatments and fee provisioning for the same are provided.
• In one embodiment a medical treatment system comprises an electronic controller having a microprocessor and a microprocessor-readable data storage medium with microprocessor-executable instructions for applying specific medical treatment control parameters to a medical treatment apparatus operatively coupled to the electronic controller. A data reader is operatively coupled to the microprocessor of the controller and receives instructions from a physical ancillary data storage medium coupled to or packaged with an ancillary treatment apparatus configured for use with the electronic medical treatment apparatus, wherein the instructions for are at least some of the instructions for applying the specific medical treatment control parameters. A display is also operatively coupled to the microprocessor of the controller to provide a visual confirmation that the electronic medical treatment apparatus is activated for use with the ancillary treatment apparatus.
• In one embodiment the electronic medical treatment apparatus is an acoustic pressure wave device including, but not limited to a shock wave device. Non-limiting and exemplary shock wave devices include an electrohydraulic shock wave device (or spark gap), electromagnetic shock wave device, piezoelectric shock wave device. In some embodiment a ballistic applicator may be used to provide acoustic pressure waves. In embodiments of the system including an acoustic pressure wave device, the ancillary treatment apparatuses include one or more of sleeve, pad, sterility barrier, reflector, lens and an applicator head.
• In embodiments of the invention, a medical treatment system further includes a physical data input device, including but not limited to a keyboard, mouse, electronic tablet, electronic measuring instruments, photographic or video data capturing instruments and like interfaces for data input to a controller. The controller in various embodiments may process the input data to provide a visual output to the display to inform a user as to what ancillary treatment apparatus and accompanying physical ancillary storage medium is appropriate from among different ancillary treatment apparatuses for use in a particular medical treatment. In particular embodiments, the data input to the data input device may include wound measurements, body area volumes, body part identification, a medical condition identification and the like.
• In one embodiment, a medical kit includes one or more ancillary treatment apparatuses and at least one treatment information storage device having information indicative of a medical treatment. In exemplary embodiments, the treatment information storage device may include information for security provisioning, indicative of medical treatment settings and/or for tracking inventory of the kit and/or the device with which the kit is used to provide medical treatment. In various embodiments, the treatment information storage device is a radio frequency identification (“RFID”) card, a dongle or a barcode.
• In embodiments, the type and number of ancillary treatment apparatus are indicative of the medical treatment, and the cost of the medical treatment is electronically stored in the treatment information storage device. Accordingly, a supplier of the medical treatment kit may obtain payment for a medical treatment upon the sale of the kit. Medical treatment kits may be sold to purchasers at different prices, based on the specific treatments that can be performed using them, based on the geographical region in which they will be used or based on any other parameters related to medical provisioning. The purchasers may be the patients receiving the medical treatment and/or medical personnel or facilities administering the medical treatment. Accordingly, the type and number of the ancillary treatment apparatus may be consistent with the medical treatment information stored on the treatment information storage device.
• In various embodiments, the ancillary treatment apparatus may be a coupling gel or material, a drape and/or a sleeve. The ancillary treatment apparatus may be any component or material configured to provide connectivity between the medical treatment apparatus and the patient. The coupling material may allow transmission of the shock wave with minimal attenuation. In some embodiments, the ancillary treatment apparatus may be any component or material for providing a sterile barrier between a medical treatment apparatus and a patient. Accordingly, the ancillary treatment apparatus may be designed to be disposable for one time use to avoid cross contamination between patients. In some embodiments, the ancillary treatment apparatus may be provided to be reusable.
• In some embodiments, the ancillary treatment apparatus and the treatment information storage device may be scanned before being placed in the kit together. This method of matching the ancillary treatment apparatus with the information storage device may be used to ensure that the components are compatible with one another and/or are appropriate for the medical treatment for which the kit is being sold. If the components are not compatible, an indication of such may be provided to a kit assembler. If detection of incompatibility was not made during assembly, the medical personnel may receive an indication that there is a problem in embodiments wherein the medical personnel has equipment for confirming the compatibility of the contents of the kit.
• In another embodiment, a medical treatment system is provided. The medical treatment system may include a medical treatment kit, a controller for controlling a medical treatment and a medical treatment apparatus for providing the medical treatment. The controller may be configured to receive the information from the treatment information storage device and/or generate corresponding control information for performing the medical treatment. The controller may also be configured to provide security by authenticating itself and/or the medical treatment apparatus with the treatment information storage device; and/or generate information for identifying itself and/or the medical treatment apparatus to provide inventory tracking. The controller may also be configured to: generate information for fee provisioning after a medical treatment has ended; and/or tabulate medical treatment data after a treatment has ended for recordkeeping purposes.
• The medical treatment in one embodiment may be the administration of shock waves for human and/or animal afflictions. The shock waves may be applied extracorporeally and produced using any methods for providing shock waves including, but not limited to, electrohydraulic, electromagnetic, piezoelectric and/or explosion detonation methods. Each treatment may include a certain number of shocks, at a certain energy level and frequency indicative of the treatment settings stored in the treatment information storage device. Based on these treatment settings, the cost of the kit, which may be the cost of the medical treatment, may be determined and paid at the time of purchase of the kit. Alternately, payment for the medical treatment may be provided after the treatment has ended through fee provisioning systems, methods and/or computer program products.
• In various embodiments, methods for providing medical treatment are provided. An exemplary method may include authenticating the controller and/or medical treatment apparatus by the region in which the controller and/or medical treatment apparatus are located; enabling the controller to operate if authentication is successful; operating the controller to perform a medical treatment via the medical treatment apparatus; and tabulating data indicative of the medical treatment for recordkeeping and for fee provisioning.
• In another embodiment, a computer program product for fee provisioning is provided. The computer program product includes a computer-readable medium having computer-readable program code stored on the computer-readable medium and configured to be accessed by a processor to cause the processor to: identify a plurality of treatment settings indicative of a medical treatment; assign a value to an identified treatment setting; identify a type of ancillary treatment apparatus to be used in providing the medical treatment; assign a value to an identified type of ancillary treatment apparatus; and determine a fee corresponding to the medical treatment. In some embodiments, fee provisioning may identify a fee based only on the medical treatment settings provided during a medical treatment.
BRIEF DESCRIPTION OF THE DRAWINGS
• These and other features and aspects of exemplary embodiments of the invention will become evident when the following detailed description is read with reference to the accompanying drawings wherein:
• FIG. 1 is a schematic illustration of a medical treatment system according to an embodiment of the invention;
• FIG. 2 is a schematic illustration of an electronic controller, ancillary physical data storage medium and wired data reader of a medical treatment system according to an embodiment of the invention;
• FIG. 3 is a schematic illustration of an electronic controller, ancillary physical data storage medium connected by a dongle in a medical treatment system according to an embodiment of the invention;
• FIG. 4 is a schematic illustration of an electronic controller, ancillary physical RFID data storage medium and RFID data reader of a medical treatment system according to an embodiment of the invention;
• FIG. 5 is a schematic illustration of an electronic controller, ancillary physical data storage medium in a label and RFID data reader of a medical treatment system according to an embodiment of the invention;
• FIG. 6 is a schematic illustration of an electronic controller, ancillary physical data storage medium and magnetic card data reader of a medical treatment system according to an embodiment of the invention;
• FIG. 7 is a schematic illustration of an electronic controller, ancillary treatment data storage medium with a bar code and bar code data reader of a medical treatment system according to an embodiment of the invention;
• FIG. 8 is a relational block diagram of the medical treatment system according to an embodiment of the invention;
• FIG. 9 is a schematic illustration of a treatment kit according to an embodiment of the invention;
• FIG. 10 is a perspective view from above of a treatment kit according to an embodiment of the invention;
• FIG. 11 is a schematic illustration of an individual treatment kit among a plurality of medical treatment kits according to an embodiment of the invention;
• FIG. 12 is a schematic illustration of a treatment kit including two ancillary treatment apparatuses of a gel and a shock wave device sleeve in an embodiment of the invention;
• FIG. 13 is a schematic illustration of a treatment kit including four ancillary treatment apparatuses of two gels, a shock wave device sleeve and a gel applicator device in an embodiment of the invention;
• FIG. 14 is a perspective view of a dispenser carton having a plurality of medical treatments kits in an embodiment of the invention;
• FIG. 15 is a table of treatment information of a medical treatment system according to an embodiment of the invention;
• FIG. 16 is a flow diagram illustrating a method of operation of a medical system according to an embodiment of the invention;
• FIG. 17 is a flow diagram illustrating a method of operation of a medical system according to an embodiment of the invention;
• FIG. 18 is a flow diagram illustrating a method of operation of a medical system according to an embodiment of the invention; and
• FIG. 19 is a flow diagram illustrating a method of operation of a medical system according to an embodiment of the invention.
DETAILED DESCRIPTION OF THE INVENTION
• Embodiments of the invention will be described with reference to the accompanying drawings and figures wherein like numbers represent like elements throughout. Further, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including”, “comprising”, or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. The terms “mounted”, “connected”, and “coupled” are used broadly and encompass both direct and indirect mounting, connecting and coupling. Further, “connected” and “coupled” are not restricted to physical or mechanical connections or couplings.
• FIG. 1 is an illustration of a medical treatment system according to an embodiment of the invention. As shown inFIG. 1, themedical treatment system100 includes amedical treatment kit110, acontroller120 and amedical treatment apparatus130.
• Controller120 is provided in embodiments as an electronic controller including a specially programmed medical system computer, including a microprocessor and microprocessor-readable storage medium of thecontroller120. The microprocessor-readable storage medium of thecontroller120 includes in embodiments microprocessor-executable instructions for applying specific medical treatment control parameters to amedical treatment apparatus130. In embodiments, medical treatment apparatus is electronic and operatively connected to anelectronic controller120 for receipt of the parameters and control of the treatment.
• In some embodiments, themedical treatment system100 also includes afee provisioning controller140, which may be located proximate to thecontroller120 or at any location within acommunication network129. In some embodiments, themedical treatment system100 also includes apatient150 and asupport structure152 on which thepatient150 may be positioned while receiving a medical treatment.
• In some embodiments, one or more components ofmedical treatment system100 may be located in a medical treatment facility (not shown) and communicatively coupled to any other component of themedical treatment system100. The one or more components may be coupled by optical, electrical, wireline or wireless media. In some embodiments, the components may be coupled by such mechanisms via a universal serial bus (“USB”) or anRS 232 port. In some embodiments, various components ofmedical treatment system100 may be located proximate to or remote from other components, and thecommunication network129 may be provided for transmitting and receiving information to and from one or more components.
• Medical treatment kit110 may be a disposable and/or consumable. Accordingly, thekit110 may be a one-time use kit or a reusable kit. Themedical treatment kit110 may be provided for the treatment of any human or animal soft, semi-soft and/or hard tissue, including, but not limited to, bone, cartilage, muscle, tendons, ligaments, joints and their capsules, internal organs, glands, skin, blood vessels, lymphatic vessels, open and closed wounds, nerves or otherwise. Thesame kits110 can be used to treat body fluids as synovial fluid, blood, etc. Additionally,medical treatment kit110 may be used for any suitable medical procedure including, but not limited to, those medical procedures directed to human or animal treatment related to wound care, laminitis, osteoarthritis, plantar fasciitis, lateral epicondylitis, ulcers, pressure sores, skin conditions, cellulite, organ cancers, enlargement or cancers of glands, cardiological and vascular afflictions, urinary and sexual diseases, bone grafting or the like.
• In the embodiment of the invention shown inFIG. 1, themedical treatment kit110 includes a treatmentinformation storage device112 and anancillary treatment apparatus114. The treatmentinformation storage device112 is a physical ancillary data storage medium such as coupled to or packaged with, including coupled to a kit container, anancillary treatment apparatus114. The treatmentinformation storage device112 may have information stored thereon, as a for performing one or more functions related to providing medical treatment on thepatient150. In embodiments, the treatmentinformation storage device112 is used withcontroller120 and includes at least some of the instructions, readable by a microprocessor of the controller, for applying a specific medical treatment control parameters for a medical treatment system. By way of example, but not limitation, treatmentinformation storage device112 may be an RFID tag, label or chip, memory stick, smart card, credit card, barcode, floppy disk, cd-rom, digital versatile disk (“DVD”) or any device configured to store information and from which information may be read. Theancillary treatment apparatus114 may be used in conjunction with themedical treatment apparatus130 to enhance the medical procedure performed on thepatient150.
• In various embodiments, the treatmentinformation storage device112 may perform payment provisioning, security, inventory tracking or medical treatment setting provisioning or any combination of these functions. In various embodiments, the treatmentinformation storage device112 may perform: storage of medical treatment settings corresponding to a medical treatment to be provided to thepatient150; enabling thecontroller120 to be powered on; providing security by authenticating thecontroller120 and/or themedical treatment apparatus130; providing the cost of themedical treatment kit110 to be charged to a purchaser of thekit110; providing information for fee provisioning; and/or tracking inventory of themedical treatment kit110, theancillary treatment apparatus114, thecontroller120 and/or themedical treatment apparatus130.
• By providing the cost of themedical treatment kit110 to be charged to a purchaser of themedical treatment kit110, a purchaser may pay for a medical treatment in advance of receiving the medical treatment. The price for themedical treatment kit110 may be the price for the medical treatment for which thekit110 is provided. Accordingly, the cost of thekit110 may increase and decrease according to the cost of the medical treatment. For example, the cost of a medical treatment for treating a large wound may be greater than that for treating a small wound. Accordingly, akit110 for treating the large wound may be a higher price than akit110 for treating the small wound. Accordingly, in these embodiments, the cost of thekit110 is the cost of the medical treatment and may not be related to the cost of theancillary treatment apparatus114 and/or the type or technology required to create the treatmentinformation storage device112. The treatmentinformation storage device112 may be read at the beginning or end of the treatment as well as during the treatment in various embodiments.
• In another embodiment, treatmentinformation storage device112 may be an RFID device. In various embodiments, the RFID device may be a tag, label or chip and may include passive, active or semi-passive technology. In some embodiments, the RFID device may include RFID chipless technology or electronic product code technology. Chipless RFID devices may allow for discrete identification of RFID tags without an integrated circuit, thereby allowing tags to be printed directly onto the surface of thekit110 at lower costs than traditional tags. In one embodiment, treatmentinformation storage device112 may be a passive tag that requires no electrical supply for powering the tag. In one embodiment, the passive tag may be the Hitachi μ-chip. The tag may be inside of amedical treatment kit110 or it can be a label placed on the outside of thekit110. In another embodiment, the treatmentinformation storage device112 may be a passive RFID tag incorporating electronic product code technology. In various embodiments, the treatmentinformation storage device112 may be a polymer tag such as that manufactured by PolyIC, which is located in Germany, or that is manufactured by Phillips, which is located in the Netherlands.
• In various embodiments, an RFID device may communicate according to the International Standards Organization (“ISO”) 14443 and/or the International Electrotechnical Commission (“IEC”) 18000-6 standards. The RFID device may communicate up to a distance of 10 cm (i.e., 4 inches) in accordance with ISO 14443. The RFID device may be included in a smart label governed by ISO 15693. In one embodiment, the RFID device is a 13.567 MHz device.
• Referring back toFIG. 1, in some embodiments, security information that may be encrypted or unencrypted may be stored in treatmentinformation storage device112. The information may be read to authenticatemedical treatment apparatus130 and/orcontroller120. The authentication may ensure compatibility between theapparatus130 and/or thecontroller120 and/or theancillary treatment apparatus114. Additionally, the information may be used to determine whether thecontroller120 is authorized to be used in the geographical region in which thecontroller120 is located.
• In each embodiment, if the components are authenticated, treatmentinformation storage device112 transmits treatment settings information to thecontroller120 thereby allowing the medical treatment to be performed. If authentication fails, treatmentinformation storage device112 operates in such a fashion so as to not allow for the medical treatment to be performed. In one embodiment, the treatmentinformation storage device112 may prevent thecontroller120 from operating.
• In one embodiment, authentication is performed as follows. The information stored on the treatmentinformation storage device112 may act as a password that is transmitted to thecontroller120. The password may be encrypted to prevent the password from being pirated and improperly enabling thecontroller120 to be turned on. If thecontroller120 matches the correct password then authentication is successful and the medical treatment is allowed. If the password is not matched, then the medical treatment is not allowed. Such may be performed by not transmitting the treatment data stored on the treatmentinformation storage device112 to thecontroller120 so thecontroller120 cannot perform the treatment or by maintaining thecontroller120 in an “off” mode. Thecontroller120 may be maintained in the off mode, for example, by maintaining a switch in the off mode or by moving an internal switch to the off mode. Accordingly, access to thecontroller120 may be denied and/or thecontroller120 may be maintained in an off position or in a state otherwise unable to perform a medical treatment if authentication is not successful.
• In another embodiment, information may be input from aninput device128 that may be used to determine an appropriatemedical treatment kit110 for treatment of apatient150 is stored on thecontroller120 before use of the treatmentinformation storage device112. Theinput device128 may include, but is not limited to, a keyboard, mouse, human interface device, image or video capture devices, temperature sensors, measuring instruments and the like. The information may be a specific body part medical condition, physical and anatomical measurements of a treatment area, information indicative of the type of treatment (e.g., hard tissue, soft tissue) and/or the type of treatment (e.g., non-ablative, which does not kill tissue, or ablative, which kills tissue, stimulation, healing or any other type of medical treatment that may be performed using thecontroller120 and medical treatment apparatus130). The medical treatment necessary to address the physical and anatomical measurements and/or provide the type of desired treatment may be determined by thecontroller120. After storing this information in thecontroller120, thecontroller120 may identify a type ofkit110 appropriate for the medical treatment.
• In some embodiments, a kit identified may be in accordance with a course of treatment utilizing different kits during the treatment regimen. The different kits may include respective ancillary physical storage medium with instructions for treatment parameters to be applied from the controller to the medical treatment apparatus at the particular stage of treatment or status of the condition. Information regarding that status of the condition, such as wound measurements, healing characteristics, and the like, may be input tocontroller120 frominput device128, for determination of a kit in the treatment regimen or the kits may include progressive predetermined treatment settings for the expected course of treatment. As exemplary non-limiting embodiments, an appropriate kit (as compared to a previous or a subsequent use kit) may include instructions to the controller to increase or decrease intensity of a parameter, change dosage and the like.
• In one embodiment, wound treatment may be identified as desired for thepatient150. In this embodiment, thekit110 may be a wound kit. Because wounds differ in size, type and appropriate treatment, the information stored in thecontroller120 may be indicative of the type ofkit110 that should be provided to treat the wound. The length, width, diameter and/or depth of the wound may be provided to determine theappropriate kit110, as well as treatment parameters forcontroller120 to apply for the treatment.
• The selected wound kit may be opened and the treatmentinformation storage device112 may be removed and scanned. In response to scanning the treatmentinformation storage device112, the treatmentinformation storage device112 may perform authentication to determine if the wound kit is appropriate for the wound. If the wound kit is appropriate, the treatment settings stored in the treatmentinformation storage device112 may be transmitted to thecontroller120. A wound kit may be determined to be appropriate based on treatment settings and/or treatment parameters. For example, treatment parameters may include an appropriate type for thecontroller120, an appropriate type for themedical treatment apparatus130 and an authorized geographical region in which thecontroller120 and/ormedical treatment apparatus130 may be sold and/or used. For example,certain controllers120 located in certain geographical regions may be authorized to operate only with certainmedical treatment kits110. Accordingly, controlling whether thecontroller120 can operate may prevent the usage ofkits110 bought at a first, low price in a first region and used in a second region wherein thekit110 would be sold at a higher price. In some embodiments, a Global Positioning System (GPS) receiver, wireless triangulation controller, Internet domain addresses and like location technologies may be used with the controller to determine a geographical region and associated geographical-based setting.
• In other embodiments, the authentication ensures that thecontroller120 is not used in regions wherein the government of the region has not authorized thecontroller120 to be used. Accordingly, acontroller120 used in an inappropriate region may not be enabled to operate because the treatmentinformation storage device112 may only authenticatecontrollers120 that it recognizes as authorized to be used in a certain region.
• In alternative embodiments, a specific measurement of a desired volume of a body area to be treated with acoustic pressure waves may be input tocontroller120 to set appropriate parameters for such volume as well as determination of anappropriate kit110 for such treatment. A density measurement of the target body tissue or part may also be input tocontroller120 for determination of appropriate treatment parameters andkit110. Further, in other embodiments, the particular body part and/or medical condition may be input tocontroller120 to set appropriate parameters for treatment of the body part and/or condition and to determine theappropriate kit110 for such treatment.
• Authentication may reduce the problem of erroneous selection ofmedical treatment kits110,controllers120 and parameters or any other device in the system. Such authentication may also increase the probability of effective treatment by reducing the probability of selecting primary and supplemental apparatus that reduce the effectiveness of one another.
• Additionally, determining the identity of the devices and ensuring that the proper devices are being used reduces the likelihood of unsafe treatment. For example, the likelihood of unsafe dosages of energy and/or an unsafe number of shocks being applied to apatient150 may be reduced because the treatment settings may be programmed into the treatmentinformation storage device112.
• By way of example, in medical treatments for human or animal wound care, treatment settings fordevices112 may differ based on the area of the wound. Thus, in different embodiments of the invention, the different medical treatment kits may have treatmentinformation storage devices112 with different pre-programmed treatment settings created forkits110 directed to treating wound areas that are small, medium, large, X-large, XX-large or XXX-large.
• In various embodiments, treatmentinformation storage device112 may store information for facilitating security formedical treatment kit110 to ensure thatmedical treatment kit110 has not been tampered with in any regard.
• In some embodiments, treatmentinformation storage device112 may be configured with a mechanism or information that may be used to track inventory ofmedical treatment kits110, perform inventory control functions, reduce theft, facilitate fee provisioning, facilitate insurance coding, facilitate provisioning of payments for medical treatments in advance of receiving the medical treatments, provide security provisioning to enable thecontroller120 to operate or the like, as described above.
• In one embodiment, the treatmentinformation storage device112 may be used to facilitate provisioning of payment for a medical treatment. In this embodiment, based on the information from a treatmentinformation storage device112, thecontroller120 may be programmed with medical treatment settings and perform the treatment. In response to the treatment ending, the treatment settings used may be recorded in a tabular form and then transmitted tofee provisioning controller140, which uses the data to calculate the payment for the treatment. Thefee provisioning controller140 may also use the data to perform insurance coding. The information may also generate data about what was done for the treatment and store the data in thecontroller120 for a period of time (or for a selected number of future treatments). The tabulated data may also be used to determine whether thecontroller120 is malfunctioning and reimburse thepatient150 if it is determined that there is malfunctioning or acts of God preventing proper operation of thecontroller120 orapparatus130. Thefee provisioning controller140 can also be used to store data for tracking the treatment of thepatient150.
• After ending treatment, the log of the treatment may be stored inside thecontroller120. The way that treatment is ended may be determined and evaluated. When treatment is ended by a shut off of thecontroller120, a hard shut off or a soft shut off may occur. As used herein, the term “hard shut off” shall mean, a shut off of thecontroller120 after a power failure, due to afaulty controller120 orapparatus130, after switching the main switch directly to turn off thecontroller120 device or by unplugging thecontroller120 from the power source. As used herein, the term “soft shut off” shall mean shut off of thecontroller120 after a proper shut off by pushing the stand-by button or activating another mechanism for properly stopping the operation of thecontroller120 and/or themedical treatment apparatus130 after a medical treatment has ended.
• When a hard shut off occurs, thepatient150 may be reimbursed for the treatment being performed. In cases wherein the log of the treatment is indicative of thecontroller120 being shut down in a manner so as to avoid detection that a medical treatment has been performed, thecontroller120 may be stopped and not started again until authorization by a third-party having the power to authorize thecontroller120 to be able to be started again. The log of treatment may be indicative of attempts to avoid detection when there have been a selected number of consecutive hard shuts. For example, after three hard shuts, thecontroller120 may be shut down until an authorized third-party starts thecontroller120 again. The pattern of attempting to avoid detection may differ from that disclosed above.
• In one embodiment, treatmentinformation storage device112 includes a barcode that can be used to transfer medical treatment settings. The barcode can also be used to provide the cost of thekit110 for payment of a medical treatment in advance of receiving the medical treatment. In some embodiments, the barcode may also be used to track inventory of thekit110.
• Treatmentinformation storage device112 may be disposable and/or consumable and thereby provided only for a single-use medical treatment or be reusable and thereby provided for more than one treatment for apatient150. Treatmentinformation storage device112 may be able to be re-charged or have information stored thereon updated, increased or decreased in value. The treatment settings or values thereof may be added, increased, decreased or otherwise changed uponmedical treatment system100 or treatmentinformation storage device112 receiving value such as monetary value. Accordingly, treatmentinformation storage device112 may be updated with a value in a manner similar to that for telephone calling cards to which value may be added. Systems and methods for adding value or changing values may be performed by any of the well-known ways of adding value to a mechanism. Alternately, adding or changing values may be performed at the manufacturer of the described system of components or via internet or electronic connection using protected encryption systems.
• Information stored on the treatmentinformation storage device112 may be stored in any manner suitable for facilitating a medical treatment. For example, in various embodiments, the information may be stored as random access memory, read only memory, flash memory or the like.
• Medical treatment kit110 also includes anancillary treatment apparatus114.Ancillary treatment apparatus114 may be disposable and/or consumable.Ancillary treatment apparatus114 may be any device designed to be used during a medical procedure. In various embodiments,ancillary treatment apparatus114 may be a device configured to generate and/or emit one or more acoustic pressure waves, including shock waves, or can be the interface used between themedical treatment apparatus130 and thepatient150. In various embodiments,medical treatment apparatus130 may be an acoustic pressure wave device. The applicator may generate in various embodiments shock waves through electromechanical, electromagnetic, explosive detonation, electrohydraulic, piezoelectric (crystals, thin films or fibers) or any other suitable methods for generating shock waves. The shock waves may be focused or non-focused and may be non-sinusoidal, sharp and high pressure waves having a relatively short distance in time between the crest and trough of the wave. In some embodiments, the shock waves are sinusoidal, ultrasonic focused or non-focused waves or microwaves.
• In one embodiment,ancillary treatment apparatus114 provides enhanced cleanliness for the medical treatment. In this embodiment, theapparatus114 may be sterile and disposable for one-time use. In this regard,ancillary treatment apparatus114 may be a covering mechanism disposed to cover at least a portion of a surface of themedical treatment apparatus130. In this regard, the covering mechanism may be disposed to be positioned betweenmedical treatment apparatus130 andpatient150 during a medical procedure to reduce the likelihood of cross-contamination between different patients that receive treatment from the samemedical treatment apparatus130. In various embodiments,ancillary treatment apparatus114 may, include, but is not limited to, a sleeve, sterility barrier, disposable or re-usable head, membrane, ellipsoidal, spherical or parabolic (or a combination thereof) reflector or disposable reflectors with variable focus, pad solution, pad with integrated antibiotics or other pharmaceuticals, drug delivery devices, gels and the like.
• Ancillary treatment apparatus114 may be disposed to be coupled tomedical treatment apparatus130 such thatancillary treatment apparatus114 pivots, or tilts, at a location at whichancillary treatment apparatus114 is coupled tomedical treatment apparatus130.Ancillary treatment apparatus114 may be disposed to be coupled tomedical treatment apparatus130 such thatancillary treatment apparatus114 moves along a first axis and/or a second axis before, after or while pivoting/tilting. The pivoting/tilting may be three dimensional. The first axis and second axis may be perpendicular to or positioned at any suitable angle to the surface ofpatient150 to which treatment is provided. Accordingly, movement may be vertical towards and away frompatient150 or front to back or side to side relative to a surface of thepatient150. For medical treatments including shock wave application, vertical movement towards and away frompatient150 may provide different depths of shock wave penetration for different vertical heights ofmedical treatment apparatus130 relative topatient150. For medical treatments such as those including cardiac treatments wherein treatment area withinpatient150 is constrained orpatient150 may not tolerate vertical movement toward or away frompatient150 or front to back or side to side treatment, pivoting/tilting movement may be provided to provide proper medical treatment. Fee provisioning may be performed based on the type of treatment provided. For example, a fee may be assessed for the different types of treatments wherein pivoting/tilting may be a greater or a lesser fee than vertical movement toward and away from the patient.
• In some embodiments,ancillary treatment apparatus114 is one of several different applicators that may be used for treatment.
• In some embodiments,ancillary treatment apparatus114 provides enhanced acoustic coupling betweenmedical treatment apparatus130 andpatient150 with minimal attenuation of shock waves that may be emitted frommedical treatment apparatus130. In this regard,ancillary treatment apparatus114 may be a gel pad that may be disposed to be positioned between the surface ofmedical treatment apparatus130 andpatient150 or coupling gel that may be disposed to be applied topatient150. Other kinds of gel pads or coupling gel can be used to attenuate the shocks and reduce the harm or injury of the shock waves in selected areas during, before and/or after the treatment area.
• In some embodiments,ancillary treatment apparatus114 may be any mechanism that aids in reducing cross-contamination between patients using themedical treatment apparatus130.
• Controller120 includesreader122,computer124,display126 anduser input apparatus128. Each of the components may include hardware, software or a combination of hardware and software configured to perform one or more functions associated with providing medical treatment and/or fee provisioning for medical treatment. In various embodiments, thecontroller120 may be operative: to receive medical treatment settings corresponding to a medical treatment to be provided to apatient150; to be powered on; to be authenticated; and/or to process information for fee provisioning. Thecontroller120 may also be configured to tabulate data and/or keep a record of the type of treatment provided including, but not limited to, the number of shock waves provided.
• Additionally, adata reader122, acomputer124 including a microprocessor and a microprocessor-readable storage medium,display126 anduser input apparatus128 may be communicatively coupled to one or more of each other through any of the media described above.
• Reader122 may be any mechanism configured to read information from treatmentinformation storage device112, including, but not limited to, optical character recognition (“OCR”) reader, barcode reader, RFID reader or the like.Reader122 may read the information by any of several well-known methods, including, but not limited to, RFID scanning or optical character recognition.
• In some embodiments,reader122 may be an RFID reader and/or a scanner that may be coupled tocontroller120 and a power supply (not shown). This RFID reader and/or scanner may be able to activate an RFID passive tag and read the information embedded in it.
• Reader122 may read the RFID device when the RFID device is within a selected proximity toreader122. In some embodiments, the selected proximity is a few centimeters in compliance with the ISO 14443 or ISO15693 standard.Reader122 and the RFID tag may be configured to communicate at specific frequencies and for different distance ranges. In one embodiment, the RFID reader may be RFID reader and writer model no. ID CPR.Mo2 manufactured by Feig Electronic and may be used in conjunction with an RS-232 interface.
• Controller120 also includescomputer124 and, in some embodiments, may also includedisplay126 anduser input apparatus128. In some embodiments,controller120 and components therein may include electromechanical components, which are activated by sophisticated software and hardware components.
• Computer124 includes software, hardware or a combination of both software and hardware configured to receive and process information indicative of one or more treatment settings read from treatmentinformation storage device112 byreader122. In one embodiment,computer124 processes the read information and generates control information configured to be received by and control the functionality ofmedical treatment apparatus130. Accordingly,medical treatment apparatus130 may receive the control information and be controlled to operate in accordance with one or more of the treatment settings stored on treatmentinformation storage device112. In some embodiments,controller120 downloads the treatment settings from treatmentinformation storage device112.
• In some embodiments,computer124 may also be configured to provide one or more functions associated with fee provisioning. In this regard,computer124 may perform a method for determining a fee associated with one or more medical treatments or an entire medical procedure that includes the one or more medical treatments. Referring toFIG. 19, the method may bemethod1100 or another suitable method for fee provisioning for medical treatments.
• Referring again toFIG. 1, in various embodiments,computer124 may be configured to enable thecontroller120 to receive medical treatment settings corresponding to a medical treatment to be provided to apatient150, be powered on, be authenticated, and/or process information for later-generating invoices for payments for the medical treatment provided.
• User input apparatus128 includes software, hardware or a combination of both software and hardware configured to receive inputs initiated by a user and translate the received inputs to signals disposed to be interpreted by one or more ofcomputer124,display126 orreader122. In one embodiment, the received inputs are translated into signals configured to causereader122 to read and/or scan the information of treatmentinformation storage device112. In one embodiment, the received inputs are translated into signals configured to cause a mechanism to write to a memory of treatmentinformation storage device112. The mechanism may thereby update one or more of the treatment settings. In one example, after thepatient150 has received a medical treatment, the mechanism may write to the memory of the treatmentinformation storage device112 to decrease the number of remaining treatments by one. In another example, after thepatient150 provides a form of payment to medical personnel, the mechanism may write to the memory of treatmentinformation storage device112 to replenish the number of shocks that thepatient150 may receive using treatmentinformation storage device112. To prevent re-usage, in another embodiment the treatmentinformation storage device112 may be destroyed after the information contained on it is transferred to thecontroller120.
• Display126 includes software, hardware or a combination of both software and hardware configured to receive and format for visual display, image information indicative of one or more treatment settings read byreader122. The visual display may be graphical, pictoral, text or otherwise. In one embodiment, thedisplay126 may be able to display the information at different angles. In one embodiment,display126 may be a graphical user interface (“GUI”). The GUI may be a touchscreen GUI or a GUI configured to receive signals from inputs received atuser input apparatus128.
• In one embodiment,display126 displays instructions readable by medical personnel for guiding the medical personnel through a procedure. In another embodiment, instructions may be provided for performing one or more of initializingcontroller120 orapparatus130; loading treatment settings and loading information indicative of the type ofmedical treatment kit110; or starting a new treatment.Display126 may output the treatment area, frequency, energy, penetration depth, applicator type, selected dose, date and/or time of treatment. Thedisplay126 may also display an image of the treatment area.
• Medical treatment apparatus130 includes software, hardware or a combination of both software and hardware configured to provide a medical treatment. Theapparatus130 may also include security authentication components driven by the hardware and software included in either the treatmentinformation storage device112 or thecontroller120.
• In some embodiments,medical treatment apparatus130 may be a device configured to generate and emit one or more shock waves by any number of methods including, but not limited to, electrohydraulic, piezoelectric (e.g., crystal, thin films or fibers), electromagnetic methods and/or explosion methods that can generate planar, radial, focused or non-focused waves. In one embodiment,apparatus130 is a spark gap generator configured to generate shock waves. In various embodiments,medical treatment apparatus130 is any mechanism configured to provide medical treatment. The medical treatment may be shock wave therapy. In some embodiments,medical treatment apparatus130 is a mechanism configured to provide shock wave treatment to the body.
• In various embodiments,medical treatment apparatus130 may be a device configured to provide an x-ray of thepatient150 or ultrasound scanning or computed tomography of the patient or any other medical treatment or scanning procedure that may be provided to a patient by an automated device.Medical treatment apparatus130 may be designed to be used in conjunction withancillary treatment apparatus114. In one embodiment,ancillary treatment apparatus114 may be mechanically, electrically, magnetically or merely physically coupled tomedical treatment apparatus130. In some embodiments, a first end ofmedical treatment apparatus130 proximate to thepatient150 may be disposed to be covered in whole or in part byancillary treatment apparatus114 thereby reducing the risk of cross-contamination between patients usingmedical treatment apparatus130.
• In various embodiments,controller120,medical treatment apparatus130 and/orancillary treatment apparatus114 may be configured with various treatment settings and/or operate according to specific treatment settings.
• With reference toFIG. 1, in some embodiments,medical treatment apparatus130 may include a shock wave housing including or configured to operate with a changeableancillary treatment apparatus114 for applying shock waves. In another example,medical treatment apparatus130 may be mountable to thesupport structure152 on whichpatient150 may be disposed while receiving treatment. Themedical treatment apparatus130 may include a number of different electrodes for different treatments.
• Themedical treatment apparatus130 may operate in response to thecontroller120 receiving treatment settings regarding voltage, energy, frequency, number and/or angle of shock waves to be applied to thepatient150. In one embodiment, a voltage of 10-20 kV may be used to generate the shock waves applied to thepatient150 at a frequency of 1-20 Hz. Shock wave application may be started and/or re-started as necessary until treatment is completed. A voltage of 5-30 kV may be used to generate the shock waves applied topatient150 at a frequency of 1-8 Hz and shock wave application may be started and/or re-started as necessary until treatment is completed.Ancillary treatment apparatus114 may be a sterility barrier or one of several different applicators that may be used with themedical treatment apparatus130.
• Medical treatment apparatus130 may dictate the Input/Output (“I/O”) information foruser input apparatus128 anddisplay126. In one embodiment, the user input apparatus may include an on/off mechanism, a mechanism for receiving treatment settings regarding energy, frequency of shock waves, a preselected dose of shock waves, the number of shocks per area, a position parameter for automatic positioning of theapparatus130 and/or an editing tool such as an electronic pencil disposed to cooperate with adisplay126 configured as a touchscreen for manually editing an image of a treatment area. A wound size may be defined with the editing tool. The editing tool may be used to identify the coordinates of a wound and such coordinates may be sent as electronic signals tomedical treatment apparatus130, which may automatically calculate the treatment area. In some embodiments, existing x-ray or ultrasound pictures may be imported intocontroller120 and may be shown ondisplay126. Accordingly, medical personnel may be able to view an internal area ofpatient150 to aid in positioningmedical treatment apparatus130.
• In another example, a computer, such as a laptop and the like, (not shown) can be coupled to themedical treatment apparatus130, to control the way the information is received from thecontroller120.Medical treatment apparatus130 may dictate the input and output information that may be displayed on the laptop or on any other suitable device configured to communicate with the laptop. For example, in one embodiment,medical treatment apparatus130 is a device that can be connected to a laptop and used by a patient or an in-home caregiver.User input apparatus128 may include an on/off mechanism for turning the laptop on and off, respectively.
• Thefee provisioning controller140 may be any mechanism configured to process received information indicative of a medical treatment and generate a value for the medical treatment. In various embodiments, thefee provisioning controller140 may be a database configured with medical treatment settings and values. Thefee provisioning controller140 may correlate the received information with the medical treatment settings and the values may be the cost of the medical treatment based on the medical treatment settings. Accordingly, the received information may be indicative of the information stored on the treatmentinformation storage device114. For example, in one embodiment, a monetary fee indicative of a cost that thepatient150 is billed or must pay at the time of the treatment is determined. The determination may be made based on the number and frequency of shock waves and the energy level of themedical treatment apparatus130 provided during the medical treatment. In this embodiment of themedical treatment system100, the monetary fee is the payment for the medical treatment. The payment is to be collected from thepatient150 at a time after the purchase of themedical treatment kit110 and after the conclusion of the medical treatment.
• Fee provisioning controller140 may be communicatively coupled to one or more of thecontroller120,medical treatment apparatus130 or treatmentinformation storage device112. In some embodiments, thefee provisioning controller140 may be located at a geographical location that is remote from themedical treatment system100. For example, as shown, thefee provisioning controller140 may be located at any address within acommunication network129.
• In another embodiment of a medical treatment system (not shown), a treatment information storage device may be used without association with any medical treatment kit. Treatment information storage device may be used in a fashion similar to a telephone calling card and may be programmed to have selected values for treatment settings.
• For example, a treatment information storage device may have a limited number of shock waves programmed thereon, based on the money value paid when the treatment information storage device was purchased. In some embodiments, these treatment information storage devices may be offered to the patient pre-loaded with a certain number of shock waves (e.g., 2500, 5000, 10000) at different costs. In some embodiments, the higher the number of shock waves loaded on the device, the higher the cost of the treatment information storage device. The number of shock waves consumed during a treatment can be deducted from an initial number of shock waves purchased on the device, and treatment may be repeated until all of the shock waves have been used. In some embodiments, after all of the shock waves have been applied and no shock waves remain, the treatment information storage device can be updated and uploaded. This credit card approach can be used for different medical treatments. Accordingly, a treatment information storage device may be independent of a medical treatment kit and therefore not associated with a certain medical treatment kit or medical treatment for a certain kind of illness. In this way, this approach allows flexibility for the patient to choose treatment setting values based on medical treatment needs (which may include more than one medical treatment need) and keep costs low instead of paying in advance for a large number of shocks, which might not be financially feasible for some patients.
• Additionally, combinations of one or more of the aforementioned embodiments can be created and other treatment information storage devices might be used to create modalities to financially charge, program treatment settings, provide security and/or keep a record of treatments.
• In some embodiments, a medical treatment kit (not shown) may be provided for the administration of pharmaceuticals and/or drugs to humans or animals. By way of example, pharmaceuticals may be those for the treatment of human or animal wounds, hard and soft tissue diseases, cardiac, orthopedic or neurological diseases and/or for provisioning of vaccines, anesthetic agents, antibiotics, contraceptives, anti-parasitic drugs or the like. In various embodiments, substances that can be pushed inside the human body, tissues or cells using a medical treatment apparatus such as a shock wave device.
• In some embodiments, the medical treatment kit may include a treatment information storage device, such as that having electronic product code technology, and an ancillary treatment apparatus such as a dispenser disposed to contain pharmaceuticals. For example, the medical treatment kit may include a syringe having a label or tag formatted with electronic product code technology. The label may have information stored therein identifying the pharmaceutical, a proper medical treatment for which the pharmaceutical may be used and proper dosage information for the medical treatment. By scanning this information and transferring it to a controller, the patient can receive the right treatment. In another embodiment the information from the syringe and/or medical container can contain programming data for the treatment setting that can be transferred to the controller before the treatment.
• In response to a reader of a controller reading the information stored in the label, the controller may determine whether the pharmaceutical is appropriate for the patient and/or for the medical treatment. In some embodiments, the controller may cross-reference information (e.g., age, allergies, etc.) in a medical history or profile of the patient to whom the pharmaceutical is to be provided to determine whether the pharmaceutical is compatible with the patient or with the treatment that the patient is scheduled to receive.
• The medical history and/or profile may be previously-stored in an information repository accessible by the controller at the location of the controller or accessible over a network at a location remote to the controller. Alternately, the medical history and/or profile may be input into a system accessible by the controller or read by a provider (e.g., doctor or nurse) of the pharmaceutical at the time of the medical treatment. For example, the medical history and/or profile may be stored on a CD, floppy disk, on paper in a patients file or otherwise. The electronic device can be customized for each patient, by having part of its memory allocated to do the customization when a series of treatment starts for the respective patient. The rest of the memory is used for treatment settings, number of shocks consumed or available, etc.
• Accordingly, the kit may be used to reduce the incidents of providing erroneous pharmaceuticals or dosages of such to patients. Such may be especially useful with pharmaceuticals that vary significantly in strength but for which the packaging of the different strengths is not significantly different and therefore may not be noticed by the provider of the pharmaceutical.
• For example, if the profile indicates that the patient is an infant, and the information that is read from the label indicates that the pharmaceutical is for an adult or is otherwise too strong for the infant receiving the medical treatment, the controller may perform steps to provide an alert such that the pharmaceutical is not provided to the infant.
• FIGS. 2,3,4,5,6 and7 depict controllers and treatment information storage devices of the medical treatment system ofFIG. 1 according to embodiments of the invention.
• With reference toFIG. 2,controller120 includes hardware positioned to readdevice112 upon insertion intoreader122. In one embodiment,device112 is inserted intoreader122 and remains during treatment.
• With reference toFIG. 3,controller120 is configured to receive treatmentinformation storage device112, which may be any type of dongle, including, but not limited to, a memory stick. The dongle may be connected to a USB or RS232 port (not shown).
• The dongle may couple to thecontroller120 and may be used to authenticate and enable thecontroller120 to operate when the dongle is coupled to thecontroller120. Accordingly, the dongle may be used as a security device.
• In one embodiment, information is stored as read only memory on a treatmentinformation storage device112 that is reusable for multiple medical treatment sessions. In this regard, a patient may provide treatmentinformation storage device112 to a medical provider at each treatment session. The information stored on treatmentinformation storage device112 may be accessed to determine and provide the aspects of the medical treatment session stored thereon. In one embodiment, each session may be associated with one or more different aspects of treatment as the patient goes through a series of treatments to complete the entire medical procedure. The information stored on the treatmentinformation storage device112 may be indicative of the aspects of each of the numerous sessions included in the entire medical procedure and may thus dictate the type of treatment to be provided at each session.
• In another embodiment, thedevice112 may be able to communicate with thecontroller120 and can retrieve information on the treatment and any other notes introduced by the physician during treatment. In this way thedevice112 may become personalized and can be used by patient to track how many treatments are left, what was done in the previous treatments, how much the costs were for the previous treatments, etc. Thesedevices112 may be given to the patients and scanned with thecontroller120 before each treatment to access the history of the previous treatments and how many treatments are left, etc. After the whole treatment is finished, if thedevice112 is reusable, the patient may return thedevice112 to a location associated with a manufacturer of thedevice112 and have thedevice112 reprogrammed for a new series of treatments.
• With reference toFIG. 4,controller120 is configured with anRFID scanning reader122 on a surface ofcontroller120 for scanning treatmentinformation storage device112. Treatmentinformation storage device112 may be an RFID tag in proximity of thescanning reader122.
• With reference toFIG. 5,controller120 may also havereader122 including antenna configured to activate a treatmentinformation storage device112. Treatmentinformation storage device112 may be an RFID device incorporated in alabel170 of a kit (not shown). In one embodiment, the treatmentinformation storage device112 may employ chipless RFID technology.Controller120 may scan the activatedRFID device112.
• With reference toFIG. 6,controller120 may include amagnetic card reader122 configured to read a magnetic stripe of a treatmentinformation storage device112, similar to a credit card reader and swiping device that can be seen in retail shops.
• With reference toFIG. 7,controller120 may include abarcode reader122 configured to read a barcode of a treatmentinformation storage device112. Treatmentinformation storage device112 may be a barcode such as may be provided on alabel170 of a kit (not shown).
• FIG. 8 is a block diagram of a medical treatment system according to an embodiment of the invention. The block diagram depicts a medicaltreatment kit subsystem210, acontroller subsystem220, a medicaltreatment apparatus subsystem230 and afee provisioning subsystem240. Medicaltreatment kit subsystem210 includes amemory212 and a kit I/O device214. In some embodiments,kit subsystem210 also includes aprocessor216.Memory212 may be any type of memory configured to maintain information regarding medical treatment and provide security via authentication of thecontroller subsystem220 and/or the medicaltreatment apparatus subsystem230. For example,memory212 may contain information indicative of one or more treatment settings of a medical treatment. Kit I/O device214 may be communicatively coupled tomemory212 and disposed to transmit fromkit subsystem210 the information indicative of the one or more treatment settings of a medical treatment. Kit I/O device214 may also be configured to receive information such as updated information indicative of new treatment settings resultant from a completed medical treatment. In one embodiment, kit I/O device214 may receive information indicating that a treatment has been administered and transmit the information toprocessor216. Theprocessor216 may decrement by one a treatment setting indicative of the number of treatments allowed to a patient using thekit subsystem210. The updated treatment setting may then be written onmemory212 for subsequent accessing and use during a next medical treatment.
• Controller subsystem220 includes amemory222, a controller I/O device224, a processor226,emission mechanism229,timer225,generator227, and, in some embodiments,controller display device228.Memory222 may be any type of memory configured to store downloaded information regarding one or more treatment settings. In one embodiment, controller I/O device224 receives information indicative of one or more treatment settings fromkit subsystem210, processes the received information to generate a control signal for controllingtreatment subsystem230. The controller I/O device224 may transmit the control information totreatment subsystem230.Controller display device228 may provide a visual display of graphics and/or text indicative of the one or more treatment settings, patient identity information, ancillary treatment apparatus selection, patient insurance information, treatment apparatus activation or the like. Additionally, in some embodiments,controller display device228 may provide a visual display of current treatment. For example,display device228 may provide an indicator of the amount of treatment remaining before, during or after a medical treatment. In another embodiment,device228 may provide a display of one or more interior body regions being studied whentreatment subsystem230 includes an x-ray device that is utilized to x-ray a region of a patient.
• In one embodiment,controller subsystem220 processes information received in processor226 and transmits the information received togenerator227 andtimer225.Generator227 andtimer225 provide control information for generating a selected number of shock waves by utilizing a selected amount of energy as determined by the one or more treatment settings transmitted fromkit subsystem210.Generator227 may include hardware or components for providing, via thetreatment subsystem230, one or more shock waves by electromechanical, electromagnetic, electrohydraulic, explosive detonation, or piezoelectric methods, which are well-known to those skilled in the art.Timer225 provides timing for emitting the one or more generated shock waves at a selected frequency as dictated by the one or more treatment settings. The one or more shock waves are emitted in a manner controlled by theemission mechanism229.
• Treatment subsystem230 includes amemory232, a treatment I/O device234 and aprocessor236. In one embodiment,memory232 may be any type of memory configured to store downloaded information regarding one or more treatment settings. In some embodiments,memory232 is any type of memory configured to store control information indicative of the one or more treatment settings or control signals for controlling the operation of thetreatment subsystem230.Treatment subsystem230 may receive control information fromcontroller subsystem220 and output shock waves or provide other medical treatment according to the control information resultant from processing in processor226,emission mechanism229,timer225 orgenerator227.
• Fee provisioning subsystem240 includes afee provisioning memory242, a fee provisioning I/O device244, afee provisioning processor246 and feeprovisioning display device248. In one embodiment,memory242 may be any type of memory configured to store information regarding one or more treatment settings, one or more ancillary treatment apparatus used during a medical treatment administered bytreatment subsystem230, and/or one or more medical treatments currently or previously performed. In one embodiment, I/O device244 receives information indicative of one or more treatment settings, one or more ancillary treatment apparatus used during a medical treatment administered bytreatment subsystem230, and/or one or more medical treatments performed.Processor246 processes the received information and determines a monetary fee indicative of the one or more treatment settings, one or more ancillary treatment apparatus used during a medical treatment administered bytreatment subsystem230, and/or one or more medical treatments performed.
• FIGS. 9,10 and11 depict medical treatment kits according to embodiments of the invention.FIGS. 12 and 13 also show views of medical treatment kits of the medical treatment system according to embodiments of the invention.FIG. 14 is a perspective view of a dispenser carton having a plurality of the medical treatments kits.FIGS. 9-13 illustrate various embodiments of kits with reference to ancillary treatment apparatus and treatment information storage devices, each of which may be designed as any of the embodiments described with reference toFIG. 1.
• With reference toFIG. 9, kit110 houses in one embodiment anancillary treatment apparatus114, such as a syringe or other dosage applicator, and treatmentinformation storage device112. With reference toFIG. 10,kit110 houses anancillary treatment apparatus114 embodied as a sleeve that may be provided on a medical treatment apparatus (not shown), and also houses a treatmentinformation storage device112 that is an RFID card. Thekit110 also includes alabel330 identifying the manufacturer of the kit in some embodiments. In this embodiment, treatmentinformation storage device112 is a barcode label. In various embodiments, treatmentinformation storage device112 may be an RFID tag, label, chip or payment/credit card. Referring toFIG. 11,kit110 includes an ancillary treatment apparatus (not shown) located on an interior ofkit110 and treatmentinformation storage device112 positioned on a label disposed to be viewed from the exterior ofkit110. In another embodiment, the label is positioned on the interior surface ofkit110 andkit110 has a transparent housing providing viewing of the label from the outside ofkit110. Referring toFIG. 12,kit110 houses twoancillary treatment apparatuses114A and114B. In the embodiment shown,kit110 includes asleeve114B andcoupling gel114A. Referring toFIG. 13,kit110 houses fourancillary treatment apparatuses114A-114B. In the embodiment shown,kit110 includes asleeve114B, two coupling gels,114A and114C and anapplicator114D. In other embodiments, the contents can be any parts used in charging for, providing or otherwise related to a medical treatment. In the embodiment shown, theapplicator114D is a disposable applicator. Inkits110, treatment information storage device (not shown) may be provided on the exterior surface of the respective kit or housed inside of the kit. In other embodiments, a treatment information storage device may be coupled to one of the ancillary treatment apparatuses or provided within the kit.
• FIG. 14 is an illustration of a dispenser carton having a plurality of the medical treatments kits such as shown in one or more ofFIGS. 9-13.
• FIG. 15 is a diagram of treatment information of a medical treatment system according to embodiments of the invention. The treatment information may include treatment parameters and/or treatment settings. The treatment parameters may include any information indicative of an aspect of a medical procedure, including, but not limited to, the aspects of the treatment style applied to the patient and the equipment used to apply the medical procedure. The treatment settings may include, but are not limited to, electronic settings for configuring thecontroller120 and/or themedical treatment apparatus130 to operate to perform the medical treatment.
• In one exemplary embodiment, the treatment parameters may include information indicative of: the number of treatments to provide to apatient710, the length of time for each of thetreatments712, the total length of time for all treatments combined714, a number of shock waves to apply to a patient in a treatment716, a number of shock waves to apply to a patient over all treatments combined718, atreatment area724, a depth of penetration of shock waves into apatient726, an ancillary treatment apparatus type728 and/or an approvedregion734 for the controller or medical treatment apparatus. The treatment settings may include a frequency at which to apply the shock waves to thepatient720, an energy setting and acontroller type732. In various embodiments, a medicaltreatment apparatus type730 may be either a treatment parameter or a treatment setting.
• With further reference toFIGS. 1 and 15, in some embodiments, the approved region setting734 may be indicative of a region for whichcontroller120,medical treatment apparatus130 and/or the medical treatment is approved. In this regard, only acontroller120,medical treatment apparatus130 or medical treatment that has been approved in a particular region may be performed using themedical treatment kit110. Accordingly, ifcontroller120 and/ormedical treatment apparatus130 is approved for use in the United States but not in Europe,medical treatment kit110 may prevent the use ofcontroller120 and/ormedical treatment apparatus130 ifmedical treatment kit110 is being presented outside of the United States. Additionally, one or more treatment settings may be designated to comply with requirements for a selected region. Accordingly,medical treatment kit110 may allow thecontroller120 to operate to provide medical treatment only in authorized regions of the world.
• With reference toFIGS. 1 and 15, in one embodiment, treatment parameters are stored on thecontroller120 and treatment settings are stored on the treatmentinformation storage device112. Accordingly, the treatmentinformation storage device112 may transfer the treatment settings to thecontroller120 upon the treatmentinformation storage device112 being read. In some embodiments, the treatment settings may include thecontroller type732 and/or the medicaltreatment apparatus type730, and the treatmentinformation storage device112 may check the type of thecontroller120 and/or themedical treatment apparatus130 against thecontroller type732 and/or medicaltreatment apparatus type730 information. If thecontroller120 and/ormedical treatment apparatus130 is determined to be the same type as the value ofcontroller type732 and/or the value of themedical treatment apparatus130, the treatmentinformation storage device112 may allow thecontroller120 to operate and/or control themedical treatment apparatus130.
• In another embodiment, one or more of the treatment parameters and one or more of the treatment settings are stored on thecontroller120 in addition to the one or more treatment settings that may be stored on the treatmentinformation storage device112.
• In one embodiment, the treatment information shown inFIG. 15 may be used as follows. A surface of a wound may be measured and the measurement information received by thecontroller120. Thecontroller120 may receive the information in response to manual entry of the information by a medical personnel or by automatic entry of the information when themedical treatment system100 includes apparatus for scanning and viewing portions of a the body of thepatient150. Based on the measurement information received by thecontroller120, thecontroller120 may identify an appropriatemedical treatment kit110 to be used for the medical treatment. The treatmentinformation storage device112 that is read by thecontroller120 may be checked to determine if the treatment settings stored on the treatmentinformation storage device112 correspond to the type ofmedical treatment kit110 that thecontroller120 determines to be appropriate. The treatment settings may be indicative of the type of medical treatment and/or the wound size for which themedical treatment kit110 is to be used. If themedical treatment kit110 is appropriate, thecontroller120 may receive the treatment settings and may be configured according to the treatment settings. When the treatment is completed, thecontroller120 may add to a memory (not shown) in thecontroller120, the measurement information. In one embodiment, the memory may be a table such as that shown inFIG. 15. Similar parameters by which thecontroller120 operated may also be saved in the table. Accordingly, in some embodiments, treatment parameters applied during a medical treatment may be stored after the treatment is completed.
• The aforementioned treatment parameters and treatment settings, along with their corresponding values, are merely exemplary and may include any other treatment parameters, treatment settings and values relevant for the treatment of any human or animal soft or hard tissue, including, but not limited to, an organ such as a liver, kidney, brain, heart, skin or any other organ, bone, teeth, gums, cartilage, muscle, tendons, ligaments, joints and their capsules, internal organs, glands, skin, blood vessels, lymphatic vessels, open and closed wounds, nerves or otherwise. Additionally, the tissue may be a part of the vascular, nervous, reproductive, urinary, lymph node, pituitary, skeletal or ocular systems. Additionally, the treatment parameters and/or treatment settings may describe aspects of treatment for any suitable medical procedure including, but not limited to, those medical procedures directed to human or animal treatment related to wound care, laminitis, osteoarthritis, plantar fasciitis, lateral epicondylitis, ulcers, pressure sores, cardiac, orthopedic or neurological treatment or bone grafting.
• FIGS. 16-18 are flowcharts illustrating methods of providing medical treatment using a medical treatment system according to embodiments of the invention.
• Referring toFIG. 16, instep810 ofmethod800, a controller configured to control an apparatus that is designed to perform a medical treatment performs initialization and is authenticated. Thecontroller120 may be authenticated with information such as a password that may be stored in a treatment information storage device.
• Instep811, whether the controller is successfully authenticated is determined. If the controller is successfully authenticated,step812 is performed. If the controller is not successfully authenticated,step813 is performed.
• Instep813, the controller is prevented from operating. In one embodiment, the controller may be prevented from operating by maintaining or changing a switch inside of the controller to an off mode.
• Instep812, the controller is enabled to operate and/or one or more treatment settings are received. Step812 may include one or more of storing previous treatment data, setting treatment area information, resetting and/or calculating a number of shock wave pulses and calculating treatment time and/or total treatment time.Steps810,811,812,813 may be a part of a security process providing secure access to the controller.
• Instep814, a determination is made as to whether each of the treatment settings has been received. In some cases, each of the treatment settings has not been received and additional information may need to be received.
• If it is determined that all of the treatment settings have not been received, the process goes to step812. If each of the treatment settings is determined to have been received, the process goes to step816. Instep816, information regarding the kit type is received. Step816 may include one or more of reading or writing a treatment information storage device from a kit to determine the kit type.
• Instep818, a determination is made as to whether the kit is acceptable. The kit type may be indicative of a size of a wound kit in some embodiments. If the wound kit corresponds to the patient wound size, and/or corresponds to a region in which the treatment is approved by the government for the region, information regarding the kit type is deemed acceptable. Otherwise, information regarding the kit type is deemed not acceptable.
• If information regarding the kit type is not acceptable, the process goes back tostep816. If information regarding the kit type is acceptable, the process goes to step820.
• Instep820, medical treatment preparation is performed. Step820 includes processing configuration information for configuring the medical treatment apparatus with the one or more of the treatment settings received. Step820 may also include performing a security process to identify and/or ensure that the treatment information storage device is authentic and to ensure that any ancillary medical treatment device and/or any medical treatment apparatus are compatible and/or appropriate for the treatment.
• Instep822, medical treatment is provided to a patient. Step822 may include providing a treatment consisting of a number of shock wave pulses or for a time period as designated by the treatment settings.
• Instep824, a determination is made as to whether the medical treatment has been completed. In some embodiments, the medical treatment is determined to have been completed if the number of shock waves designated to be provided to the patient for the medical treatment has been provided or if the total time designated for the medical treatment has elapsed.
• If the medical treatment is determined to have been completed, instep826, the data indicative of the treatment provided is stored in a memory of the controller and the medical treatment ceases. The process then continues withstep828. If the medical treatment is determined to not have been completed, the medical treatment continues in accordance withstep822.
• Instep828, a determination is made as to whether a new treatment is to be provided. If a determination is made that a new treatment is not to be provided, the process continues to step830. Instep830, the apparatus for controlling the medical treatment or the apparatus for performing the medical treatment performs shut-down operations. Shut-down operations may include writing treatment data and performing a soft shut-off of the apparatus. Shut down operations may also include tabulating treatment data including, but not limited to, energy settings, number and frequency of shocks provided and the type of medical treatment apparatus and/or ancillary treatment apparatus used.
• If a determination is made that a new treatment is to be provided, the process continues to step812 and treatment settings are again received.Method800 follows the subsequent steps as described with regard to and illustrated above inFIG. 16.
• Referring toFIG. 17, amethod900 may be performed as illustrated. Themethod900 is incorporated by reference herein in its entirety.
• Referring toFIG. 18, in some embodiments, themethod1000 may be performed as follows. Instep1010, a treatment information storage device is read by a reader. In various embodiments, the reader may be an optical reader, an RFID reader, label and/or chip reader, a barcode reader, a magnetic stripe reader or any mechanism configured to access and read information stored on the treatment information storage device. For example, the treatment information storage device may be accessed upon being inserted into a recess of the reader and the information stored on the treatment storage device may subsequently read.
• Instep1012, the controller and/or the medical treatment apparatus used to perform the medical procedure may be authenticated.
• In one embodiment,step1012 includes determining the type of prospective medical treatment apparatus and/or controller to be used in the procedure, determining the required medical treatment apparatus and/or controller as stored on the treatment storage device. If the type of prospective medical treatment apparatus and/or controller is the same as the required medical treatment apparatus and/or controller, the medical treatment apparatus and/or controller is authenticated.
• A similar process may be provided by comparing the ancillary treatment apparatus presented as the presumptive kit component to the required ancillary treatment apparatus to determine if the presumptive ancillary treatment apparatus is proper. If the comparison indicates that the required medical equipment is the same as the presumptive medical equipment, the presumptive medical equipment is authenticated and may be used during the procedure. Accordingly, the process provides a solution to address the problem of using generic substitute devices and/or incompatible devices for treatment.
• Instep1014, it is determined whether the medical equipment was successfully authenticated. If not, the process goes back tostep1012. If so, instep1016, one or more treatment settings that were stored on the treatment information storage device are stored in the memory of the controller configured to control the treatment. With reference to1 and8, instep1016, the treatment settings may be stored on thecontroller120,controller subsystem220,medical treatment apparatus130 ormedical treatment subsystem230.
• Referring back toFIG. 18, the one or more treatment settings may include information such as the treatments to provide to the patient, the length of time for each of the treatments, the total length of time for all treatments combined, a number of shock waves to apply to the patient in a treatment or over all treatments combined, a frequency at which to apply the shock waves to the patient, and/or an energy setting of the medical treatment apparatus.
• Instep1018, control information for controlling the medical treatment apparatus is received at the medical treatment apparatus. The control information may be generated by the controller as a result of the information read from the treatment storage device. The control information may be generated after the controller is authenticated. The generated information may be transmitted to and received by the medical treatment apparatus.
• Instep1020, the medical treatment procedure is performed in accordance with the one or more of the treatment settings. In one embodiment, the medical procedure is performed by utilizing the medical treatment apparatus to provide a selected number of shock waves to the patient at a selected frequency for a selected length of time, at a selected energy setting. In another embodiment, parameters indicative of the medical procedure may be so low as to prevent any medical procedure from being performed. Such may be the case if the treatment storage device has been used to obtain previous treatments and the device now needs to have additional value added to the treatment information storage device. For example, the number of shock waves to be applied may be zero and, accordingly, no medical treatment procedure will be performed.
• Instep1022, a determination is made as to whether the medical treatment is complete. In one embodiment, a number of shocks or a time for the medical procedure may be identified at the beginning of the medical procedure. The number of remaining shock waves to be applied or the remaining time duration for the medical treatment may be decreased after one or more shock waves have been applied or a portion of time has elapsed. With reference to1 and8, themedical treatment apparatus130,medical treatment subsystem230,controller120 orcontroller subsystem220 may keep a record of outstanding shock waves or time duration and determine that the treatment is complete when no more shock waves or time remains for the treatment.
• If the medical treatment is not complete, the medical treatment continues to be performed as the process goes to step1020. If the medical treatment is complete, instep1024, the one or more treatment settings are updated based on the treatment provided instep1020 and/or based on value added to the treatment information storage device. In one embodiment, a total time for a series of medical treatments may be decremented by a length of time of one or more previous or current medical treatments that has been performed. In some embodiments, the treatment storage device may be re-charged or updated with additional treatment time, number of shocks, etc. by adding additional value to the treatment storage device. Additional value may be added by any number of ways, including, but not limited to, causing a repository to associate a high dollar value with the treatment storage device in connection with money or insurance benefits provided in association with the treatment information storage device.
• In one embodiment ofmethod1000, as shown instep1026, a fee for the medical treatment may optionally be determined. The fee may be determined in accordance with themethod1100 described inFIG. 19.
• The process ofmethod1000 may be repeated any number of times as long as the treatment settings indicate that at least one treatment remains and is allowed. In some embodiments, the process may be repeated to provide the medical procedure only after a certain time interval has elapsed since a previous medical treatment. In this regard, the likelihood of overtreating a patient may be reduced.
• FIG. 19 is a flowchart illustrating a method of fee provisioning according to an embodiment of the present invention. Instep1110, one or more treatment settings are identified.
• Instep1112, the one or more identified treatment settings are assigned a value. The value may be a fee associated with each treatment setting or a fee associated with a number of treatment settings.
• Instep1114, a type of ancillary treatment apparatus to be used in providing the medical treatment designated by the treatment settings is determined for a treatment apparatus. Instep1116, the type of ancillary treatment apparatus is assigned a value. The value may be any information indicative of or that can be correlated to a monetary fee.Method1100 may optionally include astep1118 for incorporating one or more discounts in a total value. The discount may be a negotiated insurance rate or a discount offered by the medical facility or medical personnel. The discount may be a coupon or other value currently or previously provided by the patient. As noted above, the discount may be incorporated atstep1118.
• Instep1120, a fee corresponding to the medical treatment is determined. In the embodiments wherein the values assigned insteps1112 and1114 are monetary values, the fee may be determined by adding the monetary values and subtracting from a total monetary value any discounts incorporated instep1118.Method1100 may optionally continue by displaying the determined fee instep1122. With reference toFIG. 1, in some embodiments,display126 may be configured to display an image indicative of the fee determined instep1120.
• In various embodiments, methods for calculating fees for medical treatments based on ancillary treatment apparatus and/or treatment settings for a medical procedure may be done based on a certain value for each device and/or based solely on the type of medical treatment. It is important to know if the kit is sold directly to the hospital or through a distributor, because the dollar amount may be different. The kit cost may also differ based on the region (for example discount prices for markets that have in general lower income per capita—eastern part of a continent or country compared with western part of a continent or country).
• Accordingly, in some embodiments a fee may be provided that is a function of the values of the one or more treatment settings and/or the ancillary treatment apparatus. In this regard, for example, a medical treatment providing 2500 shock waves may determine that a greater fee for the medical treatment is required than the fee for a medical treatment providing 500 shock waves. Further, a medical treatment using a reusable ancillary treatment apparatus may determine a lower fee for the medical treatment than a medical treatment using a disposable ancillary treatment apparatus. Methods for calculating fees may be as provided herein or by any of the well-known methods for determining fees for medical treatments known to those in the art.
• Some embodiments of the invention include a computer program product. The computer program product may include a computer-readable medium having computer-readable program code stored thereon. The computer-readable program code of the computer-readable medium may be accessed by a processor and cause the processor to execute one or more of the methods described herein. Any processor capable of reading computer-readable program code and executing the instructions thereof may be used.
• In one embodiment, the computer-readable program code may be accessed by the processor and cause the processor to execute one or more of the methods described herein. In various embodiments, the computer program product may be executed by a processor to perform the steps ofmethods800,900,1000 or1100 or substeps thereof.
• The foregoing description of embodiments of the invention has been presented for purposes of illustration. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teaching or may be acquired from practice of the invention. The embodiments were chosen and described in order to explain the principles of embodiments of the invention and its practical application. Additionally, in the embodiments shown, one or more subsystems of systems may be combined into a single subsystem or may be segmented physically or operationally into additional subsystems. The systems and subsystems may be located at a location that is proximate to or geographically remote from any other subsystem.
• Further, the operations of one or more methods steps may be performed in a single step or performed in numerous additional steps beyond that shown and discussed. Additionally, it should be noted that although the flowcharts provided herein show specific orders of method steps, it is understood that the orders of steps may differ from what is depicted. Also, the steps could be performed concurrently or with partial concurrence. All such variations are within the scope of the invention.
• Finally, values described in the embodiments of the invention are merely exemplary and, as known by those of ordinary skill in the art, may be modified as desired while still remaining within the spirit and scope of embodiments of the invention.

Claims (23)

1. A medical treatment system comprising:

an electronic controller including a microprocessor and a microprocessor-readable data storage medium having microprocessor-executable instructions for applying specific medical treatment control parameters to a medical treatment apparatus operatively coupled to the electronic controller;

a data reader operatively coupled to the microprocessor of the controller;

an ancillary treatment apparatus configured for use with the electronic medical treatment apparatus under the specific medical treatment control parameters;

a physical ancillary data storage medium coupled to or packaged with the ancillary treatment apparatus, wherein the physical ancillary data storage medium includes at least some of the instructions for applying the specific medical treatment control parameters and said at least some of the instructions for applying the specific medical treatment control parameters are received by the data reader and readable by the microprocessor of the electronic controller; and

a display operatively coupled to the microprocessor of the controller, wherein a microprocessor-readable data storage medium of the controller includes microprocessor-executable instructions to provide a visual confirmation on the display that the electronic medical treatment apparatus is activated for use with the ancillary treatment apparatus.

2. The medical treatment system ofclaim 1, wherein the electronic medical treatment apparatus is an acoustic pressure wave device.

3. The medical treatment system ofclaim 2, wherein the ancillary treatment apparatus couples to the acoustic pressure wave device.

4. The medical treatment system ofclaim 3, wherein the ancillary treatment apparatus is selected from the group consisting of a sleeve, a pad, sterility barrier and an applicator head.

5. The medical treatment system ofclaim 2, wherein the ancillary treatment apparatus is selected from the group consisting of a reflector for the acoustic pressure wave device and a lens for the acoustic pressure wave device.

6. The medical treatment system ofclaim 1, further comprising a physical data input device operatively coupled to the controller, and wherein the controller includes a microprocessor-readable data storage medium including microprocessor-readable instructions for visually confirming on the display that information for a treatment area of a body received from the physical data input device is compatible with treatment by the electronic medical treatment apparatus according to the instructions contained on the physical ancillary data storage medium.

7. The medical treatment system ofclaim 6, wherein the electronic medical treatment apparatus is an acoustic pressure wave device and the information for a treatment area of a body includes measurements selected from the group consisting of a dimension of a wound and a volume of body area.

8. The medical treatment system ofclaim 2, further comprising a physical data input device operatively coupled to the controller, and wherein the controller includes a microprocessor-readable data storage medium including microprocessor-readable instructions for visually confirming on a display that a body part identification received from the physical data input device is compatible with treatment by the electronic medical treatment apparatus according to the instructions contained on the physical ancillary data storage medium.

9. The medical treatment system ofclaim 2, further comprising a physical data input device operatively coupled to the controller, and wherein the controller includes a microprocessor-readable data storage medium including microprocessor-readable instructions for visually confirming on the display that a medical condition identification received from the physical data input device is compatible with treatment by the electronic medical treatment apparatus according to the instructions contained on the physical ancillary data storage medium.

10. The medical treatment system ofclaim 2, further comprising a physical data input device operatively coupled to the controller, and wherein the controller includes a microprocessor-readable data storage medium having microprocessor-executable instructions for displaying that the ancillary treatment apparatus should be selected from among a plurality of available ancillary treatment apparatuses based on medical treatment data received from the physical input device.

11. The medical treatment system ofclaim 10, wherein the medical treatment data includes measurements selected from the group consisting of a dimension of a wound and a volume of body area.

12. The medical treatment system ofclaim 10, wherein the medical treatment data includes a body part identification.

13. The medical treatment system ofclaim 10, wherein the medical treatment data includes a medical condition identification.

14. The medical treatment system ofclaim 1, further comprising a physical data input device operatively coupled to the controller, and wherein the controller includes a microprocessor-readable data storage medium having microprocessor-executable instructions for displaying that the ancillary treatment apparatus should be selected from among a plurality of available ancillary treatment apparatuses based on medical treatment data received from the physical input device.

15. The medical treatment system ofclaim 14, wherein the medical treatment data includes dimensions of a body area.

16. The medical treatment system ofclaim 14, wherein the medical treatment data includes a body part identification.

17. The medical treatment system ofclaim 14, wherein the medical treatment data includes a medical condition identification.

18. The medical system ofclaim 1, wherein the physical ancillary data storage medium includes a radio frequency identification readable medium and the data reader is a radio frequency identification reader.

19. The medical system ofclaim 2, wherein the physical ancillary data storage medium includes a radio frequency identification readable medium and the data reader is a radio frequency identification reader.

20. The medical system ofclaim 19, wherein a microprocessor-readable data storage medium of the controller includes microprocessor-executable instructions to generate the microprocessor-executable instructions for applying specific medical treatment control parameters to a medical treatment apparatus operatively coupled to the electronic controller from receipt of the at least some of the instructions for applying the specific medical treatment control parameters contained on the physical ancillary data storage medium.

21. The medical system ofclaim 1, wherein a microprocessor-readable data storage medium of the controller includes microprocessor-executable instructions to generate the microprocessor-executable instructions for applying specific medical treatment control parameters to a medical treatment apparatus operatively coupled to the electronic controller from receipt of the at least some of the instructions for applying the specific medical treatment control parameters contained on the physical ancillary data storage medium.

22. The medical system ofclaim 2, wherein a microprocessor-readable data storage medium of the controller includes microprocessor-executable instructions to generate the microprocessor-executable instructions for applying specific medical treatment control parameters to a medical treatment apparatus operatively coupled to the electronic controller from receipt of the at least some of the instructions for applying the specific medical treatment control parameters contained on the physical ancillary data storage medium.

23. The medical system ofclaim 2, wherein the at least some of the instructions for applying the specific medical treatment control parameters contained on the physical ancillary data storage medium include one or more parameters selected from the group consisting of number of treatments, length of time of each treatment, total length of treatment time, number of shock to apply in each treatment, total number of shocks, frequency, energy setting, treatment area, treatment penetration depth, ancillary treatment apparatus identification, medical treatment apparatus identification, controller identification and geographic region identification.

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